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.
“This positive CHMP opinion brings us one step closer to delivering a ribavirin-free treatment option for GT1b patients with compensated cirrhosis that has demonstrated high cure rates with no treatment discontinuations in our clinical trial,” AbbVie Executive Vice President of Research & Development and CSO Michael Severino, M.D., said in a press release. “This milestone reinforces our continued commitment to provide additional treatment options for the HCV community.”
Ombitasvir/paritaprevir/ritonavir regimen in combination with dasabuvir (known as Viekira Pak in the United States) was approved in December 2014 in the U.S. for the treatment of HCV patients with a genotype 1 infection and cirrhosis. In January 2015 the European Union approved it, and it is available in the U.K. for the treatment of chronic HCV genotype 1 and 4 infections.
AbbVie was granted priority review status by the U.S. Food and Drug Administration (FDA) for its supplemental new drug application (NDA) for Viekira Pak without ribavirin for the treatment of HCV genotype 1b and compensated cirrhosis in January 2016.