Daclatasvir plus Sofosbuvir for Previously Treated or Untreated Chronic HCV Infection

In this open-label uncontrolled study, a sustained virological response at week 12 after the end of therapy was seen in 98% of those with genotype 1 infection (including those who had previously failed on telaprevir or boceprevir), 92% of genotype 2 and 89% of genotype 3.

The European Medicines Agency (EMA) recently accepted for filing a marketing authorisation application for daclatasvir, an investigational NS5A complex inhibitor, for the treatment of adults with chronic hepatitis C with compensated liver disease, including genotypes 1, 2, 3, and 4.

 

In November 2013, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the use of daclatasvir in combination with sofosbuvir in the treatment of chronic hepatitis C virus infection, in a compassionate-use programme. The recommended compassionate use is intended for adult patients at a high risk of decompensation or death within 12 months if left untreated, and who have a genotype 1 infection. It was recognised that the potential benefit of such combination therapy may extend to patients infected with other HCV genotypes. The assessment report and conditions of use of daclatasvir in combination with sofosbuvir with or without ribavirin in this setting is due to be published shortly on the EMA website.