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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of two new drugs, Maviret and Vosevi, for the treatment of chronic hepatitis C virus (HCV) infection in adults.
Maviret (AbbVie Ltd), administered once daily as three oral tablets, contains the NS3/4A protease inhibitor glecaprevir (100 mg) and the NS5A inhibitor pibrentasvir (40 mg).
Vosevi (Gilead Sciences) is a once-daily single tablet that contains the nucleotide analogue nonstructural protein NS5B polymerase inhibitor sofosbuvir (400 mg), the HCV NS5A inhibitor velpatasvir (100 mg), and the novel pan-genotypic HCV NS3/4A protease inhibitor voxilaprevir (100 mg).
“Both Maviret and Vosevi are active against all genotypes of the virus and, with some differences between the two medicines, may be specifically useful in some patients who failed or cannot use previously available therapies,” the EMA said in a news release.
“As this is considered to be of major public health interest in terms of therapeutic innovation, both medicines were evaluated under the EU’s accelerated assessment mechanism, which aims to speed up patients’ access to new medicines where there is an unmet medical need,” they note.