Gilead to Present More Than 70 Abstracts From Diverse Liver Disease Programs At The International Liver Congress™ 2021

– Interim Phase 3 Data Evaluating Hepcludex^®, a First-in-Class Entry Inhibitor, Conditionally Approved in the EU, for the Treatment of Chronic Hepatitis Delta Virus will be Presented in Official Press Program –

– One Late-Breaking, Six Oral Presentations and Posters across HDV, HCV, HBV, NASH and PSC Demonstrate the Breadth of Gilead’s Commitment to People with Liver Disease –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that more than 70 abstracts from the company’s liver disease programs will be presented at The International Liver Congress^™ 2021 (ILC) taking place from June 23-26. The breadth of data reflects Gilead’s continued commitment to liver disease, including the recent expansion into chronic hepatitis delta virus (HDV), with Hepcludex^® (bulevertide) as the first-in-class treatment for people with HDV conditionally approved in Europe. Gilead will also present clinical and real-world data on global efforts to support the World Health Organization’s goal of hepatitis C (HCV) elimination, the impact of treatment in chronic hepatitis B infection (HBV) and ongoing research in nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).

“We’re excited to join the liver community at this year’s International Liver Congress and in particular to share these Phase 3 data which reinforce the potential of Hepcludex for the treatment of HDV, the most severe form of chronic viral hepatitis,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We continue to strive to address some of the most substantial challenges in liver diseases, and we look forward to leveraging our expertise to transform the trajectory for people living with HDV.”

Gilead will present interim data on Hepcludex for the treatment of HDV from Phase 3 and Phase 2b clinical trials, which reinforce the safety and efficacy data that was used for the European Medicines Agency (EMA) conditional approval in 2020.

Interim results from the Phase 3 study (MYR301) evaluating the efficacy of Hepcludex monotherapy at low and high doses will be presented as a late-breaking poster presentation (LBP-2730) and broadcast live as part of the ILC’s Official Press Program on June 24 at 9:00 am EDT/15:00 pm CET. Additionally, interim findings from the Phase 2b study (MYR204) will be presented, evaluating the safety and efficacy of Hepcludex monotherapy and in combination with peginterferon alfa-2a. Hepcludex is not approved by the U.S. Food and Drug Administration (FDA).

“HDV only occurs in people co-infected with HBV and leads to more serious liver disease than HBV alone, complicating the diagnosis and treatment journey for this patient population,” said Tarik Asselah, Professor of Hepatology at Hôpital Beaujon, Clichy, and at the University Paris, and Head of Viral Hepatitis Team at INSERM UMR1149, France. “The data on bulevertide to be presented at ILC provide significant progress and promise for people living with chronic HDV, who have previously had very limited treatment options and a poor prognosis.”

HCV Elimination Efforts

Gilead will present real-world data from HCV screening and linkage to care initiatives which underscore the company’s dedication to global HCV elimination efforts. Additional results will be presented showcasing the potential of Epclusa^® (400 mg sofosbuvir/100 mg velpatasvir) in the test-and-treat strategy for HCV management based on a simplified monitoring algorithm for appropriate patients.

HBV Treatment and Functional Cure

Data on HBV will highlight the long-term results of switching to Vemlidy^® (tenofovir alafenamide 25 mg, TAF). Data will also be presented on Gilead’s ongoing pursuit toward HBV functional cure.

Select accepted abstracts being presented at the ILC include:

For more information, including a complete list of abstract titles being presented at the meeting, please visit: https://easl.eu/event/the-international-liver-congress-2021/scientific-programme/.

Hepcludex has been granted PRIority MEdicines (PRIME) scheme eligibility by EMA for the treatment of HDV infection and Breakthrough Therapy designation by the U.S. FDA. Bulevirtide is an investigational agent in the U.S. and outside of the European Economic Area; in these regions the safety and efficacy have not been established.

Cilofexor, firsocostat, inarigivir and selgantolimod are investigational compounds and are not approved by the FDA or any other regulatory authority; their safety and efficacy have not been established.

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

U.S. Important Safety Information 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 in adults and pediatric patients 6 years of age and older were headache and fatigue; and when used with RBV in adults with decompensated cirrhosis were fatigue, anemia, nausea, headache, insomnia and diarrhea. The most common adverse reactions (≥10%, grade 1 or 2) in pediatric patients less than 6 years of age were vomiting and spitting up the drug.

Drug Interactions

• Coadministration of EPCLUSA is not recommended with topotecan due to increased concentrations of topotecan.
• Coadministration of EPCLUSA is not recommended 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 3 years of age and older 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: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. 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 DF. 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 in Adults: 1 tablet taken once daily with food.
• Renal Impairment: 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 (HBV) infection in adults with compensated liver disease.

About HDV

Chronic hepatitis delta virus (HDV) is the most severe form of viral hepatitis and can have mortality rates as high as 50% within 5 years in cirrhotic patients. HDV occurs only as a co-infection in individuals who have hepatitis B virus (HBV). It is estimated that at least 12 million people worldwide are likely currently co-infected with HDV and HBV. HDV co-infection is associated with a faster progression to liver fibrosis, cirrhosis, hepatic decompensation and an increased risk of liver cancer and death. In the U.S. and Europe, there are approximately more than 230,000 people living with HDV, however it remains underdiagnosed globally.

About Gilead Sciences in Liver Disease

For more than 20 years, Gilead has sought to address some of the biggest challenges in liver disease. The company has transformed the trajectory of many liver diseases through a relentless pursuit of innovation and pioneering access programs to bring meaningful therapies to people around the world. More work is required, and Gilead is committed to advancing innovative therapeutics to address the most pressing unmet needs in liver disease and overcoming barriers to better care.

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 and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statement

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, including those involving Hepcludex, Epclusa, Vemlidy, cilofexor, firsocostat, inarigivir and selgantolimod; the possibility of unfavorable results from ongoing or additional clinical trials or studies, including those involving Hepcludex, Epclusa, Vemlidy, cilofexor, firsocostat, inarigivir and selgantolimod; the possibility that Gilead may make a strategic decision to discontinue development of cilofexor, firsocostat, inarigivir, selgantolimod and other investigational compounds and as a result, the compounds may never be successfully commercialized; Gilead’s ability to receive regulatory approvals in a timely manner or at all, including FDA or EMA approval of Hepcludex, and the risk that any such approvals 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, 2021, 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 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.

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

Hepcludex, 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.

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Jacquie Ross, Investors (650) 358-1054

Rhiannon Bid, Media (Europe) +44 7824 530 487

Nat Sillin, Media (U.S.) (650) 866-9374

Source: Gilead Sciences, Inc.