• Key Findings from PBC, HDV, HCV, HBV and MASH/Fibrosis Studies Affirm Commitment to Drive Life-changing Science in Liver Disease 

FOSTER CITY, Calif. / May 22, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq:GILD) today announced new research to be presented at the European Association for the Study of the Liver (EASL) Congress, June 5-8, 2024 in Milan, Italy. Key findings from more than 25 abstracts will include:

• Interim results for two years from the ASSURE study which evaluate the long-term efficacy and safety profile of investigational seladelpar for the treatment of primary biliary cholangitis (PBC);
• Results of a pooled analysis, showcasing the effects of tenofovir-based antiviral therapy in reducing long-term incidence of primary liver cancer in people living with chronic hepatitis B (HBV);
• Final results of the Phase 2b MYR204 study evaluating the efficacy and safety of Hepcludex^® (bulevirtide) in combination with pegylated interferon alfa-2a (PegIFN) in patients with compensated chronic hepatitis delta virus (HDV); and
• A late breaker presentation on the final results from the pivotal MYR301 Phase 3 study evaluating the efficacy and safety of bulevirtide as monotherapy.

“These data underline Gilead’s commitment to drive life-changing science and create healthier futures for people living with liver disease. We look forward to presenting our latest research at EASL, as we strive to deliver novel medicines to populations with high unmet medical need,” said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “The breadth of our data being presented across viral and inflammatory liver diseases, speaks to our commitment to driving positive change at every step of a person’s journey. Transforming lives goes beyond treatment, and our research, innovation and partnerships span initial awareness and education, through to screening, diagnosis, path to care and ongoing management to address current unmet needs.”

To drive efforts in supporting the World Health Organization’s (WHO) goal to eliminate viral hepatitis as a public health threat by 2030, Gilead will also present real-world data in hepatitis C (HCV) and launch a national HCV awareness program in Italy to raise awareness of the disease. In collaboration with EASL, Gilead will launch “Epatite C Mettiamoci un Punto” (Hepatitis C Let’s Put a Stop to it) in Milan to raise awareness about the disease and encourage people to get tested for HCV through EASL’s “Love Your Liver” Campaign.

Advancing Treatment options in PBC

New data demonstrating the long-term efficacy and safety profile of investigational seladelpar for the treatment of primary biliary cholangitis (PBC) will be presented at EASL. These include the first interim data from the Phase 3 open-label ASSURE study that includes people who received a second year of seladelpar treatment following their initial participation in the Phase 3 RESPONSE study. The study also includes patients with insufficient response to first-line PBC treatment, ursodeoxycholic acid (UDCA). These data evaluate the composite biochemical response (alkaline phosphatase (ALP) < 1.67x upper limit of normal (ULN), ALP decrease ≥ 15%, and total bilirubin ≤ ULN) and ALP normalization, as well as pruritus for seladelpar in the treatment of PBC which is a rare, chronic, cholestatic liver disease mainly affecting women (1 in 1,000 women over the age of 40 or about 130,000 total people in the U.S.) that impairs liver function and quality of life. The most common early symptoms of PBC are pruritus (itching) and fatigue, which can be debilitating for some patients. Progression of PBC is associated with an increased risk of liver-related mortality.

Key Findings in HDV

At the EASL Congress, Gilead will present 13 abstracts in HDV, including the Week 144 (48 Weeks off-treatment) results of the Phase 2b MYR204 study of bulevirtide with or without peginterferon alfa-2a (PegIFN) in people with chronic HDV and compensated liver disease (GS-002), and results from the pivotal Phase 3 MYR301 study assessing the efficacy and safety of bulevirtide as monotherapy as a late-breaker presentation (LB-309).

Further highlighting Gilead as a leader in HDV research, a sub-analysis of the MYR204 study (OS-122) evaluating intrahepatic virological outcomes 24 Weeks off-treatment will be presented. A pooled analysis of the MYR203, MYR204 and MYR301 studies (TOP-400) discussing the impact of nucleos(t)ide analogues alongside bulevirtide 48 Weeks off-treatment will also be shared as an oral presentation. These data evaluate the efficacy profile of bulevirtide for people living with HDV, which is considered the most severe form of viral hepatitis due to rapid disease progression towards liver failure, liver cancer and liver-related death.

Key Abstracts at EASL 2024:

For more information, including a complete list of abstract titles being presented at the meeting, please visit the EASL website.

In July 2023, the European Commission (EC) granted full Marketing Authorization (MA) for bulevirtide 2 mg for the treatment of adults with chronic HDV and compensated liver disease. Bulevirtide was initially granted conditional MA from the EC in July 2020 to provide access to people living with HDV urgent access to treatment. Bulevirtide also received full MA in Great Britian in August 2023 and in Switzerland in February 2024. In the U.S. and outside of the European Economic Area, bulevirtide is an investigational agent that is not approved for any use. In these regions, health authorities have not established the safety and efficacy of bulevirtide. Bulevirtide 10 mg is an investigational product and has not been approved anywhere globally.

Seladelpar is an investigational compound and is not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority; its safety and efficacy have not been established.

About PBC

PBC is a rare, chronic inflammatory liver disease primarily affecting women (1 in 1,000 women over the age of 40 or about 130,000 total people in the US). PBC is characterized by impaired bile flow (known as cholestasis) and the accumulation of toxic bile acids in the liver, leading to inflammation and destruction of the bile ducts within the liver and causing increased levels of ALP, ALT, and GGT, enzymes found primarily in the liver, as well as total bilirubin. The most common early symptoms of PBC are pruritus (itching) and fatigue, which can be debilitating for some patients. Progression of PBC is associated with an increased risk of liver-related mortality.

About HDV

HDV is considered the most aggressive or severe form of viral hepatitis, associated with more rapid progression towards liver-related death and liver cancer in people with hepatitis B (HBV). On average, HDV progresses to cirrhosis within 5 years and to liver cancer within 10 years. Nearly 5% of people who have a chronic infection with HBV are estimated to have HDV, equating to 12-15 million people worldwide. The prevalence of HDV infection is largely underestimated due to lack of universal testing of HBV-positive individuals for HDV.

About Gilead Sciences in Liver Disease

For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. We have helped transform hepatitis C from a chronic condition into one that can be cured for millions of people. For people living with hepatitis B or D, our focus on advancing our medicines drives hope that today’s research will turn into tomorrow’s cures. Beyond viral hepatitis, we’re working to deliver advanced treatments for people living with primary biliary cirrhosis (PBC). But our commitment doesn’t stop there. Through our ground-breaking science and collaborative partnerships, we strive to create healthier futures for everyone living with liver disease. We are committed to a future without liver disease.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials or studies, including those involving Hepcludex (bulevirtide) and seladelpar; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that the FDA and other regulatory authorities may not approve bulevirtide for the treatment of HDV and/or seladelpar for the treatment of PBC, and the risk that any such approvals, if granted, may be subject to significant limitations on use; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

Hepcludex, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.