Randomized controlled study of tenofovir and adefovir in chronic hepatitis B virus and HIV infection: ACTG A5127.

TitleRandomized controlled study of tenofovir and adefovir in chronic hepatitis B virus and HIV infection: ACTG A5127.
Publication TypeJournal Article
Year of Publication2006
AuthorsPeters 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
Corporate AuthorsACTG Protocol A5127 Team
JournalHepatology
Volume44
Issue5
Pagination1110-6
Date Published2006 Nov
ISSN0270-9139
KeywordsAdenine, Adult, Alanine Transaminase, Anti-HIV Agents, Antiviral Agents, DNA, Viral, Double-Blind Method, Female, Hepatitis B, Chronic, HIV Infections, HIV-1, Humans, Male, Middle Aged, Organophosphonates, Tenofovir, Treatment Outcome
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

DOI10.1002/hep.21388
Alternate JournalHepatology
PubMed ID17058225
PubMed Central IDPMC4114764
Grant List3U01AI38858-09S1 / AI / NIAID NIH HHS / United States
5 UO1 A1027665-18 / / PHS HHS / United States
AI-27668 / AI / NIAID NIH HHS / United States
AI25868 / AI / NIAID NIH HHS / United States
AI25915 / AI / NIAID NIH HHS / United States
AI32770 / AI / NIAID NIH HHS / United States
AI32782 / AI / NIAID NIH HHS / United States
AI38855 / AI / NIAID NIH HHS / United States
AI46370 / AI / NIAID NIH HHS / United States
AI46386 / AI / NIAID NIH HHS / United States
AI50410 / AI / NIAID NIH HHS / United States
M01-RR00096 / RR / NCRR NIH HHS / United States
P30 AI27767 / AI / NIAID NIH HHS / United States
P30 DK 26743 / DK / NIDDK NIH HHS / United States
P30 DK026743 / DK / NIDDK NIH HHS / United States
RR-00052 / RR / NCRR NIH HHS / United States
RR00046 / RR / NCRR NIH HHS / United States
RR00047 / RR / NCRR NIH HHS / United States
RR00051 / RR / NCRR NIH HHS / United States
U01 AI069502 / AI / NIAID NIH HHS / United States
U01AI38858 / AI / NIAID NIH HHS / United States