Estimating Post-treatment Recurrence After Multidrug-Resistant Tuberculosis Treatment Among Patients With and Without Human Immunodeficiency Virus: The Impact of Assumptions About Death and Missing Follow-up.
| Title: | Estimating Post-treatment Recurrence After Multidrug-Resistant Tuberculosis Treatment Among Patients With and Without Human Immunodeficiency Virus: The Impact of Assumptions About Death and Missing Follow-up. |
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| Authors: | Sauer SM; Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.; Mitnick CD; Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.; Khan U; Interactive Research and Development (IRD) Global, Singapore, Singapore.; Hewison C; Médecins Sans Frontières, Paris, France.; Bastard M; Epicentre, Paris, France.; Holtzman D; Partners in Health, Maseru, Lesotho.; Law S; Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.; Khan M; IRD Global, Durban, South Africa.; Padayachee S; IRD Global, Durban, South Africa.; Ahmed S; IRD Global, Karachi, Pakistan.; Isani AK; Centers for Disease Control and Prevention, Directorate General Health Services, Sindh, Pakistan.; Krisnanda A; IRD Global, Jakarta, Indonesia.; Vilbrun SC; The Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince, Haiti.; Bektasov S; TB National TB Center, Kazakhstan.; Kumsa A; Ministry of Health, Addis Ababa, Ethiopia.; Docteur W; Zanmi Lasante, Cange, Haiti.; Tintaya K; Socios en Salud, Lima, Peru.; McNicol M; Médecins Sans Frontières, Tbilisi, Georgia.; Atshemyan H; Médecins Sans Frontières, Yerevan, Armenia.; Voynilo T; Médecins Sans Frontières, Minsk, Belarus.; Thwe TT; Médecins Sans Frontières, Yangon, Myanmar.; Seung K; Partners in Health, Boston, Massachusetts, USA.; Brigham and Women's Hospital, Boston, Massachusetts, USA.; Rich M; Partners in Health, Boston, Massachusetts, USA.; Brigham and Women's Hospital, Boston, Massachusetts, USA.; Huerga H; Epicentre, Paris, France.; Khan P; Interactive Research and Development (IRD) Global, Singapore, Singapore.; Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, United Kingdom.; Franke M; Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA. |
| Source: | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2024 Jan 25; Vol. 78 (1), pp. 164-171. |
| Publication Type: | Journal Article |
| Language: | English |
| Journal Info: | Publisher: Oxford University Press Country of Publication: United States NLM ID: 9203213 Publication Model: Print Cited Medium: Internet ISSN: 1537-6591 (Electronic) Linking ISSN: 10584838 NLM ISO Abbreviation: Clin Infect Dis Subsets: MEDLINE |
| Imprint Name(s): | Publication: Jan. 2011- : Oxford : Oxford University Press; Original Publication: Chicago, IL : The University of Chicago Press, c1992- |
| MeSH Terms: | Tuberculosis, Multidrug-Resistant*/drug therapy ; Tuberculosis, Multidrug-Resistant*/epidemiology ; HIV Infections*/complications ; HIV Infections*/drug therapy ; HIV Infections*/epidemiology; Antitubercular Agents/therapeutic use ; Humans ; Follow-Up Studies ; HIV ; Treatment Outcome |
| Abstract: | Background: Quantification of recurrence risk following successful treatment is crucial to evaluating regimens for multidrug- or rifampicin-resistant (MDR/RR) tuberculosis (TB). However, such analyses are complicated when some patients die or become lost during post-treatment follow-up.; Methods: We analyzed data on 1991 patients who successfully completed a longer MDR/RR-TB regimen containing bedaquiline and/or delamanid between 2015 and 2018 in 16 countries. Using 5 approaches for handling post-treatment deaths, we estimated 6-month post-treatment TB recurrence risk overall and by HIV status. We used inverse-probability weighting to account for patients with missing follow-up and investigated the impact of potential bias from excluding these patients without applying inverse-probability weights.; Results: The estimated TB recurrence risk was 7.4/1000 (95% credible interval: 3.3-12.8) when deaths were handled as non-recurrences and 7.6/1000 (3.3-13.0) when deaths were censored and inverse-probability weights were applied to account for the excluded deaths. The estimated risks of composite recurrence outcomes were 25.5 (15.3-38.1), 11.7 (6.4-18.2), and 8.6 (4.1-14.4) per 1000 for recurrence or (1) any death, (2) death with unknown or TB-related cause, or (3) TB-related death, respectively. Corresponding relative risks for HIV status varied in direction and magnitude. Exclusion of patients with missing follow-up without inverse-probability weighting had a small impact on estimates.; Conclusions: The estimated 6-month TB recurrence risk was low, and the association with HIV status was inconclusive due to few recurrence events. Estimation of post-treatment recurrence will be enhanced by explicit assumptions about deaths and appropriate adjustment for missing follow-up data.; (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.) |
| Competing Interests: | Potential conflicts of interest. Bedaquiline donations made from Janssen to the Global Drug Facility were used for patients in the endTB observational study. Donations of delamanid from Otsuka were used for initial patients enrolled in the endTB observational study. The companies from which drug donations were received did not have any role on the study design, data analyses, data interpretation, or manuscript writing. C. D. M. has served as a board member of Otsuka Scientific Advisory Board. U. K. reports that the endTB Consortium coordinated donations of delamanid from Otsuka Pharmaceuticals to be used for treatment of some of the patients included in the endTB observational study. U. K. also reports that the endTB Consortium coordinated donations of bedaquiline from Janssen to be used for treatment of some of the patients included in the endTB observational study. P. K. reports honoraria for being part of an expert panel, payments made to the author, from Johns Hopkins University. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. |
| Comments: | Update of: medRxiv. 2023 May 29:2023.05.24.23290472. doi: 10.1101/2023.05.24.23290472.. (PMID: 37398252) |
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| Contributed Indexing: | Keywords: MDR-TB; competing events; inverse-probability weighting; missing follow-up; post-treatment recurrence |
| Substance Nomenclature: | 0 (Antitubercular Agents) |
| Entry Date(s): | Date Created: 20230929 Date Completed: 20240129 Latest Revision: 20260521 |
| Update Code: | 20260521 |
| PubMed Central ID: | PMC10810712 |
| DOI: | 10.1093/cid/ciad589 |
| PMID: | 37773767 |
| Database: | MEDLINE |
Journal Article