An ongoing real-world study of AbbVie’s hepatitis C virus (HCV) treatment Viekira Pak (ombitasvir/paritaprevir/ritonavir; dasabuvir), with or without ribavirin, has shown that the drug apparently works as well among those with genotype 1 of the virus as it did in clinical trials. Researchers from the AMBER trial of Viekira Pak presented their findings at the Viral Hepatitis Congress in Frankfurt, Germany.
AMBER is an ongoing, multicenter, independent investigator-initiated, open-label Phase III study conducted in Poland. So far, 186 people with genotype 1 of hep C have been enrolled, of whom 21 percent were treatment-naive and 75 percent had advanced liver fibrosis or had cirrhosis.
Participants are being treated for 12 or 24 weeks, based on current Viekira Pak prescribing information.
Thirty-nine of the participants have achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), out of 40 that have completed 12 weeks of post-treatment follow-up. This translates to a 98 percent cure rate.
Adverse physical effects have been mostly mild. Those conditions occurring in more than 10 percent of the study group have been fatigue, nausea and headache. Four percent of the participants have experienced a serious adverse health condition, including decompensated cirrhosis (the more advanced form of the disease), anemia and kidney insufficiency liver toxicity.
To read a press release about the study, click here.
Hep C Treatment Viekira Pak Works Well in Real World
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