Browsing by Author "Kumarasamy N"

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Empirical tuberculosis therapy versus isoniazid in adult outpatients with advanced HIV initiating antiretroviral therapy (REMEMBER): a multicountry open-label randomised controlled trial.
(2016-Mar-19) Hosseinipour MC; Bisson GP; Miyahara S; Sun X; Moses A; Riviere C; Kirui FK; Badal-Faesen S; Lagat D; Nyirenda M; Naidoo K; Hakim J; Mugyenyi P; Henostroza G; Leger PD; Lama JR; Mohapi L; Alave J; Mave V; Veloso VG; Pillay S; Kumarasamy N; Bao J; Hogg E; Jones L; Zolopa A; Kumwenda J; Gupta A; Centre for Infectious Diseases Research in Zambia, Lusaka, Zambia.; Perelman School of Medicine at the University of Pennsylvania, PA, USA.; Durban International CRS, Durban University of Technology, Durban, South Africa.; UNC Project, Lilongwe, Malawi.; GHESKIO, Port-au-Prince, Haiti.; BJ Medical College-Johns Hopkins Clinical Trials Unit, Pune, India.; Joint Clinical Research Centre, Kampala, Uganda.; Harvard University, Boston, MA, USA.; YRGCARE Medical Centre, VHS, Chennai, India.; Johns Hopkins Project, Blantyre, Malawi.; Johns Hopkins University School of Medicine, Baltimore, MD, USA.; Frontier Science, Buffalo, NY, USA.; Perinatal HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa.; Asociacion Civil Impacta Salud y Educacion, Lima, Peru.; UNC Project, Lilongwe, Malawi; University of North Carolina School of Medicine, Chapel Hill, NC, USA. Electronic address: mina_hosseinipour@med.unc.edu.; HJF-DAIDS, a Division of The Henry M Jackson Foundation for the Advancement of Military Medicine, Contractor to National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.; Moi University School of Medicine, Eldoret, Kenya.; Centre for the AIDS Programme of Research in South Africa, Durban, South Africa.; Stanford University, Palo Alto, CA, USA.; Evandro Chagas National Institute of Infectious Diseases/Fiocruz, Rio de Janeiro, Brazil.; Kenya Medical Research Institute, Kisumu, Kenya.; Social and Scientific Systems, Silver Spring, MD, USA.; Clinical HIV Research Unit, Department of Medicine, University of Witwatersrand, Johannesburg, South Africa.; University of Zimbabwe, Harare, Zimbabwe.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
BACKGROUND: Mortality within the first 6 months after initiating antiretroviral therapy is common in resource-limited settings and is often due to tuberculosis in patients with advanced HIV disease. Isoniazid preventive therapy is recommended in HIV-positive adults, but subclinical tuberculosis can be difficult to diagnose. We aimed to assess whether empirical tuberculosis treatment would reduce early mortality compared with isoniazid preventive therapy in high-burden settings. METHODS: We did a multicountry open-label randomised clinical trial comparing empirical tuberculosis therapy with isoniazid preventive therapy in HIV-positive outpatients initiating antiretroviral therapy with CD4 cell counts of less than 50 cells per μL. Participants were recruited from 18 outpatient research clinics in ten countries (Malawi, South Africa, Haiti, Kenya, Zambia, India, Brazil, Zimbabwe, Peru, and Uganda). Individuals were screened for tuberculosis using a symptom screen, locally available diagnostics, and the GeneXpert MTB/RIF assay when available before inclusion. Study candidates with confirmed or suspected tuberculosis were excluded. Inclusion criteria were liver function tests 2·5 times the upper limit of normal or less, a creatinine clearance of at least 30 mL/min, and a Karnofsky score of at least 30. Participants were randomly assigned (1:1) to either the empirical group (antiretroviral therapy and empirical tuberculosis therapy) or the isoniazid preventive therapy group (antiretroviral therapy and isoniazid preventive therapy). The primary endpoint was survival (death or unknown status) at 24 weeks after randomisation assessed in the intention-to-treat population. Kaplan-Meier estimates of the primary endpoint across groups were compared by the z-test. All participants were included in the safety analysis of antiretroviral therapy and tuberculosis treatment. This trial is registered with ClinicalTrials.gov, number NCT01380080. FINDINGS: Between Oct 31, 2011, and June 9, 2014, we enrolled 850 participants. Of these, we randomly assigned 424 to receive empirical tuberculosis therapy and 426 to the isoniazid preventive therapy group. The median CD4 cell count at baseline was 18 cells per μL (IQR 9-32). At week 24, 22 (5%) participants from each group died or were of unknown status (95% CI 3·5-7·8) for empirical group and for isoniazid preventive therapy (95% CI 3·4-7·8); absolute risk difference of -0·06% (95% CI -3·05 to 2·94). Grade 3 or 4 signs or symptoms occurred in 50 (12%) participants in the empirical group and 46 (11%) participants in the isoniazid preventive therapy group. Grade 3 or 4 laboratory abnormalities occurred in 99 (23%) participants in the empirical group and 97 (23%) participants in the isoniazid preventive therapy group. INTERPRETATION: Empirical tuberculosis therapy did not reduce mortality at 24 weeks compared with isoniazid preventive therapy in outpatient adults with advanced HIV disease initiating antiretroviral therapy. The low mortality rate of the trial supports implementation of systematic tuberculosis screening and isoniazid preventive therapy in outpatients with advanced HIV disease. FUNDING: National Institutes of Allergy and Infectious Diseases through the AIDS Clinical Trials Group.
Global trends in CD4 count measurement and distribution at first antiretroviral treatment initiation.
(2024-Nov-06) de Waal R; Wools-Kaloustian K; Brazier E; Althoff KN; Jaquet A; Duda SN; Kumarasamy N; Savory T; Byakwaga H; Murenzi G; Justice A; Ekouevi DK; Cesar C; Pasayan MKU; Thawani A; Kasozi C; Babakazo P; Karris M; Messou E; Cortes CP; Kunzekwenyika C; Choi JY; Owarwo NC; Niyongabo A; Marconi VC; Ezechi O; Castilho JL; Petoumenos K; Johnson L; Ford N; Kassanjee R; Department of Medicine, University of California San Diego, USA.; Institute for Implementation Science in Population Health, City University of New York, USA.; National Institute for Health and Medical Research UMR 1219, Research Institute for Sustainable Development EMR 271, Bordeaux Population Health Research Centre, University of Bordeaux, France.; Centre for Infectious Disease Epidemiology and Research, School of Public Health, University of Cape Town, South Africa. CIDER, Level 3 Falmouth Building, Anzio Road, Observatory, 7925, South Africa.; Association Nationale de Soutien aux Séropositifs et malades du SIDA-Santé PLUS (ANSS-Santé PLUS), Burundi.; Kinshasa School of Public Health, University of Kinshasa, Democratic Republic of Congo.; Centre for Reproduction and Population Health Studies, Nigerian Institute for Medical Research, Lagos, Nigeria.; Infectious Diseases Medical Centre, CART CRS, Voluntary Health Services, Chennai, India.; Fundacion Huesped, Argentina.; Emory University School of Medicine and Rollins School of Public Health, Atlanta, USA.; Research for Development (RD Rwanda), and Rwanda Military Referral and Teaching Hospital, Kigali, Rwanda.; Research Institute for Tropical Medicine, Muntinlupa City, Philippines.; Université de Lomé, Centre de Formation et de Recherche en Santé Publique, Lomé, Togo.; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, USA.; Department of Internal Medicine, Faculty of Medicine, University of Chile, and Hospital Clínico San Borja Arriarán & Fundación Arriarán, Santiago, Chile.; Department of Biomedical Informatics, Vanderbilt University Medical Center, USA.; VA Connecticut Healthcare System, Yale Schools of Medicine and Public Health, Yale University, USA.; Department of Community Health, Mbarara University of Science and Technology, Uganda.; Division of Infectious Diseases, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.; The Kirby Institute, University of New South Wales, Sydney, Australia.; Lighthouse Trust, Lilongwe, Malawi.; Centre de Prise en charge, de Recherche et de Formation (CePReF) Yopougon-Attié, Abidjan, Côte d'Ivoire.; Department of Global HIV, Hepatitis and STI Programmes, World Health Organization, Geneva, Switzerland.; SolidarMed Zimbabwe.; Infectious Diseases Institute, Makerere University, Uganda.; Division of Infectious Diseases, Vanderbilt University Medical Center, TN, USA.; Masaka Regional Referral Hospital, Masaka City, Uganda.; Department of Medicine, Indiana University School of Medicine, USA.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
BACKGROUND: While people with HIV (PWH) start antiretroviral treatment (ART) regardless of CD4 count, CD4 measurement remains crucial for detecting advanced HIV disease and evaluating ART programmes. We explored CD4 measurement (proportion of PWH with a CD4 result available) and prevalence of CD4 <200 cells/µL at ART initiation within the International epidemiology Databases to Evaluate AIDS (IeDEA) global collaboration. METHODS: We included PWH at participating ART programmes who first initiated ART at age 15-80 years during 2005-2019. We described proportions of PWH (i) with CD4 (measured within 6 months before to 2 weeks after ART initiation); and (ii) among those with a CD4, with CD4 <200; by year of ART initiation and region. RESULTS: We included 1,355,104 PWH from 42 countries in 7 regions; 63% were female. Median (interquartile range) age at ART initiation was 37 (31-44) in men and 32 (26-39) in women. CD4 measurement initially increased, or remained stable over time until around 2013, but then declined to low levels in some regions (Southern Africa, except South Africa: from 54 to 13%; East Africa 85 to 31%; Central Africa 72 to 20%; West Africa: 91 to 53%; and Latin America: 87 to 56%). Prevalence of CD4<200 declined over time in all regions, but plateaued after 2015 at ≥30%. CONCLUSIONS: CD4 measurement has declined sharply in recent years, especially in sub-Saharan Africa. Among those with a CD4, the prevalence of CD4 <200 remains concerningly high. Scaling up CD4 testing and securing adequate funding are urgent priorities.
The long-term impact of the COVID-19 pandemic on tuberculosis care and infection control measures in anti-retroviral therapy (ART) clinics in low- and middle-income countries: a multiregional site survey in Asia and Africa.
(2025-Mar-24) Ballif M; Banholzer N; Perrig L; Avihingsanon A; Nsonde DM; Obatsa S; Muula G; Komena E; Uemura H; Lelo P; Otaalo B; Huwa J; Gouéssé P; Kumarasamy N; Brazier E; Michael D; Rafael I; Ramdé R; Somia IKA; Yotebieng M; Diero L; Euvrard J; Ezechi O; Fenner L; City University of New York, Institute for Implementation Science in Population Health, New York, NY, USA.; Pediatric Hospital of Kalembelembe, Kinshasa, Democratic Republic of the Congo.; Centre for Reproduction and Population Health Studies, Nigerian Institute of Medical Research, Lagos, Nigeria.; HIV-NAT / Thai Red Cross AIDS Research Centre and Center of Excellence in Tuberculosis, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.; Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.; Infectious Diseases Institute, Makerere University College of Health Sciences, Kampala, Uganda.; Centre for Microbiology and Research, Kenya Medical Research Institute, Kisumu, Kenya.; School of Public Health, University of Cape Town, Cape Town, South Africa.; Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine, Bronx, NY, USA.; CHU Sourô Sanou, Bobo-Dioulasso, Burkina Faso.; PAC-CI program, Abidjan, Côte d'Ivoire.; Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland lukas.fenner@unibe.ch.; Department of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland.; CART Clinical Research Site, Voluntary Health Services, Chennai, India.; SolidarMed, Chiure, Mozambique.; Lighthouse Trust, Lilongwe, Malawi.; Kisesa Observation Cohort study, National Institute for Medical Reseach, Mwanza, Tanzania.; Faculty of Medicine, Udayana University, Ngoerah Hospital, Bali, Indonesia.; Centre de Traitement Ambulatoire, Brazzaville, Republic of Congo.; Department of Medicine, Moi University, AMPATH Program / Moi Teaching and Referral Hospital, Eldoret, Kenya.; CePReF, Abidjan, Côte d'Ivoire.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
BACKGROUND: The COVID-19 pandemic challenged healthcare systems, particularly in settings with high infectious disease burden. We examined the postpandemic long-term impacts of COVID-19 on tuberculosis (TB) services at anti-retroviral therapy (ART) clinics in lower-income countries. METHODS: Using standardised online questionnaires, we conducted a cross-sectional site survey among ART clinics providing TB services in Africa and Asia from July to September 2023 (site-level information and number of TB diagnoses and tests). RESULTS: Of 45 participating ART clinics, 32 (71%) were in Africa and 13 (29%) in Asia. During the COVID-19 pandemic (2020-2022), 43 (96%) clinics reported implementing social distancing or separation measures, 39 (87%) personal protections for staff members and 32 (71%) protections for patients. Infection control measures were in place in 45% of the clinics before the pandemic (until 2019), 23% introduced measures during the pandemic and 15% maintained them after the pandemic (after 2022). Service provision was affected during the pandemic in 33 (73%) clinics, including TB services in 22 (49%) clinics. TB service restrictions were addressed by introducing changes in directly observed therapy provision in 8 (18%) clinics, multimonth TB drug dispensing in 23 (51%), telehealth services in 25 (56%) and differentiated service delivery in 19 (42%). These changes were sustained after the pandemic at 4 (9%), 11 (24%), 17 (38%) and 12 (27%) clinics, respectively. Compared with 2018-2019, the number of TB diagnoses decreased sharply in 2020-2021 and improved after the pandemic. CONCLUSIONS: COVID-19 affected TB care services in ART clinics in Africa and Asia. This was paralleled by a reduction in TB diagnoses, which partly resumed after the pandemic. Infection control measures and alternative modes of service delivery were adopted during the pandemic and only partially maintained. Efforts should be made to sustain the lessons learnt during the COVID-19 pandemic, particularly approaches that reduce the risk of transmission of infectious diseases, including TB, in ART clinics.