Sebastiaan J Hullegie1, Mark A A Claassen2, Guido E L van den Berk3, Jan T M van der Meer4, Dirk Posthouwer5, Fanny N Lauw6, Eliane M S Leyten7, Peter P Koopmans8, Clemens Richter9, Arne van Eeden10, Wouter F W Bierman11, Astrid M Newsum12, Joop E Arends13, Bart J A Rijnders2. 1. Department of Internal Medicine and Infectious Diseases, Erasmus MC, Rotterdam, The Netherlands. Electronic address: b.hullegie@erasmusmc.nl. 2. Department of Internal Medicine and Infectious Diseases, Erasmus MC, Rotterdam, The Netherlands. 3. Department of Internal Medicine and Infectious Diseases, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands. 4. Department of Internal Medicine and Infectious Diseases, Academisch Medisch Centrum, Amsterdam, The Netherlands. 5. Department of Internal Medicine and Department of Medical Microbiology, Maastricht Universitair Medisch Centrum, Maastricht, The Netherlands. 6. Department of Internal Medicine and Infectious Diseases, Slotervaart Ziekenhuis, Amsterdam, The Netherlands. 7. Department of Internal Medicine and Infectious Diseases, Medisch Centrum Haaglanden, Den Haag, The Netherlands. 8. Department of Internal Medicine and Infectious Diseases, Radboud Universitair Medisch Centrum, Nijmegen, The Netherlands. 9. Department of Internal Medicine and Infectious Diseases, Rijnstate Ziekenhuis, Arnhem, The Netherlands. 10. DC Klinieken, Amsterdam, The Netherlands. 11. Department of Internal Medicine, Infectious Diseases Service, University of Groningen, Universitair Medisch Centrum Groningen, Groningen, The Netherlands. 12. Department of Internal Medicine and Infectious Diseases, Academisch Medisch Centrum, Amsterdam, The Netherlands; Department of Infectious Diseases Research and Prevention, Public Health Service of Amsterdam, Amsterdam, The Netherlands. 13. Department of Internal Medicine Division of Infectious Diseases, Universitair Medisch Centrum Utrecht, Utrecht, The Netherlands.
Abstract
BACKGROUND & AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
BACKGROUND & AIMS: 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. METHODS: 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. RESULTS: One hundred twenty-seven AHCVpatients 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. CONCLUSION: 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.
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