LONDON, Nov 18 (APM) - Gilead said on Tuesday Harvoni (ledipasvir+sofosbuvir) has been approved in Europe for hepatitis C - the first single tablet daily regimen containing two direct acting antivirals.
Harvoni is indicated for the treatment of chronic hepatitis C virus (HCV) in adults and is recommended in treatment-naïve and treatment-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.
Eight weeks of treatment with Harvoni may be considered in non-cirrhotic treatment-naïve genotype 1 patients, Gilead said.
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 is also indicated for patients with HCV who have HIV co-infection.
The once-daily single tablet regimen, which combines the NS5A inhibitor ledipasvir (90 mg) with the nucleotide analog polymerase inhibitor sofosbuvir (400 mg), eliminates the need for interferon and ribaviran therapy, Gilead said.
Now centrally approved, drugs assessors across Europe will face difficult pricing and reimbursement negotiations for the combination therapy, when many countries have yet to agree how to fund monotherapy with sofosbuvir, which was approved in Europe in January under the brand name Sovaldi.
After its first full quarter on the market, analysts predicted, due to its high price and high demand, that Sovaldi could become the biggest selling drug globally in 2014.
Harvoni was approved based on data from the Phase III ION-1, ION-2 and ION-3 studies that included more than 2,000 patients with HCV infection, and follows an accelerated assessment by the European Medicines Agency. The studies demonstrated efficacy in the indicated patient groups at differing treatment durations.
Harvoni was approved in the U.S. and Canada in October and in New Zealand earlier this month. Filings have been made in Japan and Switzerland.
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