AbbVie’s hepatitis C virus (HCV) regimen Viekira Pak (ombitasvir/paritaprevir/ritonavir; dasabuvir) boasted excellent safety and efficacy data in a large, ongoing, real-world trial. Researchers analyzed interim findings of a subset of individuals in the German Hepatitis C-Registry, which includes more than 9,000 people receiving treatment for hep C at 254 sites in Germany.
Findings were presented at the 51st International Liver Congress in Barcelona.
Among individuals treated with Viekira Pak who had results available for analysis, 96 percent of those with genotype 1 (486 of 505) and 100 percent of those with genotype 4 (53 of 53) achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure).
A safety analysis concerned 1,017 people with genotype 1 or 4 who were treated with Viekira Pak, including 22 percent with cirrhosis, 59 percent who were treated for hep C before and 59 percent who were taking medications for other conditions.
A total of 1.5 percent of the overall safety analysis group stopped treatment because of adverse health , The most common events, occurring in at least 5 percent of participants, were fatigue (24 percent), itching (10 percent), headache (9 percent), insomnia (6 percent) and nausea (5 percent). One percent (5 of 480) of those who took Viekira Pak without ribavirin and 3 percent (16 or 537) of those taking the regimen with ribavirin experienced a serious adverse health event. Fifteen people stopped treatment because of adverse health events. Two people died from heart disease; neither death was judged as related to the hep C regimen.
To read a press release about the study, click here.