FDA approves Viekira Pak treatment for Hepatitis C- AbbVIe

The FDA has approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) from AbbVie, an all-oral, interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with chronic genotype 1 (GT1) Hepatitis C virus (HCV) infection, including those with compensated cirrhosis. Viekira Pak is the only FDA-approved regimen that contains three distinct mechanisms of action - NS5A inhibitor, NS3/4A protease inhibitor and a non-nucleoside NS5B polymerase inhibitor - that work together to attack the virus at three separate stages of the disease lifecycle to inhibit it from reproducing.

The approval is based on the results from Phase II clinical trials, which showed that Viekira Pak cured 97 per-cent of liver transplant recipients and 92 per-cent of patients co-infected with HCV/HIV-1. Patients who achieve a sustained virologic response (SVR12) are considered cured of HCV.