Real-world Phase III data on Viekirax (ombitasvir/paritaprevir/ritonavir) plus Exviera (dasabuvir) shows efficacy in GT1 and GT4 hepatitis C patients- AbbVie

AbbVie has announced new real-world data with Viekirax (ombitasvir/paritaprevir/ritonavir) plus Exviera (dasabuvir) showing 96 percent of genotype 1 (GT1) hepatitis C virus infected patients (n=486/505 assessable for analysis) and 100 percent (n=53/53) of genotype 4 (GT4) patients achieved sustained virologic response at 12 weeks post-treatment (SVR12). These data support results seen in Phase III clinical trials for chronic GT1 or GT4 hepatitis C virus (HCV) infected patients treated with Viekirax (ombitasvir/paritaprevir/ritonavir tablets) and Exviera (dasabuvir tablets) with or without ribavirin (RBV).

The analysis also reports safety outcomes from 1,017 people with GT1 or GT4 chronic HCV enrolled in the German Hepatitis C-Registry (DHC-R) who have initiated treatment, representing a diverse group of patients seen in real-world settings being treated with Viekirax and Exviera. Among the patients included in the safety analysis (n=1,017), the rate of discontinuation due to adverse events (AEs) was low (1.5 percent). The most common AEs (at least 5 percent) were fatigue (24 percent), pruritus (10 percent), headache (9 percent), insomnia (6 percent) and nausea (5 percent). The results will be presented at The International Liver Congress (ILC) 2016 in Barcelona, Spain.

Comment: This therapy has joined Solvadi (sofosbuvir) and Harvoni (sofosbuvir + ledispavir) from Gilead as revolutionary oral therapies in the treatment of chronic Hepatitis C, replacing the pegylated interferon injectable drugs that carried serious side effects. The new drugs carry impressive cure rates of 90% or more in patients after 8 weeks or 12 weeks of treatment, contrasting with the 65%-70% cure rates with the pegylated interferons.