Comparison of HBV-active HAART regimens in an HIV–HBV multinational cohort
Year: 2015
Type: article
Abstract: OBJECTIVES: To explore factors associated with short and long-term hepatitis B virus (HBV) DNA suppression in a multinational cohort of HIV-HBV co-infected patients receiving HBV-active antiretrovirals. METHODS: One hundred and fifteen HIV-HBV co-infected patients participating in one of the two global randomized clinical trials conducted by the Adult AIDS Clinical Trials Group of different antiretroviral regimens received either HBV monotherapy with either lamivudine or emtricitabine (N = 56), or HBV dual therapy with tenofovir disoproxil fumarate (TDF) + lamivudine or emtricitabine (N = 59). Associations of pretreatment characteristics with the primary (HBV DNA <200 IU/ml at 24 weeks) and longitudinal outcomes through 144 weeks were explored using logistic regression. HBV drug-resistance mutations were determined by pol sequencing in those with viral rebound. RESULTS: The proportion with HBV DNA below 200 IU/ml was 60% (95% confidence interval 50-69%) at 24 weeks and 79% (95% confidence interval 69-88%) at 144 weeks. Pretreatment factors associated with the primary outcome were HBV DNA, CD4 T-cell count, and aspartate aminotransferase, but only pretreatment HBV DNA remained associated with long-term suppression (P < 0.0001). HBV therapy group was not significantly associated with the primary outcome at 24 weeks; however, longitudinally, a greater proportion in the dual-therapy group achieved HBV DNA below 200 IU/ml (P = 0.007). A higher proportion of hepatitis B e antigen-negative patients (n = 57) achieved HBV DNA below 200 IU/ml at any point, regardless of the therapy group. All 12 patients with emergence of lamivudine-resistant mutants were in the monotherapy group. CONCLUSIONS: TDF-based dual HBV-active antiretroviral therapy is preferred to treat HIV-HBV co-infected patients. In resource-limited settings in which TDF may not be universally available, lamivudine or emtricitabine HBV monotherapy is a reasonable option in patients with low HBV replication.
Source: AIDS
Institutions: Johns Hopkins University, Voluntary Health Services Hospital, University of KwaZulu-Natal, Harvard University, YR Gaitonde Centre for AIDS Research and Education, National AIDS Research Institute, University of Zimbabwe, University of Colorado Anschutz, Brigham and Women's Hospital, University of California, Los Angeles
Language: English
Topic: Hepatitis B Virus Studies
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: G1014144513, Units for HIV/AIDS Clinical Trials Networks, The Ohio State University AIDS Clinical Trials Unit, G1277947574, University of Cincinnati AIDS Clinical Trials Unit- UC ACTU, The Ohio State University AIDS Clinical Trials Unit, G1346130624, G1380633192, National AIDS Research Institute (NARI), Pune, INDIA: Clinical Trials Unit, G1479152345, G1525219707, G161582775, WASHINGTON UNIVERSITY AIDS CLINICAL TRIALS UNIT, G16708505, U.T. SOUTHWESTERN ADULT AIDS CLINICAL TRIALS UNIT, G1788832858, G185513119, Vanderbilt HIV Clinical Trials Unit, G193111053, The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit (FioTrials), G2069435444, G2135258891, University of North Carolina AIDS Clinical Trials Unit (UNC ACTU), UNIVERSITY OF SOUTHERN CALIFORNIA CLINICAL TRIALS UNIT, Optimizing Antiretroviral Therapy in HIV , ADULT AIDS CLINICAL TRIALS UNIT, Cornell Clinical Trials Unit, G3206835426, G3277483280, G3518260571, G3525517067, AIDS Clinical Trials Group Network, UCLA AIDS Prevention and Treatment Clinical Trials Unit, UCLA Los Angeles Brazil AIDS Consortium, G3810609436, ADULT THERAPEUTIC CLINICAL TRIALS PROGRAM FOR AIDS, Philadelphia IMPAACT Clinical Trials Unit, G4205250407, Northwestern University Clinical Trial Unit, Colorado AIDS Clinical Trials Unit, Durban International Clinical Trials Unit, Units for HIV/AIDS Clinical Trials Networks, Liver Cancer and the Role of Protein Hyper-Fucosylation, G5173677171, ADULT THERAPEUTIC CLINICAL TRIALS PROGRAM IN AIDS, GHESKIO HIV Clinical Trial Unit, G5332695360, The University of Rochester Clinical and Translational Science Institute, ADULT ACTG CENTRAL GROUP, Botswana-Harvard School of Public Health AIDS Initiative Partnership CTU, G5492247610, G5588634031, G5719048818, G5725406765, Statistical and Data Management Center for the AIDS Clinical Trials Group, UCSD Department of Medicine HIV/AIDS Clinical Trials Unit, G5900455136, ADULT AIDS CLINICAL TRIAL UNIT, G6103943158, Philadelphia IMPAACT Clinical Trials Unit, UNIVERSITY OF SOUTHERN CALIFORNIA CLINICAL TRIALS UNIT, UZ-UCSF Clinical Trials Unit, Partners Healthcare Systems/Harvard Medical School/Boston Medical Center AIDS CTU, UNC Clinical and Translational Science Award, University of Cincinnati AIDS Clinical Trials Unit- UC ACTU, The Malawi Clinical Trials Unit, Colorado AIDS Clinical Trials Unit, THE IMPACTA PERU CLINICAL TRIALS UNIT, Partners Healthcare Systems/Harvard Medical School/Boston Medical Center AIDS CTU, Clinical and Translational Science Center, Columbia Collaborative HIV/AIDS Clinical Trials Unit, HAWAII ACTU - ADULT THERAPEUTIC CLINICAL TRIALS PROGRAM, G749807406, HIV/AIDS Clinical Trials Unit, G766489020, Hepatitis B treatment and HIV Infection in resources limited settings, G7754564054, Identification of Altered Glycan and Glycoproteins in Viral Induced Liver Cancer, G83299872, HIV/AIDS Clinical Trials Unit, ADULT THERAPEUTIC CLINICAL TRIALS PROGRAM FOR HIV/AIDS, Chiang Mai University HIV/AIDS Clinical Trials Unit, Clinical and Translational Science Center (UL1), Weill Cornell Medicine - Rutgers New Jersey Medical School Clinical Trials Unit, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, Chicago Clinical Trials Unit, Botswana-Harvard T.H. Chan School of Public Health AIDS Initiative Partnership CTU, The Johns Hopkins University-Blantyre Clinical Trials Unit, Statistical and Data Management Center (SDMC), Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG), Penn Center for AIDS Research, The University of North Carolina Center for AIDS Research, University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit, UCLA AIDS Prevention and Treatment Clinical Trials Unit, Vanderbilt HIV Clinical Trials Unit (CTU), G967473426
OpenAlex ID: W650409306