Boceprevir, peginterferon and ribavirin for acute hepatitis C in HIV infected patients

Sebastiaan J. Hullegie, Mark A. A. Claassen, Guido E. L. van den Berk, Jan T. M. van der Meer, Dirk Posthouwer, Fanny N. Lauw, Eliane M. S. Leyten, Peter P. Koopmans, Clemens Richter, Arne van Eeden, Wouter F. W. Bierman, Astrid M. Newsum, Joop E. Arends, Bart J. A. Rijnders

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Abstract

Acute hepatitis C virus infections (AHCV) are prevalent among HIV positive men having sex with men and generally treated with pegylated interferon-alpha (PegIFN) and ribavirin (RBV) during 24weeks. The addition of a protease inhibitor could shorten therapy without loss of efficacy. We performed an open-label, single arm study to investigate the efficacy and safety of a 12-week course of boceprevir, PegIFN and RBV for AHCV genotype 1 infections in 10 Dutch HIV treatment centers. The primary endpoint of the study was achievement of sustained virological response rate at week 12 (SVR12) in patients reaching a rapid viral response at week 4 (RVR4) and SVR12 in the intent to treat (ITT) entire study population was the most relevant secondary endpoint. One hundred twenty-seven AHCV patients were screened in 16 months, of which 65 AHCV genotype 1 patients were included. After spontaneous clearance in six patients and withdrawal before treatment initiation in two, 57 started therapy within 26 weeks after infection. RVR4 rate was 72%. SVR12 rate was 100% in the RVR4 group. SVR12 rate in the ITT group was 86% and comparable to the SVR12 rate of 84% in 73 historical controls treated for 24 weeks with PegIFN and RBV in the same study centers. With the addition of boceprevir to PegIFN and RBV, treatment duration of AHCV genotype 1 can be reduced to 12 weeks without loss of efficacy. Given the high drug costs and limited availability of interferon-free regimens, boceprevir PegIFN and RBV can be a considered a valid treatment option for AHCV. ClinicalTrials.gov, number NCT01912495
Original languageEnglish
Pages (from-to)807-812
JournalJournal of Hepatology
Volume64
Issue number4
DOIs
Publication statusPublished - 2016

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