Lamivudine (Epivir-HBV) Monotherapy versus Lamivudine plus Adefovir (Hepsera)
for Chronic Hepatitis B
Several
nucleoside/nucleotide analog agents are approved or under study for the treatment
of chronic hepatitis B virus (HBV) infection,
but long-term efficacy is limited by the emergence of drug-resistant virus.
As
reported in the May 2008 Journal of Hepatology, an international team of
researchers conducted a study to compare monotherapy and combination therapy in
115 previously untreated hepatitis B "e" antigen (HBeAg) positive patients.
In this double-blind trial, participants were randomly assigned to receive either
100 mg/day lamivudine (Epivir-HBV) monotherapy
or else the same dose of lamivudine plus 10 mg/day adefovir
dipoxil (Hepsera) for 104 weeks.
Results
•
The time-weighted average change in serum HBV DNA from baseline through week 16
was -4.20 log10 copies/mL for both groups (P = 0.936).
•
After 104 weeks, the median change in serum HBV DNA from baseline was -3.41 log10
copies/mL in the monotherapy arm and -5.22 log10 copies/mL in the combination
therapy arm.
•
44% of patients in the monotherapy arm and 19% of those receiving combination
therapy experienced HBV DNA breakthrough.
•
The M204V/I mutation was detected in 43% of patients (15 of 35) in the monotherapy
arm and 15% (6 of 41) in the combination therapy arm.
•
ALT normalization occurred in 34% patients (19 of 56) in the monotherapy arm and
45% (23 of 51) in the combination therapy group (P = 0.018).
•
By week 104, HBeAg seroconversion occurred in 20% of monotherapy patients and
13% of combination therapy patients.
•
Both regimens were well tolerated.
Conclusion
Based
on these findings, the study authors concluded, "Lower rates of resistance
to lamivudine, lower serum HBV DNA levels, and higher rates of ALT normalization
were seen in the combination therapy group after two years. However, serological
outcomes were similar."
4/11/08
Reference JJY Sung,
JY Lai, S Zeuzem, and others. Lamivudine compared with lamivudine and adefovir
dipivoxil for the treatment of HBeAg-positive chronic hepatitis B. Journal
of Hepatology 48(5): 728-735. May 2008.
Results
