Gilead Sciences' hepatitis C combination drug Harvoni approved in Europe

Gilead Sciences announced Tuesday that the European Commission approved Harvoni (sofosbuvir/ledipasvir) for the treatment of chronic hepatitis C virus (HCV) infection in adults. The company said the therapy, which combines the nucleotide analogue polymerase inhibitor Sovaldi (sofosbuvir) with the NS5A inhibitor ledipasvir, is "the first once-daily single tablet regimen to treat the majority of chronic hepatitis C genotype 1 and 4 infection in adults."

In September, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion supporting approval of Harvoni. The authorisation was supported principally by data from the Phase III ION-1, -2 and -3 trials, which evaluated eight, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2000 genotype 1 HCV patients with compensated liver disease. In the studies, which included both treatment-naïve and treatment-experienced patients with or without cirrhosis, participants who received Harvoni without ribavirin experienced sustained virologic response rates at 12 weeks of 94 percent to 99 percent.

Gilead noted that Harvoni is indicated for the treatment of chronic HCV in adults and is recommended in treatment-naïve and -experienced cirrhotic and non-cirrhotic genotype 1 and 4 patients with a treatment duration of 12 or 24 weeks depending on prior treatment history and cirrhosis status. In addition, the company said that eight weeks of treatment with the therapy may be considered in non-cirrhotic treatment-naïve genotype 1 patients. Meanwhile, in genotype 1 and 4 patients with decompensated cirrhosis, and genotype 3 patients with cirrhosis and/or prior treatment failure, Harvoni should be used in combination with ribavirin for 24 weeks.

Harvoni was recently approved in the US, Canada and New Zealand. Applications for the combination treatment are also under review in Japan and Switzerland. For related analysis, see ViewPoints: First glimpse of Harvoni prescriptions suggests payers are not limiting access, and Spotlight On: Four important talking points to watch now that Gilead's Harvoni is approved.

Sovaldi, which was cleared as a single agent by the European Commission in January, generated $2.8 billion in revenue for the third quarter.

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