Gilead Sciences Inc., the Foster City, Calif., biopharma with Branford operations, says its experimental hepatitis C drug sofosbuvir, in a late-stage clinical study, was clearly superior to historical cure rates at both 12 and 16 weeks of treatment in patients who were not helped by prior therapy, Reuters reports.
The cure rate for those with genotype 2 and 3 of the serious liver disease was significantly higher for patients who received 16 weeks of treatment: 73 percent versus 50 percent for those treated for 12 weeks, according to study results released on Tuesday.
Both rates were far higher than the comparable 25 percent historic cure rate – or sustained virologic response (SVR) – for these types of patients.
New Haven drug developer Achillion Pharmaceuticals, too, is in trials for an anti-hep C treatment.
Earlier this month, Achillion and Gilead announced discontinuation of their joint development of a different formulation for an anti-hep C drug.
In the latest Gilead trial, genotype 2 patients fared better than those with genotype 3, which is more difficult to treat. Rates of SVR, which is considered tantamount to a cure, were also lower in patients suffering from cirrhosis, typically among the sickest of hepatitis patients.
The study tested sofosbuvir in combination with the older oral hepatitis treatment ribavirin in patients who did not respond to prior treatments with ribavirin and injectable interferon.
According to Gilead, no patients in the study discontinued treatment due to adverse side effects.
Fatigue, headache, insomnia and nausea were the most common adverse effects, reported in less than 15 percent of patients, Gilead said.
