FDA Approves Combination Treatment for Hepatitis C Genotype 4

The US Food and Drug Administration (FDA) has approved Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for the treatment of hepatitis C virus (HCV) genotype 4 infections in patients without scarring and cirrhosis.

According to the FDA, Technivie plus ribavirin is “the first drug that has demonstrated safety and efficacy to treat genotype 4 HCV infections without the need for co-administration of interferon.”

Approval was based on safety and efficacy data from a clinical trial that involved 135 patients with chronic HCV genotype 4 infections without cirrhosis. In the trial, 91 patients received Technivie with ribavirin once daily for 12 weeks and 44 patients were treated with Technivie once daily without ribavirin for 12 weeks.

The trials primary endpoint was 12-week sustained virologic response (SVR12). All patients who received Technivie with ribavirin achieved SVR12, compared to 91 percent of patients treated with Technivie without ribavirin.

The most common side effects reported during this trial and during previous trials for Viekira Pak (a hepatitis C treatment made up of the same three drugs as Technivie) were fatigue, asthenia, nausea, insomnia, ipruritus, and other skin reactions.

The Technivie label will include a warning that “elevations of liver enzymes to greater than five times the upper limit of normal occurred in approximately 1 percent of clinical trial participants” treated with Technivie.

Women taking contraceptives containing ethinyl estradiol should discontinue use before beginning treatment with Technivie, as liver enzyme elevations occurred more frequently in these patients during testing.