FDA Approves Sofosbuvir for Hepatitis C — Physician’s First Watch

Medical News |
December 9, 2013

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.

Reader Comments (1)

mohammed elbanhawy Physician, Dermatology, heliopolis cairo egypt

an important for egyptian phsicians and patients

Your Comment

(will not be published)

Filtered HTML

  • Allowed HTML tags: <a> <em> <strong> <cite> <blockquote> <code> <ul> <ol> <li> <dl> <dt> <dd>
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Do you have any conflict of interest to disclose?
This question is for testing whether you are a human visitor and to prevent automated spam submissions.

Vertical Tabs

* Required

Reader comments are intended to encourage lively discussion of clinical topics with your peers in the medical community. We ask that you keep your remarks to a reasonable length, and we reserve the right to withhold publication of remarks that do not meet this standard.

PRIVACY: We will not use your email address, submitted for a comment, for any other purpose nor sell, rent, or share your e-mail address with any third parties. Please see our Privacy Policy.