September 25, 2017
China Food and Drug Administration Approves Gilead’s Sovaldi® (Sofosbuvir) for Treatment of Chronic Hepatitis C Virus Infection
- Sovaldi-based Regimens Demonstrated High Rates of Sustained Virologic Response or Cure for Chinese Hepatitis C Infected Patients -
The approval of Sovaldi is supported by a Phase 3 study conducted in
HCV is the fourth-most commonly reported infectious disease in
“With the approval of Sovaldi, there is now the potential opportunity to
transform treatment for HCV patients in China,” said
Sovaldi received marketing approval from the
Gilead has been present in
Beyond the approval of Sovaldi, Gilead is studying its HCV single-tablet
regimens Harvoni® (ledipasvir/sofosbuvir) and Epclusa®
(sofosbuvir/velpatasvir) at clinical trials sites across
IMPORTANT SAFETY INFORMATION AND INDICATION FOR SOVALDI IN U.S.
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 SOVALDI. 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 posttreatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
- Contraindications to peginterferon alfa and ribavirin also apply to SOVALDI combination treatment. Refer to the Prescribing Information for peginterferon alfa and ribavirin for a list of their contraindications.
Warnings and Precautions
- Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with SOVALDI 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. 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:
St. John'swort are not recommended for use with SOVALDI as they may significantly decrease sofosbuvir plasma concentrations.
- Risk Associated with Combination Treatment: Because SOVALDI is used in combination with other antiviral drugs for the treatment of HCV infection, consult the Prescribing Information for these drugs.
Most common adverse reactions (≥20%, all grades) for:
- SOVALDI + peginterferon alfa + ribavirin combination therapy were fatigue, headache, nausea, insomnia, and anemia.
- SOVALDI + ribavirin combination therapy were fatigue and headache.
In addition to rifampin and
St. John'swort, coadministration of SOVALDI is not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of sofosbuvir, reducing its therapeutic effect.
SOVALDI is indicated for the treatment of chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen:
- genotype (GT) 1 or 4 infected adults without cirrhosis or with compensated cirrhosis, in combination with pegylated interferon and ribavirin.
- GT 2 or 3 infected patients at least 12 years of age (or ≥35 kg) without cirrhosis or with compensated cirrhosis, in combination with ribavirin.
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 in
U.S. Full Prescribing Information for Sovaldi, including BOXED WARNING is available at www.gilead.com
SOVALDI, HARVONI and EPCLUSA 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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Gilead Sciences, Inc.
Sung Lee, 650-524-7792
Sonia Choi, 650-425-5483