Gilead's Sovaldi Effective In Combination For HCV, Studies Find
By Cyndi Root
Gilead Sciences announced data from several studies of Sovaldi (sofosbuvir) in combination with other agents for the treatment of hepatitis (HCV) infection. The company reported the results in press releases and stated that it was presenting the data at the American Association for the Study of Liver Diseases in Boston. Phase 2 studies investigated sofosbuvir and GS-5816 for chronic HCV, while Phase 2 and 3 trials evaluated Harvoni (ledipasvir/sofosbuvir) in chronic HCV patients with limited or no treatment options.
Norbert Bischofberger, PhD, Executive VP at Gilead, said, “There continues to be a need for simple, interferon- and ribavirin-free treatment regimens that are effective for all hepatitis C patients, regardless of genotype.”
Sofosbuvir
Gilead’s sofosbuvir, brand name Sovaldi, was Food and Drug Administration (FDA) approved in December 2013 for the treatment of chronic HVC. Sovaldi was the first drug to demonstrate efficacy against HCV without the need for co-administration of interferon. The approval was based in part on six clinical trials of 1,947 participants and showed that Sovaldi was effective in treating different types of the hepatitis C virus. Gilead has been running multiple trials of Sovaldi in combination with other drugs to treat HCV.
Sofosbuvir/GS-5816
Dr. Bischofberger stated that the data from the sofosbuvir/ GS-5816 trials showed high efficacy and tolerability in patients with varying genotypes and disease progression. In three studies evaluating sofosbuvir/ GS-5816, patients showed sustained virologic response (SVR12) rates ranging from 88 percent to 100 percent. Gilead reports that the regime was well tolerated in the 800 patients from the three studies. Few patients discontinued treatment and a few adverse events were reported, though the ones reported included fatigue, headache, and nausea.
Sofosbuvir/Ledipasvir
The FDA approved Harvoni (ledipasvir/sofosbuvir) in October 2014 for chronic HCV patients with genotype 1 infection. The latest studies were performed on patients with decompensated cirrhosis, patients with HCV recurrence following a liver transplant, and patients who failed previous treatment with other direct acting antivirals. Dr. Bischofberger stated that chronic HCV patients with advanced liver disease are hardest to treat and they have limited treatment options. Gilead has shown in a pooled analysis that Harvoni treatment of 500 genotype 1 HCV-infected patients with compensated cirrhosis showed sustained virologic response, a rate that is considered a cure.