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FDA Approves Simeprevir to be Used with Sofosbuvir for HCV Genotype 1
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The FDA has approved changes to the simeprevir label reflecting that it can be used in combination with sofosbuvir to treat patients with chronic hepatitis C virus genotype 1 infection, according to a media alert from the FDA.
Simeprevir (Olysio, Janssen Therapeutics) is a NS3/4A protease inhibitor that functions by blocking the viral protease enzyme HCV uses to replicate. It was approved by the FDA in November of last year as part of an antiviral treatment regimen with pegylated interferon and ribavirin for patients with chronic HCV genotype 1.
Sofosbuvir (Sovaldi, Gilead Sciences), a nucleotide analog NS5B polymerase inhibitor, was approved by the FDA in December of last year as an oral tablet, to serve as a component of a combination antiviral treatment regimen to treat chronic HCV.
The combination was studied thoroughly in the COSMOS study in which 167 patients with HCV genotype 1a or 1b were randomly assigned a 12- or 24-week course of once-daily sofosbuvir plus simeprevir with or without RBV. Approximately 93% of patients treated without RBV achieved SVR12 — including those with cirrhosis and non-responders to interferon-based therapy.
According to the FDA alert, Olysio should not be taken as monotherapy, but administered in combination with either pegylated interferon alfa and ribavirin or sofosbuvir.
Perspective
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Ibrahim A. Hanouneh, MD
There are decades where nothing happens; and there are weeks where decades happen,” Vladimir Ilich Lenin said.
In December 2013, the treatment of hepatitis C virus (HCV) infection entered a new era with the introduction of two new oral anti-viral agents, sofosbuvir and simeprevir. Sofosbuvir is a nucleotide analogue inhibitor of the HCV NS5B RNA-dependent polymerase, whereas simeprevir is a specific inhibitor of the HCV NS3/4A serine protease. Evidence for the use of sofosbuvir and simeprevir combination comes mainly from the COSMOS trial recently published in Lancet.
In this trial, the overall sustained virologic response rate was 90%-94%. The combination therapy was well-tolerated with minor side effects — mainly fatigue (31%), headache (20%) and nausea (16%). Our clinical experience at Cleveland Clinic echoes the results of COSMOS trial.
In our experience, sofosbuvir and simeprevir combination is highly effective and well-tolerated in the treatment of patients with chronic HCV infection.
Although there are no head-to-head trials, sofosbuvir and simeprevir combination seems to be as effective as ledipasvir and sofosbuvir, the most recently approved oral combination in the treatment of HCV. However, the major drawback of sofosbuvir and simeprevir combination is the cost, which often exceeds that of ledipasvir and sofosbuvir.
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