The hepatitis C medication combination of Viekriax plus Exviera (with or without ribavirin) is one step closer to approval in Europe for the treatment of chronic HCV genotype 1b with compensated cirrhosis
The European Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for the recommendation of Viekriax plus Exviera, with or without ribavirin, for the treatment of chronic hepatitis C (HCV) genotype 1b infection with compensated cirrhosis.
The opinion by the CHMP now goes to the European Commission, whose members have the authority to approve the drug for the European Union.
Hepatitis C is a virus-transmitted disease that infects the liver and, in time, often leads to cirrhosis, liver cancer, and liver failure. Many people are not aware they have hepatitis C until some liver damage is noticeable, which may take several years. Some people who are infected with hepatitis C feel symptoms for a short while and then improve, but most people develop a long-term, or chronic, disease.
Although hepatitis C can lead to very serious and damaging conditions, today it is mostly manageable and patients go on to live active, full lives.
The combination of Viekrax (Abbvie’s omitasvir/paritaprevir/ritonavir) and Exviera (AbbVie’s dasabuvir) was granted a positive review based on data from the TURQUOISE-3 Phase 3 clinical trial, in which 60 treatment-experienced or treatment-naïve patients – who had failed previous treatment with pegylated interferon and ribavirin – received treatment with the direct-acting antiviral regimen without the addition of ribavirin. The entire group (100 percent) obtained sustained virologic response after three months of treatment.