Untreated hepatitis C virus genotype 1-infected patients achieved a sustained virologic response 12 weeks after treatment with ombitasvir and dasabuvir, with ribavirin, according to data from a recent study.
Researchers randomized and divided 631 patients into two groups (A, B) in a double-blind, placebo-controlled trial. Group A patients (431) received an oral regimen of ABT-450/r-ombitasvir (a once-daily dose of 150 mg of ABT-450, 100 mg of ritonavir and 25 mg of ombitasvir) and 250 mg of dasabuvir (twice daily) with ribavirin. Group B (158) received matching placebos. After the double-blind period, Group B received the active regimen as open-label therapy for 12 weeks. The mean age of group A was 49.4 years and group B was 521.2 years. The primary endpoint was sustained virologic response (SVR) at 12 weeks after treatment.
The rate of SVR12 in group A was 96.2% and higher than controls. SVR12 rate was 95.3% (95% CI, 93-97.6) among patients with hepatitis C virus (HCV) genotype 1a infection (307/322) and 98% (95% CI, 95.8-100) among patients with HCV genotype 1b infection (148/151). SVR rates were high in all subgroups, including those defined by IL28B genotype (96.5% with chronic cirrhosis; 96% non-cirrhotic) and race (96.4% among black patients and 96.2% among non-black). In group A, 0.2% (1) experienced virologic failure. Seven patients (1.5%) among group A relapsed by post-treatment week 12, of which five experienced relapse at or before the visit at post-treatment week 4. Eighty-seven percent of group A had an adverse event (AE), compared with 73.4% in group B (P<.001). Discontinuation of treatment as a result of an AE occurred in .6% of patients in each group (three in group A and one in group B).
“This large, international, phase 3 trial showed the efficacy of an interferon-free, all-oral antiviral therapy for previously untreated patients with HCV genotype 1 infection and no cirrhosis,” researchers said.
Disclosure: See the study for a full list of relevant financial disclosures.