February 26, 2015
Gilead Announces SVR12 Rates From Phase 3 Study Evaluating Harvoni® for the Treatment of Chronic Hepatitis C in Patients Co-Infected With HIV
– 96 Percent SVR12 Rate for Hepatitis C Genotypes 1 and 4 Among HIV-infected Patients on Antiretroviral Therapy –
“This trial provides strong evidence that people who are co-infected
with HIV can achieve very high rates of hepatitis C cure with a
combination direct-acting antiviral regimen,” said
ION-4 is a Phase 3, multicenter, open-label study investigating the efficacy, safety and tolerability of Harvoni treatment for 12 weeks in 335 patients with HCV genotype 1a (75 percent), 1b (23 percent) or 4 (2 percent) and HIV-1 co-infection. The study included HCV treatment-naïve (45 percent) and treatment-experienced (55 percent) patients, including patients with compensated cirrhosis (20 percent), whose HIV was suppressed using one of three HIV antiretroviral (ARV) regimens: tenofovir and emtricitabine with efavirenz (Atripla®), raltegravir or rilpivirine (Complera®).
SVR12 rates did not differ significantly by prior HCV treatment status, presence or absence of cirrhosis, or ARV regimen. No patients discontinued Harvoni due to an adverse event (AE). Of the 14 patients that did not achieve SVR12, two patients experienced virologic failure during treatment (likely due to non-compliance per physician reporting), 10 experienced virologic relapse post-treatment, one was lost to follow up and one died due to causes unrelated to study drug. The most common AEs reported were headache (25 percent), fatigue (21 percent) and diarrhea (11 percent).
Harvoni received regulatory approval for the treatment of chronic HCV
genotype 1 infection in adults in
Important Safety Information for Harvoni
Warnings and Precautions
- 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 (Sovaldi®).
Most common (≥10%, all grades) adverse reactions were fatigue and headache.
- 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.
Additionally, patients taking Harvoni concomitantly with the combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate should be monitored for tenofovir-associated adverse events.
Consult the full Prescribing Information for Harvoni for more information on potentially significant drug interactions, including clinical comments.
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical
need. The company’s mission is to advance the care of patients suffering
from life-threatening diseases. Gilead has operations in more than 30
countries worldwide, with headquarters in Foster City,
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 the supplemental New Drug Application may not be approved. In
addition, physicians and patients may not see advantages of Harvoni over
other therapies and physicians may therefore be reluctant to prescribe
the product and private and public payers may be reluctant to provide
coverage or reimbursement for the product. Further, additional studies
of Harvoni may produce unfavorable results. 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 and U.S. full Prescribing Information, including BOXED WARNING, for Atripla and Complera are available at www.gilead.com.
Atripla is a registered trademark of Bristol-Myers Squibb &
Complera and Harvoni 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.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)