Tenofovir-based regimens improve outcomes in HIV-HBV co-infection

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

Thio CL, Smeaton L, Hollabaugh K, Saulynas M, Hwang H, Saravanan S, Kulkarni S, Hakim J, Nyirenda M, Iqbal HS, Lalloo UG, Campbell TB, Lockman S, Currier JS. AIDS. 2015 Jun 19;29(10):1173-82. doi: 10.1097/QAD.0000000000000686.

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.

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Editor’s notes: Hepatitis B virus infection remains a leading cause of preventable morbidity and mortality globally, through cirrhosis and liver cancer. In settings with a high prevalence of HIV-HBV coinfection, there is an opportunity to optimise clinical management within the public health approach to antiretroviral therapy. This study adds to the evidence base suggesting that antiretroviral regimens containing lamivudine/emtricitabine and tenofovir are associated with better virologic outcomes than regimens without tenofovir for people co-infected with HIV and HBV. In this study, a post hoc analysis of two multicentre randomised controlled trials, regimens with two HBV-active agents provided more durable virologic suppression and limited the emergence of lamivudine-resistant HBV strains. Although recommendations about the treatment of HIV-HBV coinfection are incorporated into WHO antiretroviral guidelines, testing for HBV infection within antiretroviral programmes is still uncommon and tenofovir is not universally employed in standard first-line antiretroviral regimens. With an increasing number of people switching to second-line antiretroviral regimens, there is the additional challenge of identifying HBV infection in order to maintain HBV-active agents within the second-line regimen. There is now a need for better evidence around how to operationalise these recommendations within national antiretroviral programmes.        

Comorbidity, HIV Treatment
Africa, Asia, Latin America
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