{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T07:43:16Z","timestamp":1792827796616,"version":"4.5.0"},"update-to":[{"DOI":"10.1371\/journal.pntd.0012699","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2024,12,19]],"date-time":"2024-12-19T00:00:00Z","timestamp":1734566400000}}],"reference-count":30,"publisher":"Public Library of Science (PLoS)","issue":"12","license":[{"start":{"date-parts":[[2024,12,9]],"date-time":"2024-12-09T00:00:00Z","timestamp":1733702400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Hospital for Tropical Diseases Charitable Fund"}],"content-domain":{"domain":["www.plosntds.org"],"crossmark-restriction":false},"short-container-title":["PLoS Negl Trop Dis"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Introduction<\/jats:title>\n<jats:p>The World Health Organization (WHO) recommends rifampicin, dapsone and clofazimine multi-drug therapy (MDT) for the treatment of leprosy. Severe adverse effects include dapsone hypersensitivity syndrome, skin pigmentation, haemolytic anaemia, and hepatitis. At the Hospital for Tropical Diseases (HTD), London, United Kingdom monthly rifampicin, ofloxacin and minocycline (mROM) is used as first line treatment for leprosy.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Objectives<\/jats:title>\n<jats:p>To determine the clinical outcomes and experiences of individuals treated with mROM.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Methods<\/jats:title>\n<jats:p>A retrospective study of individuals with leprosy who were prescribed mROM at HTD was conducted. Demographic and clinical data were collected on outcomes including relapses, leprosy reactions, bacterial index (BI) and adverse effects. Individuals were interviewed using a semi-structured questionnaire to understand their experiences of mROM.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Results<\/jats:title>\n<jats:p>29 individuals were identified and 20 interviewed. 26 (89.7%) individuals completed monthly mROM. 9 (31%) had switched from WHO MDT to mROM (five of whom (55.6%) were interviewed). BI reduced significantly following mROM treatment (p = 0.04). 17 individuals (58.6%) experienced a leprosy reaction. One of the 29 (3.4%) relapsed. The relapse rate was 9.5\/1000 person years. 49 reports of adverse effects were either mild or moderate. The most frequent adverse effect (14\/49) reported was orange discolouration of urine. No adverse effect required hospitalisation or discontinuation of mROM. Most individuals reported that skin lesions improved by the time they had completed mROM.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec005\">\n<jats:title>Conclusions<\/jats:title>\n<jats:p>In this small study in a non-endemic setting mROM was safe, effective and acceptable. mROM therapy is associated with improvement in skin lesions, decline in bacterial index and acceptable adverse effects. Larger, prospective, randomised studies are needed to determine whether relapse rates with mROM are equivalent or better than WHO MDT and to provide robust data on the seemingly better adverse effect profile of mROM.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pntd.0012699","type":"journal-article","created":{"date-parts":[[2024,12,9]],"date-time":"2024-12-09T18:36:46Z","timestamp":1733769406000},"page":"e0012699","update-policy":"https:\/\/doi.org\/10.1371\/journal.pntd.corrections_policy","source":"Crossref","is-referenced-by-count":8,"title":["A retrospective cohort study of monthly rifampicin, ofloxacin and minocycline in the management of leprosy at the Hospital for Tropical Diseases, London, United Kingdom"],"prefix":"10.1371","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-9895-4787","authenticated-orcid":true,"given":"Priyanka","family":"Sivakumaran","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara de","family":"Barros","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vivianne Lopes","family":"Antonio Dias","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diana N.","family":"Lockwood","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen L.","family":"Walker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2024,12,9]]},"reference":[{"key":"pntd.0012699.ref001","first-page":"2022","article-title":"Leprosy: A Review of Epidemiology, Clinical Diagnosis, and Management.","author":"KH Chen","year":"2022","journal-title":"J Trop Med"},{"key":"pntd.0012699.ref002","first-page":"409","article-title":"Global leprosy (Hansen disease) update, 2022: new paradigm\u2014control to elimination.","author":"World Health Organization.","year":"2023","journal-title":"Weekly epidemiological record"},{"key":"pntd.0012699.ref003","unstructured":"World Health Organization Regional Office for South-East Asia. Guidelines for the Diagnosis, Treatment and Prevention of Leprosy. New Delhi; 2017."},{"key":"pntd.0012699.ref004","doi-asserted-by":"crossref","first-page":"388","DOI":"10.47276\/lr.90.4.388","article-title":"Levels of disability and relapse in Bangladeshi MB leprosy cases, 10 years after treatment with 6m MB-MDT.","volume":"90","author":"CR Butlin","year":"2019","journal-title":"Lepr Rev."},{"key":"pntd.0012699.ref005","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pntd.0005725","article-title":"Uniform multidrug therapy for leprosy patients in Brazil (U-MDT\/CT-BR): Results of an open label, randomized and controlled clinical trial, among multibacillary patients.","volume":"11","author":"GO Penna","year":"2017","journal-title":"PLoS Negl Trop Dis."},{"key":"pntd.0012699.ref006","article-title":"Late relapses in leprosy patients in Brazil: 10-year post-trial of uniform multidrug therapy (U-MDT\/CT-BR).","volume":"28","author":"GO Penna","year":"2024","journal-title":"Brazilian Journal of Infectious Diseases"},{"key":"pntd.0012699.ref007","unstructured":"World Health Organization. Towards Zero Leprosy.Global Leprosy (Hansen\u2019s disease) Strategy 2021\u20132030. New Delhi; 2017. licence:CCBY-NCSA3.0IGO"},{"key":"pntd.0012699.ref008","doi-asserted-by":"crossref","first-page":"232","DOI":"10.47276\/lr.91.3.232","article-title":"The adverse drug effects of dapsone therapy in leprosy: A systematic review.","volume":"91","author":"R Hilder","year":"2020","journal-title":"Lepr Rev"},{"key":"pntd.0012699.ref009","doi-asserted-by":"crossref","first-page":"453","DOI":"10.1590\/S0037-86822002000500005","article-title":"Efeitos adversos da poliquimioterapia em pacientes com hansen\u00edase: um levantamento de cinco anos em um Centro de Sa\u00fade da Universidade Federal de Uberl\u00e2ndia.","volume":"35","author":"IM Bernardes Goulart","year":"2002","journal-title":"Rev Soc Bras Med Trop"},{"key":"pntd.0012699.ref010","doi-asserted-by":"crossref","first-page":"1620","DOI":"10.1056\/NEJMoa1213096","article-title":"HLA-B*13:01 and the Dapsone Hypersensitivity Syndrome","volume":"369","author":"F-R Zhang","year":"2013","journal-title":"N Engl J Med"},{"key":"pntd.0012699.ref011","first-page":"327","article-title":"A review of side-effects experienced by patients taking clofazimine.","volume":"54","author":"VJ Moore","year":"1983","journal-title":"Lepr Rev"},{"key":"pntd.0012699.ref012","doi-asserted-by":"crossref","first-page":"327","DOI":"10.1111\/tmi.13977","article-title":"Clofazimine-induced cutaneous hyperpigmentation as a source of stigma in the treatment of leprosy: A cross-sectional study","volume":"29","author":"AS Nogueira","year":"2024","journal-title":"Tropical Medicine and International Health"},{"key":"pntd.0012699.ref013","unstructured":"Mylan. Rifampicin 300mg capsules SmPC. 18 Oct 2024 [cited 6 Nov 2024]. Available: medicines.org.uk"},{"key":"pntd.0012699.ref014","unstructured":"Ending the Neglect to Attain the Sustainable Development Goals: A Strategic Framework for Integrated Control and Management of Skin-Related Neglected Tropical Diseases. Geneva: World Health Organization; 2022. licence:CCBY-NC-SA3.0IGO"},{"key":"pntd.0012699.ref015","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pntd.0010799","article-title":"Diagnosing and treating leprosy in a non-endemic setting in a national centre, London, United Kingdom 1995\u20132018.","volume":"16","author":"DN Lockwood","year":"2022","journal-title":"PLoS Negl Trop Dis"},{"key":"pntd.0012699.ref016","first-page":"407","article-title":"Familial transmission of leprosy in post-war Britain\u2014Discrimination and dissent. QJM","volume":"101","author":"AL Gill","year":"2008","journal-title":"An International Journal of Medicine"},{"key":"pntd.0012699.ref017","doi-asserted-by":"crossref","first-page":"1115","DOI":"10.1128\/AAC.42.5.1115","article-title":"Bactericidal Activity of a Single-Dose Combination of Ofloxacin plus Minocycline, with or without Rifampin, against Mycobacterium leprae in Mice and in Lepromatous Patients","volume":"42","author":"B Ji","year":"1998","journal-title":"Antimicrob Agents Chemother"},{"key":"pntd.0012699.ref018","doi-asserted-by":"crossref","first-page":"356","DOI":"10.4103\/0378-6323.159929","article-title":"A randomized controlled trial to compare cure and relapse rate of paucibacillary multidrug therapy with monthly rifampicin, ofloxacin, and minocycline among paucibacillary leprosy patients in Agra District","volume":"81","author":"A Kumar","year":"2015","journal-title":"India. Indian J Dermatol Venereol Leprol"},{"key":"pntd.0012699.ref019","doi-asserted-by":"crossref","first-page":"197","DOI":"10.4269\/ajtmh.2004.70.197","article-title":"Parallel assessment of 24 monthly doses of rifampin, ofloxacin, and minocycline versus two years of World Health Organization multi-drug therapy for multi-bacillary leprosy","volume":"70","author":"LG Villahermosa","year":"2004","journal-title":"Am J Trop Med Hyg"},{"key":"pntd.0012699.ref020","article-title":"Common Terminology Criteria for Adverse Events (CTCAE) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.","author":"U.S Department of Health and Human Services","year":"2017","journal-title":"Available: ctep.cancer.gov"},{"key":"pntd.0012699.ref021","article-title":"Novel approaches in the treatment of Hansen\u2019s disease (Leprosy): a case series of multidrug therapy of monthly rifampin, moxifloxacin, and minocycline (RMM) in the United States.","volume":"9","author":"C Franco-Paredes","year":"2022","journal-title":"Ther Adv Infect Dis"},{"key":"pntd.0012699.ref022","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1177\/1203475420952437","article-title":"Ofloxacin-Containing Multidrug Therapy in Ambulatory Leprosy Patients: A Case Series.","volume":"25","author":"L Faust","year":"2021","journal-title":"J Cutan Med Surg"},{"key":"pntd.0012699.ref023","doi-asserted-by":"crossref","DOI":"10.3389\/fphar.2024.1346169","article-title":"Adverse reactions induced by MDT\/WHO (Rifampicin+Clofazimine+Dapsone) and ROM (Rifampicin+Ofloxacin+Minocycline) regimens used in the treatment of leprosy: a cohort study in a National Reference Center in Brazil.","volume":"15","author":"IC Celestino","year":"2024","journal-title":"Front Pharmacol."},{"key":"pntd.0012699.ref024","article-title":"In Brief: FDA warns that fluoroquinolone antibiotics can cause aortic aneurysm in certain patients","author":"FDA"},{"key":"pntd.0012699.ref025","article-title":"Fluoroquinolone antibiotics: must only be prescribed when other commonly recommended antibiotics are inappropriate","author":"Medicines and Healthcare products Regulatory Agency","year":"2024"},{"key":"pntd.0012699.ref026","article-title":"Fluoroquinolone and quinolone antibiotics: PRAC recommends restrictions on use New restrictions follow review of disabling and potentially long-lasting side effects","author":"European Medicines Agency","year":"2018"},{"key":"pntd.0012699.ref027","doi-asserted-by":"crossref","first-page":"1431","DOI":"10.1007\/s00228-019-02713-1","article-title":"Fluoroquinolones and the risk of tendon injury: a systematic review and meta-analysis","volume":"75","author":"C Alves","year":"2019","journal-title":"Eur J Clin Pharmacol"},{"key":"pntd.0012699.ref028","doi-asserted-by":"crossref","first-page":"581","DOI":"10.1530\/EOR-23-0181","article-title":"Achilles tendon complications of fluoroquinolone treatment: a molecule-stratified systematic review and meta-analysis.","volume":"9","author":"A Sangiorgio","year":"2024","journal-title":"EFORT Open Rev"},{"key":"pntd.0012699.ref029","article-title":"Ofloxacin 200mg tablets SmPC","author":"Mylan","year":"2024"},{"key":"pntd.0012699.ref030","first-page":"81","article-title":"Combination of rifapentine-moxifloxacin minocycline (PMM) for the treatment of leprosy.","volume":"71","author":"B Ji","year":"2000","journal-title":"Lepr Rev."}],"updated-by":[{"DOI":"10.1371\/journal.pntd.0012699","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2024,12,19]],"date-time":"2024-12-19T00:00:00Z","timestamp":1734566400000}}],"container-title":["PLOS Neglected Tropical Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pntd.0012699","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,12,19]],"date-time":"2024-12-19T18:57:35Z","timestamp":1734634655000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pntd.0012699"}},"subtitle":[],"editor":[{"given":"Ben","family":"Pascoe","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2024,12,9]]},"references-count":30,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2024,12,9]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pntd.0012699","relation":{},"ISSN":["1935-2735"],"issn-type":[{"value":"1935-2735","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,12,9]]}}}