Gilead Sciences, Inc. (Nasdaq: GILD) announced new data on the use of its chronic hepatitis B (HBV) and hepatitis C (HCV) medicines including safety and efficacy data on Vemlidy® (tenofovir alafenamide 25mg, TAF) in HBV patients previously treated with tenofovir disoproxil fumarate (TDF) and data on Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) and Harvoni® (ledipasvir 90mg/sofosbuvir 400mg) in difficult-to-cure HCV patient populations. These results, along with data from Gilead’s HBV cure research program, will be presented at The International Liver Congress™ (ILC) 2019 in Vienna, Austria.
“As part of our ongoing commitment to patients living with viral hepatitis, we continue to research the roles of our HBV and HCV medicines across the broadest range of patient populations. These latest data demonstrate that the efficacy of our HCV medicines is consistent in clinical trials and in real-world settings, even in difficult-to-cure patients,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead Sciences. “In HBV, our latest research reinforces the role of Vemlidy in chronic HBV management and the importance of ongoing research in pursuit of an HBV cure.” HBV Treatment: Switching from TDF to Vemlidy In a Phase 3 study, 488 virologically suppressed adult patients with chronic HBV infection receiving once-daily TDF (300 mg) were randomized to remain on TDF or switch to Vemlidy (TAF 25 mg) for 48 weeks. Vemlidy demonstrated non-inferior viral suppression (HBV DNA =20 IU/mL) compared to TDF at Week 48. Switching from TDF to Vemlidy also resulted in improvements in glomerular filtration rate (eGFRCG), a measure of kidney function, and increases in hip and spine bone mineral density (BMD), a measure of bone health, as compared with patients who continued taking TDF. Rates of adverse events and serious adverse events were similar between the two groups. Similar findings were also presented from secondary analyses of two Phase 3 studies of 1,298 patients initially randomized to receive Vemlidy or TDF. Among patients switched from TDF to Vemlidy at Week 96 or Week 144, virologic suppression (HBV DNA <29 IU/mL) was maintained in both groups at Week 192. Increases in both hip and spine BMD and eGFRCG were observed in each group switching to Vemlidy treatment.
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