Toxicity related to standard TB therapy for pulmonary tuberculosis and treatment outcomes in the REMoxTB study according to HIV status
| Autor: | Conor D. Tweed, Patrick P. J. Phillips, Kasha P. Singh, Sarah Meredith, Rodney Dawson, Andrew J. Nunn, Andreas H. Diacon, Timothy D. McHugh, Mendel Carl M, Michael E. P. Murphy, Melvin Spigelman, Stephen H. Gillespie, Lerato Mohapi, Angela M. Crook |
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| Přispěvatelé: | University of St Andrews. School of Medicine, University of St Andrews. Sir James Mackenzie Institute for Early Diagnosis, University of St Andrews. Centre for Biophotonics, University of St Andrews. Biomedical Sciences Research Complex, University of St Andrews. Infection and Global Health Division, University of St Andrews. Global Health Implementation Group, University of St Andrews. Gillespie Group, University of St Andrews. Infection Group |
| Rok vydání: | 2019 |
| Předmět: |
Male
MedDRA Respiratory System Antitubercular Agents E-DAS Cardiorespiratory Medicine and Haematology Clinical trials 0302 clinical medicine RA0421 Risk Factors RA0421 Public health. Hygiene. Preventive Medicine HIV Seropositivity Medicine Prospective Studies 030212 general & internal medicine 0303 health sciences Incidence Incidence (epidemiology) Hazard ratio 1. No poverty Pulmonary 3. Good health Treatment Outcome Infectious Diseases 6.1 Pharmaceuticals Toxicity HIV/AIDS Female Patient Safety Rifampin Infection Ethambutol Research Article Adult Pulmonary and Respiratory Medicine medicine.medical_specialty Tuberculosis Clinical Trials and Supportive Activities 03 medical and health sciences Rare Diseases SDG 3 - Good Health and Well-being Clinical Research Internal medicine Isoniazid Humans Adverse effect Tuberculosis Pulmonary lcsh:RC705-779 030306 microbiology business.industry Prevention HIV Evaluation of treatments and therapeutic interventions lcsh:Diseases of the respiratory system medicine.disease Pyrazinamide United Kingdom Clinical trial Good Health and Well Being Adverse events Multivariate Analysis Linear Models Hiv status business |
| Zdroj: | BMC pulmonary medicine, vol 19, iss 1 BMC Pulmonary Medicine, Vol 19, Iss 1, Pp 1-9 (2019) BMC Pulmonary Medicine |
| ISSN: | 1471-2466 |
| Popis: | Supported by the Global Alliance for TB Drug Development with support from the Bill and Melinda Gates Foundation, the European and Developing Countries Clinical Trials Partnership (grant IP.2007.32011.011), U.S. Agency for International Development, U.K. Department for International Development, Directorate General for International Cooperation of the Netherlands, Irish Aid, Australia Department of Foreign Affairs and Trade, and National Institutes of Health, AIDS Clinical Trials Group and by grants from the National Institute of Allergy and Infectious Diseases (NIAID) (UM1AI068634, UM1 AI068636, and UM1AI106701) and by NIAID grants to the University of KwaZulu Natal, South Africa, AIDS Clinical Trials Group (ACTG) site 31422 (1U01AI069469); to the Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, South Africa, ACTG site 12301 (1U01AI069453); and to the Durban International Clinical Trials Unit, South Africa, ACTG site 11201 (1U01AI069426); Bayer Healthcare for the donation of moxifloxacin; and Sanofi for the donation of rifampin. Background: The phase III REMoxTB study prospectively enrolled HIV-positive (with CD4+ count > 250 cells, not on anti-retroviral therapy) and HIV-negative patients. We investigated the incidence of adverse events and cure rates according to HIV status for patients receiving standard TB therapy in the trial. Methods: Forty-two HIV-positive cases were matched to 220 HIV-negative controls by age, gender, ethnicity, and trial site using coarsened exact matching. Grade 3 and 4 adverse events (AEs) were summarised by MedDRA System Organ Class. Kaplan-Meier curves for time to first grade 3 or 4 AE were constructed according to HIV status with hazard ratios calculated. Patients were considered cured if they were culture negative 18 months after commencing therapy with ≥2 consecutive negative culture results. Results: Twenty of 42 (47.6%) HIV-positive and 34 of 220 (15.5%) HIV-negative patients experienced ≥1 grade 3 or 4 AE, respectively. The majority of these were hepatobiliary disorders that accounted for 12 of 40 (30.0%) events occurring in 6 of 42 (14.3%) HIV-positive patients and for 15 of 60 (25.0%) events occurring in 9 of 220 (4.1%) HIV-negative patients. The median time to first grade 3 or 4 AE was 54 days (IQR 15.5–59.0) for HIV-positive and 29.5 days (IQR 9.0–119.0) for HIV-negative patients, respectively. The hazard ratio for experiencing a grade 3 or 4 AE among HIV-positive patients was 3.25 (95% CI 1.87–5.66, p |
| Databáze: | OpenAIRE |
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