BETHESDA, MD 25 Nov 2013—Janssen Therapeutics on November 22 announced the approval
of simeprevir oral capsules as part of a combination regimen for the treatment
of chronic hepatitis C virus (HCV) infection in adults, including patients with
compensated cirrhosis or other stable liver disease.
A spokesman for Janssen, which will market the drug
as Olysio, said the product should be available in the United States by mid-December.
Simeprevir inhibits the HCV NS3/4A protease and is
indicated, in combination with peginterferon alfa and ribavirin, for the
treatment of infections caused by HCV genotype 1, according to the drug's labeling
Up to 80% of clinical trial participants with
genotype 1 infection whose regimen included simeprevir were considered free of
HCV infection after completing their treatment.
The drug is much less effective in patients with HCV
genotype 1a with the NS3 Q80K polymorphism. The labeling recommends that
patients be screened at baseline for the presence of the NS3 Q80K variant, and
a treatment other than simeprevir considered if a positive test result occurs.
Simeprevir should never be used as monotherapy,
according to the labeling. No safe dosage of the drug is known for people of
East Asian ancestry and patients with moderate-to-severe liver impairment.
The recommended dosage of simeprevir is one 150-mg
capsule taken once daily with food and swallowed whole. The HCV protease
inhibitor should always be used in combination with peginterferon alfa and
ribavirin, with those drugs used at dosages recommended in their labeling.
The recommended duration of treatment with simeprevir
is 12 weeks of triple therapy with simeprevir, peginterferon alfa, and
ribavirin followed by 12 or 36 additional weeks of dual therapy with peginterferon
alfa and ribavirin. The duration of dual therapy depends on whether the patient
has previously been treated for HCV infection and, if so, the extent of the
response to that treatment.
HCV RNA levels should be monitored periodically during
triple and dual therapy to assess the patient's virologic response, according
to the labeling for simeprevir. All three medications should be discontinued if
the response becomes inadequate at week 4. If the response is inadequate at
week 12 or 24, after simeprevir therapy has ended, peginterferon alfa and
ribavirin treatment should be stopped.
The labeling includes a long list of drugs that adversely
affect or are adversely affected by concomitant use of simeprevir.
Serious adverse events that may occur during combination
treatment with simeprevir, peginterferon alfa, and ribavirin include serious
skin rash and photosensitivity reactions. Common but less serious adverse
events reported by patients undergoing triple therapy included mild-to-moderate
rash, itching, and nausea.
Dual therapy with ribavirin and peginterferon alfa
has been associated with embryofetal toxicity, and pregnancy must be avoided
during treatment, according to the labeling for simeprevir.
Simeprevir will be packaged in bottles of 28 and 7 capsules.
The capsules should be stored at controlled room temperature in the original
containers and protected from light.