All-oral longer regimens are effective for the management of multidrug-resistant tuberculosis in high-burden settings.
| Title: | All-oral longer regimens are effective for the management of multidrug-resistant tuberculosis in high-burden settings. |
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| Authors: | Khan PY; Interactive Research and Development Global, Singapore palwasha.khan@lshtm.ac.uk.; Clinical Research Dept, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.; These authors contributed equally.; Franke MF; Partners In Health, Boston, MA, USA.; Dept of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA.; These authors contributed equally.; Hewison C; Medical Dept, Médecins Sans Frontières, Paris, France.; Seung KJ; Partners In Health, Boston, MA, USA.; Division of Global Health Equity, Brigham and Women's Hospital, Boston, MA, USA.; Huerga H; Field Epidemiology Dept, Epicentre, Paris, France.; Atwood S; Division of Global Health Equity, Brigham and Women's Hospital, Boston, MA, USA.; Ahmed S; Interactive Research and Development, Karachi, Pakistan.; Khan M; Interactive Research and Development, Durban, South Africa.; Sultana T; Interactive Research and Development, Dhaka, Bangladesh.; Manzur-Ul-Alam M; Interactive Research and Development, Dhaka, Bangladesh.; Vo LNQ; Interactive Research and Development Global, Singapore.; Friends for International TB Relief, Ho Chi Minh City, Vietnam.; Lecca L; Socios En Salud Sucursal Peru, Lima, Peru.; Yae K; Partners In Health, Ethiopia, Addis Ababa, Ethiopia.; Kozhabekov S; Partners In Health, Almaty, Kazakhstan.; Tamirat M; Partners In Health, Lesotho, Maseru, Lesotho.; Gelin A; Zanmi Lasante, Port-au-Prince, Haiti.; Vilbrun SC; Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince, Haiti.; Kikvidze M; Médecins Sans Frontières, Georgia.; Faqirzai J; Médecins Sans Frontières, Armenia.; Kadyrov A; Médecins Sans Frontières, Kyrgyzstan.; Skrahina A; Médecins Sans Frontières, Belarus.; Mesic A; Médecins Sans Frontières, Amsterdam, The Netherlands.; Avagyan N; Medical Dept, Médecins Sans Frontières, Paris, France.; Bastard M; Field Epidemiology Dept, Epicentre, Paris, France.; Rich ML; Partners In Health, Boston, MA, USA.; Division of Global Health Equity, Brigham and Women's Hospital, Boston, MA, USA.; Khan U; Interactive Research and Development Global, Singapore.; These authors contributed equally.; Mitnick CD; Partners In Health, Boston, MA, USA.; Dept of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA.; These authors contributed equally. |
| Source: | The European respiratory journal [Eur Respir J] 2022 Jan 20; Vol. 59 (1). Date of Electronic Publication: 2022 Jan 20 (Print Publication: 2022). |
| Publication Type: | Journal Article; Research Support, Non-U.S. Gov't |
| Language: | English |
| Journal Info: | Publisher: European Respiratory Society Country of Publication: England NLM ID: 8803460 Publication Model: Electronic-Print Cited Medium: Internet ISSN: 1399-3003 (Electronic) Linking ISSN: 09031936 NLM ISO Abbreviation: Eur Respir J Subsets: MEDLINE |
| Imprint Name(s): | Publication: Sheffield, United Kingdom : European Respiratory Society; Original Publication: Copenhagen : Published jointly by the Society and Munksgaard, 1988- |
| MeSH Terms: | Antitubercular Agents*/therapeutic use ; Tuberculosis, Multidrug-Resistant*/drug therapy; Clinical Protocols ; Humans ; World Health Organization |
| Abstract: | Background: Recent World Health Organization guidance on drug-resistant tuberculosis treatment de-prioritised injectable agents, in use for decades, and endorsed all-oral longer regimens. However, questions remain about the role of the injectable agent, particularly in the context of regimens using new and repurposed drugs. We compared the effectiveness of an injectable-containing regimen to that of an all-oral regimen among patients with drug-resistant tuberculosis who received bedaquiline and/or delamanid as part of their multidrug regimen.; Methods: Patients with a positive baseline culture were included. 6-month culture conversion was defined as two consecutive negative cultures collected >15 days apart. We derived predicted probabilities of culture conversion and relative risk using marginal standardisation methods.; Results: Culture conversion was observed in 83.8% (526 out of 628) of patients receiving an all-oral regimen and 85.5% (425 out of 497) of those receiving an injectable-containing regimen. The adjusted relative risk comparing injectable-containing regimens to all-oral regimens was 0.96 (95% CI 0.88-1.04). We found very weak evidence of effect modification by HIV status: among patients living with HIV, there was a small increase in the frequency of conversion among those receiving an injectable-containing regimen, relative to an all-oral regimen, which was not apparent in HIV-negative patients.; Conclusions: Among individuals receiving bedaquiline and/or delamanid as part of a multidrug regimen for drug-resistant tuberculosis, there was no significant difference between those who received an injectable and those who did not regarding culture conversion within 6 months. The potential contribution of injectable agents in the treatment of drug-resistant tuberculosis among those who were HIV positive requires further study.; (Copyright ©The authors 2022. For reproduction rights and permissions contact permissions@ersnet.org.) |
| Competing Interests: | Conflict of interest: P.Y. Khan reports grants from Unitaid, during the conduct of the study; other (study drug donations coordinated by the endTB Consortium) from Otsuka Pharamceutical and Janssen, outside the submitted work. Conflict of interest: M.F. Franke reports grants from Unitaid, during the conduct of the study. Conflict of interest: C. Hewison reports grants from Unitaid, during the conduct of the study. Conflict of interest: K.J. Seung reports grants from Unitaid, during the conduct of the study. Conflict of interest: H. Huerga reports grants from Unitaid, during the conduct of the study. Conflict of interest: S. Atwood has nothing to disclose. Conflict of interest: S. Ahmed reports grants from Unitaid, during the conduct of the study; other (study drug donations coordinated by the endTB Consortium) from Otsuka Pharamceutical and Janssen Pharmaceutical, outside the submitted work. Conflict of interest: M. Khan has nothing to disclose. Conflict of interest: T. Sultana has nothing to disclose. Conflict of interest: M. Manzur-ul-Alam has nothing to disclose. Conflict of interest: L.N.Q. Vo reports grants and non-financial support (drugs/equipment) from Unitaid via IRD Global during the conduct of the study. Conflict of interest: L. Lecca has nothing to disclose. Conflict of interest: K. Yae has nothing to disclose. Conflict of interest: S. Kozhabekov has nothing to disclose. Conflict of interest: M. Tamirat has nothing to disclose. Conflict of interest: A. Gelin has nothing to disclose. Conflict of interest: S.C. Vilbrun has nothing to disclose. Conflict of interest: M. Kikvidze has nothing to disclose. Conflict of interest: J. Faqirzai has nothing to disclose. Conflict of interest: A. Kadyrov has nothing to disclose. Conflict of interest: A. Skrahina has nothing to disclose. Conflict of interest: A. Mesic has nothing to disclose. Conflict of interest: N. Avagyan has nothing to disclose. Conflict of interest: M. Bastard reports grants from Unitaid, during the conduct of the study. Conflict of interest: M.L. Rich reports grants from Unitaid, during the conduct of the study; personal fees for consultancy from World Health Organization, other (study drug donations coordinated by the endTB Consortium) from Otsuka Pharamceutical and Janssen, outside the submitted work. Conflict of interest: U. Khan reports grants from Unitaid, during the conduct of the study; other (study drug donations coordinated by the endTB Consortium) from Otsuka Pharamceutical and Janssen, outside the submitted work. Conflict of interest: C.D. Mitnick reports a grant from Unitaid to fund the study and that the endTB Consortium coordinated donations of delamanid (Otsuka Pharmaceutical) and bedaquiline (Janssen) to be used for treatment by some of the patients included in the endTB Observational Study. |
| Substance Nomenclature: | 0 (Antitubercular Agents) |
| Entry Date(s): | Date Created: 20210618 Date Completed: 20220202 Latest Revision: 20220202 |
| Update Code: | 20260130 |
| DOI: | 10.1183/13993003.04345-2020 |
| PMID: | 34140298 |
| Database: | MEDLINE |
Journal Article; Research Support, Non-U.S. Gov't