The European Medicines Agency (EMA) has suggested the conceding of marketing authorizations in the European Union (EU) for two new permutation therapies against chronic hepatitis C virus (HCV) infection, Epclusa and Zepatier.
HCV infection is a foremost European public health confront. It affects between 0.4% and 3.5% of the population.
Epclusa and Zepatier are from new generation of medicines for chronic HCV disease, direct-acting antivirals, that give high rates of cure of HCV infection and that have, in the past few years, reform the way this disease is treated. These medicines obstruct the action of proteins which are necessary for viral imitation. Epclusa targets the proteins NS5B and NS5A, while Zepatier targets the proteins NS3/4A and NS5A.
These new treatment allow cure of patients with chronic HCV infection without the need for interferon medicines which are linked with poor acceptability and severe side effects. In spite of the rapid development of new therapies, including interferon-free regimens, doctors and patients can still gain advantage from substitute treatment options.
Epclusa contains sofosbuvir, already approved under the name Sovaldi and as a combination therapy with ledipasvir under the name Harvoni, and velpatasvir which is a novel HCV protein inhibitor. The safety and effectiveness of Epclusa was tested in clinical trials involving over 2,000 patients, to review that the HCV was no longer detected in the blood 12 weeks after the end of treatment with or without ribavirin. Majority of the patients across all genotypes had no evident virus in their blood 12 weeks after the end of the treatment and could therefore be considered to be cured of their HCV infection. The most common side effects reported in clinical trials were headache, fatigue and nausea.
Zepatier contains two novel HCV protein inhibitors, grazoprevir and elbasvir. This fixed-dose combination of direct-acting antivirals targets genotypes 1 and 4 of the disease.
The effectiveness and protection of Zepatier was tested in clinical trials involving approximately 2,000 patients. The medicine also showed a persistent virologic response. The safety of the medicine was also measured approving and the most common side effects reported in clinical trials were fatigue, headache and nausea.
Date: 27/05/2016