FDA Approves Once-Daily Viekira XR for Hepatitis C


July 26, 2016

In a nod toward ease of use, the US Food and Drug Administration (FDA) has approved Viekira XR (AbbVie), a once-a-day version of Viekira Pak for chronic hepatitis C virus (HCV) genotype 1 infection, the agency announced today.

The new drug consists of ombitasvir, paritaprevir, and dasabuvir, along with ritonavir, which boosts the blood level of paritaprevir. Those are the same ingredients of Viekira Pak, except that ombitasvir, paritaprevir, and ritonavir are combined in one tablet, while a second tablet contains dasabuvir. Viekira Pak achieves cure rates approaching 100% in 12 weeks. A 12 -week course of treatment costs roughly $83,000.

The recommended dosage for the previously approved Viekira Pak is two tablets containing ombitasvir, paritaprevir, and ritonavir in the morning, along with one dasabuvir tablet in the morning and one in the evening, each time with a meal.

Viekira XR offers a simpler drug regimen. Patients take three tablets once a day with a meal.

Viekira XR is indicated for patients with HCV genotype 1a who do not have cirrhosis, or who have compensated cirrhosis. The treatment lasts 12 weeks for the former group and 24 weeks for the latter, who also must take ribavirin. Viekira XR is also indicated for patients with HCV genotype 1b with or without compensated cirrhosis. Their treatment regimen lasts 12 weeks.

The FDA said in a news release that it approved Viekira XR on the basis of six clinical trials that established the safety and efficacy of Viekira Pak, which has the same ingredients. The most commonly reported adverse events in the clinical trials were fatigue, itching, feeling weak or unenergetic, nausea, and trouble sleeping.

The drug is contraindicated in patients with moderate to severe hepatic impairment.

Follow Robert Lowes on Twitter @LowesRobert


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