Gilead’s Harvoni gets FDA approval for genotype 1 chronic hepatitis C treatment

Approved under the tradename Sovaldi in December 2013, Harvoni is a combination of the NS5A inhibitor ledipasvir and the nucleotide analog polymerase inhibitor sofosbuvir.

The FDA approval 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.

The trials included 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).

Beth Israel Deaconess Medical Center director of Hepatology, Harvard Medical School professor of Medicine and principal investigator in the Harvoni clinical trials 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 US.

"For the first time, the vast majority of patients can be cured with a once-daily pill in only eight or 12 weeks," Afdhal said.

Sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12) was the primary endpoint of each trial.

Harvoni has also received the priority review and breakthrough therapy designation, which are given to investigational medicines that may offer major advances in treatment over available therapies.

Gilead Sciences chairman and chief executive officer 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."

Image: Harvoni Product Photo. Photo: courtesy of Gilead.