Severe adverse events during second-line tuberculosis treatment in the context of high HIV Co-infection in South Africa: a retrospective cohort study
dc.contributor.author | Schnippel, Kathryn | |
dc.contributor.author | Berhanu, Rebecca H | |
dc.contributor.author | Black, Andrew | |
dc.contributor.author | Firnhaber, Cynthia | |
dc.contributor.author | Maitisa, Norah | |
dc.contributor.author | Evans, Denise | |
dc.contributor.author | Sinanovic, Edina | |
dc.date.accessioned | 2021-10-08T06:20:28Z | |
dc.date.available | 2021-10-08T06:20:28Z | |
dc.date.issued | 2016 | |
dc.description.abstract | Abstract Background According to the World Health Organization, South Africa ranks as one of the highest burden of TB, TB/HIV co-infection, and drug-resistant TB (DR-TB) countries. DR-TB treatment is complicated to administer and relies on the use of multiple toxic drugs, with potential for severe adverse drug reactions. We report the occurrence of adverse events (AEs) during a standardised DR-TB treatment regimen at two outpatient, decentralized, public-sector sites in Johannesburg, South Africa. Methods We reviewed medical records of the six-month intensive treatment phase for rifampicin-resistant (RR) TB patients registered May 2012 - December 2014. Patients contributed follow-up time until death, loss from treatment, censoring (6 months) or data extraction. A standardized regimen of kanamycin, moxifloxacin, ethionamide, terizidone, and pyrazinamide was used according to national guidelines. AEs were graded using the AIDS Clinical Trial Group scale. We present subhazard ratios from competing risk analysis for time to severe AE, accounting for mortality and loss from treatment. Results Across the two sites, 578 eligible patient files were reviewed. 36.7 % were categorized as low weight (≤50 kg) at DR-TB initiation. 76.0 % had no history of TB treatment prior to the current episode of RR TB. 26.8 % were diagnosed with RR TB while hospitalized, indicating poor clinical condition. 82.5 % of patients were also HIV positive, of whom 43.8 % were on ART prior to RR TB treatment and 32.1 % initiated ART with or after RR TB treatment. Median CD4 count was 114.5 (IQR: 45-246.5). Overall, 578 reports of AEs were captured for 204 patients (35.3 %) and 110 patients (19.0 %) had at least one severe AE reported. Patients with at least one AE experienced a median of 3 (IQR: 2-4) AEs per patient. HIV-positive patients with CD4 counts ≤100 cells/mm 3 and those newly initiating ART were more likely to experience a severe AE (sHR: 2.76, 95 % CI: 1.30–5.84 and sHR: 3.07, 95 % CI: 1.46–6.46, respectively). Conclusion Severe AE are common during the first 6 months of RR TB treatment and HIV-positive patients newly initiating ART have the highest subdistribution hazard ratio for severe AE, accounting for the competing risks of death and loss from treatment. | |
dc.identifier.apacitation | Schnippel, K., Berhanu, R. H., Black, A., Firnhaber, C., Maitisa, N., Evans, D., & Sinanovic, E. (2016). Severe adverse events during second-line tuberculosis treatment in the context of high HIV Co-infection in South Africa: a retrospective cohort study. <i>BMC Infectious Diseases</i>, 16(1), 174 - 177. http://hdl.handle.net/11427/34286 | en_ZA |
dc.identifier.chicagocitation | Schnippel, Kathryn, Rebecca H Berhanu, Andrew Black, Cynthia Firnhaber, Norah Maitisa, Denise Evans, and Edina Sinanovic "Severe adverse events during second-line tuberculosis treatment in the context of high HIV Co-infection in South Africa: a retrospective cohort study." <i>BMC Infectious Diseases</i> 16, 1. (2016): 174 - 177. http://hdl.handle.net/11427/34286 | en_ZA |
dc.identifier.citation | Schnippel, K., Berhanu, R.H., Black, A., Firnhaber, C., Maitisa, N., Evans, D. & Sinanovic, E. 2016. Severe adverse events during second-line tuberculosis treatment in the context of high HIV Co-infection in South Africa: a retrospective cohort study. <i>BMC Infectious Diseases.</i> 16(1):174 - 177. http://hdl.handle.net/11427/34286 | en_ZA |
dc.identifier.issn | 1471-2334 | |
dc.identifier.ris | TY - Journal Article AU - Schnippel, Kathryn AU - Berhanu, Rebecca H AU - Black, Andrew AU - Firnhaber, Cynthia AU - Maitisa, Norah AU - Evans, Denise AU - Sinanovic, Edina AB - Abstract Background According to the World Health Organization, South Africa ranks as one of the highest burden of TB, TB/HIV co-infection, and drug-resistant TB (DR-TB) countries. DR-TB treatment is complicated to administer and relies on the use of multiple toxic drugs, with potential for severe adverse drug reactions. We report the occurrence of adverse events (AEs) during a standardised DR-TB treatment regimen at two outpatient, decentralized, public-sector sites in Johannesburg, South Africa. Methods We reviewed medical records of the six-month intensive treatment phase for rifampicin-resistant (RR) TB patients registered May 2012 - December 2014. Patients contributed follow-up time until death, loss from treatment, censoring (6 months) or data extraction. A standardized regimen of kanamycin, moxifloxacin, ethionamide, terizidone, and pyrazinamide was used according to national guidelines. AEs were graded using the AIDS Clinical Trial Group scale. We present subhazard ratios from competing risk analysis for time to severe AE, accounting for mortality and loss from treatment. Results Across the two sites, 578 eligible patient files were reviewed. 36.7 % were categorized as low weight (≤50 kg) at DR-TB initiation. 76.0 % had no history of TB treatment prior to the current episode of RR TB. 26.8 % were diagnosed with RR TB while hospitalized, indicating poor clinical condition. 82.5 % of patients were also HIV positive, of whom 43.8 % were on ART prior to RR TB treatment and 32.1 % initiated ART with or after RR TB treatment. Median CD4 count was 114.5 (IQR: 45-246.5). Overall, 578 reports of AEs were captured for 204 patients (35.3 %) and 110 patients (19.0 %) had at least one severe AE reported. Patients with at least one AE experienced a median of 3 (IQR: 2-4) AEs per patient. HIV-positive patients with CD4 counts ≤100 cells/mm 3 and those newly initiating ART were more likely to experience a severe AE (sHR: 2.76, 95 % CI: 1.30–5.84 and sHR: 3.07, 95 % CI: 1.46–6.46, respectively). Conclusion Severe AE are common during the first 6 months of RR TB treatment and HIV-positive patients newly initiating ART have the highest subdistribution hazard ratio for severe AE, accounting for the competing risks of death and loss from treatment. DA - 2016 DB - OpenUCT DP - University of Cape Town IS - 1 J1 - BMC Infectious Diseases LK - https://open.uct.ac.za PY - 2016 SM - 1471-2334 T1 - Severe adverse events during second-line tuberculosis treatment in the context of high HIV Co-infection in South Africa: a retrospective cohort study TI - Severe adverse events during second-line tuberculosis treatment in the context of high HIV Co-infection in South Africa: a retrospective cohort study UR - http://hdl.handle.net/11427/34286 ER - | en_ZA |
dc.identifier.uri | http://hdl.handle.net/11427/34286 | |
dc.identifier.vancouvercitation | Schnippel K, Berhanu RH, Black A, Firnhaber C, Maitisa N, Evans D, et al. Severe adverse events during second-line tuberculosis treatment in the context of high HIV Co-infection in South Africa: a retrospective cohort study. BMC Infectious Diseases. 2016;16(1):174 - 177. http://hdl.handle.net/11427/34286. | en_ZA |
dc.language.iso | eng | |
dc.publisher.department | Health Economics Unit | |
dc.publisher.faculty | Faculty of Health Sciences | |
dc.source | BMC Infectious Diseases | |
dc.source.journalissue | 1 | |
dc.source.journalvolume | 16 | |
dc.source.pagination | 174 - 177 | |
dc.source.uri | https://dx.doi.org/10.1186/s12879-016-1933-0 | |
dc.subject.other | Adverse drug reactions | |
dc.subject.other | Antiretroviral therapy | |
dc.subject.other | HIV | |
dc.subject.other | Multi-drug resistant TB | |
dc.subject.other | Tuberculosis | |
dc.subject.other | Adolescent | |
dc.subject.other | Adult | |
dc.subject.other | Anti-HIV Agents | |
dc.subject.other | Antitubercular Agents | |
dc.subject.other | CD4 Lymphocyte Count | |
dc.subject.other | Child | |
dc.subject.other | Cohort Studies | |
dc.subject.other | Coinfection | |
dc.subject.other | Female | |
dc.subject.other | HIV Infections | |
dc.subject.other | Humans | |
dc.subject.other | Male | |
dc.subject.other | Middle Aged | |
dc.subject.other | Retrospective Studies | |
dc.subject.other | Rifampin | |
dc.subject.other | South Africa | |
dc.title | Severe adverse events during second-line tuberculosis treatment in the context of high HIV Co-infection in South Africa: a retrospective cohort study | |
dc.type | Journal Article | |
uct.type.publication | Research | |
uct.type.resource | Journal Article |
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