FDA approves combination simeprevir and sofosbuvir for HCV treatment

the Clinical Advisor take:

The United States Food & Drug Administration has approved the combination of simeprevir (Olysio) and sofosbuvir (Sovaldi) for the treatment of hepatitis C, according to a report published in MedPage Today.

The combination has been approved for the treatment of chronic genotype 1 HCV. The combination can be used without ribavirin or pegylated interferon-alfa, which had previously been the mainstays of HCV therapy. Both of those drugs are seen as difficult to tolerate and sometimes dangerous.

The drugs had been approved individually last year, but simeprevir was only approved to be used with interferon and ribavirin while sofosbuvir could be used without interferon. However, clinicians and patients had been using simeprevir and sofosbuvir together prior to FDA approval. The drugs target different aspects of viral replication – simeprevir is an NS3/4A protease inhibitor and sofosbuvir is a nucleotide analog NS5B polymerase inhibitor.

FDA based their decision on results from the COSMOS trial, a phase II study in which patients took the combination with or without ribavirin for 12 or 24 weeks.

The study found that 91% of patients who received  the combination with ribavirin reached treatment success (defined as no detectable HCV RNA 12 weeks after treatment) compared with 95% of those who did not take ribavirin. Among those who got 12 weeks of treatment, 94% reached treatment success compared with those who received 24 weeks.

Common side effects included fatigue, headache, nausea, insomnia, pruritus, rash, and photosensitivity. Patients treated for 24 weeks also reported dizziness and diarrhea.

The FDA has approved the combination of simeprevir and sofosbuvir to treat HCV.
The FDA has approved the combination of simeprevir and sofosbuvir to treat HCV.

A drug combination widely used off-label to treat hepatitis C (HCV) has been given the nod by the FDA.

The agency approved simeprevir (Olysio) and sofosbuvir (Sovaldi) as a combination for the treatment of chronic genotype 1 HCV, according to Janssen Therapeutics, the maker of simeprevir.

Importantly, the combination can be used without ribavirin or pegylated interferon-alfa, the two drugs that for years were the mainstays of HCV therapy. Both are regarded as difficult to tolerate and sometimes dangerous.

Simeprevir and sofosbuvir were initially approved within 2 weeks of one another last year, but only sofosbuvir was cleared for use without interferon; in some patients, the FDA said it could be used with ribavirin alone.

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