Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir)

Gilead Sciences, Inc. (NASDAQ: GILD) announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Epclusa^® (sofosbuvir 400mg/velpatasvir 100mg), a once-daily treatment for adults with chronic hepatitis C virus (HCV) infection with decompensated cirrhosis, and for patients with chronic HCV infection without cirrhosis or with compensated cirrhosis who have had prior treatment with a direct-acting antiviral therapy (DAA).

Until now, no treatment option has been available in Japan for the treatment of chronic HCV infection with decompensated cirrhosis, and there have been limited treatment options for patients with chronic HCV infection who have had prior treatment with a DAA. Epclusa offers a new option for both of these difficult-to-treat patient populations.

“Gilead has continued to develop new HCV therapies to help ensure all people with HCV have a chance at cure and, ultimately, to help eliminate the disease worldwide,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead Sciences. “In Japan, people with HCV who have decompensated cirrhosis or who did not achieve cure with prior HCV treatment, had few to no treatment options until now. We are pleased to offer a new treatment option to address this important clinical need in Japan.”

Epclusa is a combination treatment that contains sofosbuvir, an NS5B polymerase inhibitor that was approved in Japan as Sovaldi ^® 400 mg tablets in March 2015, and velpatasvir, an active ingredient that inhibits NS5A.

In Japan, Epclusa is indicated for the suppression of viremia in patients with chronic HCV infection. Patients with chronic HCV infection with decompensated cirrhosis should take one tablet of Epclusa once daily for 12 weeks, and patients with chronic HCV infection without cirrhosis or with compensated cirrhosis that have had prior DAA treatment experience should take one tablet of Epclusa once daily for 24 weeks, in combination with ribavirin (RBV).

The approval of Epclusa in Japan is supported by data from a Phase 3 clinical study in Japanese patients with HCV infection with decompensated cirrhosis (Study GS-US-342-4019) in which 92 percent (47/51) of patients who received Epclusa for 12 weeks achieved SVR12 (defined as undetectable HCV RNA 12 weeks after completing therapy). Patients who achieve SVR12 are considered cured of HCV. In a separate Phase 3 clinical study in Japanese patients with genotype 1 or 2 HCV infection who failed prior DAA therapy (Study GS-US-342-3921), 97 percent (58/60) of patients who received Epclusa with RBV for 24 weeks achieved SVR12. In both studies, Epclusa was generally well tolerated. Among patients receiving Epclusa for 12 weeks in GS-US-342-4019, the most common adverse event was nasopharyngitis and no patient discontinued treatment with Epclusa due to adverse events. Among patients receiving Epclusa with RBV for 24 weeks in GS-US-342-3921, the most common adverse events were viral upper respiratory tract infection and anemia and 3.3 percent of patients discontinued Epclusa due to adverse events.

The US Prescribing Information for Epclusa contains a Boxed Warning regarding the risk of hepatitis B virus reactivation in HCV/HIV co-infected patients. See below for US Important Safety Information and Indication.

EPCLUSA US Important Safety Information

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 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 Concomitant Use of EPCLUSA 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 cirrhosis were fatigue, anemia, nausea, headache, insomnia, and diarrhea.

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, 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.

US Indication

EPCLUSA is indicated for the treatment of adults with chronic hepatitis C virus (HCV) 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 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. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.

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. 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 September 30, 2018, 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.

US Full Prescribing Information for Epclusa, including BOXED WARNING, is available at www.gilead.com .

Epclusa ^® and Sovaldi ^® are registered trademarks of Gilead Sciences, Inc., or its related companies.

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

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Contact information

Sung Lee, Investors
+1 (650) 524-7792

Seiko Noma, Media Japan
+81-3-6837-0790

Arran Attridge, Media US
+1 (650) 425-8975