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Gilead Announces Presentation of More Than 40 Abstracts From Extensive Liver Disease Programs at the Digital International Liver Congress™ 2020

-- Data Reinforce Effectiveness of Epclusa® for Hepatitis C in Key Underserved Populations --

-- Hepatitis B Data Demonstrate Durable Renal and Bone Safety Benefit of Vemlidy® and Support Further Evaluation of Selgantolimod as Part of Combination Approach to Functional Cure --

-- Full Results From Phase 2 ATLAS Study Support Potential for Combination Approaches for the Treatment of Patients With Advanced Fibrosis Due to NASH --

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) announced the presentation of more than 40 abstracts reflecting the breadth of research from the company’s programs addressing significant challenges in viral hepatitis, nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) at The Digital International Liver Congress™ 2020 (ILC) from August 27-29.

Viral Hepatitis

Real-world data from several studies presented at ILC demonstrate that Epclusa® (400 mg sofosbuvir/100 mg velpatasvir) is effective in curing hepatitis C (HCV) in a broad range of people and can be utilized in underserved populations, such as those experiencing mental health disorders, incarceration or homelessness. A large real-world dataset of 1,888 adults from 33 clinical cohorts found a 98% sustained virologic response (SVR) rate among the effectiveness population (defined as patients achieving SVR or having virologic failure) with Epclusa for 12 weeks across these key underserved patient populations. Additionally, an analysis of data from eight primary care clinics in Australia found that treatment with Epclusa for 12 weeks resulted in a 98% cure rate in a marginalized, diverse patient population, including those with compensated cirrhosis.

New 96-week clinical data from a Phase 3 study in 488 virologically suppressed adults with chronic hepatitis B virus (HBV) infection demonstrated that once-daily Vemlidy® (tenofovir alafenamide 25 mg, TAF) sustained viral suppression while improving markers of renal and bone health, after switching from once-daily tenofovir disoproxil fumarate 300 mg (TDF). In HBV functional cure research, results from a Phase 2 study of 48 virally suppressed patients with chronic HBV infection showed that treatment with investigational selgantolimod, an oral selective small molecule agonist of toll-like receptor 8 (TLR8), up to 3 mg once-weekly in combination with oral antivirals for 24 weeks, was generally well tolerated and demonstrated dose-dependent pharmacodynamic activity with two out of 39 treated patients (5.1%) achieving negative hepatitis B surface antigen results after 24 weeks of treatment with selgantolimod.

NASH and Liver Disease Research

Full results from the Phase 2, randomized, double-blind, placebo-controlled ATLAS study demonstrate the potential for combination approaches to improve markers of liver health in people with advanced fibrosis due to NASH. While no regimen led to a statistically significant increase in the proportion of patients who achieved the primary efficacy endpoint of a ≥1-stage improvement in fibrosis without worsening of NASH based on traditional liver biopsy evaluation, a machine learning approach identified fibrosis regression and significant improvements in noninvasive tests of fibrosis (e.g., Enhanced Liver Fibrosis (ELF) score and liver stiffness) were observed in patients treated with the combination of cilofexor 30 mg and firsocostat 20 mg compared with placebo. This combination resulted in meaningful improvement in secondary endpoints including a ≥2-point reduction in the NAFLD Activity Score (NAS), and ≥1-grade reductions in steatosis, hepatocellular ballooning and lobular inflammation. Cilofexor and firsocostat demonstrated a favorable safety profile.

Gilead is also presenting data describing the utility of machine learning approaches to evaluate liver histology, identify histologic features associated with disease progression in NASH and PSC, and assess the impact of treatment with TDF in chronic HBV.

“The Phase 2 ATLAS study demonstrated the potential of combination therapies to improve liver histology and markers of disease activity in patients with advanced fibrosis due to NASH,” said Rob Myers, MD, Vice President and Liver Fibrosis Clinical Research Lead, Gilead Sciences. “The data from this and other Gilead clinical trials demonstrate that machine learning approaches enable quantitative and reproducible assessment of liver histology and prognosis, and may facilitate the development of novel therapies and enhanced approaches to care for people with NASH and other liver diseases.”

PSC is a rare and chronic condition that causes inflammation and scarring of the bile ducts, which may lead to liver failure and increased risk of cancer in or outside the liver. Data presented will help advance understanding of the biology and progression of PSC, and may inform future clinical development in this condition, for which a large unmet need for effective therapy exists. Gilead’s Phase 3 PRIMIS clinical trial evaluating the safety, tolerability, and efficacy of cilofexor in non-cirrhotic adults with PSC is currently recruiting.

Select accepted abstracts being presented at The Digital International Liver Conference include:

Hepatitis C Treatment for Underserved Populations

Abstract 427 (poster)

Global Real-World Evidence of Sofosbuvir/Velpatasvir (SOF/VEL) as a Highly Effective Treatment and Elimination Tool in Underserved Patient Populations Experiencing Mental Health Disorders, Incarceration or Homelessness

Abstract 419 (poster)

HCV in the Australian Primary Care Setting: Real-World Effectiveness of 12 Weeks of Sofosbuvir/Velpatasvir for the Treatment of Chronic Hepatitis C

Hepatitis B Treatment Durability and Functional Cure Research

Abstract 091 (oral)

A Phase 3 Study Comparing Switching from Tenofovir Disoproxil Fumarate (TDF) to Tenofovir Alafenamide (TAF) with Continued TDF Treatment in Virologically-suppressed Patients with Chronic Hepatitis B (CHB): Final Week 96 Efficacy and Safety Results

Abstract 071 (oral)

Efficacy and Safety of 24 Weeks Treatment with Oral TLR8 Agonist, Selgantolimod, in Virally-Suppressed Adult Patients with Chronic Hepatitis B: A Phase 2 Study

Combination Treatment for Advanced Fibrosis Due to NASH

Late Breaker Abstract 04 (oral)

Safety And Efficacy of Combination Therapies Including Cilofexor/Firsocostat in Patients With Bridging Fibrosis and Cirrhosis Due to NASH: Results of the Phase 2b ATLAS Trial

Combination Treatment for Advanced Fibrosis Due to NASH

Late Breaker Abstract 04 (oral)

Safety And Efficacy of Combination Therapies Including Cilofexor/Firsocostat in Patients With Bridging Fibrosis and Cirrhosis Due to NASH: Results of the Phase 2b ATLAS Trial

Utility of Machine Learning in Liver Diseases

Abstract 003 (poster)

Machine Learning Models Identify Histologic Features Predictive of Clinical Disease Progression in Patients With Advanced Fibrosis Due to Nonalcoholic Steatohepatitis

Abstract 101 (oral)

Convolutional Neural Networks of H&E-Stained Biopsy Images

Accurately Quantify Histologic Features of Nonalcoholic Steatohepatitis

Abstract 173 (poster)

Machine Learning Models Accurately Interpret Liver Histology and Are Associated with Disease Progression in Patients With Primary Sclerosing Cholangitis

Late Breaker Abstract 31 (poster)

Machine Learning Identifies Histologic Features Associated With Regression of Cirrhosis in Treatment for Chronic Hepatitis B

Primary Sclerosing Cholangitis Biology and Progression

Abstract 170 (poster)

Hepatic Transcriptomic Analysis Identifies a Mast Cell Gene Expression Signature that Correlates With Fibrosis Stage and is Prognostic in Patients With Primary Sclerosing Cholangitis

Abstract 169 (poster)

Removal of Fibrosis-Related Genes Identifies a Hepatic Gene Expression Signature that Identifies Canonical Signaling Pathways and is Correlated With Clinical Outcomes in Patients With Primary Sclerosing Cholangitis

Abstract 168 (poster)

Serum Bile Acid Species Are Associated With Liver Fibrosis and Clinical Disease Progression in Patients With Primary Sclerosing Cholangitis

Please see below for the U.S. Indications and Important Safety Information, including BOXED WARNINGS, for Epclusa and Vemlidy.

The safety and efficacy of selgantolimod, firsocostat and cilofexor have not been established. Selgantolimod, firsocostat and cilofexor are investigational compounds and are not approved by the U.S. FDA or any other regulatory authority.

U.S. Important Safety Information and Indication for Epclusa

BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED PATIENTS

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with EPCLUSA. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals (DAAs) and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive, in patients with serologic evidence of resolved HBV, and also in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be increased in patients taking these other agents. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

Contraindications

If EPCLUSA is used in combination with ribavirin (RBV), all contraindications, warnings and precautions, in particular pregnancy avoidance, and adverse reactions to RBV also apply. Refer to RBV prescribing information.

Warnings and Precautions

Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with EPCLUSA due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir containing regimen. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.

Risk of Reduced Therapeutic Effect Due to Use with P-gp Inducers and/or Moderate to Strong Inducers of CYP2B6, CYP2C8 or CYP3A4: Rifampin, St. John’s wort and carbamazepine are not recommended for use with EPCLUSA as they may significantly decrease sofosbuvir and/or velpatasvir plasma concentrations.

Adverse Reactions

The most common adverse reactions (≥10%, all grades) with EPCLUSA were headache and fatigue; and when used with RBV in decompensated cirrhotics were fatigue, anemia, nausea, headache, insomnia, and diarrhea.

Drug Interactions

Coadministration is not recommended with topotecan due to increased concentrations of topotecan; or with proton-pump inhibitors, phenobarbital, phenytoin, rifabutin, rifapentine, efavirenz, and tipranavir/ritonavir due to decreased concentrations of sofosbuvir and/or velpatasvir.

Consult the full Prescribing Information for EPCLUSA for more information on potentially significant drug interactions, including clinical comments.

INDICATION

EPCLUSA is indicated for the treatment of adult and pediatric patients 6 years of age and older or weighing at least 17 kg with chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis and in combination with ribavirin for those with decompensated cirrhosis.

U.S. Important Safety Information and Indication for Vemlidy

BOXED WARNING: POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B

Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted.

Warnings and Precautions

Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected Patients: Due to this risk, VEMLIDY alone should not be used for the treatment of HIV-1 infection. Safety and efficacy of VEMLIDY have not been established in HBV/HIV-1 coinfected patients. HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with VEMLIDY, and, if positive, an appropriate antiretroviral combination regimen that is recommended for HBV/HIV-1 coinfected patients should be used.

New Onset or Worsening Renal Impairment: Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of tenofovir prodrugs in both animal toxicology studies and human trials. In clinical trials of VEMLIDY, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue VEMLIDY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all patients – See Dosage and Administration.

Lactic Acidosis and Severe Hepatomegaly with Steatosis: Fatal cases have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate. Discontinue VEMLIDY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse Reactions

Most common adverse reactions (incidence ≥5%; all grades) were headache, abdominal pain, cough, back pain, fatigue, nausea, arthralgia, diarrhea, and dyspepsia.

Drug Interactions

Coadministration of VEMLIDY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and the risk of adverse reactions.

Coadministration of VEMLIDY is not recommended with the following: oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John’s wort. Such coadministration is expected to decrease the concentration of tenofovir alafenamide, reducing the therapeutic effect of VEMLIDY. Drugs that strongly affect P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) activity may lead to changes in VEMLIDY absorption.

Consult the full prescribing information for VEMLIDY for more information on potentially significant drug interactions, including clinical comments.

Dosage and Administration

Testing Prior to Initiation: HIV infection.

Prior to or when initiating, and during treatment: On a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus.

Dosage: Adults; 1 tablet taken once daily with food.

Renal Impairment, Screening, and Monitoring: Not recommended in patients with end stage renal disease (ESRD; eCrCl <15 mL/min) who are not receiving chronic hemodialysis; in patients on chronic hemodialysis, on hemodialysis days, administer VEMLIDY after completion of hemodialysis treatment.

Hepatic Impairment: Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.

INDICATION

VEMLIDY is indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations 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. In addition, there is the possibility of unfavorable results from ongoing and additional clinical trials involving Epclusa, Vemlidy, selgantolimod, cilofexor and firsocostat, and the possibility that Gilead may be unable to complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that Gilead may make a strategic decision to discontinue development of selgantolimod, cilofexor and firsocostat and other investigational compounds and as a result, the compounds may never be successfully commercialized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

U.S. Prescribing Information for Epclusa and Vemlidy including BOXED WARNINGS, are available at www.gilead.com.

Epclusa, Vemlidy, 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.

Douglas Maffei, PhD, Investors
(650) 522-2739

Darcy Bowman, Media
+353 (87) 382-6777

Source: Gilead Sciences, Inc.