Hepatology 2010 Aug 19. [Epub ahead of print]
Antiviral activity of narlaprevir combined with ritonavir and pegylated interferon in chronic hepatitis C patients.
de Bruijne J, Bergmann JF, Reesink HW, Weegink CJ, Molenkamp R, Schinkel J, Tong X, Li J, Treitel MA, Hughes EA, van Lier JJ, van Vliet AA, Janssen HL, de Knegt RJ. Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands.
Summary by C.D. Mazoff
This study explored the use of narlaprevir (SCH 900518) (with or without ritonavir) administered as monotherapy and as combination therapy with pegylated interferon-α-2b (PEG-IFN-α-2b) to HCV genotype 1-infected patients.
The study was a randomized, placebo-controlled, two-period, blinded study in 40 HCV genotype 1-infected patients (naïve and treatment-experienced), and was administered as follows:
Period 1: narlaprevir was administered for 7 days, 800 mg three times daily without ritonavir or 400 mg twice daily with 200 mg ritonavir twice daily.
Period 2: after a 4-week washout, the same dose and regimen of narlaprevir was administered in combination with PEG-IFN-α-2b for 14 days.
Upon completion of period 2, all patients initiated PEG-IFN-α-2b and ribavirin treatment.
Results: there was a mean viral load decline of at least 4 log(10) in all treatment groups and 50-60% of all patients had undetectable HCV-RNA (<25 IU/mL) after period 2.
Standard of care resulted in sustained virological response (SVR) rates of 38% and 81% in treatment-experienced and treatment-naïve patients, respectively.