FDA OKs HIV Drug Viread for Hepatitis B
Drug Is Approved to Treat Chronic Hepatitis B in Adults
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
- 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
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