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FDA Approves Sofosbuvir for Hepatitis C — Physician’s First Watch
FDA Approves Sofosbuvir for Hepatitis C
By Kristin J. Kelley
The FDA has approved sofosbuvir (Sovaldi) for treating hepatitis C virus (HCV) infection without the requirement to administer with interferon, making it the second approval for HCV in 2 weeks. The other was simeprevir (Olysio). Sofosbuvir is approved as part of a combination antiviral treatment regimen.
Sofosbuvir, which works by blocking a protein needed for viral replication, effectively treated multiple types of HCV in six clinical trials of nearly 2000 patients. Additionally, the drug was effective in patients who couldn't be treated with an interferon-based regimen and in liver cancer patients awaiting transplants. Fatigue and headache were the most common side effects. Patients cotreated with ribavirin and peginterferon-alfa also reported anemia, insomnia, and nausea.
Writing in HIV and ID Observations, Dr. Paul Sax notes that "HCV cure just got a whole lot easier" with these approvals. "Both are one pill a day. Both have far fewer side effects than any existing HCV drug. Sofosbuvir adds the benefit of having almost zero important drug-drug interactions." Both drugs are, however, very expensive: 12 weeks of sofosbuvir will be $80,000 and simeprevir will be $65,000.