US-based drug firm Gilead Sciences has expanded its hepatitis-C generic licensing agreements with India-based firms to include investigational pan-genotypic medicine GS-5816 as part of a single tablet regimen that combines it and sofosbuvir.
The investigational NS5A inhibitor GS-5816 is being evaluated in Phase-III clinical studies as part of a single tablet regimen that combines the compound and sofosbuvir for the treatment of all six genotypes of hepatitis-C, Gilead Sciences Inc said in a statement on Monday.
“The expanded agreements will allow Gilead’s India-based partners to manufacture GS-5816 and the single tablet regimen of sofosbuvir/GS-5816, once approved, for distribution in 91 developing countries…,” it added.
These countries together account for 54 per cent of the total worldwide population of individuals infected with the hepatitis-C virus, it added.
Commenting on the development, Gilead Sciences Corporate and Medical Affairs Executive Vice-President Gregg H Alton said: “Today’s announcement marks an important milestone in Gilead’s effort to make effective hepatitis C treatment accessible to as many patients, in as many places, as quickly as possible.”