Authors: Andreone P, Colombo MG, Enejosa JV, Koksal I, Ferenci P, Maieron A, et al.
Source: Gastroenterology. 2014.
BACKGROUND: & Aims: The interferon-free regimen of ABT-450 (a protease inhibitor), ritonavir, ombitasvir (an NS5A inhibitor), dasabuvir (a non-nucleoside polymerase inhibitor), and ribavirin has shown efficacy in patients with hepatitis C virus (HCV) genotype 1b infection-the most prevalent subgenotype worldwide. We evaluated whether ribavirin is necessary for ABT-450, ritonavir, ombitasvir, and dasabuvir to produce high rates of sustained virologic response (SVR) in these patients. METHODS: We performed a multicenter, open-label phase 3 trial of 179 patients with HCV genotype 1b infection, without cirrhosis, previously treated with peginterferon and ribavirin. Patients were randomly assigned (1:1) to groups given ABT-450, ritonavir, ombitasvir, and dasabuvir, with ribavirin (Group 1) or without (Group 2) for 12 weeks. The primary endpoint was SVR 12 weeks after treatment (SVR12). We assessed the noninferiority of this regimen to the rate of response reported (64%) for a similar population treated with telaprevir, peginterferon, and ribavirin. RESULTS: Groups 1 and 2 each had high rates of SVR12, which were noninferior to the reported rate of response to the combination of telaprevir, peginterferon, and ribavirin (Group1: 96.6%; 95% confidence interval [CI], 92.8%-100% and Group 2: 100%; 95% CI, 95.9%-100%). The rate of response in Group 2 was noninferior to that of Group 1. No virologic failure occurred during the study. Two patients (1.1%) discontinued the study due to adverse events, both in Group 1. The most common adverse events in Groups 1 and 2 were fatigue (31.9% vs 15.8%) and headache (24.2% vs 23.2%), respectively. Decreases in hemoglobin to below the lower limit of normal were more frequent in Group 1 (42.0% vs 5.5% in Group 2, P<.001), although only 2 patients had hemoglobin levels below 10 g/dL. CONCLUSIONS: The interferon-free regimen of ABT-450, ritonavir, ombitasvir, and dasabuvir, with or without RBV, produces a high rate of SVR12 in treatment-experienced patients with HCV genotype 1b infection. Both regimens are well tolerated, evidenced by the low rate of discontinuations and generally mild adverse events. ClinicalTrials.gov number: NCT01674725.
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