Gilead's Harvoni For HCV Virus Approved For European Marketing

Europe has joined the U.S. and New Zealand and approved Gilead’s Harvoni, a combination of sofosbuvir (brand name Sovaldi) and ledipasvir for the hepatitis C (HCV) virus. Gilead announced the approval in a press release, stating that Harvoni regulatory submissions are pending in Japan and Switzerland. The European Medicines Agency (EMA) evaluated Harvoni in an accelerated review, and the European Commission’s approval gives the agent EU-wide marketing authorization.

Graham Foster, MD, Professor of Hepatology, Queen Mary University of London, said, “Genotype 1 patients living with hepatitis C in Europe and the physicians who treat them have been waiting for a treatment advance like this for decades. With Harvoni, we have the potential to transform the way we treat people living with the most prevalent form of hepatitis C in Europe. We can now expect very high SVR rates, and for many patients, we can eliminate the need for interferon injections and ribavirin and offer a cure in a once-daily tablet.”

Harvoni is a combination of sofosbuvir, a nucleotide analog polymerase inhibitor, and ledipasvir, a NS5A inhibitor. The agents work together to interfere with HCV enzymes needed to multiply. The majority of patients who take Harvoni are considered cured in only eight weeks. Sofosbuvir, brand name Sovaldi, has caused controversy due to the considerable expense, costing $84,000 in the U.S. When Harvoni was approved in the U.S., Medscape reported that it would likely cost more than Sovaldi. In the EU, pricing and reimbursement is up to each Member State.

The European Commission granted marketing authorization to Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), a once-daily single tablet regimen. The dual agent is approved to treat the majority of chronic hepatitis C genotype 1 and 4 adult patients. The ideal patient is treatment-naïve and treatment-experienced, cirrhotic and non-cirrhotic, and genotype 1 and 4. Depending on the patient’s prior treatment history and cirrhosis status, treatment may consist of 12 or 24 weeks. Harvoni may be administered to HIV positive HCV patients. Patients with decompensated cirrhosis, cirrhosis, and/or prior treatment failure should take Harvoni with ribavirin for 24 weeks.

The European regulatory authorities relied on data from three Phase 3 studies, ION-1, ION-2, and ION-3 in order to make a decision. The studies evaluated Harvoni for 8, 12, or 14 weeks with or without ribavirin in almost 2,000 genotype 1 HCV patients with compensated liver disease.