FDA Approves New Hepatitis C Treatment Option

The FDA has approved once-daily Viekira XR (dasabuvir, ombitasvir, paritaprevir, and ritonavir) for the treatment of genotype 1 chronic hepatitis C, including patients with compensated cirrhosis.

The treatment is taken once-daily as 3 oral tablets and must be taken with a meal. In patients with genotype 1b patients it is used without ribavirin and in those with genotype 1a patients it is used with twice-daily ribavirin.
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The treatment’s safety and efficacy were examined in 7 phase 3 clinical trials involving 1076 patients, including 181 with compensated cirrhosis, who received Viekira XR for 12 or 24 weeks. Overall, 95% to 100% achieved sustained virologic response at 12 weeks.

Common side effects included nausea, itching, and sleep problems.

—Michael Potts

Reference:
Abbvie. AbbVie receives U.S. FDA approval of once-daily VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the treatment of genotype 1 chronic hepatitis C [press release]. https://news.abbvie.com/news/abbvie-receives-us-fda-approval-once-daily-viekira-xr-dasabuvir-ombitasvir-paritaprevir-and-ritonavir-for-treatment-genotype-1-chronic-hepatitis-c.htm. July 25, 2016.