Comunicado oficial da Gilead
informado a aprovação do FDA para o novo medicamento VOSEVI para re-tratamento
de Hepatite C.
U.S. FOOD AND DRUG ADMINISTRATION APPROVES GILEAD’S
VOSEVI™ (SOFOSBUVIR/VELPATASVIR/VOXILAPREVIR) FOR RE-TREATMENT OF ADULTS WITH
CHRONIC HEPATITIS C VIRUS
- Vosevi is the First Once-daily Single-Tablet HCV
Regimen Approved as Salvage Therapy for Certain Patients and Completes Gilead’s
Portfolio of Sofosbuvir-based HCV Direct-acting Antiviral (DAA) Treatments -
Foster City, Calif. – July 18, 2017 – Gilead Sciences,
Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration
(FDA) has approved Vosevi™ (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir
100 mg) tablets, a single-tablet regimen for the re-treatment of chronic
hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6
previously treated with an NS5A inhibitor-containing regimen, or with genotype
1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A
inhibitor. The approval is based on data from the Phase 3 POLARIS-1 and
POLARIS-4 studies, which evaluated 12 weeks of Vosevi in direct-acting
antiviral-experienced chronic HCV-infected patients without cirrhosis or with
compensated cirrhosis.
“Direct-acting antiviral regimens have transformed HCV
treatment and have allowed health care providers the fortunate opportunity to
cure many patients. However, for patients who require re-treatment, there
remains an unmet clinical need for an effective and well-tolerated option,”
said Ira Jacobson, MD, Chairman of the Department of Medicine at Mount Sinai
Beth Israel, New York City and a principal investigator in the Vosevi clinical
trials. “Treatment with Vosevi resulted in high cure rates in clinical studies
of patients who were not previously cured with several widely-prescribed DAA
regimens and will provide physicians with an important new therapeutic option
that could offer hope for their hardest-to-treat patients.”
Vosevi has a boxed warning in its product label
regarding the risk of hepatitis B virus (HBV) reactivation in HCV/HBV
coinfected patients. See below for important safety information.
Vosevi is the latest single-tablet regimen in Gilead’s
portfolio of sofosbuvir-based DAA treatments that offer people living with HCV
a short course of therapy to cure their HCV, with the convenience associated
with once-daily single-tablet regimens. Since 2013, Gilead has brought to
market four HCV treatments, including 3 single-table regimens. To date, more
than an estimated 1.4 million patients worldwide have been treated with
sofosbuvir-based regimens.
“The evolution of Gilead’s portfolio of HCV
single-tablet regimens has been driven by our commitment to address previously
unmet needs and put the possibility of cure within reach for as many HCV
patient populations as possible,” said John F. Milligan, PhD, Gilead’s
President and Chief Executive Officer. “The approval of Vosevi completes our
portfolio by fulfilling the unmet need for an effective regimen for patients
who could not be cured, despite prior treatment with certain DAA regimens.”
The approval of Vosevi is supported by data from the
POLARIS-1 study evaluating 12 weeks of treatment among adults with HCV genotype
1, 2, 3, 4, 5 or 6 with or without compensated cirrhosis who had failed prior
treatment with an NS5A inhibitor-containing regimen, as well as data from the
POLARIS-4 study evaluating 12 weeks of treatment among adults with HCV
genotypes 1a and 3 with or without compensated cirrhosis who had failed prior
treatment with a sofosbuvir-containing regimen that did not include an NS5A
inhibitor. In these populations across the two studies, 340 of the 353 patients
treated with Vosevi (96 percent) achieved the primary endpoint of SVR12,
defined as maintaining undetectable viral load 12 weeks after completing
therapy.
The most common adverse events (≥10% of patients)
among patients who received Vosevi were headache, fatigue, diarrhea and nausea.
The proportion of subjects who permanently discontinued treatment due to
adverse events was 0.2% for subjects who received Vosevi for 12 weeks.
U.S. Patient Support Program
To support these patients and their families, Gilead’s
U.S. Support Path® program provides information regarding access and
reimbursement coverage options to patients in the United States who need
assistance with coverage for their Gilead HCV medications, including Vosevi.
Support Path conducts benefits investigations and provides patients with
information regarding their insurance options.
Further, the Vosevi Co-pay Coupon Program offers
co-pay assistance for eligible patients with private insurance who need
assistance paying for out-of-pocket medication costs.
To learn more about Support Path for Vosevi, please
visit www.MySupportPath.com or
call 1-855-7-MYPATH (1-855-769-7284)
between 9:00 a.m. and 8:00 p.m. (Eastern), Monday through Friday.
IMPORTANT SAFETY INFORMATION
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 Vosevi. 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.
Contraindications
Vosevi is contraindicated with rifampin.
Warnings and Precautions
Serious Symptomatic Bradycardia When Coadministered
with Amiodarone: Amiodarone is not recommended for use with Vosevi 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. A fatal cardiac arrest was reported in a patient taking amiodarone who
was coadministered a sofosbuvir containing regimen. 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 Vosevi with P-gp Inducers and/or Moderate to Potent Inducers of CYP2B6,
CYP2C8 or CYP3A4: St. John’s wort and carbamazepine are not recommended for use
with Vosevi as they may significantly decrease sofosbuvir, velpatasvir, and/or
voxilaprevir plasma concentrations.
Adverse Reactions
The most common adverse reactions (≥10%, all grades)
with Vosevi were headache, fatigue, diarrhea, and nausea.
Drug Interactions
Coadministration of Vosevi is not recommended with
phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifapentine, atazanavir,
lopinavir, tipranavir/ritonavir, efavirenz, rosuvastatin, pitavastatin, and
cyclosporine due to changes (decreased or increased) in concentrations of
sofosbuvir, velpatasvir, voxilaprevir, and/or the other agent.
Consult the full Prescribing Information for Vosevi
for more information on potentially significant drug interactions, including
clinical comments.
U.S. Full Prescribing Information for Vosevi,
including BOXED WARNING, is available at www.gilead.com.
Vosevi is a trademark 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.
Anexo:
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