FDA OKs HIV Drug Viread for Hepatitis B

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Updated: 6/16 3:38 pm

Aug. 12, 2008 -- The FDA has approved the HIV drug Viread for the treatment of chronic hepatitis B in adults.

Hepatitis B is a liver disease caused by the hepatitis B virus. Here's some background information from the CDC:

  • The hepatitis B virus can spread through blood, semen, or other body fluids.
  • Hepatitis B can either be a short-term illness (acute hepatitis B) or long-standing (chronic hepatitis B).
  • Chronic hepatitis B can cause long-term health problems, including liver damage, liver failure, liver cancer, and it can be fatal.
  • The CDC recommends hepatitis B vaccination for all infants and for people at high risk of contracting hepatitis B.

Viread, taken once a day in a tablet, blocks an enzyme that the hepatitis B virus needs to replicate in liver cells, notes a news release from Viread's maker, California-based Gilead Sciences Inc.

According to Gilead, the FDA approved Viread for chronic hepatitis B in adults based on two ongoing clinical trials. For 48 weeks, patients with chronic hepatitis B either took Viread or Hepsera, another chronic hepatitis B drug made by Gilead.

In both studies, "a significantly greater percentage of patients with chronic hepatitis B who received Viread achieved a complete response to treatment compared to those who received Hepsera," states Gilead's news release.

Nausea was the most common side effect in Viread's chronic hepatitis B trials. Other reported adverse events included abdominal pain, diarrhea, headache, dizziness, fatigue, inflammation of the nose and throat, back pain, and skin rash, according to Gilead.

Gilead notes that severe, acute worsening of hepatitis B has been reported in patients who have stopped using anti-hepatitis B therapy, including Viread, so patients' liver function should be closely monitored for at least several months after stopping Viread or other anti-hepatitis B therapy.

Gilead also recommends HIV tests for all hepatitis B patients before starting treatment with Viread.

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