Ombitasvir/paritaprevir/ritonavir & dasabuvir ± ribavirin following protease inhibitors failure - A prospective multi-centre trial
BMC Infectious Diseases Apr 08, 2020
Deutsch L, Houri I, Ben-Ari Z, et al. - Researchers examined the safety and efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir (3D) ± ribavirin (RBV) in hepatitis C virus (HCV) genotype 1 patients that failed previous treatment with first generation protease inhibitors (PIs). They conducted an investigator-initiated, open-label, multi-centre clinical trial including HCV Genotype 1 patients who were previously null/partial responders or relapsers to telaprevir, boceprevir or simepravir+pegIFN/RBV and met eligibility criteria. According to label, participants were administered 3D ± RBV for 12 or 24 weeks. Treatment was initiated in 39 patients according to study protocol (59% men, age 54.0 ± 8.7 years, BMI 28.7 ± 4.5 kg/m2). Genotype 1b (9 cirrhotics) was identified in 35 patients and genotype 1a (2 cirrhotics) was identified in 4 patients. Intention-to-treat SVR12 was 92.3% and per-protocol SVR12 was 97.3%. Decline was observed in the rate of advanced fibrosis (FibroScan score F3–4) from 46.2 to 25.7% and in abnormal ALT levels from 84.6 to 8.6%. Outcomes suggest that among patients with HCV genotype 1 who failed previous first-generation PI treatment, 3D ± RBV was identified as safe and effective in attaining sustained virologic response. .
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