Telaprevir is effective given every 12 h at 750 mg with pegylated interferon-α2b and ribavirin to Japanese patients with HCV-1b IL28B rs8099917 TT
The aim of this study is to explore the efficacy, safety and pharmacokinetics of 750mg telaprevir (TVR) given at 8 or 12 hour intervals during triple therapy with peg-interferon-alfa-2b (PEG-IFN) and ribavirin (RBV) for patients with chronic hepatitis C virus (HCV) infection. 52 patients with high viral loads of genotype 1b who were expected to respond well to therapy (rs8099917 TT genotype or relapse to previous therapy) were randomly assigned to two groups who were given 750mg TVR at either 8 or 12 hour intervals (q8h or q12h) in combination with PEG-IFN and RBV for 12 weeks, followed by an 12 additional weeks of treatment with PEG-IFN and RBV alone. The primary end point of the study was undetectable HCV RNA at 12 weeks after the end of treatment (SVR12). SVR12 rates were 92.3% (24/26) for both q8h and q12h. The changes in mean log10 HCV RNA levels and viral response were also similar in q8h compared to q12h, whereas pharmacokinetic properties such as Cmax, AUC0-24h and Ctrough of TVR were slightly higher in q8h than in q12h (P>0.2). The frequency of TVR discontinuation due to anemia or renal damage was significantly higher in q12h than in q8h (6/26(23%) vs. 0/20, respectively; P=0.02). TVR given at 12 hour intervals should be considered for patients with lower body weight, especially patients with prior relapse and with IL28B polymorphisms at rs8099917 TT (interferon lambda 4 ss469415590 polymorphism TT/TT) genotype in patients with genotype 1b HCV infection.