Compassionate use of declatasvir with sofosbuvir for people in urgent need of HCV treatment
EMA press statement
On 22 November 2013, the European Medicines Agency (EMA) issued advice on compassionate use of daclatasvir in combination with sofosbuvir in patients with chronic hepatitis C in urgent need of therapy to prevent progression of liver disease.
Compassionate-use programmes are set up at the level of individual Member States. They are intended to give patients with a life-threatening, long-lasting or seriously disabling disease with no available treatment options access to treatments that are still under development and that have not yet received a marketing authorisation. In this specific case, Sweden has requested an opinion from the CHMP on the conditions under which early access through compassionate use could be given to daclatasvir, for the use in combination with sofosbuvir, with or without ribavirin, for a specific patient population.
Compassionate use is intended for adult patients at a high risk of their liver being no longer able to function normally (decompensation) or death within 12 months if left untreated, and who have a genotype 1 infection. Further, it is recognised that the potential benefit of such combination therapy may extend to patients infected with other HCV genotypes.
Daclatasvir and sofosbuvir are both first-in-class antiviral medicines against HCV. These medicines have been studied in combination, with or without ribavirin, in a clinical trial which included treatment- naive (previously untreated) with HCV genotype 1, 2 and 3, as well as patients with genotype 1 who have previously failed telaprevir or boceprevir treatment.
Results from the trial indicate high efficacy, also in those who have failed treatment with these protease inhibitors. Many such patients have very advanced liver disease and are in urgent need of effective therapy in order to cease the progression of liver injury.
The assessment report and conditions of use of daclatasvir in combination with sofosbuvir with or without ribavirin in this setting will be published shortly on the Agency’s website.
Daclatasvir is developed by Bristol-Myers Squibb and sofosbuvir is developed by Gilead.
EMA press statement. European Medicines Agency advises on compassionate use of daclatasvir, 2013. 21 November 2013.