This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database.

To summarize available information on the use of adefovir dipivoxil(Hepsera(TM) from Gilead Sciences, Inc.) to treat adults who show evidence of active hepatitis B viral replication and either persistent elevations in serum aminotransferases or histologically active disease.

There are no long-term trials comparing adefovir with current therapies from which to make a decision regarding its use. Short-term comparative trials describing surrogate endpoint responses and treatment-emergent morbidity in treatment-naive patients are also lacking. The evidence on surrogate endpoint responses in patients with documented lamivudine resistance is noteworthy. A lack of detected viral resistance is also worth mention, although this resistance may become inevitable. Differences in treatment-emergent morbidity between lamivudine and adefovir recipients have not been described, but would help define the role of adefovir. In particular, its potential nephrotoxicity during treatment and hepatotoxicity upon cessation of treatment need to be weighed against any therapeutic advantages.