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Simeprevir Approved for Hepatitis C Virus Infection

Kate Traynor

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 (PDF).External Link

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.

 

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