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U.S. Food And Drug Administration Approves Epclusa® (Sofosbuvir/Velpatasvir) for Children Ages 6 and Older or Weighing at Least 17 kg with Chronic Hepatitis C Infection

-- Pediatric approval of protease inhibitor-free, pan-genotypic, pan-fibrotic, once-daily regimen supports HCV elimination efforts by providing critical option for broad range of populations --

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Epclusa® (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) for the treatment of people with chronic hepatitis C infection (HCV) as young as 6 years of age or weighing at least 17 kg, regardless of HCV genotype or liver disease severity. The recommended dosage of Epclusa in children ages 6 years and older is based on weight and liver function. Epclusa is the first pan-genotypic, protease inhibitor-free regimen approved in the United States for adults and children.

In the United States, there are approximately 23,000-46,000 children living with HCV. Children born to mothers with HCV are a growing concern, increasing in prevalence by 60 percent from 2011 to 2014. Additionally, engagement in high‐risk practices, such as intravenous drug use, is an increasingly common route of HCV transmission in adolescents and young adults.

“While the treatment of HCV has been transformed in recent years, physicians caring for some children have still needed to take several factors into consideration, including genotype and liver disease severity, when selecting the appropriate treatment plan,” said Kathleen B Schwarz, M.D., Professor of Pediatrics, Johns Hopkins University School of Medicine. “The expanded approval of Epclusa can help eligible children living with HCV combat this life-threatening and debilitating disease.”

The approval of Epclusa is based on data from a Phase 2, open-label clinical trial (Study 1143) that enrolled 175 children who were treated with Epclusa for 12 weeks, of which 173 were included in the efficacy analysis. In children 12 to <18 years old, treatment with Epclusa resulted in a cure rate (SVR12) of 93 percent (71/76) in those with genotype 1 HCV infection and 100 percent in those with genotype 2 (6/6), genotype 3 (12/12), genotype 4 (2/2) and genotype 6 (6/6) HCV infection. In children 6 to <12 years old, the SVR rate was 93 percent (50/54) in those with genotype 1 HCV infection, 91 percent (10/11) in those with genotype 3 HCV infection, and 100 percent in those with genotype 2 (2/2) and genotype 4 (4/4) HCV infection. The safety profile of Epclusa in children 6 years of age and older treated was generally consistent with that observed in clinical trials in adults. The most common adverse reactions (incidence greater than or equal to 10 percent, all grades) observed with treatment with Epclusa for 12 weeks in adults are headache and fatigue.

“Gilead’s continued commitment to HCV elimination includes bringing our medicines to the most difficult-to-cure populations and today’s decision by the FDA represents an important step toward that goal,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “With consistently high cure rates in clinical trials and in the real world, Epclusa has the potential to help many of the children living with HCV in the United States.”

For adults, Epclusa was first approved by the FDA and European Medicines Agency (EMA) in 2016. A line extension application for the use of Epclusa in children aged 6 to <18 years of age is currently under review with the EMA.

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.

IMPORTANT U.S. SAFETY INFORMATION AND INDICATION FOR THE USE OF 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 Potent 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, oxcarbazepine, 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.

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 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 the risk that physicians may not see the benefits of prescribing Epclusa for the treatment of chronic HCV infection and the possibility of unfavorable results from ongoing and additional clinical studies involving Epclusa. Further, there is the possibility that the European Commission may not approve the line extension application for the use of Epclusa in the currently anticipated timelines or at all. 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 Annual Report on Form 10-K for the year ended December 31, 2019, 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, including BOXED WARNING, is available at www.gilead.com.

Epclusa and Gilead 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, Ph.D., Investors
(650) 522-2739

Sonia Choi, Media
(650) 425-5483

Source: Gilead Sciences, Inc.