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 | 2016-10-28T13:44:45Z | |
| dc.date.available | 2016-10-28T13:44:45Z | |
| dc.date.issued | 2016-10-21 | |
| dc.date.updated | 2016-10-21T18:20:49Z | |
| dc.description.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/mm3 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. | en_ZA |
| 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>, http://hdl.handle.net/11427/22338 | 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> (2016) http://hdl.handle.net/11427/22338 | 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. BMC Infectious Diseases, 16(1), 593. | en_ZA |
| dc.identifier.issn | 1471-2334 | en_ZA |
| 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 - 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/mm3 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 - 2016-10-21 DB - OpenUCT DO - 10.1186/s12879-016-1933-0 DP - University of Cape Town J1 - BMC Infectious Diseases LK - https://open.uct.ac.za PB - University of Cape Town 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/11427/22338 ER - | en_ZA |
| dc.identifier.uri | http://dx.doi.org/10.1186/s12879-016-1933-0 | |
| dc.identifier.uri | http://hdl.handle.net/11427/22338 | |
| 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; http://hdl.handle.net/11427/22338. | en_ZA |
| dc.language | eng | en_ZA |
| dc.language.rfc3066 | en | |
| dc.publisher | BioMed Central | en_ZA |
| dc.publisher.department | Department of Public Health and Family Medicine | en_ZA |
| dc.publisher.faculty | Faculty of Health Sciences | en_ZA |
| dc.publisher.institution | University of Cape Town | |
| dc.rights | Creative Commons Attribution 4.0 International (CC BY 4.0) | * |
| dc.rights.holder | The Author(s). | |
| dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | en_ZA |
| dc.source | BMC Infectious Diseases | en_ZA |
| dc.source.uri | http://bmcinfectdis.biomedcentral.com/ | |
| dc.subject.other | HIV | |
| dc.subject.other | Antiretroviral therapy | |
| dc.subject.other | Multi-drug resistant TB | |
| dc.subject.other | Tuberculosis | |
| dc.subject.other | Adverse drug reactions | |
| 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 | en_ZA |
| dc.type | Journal Article | en_ZA |
| uct.type.filetype | Text | |
| uct.type.filetype | Image | |
| uct.type.publication | Research | en_ZA |
| uct.type.resource | Article | en_ZA |