CHMP recommended Harvoni [Ledipasvir / Sofosbuvir] for the treatment of chronic hepatitis C
Last Updated on October 10, 2014 by Joseph Gut – thasso
October 10, 2014 – The European Medicines Agency recently has recommended the authorisation of Harvoni (ledipasvir / sofosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection in adults. HCV infection is a major European public-health challenge. It affects between 0.4% and 3.5% of the population in different European Union (EU) Member States and is the most common single cause of liver transplantation in the EU.
Harvoni belongs to a new generation of antiviral products for chronic HCV infection that have high cure rates and have recently reshaped the treatment landscape for this disease. It is a combination of the active substances sofosbuvir and ledipasvir, which block the action of proteins which are essential for HCV to replicate – the protein NS5B for sofosbuvir and NS5A for ledipasvir. These new regimens allow cure of patients with chronic HCV infection without the need for treatments involving interferons, medicines which are associated with poor tolerability and potentially serious side effects that rule out such treatment in a considerable proportion of HCV patients.
Over the past few months, the Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisations for three new medicines for the treatment of HCV. However, in the area of HCV doctors and patients can still benefit from alternative treatment options. The more treatment options that are available, the better chance a patient has to get the right treatment to cure the disease and to lead a longer and healthier life.
Harvoni was evaluated under the EMA’s accelerated assessment mechanism, a tool which aims to speed up patients’ access to new medicines where there is an unmet medical need. The opinion adopted by the CHMP at its September 2014 meeting is an intermediary step on Harvoni’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once marketing authorisation has been granted, decisions about price and reimbursement will then take place at the level of each Member State considering the potential role/use of this medicine in the context of the national health system of that country.
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We may add that very recently, the U.S. Food and Drug Administration also approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection. Harvoni is the first combination pill approved to treat chronic HCV genotype and does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
Both drug ingredients in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir. Harvoni was the third drug approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013 and Sovaldi in December 2013.
Harvoni’s efficacy was evaluated in three clinical trials enrolling 1,518 participants who had not previously received treatment for their infection (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants with cirrhosis. Participants were randomly assigned to receive Harvoni with or without ribavirin. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured.