DAVID ERIC BERNSTEIN, M.D. June 2019 Bernstein … · Green JA, Goldman JH, Bernstein DE, Barkin JS. Corneal abrasion complicating ERCP. Gastrointestinal Endoscopy 1994; 40: 261

1

DAVID ERIC BERNSTEIN, M.D. June 2019

PERSONAL

Date of Birth: April 17, 1962

Place of Birth: New York, New York

Marital Status: Married to Helen Kim, MD

EDUCATION

Undergraduate

1980-1984 The Johns Hopkins University, Baltimore, MD

B.A. June 1984

Medical

1984-1988 State University of New York at Stony Brook, Stony Brook, NY

M.D. May 1988

Postgraduate Training

1988-1991 Internal Medicine Internship/Residency

Montefiore Medical Center, Bronx, NY

1991-1993 Gastroenterology Fellowship

University of Miami Affiliated Hospitals, Miami, FL

7/1-12/31/93 Hepatology Fellowship

University of Miami Affiliated Hospitals, Miami, FL

ACADEMIC APPOINTMENTS

1/94 - 6/94 Clinical Instructor

University of Miami School of Medicine

Center for Liver Diseases

7/94 -7/96 Assistant Professor

University of Miami School of Medicine

Center for Liver Diseases

2

7/96 – 7/99 Assistant Professor of Medicine

SUNY-StonyBrook School of Medicine

1/1/02-1/1/03 Associate Professor of Medicine

SUNY-Downstate

1/03 – 6/30/09 Associate Professor of Medicine

New York University School of Medicine

7/1/09 – Professor of Clinical Medicine

Albert Einstein College of Medicine

7/1/10- Professor of Medicine

Hofstra Northwell School of Medicine

4/26/16 - Professor of Science Education

Hofstra Northwell School of Medicine

FELLOWSHIP ACTIVITIES

1/05 – 7/09 Program Director, North Shore University Hospital Fellowship in

Gastroenterology

-Successfully passed 2 RRC reviews without a single query

1994- 1996 Co-director, Fellowship in Hepatology. University of Miami School

of Medicine

NON-ACADEMIC

1/1/16- present

Vice Chair of Internal Medicine for Clinical Trials, Northwell Health

School of Medicine

1/1/12- present

Chief, Division of Hepatology, Northwell Health

Director, Sandra Atlas Bass Center for Liver Diseases, Northwell

Health

1/2005–12/31/2011

3

Chief, Division of Gastroenterology, Hepatology and Nutrition

North Shore University Hospital / Long Island Jewish Medical

Center

Major Accomplishments:

1. Successfully integrated Gastroenterology Divisions of

North Shore University Hospital and Long Island

Jewish Medical Center

2. Recruited 10 new faculty to Division from around the

country

3. Managed the successful implementation of an

electronic endoscopic medical record

4. Managed successful implementation of outpatient

electronic medical record

5. Developed and implemented focused professional

practice evaluation for the division

6. Successfully implemented system for meaningful use

in outpatient setting

7. Forged collaboration amongst the 130 members of the

division

8. Developed and implemented quality assessment and

performance improvement program for the division

9. Developed and implemented divisional policies for

physician and NP/PA credentialing and re-

credentialing

10. Led the Division to listing in the US News and World

Reports Top 50 GI Divisions in the Nation in 2011 and

2012

11. Initiated Products Committee to control inventory

8/04- 1/05 Chief, Gastroenterology

North Shore University Hospital

8/99 – 1/05 Director of Hepatology

Division of Gastroenterology, Hepatology and Nutrition


9/98- 7/99 Chief, Clinical Gastroenterology

Winthrop University Hospital

Mineola, NY 11501

7/96 – 7/99 Director, Center for Liver, Biliary and Pancreatic Diseases


4

BOARD CERTIFICATION

7/89 Diplomate, National Board of Medical Examiners

Certificate # 364117

9/91 Diplomate, American Board of Internal Medicine


Recertification valid through 12/2021

11/93 Diplomate in Gastroenterology, American Board of Internal

Medicine


Recertification valid through 11/2023

LICENSURE

1989 State of New York # 178915-1

1991 DEA Registration # BB2917790

EXPERIENCE

1983 Externship, Central Middlesex Hospital, London

1981 Fellowship, Rusk Institute of Rehabilitation Medicine

New York, New York

PUBLICATIONS

Articles in Refereed Journals

1. Bernstein DE, Olton DS. Radial maze performance in young and aged mice:

neurochemical correlates. Pharm Biochemistry and Behavior 1985; 22: 301-307.

2. Bernstein DE, Barkin JS. World Literature Review: Prophylactic sclerotherapy for

esophageal varices in men with alcoholic liver disease. Gastrointestinal Endoscopy

1992; 31:406.

3. Bernstein DE, Barkin JS. Pepto-bismol mimicking pancreatic calcification. American

Journal of Gastroenterology 1992; 87: 1677-1679.

4. Bernstein DE, Barkin JS. A new method of pneumatic dilation of the sigmoid

esophagus in achalasia. Gastrointestinal Endoscopy 1993; 39: 549-550.

5

5. Bernstein DE, Barkin JS. Enteroscopy. Practical Gastroenterology 1993; 17: 12B-12M.

6. Bernstein DE, Barkin JS, Reiner DK, Lubin J, Phillips RS, Grauer L. Standard

biopsy forceps vs large capacity forceps with and without needle. Gastrointestinal

Endoscopy 1995; 41: 573-576.

7. Bernstein DE, Dickerson G, Kim KJ, Barkin JS. Parasites in biliary tract and pancreatic

disease. Military Medicine 1994; 159: 331-338.

8. Green JA, Goldman JH, Bernstein DE, Barkin JS. Corneal abrasion complicating ERCP.

Gastrointestinal Endoscopy 1994; 40: 261.

9. Bernstein DE, Goldberg RI, Unger S. Common bile duct obstruction following T-tube

placement at laparoscopic cholecystectomy. Gastrointestinal Endoscopy 1994; 40: 362-365.

10. Bernstein DE, Schiff ER. Complications of cirrhosis. Current Opinion in

Gastroenterology 1994; 10 (3) : 289 - 294.

11. Vargas C, Bernstein DE, Reddy KR, Munnangi S, Behar S, Scott C, Parker T, Schiff

ER, Jeffers L. Diagnostic laparoscopy: A 5 year experience in a hepatology training

program. American Journal of Gastroenterology 1995; 90: 1258-1262.

12. Bernstein DE, Rogers AI. Crohn's disease and malignancy: A comprehensive review.

American Journal of Gastroenterology 1996; 91: 434-440.

13. Bernstein DE, Jeffers LJ, Reddy KR, Schiff ER. Canities and vitiligo complicating

interferon therapy. American Journal of Gastroenterology 1995; 90: 1176-1177.

14. Bernstein DE. Common helminthic infections. Federal Practitioner 1996; 13:13-28.

15. Poniachik J, Bernstein DE, Reddy KR, Jeffers LJ, Coehlo-Little ME, Civantos F, Schiff

ER. The role of diagnostic laparoscopy in the diagnosis of cirrhosis. Gastrointestinal

Endoscopy 1996; 43: 568-571.

16. Coehlo-Little ME, Jeffers LJ, Bernstein DE, Goodman JJ, Reddy KR, deMedina M, Li

X, Hill M, LaRue S, Schiff ER. Hepatitis C in alcoholic patients with and without

apparent liver disease. Alcoholism: Clinical and Experimental Research 1996; 19: 1173-

1177.

17. Ribiero A, Reddy KR, Bernstein D, Jeffers LJ, Schiff ER. Caroli’s Disease in Twins.

American Journal of Gastroenterology 1996; 91: 1024-1026.

6

18. Ribeiro A, Reddy, KR, Bernstein DE, Roth D, Jeffers LJ, Schiff ER, Laparoscopic

evaluation of liver disease in chronic renal failure prior to renal transplantation.

Gastrointestinal Endoscopy 1997; 45: 503-507.

19. Bernstein DE, Jeffers LJ, Yrizzary J, Reddy KR, Russell E, Schiff ER. Transjugular

portosystemic shunt in the treatment of intermittently bleeding stomal varices. American

Journal of Gastroenterology 1996; 91: 2237-2238.

20. Bernstein DE. Hepatitis C Diagnostic Assays. Infectious Disease Practice 1997; 7:52-

54

21. Bernstein DE, Jeffers LJ, Erhardsten E, Reddy KR, Glazer S. Squiban P, Bech R,

Hedner U, Schiff ER. rFVIIa Corrects Prothrombin Time in Cirrhotic Patients: A

Preliminary Study. Gastroenterology 1997; 113: 1930-1937.

22. Reddy KR, Levi J, Livingstone A, Jeffers L, Molina E, Kligerman S, Bernstein D,

Kodali VP, Schiff ER. Experience with Staging Laparoscopy in Pancreatic Malignancy.

Gastrointestinal Endoscopy 1999;49:498-503.

23. Ungo H, Jones D, Ashkin D, Hollender ES, Bernstein DE, Albanese A, Pitchenik AE.

Anti-tuberculosis drug-induced hepatotoxicity: the role of hepatitis C virus and the

human immunodeficiency virus. American Journal of Respiratory and Critical Care

Medicine 1998; 157:1871-1876.

24. Idrovo V, Dailey PJ, Jeffers LJ, Coehlo-Little E, Bernstein D, Bartholomew M,

Alvarez L, Urdea MS, Collins ML, Schiff ER. Hepatitis C virus RNA quantification in

right and left lobes of the liver in patients with chronic hepatitis C. J. Viral Hepat 1996

3:239-246.

24. Rizzo J, Bernstein DE, Gress F. A randomized double blind placebo controlled trial

evaluating the cost effectiveness of droperidol as a sedative pre-medication for

endoscopic ultrasound. Gastrointestinal Endoscopy 1999 Aug;50(2):178-82.

25. Rizzo J, Bernstein DE, Gress F. A performance, safety and cost comparison of

reusable and disposable endoscopic biopsy forceps: a prospective, randomized trial.

Gastrointestinal Endoscopy 2000; 51:257-261

26. Bernstein DE, Hepatitis C: controlling a silent epidemic. Internal Medicine 1998;19:26-

34.

27. Bernstein DE. Effectiveness of recombinant factor VIIa in patients with the coagulopathy

of advanced child’s B and C cirrhosis. Seminars in Thrombosis and Hemostasis 2000; 26:

437-439.

7

28. Bernstein D, Kleinman L, Barker C, Revicki D, Green J. Relationship of health related

quality of life to treatment adherence and sustained response in chronic hepatitis C patients.

Hepatology 2002; 35: 704-708.

29. Hadziyannis SJ, Sette H, Morgan T, Balan V, Diago M, Marcellin P, Bodenheimer H,

Bernstein D, Rizzetto M, Lin A, Ackrill A and the Pegasys International Study Group. Peg-

interferon alfa 2a plus ribavirin in chronic hepatitis C: randomized study of the effect of

treatment duration and ribavirin dose. Ann Int Med 2004;140:346-355.

30. Begum N, Serhat, Reich D, Bernstein D, Shapiro L. Impaired IRS-1/PI3-kinase signaling

in the liver of patients with HCV: a mechanism for increased prevalence of type 2 diabetes.

Hepatology 2003; 38:1384-1392.

31. Sullivan SD, Jensen DM, Bernstein DE, Hassanein TI, Foster GR, Lee SS, Cheinquer

H, Craxi A, Cooksley G, Klaskala W, Pettit K, Patel KK, Green J. Cost-effectiveness of

combination peginterferon alpha-2a and ribavirin compared with interferon alpha-2b and

ribavirin in patients with chronic hepatitis C. Am J Gastro 2004; 99: 1490-96.

32. Herrine SK, Brown RS, Bernstein DE, Ondovik MS, Lentz E, Te H. Peginterferon alfa 2a

combination therapies in chronic hepatitis C patients who relapsed or had viral breakthrough

on therapy with standard interferon alfa 2b plus ribavirin: A pilot study of efficacy and safety.

Digestive Disease and Science 2005;50:719-726.

33. Berg C, Goncales F, Bernstein DE, Sette H, Rasenack J, Diago M, Jensen DM, Cooksley

G, Roberts P, Ackrill AM. Re-treatment of Chronic Hepatitis C Patients After Relapse:

Efficacy of Peginterferon alfa-2a (40KD) and Ribavirin. J Viral Hepat. 2006 Jul;13(7):435-

40.

34. Khalili M, Bernstein D, Lentz E et al Pegylated interferon alpha-2a with or without

ribavirin in HCV/HIV coinfection: partially blinded, randomized multicenter trial.

Dig Dis Sci. 2005 Jun;50(6):1148-55.

35. Wynter CI, Ryan DH, May L, Oliver FW, Brown E, Hoffman EJ, Bernstein D.

Paramagnetic Europium Salen Complex and Sickle Cell Anemia. In: Gracia M, Marco JF,

Plazaola F eds, Industrial applications of the Mossbauer Effect. American Institute of

Physics 2005; 300-304.

36. Reddy KR, Govindarajan S, Hadziyannis SJ, Marcellin P, Bernstein D, Bodenheimer

H, Rakela J, Messinger D, Schmidt G, Ackrill A. Hepatic steatosis in chronic hepatitis C:

Baseline host and viral characteristics, influence on and response to therapy with

peginterferon alfa 2a and ribavirin. Journal of Viral Hepatitis 2008; 15:129-136.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itool=pubmed_Abstract&term=%22Sullivan+SD%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itool=pubmed_Abstract&term=%22Jensen+DM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itool=pubmed_Abstract&term=%22Bernstein+DE%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itool=pubmed_Abstract&term=%22Hassanein+TI%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itool=pubmed_Abstract&term=%22Foster+GR%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itool=pubmed_Abstract&term=%22Lee+SS%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itool=pubmed_Abstract&term=%22Cheinquer+H%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itool=pubmed_Abstract&term=%22Cheinquer+H%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itool=pubmed_Abstract&term=%22Craxi+A%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itool=pubmed_Abstract&term=%22Cooksley+G%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itool=pubmed_Abstract&term=%22Klaskala+W%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itool=pubmed_Abstract&term=%22Pettit+K%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itool=pubmed_Abstract&term=%22Patel+KK%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itool=pubmed_Abstract&term=%22Green+J%22%5BAuthor%5D

8

37. Jacobson I, Brown RS, Freidlich B, Afdhal N, Kwo P, Santoro J, Becker S, Wakil A,

Pound D, Godofsky E, Strauss R, Bernstein D, Flamm S, Pauly MP, Griffel LH, Brass C.

Peginterferon alfa 2b and weight based or flat dose ribavirin in chronic hepatitis C

patients: a randomized trial. Hepatology 2007; 46:971-981.

38. Feldstein RC, DeVito B, Epstein M, Bernstein D. Pinworm infection. Hospital

Physician 2008, 28.

39. Feldstein RC, Bahamonde LG, Pena ME, Bernstein DE. Sump Syndrome: a case of

endoscopic biliary rendez vous procedure. Practical Gastroenterology 2010; 34:42-44

40. Meyer DF, Tobias H, Min AD, Rajendra A, Zic I, Bretholz E, Clain DJ, Klion F,

Bernstein D, Bodenheimer HC. Retreatment of patients nonresponsive to pegylated

interferon and ribavirin with high dose consensus interferon. Hepatology Research and

Treatment 2010; 201-537827

41. Satapathy SK, Kim YJ, Kataria A, Shifteh A, Bhansali R, Cerulli M, Bernstein D.

Higher prevalence and more severe coronary artery disease in hepatitis C virus infected

patients: A case control study. Journal of Clinical and Experimental Hepatology 2013;:1-

6

42. Kowdley KV, Lawitz E, Crespo I, Hassanein T, David M, DeMIcco M, Bernstein D,

Afdhal N, Vierling JM, Gordon SC, Andeson JK, Hyland RH, Dvory-Sobol H, An D, Hindes

RG, Albanis E, Symonds WT, Berrey MM, Nelson DR, Jacobson IM. Sofosbuvir with

pegylated inteferon alfa 2a and ribavirin for treatment naive patients with hepatitis C genotype

1 infection: an open label, randomised multicenter phase 2 trial. Lancet 2013; 15: 2100-2107

43. Lawitz E, Lalezari JP, Hassasein T, Kowdley KV, Poordad FF, Sheikh AM, Afdhal NH,

Bernstein DE, Dejesus E, Freilich B, Nelson DR, Dieterich DT, Jacobson IM, Jensen D,

Abrams GA, Darling JM, Rodriguez-Torres M, Reddy KR, Sulkowski MS, Bzowej NH,

Hyland RH, Mo H, Lin M, Mader M, Hindes R, Albanis E, Symonds WT, Berrey MM, Muir

A. Sofosbuvir in combination with peginterferon alfa 2a and ribavirin for non-cirrhotic,

treatment naive patients with genotypes 1,2 and 3 hepatitis C infection: a randomised, double

blind , phase 2 trial. Lancet Infectious Disease 2013; 13:401-408.

44. Akerman S, Rahman M, Bernstein DE. Direct cholanioscopy: the North Shore experience.

Eur J Gastroenterology Hepatology 2012;24:1406-09

45. Patel Cc, Monga D, Alexander M, Magoon S, Bernstein D, Wagner J, Mattana J.

Spontaneous Clearance of Hepatitis B Surface Antigenemia After Long Term Hemodialysis.

Seminars in Dialysis 2013; 1-3

46. Ferenci P, Bernstein DE, Lalezari J, Cohen D, Luo Y, Cooper C, Tam E, Tsao N, Nyberg

A, Box T, Younes Z, Green S, Baruch Y, Bhardari B, Catuntu F, Sepe T, Chulanov V,

9

Janczewska E, Rizzardini G, Gervath J, Pianas R, Moreno C, Hassanein T, Xie W, King M,

Podsadecki T, Reddy KR. ABT-450/r-Ombitasvir and dasabuvir with or without ribavirin for

HCV. NEJM 2014; 370; 1983-1992

47. Kowdley K, Gordon S, Reddy K, Rossaro L, Bernstein D, Lawitz E, Shiffman M, Schiff

E, Ghalib R, Ryan M, Rustgi V, Chojkier M, Herring R, Di Bisceglie A, Pockros P,

Subramanian M, Svarovskaia E, Hyland R, Pang P, Symonds W, McHutchison J, Muir A,

Pound D, Fried M. Ledipasvir and Sofosbuvir for 8 or 12 Weeks for Chronic HCV without

Cirrhosis. NEJM 2014; 370:1879-1888

48. Nelson D, Cooper J, Lelazari J, Lawitz E, Pockros P, Gitlin N, Freilich B, Younes Z,

Harlan W, Ghalib R, Oguchi G, Thuluvath P, Ortiz-Lasanta G, Rabinovitz M, Bernstein

D, Bennett M, Hawkins T, Ravendhran N, Sheikh A, Varunok P, Kowdley K, Hennicken

D, McPhee F, Rana K, Hughes E. All oral 12 week treatment with daclatasvir plus

sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY3 phase study.

Hepatology 2015 61; 4: 1127-1135

49. Jensen D, Sherman K, Hezode C, Pol S, Zeuzem S, de Ledinghen V, Tran A,

Elkhashab M, Younes Z, Kugelmas M, Mauss S, Everson G, Luketic V, Vierling J,

Serfaty L, Brunetto M, Heo J, Bernstein D, McPhee F, Hennicken D, Mendez P Hughes

E Noviello S. Daclatasvir and asunaprevir plus peginterferon alfa and ribavirin in HCV

genotype 1 and 4 non-responders. J Hepatology 2015; 63: 30-37

50. Feld JJ, Moreno C, Trinh R, Tam E, Bourgeois S, Horsmans Y, Elkhashav M,

Bernstein DE, Younes Z, Reindollar RW, Larsen L, Fu B, Howieson K, Polepally A,

Pangeri A, Shulman NS, Poordad. Sustained virologic response of 100% in HCV

genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for

12 weeks. J Hepatology 2016. 64:301-307

51. Hirten R, Sultan K, Thomas A, Bernstein D. Hepatic manifestations of non-steroidal

inflammatory bowel disease therapy. World Journal Hepatology 2015; 7:2716-28

52. Hassanein T, Vierling J, Reddy KR, Cohen E, Morelli G, Mantry P, Pockros P, Wyles

D, Bernstein D, Bennett M, Kemmer N, Zamor P, Kumar S, Wang D, Cohen D,

Podsadecki T, Lawitz E. Treatment of HCV genotype 1 Infection in patients with severe

or end stage renal disease including patients with cirrhosis. Clin Gastr Hepatology (In

press)

53. Bernstein DE, Tran A, Martin P, Kowdley K, Bourliere M, Sulkowksi MS, Pockros

P, Renifo B, Wang D, Shuster D, Cohen DE, Jacobsion IM. Safety and efficacy of

ombitasvir/Paritaprevir/r and Dasabuvir with and without ribavirin in patients with

moderate renal impairment. (in preparation)

10

55. Pockros P, Reddy KR, Mantry PS, Cohen E, Bennett M, Sulkowski M, Bernstein D,

Cohen D, Shulman NS, Wang D, Khatri A, Abunimeh M, Podsadecki T, Lawitz E.

Efficacy of direct acting anti-viral combination for patients with hepatitis C virus

genotype 1 infection and severe renal impairment or end stage renal disease. Gastro

2016;2016:1590-98

56. Kwo P, Gitlin N, Nahass R, Bernstein D, Etzkorn K, Schiff E, David M, Ruane P,

Younes Z, Kalmeijer R, Sinha R, Peeters M, Lenz O, Fevery B, DeLa Rosa G, Scott J,

Witek J. Simeprevir plus Sofosbuvir (12 and 8 weeks) in hepatitis C virus genotype

infected patients without cirrhosis: Optimist-1, a phase randomized study. Hepatology

2016; 64:370-80

57. Gane E, Kowdley K, Pound D, Stedman CAM, Davis M, Etzkorn K, Gordon S, Bernstein

D, Everson G, Rodriguez-Torres M, Tsai N, Khalid O, Yang Y, Lu S, Dvory-Sobol H, Stamm

L, Brainard DM, McHutchison JG, Tong M, Chung R, Beavers K, Poulos JE, Kwo P, Nguyen

M. Efficacy of sofosbuvir, velpatasvir and GS 9857 in patients with HCV genotype 2, 3 ,4 or

6 infections in an open-label phase 2 trial. Gastroenterology 2016; 151: 902-909

58. Poordad F, Lalezari J, Asatryan A, Felizarta F, Sulkowski M, Reindollar R, Landis C,

Gordon S, Flamm S, Fried M, Bernstein DE, Lin CW, Liu R, Lovell S, Ng T, Kort J, Mensa

F. Glecaprevir and pibrentasvir for 12 weeks in patients with chronic HCV genotype 1

infection and prior direct-acting antiviral therapy. Hepatology 2017; 66:389-397

59. Bernstein DE. Roadblocks to accessing direct acting antiviral agents for treatment of

hepatitis C virus infection. Gastroenterol Hepatology 2015; 11: 331-3

60. Duddempudi AT, Bernstein DE. Hepatitis B and C. Gastroenterol Hepatol 2015;11:331-

3

61. Jones D, Boudes P, Swain M, Bowles C, Galambos M, Bacon B, Doerffel Y, Gitlin N,

Gordon S, Odin J, Sheridan D, Worns MA, Clark V, Corless L, Hartmann H, Jonas M, Kremer

A, Mells G, Buggisch P, Freilich B, Levy C, Vierling J, Bernstein DE, Hartleb M, Janczewska

E, Rochling F, Shah H, Shiffman M, Smith J, Choi YJ, Steinberg A, Varga M, Chera H,

Martin R, McWherter C, Hirschfield G. Seladelpar (MBX-8025) , a selective PPAR-δ

agonist, in patients with primary biliary cholangitis with an inadequate response to

ursodeoxycholic acid: a double-blind, randomized, placebo-controlled, phase 2, proof of

concept study. Lancet Gastroenterology and Hepatology, 2017; 2:716-26

62. Poordad F, Bernstein DE. Glecaprevir/pibrentasvir in patients with genotype 1 or 4 and

prior direct acting anti-viral treatment failure. Hepatology 2017; 66:389-397

63. Kwo P, Shiffman M, Bernstein DE. The Cochrane Review Conclusion for Hepatitis C

DAA Therapies is Wrong. Am J Gastro 2018; 113:2-4

11

64. Feld J, Bernstein DE. Ribavirin dose management in HCV patients receiving

ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin. Liver International 2018;

38: 1571-75

65. Rex D, Bhandari R, Desta T, DeMicco M, Schaeffer C, Etzkorn K, Barish C, Pruitt R,

Cash B, Quirk D, Tiongco F, Sullivan S, Bernstein D.A phase 3 study evaluating the

efficacy and safety of remimazolam compared with placebo and midazolam in patients

undergoing colonoscopy. Gastrointestinal Endoscopy 2018; 88:427-37.

66. Agbim U, Jiang Y, Kedia SK, Singal A, Ahmed A, Bhamidimarri KR, Bernstein D,

Harrison SA, Younossi ZM, Satapathy SK. Impact of non-malignant portal vein

thrombosis in transplant recipients with non-alcoholic steatohepatitis. Liver

Transplantation 2018; 25: 68-78

67. Poordad F, Pol S, Asatryan A, Buti M, Shaw D, Hezode C, Felizarta F, Reindollar R,

Gordon SC, Planko S, Fried M, Bernstein DE, Gallant J, Lin CW, Lei Y, Ng TL,

Krishnan P, Kopecky-Bromberg S, Kort J, Mensa FJ. Glecaprevir/pibrentsavir in patients

with hepatitis C genotype 1 or 4 and past direct acting antiviral treatment failure.

Hepatology 2018:67: 1253-60

68. Bernstein DE, Tran A, Martin P, Kowdley K, Bourliere M, Sulkowski MS, Pockros

P, Renjifo B, Wang D, Shuster DL, Cohen D, Jacobson I. Ombitasvir, paritaprevir,

ritonavir, and dasabuvir with and without ribavirin in patients with kidney disease.

Kidney International 2018. Accepted for publication

69. Younossi ZM, Bernstein D, Shiffman ML, Kwo P, Kim WR, Kowdley KV, Jacobson

IM. Diagnosis and management of primary biliary cholangitis. AJG 2019;114:48-63

70. Bernstein D, Tripathi R, Cohen D. Ombitasvir, paritaprevir and ritonavir with peg-

interferon alpha 2a plus ribavirin in treatment experienced patients with chronic hepatitis

C virus genotype 1 infection. Hepatic Medicine:Evidence and research. 2019;11:35-40

71. Poordad F, Sedghi S, Pockros P, Ravendhren N, Reindollar R, Lucey M, Epstein M,

Bank L, Bernstein D, Trinh R, Krishnan P, Polepally A, Unnebrink K, Martinez M,

Nelson D. Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir with low

dose ribavirin in patients with chronic hepatitis C virus genotype 1a infection without

cirrhosis. J Viral Hepatitis 2019; 26:1027-30

Book Editor

Bernstein DE. Clinics in Liver Disease: A Practical Approach to the Spectrum of Alcoholic

Liver Disease. Elsevier, Philadelphia, November 2012; Volume 16:4

12

Bernstein DE. Clinics in Liver Disease: Non-alcoholic fatty liver. Elsevier, Philadelphia,

2018. Volume 22. Number 1

Chapters

1. Bernstein DE, Manten HD. Treatment of colonic strictures. In : Barkin JS, O'Phelan CA,

eds. Advanced Therapeutic Endoscopy, Second Edition. Raven Press, New York, 1994: 231-

242.

2. Bernstein DE, Barkin JS. Enteroscopy. In: Barkin JS, O'Phelan CA, eds. Advanced

Therapeutic Endoscopy, Second Edition. Raven Press, New York, 1994: 191-196.

3. Bernstein D, Schiff ER. Hepatitis C. In: Feldman M, Maddrey WC eds. Gastroenterology

and Hepatology: The Comprehensive Visual Reference, Volume 1 The Liver. Current

Medicine 1996. 5.1 - 5.19

4. Bernstein DE, Phillips RS. Portal Gastropathy. Gastrointestinal Endoscopy Clinics of

North America. October 1996; 6: 697-708.

5. Bernstein DE, Tripodi J. Fulminant Hepatic Failure. Critical Care Clinics of North America

March 1998; 14:181-197.

6. Bernstein DE, Tripodi J, Spadafora P. Fulminant Hepatic Failure. In:Cunha BA, ed.

Infectious Diseases in Critical Care Medicine. Marcel Dekker, New York, 1998: 645-654.

7. Bernstein, DE. Liver Biopsy. In: VanDam J, Wong R. Handbook of Gastrointestinal

Endoscopy. Landes Bioscience, Texas. 2004

8. Bernstein D, Schiff ER. Hepatitis C. In: Feldman M, Maddrey WC eds. Gastroenterology

and Hepatology: The Comprehensive Visual Reference, Second Edition, Volume 1 The Liver.

Current Medicine 2000.

9. Satapathy SK, Bernstein DE. Dermatologic Disorders and the Liver. In: Clinics of Liver

Disease, February 2011 15:165-182

10. Sultan K, Shapira J, Bernstein D. Gastroenterology and Hepatology Evaluation. In:

Molmenti et al. Kidney and Pancreas Transplantation 2015. 47-51

11. Duddempudi A, Bernstein D. Hepatitis B and C. In: Clinics in Geriatric Medicine,

February 2014. 30: 149-167

12. Hirten R, Bodenheimer H, Bernstein D. Diabetes and Liver Disease. In: Poretsky.

Principles of Diabetes Mellitus 2017; 705-729

13

13. Lim H, Bernstein DE, Risk Factors for the Development of NAFLD/NASH, including

genetics. In, Clinics in Liver Disease 2018, Vol 22, p. 39-57

Other Publications

1. Bernstein DE, Barkin JS. Enteroscopy. In: Twelfth Annual Post Graduate Course:

Advanced Therapeutic Endoscopy March 19-21, 1993 Syllabus. Miami Beach, Florida

2. Bernstein DE. Section Editor of American College of Gastroenterology Audio Tape Series

on Liver Disease. Volume 8.4 March/April 1997

3. Bernstein D. Response to Letter to the Editor. Gastroenterology 1998; 115:800.

4. Bernstein David. Treatment of HCV with Pegasys. Clinical Implications: Hepatitis in the

New Millennium. An interactive compendium of presentations, interviews and abstracts.

American College of Gastroenterology 2001.

5. Reply to letter to the editor. Bernstein D. Hepatology 2002; 36:768.

6. Bernstein D. Medscape Online 2002. Update on Hepatitis C. Placed online September 2002

7. Bernstein D. Cost-effectiveness of treatment for chronic hepatitis C infection. Letter to the

editor. JAMA 2003;290:1993.

8. Bernstein D. Hepatitis C in a correctional facility. Letter to the editor, Ann Int Med January

20, 2004

9. Bernstein D. Management of the toxicities and Side effects of Peginterferon and ribavirin.

In: Critical Issues in the Management and Treatment of hepatitis C. HIV and Hepatitis.com

December 2003

10. Bernstein DE, George K. American Pharmacists Association New Product Bulletin on

Pegasys and Copegus. October 2003.

11. Bernstein D. Health Related Quality of Life and Hepatitis C. The HCV Advocate Medical

Writers Circle. July 2003

12. Bernstein D. The Importance of Laboratory Test results in Hepatitis C Infection. The HCV

Advocate Medical Writers Circle. May 2002.

PRESENTATIONS

14

Radial maze performance in young and aged mice: neurochemical correlates. Society for

Neuroscience meeting. Boston, Massachusetts. November 1983.

Standard biopsy forceps vs large capacity forceps with and without needle.

Florida Gastroenterological Society meeting. Captiva Island, Florida. October

1992.

Recombinant factor VIIa in the treatment of prolonged prothrombin times in cirrhotics.

Plenary Session AASLD. Chicago, Ill November 7, 1995.

The effect of recombinant factor VIIa on the hematological parameters of diffuse

intravascular coagulation in cirrhotic patients. Plenary Session. International Association of

Liver Disease General Meeting. Capetown, South Africa, February 1996

Recombinant factor VIIa in the coagulopathy of cirrhotics. Bockus International Society of

Gastroenterology Meeting, Dublin, Ireland October 1996

The use of recombinant factor VIIa in connection with liver biopsy. Fourth symposium on

new aspects of hemophilia treatment. Copenhagen, Denmark September 20, 1997

Activation of the extrinsic pathway in patients with liver disease: a place for rFVIIa. Joint

Meeting of the French Society of Heart Disease and the French Society of Hematology, Lille,

France, April 1998

New therapies in the treatment of hepatitis C. Bockus International Society of

Gastroenterology Meeting, Graz, Austria September 1998

Low dose interferon-ribavirin therapy is as efficacious as regular strength RebetronR for

the treatment of naive hepatitis C patients. American College of Gastroenterology, Plenary

Session, New York October 2000

Aytug S, Reich D, Shapiro L, Bernstein D, Begum N. Impaired insulin receptor substrate

(IRS-1) tyrosine phosphorylation and signaling in liver patients with hepatitis C infection:

a possible mechanism for increased prevalence of type 2 diabetes. American Diabetes

Association 62nd Scientific Meeting, Plenary Session June 16, 2002

Quality of Life in Hepatitis C. Hepatitis Forum II, Montreux, Switzerland November 2003

ABSTRACTS

15

1. Barkin JS, Lubin J, Reiner DK, Phillips RS, Grauer L, Bernstein D. Standard biopsy

forceps vs large capacity forceps with and without needle. American Journal of

Gastroenterology 1992;87: 489.

2. Bernstein DE, Rogers A, Livingstone A. Malignant stricture in Crohn's disease.

American Journal of Gastroenterology 1993; 88:1694.

3. Bernstein DE, Goldberg RI, Unger S. Common bile duct obstruction following T-tube

placement at laparoscopic cholecystectomy. American Journal of Gastroenterology 1993;

88: 1694.

4. Bartholomew M, Kuhns MC, Rustgi V, Reddy KR, Jeffers LJ, deMedina M, McNamara

A, Gagnier S, Bernstein D, O'Sullivan H, Albuquerque AV, Schiff ER. Decline in HCV

anti-core IgG level correlates with response to therapy. Hepatology 1994; 20: 160A.

5. Lavergne J, Jeffers LJ, Reddy KR, Silva M, Roach K, deMedina M, Kuhns MC,

McNamara A, Hill M, Bernstein D, Schiff ER. Long-term followup of hepatitis C

sustained responders to IFN alfa-2B. Hepatology 1994; 20: 169A.

6. Aiza I, deMedina M, Li XM, Poniachik J, Bartholomew M, Jeffers LJ, Reddy KR,

Bernstein D, Roach K, Hill M, LaRue S, Schiff ER. Evaluation of RIBA HCV 2.0 SIA

indeterminate specimens by RIBA HCV 3.0 and HCV-RNA by PCR. Hepatology 1994;

20: 240A.

7. Poniachik J, Bartholomew M, Jeffers LJ, Reddy KR, Bernstein D, Roach K, Schiff ER.

Do platelet and/or lymphocyte counts increase after interferon treatment in patients with

HCV infection. Hepatology 1994; 20: 388A.

8. Kapel RC, Bernstein D, Schiff ER. " Strongyloma"--a papillomatous mass at the ampulla

of Vater. Gastrointestinal Endoscopy 1995; 41: 366A.

9. Poniachik J, Munnangi S, Jonnalagadda S, Bartholomew M, Banks T, Cornnell T,

Bernstein DE, Reddy KR, Schiff ER. The role of laparoscopy in the diagnosis of cirrhosis.

Gastrointestinal Endoscopy 1995; 41: 432A.

10. Bartholomew M, Vicary C, Roach K, Bernstein D, deMedina M, Tzakis AG, Schiff

ER. Use of lamivudine in the treatment of recurrent hepatitis B post-liver transplantation.

Gastroenterology 1995; 108: 1030A.

11. Li XM, Jeffers LJ, deMedina M, Roberts EA, Reddy KR, Bernstein DE, Schiff ER.

Confocal laser scanning microscopy observation of cultured human hepatocytes induced

with HCV in vitro. Gastroenterology 1995; 108: 1109A.

16

12. Poniachik J, Jeffers LJ, Bartholomew M, Ocur L, Bernstein D, deMedina M,

O'Sullivan H, Schiff ER. Abstinence from alcohol does not affect HCV replication.


13. Kuhns MC, Bartholomew M, Rustgi V, Reddy KR, Jeffers, LJ, de Medina M,

McNamara, Burres B, Johnson R, Bernstein D, O’Sullivan H, Schiff ER. Changes in HCV

anti-core and anti-E2 antibody levels relative to response to interferon treatment.

Hepatology 1995; 22: 171A.

14. Jeffers LJ, Piatak M, Bernstein DE, Reddy KR, Lifson JD, Yun A, Coehlo-Little E, de

Medina M, Kim JP, Schiff ER. Hepatitis G virus infection in patients with acute and chronic

liver disease of unknown etiology. Hepatology 1995; 22: 182A.

15. Bozkaya H, Reddy KR, Jones EJ, Avola B, Jeffers LJ, Bernstein D, de Medina M,

Schiff E. Absence of unique HBV mutation in North American patients with fulminant

hepatitis B. Hepatology 1995; 22: 260A.

16. Poniachik J, Reddy R, Jeffers L, Bernstein D, Jonnalagadda S, de Medina M,

O’Sullivan H, Li X, Schiff ER. Quantitative hepatitis B virus DNA and hepatitis C virus

RNA levels in co-infected patients. Hepatology 1995; 22: 266A.

17. Reddy KR, Bacon BR, Tzakis A, Neuschwander-Tetri BA, Jeffers LJ, Di Bisceglie AM,

Bernstein DE, Weppler D, Webb M, Nery J, deMedina M, Viciana A, Schiff ER. Hepatic

iron concentration in end stage liver disease secondary to chronic hepatitis C and / or

alcoholic liver disease. Hepatology 1995; 22: 275A.

18. Bernstein DE, Glazer S, Jeffers LJ, Squiban P, Reddy KR, Roach K, Seale R,

Erhardsten E, Schiff ER. Recombinant VIIa in the treatment of prolonged prothrombin

times in cirrhotics. Hepatology 1995; 22: 289A.

19. Jeffers LJ, Banks AT, Jonnalagadda S, Maertens G, Reddy KR, Bernstein DE,

Ducatteeuw A, Wolfe L, Lombardi S, Price B, de Medina M, Schiff ER. E1 antibody level

monitoring predicts long term response of hepatitis C virus infection in patients treated with

interferon. Hepatology 1995; 22: 291A.

20. Bernstein DE, Glazer S, Jeffers LJ, Reddy KR, Squiban P, Bech RN, Roach KR, Seale R,

Erhardtsen E, Schiff ER. The effect of recombinant factor VIIa on the

hematologicalparameters of diffuse intravascular coagulation in cirrhotic patients.

Hepatology 1996;23:I-18A.

21. Ungo JR, Ashkin D, Hollender ES, Ryan SD, Bernstein D, Albanese AP, Pitchenik

AE. Anti-tuberculosis drug induced hepatotoxicity: the possible role of hepatitis viruses.

American Journal of Respiratory and Critical Care Medicine 1996; 153: A410.

17

22. Ungo JR, Ashkin D, Hollender ES, Ryan SD, Albanese AP, Bernstein D, Pitchenik

AE. Alpha interferon treatment of hepatitis C in TB patients who developed drug induced

hepatotoxicity. American Journal of Respiratory and Critical Care Medicine 1996; 153:

A487.

23. Feun LG, Reddy KR, Yrizzary JM, Guerra JJ, Bernstein D, Jeffers LJ, Ardalan B,

Livingstone A, Levi J, Savaraj N, Hurley J, Murray T, Scagnelli T. Phase I-II trial of

lipiodol chemoembolization with cis-platin and thiotepa for unresectable liver tumors.

Proceedings of the American Society of Clinical Oncology May 1996

24. Leon R, Dawson G, Jeffers L, Reddy R, Kuhns M, de Medina M, Bernstein D, Idrovo

V, Schiff E. GBV-C virus infection in patients with acute and chronic liver disease of

unknown origin. IX Triennial International Symposium, Rome, Italy April 21-25, 1996

25. Li XM, Jeffers LJ, Liu H, Bernstein D, Garon C, Fischer ER, Scheffel J, Moore B, Reddy

KR, deMedina M, Schiff ER. Human megakaryoblastic leukemia cell line is shedding

hepatitis C virus. Gastroenterology 1996; 110: A1251.

26. Reddy KR, Weppler D, Zervos XA, Nery JR, Webb MG, Khan MF, Gavlik A, Dupont

L, DeMedina M, Goldberg M, Bernstein D, Jeffers LJ, Tzakis AG, Schiff ER. Recurrent

HCV infection following OLTx: the role of early post OLTx interferon treatment.

Hepatology 1996; 24:295A.

27. Weppler D, Reddy KR, Fragulidis GP, Cirocco R, Zervos XA, Nery JR, Webb MG,

Khan MF, Gavlik A, Dupont L, DeMedina M, Goldberg M, Bernstein D, Jeffers LJ, Schiff

ER, Tzakis AG. Rejection vs. recurrence --the role of clinical diagnosis, viremia and

histology after OLTx for hepatitis C disease. Hepatology 1996;24:297A.

28. Ribiero A, Goldberg M, Reddy KR, Bacon B, Jeffers LJ, Bernstein D,

Neuschwander-Tetri BA, Weppler D, Tzakis A, Schiff ER. Hemochromatosis: an

unrecognized entity until liver transplantation. American Journal of Gastroenterology 1996;

91:A280.

29. Tagle FM, Ribiero A. Bernstein D, Jeffers L, Reddy KR, Goldberg M, Schiff ER.

Laparoscopy for the diagnosis of the “Jelly Belly” syndrome. American Journal of

Gastroenterology 1996; 91:A626.

30. Ribeiro A, Goldberg MS, Khan RT, Bernstein DE, Jeffers LJ, Reddy KR, Schiff ER.

Liver transplantation in the elderly: outcomes and risk factors. Hepatology 1996; 24: 242A.

31. Li XM, Liu HP, Jeffers LJ, Lian E, Yu TF, Reddy KR, deMedina M, Bernstein D,

Schiff E. Hepatitis GB-C virus in patients with bleeding disorders. Hepatology 1996;

24:539A.

18

32. Bernstein DE, Jeffers LJ, Reddy KR, Bech RM, Hedner U, Schiff ER. The use of

recombinant factor VIIa in advanced liver disease. XVI Congress of the International Society

on Thrombosis and Hemostasis, Florence, Italy June 1997

33. Leon R, Milikowsky C, Jeffers L, Reddy KR, Watane A, Molina E, Fazel A, Civantos F,

Bernstein D, Nader A, Schiff ER. Laparoscopic and histological findings in patients with

chronic hepatitis C. Correlation with platelet count. Gastrointestinal Endoscopy 1997;

45:AB147.

34. Bernstein DE, Gress F, Tripodi J, Stein L, Burakoff R. Transabdominal ultrasound guided

percutaneous liver biopsy: a randomized trial to evaluate safety, efficacy, and cost analysis.

Gastroenterology 1997. A4.

35. Bernstein DE. The use of recombinant factor VII in connection with liver biopsy. Blood,

Coagulation and Fibrinolysis 1998; 9: S158 (Suppl.1)

36. Bernstein DE, Gress F, Rizzo J, Tripodi J, Burakoff R. Percutaneous liver biopsy with

determination of the skin to liver distance (SLD): An outcome analysis. Gastroenterology

1998; 114:A4

37. Gress F, Rizzo J, Snady H, Ciaccia D, Bernstein D, Lehman G. Using endoscopic

ultrasound (EUS) for preoperative stating in patients with pancreatic cancer (PCa): Predictors

of survival. Gastroenterology 1998; 114:A463

38. Jeffers LJ, Bernstein DE, Erhardsten E, Acebo W, Reddy KR, Bech RM, Schiff ER. The

use of recombinant factor VIIA (rFVIIA) in laparoscopic liver biopsy (LB): A pilot trial.

Gastroenterology 1998; 114:A1264.

39. Kahn R, Jafri W, Vadalamenti S, Jeffers L, Bernstein D, Schiff ER Hypertriglyceridemia:

An explanation of persistent ALT elevation despite favorable virologies response to

Interferon/Ribavirin treatment of chronic hepatitis C. Gastroenterology 1998; 114:A1272.

40. Rizzo J, Bernstein DE, Tripodi J, Gress F. A performance, safety and cost comparison

of reusable versus disposable endoscopic biopsy forceps. Gastrointestinal Endoscopy

1998;47: AB58.

41. Bernstein DE, Khan R, Jeffers LJ, Reddy KR, Schiff ER. Low dose ribavirin in

combination with interferon for the treatment of hepatitis C non-responder and relapse

patients. Hepatology 1998; 28:702A.

42. Rizzo J, Bernstein DE, Coyle V, Spitz L, Gress F. A Randomized double blind placebo

controlled cost effective analysis of droperidol as a sedative premedication for endoscopic

ultrasound. Gastroenterology 1999;116.A3199.

19

43. Bernstein DE, Tiev M, Jeffers LJ, Lake-Bakaar G. Low dose ribavirin plus high dose

interferon for 1 year is effective in the treatment of hepatitis C patients who were initially

either relapsers or non-responders to interferon monotherapy. Gastroenterology 2000; 118.

A

44. Bernstein DE, Tiev M, Steinberg SE. Low dose interferon-ribavirin therapy is as

efficacious as regular strength RebetronR for the treatment of naive hepatitis C patients.

Gastroenterology 2000; 118

45. Di Bisceglie A, Bernstein DE,, Rustgi VR, Gitlin N, Jeffers LJ, Simon D, Pappas SC.

Pegylated (40kDa) Interferon Alfa 2a (PEGASYS)in New Combination Therapies: A

preliminary report of a randomized, multi-center efficacy and safety study. Hepatology

2000

46. Bernstein DE, Tiev M, Steinberg SE. Low dose interferon-ribavirin therapy is as

efficacious as regular strength RebetronR for the treatment of naive hepatitis C patients.

American Journal of Gastroenterology 2000

47. Bernstein DE, Tiev M, Jeffers LJ, Lake-Bakaar G. Low dose ribavirin plus high dose

interferon for 1 year is effective in the treatment of hepatitis C patients who were initially

either relapsers or non-responders to interferon monotherapy. American Journal of

Gastroenterology 2000

48. Herrine SK, Brown R, Esposito S, Lok A, Galati J, Bernstein DE, Campagna J.

Pegylated interferon alfa-2a in combination with ribavirin, mycophenolate mofetil,

amantidine or amantidine plus ribavirin in patients that relapsed on Rebetron therapy: a

preliminary report of a randomized, multi-center efficacy and safety study.

Gastroenterology 2001;120: 1966A.

49. Di Bisceglie A, Bernstein DE,, Rustgi VR, Gitlin N, Jeffers LJ, Simon D, Capagna J,

Pappas SC. Pegylated (40kDa) Interferon Alfa 2a (PEGASYS)in New Combination

Therapies: A preliminary report of a randomized, multi-center efficacy and safety study.

Journal of Hepatology 2001; 34: A408, p 143.

50. Bernstein DE, Cooksley G, Fried MW et al. Correlation of health related quality of

life with virological response and early treatment discontinuation in patients treated with

pegylated (40kDa) interferon alfa 2-a compared with standard interferon alfa-2a.


51. Khalili M, Hoffman-Terry M, Hassanein T, Bernstein DE, Harb G, Lentz E, Pearson D.

Safety and efficacy of peginterferon alfa-2a in the treatment of patients coinfected with HIV

and HCV: preliminary results from a randomized multicenter trial. Hepatology 2001; 34:

623A.

20

52. Steinberg B, Bernstein DE, Hirsch B, Kahn E, Steinberg S. Histopathology of the liver in

autopsied AIDS patients from the pre-HAART era: correlation with hepatitis C serological

status. Hepatology 2001;34:1265A.

53. Steinberg B, Hirsch B, Bernstein D, Steinberg S, Kaplan M. Prevalence of hepatitis B

surface antigen and hepatitis C antibody in patients who expired secondary to HIV-related

infections in a community hospital in the pre-HAART era. Hepatology 2001; 34:2070A.

54. Afhdal N, Flamm S, Imperial J, Malet P, Tong M, Herrine S, Brown R, Esposito S,

Bernstein D, Campagna J. Analyses of 40 kD peginterferon alfa 2a (Pegasys) in combination

with ribavirin, mycophenolate mofetil, amantidine or amantidine plus ribavirin in patients

that relapsed on Rebetron therapy: a preliminary report of a randomized, multi-center

efficacy and safety study. Hepatology 2001; 34; 243A.

55. Jacobson I, Brown R, Bernstein D, Bruno C, Spivey J, lawitz et al. Pegylated interferon

alfa 2b and fixed versus weight based ribavirin dosing for treatment naive patients with

chronic hepatitis C. Hepatology 2001; 34:1648A

56. Aytug S, Reich D, Shapiro L, Bernstein D, Begum N. Impaired insulin receptor substrate

(IRS-1) tyrosine phosphorylation and signaling in liver patients with hepatitis C infection: a

possible mechanism for increased prevalence of type 2 diabetes. American Diabetes

Association 62nd Annual Meeting, San Francisco CA June 2002

57. Herrine SK, Brown R, Esposito S, Bernstein DE, Te H, Galati J, Lok ASF, Ondovik MS,

Lentz E, Harb G. Efficacy and safety of 40kDa Peginterferon alfa-2a combination therapies

in patients that relapsed on Rebetron therapy. Hepatology 2002

58. Goncales F, Bernstein D, Berg C, Sette H, Rasenack J, Diago M, Jensen D, Cooksley G,

Ackrill A. Peginterferon alfa 2a plus ribavirin in chronic hepatitis C: retreatment of patients

who relapsed virologically after 24 weeks of therapy. AASLD 2003

59. Jensen D, Bernstein D, Hassanein T, Foster G, Lee S, Cheinquer H, Craxi A, Cooksley G,

Brunda M, Green J, Cost-effectiveness of Peg-interferon alfa 2a plus ribavirin compared with

interferon alfa-2b plus ribavirin in chronic hepatitis C. AASLD 2003

60. Hoffman-Terry M, Khalili M, Bernstein D et al. Safety and efficacy of peg-interferon alfa

2a with and without ribavirin in the treatment of patients co-infected with HIV and HCV:

preliminary results from a randomized, multicenter trial. ICAAC 2002 San Diego Ca. Poster

# 1725

61. Khalili M, Hoffmann-Terry M, Fisher E, Bernstein D, Lentz E, Barylski C, Harb G.

Efficacy and safety of peg-interferon alfa 2a treatment of patients with HIV/HCV: results of

a multicenter trial. ICAAC 2003

21

62. Sullivan SD, Jensen DM, Bernstein DE, Hassanein TI, Foster GR, Lee SS, Cheinquer H,

Craxi A, Cooksley WGE, Klaskala W, Pettit K, Patel KK, Green J. Cost-effectiveness of

combination peg-interferon alfa 2a and ribavirin compared with interferon alfa 2b and

ribavirin for patients with chronic hepatitis C. AASLD 2003

63. Sarij S, Gross S, Oh CK, Bernstein D. Paraesophageal hernia resulting in intrathoracic

volvulus. American Journal of Gastroenterology 2004; 99: S40 (A119)

64. Jacobson I, Brown R, Frelich B, Afdhal N, Kwo P, Santoro J, Becker S, Wakil A,

Pound D, Godofsky E, Strauss R, Bernstein D, Flamm S et al. Weight based ribavirin

dosing increases sustained viral response in patients with chronic hepatitis C: final results

of the WIN-R study. Hepatology 2005; 42:749A.

65. Jalal PK, DeVito B, Greenberg R, Lee TP, Bernstein DE. Gastric Retention is Common

with In-Patient Wireless Capsule Endoscopy. Gastrointestinal Endoscopy 2006; 63: AB 178

(M1347)

66. Kwo P, Jacobson I, Brown R, Freilich B, Afdahl N, Santoro J, Becker S, Wakl A, Pound

D, Godolofsky E, Strauss R, Bernstein DE, Flamm S et al. Prior HCV treatment Experience

and its relationship to sustained virological response: an analysis of the WIN-R study

database. Gastroenterology 2006; 130: A836 (T1802)

67. Zeuzem S, Hadyziyannis S, Morgan T, Diago M, Marcellin P, Bernstein D, Pockros P,

Lin A, Willems, Shiffman M. The effect of week 4 virological response on the outcomes of

genotype 2 and 3 patients treated with peg-interferon alfa 2a plus high or low dose ribavirin.

Hepatology 2006; 44: A209 (Oral presentation)

68. Mian N, DeVito B, Kim A, Lee TP, Bernstein DE. CMV Rectal Ulcer in an

Immunocompetent Young Woman. Amer J Gastro 2006

69. Mian N, DeVito B, Lee TP, Bernstein D. Gastrointestinal Amyloidosis Presenting as

Irritable Bowel Syndrome. Amer J Gastro 2006

70. Mian N, Bernstein D, Bonapace E, Katz S. A Case of Recurrent Epiploic

Appendagitis. Amer J Gastro 2006

71. Mian N, Bernstein D, Bonapace E, Katz S. Small Bowel Pseudopolyps: a unique

finding on capsule endoscopy in a patient with Crohn’s disease. Amer J Gastro 2006

72. Mian N, DeVito B, Hirsch B, Lee TP, Salvemini J, Bernstein D. Disseminated Herpes

Simplex 2 infection with hepatitis in a patient taking Alefacept for psoriasis. Amer J

Gastro 2006

22

73. Sood S, Yaskiv O, DeVito B, Lee TP, McGowan J, Kahn E, Bernstein D. AIDS

associated arteriopathy as etiology of non-infectious recto-colonic ulcerations in an adult:

the first reported case. Amer J Gastro 2006

74. Sood S, Rosen E, DeVito B, Lee TP, Bernstein D. Acute pancreatitis secondary to

ESWL. Amer J Gastro 2006

75. Sood P, Sood Shivani S, Lee TP, Bernstein D. Median arcuate Ligament Syndrome: a

lesser known entity with an atypical presentation. Amer J Gastro 2006

76. Frelich B, Hu KQ, Jacobson I, Brown R, Afdhal N, Kwo P, Santoro J, Becker S, Wakil

A, Pound D, Godofsky E, Strauss R, Bernstein D, Falmm S, Bala N, araya V, Griffel L, Brass

C. Prospective analysis of sustained viral response to peg-interferon alfa 2b and ribavirin

treatment in Asian and Hispanic patients with chronic hepatitis C: results of the WIN-R trial.

Hepatology 2006; 44:320A.

77. Zeuzem S, Fried M, Reddy KR, Marcellin P, Diago M, Craxi A, Pockros P, Rizzetto M,

Bernstein D, Shiffman M, Lin A, Hadziyannis S, Improving the clinical relevance of pre-

treatment viral load as a predictor of sustained virological response in patients infected with

hepatitis C genotype 1 treated with pegylated interferon alfa 2a plus ribavirin. Hepatology

2006; 44: 267A.

78. Willems B, Hadziyannis SJ, Morgan T, Diago M, Marcellin P, Bernstein D, Pockros P,

Lin A, Shiffman ML, Zeuzem S. Should treatment with pegylated interferon plus ribavirin be

intensified in patients with HCV genotype 2/3 without a rapid virological response. J

Hepatology 2007

79. Willems B, Hadziyannis SJ, Morgan T, Diago M, Marcellin P, Bernstein D, Pockros P,

Lin A, Shiffman ML, Zeuzem S. Increased SVR rate with 48 weeks treatment and higher

RBV dose in HCV genotype 2/3 patients without a rapid virological response treated with

peginterferon alfa 2a plus RBV. Gastroenterology 2007.

80. Sheikh F, DeVito B, Bernstein D. Percutaneous endoscopic gastrostomy tubes: how safe

are they? Amer J Gastro 2009;104; S411 (A1117)

81. Sheikh F, DeVito B, Bernstein D. Outcomes after Percutaneous endoscopic gastrostomy

tube placement: Does the indication make a difference? Amer J Gastro 2009;104; S411

(A1118)

82. Green B, Mehrotra B, Gecelter G, Bernstein D, Kaushik N. Endoscopic ultrasound

compared to laparoscopy for staging of pancreatico-biliary malignancy. Amer J Gastro 2009;

104: S63 (A159)

23

83. Nelson DR, Lalezari J, Lawitz E, Hassanein T, Kowdley K, Poordad F, Sheikh A, Afdhal

N, Bernstein DE et al. PSI-7977 QD plus PEG/RBV in HCV GT1: 98% rapid virologic

response, copete early virologic response: The PROTON study. EASL 2011

84. Lawitz E, Lalezari JP, Hassanein T, Kowdley K, Poordad F, Sheikho M, Afdhal N,

Bernstein D, DeJesus E, Frelich B, Nelson D, Dieteriech D, Jacobson I, Jensen D, Abrams G,

Darling J, Reddy K, Sulkowski M, Bzowej N, DeMicco M, Strohecker J, Hyland R, Mader

M, Albanis E, Symonds W, Berrey M. PSI-7977 400 mg with PEG/RBV provides 93% SVR

across HCV GT 1,2,3. HepDart 2011

85. Gaglio PJ, Petschow BW, Brown R, Jacobson I, Bernstein D, Palmer M, Perumalswami

P, Dieterich D. Proactive Birth Cohort and Risk Based Hepatitis C Screening: Hep C Link to

Care NYC. EASL 2012

86. Sheikh F, Bernstein D. Severe Pancreatitis secondary to Intra-Gastric Balloon Placement.

American Journal of Gastroenterology 2012;107;S332 (A805)

87. Cheong M, Coronel M, Vamadevan A, Bernstein D. Hyperthyroidism presenting as acute

hepatitis. American Journal of Gastroenterology 2012;107;S433 (A1073)

88. Inamdar S, Sultan K, Bernstein D. Increased risk of Non alcoholic fatty liver disease

among patients with inflammatory bowel disease. American Journal of Gastroenterology

2012;107;S666 (A1647)

89. Segal TR, Bernstein S, Di W, Marchesi DE, Bernstein D. The Prevalence of hepatitis B

and C virus infection at a university hospital infertility center. APASL 2013.

90. Lane S, Cline S, Szabo S, Beusterien K, Hautamaki E, Bernstein D, Gooch K.

Understanding the impact of a cure for hepatitis C from a patient perspective. Viral Hepatitis

Conference 2013, Frankfort, Germany

91. Brown K, Bacon B, Balart L, Bernstein D, Brown R, Flamm S, Harrison S, Kugelmas M,

Kwo P, LaBrecque D, Neff G, Patel V, Reau N, Reddy R, Regenstein F, Schiff E, Shiffman

M, Poordad F. Hepatitis C Therapy in Community Practice: An educational partnership

program between academic and community practices. Am J Gastro 2013; 108: S122 (A408)

92. Hayes Christi Ann, Paul D, Savona S, Bernstein DE. Hepatitis B and C in patient’s

receiving chemotherapy. ASCO 2014

93. Gomez M, Marinho RT, Vila RP, Bernstein D, Rodriguez-Perez F, Hassanein T, Reddy

KR, Tsai N, Lovell S, Enejosa J, Luo Y, Cohen D, Pedroso M. Colombo M. Low incidence

of hyperbilirubinemia events with RBV-free regimen of ABT-450/R/ABT-267 and ABT-333

in HCV genotype 1 patients. UEGW 2014

24

94. Bernstein D, Marinho R, Cohen D, Bredeek F, Schneider F, Norkrans G, Curescu M,

Bennett M, Maevskaya M, Fessel J, Xie W, Luo Y, Enejosa J. Adherence to prescribed doses

of ABT450/r/ABT 267, ABT333 and ribavirin in the phase 3 PEARL II, PEARL III and

PEARL IV trials. UEGW 2014

95. Ferenci P, Nyberg A, Enayati P, Bernstein D, Baruch Y, Caruntu F, Chulanov V,

Janczewska E, Younes Z, Marinho RT, Rizzardini G, Gervain J, Planas R, Moreno C, Xie W,

Collins C, Cohen D, King M, Podsadecki T, Reddy KR. Pearl III-12 weeks of ABT-450/r/267

+ ABT 333 achieved SVR >99% of 419 treatment naïve HCV genotype 1b infected patients

with or without ribavirin. Austrian Gastroenterology and Hepatology Congress 2014

96. Ferenci P, Nyberg A, Enayati P, Bernstein D, Baruch Y, Caruntu F, Chulanov V,

Janczewska E, Younes Z, Marinho RT, Rizzardini G, Gervain J, Planas R, Moreno C, Xie W,

Collins C, Cohen D, King M, Podsadecki T, Reddy KR. Pearl III-12 weeks of ABT-450/r/267

+ ABT 333 achieved SVR >99% of 419 treatment naïve HCV genotype 1b infected patients

with or without ribavirin. EASL 2014

97. Jensen D, Sherman K, Hezode C, Pol S, de Ledinghen V, Tran A, Elkhashab M, Younes

Z, Kugelmas M, Mauss S, Everson G, Luketic V, Vierling J, Serfaty L, Brunetto M, Heo J,

Bernstein D, McPhee F, Hennicken D, Mendez P, Hughes E, Noviello S. Daclatasvir and

asunaprevir plus peginterferon alfa 2a and ribavirin in patients with HCV genotype 1 or 4

infection: Phase 3 Hallmark-Quad results. ID week 2014

98. Kowdley K, Gordon S, Reddy KR, Rossaro L, Bernstein D, An D, Svarovskaia E, Hyland

R, Pang P, Symonds W, Muir A, Pockros P, Pound D, Fried M. Sofosbuvir/ledipasvir with

and without ribavirin compared to sofosbuvir/ledispasvir for 12 weeks in treatment naïve non-

cirrhotic genotype 1 HCV infected patients: the phase 3 ION-3 study. DDW 2014 Abstract

764

99. Bernstein D, Lalezari J, Luo Y, Box T, Younes Z, Green S, Bhandari B, Sepe T, Cooper

C, Tam E, Tsai N, Hassanein T, Xie W, Podsadecki T. Pearl IV: a 12 week regimen of ABT-

450/r/ABT-267 and ABT-333 with and without ribavirin achieves SVR 12 rates > 90% in

treatment naïve adults infected with hepatitis C virus genotype 1a. DDW 2014 Abstract

Su1061

100. Marinho RT, Ferenci P, Nyberg A, Enayati P, Bernstein D, Baruch Y, Caruntu F,

Chulanov V, Janczewska E, Younes Z, Rizzardini G, Cohen D, King M, Podsadecki T, Reddy

KR. Pearl III: 12 weeks of ABT -450/r/267+ABT 333 achieved SVR in >99% of 419

treatment naïve HCV genotype 1b-infected adults with or without ribavirin. Semana Digestiva

2014, June 5-7 2014. Estoril, Portugal

101. Ferenci P, Nyberg A, Enayati P, Bernstein D, Caruntu F, Chulanov V, Janczewska E,

Younes Z, Marinho R, Rizzardini G, Gervain J, Planas R, Moreno C, Xie, W, Cohen D, King

M, Podsadecki S, Reddy KR. Pearl III: 12 weeks of ABT -450/r/267+ABT 333 achieved SVR

25

in >99% of 419 treatment naïve HCV genotype 1b-infected adults with or without ribavirin.

Hepatologia do Milenio Congress, July 23-25 2014, Bahia, Brazil

102. Diago M, Andreone P, Forton D, ReesinkHW, Rustgi V, Bernstein D, Sepe T, Vierling

J, King W, Cohen D, Ferenci P. Management of hemoglobin decrease in patients treated with

ABT-450/ritonavir/ombitasvir and dasabuvir with or without ribavirin in HCV genotype 1

infected patients. UEWG 2014. Vienna, Austria. #OP024 (oral presentation)

103. Bernstein DE, Nevens F, Enejosa JV, Rodriguez-Perez F, Ozaras R, Moreno C, Brunetto

MR, King M, CohenD. High SVR 12 rates in HCV genotype 1b infected patients receiving

Ombitasvir/ABT-450/r and Dasabuvir with and without Ribavirin regardless of baseline

characteristics. ICAAC 2014 Washington DC. Abstract V-672 (oral presentation)

104. Rustgi V, Bernstein D, Sepe T, King W, Diago M, Andreone P, Forton D, Reesink H,

Ferenci P, Hu Y, Enejosa J, Cohen D, Luo Y, Pedrosa M, Vierling J. Management of

hemoglobin decrease in patients treated with ABT-450/ritonavir/ombitasvir and dasabuvir

with or without ribavirin in HCV genotype 1 infected patients. Am J Gastroenterology 2014;

109; Supplement 2: S-133: Abstract 443

105. Bernstein D, Tsai N, Hassanein T, Rodriquez-Perez F, Romero-Gomez M, Marinho R,

Planas-Vila R, Colombo M, Lovell S, Enejosa J, Luo Y, Cohen D, Pedrosa M, Reddy KR.

Low Incidence of Hyperbilirubinemia events with ABT-450/r-Ombitasvir and Dasabuvir

with or without ribavirin in HCV genotype 1 infected patients. Am J Gastroenterology 2014;

109; Supplement 2: S-133: Abstract 445

106. Nelson D, Reddy KR, DiBisceglie A, Ferenci P, Crawford D, Stauber R, Yakovlev

A, de Ledinghen V, Hinrichsen H, BernsteinD, de Knegt R, Hassanein T, Norris S, Xiong

J, McGovern B, Agarwal K. ABT-450/r/Ombitasvir plus Dasabuvir with or without

ribavirin in HCV genotype 1 infected patients with history of depression or bipolar

disorder: pooled analysis of efficacy and safety in Phase 3 Trials. Hepatology 2014;

60:Abstract 1972

107. Vierling J, Puoti M, Bernstein D, Tsai N, Weiland O, Gomez M, Caruntu F, DuFour

J, Calinas F, Larsen L, Tatsch F, Andreone P. Efficacy by race or geographic region in

HCV genotype 1 infected patients treated with ABT-450/ritonavir/Ombitasvir and

dasabuvir with or without ribavirin. Hepatology 2014; 60: Abstract 1968.

108. Bernstein DE, MArinho R, Cohen D, Bredeek F, Schneider F, Norkrans G, Curescu

M, Bennett M, Maevskaya M, Fessel J, Xie W, Luo Y, Enejosa. Adherence to prescribed

doses of ABT-450/r/Ombitasvir , dasabuvir and ribavirin in the phase 3 PERAL II,

PEARL III and PEARL IV trials. Hepatology 2014; 60: Abstract 1953

109. Bernstein DE, Mangia A, Brau N, Yang J, Ma J, Hyland R, Pang P, McHutchison J,

Reddy KR, Fried M. Concordance between SVR-4, SVR-12 and SVR-24 in genotype 1

26

HCV infected patients who received all oral fixed dose combination ledipasvir/sofosbuvir

with or without ribavirin in phase 3 clinical trials. Hepatology 2014; 60: Abstract 1947

110. Bernstein D, Luo Y, Lalezari J, Wyles D, King W, Tsai N, David M, Sepe T, Fessel J, King M, Podsadecki T, Cooper C. Pearl IV trial: Subgrop analysis of genotype 1a infected patients treated with Dasabuvir plus Ombitasvir/ABT-450/r with or without ribavirin. Hepatology 2014 Abstract 1933

111. Nelson D, Bernstein D, Freilich B , Lawitz E,Hawkins T, Pockros P, Thuluvath P,

Younes Z, Bennett M, Ghalib R, Ruane P, Tong M, Bhore R, Yin P, Noviello S, Rana K. ALL-ORAL 12-WEEK COMBINATION TREATMENT WITH DACLATASVIR (DCV) AND SOFOSBUVIR (SOF) IN TREATMENT-EXPERIENCED PATIENTS INFECTED WITH HCV GENOTYPE (GT) 3: A SUBANALYSIS OF THE ALLY-3 PHASE 3 STUDY. Gastroenterology 2015; 148: S-1003

112. Nelson D, Bernstein D, Freilich B , Lawitz E,Hawkins T, Pockros P, Thuluvath P,

Younes Z, Bennett M, Ghalib R, Ruane P, Tong M, Bhore R, Yin P, Noviello S, Rana K. ALL-ORAL 12-WEEK COMBINATION TREATMENT WITH DACLATASVIR (DCV) AND SOFOSBUVIR (SOF) IN TREATMENT-EXPERIENCED PATIENTS INFECTED WITH HCV GENOTYPE (GT) 3: A SUBANALYSIS OF THE ALLY-3 PHASE 3 STUDY. J Hepatology 2015; 62:S624 113. Nelson D, Cooper J, Lalezari J, Lawitz E, Pockros P, Gitlin N, Freilich B, Younes Z, Harlan W, Ghalib R, Oguchi G, Thuluvath P, Ortiz-Lasanta G, Rabinovitz M, Bernstein D, Bennett M, Hawkins T, Ravendhran N, Sheikh A, Varunok P, Kowdley K, Hennicken D, McPhee F, Rana K, Hughes E. ALL-ORAL 12-WEEK COMBINATION TREATMENT WITH DACLATASVIR (DCV) AND SOFOSBUVIR (SOF) IN TREATMENT-EXPERIENCED PATIENTS INFECTED WITH HCV GENOTYPE (GT) 3: ALLY-3 PHASE 3 STUDY. Hepatology 2014. 6: 1268A (Abstract LB-3) 114. Jacobson IM, Pockros PJ, Sulkowski MS, Bernstein DE, Kowdley KV, Bourliere M, Wang D, Menon R, Abunimeh M, Renjifo B, Reindollar R, Cohen DE, Martin P. Treatment with ombitasvir/paritaprevir/r plus dasabuvir with ribavirin is not associated with adverse changes in renal function: an analysis of 4 phase 2/3 trials. HepDart 2015. Maui, HI 115. Sulkowski MS, Pockros PJ, Jacobson IM, Bernstein DE, Tatsch F, Enjifo B, Wang D, Cohen D, Martin P. Efficacy and safety among patients treated with ombitasvir/paritaprevir/r plus dasabuvir with or without ribavirin according to baseline renal function: analysis of six phase 3 trials. HepDart 2015. Maui HI 116. Bernstein D, Landis C, Lawitz E, Luetkemeyer AF, Harrris M, Bhore R, Swenson ES, Ackerman P, Rana K, Dieterich D. Integrated safety analysis of daclatasvir plus

27

sofosbuvir with or without ribavirin in patients with HCV genotype 3 infection. HepDArt 2015. Maui, HI 117. Pockros PJ, Reddy KR, Mantry PS, Cohen E, Bennett M, Sulkowski MS, Bernstein D, Podsadecki T, Wang D, Lawitz E. RUBY-1: Ombitasvir/paritaprevir/r plus dasabuvir with and without ribavirin in HCV genotype 1 with renal disease 118. Pockros P, Reddy KR, Mantry S, Cohen E, Bennett M, Sulkowski M, Bernstein D, Podsadecki T, Cohen D, Shulman N ,Wang D, Khatri A, Abunimeh M, Lawitz E. Safety of ombitasvir/paritaprevir/ritonavir plus dasabuvir for treating HCV G1 infection with severe renal impairment or end stage renal disease: the Ruby 1 study. J Hepatology 2015; 62: S 257 (Abstract LB 4281) 119. Kwo P, Gitlin N, Nahass R, Bernstein D, Etzkorn K, Rojter S, Schiff E, Davis M, Ruane P, Younes Z, Kalmeijer R, Peeters M, Lenz O, Fevery B, DeLa Rosa G, Scott J, Sinha R, Witek J,. A phase 3, randomized, open-label study to evaluate the efficacy and safety of 8 and 12 weeks of simeprevir and sofosbuvir in treatment naïve and experienced patients with chronic HCV infection without cirrhosis: Optimist 1. J Hepatology 2015; 62: S270 (Abstract LB-4326) 120. Reau N, Fried M, Wedemeyer H, Cooper C, Diago M, Craxi A, Strasser S, S,

DuFour JF, Xie W, Larsen L, Dumas E, BernsteinD. High SVR rates despite multiple

negative predictors in genotype 1 patients receiving ombitasvir/parataprevir/r, dasabuvir

with and without ribavirin for 12 and 24 weeks: integrated analysis of 6 phase 3 trials. J

Hepatology 2015; 62: S623-4

121. Reau N, Fried M, Wedemeyer H, Cooper C, Diago M, Craxi A, Strasser S, S,

DuFour JF, Xie W, Larsen L, Dumas E, BernsteinD. High SVR rates despite multiple


with and without ribavirin for 12 and 24 weeks: integrated analysis of 6 phase 3 trials.

Korean Liver Meeting, Busan Korea 2015

122. Reau N, Fried M, Wedemeyer H, Cooper C, Diago M, Craxi A, Strasser S, S,

DuFour JF, Xie W, Larsen L, Dumas E, Bernstein D. High SVR rates despite multiple


with and without ribavirin for 12 and 24 weeks: integrated analysis of 6 phase 3 trials.

Korean Liver Meeting, Gastroenterology 2015; 148. S-1002

123. Reau N, Poordad F, Enejosa JV, Siddique A, Aguilar H, Lalezari J, Felizarta F,

Varunok P, Bernstein D, Dieterich D, Everson G, Hu YB, Pilot-Matias T, Shulman N,

Arora S. Preliminary safety and efficacy results from Topaz-II: a phase 3b study

evaluating long term clinical outcomes in HCV genotype 1-infected patients receiving

ombitasvir/paritaprevir/ritonavir and dasabuvir + ribavirin. AASLD 2015 Abstract 1065

28

124. Zeuzem S, Jacobson IM, Feld JJ, Wedemeyer H, Forns X, Andreone P, Colombo

MG, Bernstein D, Poordad F, Hezode C, Podsadecki T, Xie W, Pilot-Matias T, Vilchez

R, Vierling J. Long term efficacy of ombitasvir/paritaprevir/and dasabuvir with or

without ribavirin in HCV genotype 1 infected patients with or without cirrhosis. AASLD

2015

125. Poordad F, Feld J, Trinh R, Horsmans Y, Elkashab M, Bourgeois S, Lee S, Moreno

C, Bernstein D, Younes Z, Polepally A, Howieson K, Fu B, Ball G, Shulman N, Tam E.

Tuequoise-III: 12 weeks regimen of ombitasvir/paritaprevir/r and dasabuvir for patients

with HCV genotype 1B and cirrhosis. AASLD 2015

126. Feld J, Bernstein D, Younes Z, Van Vlierberghe H, Ball G, D’Amico R, Ferenci P.

Clinical management of ribavirin dosing in HCV infected patients with anemia related

events receiving ombitasvir/paritaprevir/r and dasabuvir. AASLD 2015. Abstract 1067

127. Bernstein D, Landis C, Lawitz E, Luetkemeyer AF, Harrris M, Bhore R, Swenson

ES, Ackerman P, Rana K, Dieterich D. Integrated safety analysis of daclatasvir plus

sofosbuvir with or without ribavirin in patients with HCV genotype 3 infection.

Hepatology 2015. AASLD 2015. Abstract 726

128. Kowdley KV, Angus P, Bernstein D, Bronowicki JP, Leroy V, Pockros PJ, Bhore R,

Rama K, Jimenez-Exposito MJ. All oral treatment with daclatasvir plus sofosbuvir +

ribavirin in HCV genotype 3 infected patients with advanced fibrosis or cirrhosis: an

analysis of ALLY 3 and ALLY 3+. HepDart 2015, Maui, HI

129. Sulkowski M, Pockros P, Jacobson I, Bernstein D, Tatsch F, Renjifo B, Wang D,

Cohen D, Martin P. Efficacy and safety of ombitasvir/paritaprevir/and dasabuvir with or

without ribavirin according to baseline renal function: Analysis of 2005 patients enrolled

in 6 phase 3 trials. HepDart 2015, Maui, HI

130. Jacobson I, Pockros P, Sulowiski M, Bernstein D, Kowdley K, Bourliere M, Wang

D, Abunimeh M, Renjifo B, Reindel R, Cohen D, Martin P. Treatment with

ombitasvir/paritaprevir/and dasabuvir with ribavirin was not associated with changes in

renal function: An analysis of 1211 patients enrolled in 4 phase 2 and 3 trials. HepDArt

2015, Maui, HI

131. Bernstein D, Landis C, Lawitz E, Luetkemeyer AF, Harris M, Bhore R, Swenson

ES, Ackerman P, Rana K, Dieterich D. Integrated safety analysis of daclatasvir plus

sofosbuvir, with or without ribavirin, in patients with HCV genotype 3 infection.

HepDart 2015, Maui, HI

132. Poordad F, Gordon SC, Asatryan A, Felizarta F, Reindollar RW, Landis C, Fried

MW, Bernstein DE, Ng T, Lin CW, Liu R, Kort J, Mensa FJ. High efficacy of ABT-493

29

and ABT-530 in HCV Genotype 1 infected patients who have failed DAA containing

regimens: The Magellan-1 study. EASL 2016

133. Hassanein T, Vierling J, Reddy KR, Cohen E, Morelli G, Mantry PS, Pockros P,

Wyles D, Bernstein DE, Bennett M, Kemmer N, Zamor PJ, Kumar S, Wang D, Cohen D,

Podsadecki T, Lawitz E. Treatment of HCV genotype 1 infection in patients with severe

or end stage renal disease including patients with cirrhosis. EASL 2016

134. Gane EJ, Nguyen M, Kwo P, Kowdley K, Reau N, Jacobson I, Curry M, Pearlman

B, Khalid O, Everson G, Gordon S, Poulos J, Sheikh A, Bernstein D, Yang J, Stamm L,

An D, Dvory-Sobol H, Brainard D, McHutchison JG, Tong M, Tsai N, Beavers KL,

Rabinowitz M, Shiffman M, Stedman C, Lawitz E. Short-duration treatment with

Sofosbuvir/velpatasvir plus GS-9857 in treatment naïve genotype 1-6 HCV infected

patients with or without cirrhosis. EASL 2016

135. Kowdley KV, Angus P, Bernstein D, Bronowicki D, Leroy V, Pockros P, Bhore R,

Rena K, Jimenez-Esposito MJ. All oral treatment with daclatasvir plus sofosbuvir +

ribavirin in HCV genotype 3 infected patients with advanced fibrosis or cirrhosis: an

analysis of ALLY3 and ALLY 3+. EASL 2016

136. Bernstein DE, Lee S. Access to direct acting anti-viral therapies for HCV infection:

an analysis to various DAA therapies and copays by select insurance carrier. Am J Gastro

2016. P442

137. Bernstein DE, Lee S, Lee TP. An analysis of virological failure patients treated for

hepatitis C with direct acting anti-viral therapy in a community based practice: is the real

world like clinical trials. Am J Gastro 2016; P1984

138. Hung CK, Bernstein DE, Fan C, Lee TP. Malignant cholangiocarcinoma arising

from biliary hamartoma: a rare and potentially misdiagnosed entity. Am J Gastro 2016.

P1290

139. Patel A, Bernstein D, Lee TP. Fulminant hepatic failure secondary to hepatitis A in a

patient with non-alcoholic fatty liver disease. Am J Gastro 2016; P 2054

140. Grebely J, Jacobson I, Kayali Z, Verna E, Shiffman ML, Hyland RH, Stamm LM,

Huang KC, Brainard DM, McHutchison JG, Pol S, Chung R, BernsteinD, Dore G.

SOF/VEL/VOX for 8 or 12 weeks is well tolerated and results in high SVR12 rates in

patients receiving opioid substitution therapy. EASL 2017

141. Hirschfeld G, Bowlus C, Harrison S, Galambos C, Borg B, Gordon S, Gitlin N,

Hassanein T, Odin J, Bacon B, Bernstein DE, Vierling J, Steinberg A, Choi YJ, Varga M,

Martin R, McWherter C, Boudes P, Jones D. Treatment efficacy and safety of low dose

seladelpar, a selective PPAR- agonist in patients with primary biliary cholangitis: 12

30

week interim analysis of an international, randomized, dose ranging phase 2 study.

(Abstract LB-4) Hepatology 2017 (December)

142. Hirschfeld G, Boudes P, Bowlus C, Gitlin N, Galambos C, Harrison S, Gordon S ,

Aspinell R, Dorffell Y, Kremer A, Bacon B, Berg C, Borg B, Hassanein T, Odin J,

Shiffman M, Thuluvath P, Thorbourn D, Bernstein DE, Buggisch P, Corless L, Levy C,

Mayo M, Swain M, Vierling J, Worns M, Steinberg S, Sandrin B, Choi YJ, Varga M,

Martin R, McWherter C, Jones D. Treatment efficacy and safety of seladelpar, a selective

PPAR- agonist in patients with primary biliary cholangitis: 12 and 24 week analysis of

an ongoing, international, randomized, dose ranging phase 2 study. J Hep 2018 (LB

abstract EASL 2018)

143. Bernstein D, Lee S, Lee TP, Tiev M. Direct acting anti-viral therapies are safe and

effective in octogenarian patients with chronic HCV infection. Gastroenterology 2018.

144. Patel AV, Ashamalla M, Jotwani P, Bernstein D. Lee TP. Surveillance for

hepatocellular carcinoma in the elderly: An opportunity to improve. Gastroenterology

2018.

145. Levy C, Bowlus C, Carey E, DeMuth G, Deane K, Mayo M, Kim WR, Bacon B,

Bernstein D, Thuluvath P, Weiss LM, Fried M. Primary biliary cholangitis in the US:

Clinical characteristics of patients enrolled in Target-PBC. Gastroenterology 2018.

146. Levy C, Bowlus C, Carey E, DeMuth G, Deane K, Mayo M, Kim WR, Bacon B,

Bernstein D, Thuluvath P, Weiss LM, Iloeje U, Erickson M, Strauss M, Fried M. Primary

biliary cholangitis in the US: Real World Effectiveness of Obetacholic acid in Target-

PBC. Gastroenterology 2018.

147. Hung CK, Demabildo M, Bernstein DE, Lee TP. The effectiveness of inpatient

reflex hepatitis C PCR testing in tertiary medical centers. Amer J Gastro 2018; Poster

1492

148. Patel AV, Ashmallah M, Jotwani PM, Demabildo M, Bernstein De, Lee TP.

Implementation of quality improvement measures improve hepatocellular carcinoma

surveillance among individuals with cirrhosis. Amer J Gastro 2018. Poster 1481.

149. Kremer AE, Bowlus C, Neff G, Aspinl R, Galambos M Goel A, Hirschfeld G, Mayo

M, Swain M, Borg B, Dorffel Y, Gordon S, Harrison S, Jones D, Thuluvath P, Levy C,

Sheridan D, Stanca C, Bacon B, Berg C, Hassanein T, Odin J, Shiffman M, Thorburn D,

Vierling J, Bernstein D, Buggish P, Corless L, Landis C, Peyton A, Shah H, Worns MA,

Gitlin N, Steinberg S, Bergheanu S, Amato G, Choi YJ, Rosenbusch S, Varga M,

McWherter C. Boudes P. Effect of seladelpar on pruritus in PBC : 26 week analysis of on

going international, randomized, dose ranging phase 2 study. Hepatology 2018, Poster

presentation AASLD 2018 LB-26

31

150. Bowlus C, Neff G, Aspinall R, Galambos M, Goel A, Hirschfeld G, Kremer A,

Mayo M, Swain M, Borg B, Dorffel Y, Gordon S, Harrison S, Jones D, Thuluvath P,

Levy C, Sheridan D, Stanca C, Bacon B, Berg C, Hassanein T, Odin J, Shiffman M,

Thorburn D, Vierling J, Bernstein D, Buggish P, Corless L, Landis C, Peyton A, Shah H,

Woerns M, Gitlin N, Steinberg A, Bergheanu S, Amato G, Choi YJ, Rosenbusch S,

Varga M, McWherter C, Boules P. Efficacy and safety of seladelpar, a selective PPAR

delta agonist, in PBC: 52 week analysis of an ongoing international randomized dose

ranging phase 2 study. AASLD 2018, LB-3

REVIEWER FOR PEER REVIEW JOURNAL

Gastrointestinal Endoscopy 1996 -

American Journal of Gastroenterology 1998-

Federal Practitioner 1997-

Annals of Internal Medicine 1998-

Internal Medicine 1997-

American Family Physician 2001-

PharmacoEconomics 2002-

Journal of Hepatology 2002-

Medical Science Monitor 2003-

Hepatology 2002-

Gastroenterology 2003-

Journal of Substance Abuse Treatment 2007-

SELECTED INVITED LECTURES

ACG Hepatology School

Washington, DC

Assessment and Treatment of chronic hepatitis C

32

Primary Biliary Cholangitis and Primary Sclerosing Cholangitis

June 7, 2019

Queens Hospital Center

Medical Grand Rounds

Fatty Liver Disease

April 17, 2019

APASL Single Topic Conference

Beijing, China

Licensed therapies and experimental new agents for PBC

December 7, 2018


Nashville, TN

1. HCV- Treatment and Post-treatment follow up

2. Primary Biliary Cholangitis

November 30, 2018

Current Issues in GI and Liver Disease

Uniondale, NY

So Long C, Hello B

November 3, 3018

ACG Annual Scientific Meeting

Breakfast Session F: Autoimmune Liver Disorders:

PBC, PSC and Autoimmune Hepatitis

Philadelphia, PA

October 9, 2018

ACG Postgraduate Course

Learning Lunch: Hepatitis B Reactivation

Philadelphia, PA

October 7, 2018

ACG Postgraduate Course

Session 1B: NAFLD/NASH

Philadelphia, PA

October 6, 2018

ACG Midwest Regional Postgraduate Course

Indianapolis, IN

33

1. Hepatitis C treatment: drug therapy and long term follow up for HCC

2. What’s New in Cirrhosis Management: Medications, treatment complications, and

referral for transplantation

August 25, 2018

ACG Hepatitis School

Indianapolis, IN

1. HCV- Treatment and post-treatment follow up

2. Metabolic Liver Disorders

3. Primary Biliary Cholangitis

August 24, 2018

DDW 2018

State of the Art Lecture: 100% HCV Cure: Influencing Society to Treat

8-9 AM

Washington, DC 2018

June 3, 2018

New York State 2018 Clinical Conference on HIV and HCV

Hepatitis C Treatment in 2018

Rochester, NY

April 27, 2018

Canadian Association of Gastroenterology Annual Meeting

Toronto, Canada

Managing Complications of End-Stage Liver Disease Symposium – Moderator

February 11, 2018

Canadian Association of Gastroenterology Annual Meeting

Toronto, Canada

What’s New in Viral Hepatitis Symposium – Moderator

Topic: Update on the Treatments of Hepatitis C and access to care

February 10, 2018

Coney Island Hospital


Hepatitis C in 2018

February 1, 2018

NYSGE Annual Meeting

NY, NY

Topic: HCV Treatment Guidelines

December 13, 2017

34

Northwell Health Division of Endocrinology

Grand Rounds

NASH: an update

December 1, 2017

Brooklyn Hospital Center


Hepatitis C

November 21, 2017

Japan Society of Anesthesia

Tokyo, Japan

The use of remimazolam in Procedural Sedation

November 3, 2017


Northwell Health Forest Hills

Hepatitis B

October 4, 2017

Emerging Topics in Liver Disease

Houston, TX

State of the Art Lecture: Hepatitis B

September 16, 2017

Bockus International Society of Gastroenterology Annual Meeting

Warsaw, Poland

State of the Art Lecture: Hepatitis C

June 9, 2017

Endocrinology Grand Rounds

Northwell Health

Update on Hepatitis C

March 24, 2017

New York State Commissioner of Health Medical Grand Rounds

SUNY-Upstate

Baby Boomer Health: Undiagnosed Conditions of Persons born between 1945-1965:

Epidemiology of Hepatitis C in New York State

March 21, 2017

Lenox Hill Hospital Medical Grand Rounds

Update on HCV

35

March 17, 2017


Las Vegas, NV

1. Treatment of Hepatitis C genotype 1

2. Hepatic Encephalopathy

March 10, 2017

ACG Southern Regional Course

Nashville, TN

Primary Care for the Patient with Cirrhosis

December 3, 2016


Nashville, TN

1. Treatment of Hepatitis C Genotypes 2, 3 and 4

2. HCV and renal disease

December 2, 2016

Northwell Women’s Health Conference

Liver Wellness in Women

October 22, 2016


North Shore Hospital Forest Hills

Update on HCV

October 5, 2016


Minneapolis, MN



August 26, 2016

ACG Regional Course

Washington, DC

Acute on Chronic Liver Disease

June 26, 2016


Washington, DC



36

7. Treatment of Hepatitis B

June 24, 2016

NYC Department of Health

Long Island City, New York


June 21, 2016


Brooklyn, NY

Update on the Treatment of Hepatitis B

June 10, 2016

New York American College of Physicians Annual Meeting

Westchester, NY

Update in the management and diagnosis of hepatitis C or Wow, we did it!

June 4, 2016

Gastroenterology Grand Rounds

Huntington Hospital, NY

NASH: An update in 2016

June 3, 2016

Association of Chinese American Physicians

Flushing, NY

Advances in the Treatment of Hepatitis B and C

May 22, 2016

Gulf Congress of Clinical Microbiology and Infectious Diseases

Dubai, UAE

Viral Hepatitis: Can we eradicate it globally soon?

May 5, 2016

Gulf Congress of Clinical Microbiology and Infectious Diseases

Dubai, UAE

Hepatitis C: The Dream of Cure

May 5, 2016

National Kidney Foundation

New York, NY

Hepatitis C: New therapies, new controversies

March 24, 2016

37



March 23, 2016

Liver Disease in Women

ACG Governors/ASGE Best Practice Course

Scottsdale, AZ

January 30, 2016

Hepatitis C in Special Populations

NYSGE Annual Course

Manhattan, NY

Renal disease and HCV

December 18, 2015

HepDart

Maui, HI

Access to hepatitis C therapies

December 6, 2015


Nashville, TN



Diagnosis and staging of chronic liver disease

December 4, 2015

Kings County Medical Center

Infectious Diseases Grand Rounds

Updated Treatment Guidelines for HCV Infection

December 2, 2015

SUNY-StonyBrook University Hospital

StonyBrook, NY


Hepatitis C Genotype 3

November 4, 2015

Henry Ford Hospital

Detroit, MI


38

Access to Hepatitis C Therapies

October 29, 2015

Henry Ford Hospital

Detroit, MI


Treatment of Renal Disease in Chronic Hepatitis C

October 29, 2015

Bockus International Society of Gastroenterology

Lima, Peru

Hepatitis B: Current and Future Therapies

October 2, 2015


Boston, MA

Treatment of Hepatitis C Genotypes 2, 3 and 4

Side effects of hepatitis therapies


June 12, 2015


Las Vegas, NV

Treatment of Hepatitis C Genotypes 2, 3 and 4

Side effects of hepatitis therapies


January 23, 2015

Hepatobiliary Disease in Clinical Practice

Update XXI

Miami, FL

Access to Hepatitis C Therapy

March 13, 2015

Medicine Grand Rounds


Update on HCV

November 26, 2014

Viral Hepatitis Update

Honolulu, Hawaii

39

HCV evaluation and treatment

November 15, 2014

Medicine Grand Rounds


The future of HCV infection is here

November 4, 2014

Ohio Gastroenterology Society Annual Meeting

Columbus, Ohio

Hepatitis C: The past, present and future

September 6, 2014


Cairo, Egypt

DAA’s and liver fibrosis

June 12, 2014


Cairo, Egypt

DAA’s in chronic hepatitis C, what is in the pipline

June 13, 2014

Infectious Disease Grand Rounds



January 31, 2014

Current Issues in GI and Liver Disease 2013

North Shore LIJ Health System

Update in Hepatitis C Management

November 16, 2013

Current Issues in GI and Liver Disease 2013


Moderator: Liver Disease Session

November 16, 2013


Update in Hepatitis C Management

November 16, 2013


40

Nassau University Medical Center

October 29, 2013

Update of Hepatitis C

CHCANYS Annual Meeting

October 26, 2013

Saratoga, NY

Update on Hepatitis C: 2013

Endocrine Grand Rounds

North Shore-LIJ HYealth System

October 24, 2013

Non-Alcoholic Fatty Liver Disease

ACG Annual Meeting

Hepatitis C Symposium

New Treatments for Hepatitis C

October 14, 2013

San Diego, CA



June 18, 2013

Topic: New therapies for hepatitis C



November 27, 2012

Topic: Update in Hepatitis C

Viral Hepatitis in Hawaii-2012

November 17, 2012

Topic: The Evaluation of the Hepatitis C Patient Prior to Therapy


North Shore-Forest Hills

5/16/2012

Topic: Update in Hepatitis C

2nd Annual HIV Clinical Care Symposium

Sponsored by Albany Medical College and the New York State Department of Health

4/25/2012

Bolton Landing , NY

Topic: Hepatitis C Treatment in the Co-infected Patient

41

NYS Department of Health Viral Hepatitis Conference

Manhattan, NY

Topic: Hepatitis C Virus: A guide to pre-treatment evaluation

March 20, 2012

American College of Gastroenterology 2012 Best Practices / Governor’s Course

Huntington Beach, CA

1/28/2012

Topic” Protease Inhibitors in Hepatitis C



Hepatitis C

September 1, 2011

Long Island Regional Hepatitis C Task Force Kick-Off Meeting

Lindenhurst, NY

Keynote Speaker-Hepatitis C Burden of Disease

February 17, 2011

Lenox Hill Hospital

Manhattan, NY

Topic: Hepatitis B

GI Grand Rounds

October 26, 2010

North Shore University Hospital/Long Island Jewish Medical Center

Manhasset, NY

An Update on Hepatitis C

August 19, 2010

Richmond University Medical Center

Staten Island, NY

CPC Discussant

April 27, 2010


Marrakesh. Morocco

Topic: Percutaneous Gastrostomy Tubes in a Community Hospital

March 18, 2010

42


Queens Hospital

Topic: Update on the Management of Hepatitis C

June 4, 2008

Nassau University Hospital Medical Center

19th Annual Symposium

Issues in HIV Care: 2008 Update

Topic: Hepatitis B and C Management

June 3, 2008

ACG/FGS 2008 Regional Course

Key West, Florida

Topic: Update on Hepatitis C

NASH: An Update

March 29, 2008

NYS Department of Health Symposium

New York, NY

Topic: Hepatitis C: Is it curable

March 25, 2008

ACG 2008 Regional Course

NYC, NY

Topic: Hepatitis C: What do to in the Non-Responder

March 16, 2008

ACG 2008 Regional Course

NYC, NY

Topic: Difficult Cases in Chronic Hepatitis

March 15, 2008

Pediatric Gastroenterology Grand Rounds

Schneider Children’s Hospital

Topic: Update on Hepatitis C

March 14, 2008



Topic: Wilson’s Disease

March 13, 2008


43

North Shore University Hospital- Huntington

Topic: New Developments in Chronic Hepatitis C Therapy

January 18, 2007



Topic: New Developments in Chronic Hepatitis C Therapy

October 19, 2006

New York City Department of Health

Viral Hepatitis Symposium

Topics: 1. Management of Hepatitis C Infection

2. Managing Hepatitis C-Hepatitis B-HIV

October 13, 2006

Mt Sinai Medical Center

2nd Annual Hepatology Update: Science in the City

Mt Sinai Medical Center

October 7, 2006


Southside Hospital

Topic: Advances in the Treatment of Hepatitis C

May 5, 2006


Topic: Hepatitis B

Dominican Republic

February 2006

Keynote Speaker

Costa Rica Gastroenterological Association

San Jose, Costa Rica

Topic: Hepatitis B


NSUH-Plainview

Update in Liver Transplantation

2005


LIJ Medical Center

Hepatitis B

44

2005


Albany Medical Center

Hepatitis B

2005

Detroit Gut Club

Advances in the Treatment of Hepatitis C

2005

New York State Society of Physician Assistants Annual Meeting


2005

National Association of Community Physicians Annual Meeting

Keynote Speaker


Denver, Colorado

2005

Mt Sinai Medical Center Annual Update in Hepatology

Update on Hepatitis B

2005

Albany Gut Club

Update on the Treatment of Hepatitis B

2005

NSUH Dental Grand Rounds


2005


Peninsula Medical Center

Topic: Treatment of Hepatitis C

October 21,2004

Vietnam Association for the Study of Liver Diseases

Ho Chi Minh City, Vietnam

Effectiveness of recombinant factor VIIa in patients with the coagulopathy of advanced

Child’s B and C Cirrhosis

September 10, 2004

45

Portugese National Congress of Gastroenterology

Figueira da Foz, Portugal

State of the Art lecture


June 4, 2004

Update on Liver Transplantation


South Nassau Communities Hospital

April 27, 2004

Update on Liver Transplantation

Surgical Grand Rounds

North Shore University Hospital-Plainview

March 16, 2004

Management of Hepatitis C

Sociedad Dominicana De Gastroenterologia

XII National Congress

Punta Cana, Dominican Republic

December 14, 2003

Management of Hepatitis B

Sociedad Dominicana De Gastroenterologia

XII National Congress

Punta Cana, Dominican Republic

December 14, 2003

An Update of the Evaluation and Management of Hepatitis C

Orange County Gastroenterology Society

December 9, 2003

Internet Audio Conference

September 25, 2003

Topic: Hepatitis C: Diagnosis and treatment of a silent epidemic

Transmitted to 163 hospitals around continental United States


Wycoff Hospital

46

Topic: Hepatitis A and B Vaccination

August 5, 2003


North Shore University Hospital – Plainview

Topic: Liver Transplantation

May 1, 2003


Albany Medical Center

Topic: An Update on Hepatitis C

May 8, 2003


University of Texas-Antonio

Topic: An Update on Hepatitis C

March 6, 2003


Long Island Jewish Hospital

Topic: Hepatitis C

February 21, 2003

Surgical Grand Rounds

North Shore Hospital-Plainview

Topic: Liver transplantation

October 15, 2002



Topic: Hepatitis C

September 26, 2002


Stamford Hospital

Topic: Advances in the Understanding of Hepatitis C

April 17, 2002


SUNY-Downstate School of Medicine


March 12, 2002

47


SUNY-Downstate School of Medicine


March 12, 2002


The Reading Hospital


March 6, 2002


Hackensack University Hospital


March 5, 2002


Atlantic City Medical Center

Topic: Extrahepatic manifestations of hepatitis C

January 14, 2002


Nassau University Hospital

Topic: HIV and HCV Co-infection

January 3, 2002


Bronx, VA Medical Center


December 28, 2001

Surgical Pathology Grand Rounds

North Shore University Hospital-Manhasset

Advances in the Treatment of Liver Diseases

November 7, 2001


Long Beach Hospital

September 21, 2001

Topic: Hepatitis C


Peninsula Hospital

48

September 9, 2001

Topic: Hepatitis C


North Shore University Hospital-Manhasset

August 23, 2001

Topic: Hepatitis C

Management of Chronic Hepatitis C Infection

11th European Congress of Clinical Microbiology and Infectious Diseases

Istanbul, Turkey

March 2001


Coney Island Hospital

March 15, 2001

Topic: Portal Hypertension


Long Island College Hospital

March 1, 2001

Topic: Portal hypertension


North Shore University Hospital-Huntington

February 2, 2001



North Shore University Hospital-Forest Hills

February 15, 2001

Topic: Hepatitis C


St John’s Hospital

January 12, 2001

Topic: Hepatitis C


North Shore University Hospital at Glen Cove

September 26, 2000

Topic: Hepatitis C

Bockus International Society of Gastroenterology Meeting

49

Barcelona, Spain

September 15-18, 2000

Topic: Update on the Treatment of Chronic Hepatitis C

ADAP 2000. National AIDS Drug Assistance Educational Forum

Washington, DC

June 12, 2000

Topic: Update on the treatment of HCV/HIV

South Nassau Communities Hospital

Oceanside, NY


Topic: Hepatitis C

April 14, 2000

North Shore University Hospital at Forest Hills

Forest Hills, NY


Topic: Hepatitis C

February 15, 2000


Manhasset, New York


Topic: Hepatitis C

September 27, 1999

North Shore University Hospital at Plainview

Plainview, NY


Topic: Hepatitis C

September 8, 1999

Hackensack Medical Center

Hackensack, NJ


Topic: Hepatitis C

June 3, 1999

Montefiore Medical Center

Bronx, NY


Topic; Portal Hypertension

50

February 25, 1999

Brookhaven Memorial Hospital

Patchogue, New York


Topic: Hepatitis C

January 28, 1999

New York University Hospital

New York, NY

GI Grand Rounds


January 26, 1999

West Palm Beach VA Medical Center

West Palm Beach, FL



January 6, 1999

Flushing Hospital

Flushing, NY



December 22, 1998

Bronx Lebanon Hospital

Bronx, NY



December 3, 1998

NBC Nightly News

December 1, 1998

Interview: Hepatitis C

Course Director, Symposium on Hepatitis C

New York Palace Hotel

November 20, 1998

Staten Island Hospital

Staten Island, NY


Topic: Hepatitis C

51

October 27, 1998

Moses Taylor Hospital

Scranton, PA


Topic: Autoimmune Liver Disease

July 1, 1998

Wycoff Hospital

Brooklyn, NY


Topic: Hepatitis C

June 9, 1998

Peninsula Hospital

Queens, New York


Topic: Hepatitis C

May 12, 1998

Long Beach Hospital

Long Beach, NY


Topic: Hepatitis C

April 23, 1998

Long Beach Hospital

Long Beach, NY


Topic: Hepatitis B

April 7, 1998

Flushing Hospital

Flushing, NY


Topic: Hepatitis C

March 10, 1998

Texas Tech Medical Center at Amarillo

Amarillo, Texas



February 11, 1998

52

LSU Medical Center

Shreveport, Louisiana


Topic: Hepatitis C

February 10, 1998

Winthrop-University Hospital

Update in Gastroenterology

Garden City Hotel, NY

Topic: Hepatitis C

December 6, 1997


Bayonne Hospital, Bayonne NJ

Topic: Hepatitis C

December 7, 1997


Long Island Jewish Medical Center

New Hyde Park, NY


November 17, 1997


Baystate Medical Center

Springfield, MA

Topic: Hepatitis C

October 15, 1997


Huntington Hospital


October 16, 1997


Mid-Island Hospital

Bethpage, NY

Topic: Autoimmune Hepatitis

October 13, 1997


Mount Sinai Medical Center

Miami Beach, FL

53


September 12, 1997

OB-GYN Grand Rounds


Mineola, NY

Topic: Liver Disease in Pregnancy

August 8, 1997


Guthrie Clinic

Sayer, PA

Topic: Hepatitis C

July 25, 1997


Franklin General Hospital

Franklin Square, NY

Topic: Hepatitis C

June 26, 1997

American College of Physicians-Winthrop University Hospital

Internal Medicine Board Review

May 14, 1997

Topic: Hepatitis


Mt Sinai-Elmhurst Hospital

Queens, NY

Topic: Hepatitis C

April 28, 1997

West Indian Gastrointestinal Association

Ocho Rios, Jamaica

Topic: Hepatitis C

April 25, 1997

Chilton Memorial Hospital GI Grand Rounds

Wayne., NY

Topic: Hepatitis C

April 14, 1997

Nassau County Medical Center

OB/GYN Grand Rounds

54

Mineola, NY


April 8, 1997


Vascular Surgery Grand Rounds

Mineola, NY

Topic: Update on the Treatment of Portal Hypertension

February 10, 1997

New Jersey College of Medicine and Dentistry

OB/GYN Grand Rounds

Topic: Hepatitis C

February 5, 1997

Brookhaven Memorial Hospital


Topic: Hepatitis C

January 24, 1997

Hempstead General Hospital


Topic: Hepatitis C

1/21/97

Peninsula General Hospital


Topic: Hepatitis C

1/16/97

A.G. Holly Hospital, Lantana, FL

Grand Rounds

Topic: Drug Induced Hepatitis, TB and Hepatitis C

1/15/97



Topic: Update on the Treatment of Hepatitis B and C

December 18, 1996

Queens Hospital Center of Mt. Sinai Hospital, Queens NY


Topic: Hepatitis C

November 21, 1996

55

North Shore University Hospital at Syosset


Topic: Hepatitis C

November 14, 1996

Sobelsohn School CME Lecture Series

Radisson Empire Hotel, NYC, NY

October 14, 1996

Topic: Natural History of Hepatitis C

Sobelsohn School CME Lecture Series

Garden City Hotel, Garden City, NY

October 3, 1996


Mid-Island Hospital CME Lecture Series

Plainview, NY

October 1, 1996

Topic: Hepatitis C

American College of Physicians-Winthrop University Hospital

Internal Medicine Board Review

May 16, 1996

Topic: Hepatitis

Sylvester Cancer Center Japanese Clinical Exchange Program #3411, University of Miami

April 9, 1996

Topic: Coagulation disorders in liver disease


Hollywood Memorial Hospital, Hollywood FL

March 27, 1996

Topic: Hepatitis C

Cedars Medical Center, Miami FL

Update in Gastroenterology and Hepatology

March 23, 1996

Topic: Coagulation Disorders in Liver Disease


Baptist Memorial Hospital, Miami FL

March 20, 1996

Topic: Update in Viral Hepatitis

56

IV Annual Selected Topics in Gastroenterology. Gastroenterology Group of South Florida

February 10, 1996

Topic: Hepatitis C

Collier County Health Center, Immokalee, Florida

December 8, 1995 Grand Rounds

Topic: Hepatitis C


November 12, 1995

Topic: Coagulation disorders in liver disease

Third Symposium on New Aspects of Haemophilia Treatment, Copenhagen, Denmark

September 23, 1995

Topic: Factor VIIa in liver disease


September 19, 1995

Topic: Autoimmune Hepatitis


March 21, 1995

Topic: Autoimmune Hepatitis/PBC

Lawnwood Memorial Hospital--Medical Grand Rounds

August 24, 1995

Topic: Hepatitis C

Gandhi Medical College, Hyderabad, India December 23, 1994

Topic: TIPS

Indian Society of Gastroenterology, A.P. Chapter, Hyderabad, India

December 17, 1994


SHARE/University of Pittsburgh Review of Internal Medicine, Hyderabad, India

December 16, 1994

Topic: TIPS

Robert Wood Johnson School of Medicine, Division of Gastroenterology, Grand Rounds

October 14, 1994

Topic: Chronic Hepatitis C and its Treatment

57

ZymoGenetics, Seattle, WA September 27, 1994

Topic: Prevalence of Liver Disease in the United States

21st Annual Board Review Course in Internal Medicine, University of Miami School of

Medicine August 1994

Topic: 1. Cirrhosis and its Complications

2. Pearls in Hepatology

Cedars Medical Center, Miami Florida Grand Rounds March 2, 1994

Topic: Push Enteroscopy

VISITING PROFESSORSHIPS

Medinova Medical Center, Hyderabad, India

December 1994 - Therapeutic ERCP

RESEARCH EXPERIENCE

Foundation Grants

Gilead Foundation: Universal hepatitis screening in primary care and linkage with therapy. 2017-

2020 $2,119,672

Industry Sponsored

1. A Multicenter Double-Blinded Study in Non-Cirrhotic Patients with Chronic Hepatitis C Who

are Non-Responders to Prior Interferon Alfa or Interferon Alfa+Ribavirin Therapy, Comparing

Treatment with Thymosin Alfa-2a with Peginterferon Alfa-2a + Placebo: Protocol T1-CHC-

2K0803a

2. A Multicenter Double-Blinded Study in Patients with Compensated Cirrhosis Due to Chronic

Hepatitis C who are Non-Responders to Prior Interferon Alfa or Interferon Alfa+Ribavirin

Therapy, comparing treatment with Thymosin Alfa 1 + PEG interferon Alfa-2a with PEG

interferon Alfa-2a + Placebo: Protocol T-CHC-2K0804

3. An Open-Label, Multicenter Protocol, Providing Pegylated Interferon Alfa-2a (PEGASYS) as

Monotherapy or in Combination with Ribavirin (COPEGUS) for Patients with Chronic Hepatitis

C Who Have Participated in Previous Roche Protocols: Protocol NV17590D Roche

58

4. Randomized, Multicenter, Open Label, Phase IV Study Evaluating the Efficacy and Safety of

16-Week Treatment with PEGASYS in Combination with COPEGUS in Interferon-Naïve

Patients with Chronic Hepatitis C Genotype 2 or 3 Virus Infection: Protocol NV17317 Roche

5. Randomized Multicenter, Double-Blind, Phase IV Pilot Study Evaluating the Effect of

PEGASYS dose of 180mg or 270 mg in Combination with COPEGUS doses of 1200 mg or

1600 mg on Viral Kinetics, Virological Response, Pharmacokinetics, and Safety in Interferon-

naïve Patients with Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and

Body Weight Greater than 85K: Protocol NV17318 Roche

6. A Phase 2b Study of Merimepodib in Combination with Pegylated Interferon Alfa-2a

(PEGASYS) and Ribavirin in Subjects with Chronic Genotype 1 Hepatitis C Non-Responsive to

Prior Therapy with Pegylated Interferon Alfa and Ribavirin: Protocol VX03-497-205 Vertex

7. An Open Label, Multicenter, Efficacy and Safety Study of PEGASYS + Ribavirin in Patients

with Chronic HCV Infection Who Are Unable to Tolerate or Who do not Respond to 12 Weeks

of Therapy with PEGIntron + Ribavirin: Protocol ML16965

8. Phase III Randomized, Placebo-Controlled Study of Sorafenib in Patients with Advanced

Hepatocellular Carcinoma: Protocol 100554 Bayer

9. A Randomized, Double-Blind Study of GT267-004 vs. Vancomycin, and GT267-004 vs.

Metronidazole, in Patients with C. Difficile-Associated Diarrhea: Protocol GD3-170-301

Genzyme

10. Cumulative Meta-analysis of Individual Patient Data: Efficacy of Pegylated Interferon

Treatment Regimens in Chronic HCV: Protocol HEP C ScheringPlough

11. A Double-Blind, Randomized, Controlled Trial of Rifaximin Compared to Vancomycin for

the Treatment of Clostridium Difficile-Associated Diarrhea: Protocol RFCL3001

12. An Open-Label, Multicenter Protocol Providing Pegylated Interferon Alfa-22 (PEGASYS) as

Monotherapy or in Combination with Ribavirin (COPEGUS) for patients with Chronic Hepatitis

C who have Participated in Previous Roche Protocols: Protocol NV17590 Roche

13. A Randomized, Multicenter, Double Blinded, Phase IV Study Comparing the Safety and

Efficacy of Pegasys 180 ug plus Copegus 1000 or 1200mg to the Currently Approved

Combination of Pegasys 180ug plus Copegus 800mg in Interferon-naïve Patients with Chronic

Hepatitis C Genotype 1 Virus infection Co-infected with Human Immunodeficiency Virus (HIV-

1): Protocol NV18209 Roche

14. A Phase III, Randomized, Open-Label Study of the Safety and Efficacy of Two Dose Levels

of Interferon Alfacon-1 (Infergen, CIFN) plus Ribavirin Administered Daily for 48 Weeks vs.

59

No-treatment in Hepatitis C Infected Patients Who Are Non-responders to Previous Pegylated

Interferon Alfa plus Ribavirin Therapy: Protocol IRHC-001 Valeant formerly Intermune

15. A Phase III, Randomized, Open-Label Study of the Safety and Efficacy of Two Dose Levels

of Daily Interferon alfacon-1 Plus Ribavirin in Hepatitis D Infected Patients Who Failed to

Achieve Virologic Response After Previous Pegylated Interferon Alfa plus Ribavirin Therapy

and During at Least 24 Weeks of No Treatment in IRHC-001: Protocol IRHC-002 Valeant

formerly Intermune

16. A 6-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study, to Assess the

Efficacy and Safety of Tegaserod (6mg bid) and Placebo in Female Patients with Dyspepsia:

Protocol CHTF919D2302 Novartis

17. A Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF vs. Adefovir

Dipivoxil for the Treatment of Presumed Pre-Core Mutant Chronic Hepatitis B: Protocol GS-US-

174-0102 Gilead

18. A Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF vs. Adefovir

Dipivoxil for the Treatment of HBeAG Positive Chronic Hepatitis B: Protocol GS-US-174-0103

Gilead

19. Comparison of PEG-Intron 1.5ug/kg/wk Plus REBETOL vs. PEG-Intron 1 ug/kg/wk Plus

REBETOL vs. PEGASYS 180ug/wk Plus COPEGUS in Previously Untreated Adult Subjects

with Chronic Hepatitis C Infected with Genotype 1: Protocol P03471a Schering Plough

20. Randomized, Double-blind Multicenter Study of Visilizumab vs. Placebo in subjects with

Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study:

Protocol PDL 291-417 Valeant

21. A Phase II, Randomized Double-Blind, Multicenter, Dose Exploration Study of Visilizumab

in Subjects with Intravenous Steroid Refractory Ulcerative Colitis Visilizumab: Protocol PDL

291-418 Protein Design Lab

22. Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of

Viramidine to Ribavirin in Treatment-Naïve Patients with Chronic Hepatitis C: Protocol

RNA003142-301 Valeant

23. Randomized, Double-Blind Multicenter Study to Compare the Safety and Efficacy of

Viramidine to Ribavirin in Treatment-Naïve Patient with Chronic Hepatitis C: Protocol

RNA003142-302 Valeant

24. A Phase 2 Study of Vx950 in Combination with Peginterferon Alfa-2a (Pegasys) with and

without Ribavirin (Copegus) in Subjects with Hepatitis C: Protocol VX950-104 Vertex

60

25. A Double blind randomized placebo controlled multicenter, phase II parallel dose ranging

study to assess the antifibrotic activity of G1262570 in Chronic Hepatitis C subjects with hepatic

fibrosis who have failed prior antiviral therapy: Protocol FBX104114 GSK

26. A phase II randomized multicenter double blind study evaluating the safety and tolerability

of the HCV polymerase inhibitor prodrug (RO4588161) when given in combination with

Pegasys with or without Copegus vs. the currently approved combination with Pegasys and

Copegus in treatment-naïve patients with chronic hepatitis C genotype 1 virus infection:

Protocol# PV18369 Roche

27. A double blind, randomized placebo controlled study of adefovir dipivoxil for the treatment

of patients with HbeAg+ chronic hepatitis B virus infection. GS98437. Sponsor: Gilead Sciences

28 Infergen treatment of hepatitis C patients with persistently normal alaine aminotransferase

levels. 980263. Sponsor: Kenneth Sherman, MD/ Amgen

29. A randomized, open label, multicenter, efficacy and safety study of Pegasys plus amantadine,

and Pegasys plus amantadine plus ribavirin, and comparison of Rebetron with Pegasys plus

|cellcept, as initial treatment in patients with chronic hepatitis C infection. NR15953. Sponsor:

Roche

30. A Phase III, Randomized, multicenter, Efficacy and Safety Study Examining the Effects of

the Duration of Treatment and the Daily Dose of Ribavirin in Patients with Chronic Hepatitis C

Virus Infection Treated with the combination of Peginterferon alfa-2a and Ribavirin. Protocol

NV15942. Sponsor: Roche

31. A randomized, open label, multicenter, efficacy and safety study of Pegasys plus ribavirin,

Pegasys plus cellcept, Pegasys plus amantadine, or Pegasys plus amantadine plus ribavirin in

patients with chronic HCV infection who relapsed on Rebetron therapy. NR 15954. Sponsor:

Roche

32. A protocol for re-treatment with the combination of peginterferon alfa-2a and ribavirin for

patients with chronic hepatitis C in original study NV15942 who relapsed virologically after

completing 24 weeks of treatment. WV16143. Sponsor: Roche

33. A Randomized, Partially-Blinded, Multicenter, Phase II Study Investigating the Efficacy and

Safety of Peginterferon alfa-2a (Ro 25-8310) and Peginterferon alfa-2a with Ribavirin (Ro 20-

9963) in Treatment -Naive Patients with Chronic Hepatitis C Coinfected with Human

Immunodeficiency Virus NR16155. Sponsor: Roche

34. An open-label randomized, parallel-group study comparing the effectiveness of Procrit

(Epoetin alfa) administered once weekly versus standard of care in hepatitis C/HIV co-infected

patients treated with combination ribavirin/interferon. PR99-30-033. Sponsor: Ortho Biotech

Products

61

35. Comparison of PEG Interferon alfa-2b plus Ribavirin Given as a Fixed Dose or on a Weight

Optimized Basis for Treatment of Chronic Hepatitis C in Previously Untreated Adult Subjects.

IND # 9243 Sponsor: Ira Jacobson, MD/ Schering

36. Dose comparison study of PEGInterferon alfa-2b + Ribavirin for patients with chronic

hepatitis C who have not responded to standard interferon + Ribavirin. Sponsor: John Gross,

MD/ Scherring

37. A prospective, randomized, multicenter, open-label, comparative safety study of Pegasys vs.

Pegasys plus ribavirin treatment in patients with chronic hepatitis C. NR16161. Sponsor: Roche

38. An Extension protocol to evaluate the long-term effects of treatment with peg interferon

alfa-2a (PEGIFN) or interferon-based therapies for patients with chronic hepatitis C. Protocol

NV15908. Sponsor: Roche

39. A phase III study of the safety and antiviral activity of entecavir vs. lamivudine in adults

with chronic hepatitis B infection who are negative for hepatitis B e antigen. A1463-027.

Sponsor:Bristol-Myers Squibb

40. A phase III study of the safety and antiviral activity of entecavir vs. lamivudine in adults

with chronic hepatitis B infection who are positive for hepatitis B e antigen A1463-022.

Sponsor:Bristol-Myers Squibb

41. A phase III study of the comparsion of entecavir to lamvudine in chronic hepatitis B subjects

with incomplete response to current lamvudine thjerapy. A1463-26. Sponsor:Bristol-Myers

Squibb

42. A phase II, double-blind, randomized, plcebo-controlled, multicenter study of the safety and

antifibrotic effeicacy of interferon-gamma 1B in patients with severe liver fibrosis or

compensated cirrhosis due to hepatitis C. GILF-001. Sponsor: Intermune

43. A multicenter double-blind study in patients with compensated cirrhosis due to chronic

hepatitis C who are nonresponders to prior interferon alfa or interferon alfa + ribavirin therapy,

comparing treatment with thymosin alpha 1 + peginterferon alfa-2a with peginterferon alfa-2a +

placebo. T1-CHC-2K0804. Sponsor: SciClone

44. A multicenter double-blinded study in non-cirrhotic patients with chronic hepatitis C who are

non-responders to prior interferon alfa or interferon alfa + ribavirin therapy, comparing treatment

with thymosin alpha 1 + peginterferon alfa-2a with peginterferon alfa-2a + placebo. T1-CHC-

2K0803a. Sponsor: SciClone

62

45. A phase IIIB observational study of the durability of seroconversion in patients with chronic

Hepatitis B virus infection who have seroconverted while participating in a previous Gilead-

sponsored study of adefovir dipivoxil. GS 00-481. Sponsor: Gilead Sciences.

46. PegInterferon alpha 2b + ribavirin for treatment of chronic hepatitis C infection in HIV-

infected persons not previously treated with interferon. HRN-005. Sponsor: Hepatitis Resource

Network/ Schering

47. An open label, multicenter, efficacy and safety study of Pegasys plus ribavirin in patients

with chronic HCV infection who are unable to tolerate or who do not respond to 12 weeks of

therapy with PEG-Intron plus ribavirin. ML16965. Sponsor: Roche

48. A randomized, double-blind trial for LdT (Telbivudine) versus Lamivudine in adults with

compensated chronic hepatitis B: NV-02B-007. Sponsor: Idenix Pharmaceuticals, Inc.

49. Randomized, multicenter, open label, phase IV study eva luating the efficacy and safety of

16 week versus 24-week treatment with Pegasys in combination with Copeg us in interferon-

naïve patients with chronic hepatitis C genotype 2 or 3 virus infection. NV17317 C Sponsor:

Roche

50. A randomized, doulble-blind, multicenter stduy comparing the safety and efficacy of

viramidine to ribavirin intreatment-naïve patients with chronic hepatitis C. Sponsor –RibaPharm

51. A double blind, randomized placebo controlled study of adefovir dipivoxil for the treatment

of patients with HbeAg+ chronic hepatitis B virus infection. GS98447 (Gilead)

52. A prospective, randomized, multicenter, open-label, comparative safety study of Pegasys vs

Pegasys plus ribavirin treatment vs twelve week treatment delay in patients with hepatitis C.

(Roche)

53. PEGIntron 1.5 ug/kg a week plus 1200 mg a day of ribavirin versus PEGIntron a week 1.5

ug/kg plus 800 mg a day of ribavirin for the treatment of patients with hepatitis C who have

previously been treated: a multi-center, phase 3b, randomized, efficacy trial (Schering)

54. PEGIntron 1.5 ug/kg a week plus 1200 mg a day of ribavirin versus PEGIntron a week 1.5

ug/kg plus 800 mg a day of ribavirin for the treatment of patients with hepatitis C who have

previously not responded to either interferon monotherapy or combination interferon and

ribavirin: a multi-center, phase 3b, randomized, efficacy trial (Schering)

55. An open-label, randomized, parallel group study comparing the effectiveness of Procrit

administered once weekly versus standard of care in hepatitis C/HIV co-infected patients treated

with combination ribavirin/interferon. (Ortho Biotech)

63

56. A randomized, open label, multi-center, efficacy and safety study of Pegasys plus

amantidine,, and Pegasys plus amantidine plus ribavirin, and Pegasys plus Cellcept in patients

with chronic hepatitis C infection who relapsed after Rebetron therapy. (Roche)

57. A Phase III, randomized, multicenter, efficacy and safety study examining the effects of the

duration of treatment and the daily dose of ribavirin in patients with chronic hepatitis C virus

infection treated with the combination of interferon and ribavirin. (Roche)

58. A Phase III Open-Label, Randomized, Multicenter, Parallel Dose Efficacy and Safety Study

Comparing Pegylated-Interferon -2a (Ro 25-8310) plus ribavirin to a Standard Regimen of

Roferon-A plus ribavirin in the Treatment of Patients with Chronic Hepatitis C (Roche)

59. Two doses of Infergen therapy for the treatment of naïve hepatitis C patients with normal

liver enzymes. Amgen

60. A Phase III Open-Label, Randomized, Multicenter, Parallel Dose Efficacy and Safety Study

Comparing Pegylated-Interferon -2a (Ro 25-8310) to a Standard Regimen of Roferon-A in the

Treatment of Patients with Chronic Hepatitis C (Roche)

61. Alpha Interferon + Ribavirin 600mg/day vs alpha IFN + Ribavirin 1000mg/day for the

Treatment of IFN Naïve Hepatitis C Patients. Schering-Plough

62. A pilot, randomized, double blind, safety, efficacy, and pharmacokinetics study of oral

lobucavir compared to placebo in HBV. Smith KlineBeecham

63. The use of recombinant factor VIIa in end-stage cirrhotic patients requiring liver biopsy.

NovoNordisk

64. A Phase 3 Study To Compare The Safety And Efficacy Of AlferonR N Injection To IntronR A

In Previously Untreated Patients With Chronic Hepatitis C Infection. Interferon Sciences

65. Alpha Interferon + Ribavirin 600mg/day vs alpha IFN + Ribavirin 1000mg/day for the

Treatment of IFN Non-responder and Relapse Patients. Schering-Plough

66. Factor VIIa in the treatment of the coagulapathy of liver disease. ZymoGenetics Seattle, WA

67. A multi-center, double blind, placebo controlled, randomized dose escalation, pilot study of

Tucaresol in patients with chronic hepatitis B infection. Burroughs-Wellcome

68. Screening procedure for identification of patients for participation in research protocols

evaluating Intron A, alone or in combination with other agents for the treatment chronic hepatitis

C. Schering-Plough

64

69. A double blind, placebo controlled, multicenter, phase IIIA study to assess the safety and

efficicacy of oral famciclovir for the treatment of chronic wild type profile (HBeAg positive)

hepatitis B. Smith Kline Beecham

70. An outpatient, multicenter randomized phase I/II interpatient dose finding study evaluating

the safety of subcutaneous Betaseron Interferon beta-1b at three dose levels of a standard dose of

subcutaneous Intron interferon alpha-2b therapy in chronic hepatitis C infected patients who

have relapsed following a documented response to standard IFN alpha therapy. Chiron

71. Continuous vs. 24 week courses of Intron A therapy for treatment of relapse in patients

with chronic hepatitis C. Schering-Plough

72. A study of lamivudine or placebo in patients with chronic hepatitis B infection who are

treatment naive. Glaxo

73. Lamivudine open label protocol for treatment of patients with recurrent hepatitis B viral

infection after liver transplantation. Glaxo

74. A continuation study of lamivudine in patients with chronic hepatitis B infection. Glaxo

75. A placebo controlled study of lamivudine and Intron A in patients with chronic hepatitis B

who are interferon alpha non-responders. Glaxo

76. A pilot study to assess the safety and efficacy of lamivudine during the course of liver

transplantation for patients with chronic hepatitis B infection. Glaxo

77. Concentration-controlled trial of oral nalmefene in cholestatic pruritus. Baker-Norton

78. A phase III study a randomized partially blinded placebo controlled phase 3 trial of telepravir

administered twice daily or every 8 hours in combination with peglated interferon alfa and

ribavirin in treatment-naïve subjects with genotype 1 chronic hepaptitis C virus infection

(VX950-C211) Tibotec

79. A Multi-center, Placebo-Controlled, Dose Ranging Study to Investigate the Safety

Tolerability, Pharmacokinetics and Pharmacodynamics following Oral Administration of PSI-

7977 in Combination with Pegylated Interferon and Ribavirin in Treatment-Naïve Patients with

Chronic HCV Infection Genotype 1, and an Open Label Assessment of PSI-7977 in Patients with

HCV Genotypes 2 or 3 (Pharmasett)

80. A Randomized, Open Label, Multicenter, Dose and Duration Finding Study to Evaluate the

Sustained Virologic Response of the HCV Protease Inhibitor Danoprevir (RO5190591) Boosted

with Low Dose Ritonavir (danoprevir/r) in Combination with Pegasys® and Copegus® Versus

Pegasys® and Copegus® Alone in Treatment-Naïve Patients with Chronic Hepatitis C Genotype

1 or 4 Virus Infection (Roche)

65

81. An open-label, multi-centre rollover study to assess the safety and efficacy of eltrombopag in

thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to

initiate antiviral therapy (peginterferon alfa-2a or peginterferon alfa-2b plus ribavirin) ENABLE-

ALL (GSK)

82. HCV phase 11b clinical trial using protease inhibitor BI 201335

83. Long-Term Follow-Up of Subjects in a Phase 1, 2, or 3 Clinical Trial in Which Boceprevir or

Narlaprevir was Administered for the Treatment of Chronic Hepatitis (Merck)

84. A Blinded, Randomized, Multicenter Study to Evaluate the Safety, Tolerability,

Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-450 with Ritonavir (ABT-

450/r) and ABT-072 Dosed in Combination with Ribavirin (RBV) and Peginterferon alfa-2a

(pegIFN) in Chronic Hepatitis C Virus (HCV) Genotype 1-Infected Subjects with Null Response

to Prior Standard of Care (SOC) Treatment (Abbott)

85. An Open Label, Randomized, Multi-center Study to Evaluate the Safety, Tolerability,

Pharmacokinetics, and Antiviral Activity of two doses of ABT-450 with Ritonavir (ABT-450/r)

in combination with ABT-072 with or without Ribavirin (RBV) for 12 or 24 weeks in

Treatment-Naïve Subjects with Genotype 1 Chronic Hepatitis C Virus Infection (Abbott)

86. A Phase 3, Dose Response Study of Obeticholic Acid (OCA) in Primary Biliary Cirrhosis

(Intecept)

87. A Phase 2b, Randomized Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24

Weeks of Response Guided Therapy with GS-9190, GS-9256, Ribavirin (Copegus) and

Peginterferon Alfa 2a (Pegasys) in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis

C Virus Infection (Gilead)

88. A Phase 2b randomized, double-blind, placebo-controlled trial evaluating response guided

therapy with Gs5885 alone or in combination with GS 9451 with peginterferon Alfa 2a and

ribavirin in treatment naïve subjects with chronic Hepatitis C infection genotype 1 (Gilead)

89. A Phase 2b randomized, double-blind, placebo-controlled trial evaluating response guided

therapy using combinations of oral GS5885 and/or GS9451 with peginterferon Alfa 2a and

Ribavirin in treatment experienced subjects with chronic genotype 1 (Gilead)

90. A long term follow-up registry for subjects who achieve a sustained virologic response to

treatment in Gilead-Sponsored trials in subjects with chronic Hepatitis C infection (Gilead)

91. A long term follow-up registry study of subjects who did not achieve sustained virologic

response in Gilead-Sponsored trials in subjects with chronic Hepatitis C infection (Gilead)

66

92. A Multi-center, Placebo-Controlled, Dose Ranging Study to Investigate the Safety

Tolerability, Pharmacokinetics and Pharmacodynamics following Oral

Administration of PSI-7977 in Combination with Pegylated Interferon and

Ribavirin in Treatment-Naïve Patients with Chronic HCV Infection Genotype 1

(Gilead/Pharmasset)

93. A phase 3, multicenter randomized, active-controlled study to investigator the safety and

efficacy of PSI 7977 and ribavirin for 12 weeks compared to pegylated interferon

and ribavirin for 24 weeks in treatment naïve patients with chronic genotype 2 or

3 HCV infection (Gilead/Pharmasset)

94. A phase 3, safety and efficacy study of Boceprevir in previously untreated subjects with

chronic hepatitis C genotype 1 (Schering)

95. Boceprevir and Peginterferon/Ribavirin for the Treatment of Chronic Hepatitis C in

Treatment-Naïve Subjects: A Comparison of Erythropoeitin use vs. Ribavirin Dose Reduction

for the Management of Anemia (Schering)

96. Extended: A 3-Year, Virology Follow up Study in Subjects Previously Treated with

Teleprevir in Selected Clinical Studies (Vertex)

97. HCV treatment Naïve, HCV Previous Partial Responder or Relapsers, HCV Patients with

Compensated Cirrhosis, and HCV Historic Null Responder patients with Genotype 1 Meds used

= Boceprevir 800mg po TID + Peg+RBV (CLDF)

98. Treatment of naïve patients with Compensated Cirrhosis; partial and null responders with

Genotype 1 Telaprevir , VX 222, Peg-IFN + RBV (Vertex)

99. HCV co infected study HIV naïve patients with genotype 1a/b WITHBMS 790052

60mg/QD + Peg-IFN + RBV (BMS)

100. An Open Label Study with BMS-790052 and BMS-650032 (DUAL) Null/Partial

Responders to P/R; P/R Ineligible-Naïve/Tolerant Subjects with Genotype 1B (BMS)

101. An Open Label Study with BMS-790052 + BMS-650032 Plus Peginterferon and Ribavirin

(QUAD) Null/Partial Responders to P/R with GT 1a/1b (BMS)

102. An Open-Label Study to Evaluate the Safety and Efficacy of IDX184 in Combination with

Telaprevir and Ribavirin for 12 Weeks in Subjects with Genotype 1 Chronic Hepatitis C

Infection (Idenix)

103. A long-term monitoring study to evaluate the persistence of direct acting antiviral

treatment-resistant mutations or the durability of sustained virological response in patients

treated with DAA-containing regimens for chronic hepatitis C infection (Roche)

67

104. An open-label, single-arm, roll-over trial of telaprevir in combination with pegylated

interferon alfa-2a (Pegasys®) and ribavirin (Copegus®) for subjects from the control group of

the VX 950 TiDP24 C216 trial who failed therapy for virologic reasons (Tibotec)

105. Long-Term Follow-Up of Subjects in a Phase 1, 2, or 3 Clinical Trial for the Treatment of

Chronic Hepatitis C in which Boceprevir or Narlaprevir was Administered for the Treatment of

Chronic Hepatitis C (Merck)

106. An open label, multi-centre rollover study to assess the safety and efficacy of eltrombopag

in thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible

to initiate antiviral therapy (Glaxo Smth Kline)

107. A MULTI-CENTER, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO

INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND

PHARMACODYNAMICS FOLLOWING ORAL ADMINISTRATION OF PSI-7977 IN

COMBINATION WITH PEGYLATED INTERFERON AND RIBAVIRIN IN TREATMENT-

NAÏVE PATIENTS WITH CHRONIC HCV INFECTION GENOTYPE 1, AND AN OPEN

LABEL ASSESSMENT OF PSI-7977 IN PATIENTS WITH HCV GENOTYPES 2 OR 3

(Pharmasset)

108. A Randomized, Open label, Multicenter, Dose and Duration Finding Study to Evaluate the

Sustained Virologic Response of the HCV Protease Inhibitor Danoprevir (RO5190591) Boosted

with Low Dose Ritonavir (danoprevir/r) in Combination with Pegasys® and Copegus® versus

Pegasys® and Copegus® alone in Treatment-Naïve Patients with Chronic Hepatitis C Genotype

1 or 4 Virus Infection (Roche)

109. A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24

Weeks of Response Guided Therapy With GS-9190, GS-9256, Ribavirin (Copegus®) and

Peginterferon Alfa 2a (Pegasys®) in Treatment Naïve Subjects with Chronic Genotype 1

Hepatitis C Virus Infection (Protocol No. GS-US-196-0123) (Gilead)

110. A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24

Weeks of a Four-Drug Regimen and 24 Weeks of a Three-Drug Regimen of GS-9451,

Peginterferon Alfa 2a (PEG, Pegasys®) and Ribavirin (RBV, Copegus®) With and Without

Tegobuvir (GS-9190) Followed by Response Guided PEG and RBV in Treatment Naïve

Subjects with Chronic Genotype 1 Hepatitis C Virus Infection (Gilead)

111. A phase III, randomized, double-blind and placebo-controlled study of once daily BI

201335 120 mg for 24 weeks and BI201335 240 mg for 12 weeks in combination with pegylated

interferon-alpa and ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C

infection (Boehringer Ingelheim Pharmaceutical)

68

112. A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the

Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon

a-2a (Pegasys®) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or

Peginterferon a-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive

or HBeAg-Negative Chronic Hepatitis B (CHB) (Gilead)

113. A Phase 2B multicenter, randomized study to evaluate the safety, tolerability and efficacy

of Pegylated Interferon Lambda (BMS-914143) administered with Ribavirin plus a single direct

antiviral agent (BMS-790052 or BMS-650032) (Part A) and of Pegylated Interferon Lambda

(BMS-914143) administered with or without Ribavirin plus 2 direct antiviral agents (BMS-

790052 and BMS-650032) (Part B) (Bristol-Myers Squibb)

114. A Randomized, Open-label, Multicenter Study to Evaluate the Sustained Virologic

Response of the HCV Protease Inhibitor Danoprevir Boosted with Low Dose Ritonavir

(Danoprevir/r) and Copegus®, in Combination with the HCV Polymerase Inhibitor Prodrug

RO5024048 and/or Pegasys® in Chronic Hepatitis C Genotype 1 Patients Who Failed with a

Previous Course of Peginterferon alfa plus Ribavirin Combination Therapy (Roche)

115. A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response

Guided Therapy with GS-5885 Alone or in Combination with GS-9451 or GS-9256 with

Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1

Hepatitis C Virus Infection (Protocol No. GS-US-256-0148) (Gilead)

116. A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response

Guided Therapy using Combinations of Oral Antivirals (GS-5885, tegobuvir, and/or GS-9451)

with Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects with Chronic

Genotype 1 Hepatitis C Virus Infection (Gilead)

117. A phase III, open-label study of once daily BI 201335 240 mg for 24 weeks in combination

with pegylated interferon-a (PegIFN) and ribavirin (RBV) in patients with genotype 1 chronic

hepatitis C infection who failed a prior PegIFN/RBV treatment (Boehringer Ingelheim

Pharmaceuticals)

118. A Randomized, Open Label, Multi-center Study to Evaluate the Antiviral Activity, Safety,

and Pharmacokinetics, of ABT-450 with Ritonavir (ABT-450/r) in combination with ABT-267

and/or ABT-333 With and Without Ribavirin (RBV) for 8, 12 or 24 weeks in Treatment-Naïve

and Null Responder Subjects with Genotype 1 Chronic Hepatitis C Virus Infection (Abbvie)

119. A Phase 2 Randomized, Open-Label, Exploratory Trial of GS-5885, GS-9451 with

Peginterferon Alfa 2a (PEG) and Ribavirin (RBV) in Treatment-Naïve Subjects with Chronic

Genotype 1 Hepatitis C Virus Infection and IL28B CC Genotype (Gilead)

69

120. A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic

Response to Treatment in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C

Infection (SVR Registry) (Gilead)

121. A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained

Virologic Response in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection

(Sequence Registry) (Gilead)

122. A Phase 3b Study of 2 Treatment Durations of Telaprevir, Peginterferon Alfa-2a

(Pegasys®), and Ribavirin (Copegus®) in Treatment-Naive and Prior Relapser Subjects With

Genotype 1 Chronic Hepatitis C and IL28B CC Genotype (Vertex)

123. OPTIMAL Boceprevir in Community Practice: Assessing Safety, Efficacy, Compliance

and Quality of Life, Impact of Educational Program (Merck)

124. A Phase 3, Double Blind, Placebo Controlled Trial and Long Term Safety Extension of

Obeticholic Acid in Patients with Primary Biliary Cirrhosis (Intercept)

125. A Phase 3, Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and

Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and

Ribavirin for 24 Weeks in Treatment-Naïve Patients with Chronic Genotype 2 or 3 HCV

Infection (Pharmasset)

126. A Phase 3, Open Label Study of Safety and Efficacy with BMS-790052 plus Pegylated-

Interferon Alfa 2a and Ribavirin in Previously Untreated HCV Patients Coinfected with Human

Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) (Bristol-Myers Squibb)

127. Non-Interventional, Prospective, Cohort Study of the Effectiveness, Safety, and Utilization

of Two Approved Pegylated Interferon-Based Direct Acting Antiviral Triple Therapies in the

Management of Genotype 1 Chronic Hepatitis C in Routine Clinical Practice in the USA

(Genentech)

128. A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2b Study to Compare

the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir, Peginterferon-Alfa-2,

Ribavirin) to Triple Therapy (with VX-222-Placebo) in subjects With Genotype 1 Chronic

Hepatitis C With Compensated Cirrhosis (Vertex)

129. An Open-Label Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of

Direct-Acting Antiviral Agent (DAA) Treatment in Combination with Peginterferon a-2a and

Ribavirin (pegIFN/RBV) in Chronic Hepatitis C Virus (HCV) Infected Subjects Who Have

Experienced Virologic Failure in a Previous Abbott DAA Combination Study (Abbvie)

130. A Phase 3, Open-Label Study with Asunaprevir and Daclatasvir Plus Peginterferon Alfa-2a

(Pegasys) and Ribavirin (Copegus) (P/R) (QUAD) for Subjects Who Are Null or Partial

70

Responders to Peginterferon Alfa 2a or 2b Plus Ribavirin with Chronic Hepatitis C Genotypes 1

or 4 Infection (Bristol-Myers Squibb)

131. A Phase 3 Study with Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders

to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-

Naive Subjects with Chronic Hepatitis C Genotype 1b Infection (Bristol-Myers Squibb)

132. An Open-Label Re-treatment Study with Peg-Interferon Alfa-2a, Ribavirin and BMS-

790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C (Bristol-Myers

Squibb)

133. A long-term monitoring study to evaluate the persistence of direct acting antiviral (DAA)

treatment-resistant mutations or the durability of sustained virological response (SVR) in

patients treated with DAA- containing regimens for chronic hepatitis C infection (Roche)

134. An Open-Label Study to Evaluate the Safety and Efficacy of IDX184 in Combination with

Telaprevir and Ribavirin for 12 Weeks in Subjects with Genotype 1 Chronic Hepatitis C

Infection (Idenix)

135. An Open-Label Study of GS-7977 + Ribavirin for 12 Weeks in Subjects with Chronic HCV

Infection who Participated in Prior Studies Evaluating GS-7977 (Gilead)

136. Comparative Assessment of Effectiveness of Antiviral Therapies in Hepatitis C

(COMPASS)A Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety

of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With

and Without Ribavirin (RBV) in Treatment-Naïve Adults with Genotype 1b Chronic Hepatitis C

Virus (HCV) Infection (PEARL-III) (Abbvie)

137. A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and

Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin for 12 and 24 Weeks in

Treatment-Naïve Subjects with Chronic Genotype 1 HCV Infection (Gilead)


Safety of Sofosbuvir/GS-5885Fixed-Dose Combination ± Ribavirin for 12 and 24 Weeks in

Treatment-Experienced Subjects with Chronic Genotype 1 HCV Infection (Gilead)

139. A Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy and Safety of the

Combination of DAAs With and Without Ribavirin (RBV) in Treatment-Naïve Adults with

Genotype 1a Chronic Hepatitis C Virus (HCV) Infection (PEARL-IV) (Abbvie)

140. A Randomized Study to Evaluate the Safety and Efficacy of IDX719 in Combination with

Simeprevir and Ribavirin for 12 Weeks in Subjects with Chronic Hepatitis C Infection (Idenix)

71

141. A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of the Combination

Regimen of MK-5172 and MK-8742 +/-Ribavirin (RBV) in Subjects with Chronic Hepatitis C

Virus Infection (Merck)

142. A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-

450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered with Ribavirin

(RBV) in Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis

(TURQUOISE-II) (Abbvie)

143. A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and

Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Naïve Subjects with Chronic

HCV Infection (Gilead)


Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin for 8 Weeks and

Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Treatment-Naïve Subjects with

Chronic Genotype 1 HCV Infection (Gilead)

145. A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and

Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment Experienced Subjects with

Chronic HCV Infection (Gilead)

146. A Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Antiviral

Activity of the Combination of ABT 450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT

333 With and Without Ribavirin in Treatment-Experienced Subjects with Genotype 1b Chronic

Hepatitis C Virus (HCV) Infection (PEARL–II) (Abbvie)

147. A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-

Acting Antiviral Agent (DAA) Therapy in Subjects Who Participated in Phase 2 or 3 Clinical

Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection (Abbvie)

148. An Open-Label, Sequential Arm, Multicenter Study to Evaluate the Antiviral Activity,

Safety and Pharmacokinetics of ABT-450 with Ritonavir (ABT-450/r) Dosed in Combination

with ABT-267 With and Without Ribavirin (RBV) in Treatment-Naïve Subjects with Genotype

1, 2 or 3 Chronic Hepatitis C Virus (HCV) Infection (Abbvie)

149. An Open-Label, Multicenter Study To Evaluate The Efficacy And Safety Of

Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin For 12 or 24 Weeks In Chronic

Genotype 1 HCV Infected Subjects Who Participated In A Prior Gilead-Sponsored HCV

Treatment Study (Gilead)

150. A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial

Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-

72

Like 2 (LOXL2), in Subjects with Advanced Liver Fibrosis but not Cirrhosis Secondary to Non-

Alcoholic Steatohepatitis (NASH)

151. A Randomized, Open-Label, Dose Ranging Study to Evaluate the Safety, Tolerability,

Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-493 and ABT-530 in Adult

Subjects with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (Abbvie)

152. A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naïve and Treatment

Experienced Subjects with Genotype 3 Chronic Hepatitis C Infection, Randomised, placebo-

controlled, multi-centre study to assess the efficacy and safety of eltrombopag in

thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to

initiate antiviral therapy (peginterferon alfa-2a) (Bristol Myers Squibb)

153. A Long-Term Follow-up Study to Evaluate the Durability of Virologic Response and/or

Viral Resistance Patterns of Subjects With Chronic Hepatitis C Who Have Been Previously

Treated with MK-5172 in a Prior Clinical Trial (Merck)

154. Multicenter, Prospective Evaluation of the Beckman Coulter DxN HBV Viral Load Assay

as an Aid in the Management of HBV-infected Individuals Undergoing Antiviral Therapy

Collection of Plasma Samples From Individuals Initiating Therapy with Entecavir or Tenofovir

for Chronic Hepatitis B Virus Infection for the Clinical Evaluation of the Aptima HBV Quant

Assay (Beckman Coulter)


Safety of a 12- or 8-Week Treatment Regimen of Simeprevir in Combination with Sofosbuvir in

Treatment-Naïve and -Experienced Subjects with Chronic Genotype 1 Hepatitis C Virus

Infection Without Cirrhosis (Janssen)

156. Collection of Blood Specimens from Subjects Infected with Chronic Hepatitis C

(Genotypes 2 and 3) and Treated with Sofosbuvir plus Ribavirin (Roche Molecular Systems)

157. An Open-Label, Multicenter Study to Evaluate Long-term Outcomes with ABT-

450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV)

in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ II) (Abbvie)

158. A Multicenter, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability

and Efficacy of IDN-6556 in Subjects with Liver Cirrhosis (Conatus)

159. An Open-Label Study to Evaluate the Safety and Efficacy of

Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with or without Ribavirin (RBV) in Adults with

Genotype 1 Chronic Hepatitis C Virus (HCV) Infection, with Severe Renal Impairment or End-

Stage Renal Disease (RUBY-I) (Abbvie)

73

160. An Open Label Pilot Trial to Evaluate the Safety, Tolerability and Efficacy of IDN-6556 in

Cirrhotic Subjects with Portal Hypertension (Conatus)

161. A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and

Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks with Sofosbuvir and

Ribavirin for 12 Weeks in Subjects with Chronic Genotype 2 HCV Infection (Gilead)

162. An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-

450/Ritonavir and Dasabuvir in Adults with Genotype 1b Chronic Hepatitis C Virus (HCV)

Infection and Cirrhosis (Abbvie)

163. A RANDOMIZED, OPEN-LABEL, MULTICENTER, CONTROLLED STUDY TO

ASSESS SAFETY AND EFFICACY OF ELAD® IN SUBJECTS WITH SEVERE ACUTE

ALCOHOLIC HEPATITIS (SAAH) AND LILLE SCORE FAILURE (Vital Therapies)

164. An Open Label Study to Evaluate The Efficacy And Safety Of Sofosbuvir/GS-5816 Fixed

Dose Combination With Ribavirin For 24 Weeks In Chronic HCV Infected Subjects Who

Participated In A Prior Gilead Sponsored HCV Treatment Study (Gilead)

165. A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of

GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects with Chronic Non-

Genotype 1 HCV Infection (Gilead)

166. A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of

GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects with Chronic Genotype

1 HCV Infection (Gilead)

167. A Registry for Subjects with Cirrhosis Who Achieve a Sustained Virologic Response

Following Treatment with a Sofosbuvir-Based Regimen without Interferon for Chronic Hepatitis

C Infection in Gilead-Sponsored Trials (Gilead)

168. Clinical Evaluation of the Xpert® HCV VL Assay (Cepheid)

169. A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the

Combination Regimen of MK-5172 and MK-3682 with Either MK-8742 or MK-8408 in

Subjects with Chronic HCV GT1, GT2, and GT4 Infection (Merck)

170. A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 2

Clinical Trial to Evaluate the Safety and Efficacy of GR-MD-02 for the Treatment of Liver

Fibrosis and Resultant Portal Hypertension in Patients with NASH Cirrhosis The NASH-CX

Trial 1 (Galectin)

171. A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and

Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without Ribavirin

74

in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection who Failed a Prior

Direct-Acting Antiviral Agent (DAA)-Containing Therapy (Gilead)

172. A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study

Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic

Steatohepatitis (Intercept)

173. A multi-part, randomized, double-blind, placebo-controlled study to assess the safety,

tolerability and efficacy of LJN452 in patients with Primary Biliary Cirrhosis (Novartis)

174/ An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of

Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Low-Dose Ribavirin QD in Subjects with

Genotype 1a Chronic Hepatitis C Virus Infection (GEODE II) (Abbvie)

175. A 12-week, double-blind, randomized, placebo-controlled, Phase 2 study, to evaluate the

effects of two doses of MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) and an

inadequate response to ursodeoxycholic acid (UDCA) (CymaBay Therapeutics)

176. A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety

and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks

Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct Acting Antiviral-Naïve Subjects

with Chronic HCV Infection

177. A phase 3 randomized, open label study of the safety and efficacy of two dose levels of

interferon alfacon 1 (Infergen CIFN) plus ribavirin administered daily for 48 weeks in Hep C

infected patients who are nonresponsive to previous pegylated interferon (Interimmune)

178. A Phase 2 Study of Telaprevir (VX-950) in Combination with Peginterferon a-2a

(Pegasys®), and Ribavirin (Copegus®) in Subjects with Genotype 1 Hepatitis C Who Have Not

Achieved Sustained Viral Response with a Prior Course of Interferon-Based Therapy (Vertex)

179. A Multicenter Double-Blinded Study in Non-Cirrhotic Patients With Chronic Hepatitis C

Who Are Non-Responders to Prior Interferon Alfa or Interferon Alfa+Ribavirin Therapy

Comparing Treatment With Thymosin Alpha1+Peginterferon Alfa-2a (Sciclone)

180. A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530

in Adults with Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated

Cirrhosis (Abbvie)

181. A phase II study of VX-950 in combination with Peginterferon Alfa-2a (Pegasys) with and

without Ribavirin (Copegus) in subjects with Hepatitis C (Vertex)

75

182. A phase 2b study of merimepodib in combination with pegylated interferon alpha and

ribavirin in subjects with chronic genotype 1 hepatitis c non responsive to prior therapy with

pegylated interferon alfa and ribavirin (Vertex)

183. A Comparative Study of Chronic Hepatitis B Subjects Treated with Entecavir Plus

Tenofovir Combination Therapy vs Entecavir Monotherapy in Adults who are Treatment Naïve

to Nucleosides and Nucleotides: The BE-LOW Study" (Bristol Myers Squibb)

184. A randomized, multicenter, double blinded, phase IV study comparing the safety and

efficacy of Pegasys 180 ug plus Copegus 1000 or 1200 mg to the currently approved

combination of Pegasys 180 ug plus Copegus 800 mg in interferon naive patients (Roche)

185. Satavaptan in the Prevention of Ascites Recurrence: a double-blind, randomized, parallel-

group comparison of satavaptan at 5 to 10 mg daily versus placebo in the absence of diuretics in

patients with recurrent ascites due to cirrhosis (Sanofi-Aventis)

186. A randomized, double-blind, placebo-controlled, Phase III trial of 2 regimens of telaprevir

(with and without delayed start) combined with pegylated interferon alfa-2a (Pegasys®) and

ribavirin (Copegus®) in subjects with chronic genotype 1 hepatitis C infection who failed prior

pegylated interferon plus ribavirin treatment. (Tibotec)

187. A Multicenter, randomized, open-label, controlled study of the effect of treatment with once

weekly Pegasys® plus daily Copegus® with or without concomitant pioglitazone (Actos®) on

early viral kinetics in treatment-naïve patients with chronic hepatitis (Roche)

188. A Multicenter Screening Protocol to Assess Patients with Genotype 1 Chronic Hepatitis C

Virus Infection for Eligibility to Participate in Phase 2B Protocol PV18370 That Will Compare

the Efficacy and Safety of the HCV Polymerase Inhibitor in Combinat (Roche)

189. A Rollover Protocol of Telaprevir (VX-950) in Combination with Peginterferon Alfa-2a

(Pegasys®), and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of

Study VX06-950-106 Who do not Achieve or Maintain an Undetectable HCV RNA

Randomized double blind, multicenter study to compare the safety and efficacy of viramidine to

ribavirin in treatment naive patients with chronic hepatitis C (Vertex)

190. A Double-Blind, Randomized, Placebo-Controlled Multi-Centre, Phase II Parallel Dose-

Ranging Study to Assess the Antifibrotic Activity of GI262570 in Chronic Hepatitis C Subjects

with Hepatic Fibrosis who Have Failed Prior Therapy (GlaxoSmithKline)

191. An open-label, multicenter protocol providing pegylated interferon alfa-2a (PEGASYS®)

as monotherapy or in combination with ribavirin (COPEGUS®) for patients with chronic

hepatitis C who have participated in previous Roche or Roche partner protocols (Roche)

76

192. A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon

Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naïve Subjects with Genotype 1

Chronic Hepatitis C (Vertex)

193. NV 19865-A Phase II, Randomized, Double-Blinded, Multicenter, Dose Finding Study

Evaluating the Efficacy and Safety of the HCV Polymerase Inhibitor Prodrug (RO4588161)

When Given In Combination with Pegasys and Copegus Versus the Currently Approved

Therapy (Roche)

194. An open label, multicenter protocol providing pegylated interferon alfa-2A (PEGASYS) as

monotherapy or in combination with ribavirin (COPEGUS) for patients with chronic hepatitis C

who have participated in previous Roche protocols (Roche)

195. The ATOMIC Study: A Multicenter, Open-label, Randomized, Duration Finding Study to

Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics following Oral

Administration of PSI-7977 in Combination with Pegylated Interferon and Ribavirin in

Treatment-Naïve Patients with Chronic HCV Infection Genotype 1, 4, 5, or 6 (Pharmasset)

196. A phase 1b randomized, placebo controlled clinical trial to study the safety and efficacy of

MK-7009 in Hepatitis C infected patients (Merck)

197. Cumulative Meta-analysis of Individual Patient Data: Efficacy of Pegylated Interferon

Treatment Regimens in Chronic HCV (Integrated Therapeutic Group)

198. A Phase 3, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of

Albumin Interferon Alfa-2b (alb-IFN) in Combination with Ribavirin Compared with

Peginterferon Alfa-2a (PEGASYS® or PEG-IFNa2a) in Combination with Ribavirin (Human

Genome Sciences)

HONORS

ACG Category Award (Liver) ACG Annual Meeting Las Vegas 2016:

An analysis of virological failure patients treated for hepatitis C with direct acting anti-viral therapy

in a community based practice: is the real world like clinical trials (poster 1984)

Physician of the Year, American Liver Foundation Annual Meeting, October 2016

Honoree, North Shore University Hospital Annual Golf Outing July 2016

Recipient, Sheila Sherlock Prize for Best Clinical Paper, 1996 International Association for the Study

of the Liver, Capetown, South Africa, March 1996

77

Winthrop University Hospital Outstanding Academic Teaching Attending of the Year 1997-1998

American Liver Foundation Community Physician of the Year, 2000-2001

Nominated for Quality of Life Paper of the Year by the International Society for Quality of Life

Prague, Czech Republic November 2003

“Man of the Year” Honoree for Parker Geriatric Center 2005

Castle-Connelly Best Doctors in New York, 2006-

ACG Board of Governors Service Award 2007-2008

Holocaust Memorial and Tolerance Center of Nassau County Annual Honoree 2011

American College of Gastroenterology Senior Governor’s Award 2013

Distinguished Alumni Award SUNY-StonyBrook School of Medicine Awarded 2015

Crohns and Colitis Foundation Long Island Annual Golf Outing Honoree 2019v/

PROFESSIONAL

Academy Memberships

Hofstra Academy of Medical Educators (Inaugural Member) 2017

Society Memberships

Fellow, American College of Physicians 1996

Fellow, American Gastroenterological Association 2006

Fellow, American Association for the Study of Liver Diseases 2014

Fellow, American College of Gastroenterology 1996

Bockus International Society of Gastroenterology 1994

European Association for the Study of Liver Diseases 1996

Asian Pacific Society for the Study of Liver Diseases 2010

Alliance for Academic Internal Medicine (AAIM) 2010

Society Offices

Regional Counselor, ACG 2012-2013

78

Governor, ACG Long Island 2007-2013

Alternate Delegate, Dade County Medical Association 1/96-7/96

Member, ACG Committee on Educational Affairs 1997-2000

Member, ACG Sub-Committee on Self-Assessment 1998-2000

Member, ACG Abstract Scoring Subcommittee 1998-2017

Member, ACG Practice Parameters Committee 2004 -2010

Liver and Pancreas Sub-Committee

Member, ACG Credentials Committee 2008-2014

Member, ACG Committee on National Affairs 2010-2016

Member, ACG Membership Committee 2012-2014

Member, AASLD Clinical Practice Committee 2000-2002

Member, AASLD Finance Committee 2006-2009

Treasurer, Bockus Society 1999-

President, Bockus Society 2012-2015

Research Committee, Bockus Society 1998-

Treasurer, New York Gastroenterological Society 2000-2001

Vice-President, New York Gastroenterological Society 2001-2002

President, New York Gastroenterological Society 2002-2003

NYSGE Executive Council 2008-2010

AAIM Advocacy Committee 2011-2013

ACP, NY Chapter, Ethics Committee 2012-2015

President, ACP Chapter, Nassau County 2015-2017

Treasurer, Empire Liver Foundation 2013-

EDUCATIONAL ACTIVITIES

Courses Directed

Date Institution Title Enrollment 6/9/2019 ACG Course Director, ACG Hepatitis School, Washington, DC 280

11/30/18 ACG Course Director, ACG Hepatitis School, Nashville, TN 250

8/24/2018 ACG Course Director, ACG Hepatitis School, Indianapolis, IN 175

3/10/2017 ACG Course Director, ACG Hepatitis School, Las Vegas, NV 250

2/2017 Hofstra Northwell

School of Medicine Co-Course Director, Fueling the Body Course


8/26/16 ACG Course Director, ACG Hepatitis School, Minneapolis, MN 120

6/24/16 ACG Course Director, ACG Hepatitis School, Washington, DC 220

2/2016 Hofstra Northwell

School of Medicine Co-Course Director, Fueling the Body Course


6/12/2015 ACG Course Director, ACG Hepatitis School, Boston , M 160

1/23/2015 ACG Course Director, ACG Hepatitis School, Las Vegas, NV 250

9/19/2014 ACG Course Director, ACG Hepatitis School Chicago, Ill 150

79

12/6/2013 ACG Co-director, ACG Hepatitis School, Nashville, TN 250

11/16/2013 NSUH Co-Director, Current Issues in GI and Liver 150

Disease 2013

4/12/2013 ACG Co-director, ACG Hepatitis School, Washington DC 180

10/2012 NSUH Co-Director, Current Issues in GI and Liver 200

Disease 2012

7/02 Southampton Hospital Sharps Prevention Program with Dept. of Labor 75

3/01 North Shore Sharps Prevention Program with Dept. of Labor 300

9/98 Bockus Society Scientific Program, Graz, Austria 100

12/6/97 Winthrop Univ Hospital Update in Gastroenterology 50

5/94 Univ. of Miami Mechanisms of Disease Course for Second Year Medical 160

Students, Hepatology Section





2/94 Univ. of Miami Internal Medicine Update 1994, Hepatology Section 350



8/94 Univ. of Miami 21st Annual Board Review Course in Internal Medicine, 700

Hepatology Section

8/95 Univ. of Miami 22nd Annual Board Review Course in Internal Medicine, 750

Hepatology Section

5/94 Univ. of Miami Review Course in Internal Medicine, Hepatology Section 350



3/95 Univ. of Miami Hepatobiliary Disease in Clinical Pratice:Update XI 400

COMMUNITY ACTIVITIES

1. Member, Advisory Board, Don Monti Memorial Research Foundation

2. Consultant, New York State Department of Health: Developed and authored treatment

guidelines for chronic hepatitis C infection for New York State

3. Executive committee, Johns Hopkins University Alumni Organization

4. Member, North Shore Audobon Society

5. Guest appearance, September 30, 1996 “The Senior Medical Hour with Dr. Ron

Adelman”

Cable TV Channels 1 and 45

Topic: Liver Disease

6. Medical Advisory Board, American Liver Foundation

80

7. Columnist, Anton Community Newspapers, “LiverLines” which is published every other

week in 22 newspapers since 1999

8. Quoted in LA Times, Forbes, Washington Post, Reuters, Dow Jones

9. Co-Chairperson, American Liver Foundation Annual Charity Golf Tournament 2000-

2002

10. Guest appearance, Fox-5 Good Day New York October 3, 2002

11. Co-Chairman, Scientific Committee, Moroccan American Health Care Foundation

12. Guest lecturer on “Co-infection with hepatitis C and HIV” at www.hepwatch.com

13. Medical Advisory Board, NATAP HCV Newsletter (started March 2003)

14. Physician Advisory Panel, PBCers

15. Frequent appearances on local New York Television stations

16. Member, East Hills Medical Commission July 2007-

17. Member, NYS Hepatitis C Elimination Task Force 2018-

Department of Health Appointments

1. NYS Department of Health, Hepatitis C Advisory Council, February 2008 – present

2. NYS Department of Health, HCV Elimination Task Force 2018-

3. Member, Committee on Office Based Surgery Advisory Group, 2009 - present

4. Keynote Speaker, NYS DOH Hepatitis C Conference

Topic: Hepatitis C : Is it curable?

March 25, 2008

5. Speaker, NYS DOH Hepatitis C Conference

Topic: Non anti-viral management of hepatitis C patients

6. CHICANYS Hepatitis C Medical Advisor for Hepatitis C and lead physician ECHO project

for NY State

HOSPITAL APPOINTMENTS AND COMMITTEES


1. Chairman, Performance Improvement, Division of Gastroenterology 2000-2011

2. Chairman, Nutrition Committee, NSUH 2006- 2015

2. Department of Medicine Performance Improvement Committee 2000-2005

3. Medical Records Committee 2001-2003

4. North Shore Hospital Research Committee 2001- 2007

5. North Shore University Hospital Library Committee 2004-2015

6. Clinical Institutional Biosafety Committee 2016 -


1. Educational Director, Division of Gastroenterology, 1997- 1999

http://www.hepwatch.com/

81

2. Department of Medicine Morbidity and Mortality Committee 1997- 1999

3. Ambulatory Surgery and Endoscopy Reengineering Committee 1997- 1999

4. Faculty Practice Advisory Committee 1997- 1999

5. Chairman, Human Resources Subcommittee, Dept of Medicine 1998- 1999

REFERENCES

Available upon request

Documents

DAVID ERIC BERNSTEIN, M.D. June 2019 Bernstein … · Green JA, Goldman JH, Bernstein DE, Barkin JS. Corneal abrasion complicating ERCP. Gastrointestinal Endoscopy 1994; 40: 261