Gilead Sciences has gained its first approval for hepatitis C (HCV) virus in China after regulators green-lit its once-daily oral nucleotide analog polymerase inhibitor, Sovaldi
The China Food and Drug Administration approved Sovaldi for the treatment of adults and adolescents infected with HCV genotype 1, 2, 3, 4, 5 or 6 as a component of a combination antiviral treatment regimen.
The approval is supported by a Phase 3 study conducted in China, presented earlier this year at the Asian Pacific Association for the Study of the Liver (APASL) meeting.
The study evaluated Sovaldi in combination with ribavirin (RBV) or pegylated interferon+ribavirin (PegIFN+RBV) across a range of difficult-to-cure patient populations, including treatment-experienced patients and those with compensated cirrhosis.
In this study, the safety profiles of the regimens were consistent with the known side effects of pegylated interferon and/or ribavirin.
The most common adverse events were haematological abnormalities and pyrexia.
HCV is the fourth-most commonly reported infectious disease in China, with approximately 10 million people infected.
“With the approval of Sovaldi, there is now the potential opportunity to transform treatment for HCV patients in China,” said John F. Milligan, PhD, Gilead’s President and CEO.