FDA Approves Genotype 4 Hepatitis C Treatment

Technivie with ribavirin is the first drug to demonstrate safety and efficacy in genotype 4 infections without interferon.

Technivie with ribavirin is the first drug to demonstrate safety and efficacy in genotype 4 infections without interferon.

The FDA today approved ombitasvir, paritaprevir and ritonavir (Technivie) for use in combination with ribavirin for hepatitis C virus (HCV) genotype 4 in patients without scarring and cirrhosis.

Technivie with ribavirin is the first drug to demonstrate safety and efficacy in HCV genotype 4 infections without the need for combination therapy with interferon, according to the FDA. The 3-drug combination is comprised of the same drugs used in Abbvie’s Viekira Pak.

The approval was based on safety and efficacy data from a clinical trial that enrolled 135 patients with chronic genotype 4 HCV infection without cirrhosis. In the trial, 91 patients received Technivie with ribavirin once daily for 12 weeks, while 44 patients received Technivie once daily without ribavirin for 12 weeks.

The primary endpoint was 12-week sustained virologic response (SVR12).

All of the patients in the Technivie with ribavirin cohort achieved SVR12, compared with 91% of patients treated with Technivie without ribavirin.

The most common side effects reported from Technivie were fatigue, asthenia, nausea, insomnia, ipruritus, and other skin reactions.

The Technivie will include a boxed warning indicating elevated liver enzymes greater than 5 times the upper limit of normal occurred in approximately 1% of clinical trial participants treated with Technivie.

Women taking contraceptives containing ethinyl estradiol should discontinue use before starting a Technivie regimen, due to liver enzyme elevations that occur more frequently in these patients.