P0890 : Novel cyclophilin inhibitor CPI-431-32 shows broad spectrum antiviral activity by blocking replication of HCV, HBV and HIV-1 viruses

Methods: This study enrolled 415 adult HCV genotype 1-infected patients without cirrhosis, who were either treatment-naive (N=312) or treatment-experienced (N=103). All patients received a twice-daily fixed-dose combination of DCV 30mg, ASV 200mg, and BCV 75mg for 12 weeks. For this analysis, baseline characteristics as predictors of SVR at posttreatment week 12 (SVR12) are assessed using a multivariate logistic regression model. Results: Overall, SVR12 was achieved by 92% of treatment-naive patients and 89% of treatment-experienced patients. Patients with genotype 1b infection were most likely to achieve SVR12 (Figure; Odds Ratio [OR] 14.4; CI 1.9–109.1). There was a trend toward greater likelihood of SVR12 in patients with baseline HCVRNA <800,000 IU/ml (OR 4.0, CI 0.9–17.5), age <65 years (OR 2.0, CI 0.5–8.3), higher body mass index (BMI; OR 1.8, CI 0.6–5.2) and IL28B genotype CC (OR 1.8, CI 0.7–4.6). Prior treatment experience, gender and NS5A variants L31 or Y93 at baseline were not predictive of SVR. Race did not appear to influence SVR12 rates; of the 41 black patients enrolled in the study, 38 (93%) achieved SVR12. Conclusions: The all-oral, fixed-dose combination of DCV, ASV, and BCV achieved high rates of SVR12 in non-cirrhotic patients with HCV genotype 1 infection. Genotype 1b was the strongest predictor of SVR12. Baseline factors that have previously been shown to impact response to anti-HCV therapies, such as age, race, prior treatment experience, BMI or high baseline HCVRNA had minimal impact on SVR12 rates in this study.