Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12 weeks

Background & Aims Patients with chronic hepatitis C virus (HCV) infection and cirrhosis have a higher risk for liver-related complications and have historically been more difficult to cure than patients without cirrhosis. We evaluated the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir, without ribavirin, for 12 weeks in patients with HCV genotype 1b infection and compensated cirrhosis. Methods Treatment-naïve and peginterferon/ribavirin treatment-experienced patients received 12 weeks of ombitasvir/paritaprevir/ritonavir (25/150/100 mg once daily) and dasabuvir (250 mg twice daily). Key inclusion criteria were hemoglobin ≥10 g/dl, albumin ≥2.8 g/dl, platelet count ≥25 × 10⁹/L, creatinine clearance ≥30 ml/min, and Child-Pugh score ≤6. Efficacy was assessed by the percentage of patients achieving SVR (HCV RNA <25 IU/ml) 12 weeks post-treatment (SVR12). Efficacy and safety were assessed in all patients receiving study drug. Results Sixty patients with HCV genotype 1b infection and cirrhosis received treatment. The study population comprised 62% male, 55% treatment-experienced, 83% with IL28B non-CC genotype, 22% with platelet count <90 × 10⁹/L, and 17% with albumin <3.5 g/dl. All 60 patients completed treatment, and SVR12 was achieved in 100% (95% CI, 94.0-100%) of patients. The most common adverse events were fatigue (22%), diarrhea (20%), and headache (18%). Only one patient (1.7%) experienced a serious adverse event. Laboratory abnormalities were infrequently observed and not clinically significant. Conclusions The HCV regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir without ribavirin for 12 weeks achieved 100% SVR12 and was well tolerated in HCV genotype 1b-infected patients with cirrhosis, suggesting that this 12-week ribavirin-free regimen is sufficient in this population.