The company’s decision is supported by the US Food and Drug Administration (FDA).
Before coming to this decision, the company has evaluated and reported two serious adverse events in patients recruited in two separate studies who were receiving a four-drug regimen of GS 9190 and one of two protease inhibitors (GS 9451 in one study and GS 9256 in the second study).
GS 9190 is an experimantal HCV NS5B polymerase inhibitor; pegylated interferon and ribavirin.
Further, Gilead has decided to go ahead with the studies that include the combination of GS 9451 (an investigational protease inhibitor), GS 5885 (an investigational NS5A) and pegylated interferon and ribavirin.