Gilead’s Harvoni receives FDA approval for hepatitis C genotype 1 infection

Gilead Sciences has received approval from US Food and Drug Administration for Harvoni (ledipasvir 90mg/sofosbuvir 400mg), a once-daily single tablet regimen to treat chronic hepatitis C genotype 1 infection in adults.

Obtained approval under the tradename Sovaldi in December 2013, Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analogue polymerase inhibitor sofosbuvir.

Harvoni clinical trials principal investigator Nezam Afdhal said: “By providing very high cure rates in as little as eight weeks and completely eliminating the need for interferon and ribavirin, which are challenging to take and tolerate, Harvoni significantly advances treatment for patients with the most common form of hepatitis C in the United States.”

The approval was based on data from three Phase III trials, ION-1, ION-2 and ION-3, which assessed 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.

The studies comprised non-cirrhotic treatment-naïve patients (ION-3), cirrhotic and non-cirrhotic treatment-naïve patients (ION-1) and cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor (ION-2).

Sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12) was the primary end-point of each study, said Gilead.

Gilead Sciences CEO John Martin said: “Unlike other serious chronic diseases, hepatitis C can be cured and Harvoni offers patients the potential for a cure in as little as eight weeks.

“Gilead is proud to have played a role in developing a once-daily therapy that is safe, simple and well-tolerated. We are now working to ensure rapid and broad access to Harvoni.”