Novel HCV Infection Combo Tx Gets FDA OK

The Food and Drug Administration (FDA) has approved Viekira Pak (ombitasvir, paritaprevir, ritonavir with dasabuvir tablets; AbbVie) for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 infection, including cirrhosis.

Viekira Pak is comprised of three new agents that work together to inhibit HCV growth. It also contains ritonavir which is used to boost levels of paritaprevir. Viekira Pak can be used with or without ribavirin. Ombitasvir is an HCV NS5A inhibitor that blocks viral RNA replication and virion assembly. Paritaprevir is an HCV NS3/4A protease inhibitor, which is involved in proteolytic cleavage of the HCV encoded polyprotein and is essential for viral replication. Dasabuvir is a non-nucleoside inhibitor of the HCV RNA-dependent RNA polymerase encoded by NS5B, which is important in viral genome replication.

The efficacy of Viekira Pak was studied in six clinical trials (n=2,308) that enrolled patients with chronic HCV infection with and without cirrhosis. Based on the study’s design, patients were randomized to receive Viekira Pak or placebo; Viekira Pak with or without ribavirin; or Viekira Pak with ribavirin for 12 or 24 weeks. The study endpoint was sustained virologic response (SVR) at 12 weeks, indicating cure of infection. Across various study populations, 91–100% of patients who were treated with Viekira Pak achieved SVR, including patients who were considered difficult to treat.

Viekira Pak was designated breakthrough therapy and was reviewed under the FDA’s priority review program. Viekira Pak is available in a fixed-dose combination of ombitasvir/paritaprevir/ritonavir 12.5mg/75mg/50mg with dasabuvir 250mg tablets. Each monthly carton contains four weekly cartons and each carton contains seven daily dose packs. The daily dose packs contain two ombitasvir/paritaprevir/ritonavir tablets and two dasabuvir tablets.

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