Danoprevir with peginterferon and ribavirin achieves sustained virologic response

SAN FRANCISCO — Hepatitis C patients who were given response-guided danoprevir combined with ribavirin plus peginterferon alfa-2a achieved high sustained virologic response rates, researchers announced here at The Liver Meeting.

The ATLAS study included 225 treatment-naïve non-cirrhotic adults with hepatitis C genotype 1 infection. Randomized subjects received 12 weeks of treatment with various doses and treatment schedules of danoprevir or placebo, in combination with ribavirin.

Ribavirin was continued for 12 more weeks in patients with early rapid virologic response. Subjects who did not achieve the early response were treated with ribavirin for 48 weeks.

High sustained virologic response rates were higher in the subjects who received danoprevir, ranging from 68% to 83%, compared with subjects who received placebo, at 43%. The rates in those who had an early rapid virologic response ranged from 87% to 95%.

Rates of serious adverse events were 7% to 8% in danoprevir subjects and 19% in placebo subjects. Adverse events with an incidence greater than 10% higher in danoprevir subjects compared with placebo were fatigue, pyrexia, decreased appetite, anxiety and erythema at the site of the injection.

“Studies are currently being conducted with lower doses of [danoprevir] boosted with ritonavir to reduce overall [danoprevir] exposure while maintaining the potent antiviral activity,” the presentation abstract said.

Disclosure: Research funded by Roche.