Gilead Sciences, Inc. announced it will present 32 scientific presentations related to its approved medicines and investigational therapies for the treatment of chronic hepatitis C virus (HCV) infection at The Liver Meeting 2015 in San Francisco.
Data include results from studies of Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir) that advance the understanding of the profiles of these drugs in several patient populations. Detailed results from the four phase 3 ASTRAL studies evaluating the company’s next potential single tablet regimen – a once-daily combination of velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, with sofosbuvir (SOF) – also will be presented.
“We continue to advance our understanding of the safety and efficacy of Sovaldi and Harvoni in diverse groups of HCV patients, including several special patient populations that historically have not been studied,” said Norbert Bischofberger, PhD, executive vice president of research and development and chief scientific officer at Gilead.
“We are also pleased to share data evaluating our next-generation investigational sofosbuvir-based therapies SOF/VEL and SOF/VEL plus GS-9857. In total, the data highlighted this week demonstrate the strength of sofosbuvir as the backbone of multiple hepatitis C treatment regimens in numerous hepatitis C-infected patient populations.”
Harvoni is the first single tablet regimen for the treatment of chronic HCV genotype 1. Following the US Food and Drug Administration’s approval of Gilead’s supplemental new drug application on November 12, 2015, Harvoni is now also indicated for genotypes 4, 5 and 6. Data presented this week demonstrate the efficacy and safety profile of Harvoni in populations with unmet medical needs including pre- and post-liver transplant patients with decompensated cirrhosis. In addition, the presentation also describes a review of safety data from the SOLAR-1 and SOLAR-2 studies that suggest a new algorithm for the detection of potential drug-induced liver injury in patients with decompensated cirrhosis receiving direct acting antiviral-based regimens. A new analysis and an additional study describe the efficacy and safety of Harvoni in Asian patients and in patients with hereditary bleeding disorders.
Results and new analyses from several studies highlighting the utility of Sovaldi in combination with other agents in several diverse and newly-studied populations, including Asian patients and those with severe renal impairment also will be presented this week. Sovaldi is approved in combination with other agents for the treatment of genotypes 1-4 chronic HCV infection.
Detailed results from Gilead’s four phase 3 ASTRAL studies of SOF/VEL in patients with genotype 1-6 chronic HCV infection, ASTRAL-1 (Oral LB-2), ASTRAL-2, ASTRAL-3 and ASTRAL-4, will be presented at various times throughout The Liver Meeting 2015. Based on these data, Gilead submitted a new drug application (NDA) for SOF/VEL to the FDA on October 28, 2015. The company plans to submit a regulatory application for approval of SOF/VEL in the European Union by the end of the year. If approved, SOF/VEL would be Gilead’s third HCV medication and the first all-oral, pan-genotypic, single tablet HCV regimen.
Gilead also will present new data from a study evaluating the safety and efficacy of the combination of SOF/VEL with GS-9857, an investigational pangenotypic NS3/4A protease inhibitor, in patients with HCV genotype 1 and 3 infection. Based on these data, SOF, VEL and GS-9857 co-formulated into a fixed-dose combination will be advanced into phase 3 studies.
