Gérard-Menan Kouamé1,2, Anders Boyd3, Raoul Moh1,2,4, Anani Badje1,2, Delphine Gabillard1,2, Eric Ouattara1,2,5, Jean-Baptiste Ntakpe1,2, Arlette Emième6, Sarah Maylin7, Mariama Abdou Chekaraou8, Serge-Paul Eholié1,2,4, Fabien Zoulim8, Karine Lacombe3, Xavier Anglaret1,2, Christine Danel1,2. 1. INSERM 1219, University of Bordeaux, France. 2. Programme PAC-CI, ANRS Research site, Abidjan, Côte d'Ivoire. 3. INSERM, UMR_S1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France. 4. Service des Maladies Infectieuses et Tropicale, Abidjan, Côte d'Ivoire. 5. Interdepartmental Centre of Tropical Medicine and Clinical International Health, Division of Infectious and Tropical Diseases, Department of Medicine, University Hospital Centre, Bordeaux. 6. CeDReS, CHU Treichville, Abidjan, Côte d'Ivoire. 7. Laboratoire de Virologie, Hopital Saint-Louis, Assistance Publique-Hopitaux de Paris. 8. Centre de Recherche sur le Cancer de Lyon, INSERM, Lyon University, Hospices Civils de Lyon, Lyon, France.
Abstract
Background: In human immunodeficiency virus (HIV)-infected patients, hepatitis B virus (HBV) coinfection increases the risk of disease progression. Tenofovir plus emtricitabine/lamivudine (TDF/XTC)-basedantiretroviral therapy (ART), which suppresses HIV and HBV replication, has the potential for decreasing this risk. Here, we analyze the association between HBV replication, early ART, and mortality in West African adults. Methods: The Temprano randomized controlled trial assessed the benefits of immediately initiating vs deferring ART in HIV-infected adults with high CD4 counts. After trial completion, participants continued follow-up in a posttrial phase. We analyzed the association between HBV status, immediate ART, and mortality over the entire trial and posttrial follow-up using multivariable Cox proportional hazards regression. Results: A total of 2052 HIV-infected adults (median baseline CD4 count, 464 cells/μL) were followed for 9394 person-years. At baseline, 1862 (91%) were HIV monoinfected and 190 (9%) HIV/HBV coinfected. Of the latter, 135 (71%) had plasma HBV DNA <2000IU/mL and 55 (29%) HBV DNA ≥2000 IU/mL. The 60-month probability of death was 11.8% (95% confidence interval [CI], 5.4%-24.5%) in coinfected patients with HBV DNA ≥2000 IU/mL; 4.4% (95% CI, 1.9%-10.4%) in coinfected patients with HBV DNA <2000 IU/mL; and 4.2% (95% CI, 3.3%-5.4%) in HIV-monoinfected patients. Adjusting for ART strategy (immediate vs deferred), the hazard ratio of death was 2.74 (95% CI, 1.26-5.97) in coinfected patients with HBV DNA ≥2000 IU/mL and 0.90 (95% CI, .36-2.24) in coinfected patients with HBV DNA <2000 IU/mL compared to HIV-monoinfected patients. There was no interaction between ART strategy and HBV status for mortality. Conclusions: African HIV/HBV-coinfected adults with high HBV replication remain at heightened risk of mortality in the early ART era. Further studies are needed to assess interventions combined with early ART to decrease mortality in this population. Clinical Trials Registration: NCT00495651.
RCT Entities:
Background: In human immunodeficiency virus (HIV)-infectedpatients, hepatitis B virus (HBV) coinfection increases the risk of disease progression. Tenofovir plus emtricitabine/lamivudine (TDF/XTC)-based antiretroviral therapy (ART), which suppresses HIV and HBV replication, has the potential for decreasing this risk. Here, we analyze the association between HBV replication, early ART, and mortality in West African adults. Methods: The Temprano randomized controlled trial assessed the benefits of immediately initiating vs deferring ART in HIV-infected adults with high CD4 counts. After trial completion, participants continued follow-up in a posttrial phase. We analyzed the association between HBV status, immediate ART, and mortality over the entire trial and posttrial follow-up using multivariable Cox proportional hazards regression. Results: A total of 2052 HIV-infected adults (median baseline CD4 count, 464 cells/μL) were followed for 9394 person-years. At baseline, 1862 (91%) were HIV monoinfected and 190 (9%) HIV/HBVcoinfected. Of the latter, 135 (71%) had plasma HBV DNA <2000 IU/mL and 55 (29%) HBV DNA ≥2000 IU/mL. The 60-month probability of death was 11.8% (95% confidence interval [CI], 5.4%-24.5%) in coinfectedpatients with HBV DNA ≥2000 IU/mL; 4.4% (95% CI, 1.9%-10.4%) in coinfectedpatients with HBV DNA <2000 IU/mL; and 4.2% (95% CI, 3.3%-5.4%) in HIV-monoinfectedpatients. Adjusting for ART strategy (immediate vs deferred), the hazard ratio of death was 2.74 (95% CI, 1.26-5.97) in coinfectedpatients with HBV DNA ≥2000 IU/mL and 0.90 (95% CI, .36-2.24) in coinfectedpatients with HBV DNA <2000 IU/mL compared to HIV-monoinfectedpatients. There was no interaction between ART strategy and HBV status for mortality. Conclusions: African HIV/HBV-coinfected adults with high HBV replication remain at heightened risk of mortality in the early ART era. Further studies are needed to assess interventions combined with early ART to decrease mortality in this population. Clinical Trials Registration: NCT00495651.
Authors: T P Goverwa-Sibanda; C Mupanguri; C Timire; A D Harries; S Ngwenya; E Chikwati; C Mapfuma; F Mushambi; H Tweya; M Ndlovu Journal: Public Health Action Date: 2020-09-21
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