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High SVR Rates Achieved in HCV Patients Taking Investigational Antiviral
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Previously untreated patients with genotype 1b chronic hepatitis C virus infection achieved 12-week sustained virologic response with an investigational, oral, ribavirin-free, two direct-acting antiviral treatment with ombitasvir/paritaprevir/ritonavir, according to a press release.
The phase 3 multicenter GIFT-I study aimed to evaluate the safety and efficacy of 12 weeks of once daily treatment with a fixed-dose combination of paritaprevir/ritonavir (150/100 mg) plus ombitasvir (25 mg) in 363 adult Japanese patients with chronic genotype 1b HCV infection, the release said. The cohort included a subgroup of 112 treatment-naïve patients without cirrhosis who were eligible for therapy with interferon with or without ribavirin and had a high viral load (≥100,000 IU/mL), each of whom received at least one dose of the double-blind active study drug, and 95 percent achieved 12-week sustained virologic response.
“AbbVie is committed to advancing HCV care with the goal of evaluating our treatment in a broad range of patients around the world,” Scott Brun, MD, AbbVie’s vice president of pharmaceutical development, said in the release. “The GIFT-I results are encouraging and support moving forward with our Japan development program, with a local regulatory submission anticipated in the first quarter of 2015.”
The most common adverse events were nasopharyngitis (16.7% vs. 13.2% with placebo), headache (8.8% vs. 9.4%) and edema peripheral (5.1% vs. 0%). Two patients discontinued treatment due to adverse events and within the primary efficacy patient population there were no on-treatment virologic failures and three patients relapsed.
AbbVie will report detailed results at future scientific meetings and in publication, the release said.