{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T09:10:45Z","timestamp":1774343445738,"version":"3.50.1"},"reference-count":31,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2026,3,21]],"date-time":"2026-03-21T00:00:00Z","timestamp":1774051200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000200","name":"United States Agency for International Development","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100000200","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["TropicalMed"],"abstract":"<jats:p>The introduction of significantly shorter, all-oral regimens has significantly shifted the management of drug-resistant tuberculosis (DR-TB) towards a more tolerable and patient-centred therapeutic approach that aims to enhance treatment adherence, clinical outcomes, and quality of life among patients. Nigeria has gradually adopted this all-oral, shorter regimen, but the impact of this regimen in programmatic settings has not yet been studied. In 2022, a longitudinal, two-armed cohort study was conducted to explore the effectiveness, safety, and feasibility of the all-oral shorter regimen in the programmatic management of RR\/MDR-TB in Nigeria. Consenting and eligible RR\/MDR-TB patients receiving the all-oral regimen (intervention group) in four states were consecutively enrolled and compared to those receiving the standard of care (SOC). Treatment effectiveness, proportion, and 95% confidence intervals of favourable and unfavourable outcomes were measured at the end of treatment and during follow-up (six and 12 months post-treatment). In total 383 Participants were followed monthly throughout the 9\u201312-month treatment phase and then reassessed at 6 and 12 months after treatment completion, giving a total possible observation period of up to 24 months (185 received the intervention and 198 the standard of care). At the end of follow-up, there was a higher but non-significant proportion of favourable outcomes among the intervention vs. SOC group (80% vs. 69.7%); a higher proportion of favourable outcomes was also noted at the end of treatment among intervention participants (81.1 vs. 76.8%). Around one third of patients reported at least one serious adverse event (SAE), with no significant differences between arms, and none were deemed related to the use of medication. Intervention participants reported greater improvements in health-related quality of life between baseline and four months compared to those receiving the SOC. These findings support the programmatic use of all-oral shorter treatment for RR\/MDR-TB as a regimen that is effective, tolerable, safe, and associated with enhanced health-related quality of life for patients in Nigeria.<\/jats:p>","DOI":"10.3390\/tropicalmed11030084","type":"journal-article","created":{"date-parts":[[2026,3,23]],"date-time":"2026-03-23T13:53:34Z","timestamp":1774274014000},"page":"84","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Evaluating Treatment and Safety Outcomes of a Shorter Regimen for Drug-Resistant TB in Nigeria: An Implementation Research Study"],"prefix":"10.3390","volume":"11","author":[{"given":"Victor","family":"Babawale","sequence":"first","affiliation":[{"name":"National Tuberculosis and Leprosy Control Programme, Federal Ministry of Health, Abuja 900288, Nigeria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Clement","family":"Adesigbin","sequence":"additional","affiliation":[{"name":"National Tuberculosis and Leprosy Control Programme, Federal Ministry of Health, Abuja 900288, Nigeria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4229-365X","authenticated-orcid":false,"given":"Corinne S.","family":"Merle","sequence":"additional","affiliation":[{"name":"The Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organisation, 1211 Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vanessa","family":"Veronese","sequence":"additional","affiliation":[{"name":"The Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organisation, 1211 Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fatimata Bintou","family":"Sall","sequence":"additional","affiliation":[{"name":"The Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organisation, 1211 Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benjamin Seydou","family":"Sombie","sequence":"additional","affiliation":[{"name":"The Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organisation, 1211 Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-9112-9881","authenticated-orcid":false,"given":"Eunice Nnaisa","family":"Jiya-Chitumu","sequence":"additional","affiliation":[{"name":"National Tuberculosis and Leprosy Training Center Saye-Zaria, Zaria 810241,  Nigeria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8319-1927","authenticated-orcid":false,"given":"Chizaram","family":"Onyeaghala","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, University of Port Harcourt Teaching Hospital, Port Harcourt 500102, Nigeria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adegboyega Moses","family":"Oyefabi","sequence":"additional","affiliation":[{"name":"Department of Community Medicine, Kaduna State University, Kaduna 800283, Nigeria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4804-303X","authenticated-orcid":false,"given":"Rotimi Samuel","family":"Owolabi","sequence":"additional","affiliation":[{"name":"University of Abuja Teaching Hospital, Gwagwalada, Abuja 902101, Nigeria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Osman","family":"Eltaye","sequence":"additional","affiliation":[{"name":"Damien Foundation Belgium, Ibadan 200273,  Nigeria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Olusoji","family":"Ige","sequence":"additional","affiliation":[{"name":"University College Hospital, Ibadan 200285, Nigeria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ogiri","family":"Sam","sequence":"additional","affiliation":[{"name":"World Health Organization, Abuja 900211, Nigeria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7906-0521","authenticated-orcid":false,"given":"Obioma","family":"Akaniro","sequence":"additional","affiliation":[{"name":"National Tuberculosis and Leprosy Control Programme, Federal Ministry of Health, Abuja 900288, Nigeria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adebola","family":"Lawanson","sequence":"additional","affiliation":[{"name":"National Tuberculosis and Leprosy Control Programme, Federal Ministry of Health, Abuja 900288, Nigeria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Victor","family":"Ombeka","sequence":"additional","affiliation":[{"name":"National Tuberculosis and Leprosy Control Programme, Federal Ministry of Health, Abuja 900288, Nigeria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Muse","family":"Fadeyi","sequence":"additional","affiliation":[{"name":"Damien Foundation Belgium, Ibadan 200273,  Nigeria"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2026,3,21]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"S20","DOI":"10.1016\/j.ijid.2022.03.026","article-title":"Drug resistant TB\u2013latest developments in epidemiology, diagnostics and management","volume":"124","author":"Tiberi","year":"2022","journal-title":"Int. J. Infect. Dis."},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"Xi, Y., Zhang, W., Qiao, R.J., and Tang, J. (2022). Risk factors for multidrug-resistant tuberculosis: A worldwide systematic review and meta-analysis. PLoS ONE, 17.","DOI":"10.1371\/journal.pone.0270003"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"103","DOI":"10.1016\/j.ijtb.2022.03.021","article-title":"Outcomes and adherence of shorter MDR TB regimen in patients with multidrug resistant tuberculosis","volume":"70","author":"Kumari","year":"2023","journal-title":"Indian J. Tuberc."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"38","DOI":"10.5588\/pha.21.0041","article-title":"High success and low recurrence with shorter treatment regimen for multidrug-resistant TB in Nepal","volume":"11","author":"Koirala","year":"2021","journal-title":"Public Health Action"},{"key":"ref_5","unstructured":"WHO (2023). Global Tuberculosis Report, WHO."},{"key":"ref_6","doi-asserted-by":"crossref","unstructured":"Shibabaw, A., Gelaw, B., Gebreyes, W., Robinson, R., Wang, S.H., and Tessema, B. (2020). The burden of pre-extensively and extensively drug-resistant tuberculosis among MDR-TB patients in the Amhara region, Ethiopia. PLoS ONE, 15.","DOI":"10.1371\/journal.pone.0229040"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1055\/s-0040-1722535","article-title":"Adverse drug reactions with first-line and second-line drugs in treatment of tuberculosis","volume":"57","author":"Prasad","year":"2021","journal-title":"Ann. Natl. Acad. Med. Sci."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"e20200009","DOI":"10.36416\/1806-3756\/e20200009","article-title":"Shortened tuberculosis treatment regimens: What is new?","volume":"46","author":"Silva","year":"2020","journal-title":"J. Bras. Pneumol."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"e036599","DOI":"10.1136\/bmjopen-2019-036599","article-title":"Cost-effectiveness of new MDR-TB regimens: Study protocol for the TB-PRACTECAL economic evaluation substudy","volume":"10","author":"Sweeney","year":"2020","journal-title":"BMJ Open"},{"key":"ref_10","doi-asserted-by":"crossref","unstructured":"Jakasania, A., Shringarpure, K., Kapadia, D., Sharma, R., Mehta, K., Prajapati, A., and Kathirvel, S. (2020). \u201cSide effects--part of the package\u201d: A mixed methods approach to study adverse events among patients being programmatically treated for DR-TB in Gujarat, India. BMC Infect. Dis., 20.","DOI":"10.1186\/s12879-020-05660-w"},{"key":"ref_11","unstructured":"World Health Organization (2020). WHO Consolidated Guidelines on Tuberculosis: Module 4: Treatment-Drug-Resistant Tuberculosis Treatment, World Health Organization."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"1858","DOI":"10.1016\/S0140-6736(22)02078-5","article-title":"Evaluation of two short standardised regimens for the treatment of rifampicin-resistant tuberculosis (STREAM stage 2): An open-label, multicentre, randomised, non-inferiority trial","volume":"400","author":"Goodall","year":"2022","journal-title":"Lancet"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"e042390","DOI":"10.1136\/bmjopen-2020-042390","article-title":"Economic evaluation protocol of a short, all-oral bedaquiline-containing regimen for the treatment of rifampicin-resistant tuberculosis from the STREAM trial","volume":"10","author":"Rosu","year":"2020","journal-title":"BMJ Open"},{"key":"ref_14","first-page":"e934292-1","article-title":"Updates from the World Health Organization (WHO) on global treatment recommendations for drug-susceptible and multidrug-resistant tuberculosis","volume":"27","author":"Parums","year":"2021","journal-title":"Med. Sci. Monit. Int. Med. J. Exp. Clin. Res."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"683","DOI":"10.2147\/JPR.S400659","article-title":"Healthcare costs, time to fitness for work, and related factors in chronic complex regional pain syndrome: A comparative and longitudinal study of 5-year follow-up","volume":"16","author":"Duong","year":"2023","journal-title":"J. Pain Res."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"246","DOI":"10.1016\/S2213-2600(18)30104-8","article-title":"Time to revise WHO-recommended definitions of MDR-TB treatment outcomes","volume":"6","author":"Lange","year":"2018","journal-title":"Lancet Respir. Med."},{"key":"ref_17","unstructured":"World Health Organization (2017). Global Tuberculosis Report 2017."},{"key":"ref_18","unstructured":"(2025, December 05). The Special Programme for Research and Training in Tropical Diseases (TDR). ShORRT Initiative, TDR, 2019. Available online: https:\/\/tdr.who.int\/activities\/shorrt-research-package."},{"key":"ref_19","first-page":"S1","article-title":"COPD: Consensus Recommendations for early diagnosis and treatment","volume":"55","author":"Doherty","year":"2006","journal-title":"J. Fam. Pract."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"1214","DOI":"10.1164\/rccm.202107-1779OC","article-title":"An all-oral 6-month regimen for multidrug-resistant tuberculosis: A multicenter, randomized controlled clinical trial (the NExT study)","volume":"205","author":"Esmail","year":"2022","journal-title":"Am. J. Respir. Crit. Care Med."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"117","DOI":"10.1016\/S2213-2600(23)00389-2","article-title":"Short oral regimens for pulmonary rifampicin-resistant tuberculosis (TB-PRACTECAL): An open-label, randomised, controlled, phase 2B-3, multi-arm, multicentre, non-inferiority trial","volume":"12","author":"Berry","year":"2024","journal-title":"Lancet Respir. Med."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"148","DOI":"10.1016\/j.ijid.2022.11.007","article-title":"Effectiveness and safety of bedaquiline-based, modified all-oral 9\u201311-month treatment regimen for rifampicin-resistant tuberculosis in Vietnam","volume":"126","author":"Nguyen","year":"2023","journal-title":"Int. J. Infect. Dis."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"10","DOI":"10.4081\/monaldi.2021.1679","article-title":"Effectiveness and safety of fully oral modified shorter treatment regimen for multidrug-resistant tuberculosis in Georgia, 2019\u20132020","volume":"91","author":"Avaliani","year":"2021","journal-title":"Monaldi Arch. Chest Dis."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"1835","DOI":"10.1111\/bcp.15102","article-title":"Population pharmacokinetics and target attainment analysis of linezolid in multidrug-resistant tuberculosis patients","volume":"88","author":"Tietjen","year":"2022","journal-title":"Br. J. Clin. Pharmacol."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"2083","DOI":"10.1093\/cid\/ciab335","article-title":"Effectiveness and cardiac safety of bedaquiline-based therapy for drug-resistant tuberculosis: A prospective cohort study","volume":"73","author":"Brust","year":"2021","journal-title":"Clin. Infect. Dis."},{"key":"ref_26","first-page":"1441","article-title":"Hepatotoxicity During Treatment for Multidrug Resistant Tuberculosis","volume":"44","author":"Oscanoa","year":"2021","journal-title":"Drug Saf."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"129","DOI":"10.4103\/ijmy.ijmy_57_21","article-title":"Early safety and efficacy of linezolid-based combination therapy among patients with drug-resistant tuberculosis in North-western Nigeria","volume":"10","author":"Dayyab","year":"2021","journal-title":"Int. J. Mycobacteriol."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"2","DOI":"10.5588\/pha.20.0026","article-title":"Adverse events using shorter MDR-TB regimens: Outcomes from Port Moresby, Papua New Guinea","volume":"11","author":"Mason","year":"2021","journal-title":"Public Health Action"},{"key":"ref_29","doi-asserted-by":"crossref","unstructured":"Kizito, E., Musaazi, J., Mutesasira, K., Twinomugisha, F., Namwanje, H., Kiyemba, T., Freitas Lopez, D.B., Nicholas, N.S., Nkolo, A., and Birabwa, E. (2021). Risk factors for mortality among patients diagnosed with multi-drug resistant tuberculosis in Uganda-a case-control study. BMC Infect. Dis., 21.","DOI":"10.1186\/s12879-021-05967-2"},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"13","DOI":"10.5897\/JPHE2019.1129","article-title":"Survival and predictors of mortality from multidrug resistant tuberculosis (MDR-TB) among patients treated at MDR-TB Referal Hospitals in Ethiopia: A retrospective cohort study","volume":"12","author":"Shimbre","year":"2020","journal-title":"J. Public Health Epidemiol."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"825","DOI":"10.4103\/njcp.njcp_734_22","article-title":"Predictors of Mortality among Drug Resistant Tuberculosis Patients in Kaduna State, Nigeria","volume":"26","author":"Oyefabi","year":"2023","journal-title":"Niger. J. Clin. 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