June 28, 2016
U.S. Food and Drug Administration Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C
– Epclusa is the First and Only All-Oral, Pan-genotypic Single Tablet Regimen for Chronic Hepatitis C Virus Infection and Gilead’s Third Sofosbuvir-Based Regimen –
“The approval of Epclusa represents an important step forward in the
global effort to control and potentially eliminate HCV as it provides a
safe, simple and effective cure for the majority of HCV-infected
patients, regardless of genotype,” said
Photos and multimedia gallery available at www.GileadHCVMedia.com.
Epclusa’s approval is supported by data from four international Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 patients with genotype 1-6 chronic HCV infection, without cirrhosis or with compensated cirrhosis received 12 weeks of Epclusa. The ASTRAL-4 study randomized 267 patients with genotype 1-6 HCV infection, with decompensated cirrhosis (Child-Pugh B), to receive 12 weeks of Epclusa with or without RBV or 24 weeks of Epclusa. The primary endpoint for all studies was SVR12.
Of the 1,035 patients treated with Epclusa for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved SVR12. In ASTRAL-4, patients with decompensated cirrhosis receiving Epclusa with RBV for 12 weeks achieved a high SVR12 rate (94 percent) compared to those who received Epclusa for 12 weeks or 24 weeks (83 percent and 86 percent, respectively).
Headache and fatigue were the most common adverse reactions (≥10 percent) experienced by HCV-infected patients treated with Epclusa in ASTRAL-1, ASTRAL-2 and ASTRAL-3 and occurred at a similar or higher frequency in placebo-treated patients. In the 87 HCV-infected patients with decompensated cirrhosis treated with Epclusa and ribavirin in the ASTRAL-4 study, fatigue, anemia, nausea, headache, insomnia and diarrhea were the most common adverse reactions (≥10 percent). Two and four patients treated with Epclusa and Epclusa with RBV respectively discontinued treatment due to adverse events.
“Today’s approval represents a significant advance for patients with HCV
genotypes 2 and 3, who previously required more complex and costly
Epclusa should not be administered with ribavirin in patients for whom ribavirin is contraindicated. See below for Important Safety Information for Epclusa.
U.S. Patient Support Program
To assist eligible hepatitis C patients in
- Call center staffed with associates trained to help patients and their providers with insurance-related needs.
- Education and support, including a 24/7 nursing support service line.
The Epclusa Co-pay Coupon Programs, which provide co-pay assistance
for eligible patients with private insurance who need assistance
paying for out-of-pocket medication costs. Most patients will pay no
- The Support Path Patient Assistance Program, which will provide Epclusa at no charge for eligible patients with no other insurance options.
Gilead also provides support to independent non-profit organizations that provide assistance for eligible federally-insured and privately-insured patients who need help covering out-of-pocket medication costs.
To learn more about Support Path for Epclusa, please visit www.MySupportPath.com
or call 1-855-769-7284 between
The prevalence of HCV genotypes varies regionally throughout the world. In resource-limited settings genotype testing can often be costly or unreliable, posing yet another barrier to treatment. As a pan-genotypic therapeutic option, Epclusa eliminates the need for genotype testing and has the potential to accelerate access to treatment for patients worldwide.
Gilead is committed to helping enable access to Epclusa around the
world. Gilead works with a network of regional business partners,
generic licensing partners, the
IMPORTANT SAFETY INFORMATION
If EPCLUSA is used in combination with ribavirin (RBV), all contraindications, warnings and precautions, and adverse reactions to RBV also apply. Refer to RBV prescribing information.
Warnings and Precautions
Risk of Serious Symptomatic Bradycardia When Sofosbuvir Is Coadministered with Amiodarone and Another HCV Direct Acting Antiviral: 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. 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 cirrhotics 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.
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 risks that
physicians and patients may not see advantages of Epclusa over other
therapies and may therefore be reluctant to prescribe the product, and
the risk that payers may be reluctant to approve or provide
reimbursement for the product. 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
U.S. Full Prescribing Information for Epclusa is available at www.gilead.com.
Epclusa is a registered trademark of
For more information on
Gilead Sciences, Inc.
Sung Lee, 650-524-7792
Cara Miller, 650-522-1616