25 July 2016 - New extended-release formulation is the first all-oral, co-formulated treatment containing the three direct-acting antiviral components of Viekira Pak for adult patients with genotype 1 chronic hepatitis C virus infection.

AbbVie today announced that the U.S. FDA has approved a new drug application for Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended-release tablets. Viekira XR is a once-daily, extended-release co-formulation of the active ingredients in Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and is for the treatment of patients with chronic genotype 1 hepatitis C virus infection, including those with compensated cirrhosis (Child-Pugh A). Viekira XR is not for people with decompensated cirrhosis.

Viekira XR is the first co-formulated three direct-acting antiviral treatment for adult patients with genotype 1 hepatitis C virus infection. Viekira XR is given once-daily as three oral tablets and must be taken with a meal. It is used without ribavirin in genotype 1b patients and in combination with twice daily ribavirin in genotype 1a patients. The approval is supported by Phase 3 clinical trials for Viekira Pak which include data that demonstrated 100% sustained virologic response 12 weeks following treatment (SVR12) in GT1b patients with 12 weeks of therapy without ribavirin and 95% SVR12 in genotype 1a patients when used with ribavirin for 12 or 24 weeks of therapy.

Read AbbVie press release