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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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FDA-approved
Monotherapies for HBV

 Epivir-HBV (lamivudine; 3TC)
Intron A (interferon alfa-2b)
Hepsera (adefovir dipivoxil)
Baraclude (entecavir)
Pegasys (peginterferon alfa-2a)