Viekirax/Exviera combination yields 98% SVR in patients with HCV

AbbVie announced interim results of its AMBER study where 98% of Polish patients with hepatitis C virus infection treated with Viekirax and Exviera achieved a sustained virologic response at 12 weeks.

The AMBER study is a multicenter, open-label study conducted in Poland. Patients with HCV genotype 1 (n = 186) or genotype 4 (n = 10) were assigned to receive Viekirax (ombitasvir/paritaprevir/ritonavir, AbbVie) and Exviera (dasabuvir, AbbVie) with or without ribavirin for 12 or 24 weeks. Patient visits were scheduled on day 0, end of treatment and at follow-up week 12.

The interim results, according to the release, were of 40 Polish patients treated with the combination regimen with or without ribavirin for 12 weeks. Of these patients, 98% (n = 39) achieved SVR12.

An interim safety analysis of all 186 patients reported that patients experienced mostly mild adverse events. The most common adverse events were fatigue, nausea and headache. Serious adverse events occurred in 4% of the patients, which included hepatic decompensation, anemia and kidney insufficiency hepatotoxicity.

“These interim results from the AMBER study help to support the results that we saw with the [Viekirax plus Exviera] regimen in clinical trials,” Robert Flisiak, MD, PhD, of the Medical University of Bialystok, Poland, and AMBER study researcher, said in the release. “Importantly, viral cure rates were high even though most patients were treatment experienced and had advanced liver disease, characteristics that are usually more difficult to treat.”

Disclosures: Healio.com/Hepatology was unable to confirm relevant financial disclosures for Flisiak at the time of publication.