FDA Approves 3-Drug Combo for the Treatment of Hepatitis C

The US Food and Drug Administration (FDA) has announced the approval of a new combination treatment for hepatitis C virus (HCV).

The Viekira Pak, which consists of ombitasvir, paritaprevir, and ritonavir tablets and is co-packaged with dasabuvir tablets, is a treatment option for patients with hepatitis C genotype 1, as well as HCV patients with cirrhosis.

A statement from the FDA said the 3 drugs in the Viekira Pak “work together to inhibit the growth of HCV.” While ombitasvir, paritaprevir, and dasabuvir are all newly approved drugs the statement noted that ritonavir had been previously approved and is included because it increases blood levels of paritaprevir.

According to the FDA, “Viekira Pak can be used with or without ribavirin, but it is not recommended for patients whose liver is unable to function properly.”

Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA Center for Drug Evaluation, said in the statement that, “The new

Generation of therapeutics for hepatitis C virus is changing the treatment paradigm for Americans living with the disease.” He added, “We continue to see the development of new all-oral treatments with very high virologic response rates and improved safety profiles compared to some of the older interferon-based drug regimens.”

Approval for Viekira Pak came after its efficacy was evaluated in 6 clinical trials involving more than 2300 patients with HCV infection (with or without cirrhosis). Those studies included some patients receiving Viekira Pak or placebo, or Viekira Pak with or without ribavirin for 12 or 24 weeks.

The results of the studies showed that 91 to 100% of participants who received Viekira Pak achieved sustained virologic response when taking the recommended dose. Common side effects reported included feeling weak or tired, itching, nausea, and trouble sleeping.

The Viekira Pak is the latest drug approved for chronic HCV, joining Olysio (simeprevir), Sovaldi (sofosbuvir), and Harvoni (ledipasvir and sofosbuvir).

Viekira Pak is marketed by Abbvie Inc., Olysio is marketed by Janssen Pharmaceuticals, Sovaldi and Harvoni are marketed by Gilead Sciences.