European Panel Endorses Combo Hepatitis C Treatment (Harvoni)

Miriam E. Tucker


September 26, 2014

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended marketing authorization for the combination ledipasvir/sofosbuvir (Harvoni, Gilead Sciences, Inc) for the treatment of chronic hepatitis C virus infection in adults.

The once-daily fixed-dose combination of the NS5A inhibitor ledipasvir and the nucleotide analog polymerase inhibitor sofosbuvir was evaluated under the agency's accelerated assessment mechanism, which is designed to speed up patients' access to new medicines where there is an unmet medical need.

Hepatitis C infection affects between 0.4% and 3.5% of the population in different European Union member states. Sofosbuvir/ledipasvir is among a "new generation of antiviral products for chronic [hepatitis C virus] infection that have high cure rates and have recently reshaped the treatment landscape for this disease" without the need for interferons, according to a European Medicines Agency statement.

"The benefits with Harvoni with or without ribavirin are very high efficacy against genotypes 1, 3, and 4, including patients post-transplant and/or with compensated cirrhosis. The most common side effects are fatigue and headache," the European Medicines Agency said.

Sofosbuvir alone was granted marketing authorization throughout the European Union under the trade name Sovaldi on January 16, 2014.

Once marketing authorization for the combination 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."

In the United States, the ledipasvir/sofosbuvir fixed-dose combination for chronic hepatitis C genotype 1 infection has received priority review designation from the US Food and Drug Administration, with a decision expected by October 10, 2014.


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