LB-37. Boceprevir plus peginterferon/ribavirin for the treatment of HCV/HIV co-infected patients: Interim On-Treatment Results
Session: Oral Abstract Session: Late Breaker Oral Abstracts
Saturday, October 22, 2011: 7:00 PM
Room: 156ABC

 

Background: Addition of boceprevir (BOC) to peginterferon (P) and ribavirin (R) significantly increases SVR among HCV monoinfected patients and holds promise for the treatment of HCV in HIV-infected persons for whom SVR rates have been low. The objective of this phase 2 trial was to investigate the efficacy and safety of BOC plus P/R in HCV/HIV coinfected patients.

                        

Methods: Patients with untreated hepatitis C genotype 1 infection and HIV RNA <50 copies/mL were randomized in a 1:2 ratio to the control:experimental arms, stratified by: cirrhosis (yes vs no) and baseline HCV-RNA (<800,000 IU/mL vs ≥800,000 IU/mL). Patients were randomized to receive P (PEG 2b 1.5 ug/kg/wk)/R (600 – 1400/mg/day according to weight) + BOC 800 mg TID or P/R + placebo for 44 weeks. All had a 4-week lead-in of P/R. Antiretroviral regimens that included NNRTIs, unboosted protease inhibitors, zidovudine, or didanosine were not permitted.

Results: 100 patients were randomized between 11/2009 and 12/2010; 2 patients in the BOC arm did not receive medication; thus, 34 control and 64 experimental patients were treated.  The majority were non-cirrhotic (95%), white (82%), male (69%) with a median age of ~ 43 years, most had high HCV RNA (88%) and HCV genotype 1a (65%). At treatment weeks (TW) 8 and 12, the rate of undetectable HCV RNA was 22.8 and 33.5% higher in the BOC arms compared to control, respectively (Table).  Discontinuation due to adverse events occurred in 14% and 9% in the BOC and control groups, respectively. Compared to P/R, BOC patients were more likely to have dysgeusia, vomiting, anorexia, and neutropenia; rates of anemia were similar in both groups. At TW12, there were no marked differences in CD4 count or % of subjects with HIV RNA <50 copies/ml in the treatment groups.

Table: Percentage of Patients with Undetectable HCV RNA* Through TW12

Conclusion:  The addition of BOC to P/R was associated with higher rates of undetectable HCV RNA at TWs 8 and 12; the safety and tolerability profile was similar to that observed in HCV monoinfected patients.  These preliminary data support further studies of BOC plus P/R for the treatment of HCV in HIV-infected patients.

 


Subject Category: V. Virology including clinical and basic studies of viral infections, including hepatitis

Mark Sulkowski, MD1, S Pol2, Curtis Cooper, MD3, H Fainboim4, Jihad Slim, MD5, Antonio Rivero6, Seth Thompson7, Wayne Greaves7, Janice Wahl8 and Josep Mallolas9, (1)John Hopkins University School of Medicine, Baltimore, MD, (2)Hopital Cochin, Paris, France, (3)The Ottawa Hospital, Ottawa, ON, Canada, (4)Hospital De Infecciosas, Buenos Aires, Argentina, (5)Saint Michael's Medical Center, Newark, NJ, (6)Hospital Universitario Reina Sofia, Córdoba, Spain, (7)Merck Sharp & Dohme, Whitehouse Station, NJ, (8)Merck Sharp &Dohme, Whitehouse Station, NJ, (9)Hospital Clinic i Provincial, Barcelona , Spain

Disclosures:

M. Sulkowski, Merck: Investigator and Scientific Advisor, Consulting fee and Research support
Vertex: Investigator and Scientific Advisor, Consulting fee and Research support
Abbott: Investigator and Scientific Advisor, Consulting fee and Research support
BMS: Investigator and Scientific Advisor, Consulting fee and Research support
BIPI: Investigator and Scientific Advisor, Consulting fee and Research support
Tibotec: Investigator and Scientific Advisor, Consulting fee and Research support
Pharmasset: Investigator and Scientific Advisor, Consulting fee and Research grant
Novartis : Investigator and Scientific Advisor, Consulting fee and Research support
Roche/Genentech: Investigator and Scientific Advisor, Consulting fee and Research grant

S. Pol, MSD: Consultant, Consulting fee

C. Cooper, MSD: Consultant and Scientific Advisor, Consulting fee

H. Fainboim, None

J. Slim, None

A. Rivero, None

S. Thompson, MSD: Employee, Possible stock options included in employee benefit and Salary

W. Greaves, MSD: Employee, Possible stock options included in employee benefit and Salary

J. Wahl, MSD: Employee, Possible stock options included in employee benefit and Salary

J. Mallolas, None

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