January 08, 2019
Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir)
- Epclusa is the First Approved Treatment for Adults with Chronic
Hepatitis C Virus with Decompensated Cirrhosis in
Until now, no treatment option has been available in
“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
Epclusa is a combination treatment that contains sofosbuvir, an NS5B
polymerase inhibitor that was approved in
The approval of Epclusa in
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.
- 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.
- 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.
- 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.
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
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
US Full Prescribing Information for Epclusa, including BOXED WARNING, is available at www.gilead.com.
Epclusa® and Sovaldi®
are registered trademarks of
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190107006131/en/
Sung Lee, Investors
+1 (650) 524-7792
Seiko Noma, Media Japan
Arran Attridge, Media US
+1 (650) 425-8975