Gilead to Present 50 Abstracts Across NASH, PSC, HBV and HCV at The Liver Meeting® 2018

Gilead to Present Wide-Ranging New Data on Treatment and Diagnosis of Liver Diseases at The Liver Meeting® 2018

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-- More Than 50 Abstracts Across NASH, PSC, HBV and HCV Reflect Ongoing Commitment to Advancing the Care of People with Liver Disease--

FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 11, 2018-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that data from the company’s liver disease research and development programs in nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), hepatitis B virus (HBV) infection and hepatitis C virus (HCV) infection will be presented at The Liver Meeting® 2018 in San Francisco from November 9-13, 2018. The data reflect Gilead’s ongoing commitment to advancing the care of patients with serious liver diseases.

“Gilead has transformed the treatment of viral liver diseases with innovative medicines that have cured HCV and significantly improved treatment of HBV for millions around the world,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research & Development, Gilead Sciences. “Today, we are working to bring this expertise and commitment to other serious liver diseases with significant unmet medical needs, such as advanced fibrosis due to NASH and PSC – two diseases with no or limited treatment options.”

Advanced Fibrosis due to NASH
Individuals with advanced fibrosis, defined as bridging fibrosis (F3) or cirrhosis (F4), are at a significantly higher risk of liver-related mortality. Gilead is advancing multiple investigational compounds for the treatment of advanced fibrosis due to NASH. Data being presented at the meeting further elucidate the potential role and safety profile of three compounds in development.

The non-steroidal FXR agonist GS-9674 leads to significant reductions in hepatic steatosis, serum bile acids, and liver biochemistry in a Phase 2, randomized, placebo-controlled trial of patients with NASH (poster #0736)
Hepatic metabolomics and plasma microRNA analysis of combinations of an ASK1 inhibitor, an ACC inhibitor, and an FXR agonist in the rat choline-deficient high fat diet model reveal reductions in oxidative stress, inflammation and fibrosis (poster #1265)

Currently, liver biopsy is the standard method to diagnose advanced fibrosis due to NASH. This invasive and costly procedure presents challenges to appropriate diagnosis and treatment. Data being presented at The Liver Meeting describe the potential role and sequence of noninvasive tests in the diagnosis of advanced fibrosis due to NASH and patient-reported outcomes from two global Phase 3 trials evaluating the investigational ASK1 inhibitor selonsertib.

Algorithms using noninvasive tests can accurately identify patients with advanced fibrosis due to NASH: Data from STELLAR clinical trials (late-breaking poster #LB-10)
Routinely available noninvasive tests discriminate advanced fibrosis due to NASH in the Phase 3 STELLAR trials of the ASK1 inhibitor selonsertib (poster #1674)
Severe impairment of patient-reported outcomes in patients with advanced fibrosis due to NASH (poster #1683)
Advanced fibrosis based on noninvasive tests in NASH is associated with impairment of patient-reported outcomes (poster #1991)

PSC
Data will be presented from a Phase 2 trial evaluating the investigational non-steroidal farnesoid X receptor (FXR) agonist GS-9674 in PSC. PSC is a rare and chronic condition that causes inflammation and scarring of the bile ducts, which can lead to liver failure. There are limited treatment options currently available for patients with PSC.

The non-steroidal FXR agonist GS-9674 improves liver biochemistry and decreases serum bile acids in patients with PSC: A Phase 2, randomized, placebo-controlled trial (oral presentation #0043)

HBV Functional Cure

Data will also be presented from Gilead’s ongoing program directed at achieving a functional cure for HBV by maintaining viral suppression without ongoing therapy. GS-9688, an investigational oral selective toll-like receptor 8 (TLR8) agonist, is the subject of several studies to be presented, including first-in-human clinical results and Phase 1b results from evaluation in patients with chronic hepatitis B. 

First in human study of GS-9688, an oral Toll-like Receptor 8 (TLR8) agonist, in healthy volunteers: assessment of safety, tolerability, pharmacokinetics, pharmacodynamics and food effect (poster #0390)
Pharmacodynamic response to oral administration of the selective toll-like receptor 8 agonist GS-9688 in healthy volunteers (poster #0456)
Safety, pharmacokinetics and pharmacodynamics of oral TLR8 agonist GS-9688 in patients with chronic hepatitis B: a randomized, placebo-controlled, double-blind Phase 1b study (poster #0401)

GS-9674, selonsertib and GS-9688 are investigational compounds and are not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. Their safety and efficacy have not been established.

Viral Hepatitis Treatment
Viral hepatitis presentations include studies of Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) and Harvoni® (ledipasvir 90mg/sofosbuvir 400mg) in difficult to cure HCV populations and data demonstrating the role of Vemlidy® (tenofovir alafenamide 25mg, TAF) in the management of chronic hepatitis B.

Sofosbuvir/velpatasvir for 12 weeks is safe and effective in patients undergoing dialysis (late-breaking poster #LB-15)
Ledipasvir/sofosbuvir for 12 weeks is safe and effective in children 3 to <6 years old with chronic HCV infection (oral presentation #0184)
Three year efficacy and safety of TAF compared to tenofovir disoproxil fumarate (TDF) in HBeAg-negative and HBeAg-positive patients with chronic hepatitis B (poster #0404)
Safety and efficacy at 1 year in post liver transplant patients with chronic kidney disease receiving tenofovir alafenamide for HBV prophylaxis (poster #1225)

EPCLUSA and HARVONI are each indicated in the U.S. for the treatment of chronic HCV infection in patients with no cirrhosis or compensated cirrhosis: EPCLUSA for adults with genotypes 1-6; and HARVONI for patients 12 years and older with genotypes 1, 4, 5 and 6. VEMLIDY is indicated for the treatment of chronic HBV infection in adults with compensated liver disease. The US product labels for EPCLUSA, HARVONI, and VEMLIDY each contain a BOXED WARNING: for EPCLUSA and HARVONI, the risk of hepatitis B reactivation in HCV/HBV co-infected patients; and for VEMLIDY, the risk of post-treatment acute exacerbation of HBV. See below for U.S. Important Safety Information.

The safety and efficacy of EPCLUSA in HCV patients undergoing dialysis and HARVONI in HCV patients ages 3 to up to 6 years of age have not been established.

Read full release: https://www.marketwatch.com/press-release/gilead-to-present-wide-ranging-new-data-on-treatment-and-diagnosis-of-liver-diseases-at-the-liver-meeting-2018-2018-10-11

For more information, including a complete list of abstract titles at the meeting, please visit: http://www.aasld.org/events-professional-development/liver-meeting.