Suggested Research Questions Submitted by Stakeholders C... · 2014. 10. 17. · 3. Significant burden in the US population. An estimated 750,000 patients with HCV receive health

Suggested Research Questions Submitted by

Stakeholders

Hepatitis C Workshop

October 17, 2014

Patient-Centered Outcomes Research Institute 1828 L St., NW, Suite 900 Washington, DC 20036 (202) 827-7700 [email protected] | www.pcori.org

Suggested Research Questions Submitted by Stakeholders 2

I. Care Delivery 1) What are the comparative benefits or risk of use of the new treatments (that do not include Interferon)

for patients with Hepatitis C, by primary care providers to improve treatment availability to minority Patient populations and timing of treatment.

2) How does team based care compare to sole provider care when managing adherence to treatment plans in hepatitis C patients with multiple co-morbid conditions (diabetes, substance use, depression, illness, homelessness)?

3) There is a great shortage of skilled healthcare professionals in the United States that can treat HCV. Can primary care clinicians in the United States be trained to diagnose, evaluate and treat HCV with the same safety and efficacy as specialists?

4) What are comparative benefits and risks of electronic health record (EHR)-based reminders for the screening of hepatitis C in adults born between 1945 and 1965?

5) How do patient navigation approaches compare in optimizing linkage of care between primary care and specialty physicians for patients with chronic hepatitis C infection

6) Comparative Effectiveness of Intensity of Case Management on Medication Adherence & Cure Rate CER Question: What is the comparative effectiveness of intensive and intermediate case management strategies on sustained viral response and treatment medication adherence in patients with chronic hepatitis C infection who are at high and average risk of nonadherence? P1: Patients with chronic hepatitis C infection at high risk of nonadherence P2: Patients with chronic hepatitis C infection at average risk of nonadherence I: Intensive case management C: Intermediate case management O1: Sustained viral response O2: Adherence i the components of intensive and intermediate case management need to be determined.

7) Do patients with HCV and Medicaid coverage living in states with greater restrictions on HCV therapy have poorer health outcomes compared to Medicaid patients with fewer restrictions? Do health outcomes vary in patients with HCV based on state Medicaid coverage policy? Patient population of focus: Patients with HCV and Medicaid coverage 1. Health care decisions the research is intended to inform: Medicaid coverage policies 2. Clinical interventions and their respective benefits and harms to be compared: Differential Medicaid coverage policies can result in differential access to medications to treat HCV, and possibly health outcomes and complications associated with HCV. Additional information to increase the meaningfulness of the CER question 1. Meaningful difference in study endpoints/outcomes from the patient’s perspective. Different states have different numbers of steps required before Medicaid Patients may receive medications to treat HCV. This could differentially impact time to cure for HCV. Equally important, this could also have an effect on comorbidities, complications, and medical costs that patients have on a state by state basis. 2. Gaps in evidence. These decisions are generally made on a local (statewide) basis, without consideration of evidence with other state programs. 3. Significant burden in the US population. An estimated 750,000 patients with HCV receive health care coverage from Medicaid or through the prison system. 4. Likelihood of implementation in practice: High potential of policy implications if we come to understand that limiting access can potentially increase complications associated with hcv.

8) With respect to HCV drug treatment, what clinical strategies can optimize patient adherence to treatment regimens?

9) Compare the rates of SVR, adherence and drug resistance in HCV patients with behavioral health issues, including diagnoses psychiatric and substance abuse disorders, with and without support through a comprehensive medication therapy management program.


a. Or MTM vs. CBT

10) Compare the rates of SVR, adherence and drug resistance in HCV patients F1, F2 treated by primary care physicians versus same patient population treated by hepatologists.

11) What are the comparative hepatitis C testing rates of patients born from 1945-1965 as initiated by legislatively mandated offers to test, EMR prompts by year of birth and voluntary physician compliance with CDC and USPSTF recommendations?

12) What are the comparative rates of successful adherence and completion of hepatitis C treatment for patients receiving treatment education and support via case management, support groups, and one on one physician interaction?

13) Government regulations and/or insurance providers must reform current restrictions on patients’ access to new HCV medications. How will this be addressed by this group?

14) Should hepatitis C patients be allowed to receive treatment from primary care providers?Currently many payers require prescribing physicians to have subspecialty training or extensive prior experience treating hepatitis C, limiting the ability of patients to receive care and the capacity of healthcare systems to provide care to all patients needing it. Patient population: People with hepatitis CHealthcare decision: Who should be allowed to prescribe antiviral treatment for hepatitis C?Clinical intervention: Treatment by primary care physicians vs. referral to specialists. Benefits and harms: Receipt of antiviral therapy, satisfaction with care received, completion of therapy, cure of infection, prescribing errors, adverse events

15) What adherence support would benefit patients receiving treatment for hepatitis C? Patient population: Patients with hepatitis C, including subgroups such as those struggling with substance use or mental health conditions Healthcare decision: Should adherence support be offered to patients undergoing antiviral treatment of hepatitis C? Clinical intervention: Many different types of adherence interventions have evidence of efficacy. Benefits and harms: Retention in care, adherence, completion of therapy, cure of infection

16) What is the most effective mechanism of linking hepatitis C virus (HCV)-infected persons to curative treatment?


17) Question: What is the optimal approach to identifying and treating HIV-coinfected HCV-infected MSM? Do HIV outreach efforts have sufficient bandwidth to include HCV treatment/prevention, or are alternate approaches needed? Should HCV screening/treatment be considered only among those patients who have the ability to take ARVs (ie HCV is in the ‘second position’ to HIV), or is a more efficient approach to tackle HCV at the same time as the HIV diagnosis/treatment (eg., potentially leading to treatment of both conditions together, or to treating HCV with a short regimen in a population that includes subjects who are unable or unwilling to participate in long-term ARV therapy)? Context: CDC estimates that sexual transmission accounts for ~10 to 15% of the attributable risk for HCV transmission in the United States. This ‘sexual’ risk is not distributed evenly in the population – event rates are highest among HIV-positive men-having-sex-with-men, even when adjusting for IV drug use. The risk appears to be attributable to unprotected anal intercourse, with co-factors of presence of other STIs and use of non-injection drugs. There is a substantial set of outreach programs to prevent and treat HIV infection among MSM. These efforts are focused on increasing adherence to safer-sex practices and diagnosing/treating HIV infection. However, coverage/attention to HCV has been variable, in part due to the complexity of prior HCV therapies and the limited bandwidth to focus on matters other than HIV and acute STIs. Given the alarming increase in HCV infection in these Patient populations and timing of treatment, and the potential mixing with the IVDU, treated HIV, and otherwise healthy MSM Patient populations and timing of treatment, interventions are needed. This population has not been fully covered in clinical trials, although Merck is conducting a dedicated trial in HIV-co-infected HCV-infected patients (these patients are likely to be ‘stable’ and less likely to be engaged in high-risk behaviors).

18) Question: What is the optimal means to address imbalances in health system incentives for treating Hepatitis C patients? Context: In Phase 3 trials, administration of the new, all oral, anti-HCV regimens results in achievement of SVR in over 90% of patients. Future HCV regimens will have fewer side effects and a shorter duration of therapy. However, the U.S. healthcare system is fragmented and therefore creates significant disincentives for using these treatments. The costs are front-loaded at the time of treatment, yet the benefits of treatment occur many years into the future. For example, a health plan faced with treating patients in their 50s pay the full costs, but most of the benefit will occur after those patients become eligible for Medicare. It will be important to develop and test models that monetize and amortize future health benefits so that the future value of those benefits is known at the time that a transfer to a new health plan (like Medicare) occurs. The next step would be to create a process for health plans that enroll new patients who have received HCV treatment to provide remuneration from the new health plan for that member for the remaining value of the patient’s health benefits. Addressing this problem will eliminate disincentives for treating HCV patients and address one of the key flaws in our fragmented health care system that are absent in single payer health systems. This approach would also have potential applications for other highly effective treatment with upfront costs and benefits that go into the future such as bariatric surgery.


19) Question: Which is the optimal approach to screen and treat Intravenous Drug Users infected with HCV: (a) as part of methadone maintenance clinics; (b) as part of inpatient/outpatient addiction programs; (c) as part of a comprehensive harm-reduction strategy (needle exchange, education/counselling, medical care without requirement for discontinuation of drug use) Context: IV drug users represent the primary means of transmission of HCV currently in the United States, and they are difficult to access Patient populations and timing of treatment (chaotic lives, limited access to health care, etc.). They may also have significant co-morbidities (eg. HIV, malnutrition, organ damage from contaminants of IV drugs, etc.). This population is generally under-represented in Phase 3 studies, although Merck is conducting a Phase 3 trial focused on treating HCV infection in IVDU patients who are in methadone maintenance or outpatient treatment settings (subjects who occasionally relapse or who are sporadic users can be enrolled). Given the importance of this population in the overall HCV transmission cycle and the population’s unique social and medical co-morbidities, it is imperative to determine the most effective means to treat these patients in the real world.

20) How do multidisciplinary clinical management programs compare for promoting adherence to hepatitis C treatment regimens and encouraging therapy completion?

21) What are models of care to provide hepatitis C treatment for people who inject drugs, including integration into usual practice, harm-reduction models, opiate-replacement programs, drug rehabilitation programs, or other settings? What are comparative benefits and risks of two or more approaches?

22) How do systems that monitor or enhance adherence to hepatitis C regimens compare for improving SVR rates in persosn with active substance use issues or psychiatric comorbidity?

23) Are real-world SVR rates achieved with DAAs the same when treatment is delivered by trained primary care MDs or non-MD providers (e.g., PharmDs, NPs, PAs, APRNs) as treatment delivered by specialists? Do the results vary by stage of hepatic fibrosis?

24) Are real-world SVR rates achieved with DAAs the same for patients in urban centers and those in rural or highly rural areas?


II. Head-to-Head Trials 25) Which of two all-oral inteferon-free strategies for the treatment of chronic genotype 1 hepatitis C

infection, including sofosbuvir/ledipasvir and paritaprevir/ritonavir/ombitasvir/dasabuvir +/- ribavirin, will maximize sustained virologic response (SVR) and minimize adverse effects and harm? a. in patients without cirrhosis b. in patients with compensated cirrhosis c. in patients with decompensated cirrhosis d. in patients who are post-liver transplant e. in patients with HCV-HIV coinfection f. in patients with end-stage renal disease (ESRD) g. in patients who inject drugs (PWID)

26) Which of the available therapies - existing and recently introduced - for treatment of Hep C demonstrate the best outcomes with the fewest side effects? Are there differences in outcomes based on timing of administration (i.e. disease stage)? How do the various available treatments compare on patient adherence?

27) What treatment dosages and durations of therapies have the best long term results and fewest side effects? We know new drugs are well-tolerated in the short term, but studies have been done with breakthrough designation and too little data.

28) With a new generation of drugs that offer high rates of sustained virologic response (SVR) -- effectively curing the disease -- there's some concern about reinfection, particularly among IV drug users. What are the real-world rates of reinfection, and what post-SVR patient management strategies can be most effective in preventing reinfections?

29) Are the newer Hepatitis C drugs less, equal to, or more clinically effective than standard of care treatment for those with Hepatitis C genotypes 1, 2, and 3 in the Medicaid population?

30) If clinical effectiveness is equal to standard of care, are there benefits to the newer hepatitis C drugs in the Medicaid population with Hepatitis C (genotypes 1, 2, and3) that would recommend the drug over standard of care?

31) Which of the various therapies for hepatitis C maximizes cure rates in patients with hepatitis C and minimizes side effects and treatment discontinuation?

32) What are the outcomes of HCV patients treated with DAA-based combination regimens in the real-life situation? Several DAA-based regimens for treatment of hepatitis C have either been approved or pending approval in the next year or so. They all have efficacy of 80-90% SVR rate depending on regimens, viral genotypes and other modifying factors. There are still several major unanswered questions, such as: do the response rates in real life mirror those from the phase 3 trials, what is the extended SVR of these regimens, what is the long-range and population-based toxicity of these regimens, how are these regimens directly compared with one another in terms of response rate, what situation would one regimen be used over the others, and do patients who are traditionally difficult to treat, like those with cirrhosis, end-stage liver disease, liver transplantation or renal disease, respond equally well to these regimens? These questions cannot be easily answered but at least can be adequately addressed by conducting and establishing a large clinical registry and database to collect, monitor and analyze a large population of HCV patients in the US, who may or may not undergo treatment with these DAA-base regimens in the next 5 years.


33) What is the most effective DAA-based combination regimen in treating HCV patients with genotype 1? The majority of HCV patients in the US are infected with genotype 1. To determine the most effective regimen for this genotype, a direct comparative treatment trial with several regimens (perhaps 3) can be performed.

34) Would those failing one DAA-based combination regimen respond to another regimen?Although the response rates for many of the DAA regimens are 80-90%, some patients still fail such treatments. The key question is whether they will respond to another DAA regimen equally well as the treatment naïve patients. A comparative clinical study can address this question.

35) Does interferon still play a role in treatment of HCV patients? The interesting question of whether interferon can shorten the duration of DAA-based regimen – let’s say from 12 weeks to 4-8 weeks – may be of great interest. While interferon is not well tolerated, a 4-week course may be acceptable by most patients. A comparative clinical trial of a standard DAA regimen with the same regimen and peginterferon but a shorter duration can address this question.

36) What are the comparative rates of decompensated cirrhosis, liver transplant, hepatocellular carcinoma, mortality for patients who achieve a SVR at 24 weeks after treatment with each of the available treatments/treatment combinations for chronic HCV infection? a. What is their quality of life during and after treatment for each of the available treatments/treatment combinations?

37) What are the comparative relapse rates for patients who achieve a SVR at 24 weeks after treatment with each of the available treatments/treatment combinations for chronic HCV infection? a. Do the comparative relapse rates vary by the length of treatment regimens, characteristics of patients, patient comorbidities, patient adherence to treatment regimen, length of infection with HCV or extent of hepatic damage?

38) Is the magnitude of reduction in risk from complications of hepatitis C, particularly hepatocellular carcinoma, the same with sustained viral response achieved by interferon-free regimens as it is for SVR achieved by interferon-based regimens?

39) Are DAAs effective in preventing infection after high-risk exposures due to either a) needlesticks in health care workers or b) injection drug users who share needles?


III. Patient Populations and Timing of Treatment 40) What are the comparative benefits and risks of treating people who inject drugs with the all oral

antiviral therapies (interferon-free) for hepatitis C?

41) What are safety profile and effectiveness of HCV therapy in patients with renal insufficiency and those on hemodialysis? a. Patient population of focus Patients with HCV and renal insufficiency (e.g., CKD stages 4-5) b. Health care decision(s) the research is intended to inform Choosing HCV treatments to achieve sustained virologic response (SVR) in patients with CKD stages 4/5 and reduce mortality c. Clinical interventions and their respective benefits and harms to be compared Current available HCV therapy options and their benefits (i.e., SVR and overall mortality) and harm (adverse events and contraindications).

42) What are comparative survival benefits of achieving SVR at early fibrosis stages (e.g. F0-F2) for patients with HCV? a. Patient population of focus Patients with HCV b. Health care decision(s) the research is intended to inform Choosing HCV treatments to achieve sustained virologic response (SVR) at early fibrosis stages and reduce mortality c. Clinical interventions and their respective benefits and harms to be compared Mortality with SVR at early fibrosis stage VS morality with SVR at late fibrosis stage VS mortality without SVR. Mortality could be disaggregated into specific causes (e.g. liver-, CV-, renal-related) to encompass proposed research questions 5 and 6. Would or should this study include patients co-infected with Hepatitis C and HIV?

43) Are there subpopulation differences in the cure rate using Solvaldi and should we revise the indications for treatment?

44) Compare effectiveness of these therapies on population subsets, such as: • Hep C patients previously treated and failed on older drug regimens • Different racial and ethnic Patient populations and timing of treatment

45) Comparative Effectiveness of Timing of Treatment InitiationCER Question: What is the comparative effectiveness of the following 3 treatment strategies on development of cirrhosis in patients with chronic hepatitis C infection treated with direct acting antiviral agents?1. Initiating treatment at Metavir stage 1 (F1)2. Initiating treatment at Metavir stage 2 (F2)3. Initiating treatment at Metavir stage 3 (F3)P: Patients with chronic hepatitis C infection treated with directly acting antiviral agents; stratified by genotypes.I: Initiating treatment with direct acting antiviral agents at Metavir stage 3 (or F3)C1: Initiating treatment with direct acting antiviral agents at Metavir stage 1 (or F1)C2: Initiating treatment with direct acting antiviral agents at Metavir stage 2 (or F2)O: Cirrhosis (or F4)


46) Do patients with undiagnosed and untreated HCV carry a significant societal burden due to fatigue, presenteeism and other factors associated with quality of life? Improved quality of life and function compared to patients with mild HCV who are not treated? 1. Patient population of focus: the patient population of focus would be all patients with HCV in the United States. While CDC recommendations are to treat all diagnosed patients, treatment guidelines recommend waiting to treat only those patients who are F3/F4. 2. Health care decisions the research is intended to inform: What are the consequences of waiting to treat patients until there is more severe liver damage? Should patients be treated earlier? 3. Clinical interventions and their respective benefits and harms to be compared: Treating F0-F1 patients with new DAA therapies vs. waiting until the disease has progressed to a more severe state. Additional information to increase the meaningfulness of the CER question 1. Meaningful difference in study endpoints/outcomes from the patient’s perspective. Understanding the impairment caused by HCV before progression to cirrhosis can guide treatment paradigms. With new therapies that have a much higher cure rate, the opportunity to intervene earlier in patients’ disease course may offer benefits beyond cure. Endpoints to consider would be physical function, participation in normal activities of daily living and fatigue. 2. Gaps in evidence. There is substantial evidence documenting the impairment on energy, presenteeism and quality of life for patients with HCV, but these focus on all patients, or those with cirrhosis. 3. Significant burden in the US population. Approximately 3.2 million patients have HCV, many of whom are asymptomatic, and may not even know they have the disease. Treatment paradigms vary with regard to the appropriateness of treating those who have mild disease. 4. Likelihood of implementation in practice. Uncertain

47) Do health outcomes of patients successfully treated for HCV differ based on chronic comorbidity? 1. Patient population of focus: Patients with HCV and select comorbid conditions – e.g. Diabetes mellitus, cardiovascular disease, chronic kidney disease 2. Health care decisions the research is intended to inform: This answers the question of whether treating HCV will help management of identified comorbidities. 3. Clinical interventions and their respective benefits and harms to be compared: HCV treatment and appropriate chronic comorbidity treatment. Additional information to increase the meaningfulness of the CER question 1. Meaningful difference in study endpoints/outcomes from the patient’s perspective. Evolution and control of diabetes, cardiovascular diseases, etc., before and after HCV therapy. If a patient achieves SVR, will he/she need less medication to control their diabetes or cardiovascular disease long term? 2. Gaps in evidence. HCV is a complex disease with higher prevalence of comorbidities. Will control of HCV help control those comorbidities? 3. Significant burden in the US population. The US HCV medically insured population is highly comorbid. In addition to increasing all cause mortality, HCV Infected patients report almost double the number of comorbidities compared to non-infected controls. 4. Likelihood of implementation in practice. Has significant potential to be incorporated into practices, if we come to understand that by treating HCV can have broader extrahepatic manifestations.

48) What are the real world results (outside of clinical trial) in HCV patients living with cirrhosis versus those with more mild liver disease?


49) More safety data in subPatient populations and timing of treatment underrepresented in clinical trials (e.g. older people, minorities)

50) Compare the rates of SVR, adherence, and drug resistance in similar settings treating all HCV infected patients versus those treating only F3 and above.

51) What services are necessary for which groups of people to benefit from hepatitis C treatment? Examples of clinical interventions to be compared (any of the following):Case managementPatient navigationPeer support or peer navigationGroup treatment modelsNetwork or community-mobilization interventionsIntegrated multidisciplinary services (mental health, substance abuse, primary and secondary care)Other interventions (directly observed therapy, contingency management, technological approaches)Standard care with none of the above enhancementsTreatment in substance abuse treatment programsTreatment by hepatitis specialistsTreatment by community-based primary care physiciansTreatment in community-based syringe services programs (“needle exchange” programs)Deferral of treatment until behavioral or psychosocial barriers have been addressedClinicians, program administrators, health systems, payers, public health officials, and policymakers face decisions about which of the above services or approaches should be taken with subpopulations of patients with hepatitis CAny number of research questions can be constructed for the following patient populations and timing of treatment and clinical interventions:Patient population of focus: People with hepatitis C. Important subgroups of patients who may be denied care or have different needs are people with hepatitis C who: receive care from safety-net health facilities are living in poverty are uninsured are homeless are living in correctional facilities or under correctional supervision consume alcohol heavily use illicit drugs: occasional marijuana users heavy marijuana users medical marijuana users people who use noninjected drugs — crystal meth, MDMA, ecstasy, cocaine, heroin, pharmaceutical opioids people who inject illicit drugs while receiving substance use treatment (eg opioid substitution therapy) people who inject illicit drugs and do not receive substance use treatment people receiving substance use treatment (e.g. opioid substitution therapy) who do not currently use illicit drugs Each of these groups suffers from poor access to care or denial of treatment stemming from uncertainty about whether and how they should receive antiviral treatment for hepatitis C Healthcare decision: Which groups of patients should receive hepatitis C treatment and what services should be provided?

52) Should patients be required to undergo urine toxicology screening before receiving hepatitis C treatment? This question has little scientific merit but is of importance to patients because many payers currently require patients to undergo urine toxicology screening before receiving hepatitis C treatment. Patient population: People with hepatitis C Healthcare decision: Should urine toxicology screening be required before hepatitis C treatment? Clinical intervention: Hepatitis C treatment with or without prior urine toxicology screening Benefits and harms: Receipt of antiviral therapy, completion of therapy, cure of infection, adverse events


53) Can antiviral therapy reduce transmission of hepatitis C? In our work with people in communities affected by injection drug use our patients have expressed an intense desire for their communities to be free of hepatitis C transmission and the risk of hepatitis C Patient population: People with and at risk of hepatitis C, including: (a) people who inject illicit drugs, (b) young people who inject illicit drugs (among whom transmission rates are much higher), and (c) young people using pharmaceutical opioids for nonmedical purposes (among whom new epidemics are being observed across the nation) Healthcare decision: Treatment of hepatitis C in people at risk of transmitting the infection Clinical intervention: Outreach to identify people acquiring and at risk of acquiring hepatitis C, testing, and antiviral treatment vs. current standard (usual care) Benefits and harms: Reduction of HCV transmission

54) What are the harms and benefits of limiting antiviral treatment for hepatitis C to patients with advanced fibrosis? This question has little scientific merit but is of intense importance to patients because many payers currently require patients to have advanced fibrosis or cirrhosis to receive hepatitis C treatment. Patient population: Patients with hepatitis C Healthcare decision: Treat all patients vs. treat only those with advanced fibrosis Clinical intervention: Antiviral therapy vs. deferred treatment for patients with less advanced fibrosis Benefits and harms: Clinical outcomes, including quality of life, patient satisfaction, incidence of adverse outcomes including liver failure, liver transplantation, death. This question would not lend itself to an ethical randomized clinical trial but could be studied using large observational datasets, as long as important confounders could be controlled for. To some extent, however, this question has been addressed in a number of studies completed or underway.

55) What interventions can reduce transmission of hepatitis C?New HCV epidemics are being observed across the nation among young people using pharmaceutical opioids for nonmedical purposes. In our work with people in communities affected by illicit drug use our patients have expressed a strong desire for their communities to be free of hepatitis C transmission and the risk of hepatitis C. Patient population: Young people using pharmaceutical opioids for nonmedical purposes with or at risk of hepatitis CHealthcare decision: Outreach to identify with people acquiring and at risk of acquiring hepatitis C and intervention to interrupt transmissionClinical intervention: Many different types of interventions have evidence of efficacy, including peer education, counseling and testing, syringe access, network interventions, community mobilization, opioid substitution therapy, overdose prevention, and antiviral therapy for hepatitis CBenefits and harms: Reduction of HCV transmission

56) Mental Health and HCV What are the comparative cognitive side effects of treating HCV infected individuals diagnosed with mental diseases with the new HCV medications?

57) Delay in HCV treatment How does treating patients for Hepatitis C before symptoms occur or treating after the onset of symptoms comparatively affect patient health outcomes?

58) Enrolling more African Americans in Clinical trials What are the clinical outcomes in African Americans, with genotype 1, who experience SVR following antiviral treatment versus those who do not experience SVR?


59) What is the comparative benefit of treating Chronic Hepatitis C in early versus late stages of liver disease severity?

60) What is the real-world effectiveness and toxicity of DAA-based, interferon-free hepatitis C treatments in patients who have not been previously considered candidates for treatment because of serious mental illness, ongoing substance use disorders, or alcohol use disorders?

IV. Screening and Diagnostic Tests 61) What would be the comparative benefits and risks of FibroScan verses liver biopsy in staging patient

diagnosed with hepatitis C?

62) Does screening with a rapid anti-HCV Ab test compared to conventional testing impact informing the population of their HCV antibody status?

63) How does the conventional two step screening and confirmation (anti-HCV Ab followed by HCV PCR if positive) compare to a reflex test (anti-HCV Ab followed by reflex HCV PCR on the same sample) to inform individuals of their HCV status, especially those low-income underinsured subjects?

64) Does the method of screening impact the rates of linkage to care, especially in point of care sites such as urgent care, walk-in clinics and the ER?

65) What are the comparative benefits and risks of liver biopsy versus noninvasive serum fibrosis tools in assessing stage of liver disease in patients with chronic hepatitis C infection to guide treatment decisions?

V. Other Statements and Questions, not CER 66) How would patient outcomes data such as improvement in quality of life and decreased hospitalization

be gathered - would it be by use of data collection by questions generated in EHR. Would staff be located in offices to gather and collect? Or, would data be collected by telephone with patients.

67) How will the availability of all-oral drug regimens for HCV affect the clinical dynamics of patient management? HCV patients historically have been treated by hepatologists and GI physicians, but new agents eliminate the need for response guided therapy for most patients. Will this expand the base of providers who treat HCV to general internists and primary care physicians?

68) Full Disclosure in plain language (Layman’s Terms) is needed to fully inform patients of their options and limitations regarding available medications, their mechanism of action, and potential side effects and the cost. How will this be addressed by this group?

69) How is care structured to achieve these outcomes? How often are they seen by a health care provider, called on the phone, and provided additional services for medical, mental health, or chemical dependency treatment or social services? How many doses of medications are they prescribed or given at each visit (e.g., a month’s supply)?

70) Many insurance companies are limiting access to treatment to those individuals who have advanced fibrosis. What are the benefits and harms of waiting for treatment for individuals who desire treatment


and for whom providers judge treatment to be appropriate, but are denied coverage of hepatitis C treatment? What is the impact on caregivers?

71) Does antiviral therapy ameliorate the common nonspecific symptoms of chronic hepatitis C? Patient population: People with hepatitis C Healthcare decision: Should I undergo antiviral therapy for hepatitis C? Clinical intervention: Antiviral therapy for hepatitis C Benefits and harms: Reduction of fatigue, cognitive impairment, depression; improvement of quality of life This question could be addressed ethically in a clinical trial of patients with nonspecific symptoms of hepatitis C but less advanced liver disease who could be randomized to immediate vs. delayed therapy.

72) What are the guidelines in assessing and combining various real world effectiveness data in the treatment of Chronic Hepatitis C? What are the recommendations in terms of their inclusion in Product Information or disease guidelines? What are the guidelines on their dissemination?

73) How would the patient population be identified and gathered would this be done by physicians in practice supplying patient with the Hepatitis C diagnosis - EHR diagnosis codes? And, or will the patient population be identified and gathered after staging - in other words will patients be identified after receiving liver biopies or after having a FibroScan performed?

74) Background: Birth cohort screening (between 1945-1965) is recommended by the CDC and supported by USFPTF and CMS. Has birth cohort screening increased identification of individuals with previously undiagnosed chronic hepatitis C and are these individuals effectively linked to providers with experience in HCV therapy? 2. Eradication of HCV has multiple health benefits including a decrease in all-cause mortality. Yet many health plans limit access to treatment due to limited resources. Do patients chronically infected with HCV have equal access to HCV therapy and are there disparities between those that receive treatment compared to those that are denied access? A. Not all HCV treatment is equal. If treatment can be obtained, are their differences in the therapy that patients have access to and does this vary with socioeconomic status? 3. Liver related benefit of HCV eradication is well established, however controversy exists regarding other benefits. Does eradication of virus improve (1) quality of life and (2) decrease health care utilization and does this vary

75) What screening guidelines are likely to identify the greatest number of individuals with Hepatitis C?

76) Given the recent FDA approval of a potential cure for Hepatitis C, should we be recommending universal screening for Hepatitis C?

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Suggested Research Questions Submitted by Stakeholders C... · 2014. 10. 17. · 3. Significant burden in the US population. An estimated 750,000 patients with HCV receive health