The Pharmaceutical Journal
Vol 270 No 7243 p467
5 April 2003

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New drug treatment for hepatitis B

Adefovir dipivoxil (Hepsera), a new treatment for chronic hepatitis B is being launched by Gilead Sciences (see p472). Stock will be available from 7 April.

Adefovir dipivoxil is an oral prodrug of adefovir, a nucleotide analogue of adenosine monophosphate. It is licensed for use in adults with decompensated liver disease, as well as compensated liver disease where there is evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and active liver inflammation and fibrosis.

The launch follows two recent studies showing positive results in patients with chronic hepatitis B after 48 weeks of treatment with adefovir dipivoxil.

In one study of 515 patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B, more patients who received adefovir dipivoxil 10mg or 30mg daily than received placebo had histological liver improvement. In addition, more patients treated with adefovir dipivoxil had a reduction in serum hepatitis B virus (HBV) DNA levels, undetectable levels of serum HBV DNA, normalisation of alanine aminotransferase levels, and HBeAg seroconversion. The 10mg dose had a favourable risk-benefit profile for long-term treatment, say the researchers (New England Journal of Medicine 2003;348:808).

In the other study of 185 patients with HBeAg-negative chronic hepatitis B, alanine aminotransferase levels had normalised at week 48 in 72 per cent of patients receiving adefovir dipivoxil 10mg daily compared with 29 per cent of those receiving placebo (ibid, p800).