The U.S. Food and Drug Administration (FDA) has approved AbbVie’s once-daily hepatitis C virus (HCV) regimen Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for people with genotype 1 of the virus, including those with compensated cirrhosis, Medscape reports. The new regimen is an extended-release version of Viekira Pak (ombitasvir/paritaprevir/ritonavir; dasabuvir).
The dosing for Viekira XR involves three tablets daily with a meal. People with genotype 1b can take the regimen without ribavirin, while those with genotype 1a should add ribavirin twice daily.
Those with genotype 1a who do not have cirrhosis should be treated for 12 weeks, while those with this genotype who have compensated cirrhosis should take the regimen for 24 weeks. People with genotype 1b should be treated for 12 weeks, including those without cirrhosis and those with compensated cirrhosis.
The FDA approval is based on Phase III clinical trials of Viekira Pak showing that 100 percent of participants with genotype 1b achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure); they were treated for 12 weeks without ribavirin. Participants with genotype 1a added ribavirin and were treated for 12 or 24 weeks; 95 percent were cured.
The treatment is not approved for those with decompensated cirrhosis.
The wholesale price of Viekira XR is about $83,000 for a 12-week regimen.
To read a press release about the FDA approval, click here.
To read the Medscape article, click here (free registration with the site is required).