Comparison of HBV-active HAART regimens in an HIV-HBV multinational cohort: outcomes through 144 weeks.

TitleComparison of HBV-active HAART regimens in an HIV-HBV multinational cohort: outcomes through 144 weeks.
Publication TypeJournal Article
Year of Publication2015
AuthorsThio CL, Smeaton L, Hollabaugh K, Saulynas M, Hwang H, Saravanan S, Kulkarni S, Hakim J, Nyirenda M, Iqbal HSyed, Lalloo UG, Campbell TB, Lockman S, Currier JS
JournalAIDS
Volume29
Issue10
Pagination1173-82
Date Published2015 Jun 19
ISSN1473-5571
KeywordsAdult, Antiretroviral Therapy, Highly Active, Antiviral Agents, Drug Resistance, Viral, Female, Hepatitis B virus, Hepatitis B, Chronic, HIV Infections, Humans, Longitudinal Studies, Male, Mutation, Treatment Outcome, Viral Load
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.

DOI10.1097/QAD.0000000000000686
Alternate JournalAIDS
PubMed ID26035319
PubMed Central IDPMC4535336
Grant List1U01AI069399-01 / AI / NIAID NIH HHS / United States
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