19 th CROI, Seattle, WA, 2012. La Pedrera, Barcelona – March 13 th 2012 19 th CROI, Seattle, WA, 2012. La Pedrera, Barcelona – March 13 th 2012 Dr. José

19th CROI, Seattle, WA, 2012.La Pedrera, Barcelona – March 13th 201219th CROI, Seattle, WA, 2012.

La Pedrera, Barcelona – March 13th 2012

Dr. José M. MiróInfectious Diseases Service - ICMiD

Hospital Clinic - IDIBAPS University of Barcelona

Barcelona (Spain)

Dr. José M. MiróInfectious Diseases Service - ICMiD

Hospital Clinic - IDIBAPS University of Barcelona

Barcelona (Spain)

Summary I: Opportunistic Infections HCV/HBV Co-Infections & Tumors

Summary I: Opportunistic Infections HCV/HBV Co-Infections & Tumors

E-mail address: [email protected] address: [email protected]

Egger, #100

Egger, #100

Egger, #100

Egger, #100

Tuberculosis TB-IRIS Opportunistic infections Hepatitis co-infections Tumors


OIs, Hepatitis Coinfections & Tumors


A5221/STRIDE A5221/STRIDE CAMELIA CAMELIA SAPITSAPIT

EndpointsEndpoints

SitesSites

No. No.

ArmsArms

800/800800/800

Africa, Asia, SA, NAAfrica, Asia, SA, NA

215/215215/215660/660660/660

CambodiaCambodia South AfricaSouth Africa

Imm vs. 8-24 wkImm vs. 8-24 wkImm vs. 8 wkImm vs. 8 wkImm vs. 8-12 wkImm vs. 8-12 wk

Death, AIDSDeath, AIDS DeathDeath Death, AIDSDeath, AIDS

When to Start cART During TB Treatment (N Engl J Med, October 20th, 2011)

When to Start cART During TB Treatment (N Engl J Med, October 20th, 2011)

Immediate = First 2 weeks.Immediate = First 2 weeks.

Effects of ART timing on outcomes in CAMELIA and patients with CD4 < 50 in STRIDE and SAPIT

0

5

10

15

20

25

30

CAMELIA STRIDE SAPIT

Immediate Early

34% ↓ p=0.004

42% ↓ p=0.02

68% ↓ p=0.06

NEJM, 2011

AIDS or death

0

2

4

6

8

10

12

14

STRIDE SAPIT

AID

S o

r death

Immediate Early

p=0.67

p=0.34

NEJM, 2011.

Effects of ART timing on outcomes in CAMELIA and patients with CD4 > 50 in STRIDE and SAPIT

Day 0

TB treatment

2RHZE/4RH

Week8 Week 4

Week 2

Rd

Anti TB week 8 (arm 3)

week 1(arm 1)

Week12 Week 20 Week 24

Between arm transfers

cART d4T/AZT/TDF-3TC-EFV

week 4(arm 2)

Wondwossen Amogne Degu , #144

Study Design

RCT to Determine Efficacy and Safety of cART 1 Week after TB Therapy in Patients with CD4 <200 Cells/µL - Ethiopia

Wondwossen Amogne Degu #144Wondwossen Amogne Degu #144


P=0.4


Degu#144Degu#144


Degu#144Degu#144

Degu#144Degu#144


95% CI

0.5-2.9

0.8-7.7

1.1-15.2

TB Incidence Increase after Cessation of 36 Months’ Isoniazid Prophylaxis (IPT) in HIV+ Adults: Botswana

Samandari#147

Samandari#147

Samandari#147

Post-trial (no IPT) n=1678

6H36H

Cumulative TB incidence in the in-trial & post-trial period by study arm for all participants

Cum

ulati

ve T

B in

cide

nce

P=0.04P=0.52

6H 36H

In trial n=1995

6H36H

Nuermberger #127

Nuermberger #127

Nuermberger #127

Nuermberger #127





Effects of ART timing on TB-IRIS among patients in STRIDE, SAPIT and CAMELIA trials

0

5

10

15

20

25

30

35

STRIDE SAPIT CAMELIA

IRD

Immediate Early

P<0.01

P<0.01

NEJM; 2011

P<0.05

Severity and Timing of Paradoxical TB-IRIS

• TB IRIS occurred 7.6% (61/806)

* Significant interaction between CD4 + and arm, p =0.014

CD4+ < 50 n= 285

CD4+ ≥ 50 n=521

11.5% (33/285)

5.4% (28/521)

Earlier ART(n=405)

10.4% (42/405)

18.8% (27/ 144)

5.5% (15/261)

Later ART(n=401)

4.7% (19/401)

4.3% (6/141)

5.0% (13/260 )

Luetkemeyer#145

Luetkemeyer#145

Luetkemeyer#145

Management of TB IRIS

• 31% required hospitalization for TB IRIS • No deaths attributed to TB IRIS • 54% received corticosteroids, median treatment 15

days (IQR 7,32) • Infrequent interruption of TB treatment (3) or ART(3)• 34% of those diagnosed with IRIS underwent ≥ 1

invasive procedure: • Lumbar puncture (2)• Thoracentesis (1)• Liver biopsy (1)• Surgical pleural drainage (2)

• FNA (10)• Outpatient abscess drainage (3)• Surgical abscess drainage (1)• Lymph node biopsy (5)

• CRP rapidly decreased on prednisone

Meintjes #146

Research questions

1. What is the effect of prednisone on mycobacterial-specific T-cells and cytokine/chemokine concentrations in TB-IRIS?

2. What is the cellular source of pro-inflammatory cytokines in TB-IRIS?

Meintjes #146

Meintjes #146

Meintjes #146

Neutrophils and monocytes an important source of TNF, IL-6 and IL-12p40 in HIV-TB with higher production of

IL12p40 and TNF by neutrophils in TB-IRIS (preliminary)





• Early vs. Deferred (10 weeks) cART in Cryptococcal Meningitis (N=54)– Rx: Fluconazole 800 mg daily and

d4T/3TC/NVP– No use of amphotericin or management of

raised intracranial pressure

• Mortality: 87% early vs. 37% delayed (P=0.002)– Most deaths in immediate ART group occurred

within the first month, possibly due to IRIS– Fluconazole-NVP drug interaction postulated

• Early vs. Deferred (10 weeks) cART in Cryptococcal Meningitis (N=54)– Rx: Fluconazole 800 mg daily and

d4T/3TC/NVP– No use of amphotericin or management of

raised intracranial pressure

• Mortality: 87% early vs. 37% delayed (P=0.002)– Most deaths in immediate ART group occurred

within the first month, possibly due to IRIS– Fluconazole-NVP drug interaction postulated

HIV-associated Cryptococcal Meningitis (Uganda):Immediate vs. Deferred cART

Makadzange A, et al. Clin Infect Dis. 2010; 50(11):1532-8.

Comparison of Kaplan-Meier Survival Estimatesby Treatment Group

Comparison of Kaplan-Meier Survival Estimatesby Treatment Group

1.00

1.00

0.75

0.75

0.00

0.00

0.25

0.25

00 200200 400400 600600 800800

Time to Death (in days)Time to Death (in days)

0.50

0.50

Time to Death (days)Time to Death (days)

P=0.028P=0.028Deferred

Early

Su

rviv

alS

urv

ival

Immediate vs. Deferred cART in Fungal OIs (ACTG A5164) Zolopa AR, et al. PLoS ONE. 2009;4(5):e5575. Epub 2009.

Immediate cART is beneficial

in the ACTG trial !

Chang#955

Chang#955

Chang#955

Chang#955

Benson#96

Benson#96

ZOSTAVAX Is Generally Safe and Immunogenic in HIV+ Adults Virologically Suppressed on ART: Results of a Phase 2, Randomized,

Doubleblind, Placebo-controlled (3:1) Trial

Risk of recurrent/severe herpes zoster (HZ) is increased in HIV+ patients. ZOSTAVAX® (ZV; zoster vaccine live) is generally safe and effective in reducing HZ incidence/severity in HIV– adults ≥50 years old, but has not been evaluated in HIV+ adults. Two doses (day 0, week 6)

Risk of recurrent/severe herpes zoster (HZ) is increased in HIV+ patients. ZOSTAVAX® (ZV; zoster vaccine live) is generally safe and effective in reducing HZ incidence/severity in HIV– adults ≥50 years old, but has not been evaluated in HIV+ adults. Two doses (day 0, week 6)

Conclusions: Administration of 2 doses of ZV in HIV+ adults (CD4 ≥200 copies/μL) virologically suppressed on ART was generally safe (HZ 2 ZV vs. 2 PBO), and immunogenic (mainly CD4>350). Conclusions: Administration of 2 doses of ZV in HIV+ adults (CD4 ≥200 copies/μL) virologically suppressed on ART was generally safe (HZ 2 ZV vs. 2 PBO), and immunogenic (mainly CD4>350).

Tebas#97

Tebas#97

Improved Immunogenicity with High-dose Seasonal Influenza Vaccine in HIV+ Individuals: A Double-blinded, Randomized Trial Comparing

Fluzone High-Dose with Fluzone

HIV (+) Individuals

D0

Immunogenecity evaluations

Vaccine dosing

Fluzone-HD (180µg) (n=97)

Fluzone-SD (45µg) (n=93)

D21-28

Fluzone-HD was approved by the FDA in December of 2009 for adults 65 years and older.

Tebas#97

Tebas#97



Standard Dose High Dose P(n = 93), (n = 97),

% subjects (95% CI) % subjects (95% CI)*Seroprotection H1N1 87(80-94) 96(92-100) 0.029 H3N2 92(87-98) 96(92-100) 0.315 B 80(71-88) 91(85-97) 0.03

Seroconversion H1N1 59 (49-69) 75(67-84) 0.018 H3N2 74(65-83) 78(70-87) 0.5 B 34(25-44) 56(46-66) 0.003

*Seroprotection defined as antibody titers ≥ 1:40.Seroconversion defined as a four-fold increase in antibody titers from baseline.

Tebas#97

Tebas#97



0 21

Med

ian

GM

T T

iter

(95

% C

I)

0

200

400

600

800

1000

Fluzone SDFluzone HD

0 21

0

200

400

600

800

1000

1200

0 21

0

20

40

60

80

100

120

140

160

180

200

H1N1 H3N2 FluB

*p=0.008 p=0.001 P<0.001

* Comparison between arms at day 21

Tebas#97

Tebas#97

Standard Dose High Dose (n = 8), (n = 14),

% subjects % subjects*Seroprotection H1N1 75 93 H3N2 50 79 B 36 64

Seroconversion H1N1 50 79 H3N2 50 71 B 25 36*Seroprotection defined as antibody titers ≥ 1:40.Seroconversion defined as a four-fold increase in antibody titers from baseline.

• Overall response is lower, but HD also superior• Overall response is lower, but HD also superior

Maldarelli#375

Maldarelli#375

No Effect of Influenza Vaccination on Levels of Persistent Viremia in Individuals on Suppressive cART





Boesecke,#133

pegIFN + RBV in Acute HCV:EVR & SVR all GT

284 HIV-infected male patients from 4

European countries (UK, France,

Germany, Austria) with diagnosed

acute HCV infection were treated early

with pegylated interferon and ribavirin

(n=254) or pegylated interferon alone

(n=30). In 88% of cases weight-adapted

dosage of ribavirin (wt ≤75kg: 1000mg;

wt >75kg: 1200mg/d) was used.

Boesecke,#133

pegIFN + RBV in Acute HCV:EVR & SVR only GT 1/4

85,7

707166,5

0

10

20

30

40

50

60

70

80

90

EVR SVR

% pegIFN mono

pegIFN/ RBV

p=0,236

p=0,751

174/22114/2012/14 137/193

Boesecke,#133

pegIFN + RBV in Acute HCV:EVR & SVR only GT 2/3

66,760

96

0

10

20

30

40

50

60

70

80

90

100

EVR SVR

% pegIFN mono

pegIFN/ RBV

94

p=0,029 p=0,007

4/6 24/25 6/10 31/33

Boesecke,#133

pegIFN + RBV in Acute HCVSummary

For GT 2/3 infections addition of Ribavirin shows

beneficial effect on cure rates.

For GT 1/4 infections the role of RBV needs further

evaluation.

In addition the role of DAAs in treatment of AHC needs

to be explored.

Ingiliz#752

Hepatitis C Reinfection in HIV+ MSM

45 HIV+ MSM with acute HCV infection

40 SVR5 SCEpisode 1

16 SVR3 SCEpisode 2(8 pending)

4 SC2 SVR

Episode 3(1 pending)

1SC

Episode 4 1SCSC=spontaneous clearance, SVR=sustained virological response, C=chronification

Ingiliz#752


Genotype distribution at first and second HCV episode (n=45) and genotype switches (n=26)

1 3 1

1 4 1

1a 4, 4d 6

1a 3a 1

1a 1b 1

1b 1a 1

1b 4, 4d 2

3 1a 4

3 4 1

3a 1 1

4 1a,b 6

4d 1b 1

26 (58%)


Ingiliz, CROI 2012, Abstract # Q-1004

Switcher Non-Switcher Clearer Non-Clearer

Median HCV-RNA [IU/mL] 310000 360000 n.s. 210200 507400 n.s.

Median ALT [U/L] 301 463 n.s. 498 306 n.s.

Median AST [U/L] 138 203 n.s. 296 139 n.s.

Median GGT [U/L] 194 179 n.s. 268 180 n.s.

Median CD4 cells [/mm3] 498 492 n.s. 681 472 p=0.03

ART [n] (%) 19 (73) 11 (61) n.s. 4 (57) 26 (68) n.s.

IL28B C/C [n] (%) 5 (33) 5 (38) n.s. 4 (80) 7 (29) p=0.05

Patients with or without genotype switch and with or without viral clearance at second HCV episode

Ingiliz#752

Virion assembly

Translation and polyproteinprocessing

RNA replication

Receptor bindingand endocytosis

Fusion anduncoating

(+) RNA

Transport and release

Treatment Targets against HCV

Protease Inhibitors

Boceprevir*

Telaprevir* *NS3/4A PIs

Study 110: Telaprevir in HIV/HCV

co-infected patientsPart A: no ARTPart A: no ART

240 48 72Weeks 12 36

PR PR

PR PR

T/PR TVR + PR Follow-upSVR

Follow-upPR48

(control)

SVRPbo + PR

PR PR

PR PR

Follow-upPR48

(control)

SVRPbo + PR

T/PR TVR + PR Follow-upSVR

Part B: ART (EFV/TDF/FTC or ATV/r + TDF + FTC or 3TC)Part B: ART (EFV/TDF/FTC or ATV/r + TDF + FTC or 3TC)

PR – Pegylated interferon/ribavirin, TVR – Telaprevir,SVR – Sustained virologic responseDieterich D

#46

Dieterich D#46

71

33

69

50

80

50

74

45

0

10

20

30

40

50

60

70

80

90

100

Pat

ient

s w

ith

Und

etec

tabl

e H

CV

RN

A (

%)

No ART EFV/TDF/FTC ATV/r/TDF/FTC Total

n/N =n/N = 5/75/7 11/1611/16 12/1512/15 28/3828/38

T/PRT/PR PRPR2/62/6 4/84/8 4/84/8 10/2210/22

Study 110: SVR Rates 12 Weeks Post-Treatment (SVR12)

*Patient was defined as SVR12 if HCV RNA was < LLOQ in the visit window*Patient was defined as SVR12 if HCV RNA was < LLOQ in the visit window

Sulkowski #47

Study Design: BOC + PEG/RBV for HCV/HIV co-infection (SVR12 results)

• Two-arm study, double-blinded for BOC, open-label for PEG2b/RBV– 2:1 randomization (experimental: control)– Boceprevir dose 800 mg TID

• 4-week lead-in with PEG2b/RBV for all patients– PEG-2b 1.5 µg/kg QW; RBV 600-1400 mg/day divided BID

• Control arm patients with HCV-RNA ≥ LLOQ at TW 24 were offered open-label PEG2b/RBV+BOC via a crossover arm

Weeks 12 24 28 48 72

PEG2b+RBV 4 wk

Placebo + PEG2b + RBV44 wk

Boceprevir + PEG2b + RBV44 wk

Follow-upSVR-24 wk

Follow-upSVR-24 wk

PEG2b+RBV 4 wk

Arm 1

Arm 2

Futility Rules

Sulkowski #47

8.814.7

23.532.4 29.4 26.5

4.7

42.2

59.4

73.465.6

60.7

0

20

40

60

80

100

4 8 12 24 EOT SVR12

Treatment Week

PR B/PR

%

HC

V R

NA

Un

det

ecta

ble

3/34 3/64 5/34 27/64 8/34 38/64 11/34 47/64

Virologic Response Over Time†

10/34 9/3442/64 37/61

† Three patients undetectable at FW4 have not yet reached FW12 and were not included in SVR12 analysis.

Tolerability and safety: first signals from pilot trials

• 34% and 23% of T/PR and PR patients, respectively had rash; no severe rashes were reported in either group

• Preliminary safety data of B/PR in co-infected patients showed a profile consistent with that observed in mono-infected patients (anemia 41% vs. 26%)

• HIV Breakthroughs were observed in 3/64 patients in the B/PR group and 4/34 patients in the control group

Dieterich, # 46Sulkowski # 47

Management Issues with Co-medicationshttp://www.interaccionesVIH.com

Resumen VII – Interacciones farmacológicas y farmacocinética

Dr. Esteve Ribera

Dieterich, # 46Sulkowski # 47

Futility rules

W4 W12 W24W4 W12 W24 W48

HCV -RNA>1000 IU/ml

PEG -IFN+RBV

Stop

Telaprevir

HCV - RNA>1000 IU/ml

Stop

HCV -RNA>20 IU/ml

Stop

PEG -IFN+RBV

Boceprevir

HCV -RNA>100 IU/ml

Stop

HCV -RNA>20 IU/ml

Stop

Initial HCV RNA decline provides information on treatment prediction outcome

HCV GT-1 SVR Rates Over Time According to the Type of anti-HCV Therapies

IFN

IFN + RBV

Peg-IFN + RBV

Peg-IFN+ RBV + Boceprevir/Telaprevir

15-20%

35-40%

45-50%

70-75%

-

-

17-35%

61-74%

1990

1998

2001

2011

HCV HCV/HIV

*Monitor fibrosis stage annually, preferably with two established methods. Treat with triple therapy, if rapid progression.

Management of HCV/HIV Coinfected GT-1 Patients According to Fibrosis Stage & Prior Rx Outcome

Rockstroh#72

• INX-184 (Inhibitex)

DAA in the Pipeline (2012-20)phase 1 phase 3phase 2

NS3protease inhibitors

NS5B polymeraseinhibitors

•Telaprevir (Vertex/Johnson& Johnson)

•Boceprevir (MSD)

NS5Ainhibitors

• ACH-1625 (Achillion)• BMS-650032 (BMS)• PHX1766 (Phenomix)• VX-813 (Vertex)• GS-9256 (Gilead)• GS-9451 (Gilead)

• MK-0608 (Merck)• VCH-222, -759, 916

(ViroChem)

• ABT-450 (Abbott/Enanta)• BI 201335 (Boehringer)• CTS1027 (Conatus)• ITMN-191-Danoprevir-R7227

(InterMune/Roche)• MK-7009-Vaniprevir (MSD)• Narlaprevir (MSD)• TMC435 (Medivir/J&J)

• ABT-333 (Abbott)• ANA598 (Anadys)• BI 207127 (Boehringer)• Filibuvir (Pfizer) • GS 9190 (Gilead)

• BMS-790052 (BMS)• PPI-461 (Presidio)• GS-5885 (Gilead)

Nucleos/tide • IDX184 (Idenix)• PSI-7851/7977 (Pharmasset)• R7128 (Pharmasset/Roche)• GS7977 (Gilead)

Non-nucleoside

• GS-7977 is a potent, specific HCV nucleotide analog

• Safe and well-tolerated in clinical studies

• Once daily, with or without food• Potent antiviral activity• High barrier to resistance

– No virologic breakthrough to date

O

C H

FHO

ON

NH

O

O

PO

O

NH

O

O C H3

GS-7977 Background

Lawitz E, et al. J Lawitz E, et al. J Hepatol 2011; 54: S543. 2011; 54: S543. Lawitz E, et al. J Lawitz E, et al. J Hepatol 2011; 54: S543. 2011; 54: S543.

• To evaluate the antiviral activity of 12 weeks GS-7977 + RBV in genotype 1 patients who were either:

– Prior null responders (<2 log10 reduction in HCV RNA at Week 12 of a Peg/RBV regimen)

– Treatment-naïve

• RBV dosing in all arms, independent of HCV genotype, was 1000 mg for patients <75 kg and 1200 mg for those ≥75 kg

ELECTRON Study Design for HCV Genotype 1 - Interferon-Free/-Sparing Regimens

Genotype 1 Treatment-naïve (GS-7977 + RBV)Genotype 1 Treatment-naïve (GS-7977 + RBV)

Genotype 1 Null Responders (GS-7977 + RBV) Genotype 1 Null Responders (GS-7977 + RBV)

n=25

SVR12

SVR12

n=10

4 8Wk 0 12 24

Gane#54LB

Time (Weeks)

0 1 2 3 4

HC

V R

NA

(lo

g 10I

U/m

l)

0

1

2

3

4

5

6

7

GS-7977/RBV GT-1 Null Responders GS-7977/RBV GT-1 Treatment NaiveGS-7977/RBV GT2/3 Treatment Naive

Assay LLOD 15 IU/mLAssay LLOD 15 IU/mL

Rapid Rapid Viral Suppression in Prior Null and Treatment-Naïve Genotype 1 Patients

Genotype 1 null respondersGenotype 1 treatment-naïveGenotype 2/3 treatment-naïve

Gane#54LB

Gane#54LB

100% Genotype 1 Prior Null RespondersHad HCV RNA <LOD at End of Treatment

Genotype 1

Null Responders

(N=10)

Genotype 1

Treatment-naïve

(N=25)

Genotype 2/3 Treatment-naïve

(N=10)

n/N % <LOD n/N % <LOD n/N % <LOD

Week 1 1/10 10 7/25 28 2/10 20

Week 2 7/10 70 17/24 71 10/10 80

Week 4 10/10 100 25/25 100 10/10 100

Week 10 9/9 100 25/25 100 10/10 100

Week 11 9/9 100 16/16 100 10/10 100

Week 12 9/9 100 6/6 100 10/10 100

SVR 4 1/9 11 -- -- 10/10 100





Cancer Stage, Age at Diagnosis, and Survival Comparing HIV+ vs. HIV- Individuals with Common Non-AIDS-Cancers

Silverberg, #903

Silverberg, #903

Source population: 22,081 HIV(+) and 230,069 HIV(‐) individuals matched by age, sex, clinic, and initial year of follow‐up.Source population: 22,081 HIV(+) and 230,069 HIV(‐) individuals matched by age, sex, clinic, and initial year of follow‐up.

Objective: To compare age at diagnosis, stage at diagnosis and 5‐year survival for HIV(+) and HIV(‐) individuals diagnosed with prostate, anal, lung and colorectal cancers, and Hodgkin lymphoma.

Objective: To compare age at diagnosis, stage at diagnosis and 5‐year survival for HIV(+) and HIV(‐) individuals diagnosed with prostate, anal, lung and colorectal cancers, and Hodgkin lymphoma.


Silverberg, #903

Silverberg, #903


Silverberg, #903

Silverberg, #903

Incidence and Predictors of Non-Hodgkin Lymphoma Among HIV-Infected Persons on Suppressive ART

Achenbach, #131

Achenbach, #131

• HIV-infected persons continue to have high incidence of NHL despite suppressive ART– Our study: 15 cases per 10k py– U.S. SEER rate (2004-2008): 2 per 10k py– Kaiser Permanente HIV-negative: 1.7 per 10k py

• Level of immune suppression continues to be an independent predictor of NHL after controlling for age, race, and sex.

• HIV viremia, even low level, also likely contributes to NHL risk.

• HIV-infected persons continue to have high incidence of NHL despite suppressive ART– Our study: 15 cases per 10k py– U.S. SEER rate (2004-2008): 2 per 10k py– Kaiser Permanente HIV-negative: 1.7 per 10k py

• Level of immune suppression continues to be an independent predictor of NHL after controlling for age, race, and sex.

• HIV viremia, even low level, also likely contributes to NHL risk.

AIDS-PCNSL Treated with HAART and Radiation-Sparing Therapy: Rituximab, Methotrexate and

Leucovorin [NCT00267865]

Uldrick #911

Uldrick #911

Median (range) follow-up 42 months (7 months ‐ 7 years)

78% (60 to 90%)

Treatment of Anal Intraepithelial Neoplasia in 148 HIV+ MSM: A Triple-arm RCT of Imiquimod, Topical

5-Fluoruracil (5FC), and Electrocautery

Richel#135LBRichel

#135LB

ImiquimodImiquimod 5FC5FC ElectrocauteryElectrocautery P valueP value

Complete response

Recurrence at 6 months

Severe Side Effects

Complete response

Recurrence at 6 months

Severe Side Effects

26%

25%

43%

26%

25%

43%

17%

57%

27%

17%

57%

27%

41%

17%

18%

41%

17%

18%

=0.03

-

=0.02

=0.03

-

=0.02

Imiquimod, 3 times weekely; 5-fluoruracil (5FC), twice a week; Electrocautery, monthlyDuration of the treatment: 4 months.

Evaluation: high-resolution anoscopy with biopsies 4 weeks and 6 months after treatment.

Imiquimod, 3 times weekely; 5-fluoruracil (5FC), twice a week; Electrocautery, monthlyDuration of the treatment: 4 months.

Evaluation: high-resolution anoscopy with biopsies 4 weeks and 6 months after treatment.

CJ AchenbachC. Boesecke

C. ChangK. DooleyM. EggerX. Forns

CJ AchenbachC. Boesecke

C. ChangK. DooleyM. EggerX. Forns

AcknowledgementsAcknowledgements

http://retroconference.orghttp://retroconference.org

A. LuetkemeyerG. Meintjes

E. NuermbergerJ. RockstrohW. SimonsP. Tebas

A. LuetkemeyerG. Meintjes

E. NuermbergerJ. RockstrohW. SimonsP. Tebas

Documents

19 th CROI, Seattle, WA, 2012. La Pedrera, Barcelona – March 13 th 2012 19 th CROI, Seattle, WA, 2012. La Pedrera, Barcelona – March 13 th 2012 Dr. José