From: "U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>
Date: Tue, 18 Jul 2017 15:13:28 -0500
Title: FDA approves Vosevi for Hepatitis C
Informationabout FDA Hepatitis product approvals, safety warnings, medical product labeling changes, notices of upcoming public meetings, and notices about proposed regulatory guidances.
On July 18, 2017, the U.S. Food and Drug Administration
approved Vosevi to treat adults with chronic hepatitis C virus (HCV)
genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis.
Vosevi is a fixed-dose, combination tablet containing two previously approved
drugs – sofosbuvir and velpatasvir – and a new drug, voxilaprevir.
Vosevi is
the first treatment approved for patients who have been previously treated
with the direct-acting antiviral drug sofosbuvir, or other drugs for HCV that
inhibit a protein called NS5A.
“Direct-acting antiviral drugs" prevent the
virus from multiplying and often cure HCV.
Vosevi provides a treatment option
for some patients who were not successfully treated with other HCV drugs in
the past,” said Edward Cox, M.D., director of the Office of Antimicrobial
Products in the FDA’s Center for Drug Evaluation and Research.
The safety and efficacy of Vosevi was
evaluated in two Phase 3 clinical trials that enrolled approximately 750
adults without cirrhosis or with mild cirrhosis.
There are at least six HCV
genotypes, or strains, which are genetically distinct groups of the virus.
Knowing the strain of the virus can help inform treatment recommendations.
Approximately 75 percent of Americans with HCV have genotype 1; 20-25 percent
have genotypes 2 or 3; and a small number of patients are infected with
genotypes 4, 5 or 6.
The first trial compared 12 weeks of Vosevi
treatment with placebo in adults with genotype 1 who had previously failed
treatment with an NS5A inhibitor drug. Patients with genotypes 2, 3, 4, 5 or
6 all received Vosevi.
The second trial compared 12 weeks of
Vosevi with the previously approved drugs sofosbuvir and velpatasvir in
adults with genotypes 1, 2 or 3 who had previously failed treatment with
sofosbuvir but not an NS5A inhibitor drug.
Results of both trials demonstrated that
96-97 percent of patients who received Vosevi had no virus detected in the
blood 12 weeks after finishing treatment, suggesting that patients’ infection
had been cured.
Treatment recommendations for Vosevi are
different depending on viral genotype and prior treatment history.
The most common adverse reactions in
patients taking Vosevi were headache, fatigue, diarrhea and nausea.
Vosevi is contraindicated in patients
taking the drug rifampin.
Hepatitis B virus (HBV) reactivation has
been reported in HCV/HBV coinfected adult patients who were undergoing or had
completed treatment with HCV direct-acting antivirals, and who were not
receiving HBV antiviral therapy. HBV reactivation in patients treated with
direct-acting antiviral medicines can result in serious liver problems or
death in some patients. Health care professionals should screen all patients
for evidence of current or prior HBV infection before starting treatment with
Vosevi.
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