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|Gilead Announces Scientific Presentations Demonstrating Efficacy of Harvoni® (Ledipasvir/Sofosbuvir) in Special Patient Populations With HCV Infection|
-- Results Presented at The International Liver Congress™ 2017 Highlight Progress for the Treatment of Pediatric HCV and Adult HCV/HBV Co-Infected Patient Populations --
Harvoni is approved in
Harvoni has a boxed warning in its product label regarding the risk of hepatitis B virus reactivation in HCV/HBV co-infected patients. See below for important safety information.
“Gilead continues to study the safety and efficacy of our medicines in
HCV-infected patients with unmet medical need, to help realize the
potential for cure,” said
Children Aged 6 to 11 Years with Chronic HCV
The estimated prevalence of HCV infection in children is up to 0.4
Results from an open-label Phase 2 study, led by
HCV/HBV Co-infected Patients
The global prevalence of HCV/HBV co-infection is estimated to be 1.7–3.9 million. Reactivation of HBV infection during treatment of HCV infection with direct-acting antiviral agents has been reported in the postmarketing setting. However, clinical trials to more systematically assess the safety and efficacy of direct-acting antiviral therapy in HCV/HBV co-infected patients with active HBV infection have not been conducted.
This Phase 2, open-label study led by
Three patients had serious adverse events that were not considered to be drug-related, including optic neuritis, post-procedural bleeding and duodenal ulcer bleeding. The most common adverse events reported (≥5 percent of patients) were headache, upper respiratory infection and fatigue.
Of the 111 patients enrolled, 23 (21 percent) experienced an increase in HBV DNA of at least 2 log10 IU/mL during or following Harvoni treatment. However, no patient experienced a grade 3 or 4 ALT increase or any clinical manifestations suggestive of HBV reactivation. There were two patients that started HBV treatment based on increases in HBV DNA and mild elevations in ALT without symptoms.
Further information about the clinical studies described above can be found at www.clinicaltrials.gov.
Certain uses for Harvoni highlighted above are investigational and have not been determined to be safe or efficacious.
U.S. Important Safety Information for Harvoni
BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HBV/HCV COINFECTED PATIENTS
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with Harvoni.
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.
Warnings and Precautions
Most common (≥10%, all grades) adverse reactions were fatigue, headache and asthenia.
Consult the full Prescribing Information for Harvoni for more information on potentially significant drug interactions, including clinical comments.
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 Harvoni in
special patient populations with HCV infection. 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
Harvoni is a registered trademark of
For more information on
Gilead Sciences, Inc.
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