Subject: FDA approves Epclusa for treatment of chronic Hepatitis C virus infection
From: "U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>
Date: Tue, 28 Jun 2016 14:11:25 -0500
Title: FDA approves Epclusa for treatment of chronic Hepatitis C virus infection
Informationabout FDA Hepatitis product approvals, safety warnings, medical product labeling changes, notices of upcoming public meetings, and notices about proposed regulatory guidances.
On June 28, 2016, FDA approved Epclusa to treat adult
patients with chronic hepatitis C virus (HCV) both with and without
cirrhosis (advanced liver disease). For patients with moderate to severe
cirrhosis (decompensated cirrhosis), Epclusa is approved for use in
combination with the drug ribavirin. Epclusa is a fixed-dose combination
tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir,
a new drug, and is the first to treat all six major forms of HCV.
“This
approval offers a management and treatment option for a wider scope of
patients with chronic hepatitis C,” said Edward Cox, M.D., director of
the Office of Antimicrobial Products in the FDA’s Center for Drug
Evaluation and Research.
Hepatitis C is a viral disease that
causes inflammation of the liver that can lead to diminished liver
function or liver failure. There are at least six distinct HCV
genotypes, or strains, which are genetically distinct groups of the
virus. Knowing the genotype helps inform treatment recommendations and
the duration of treatment. Approximately 75 percent of Americans with
HCV have genotype 1; 20-25 percent have genotypes 2 or 3; and a small
numbers of patients are infected with genotypes 4, 5 or 6. According to
the Centers for Disease Control and Prevention, HCV infection becomes
chronic in approximately 75 to 85 percent of cases. Patients who suffer
from chronic HCV infection over many years may have complications, such
as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in
the abdomen, infections, liver cancer and death.
The safety and
efficacy of Epclusa for 12 weeks was evaluated in three Phase III
clinical trials of 1,558 subjects without cirrhosis or with compensated
cirrhosis (mild cirrhosis). Results demonstrated that 95–99 percent of
patients who received Epclusa had no virus detected in the blood 12
weeks after finishing treatment, suggesting the patients’ infections had
been cured. The safety and efficacy of Epclusa was also evaluated in a
clinical trial of 267 subjects with decompensated cirrhosis (moderate to
severe cirrhosis), of whom 87 subjects received Epclusa in combination
with ribavirin for 12 weeks, and 94 percent of these patients had no
virus detected in the blood 12 weeks after finishing treatment.
The
most common side effects of Epclusa include headache and fatigue.
Epclusa and ribavirin combination regimens are contraindicated for
patients for whom ribavirin is contraindicated.
Epclusa carries a
warning for patients and health care providers that serious slowing of
the heart rate (symptomatic bradycardia) and cases requiring pacemaker
intervention have been reported when amiodarone is used with sofosbuvir
in combination with another HCV direct-acting antiviral.
Co-administration of amiodarone with Epclusa is not recommended. Epclusa
also carries a warning not to use with certain drugs that may reduce
the amount of Epclusa in the blood which could lead to reduced efficacy
of Epclusa.
Epclusa was reviewed under the FDA’s priority review
program, which provides for an expedited review of drugs that treat
serious conditions and, if approved, would provide significant
improvement in safety or effectiveness.
Epclusa is manufactured and marketed by Gilead Sciences, Inc., of Foster City, California.
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