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- Title
Toxicity related to standard TB therapy for pulmonary tuberculosis and treatment outcomes in the REMoxTB study according to HIV status.
- Authors
Tweed, Conor D.; Crook, Angela M.; Dawson, Rodney; Diacon, Andreas H.; McHugh, Timothy D.; Mendel, Carl M.; Meredith, Sarah K.; Mohapi, Lerato; Murphy, Michael E.; Nunn, Andrew J.; Phillips, Patrick P. J.; Singh, Kasha P.; Spigelman, Melvin; Gillespie, Stephen H.
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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 < 0.01). Cure rates were similar, with 38 of 42 (90.5%) HIV-positive and 195 of 220 (88.6%) HIV-negative patients (p = 0.73) cured at 18 months.<bold>Conclusions: </bold>HIV-positive patients receiving standard TB therapy in the REMoxTB study were at greater risk of adverse events during treatment but cure rates were similar when compared to a matched sample of HIV-negative patients.
- Subjects
TUBERCULOSIS; HIV status; TREATMENT effectiveness; HIV-positive persons; ADVERSE health care events
- Publication
BMC Pulmonary Medicine, 2019, Vol 19, Issue 1, pN.PAG
- ISSN
1471-2466
- Publication type
journal article
- DOI
10.1186/s12890-019-0907-6