| Author | Gupta, Amita | |
| Author | Sun, Xin | |
| Author | Krishnan, Sonya | |
| Author | Matoga, Mitch | |
| Author | Pierre, Samuel | |
| Author | McIntire, Katherine | |
| Author | Koech, Lucy | |
| Author | Faesen, Sharlaa | |
| Author | Kityo, Cissy | |
| Author | Dadabhai, Sufia S. | |
| Author | Naidoo, Kogieleum | |
| Author | Samaneka, Wadzanai P. | |
| Author | Lama, Javier R. | |
| Author | Veloso, Valdiléa G. | |
| Author | Mave, Vidya | |
| Author | Lalloo, Umesh | |
| Author | Langat, Deborah | |
| Author | Hogg, Evelyn | |
| Author | Bisson, Gregory P. | |
| Author | Kumwenda, Johnstone | |
| Author | Hosseinipour, Mina C. | |
| Access date | 2024-05-22T00:16:46Z | |
| Available date | 2024-05-22T00:16:46Z | |
| Document date | 2022 | |
| Citation | GUPTA, Amita et al. Isoniazid Adherence Reduces Mortality and Incident Tuberculosis at 96 Weeks Among Adults Initiating Antiretroviral Therapy With Advanced Human Immunodeficiency Virus in Multiple High-Burden Settings. Open Forum Infectious Diseases, v. 9, n. 7, p. 1-9, Jul. 2022. | en_US |
| ISSN | 2328-8957 | en_US |
| URI | https://www.arca.fiocruz.br/handle/icict/64177 | |
| Description | ACTG A5274/REMEMBER Study Team. | en_US |
| Sponsorship | This work was funded by the US National Institutes of Health, National Institute of Allergy and Infectious Diseases through the AIDS Clinical Trials Group (Grants AI68636, AI069450, and UM1 AI068634) and the US National Institutes of Health, National Institute of Allergy and Infectious Diseases (Grant UM1AI069465; to A. G.). S. K. was funded by the National Institutes of Health (Grant T32 AI007291-27). Pharmaceutical support was provided by Gilead Sciences. | en_US |
| Language | eng | en_US |
| Publisher | Oxford | en_US |
| Rights | open access | en_US |
| Title | Isoniazid Adherence Reduces Mortality and Incident Tuberculosis at 96 Weeks Among Adults Initiating Antiretroviral Therapy With Advanced Human Immunodeficiency Virus in Multiple High-Burden Settings | en_US |
| Type | Article | en_US |
| DOI | 10.1093/ofid/ofac325 | |
| Abstract | Background: People with human immunodeficiency virus (HIV) and advanced immunosuppression initiating antiretroviral therapy (ART) remain vulnerable to tuberculosis (TB) and early mortality. To improve early survival, isoniazid preventive therapy (IPT) or empiric TB treatment have been evaluated; however, their benefit on longer-term outcomes warrants investigation. Methods: We present a 96-week preplanned secondary analysis among 850 ART-naive outpatients (≥13 years) enrolled in a multicountry, randomized trial of efavirenz-containing ART plus either 6-month IPT (n = 426) or empiric 4-drug TB treatment (n = 424). Inclusion criteria were CD4 count <50 cells/mm3 and no confirmed or probable TB. Death and incident TB were compared by strategy arm using the Kaplan-Meier method. The impact of self-reported adherence (calculated as the proportion of 100% adherence) was assessed using Cox-proportional hazards models. Results: By 96 weeks, 85 deaths and 63 TB events occurred. Kaplan-Meier estimated mortality (10.1% vs 10.5%; P = .86) and time-to-death (P = .77) did not differ by arm. Empiric had higher TB risk (6.1% vs 2.7%; risk difference, -3.4% [95% confidence interval, -6.2% to -0.6%]; P = .02) and shorter time to TB (P = .02) than IPT. Tuberculosis medication adherence lowered the hazards of death by ≥23% (P < .0001) in empiric and ≥20% (P < .035) in IPT and incident TB by ≥17% (P ≤ .0324) only in IPT. Conclusions: Empiric TB treatment offered no longer-term advantage over IPT in our population with advanced immunosuppression initiating ART. High IPT adherence significantly lowered death and TB incidence through 96 weeks, emphasizing the benefit of ART plus IPT initiation and completion, in persons with advanced HIV living in high TB-burden, resource-limited settings. | en_US |
| Affilliation | Johns Hopkins University. Baltimore, Maryland, USA. | en_US |
| Affilliation | Harvard T.H. Chan School of Public Health. Boston, Massachusetts, USA. | en_US |
| Affilliation | Johns Hopkins University. Baltimore, Maryland, USA. | en_US |
| Affilliation | UNC Project. Lilongwe, Malawi. | en_US |
| Affilliation | Les Centres GHESKIO. Port-Au-Prince, Haiti. | en_US |
| Affilliation | Johns Hopkins University. Baltimore, Maryland, USA. | en_US |
| Affilliation | Kenya Medical Research Institute/Walter Reed Project. Kericho, Kenya. | en_US |
| Affilliation | University of Witwatersrand. Faculty of Health Sciences. Clinical HIV Research Unit. Johannesburg, South Africa. | en_US |
| Affilliation | Joint Clinical Research Centre. Kampala, Uganda. | en_US |
| Affilliation | Johns Hopkins University. Baltimore, Maryland, USA. | en_US |
| Affilliation | Centre for the AIDS Programme of Research in South Africa. Durban, South Africa. | en_US |
| Affilliation | University of Zimbabwe Clinical Trials Research Centre. Harare, Zimbabwe. | en_US |
| Affilliation | Asociacion Civil Impacta Salud y Educacion. Lima, Peru. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Johns Hopkins University. Baltimore, Maryland, USA. | en_US |
| Affilliation | Enhancing Care Foundation. Durban University of Technology. Durban, South Africa. | en_US |
| Affilliation | Kenya Medical Research Institute/Walter Reed Project. Kericho, Kenya. | en_US |
| Affilliation | Social & Scientific Systems. Inc., a DLH Holdings Company. Silver Spring, Maryland, USA. | en_US |
| Affilliation | University of Pennsylvania Perelman School of Medicine. Philadelphia, Pennsylvania, USA. | en_US |
| Affilliation | University of Malawi. Department of Medicine. Zomba, Malawi. | en_US |
| Affilliation | Les Centres GHESKIO. Port-Au-Prince, Haiti. | en_US |
| Subject | Isoniazid adherence | en_US |
| Subject | Isoniazid preventive therapy | en_US |
| Subject | Strategy trial | en_US |
| Subject | Tuberculosis and HIV | en_US |
| Subject | Tuberculosis prophylaxis | en_US |
| e-ISSN | 2328-8957 | |
