– More than 30 Abstracts Across HDV, HCV, HBV, NASH and PSC Reflect Gilead’s Ongoing Commitment to Addressing Challenges Facing People Living With Liver Diseases –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of new clinical and real-world data at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®, taking place from November 12-15. Presentations include the impact of treatment with bulevirtide, an investigational treatment for people with chronic hepatitis delta virus (HDV) in the U.S. that is conditionally approved in Europe, real-world data on global efforts to support the World Health Organization’s goal of hepatitis C (HCV) elimination and long-term results from ongoing studies in the treatment of chronic hepatitis B infection (HBV).

“We are relentlessly working to improve upon innovative therapies to meet the unmet needs of people living with challenging liver diseases, including HDV where there is a significant unmet need,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We’re excited to share data from our robust clinical development programs at AASLD’s The Liver Meeting®,including the latest data demonstrating the positive impacts of bulevirtide for people living with HDV.”

Hepcludex® (bulevirtide) has been granted PRIority MEdicines (PRIME) scheme eligibility by the European Medicines Agency (EMA) for the treatment of HDV infection and Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA). Bulevirtide is an investigational agent in the U.S. and its safety and efficacy have not been established.

Patient Impact of HDV Treatment

HDV infection (which is always associated with HBV infection) leads to a more rapid progression to liver fibrosis, cirrhosis, hepatic decompensation and an increased risk of liver cancer and death compared to HBV mono-infection. Gilead will present the latest findings from a Phase 3 trial that evaluated patient reported outcomes following treatment with bulevirtide after 24 weeks, demonstrating that people reported improvements in general health, bodily pain, vitality and social and emotional functioning compared to those in the delayed treatment arm of this study (Poster of Distinction 680).

Meeting the Needs of Key Populations Living With HCV

To achieve HCV elimination, people living with HCV globally need to be able to access effective and well-tolerated treatment alongside their other medications. Data will be presented on the safety and efficacy of Epclusa® (400 mg sofosbuvir/100 mg velpatasvir) in a broad range of people, including those with co-morbidities (PO-0940, 0927). An additional study evaluates the outcomes of tailored strategies and innovative approaches in efforts to engage people who inject drugs in HCV care (OS-97). The U.S. product label for Epclusa contains a BOXED WARNING for the risk of hepatitis B reactivation in HCV/HBV co-infected patients. See below for U.S. Important Safety Information.

Long-term Treatment With Vemlidy in HBV

In HBV, Gilead continues to expand upon the established safety and efficacy profile of Vemlidy® (tenofovir alafenamide 25mg, TAF) with data demonstrating a sustained virological response in heavily pre-treated patients with multidrug-resistant HBV for up to 144 weeks (PO-812). Additional data evaluate treatment with Vemlidy in a variety of special patient populations, including people living post-liver transplant with chronic kidney disease and pregnant and breastfeeding women (PO-803, 772). In another analysis, treatment with Vemlidy compared to tenofovir disoproxil fumarate (TDF) revealed a similar low risk for atherosclerotic cardiovascular disease (ASCVD) using a validated risk calculator, despite differences in their fasting lipid profiles (PO-771).

Vemlidy is indicated for the treatment of chronic HBV in adults with compensated liver disease. The use of Vemlidy for other patient populations is investigational, and the safety and efficacy for these uses have not been established. The U.S. full Prescribing Information for Vemlidy contains a BOXED WARNING for post-treatment severe acute exacerbation of hepatitis B. See below for U.S. Important Safety Information.

Liver Fibrosis

Gilead will present findings from an analysis of the associations between weight loss and changes in clinical and histologic parameters and disease progression in patients with bridging fibrosis (F3) and compensated cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH). Results indicate that people with >5% weight loss over 48 weeks were more likely to achieve NASH resolution, but liver fibrosis improvement was comparable to those with