Gilead’s hepatitis C drug Harvoni gets marketing authorization in Europe

Harvoni is a combination of the NS5A inhibitor ledipasvir (LDV) and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) and is indicated to treat adults with chronic hepatitis C virus (HCV).

The marketing authorization is based on data from three Phase III trials, ION-1, ION-2 and ION-3, which evaluated eight, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease.

In January 2014, Harvoni was approved by the European Commission under the tradename Sovaldi.

The drug 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.

The company said that eight weeks of treatment with Harvoni may be considered in non-cirrhotic treatment-naïve genotype 1 patients.

Harvoni should be used in combination with ribavirin for 24 weeks in genotype 1 and 4 patients with decompensated cirrhosis, and genotype 3 patients with cirrhosis and/or prior treatment failure.

Queen Mary University professor of Hepatology Graham Foster 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."

The European approval was also supported by preliminary data from the SOLAR-1 trial, which assessed difficult to treat patients with decompensated cirrhosis and patients who have undergone liver transplantation, as well as from the ERADICATE trial, which evaluated genotype 1 HCV patients co-infected with HIV.