April 21, 2017
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.
- If Harvoni 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
- Risk of Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with Harvoni 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 of Harvoni Due to P-gp Inducers: Rifampin and St. John’s wort are not recommended for use with Harvoni as they may significantly decrease ledipasvir and sofosbuvir plasma concentrations.
- Related Products Not Recommended: Harvoni is not recommended for use with other products containing sofosbuvir.
Most common (≥10%, all grades) adverse reactions were fatigue, headache and asthenia.
- In addition to rifampin and St. John’s wort, coadministration of Harvoni is also not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of ledipasvir and sofosbuvir, reducing the therapeutic effect of Harvoni.
- Coadministration of Harvoni is not recommended with simeprevir due to increased concentrations of ledipasvir and simeprevir. Coadministration is also not recommended with rosuvastatin or co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate due to increased concentrations of rosuvastatin and tenofovir, respectively.
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
U.S. full prescribing information for Harvoni, including BOXED WARNING, is available at www.gilead.com.
Harvoni is a registered trademark of
For more information on
Gilead Sciences, Inc.
Sung Lee, 650-524-7792 (Investors)
Mark Snyder, 650-522-6167 (Media)