Randomized controlled study of tenofovir and adefovir in chronic hepatitis B virus and HIV infection

ACTG A5127

Marion G. Peters, Janet Andersen, Patrick Lynch, Tun Liu, Beverly Alston-Smith, Carol L. Brosgart, Jeffrey M. Jacobson, Victoria A. Johnson, Richard B. Pollard, James F. Rooney, Kenneth E. Sherman, Susan Swindells, Bruce Polsky

Research output: Contribution to journalArticle

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Abstract

Chronic hepatitis B virus (HBV) infection is an important cause of morbidity and mortality in subjects coinfected with HIV. Tenofovir disoproxil fumarate (TDF) and adefovir dipivoxil (ADV) are licensed for the treatment of HIV-1 and HBV infection, respectively, but both have in vivo and in vitro activity against HBV. This study evaluated the anti-HBV activity of TDF compared to ADV in HIV/HBV-coinfected subjects. ACTG A5127 was a prospective randomized, double-blind, placebo-controlled trial of daily 10 mg of ADV versus 300 mg of TDF in subjects with HBV and HIV coinfection on stable ART, with serum HBV DNA ≥ 100,000 copies/mL, and plasma HIV-1 RNA ≤ 10,000 copies/mL. This study closed early based on results of a prespecified interim review, as the primary noninferiority end point had been met without safety issues. Fifty-two subjects were randomized. At baseline, 73% of subjects had a plasma HIV-1 RNA < 50 copies/mL, 86% were HBeAg positive, 94% were 3TC resistant, median serum ALT was 52 IU/L, and 98% had compensated liver disease. The mean time-weighted average change in serum HBV DNA from baseline to week 48 (DAVG48) was -4.44 log10 copies/mL for TDF and -3.21 log10 copies/mL for ADV. There was no difference in toxicity between the 2 treatment arms, with 11 subjects (5 ADV and 6 TDF) experiencing elevations of serum ALT on treatment. In conclusion, over 48 weeks, treatment with either ADV or TDF resulted in clinically important suppression of serum HBV DNA. Both drugs are safe and efficacious for patients coinfected with HBV and HIV.

Original languageEnglish (US)
Pages (from-to)1110-1116
Number of pages7
JournalHepatology
Volume44
Issue number5
DOIs
StatePublished - Nov 1 2006

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Tenofovir
Chronic Hepatitis B
Virus Diseases
Hepatitis B virus
HIV Infections
HIV
HIV-1
Serum
DNA
adefovir
RNA
Lamivudine
Hepatitis B e Antigens

ASJC Scopus subject areas

  • Hepatology

Cite this

Peters, M. G., Andersen, J., Lynch, P., Liu, T., Alston-Smith, B., Brosgart, C. L., ... Polsky, B. (2006). Randomized controlled study of tenofovir and adefovir in chronic hepatitis B virus and HIV infection: ACTG A5127. Hepatology, 44(5), 1110-1116. https://doi.org/10.1002/hep.21388

Randomized controlled study of tenofovir and adefovir in chronic hepatitis B virus and HIV infection : ACTG A5127. / Peters, Marion G.; Andersen, Janet; Lynch, Patrick; Liu, Tun; Alston-Smith, Beverly; Brosgart, Carol L.; Jacobson, Jeffrey M.; Johnson, Victoria A.; Pollard, Richard B.; Rooney, James F.; Sherman, Kenneth E.; Swindells, Susan; Polsky, Bruce.

In: Hepatology, Vol. 44, No. 5, 01.11.2006, p. 1110-1116.

Research output: Contribution to journalArticle

Peters, MG, Andersen, J, Lynch, P, Liu, T, Alston-Smith, B, Brosgart, CL, Jacobson, JM, Johnson, VA, Pollard, RB, Rooney, JF, Sherman, KE, Swindells, S & Polsky, B 2006, 'Randomized controlled study of tenofovir and adefovir in chronic hepatitis B virus and HIV infection: ACTG A5127', Hepatology, vol. 44, no. 5, pp. 1110-1116. https://doi.org/10.1002/hep.21388
Peters MG, Andersen J, Lynch P, Liu T, Alston-Smith B, Brosgart CL et al. Randomized controlled study of tenofovir and adefovir in chronic hepatitis B virus and HIV infection: ACTG A5127. Hepatology. 2006 Nov 1;44(5):1110-1116. https://doi.org/10.1002/hep.21388
Peters, Marion G. ; Andersen, Janet ; Lynch, Patrick ; Liu, Tun ; Alston-Smith, Beverly ; Brosgart, Carol L. ; Jacobson, Jeffrey M. ; Johnson, Victoria A. ; Pollard, Richard B. ; Rooney, James F. ; Sherman, Kenneth E. ; Swindells, Susan ; Polsky, Bruce. / Randomized controlled study of tenofovir and adefovir in chronic hepatitis B virus and HIV infection : ACTG A5127. In: Hepatology. 2006 ; Vol. 44, No. 5. pp. 1110-1116.
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abstract = "Chronic hepatitis B virus (HBV) infection is an important cause of morbidity and mortality in subjects coinfected with HIV. Tenofovir disoproxil fumarate (TDF) and adefovir dipivoxil (ADV) are licensed for the treatment of HIV-1 and HBV infection, respectively, but both have in vivo and in vitro activity against HBV. This study evaluated the anti-HBV activity of TDF compared to ADV in HIV/HBV-coinfected subjects. ACTG A5127 was a prospective randomized, double-blind, placebo-controlled trial of daily 10 mg of ADV versus 300 mg of TDF in subjects with HBV and HIV coinfection on stable ART, with serum HBV DNA ≥ 100,000 copies/mL, and plasma HIV-1 RNA ≤ 10,000 copies/mL. This study closed early based on results of a prespecified interim review, as the primary noninferiority end point had been met without safety issues. Fifty-two subjects were randomized. At baseline, 73{\%} of subjects had a plasma HIV-1 RNA < 50 copies/mL, 86{\%} were HBeAg positive, 94{\%} were 3TC resistant, median serum ALT was 52 IU/L, and 98{\%} had compensated liver disease. The mean time-weighted average change in serum HBV DNA from baseline to week 48 (DAVG48) was -4.44 log10 copies/mL for TDF and -3.21 log10 copies/mL for ADV. There was no difference in toxicity between the 2 treatment arms, with 11 subjects (5 ADV and 6 TDF) experiencing elevations of serum ALT on treatment. In conclusion, over 48 weeks, treatment with either ADV or TDF resulted in clinically important suppression of serum HBV DNA. Both drugs are safe and efficacious for patients coinfected with HBV and HIV.",
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