Tenofovir and Adefovir Both Suppress HBV Replication in HIV-HBV Coinfected Patients
By
Liz Highleyman Several
antiviral agents are active against both HIV and hepatitis B virus (HBV). These
include the approved anti-HBV therapies lamivudine
(3TC; Epivir) and adefovir (Hepsera), as well
as tenofovir DF (Viread), which is approved for HIV
and under study for hepatitis B. As
reported in the November 2006 issue of Hepatology, researchers conducted
a prospective, double-blind study (ACTG A5127) comparing tenofovir and adefovir
in HIV-HBV coinfected patients. At
total of 52 participants were randomly assigned to receive 10 mg once-daily adefovir
or 300 mg once-daily tenofovir. At the start of the study, subjects were on stable
antiretroviral therapy. Serum HBV DNA levels were >/= 100,000 copies/mL, and
plasma HIV RNA levels were </= 10,000 copies/mL. Results
At baseline,
73% of subjects had HIV viral load < 50 copies/mL, 86% were HBeAg positive,
94% had lamivudine-resistant HBV, the median serum ALT level was 52 IU/L, and
98% had compensated liver disease.
The mean time-weighted average decrease in serum HBV DNA from baseline to week
48 was 4.44 log copies/mL in the tenofovir arm vs 3.21 log copies/mL in the adefovir
arm.
There was no difference in toxicity between the 2 treatment arms, with 11 subjects
(5 in the adefovir arm and 6 in the tenofovir arm) experiencing ALT elevations
while on treatment.
The study closed early based on results of a pre-specified interim review, since
the primary non-inferiority endpoint had been met without safety issues.
Conclusion In
conclusion, the authors wrote, "over 48 weeks, treatment with either adefovir
or tenofovir resulted in clinically important suppression of serum HBV DNA. Both
drugs are safe and efficacious for patients coinfected with HBV and HIV." 12/05/06 Reference M
G Peters, J Andersen, P Lynch, and others. Randomized controlled study of tenofovir
and adefovir in chronic hepatitis B virus and HIV infection: ACTG A5127. Hepatology
44(5): 1110-1116. November 2006. |