August 13, 2008
Drug is approved to treat chronic hepatitis B in adults. 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.
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 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.
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.
Source: webmd.com
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