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• W2321880263 abstract "In their opinion article, O’Brien et al.[1] argue that moxifloxacin (MFX) is preferable to clarithromycin (CLA) as a companion drug to rifampicin (RIF) when treating Buruli ulcer with an oral regimen in HIV-co-infected patients. Fortunately, HIV is not the driving force in the emergence of Buruli ulcer. Buruli ulcer mainly affects children, and the highest Buruli ulcer case rates are observed in rural areas of West Africa where HIV prevalence is low [2]. We concur that oral therapy is highly desirable. However, we believe that the combination of RIF and CLA is currently the better alternative. In the mouse model, there were clear indications that MFX was inferior to CLA either given alone or in combination with RIF [3]. The authors argue that anefavirenz (EFV) containing combination antiretroviral therapy, in combination with RIF, would induce CYP3A4-mediated metabolism of CLA, potentially leading to sub-therapeutic concentrations of CLA. The interaction of CYP3A4 inducers with CLA is indeed a concern. Pharmacokinetic data in Buruli ulcer patients treated with RIF-CLA combination show that a dosage of 7.5 mg/kg already gives median concentrations above the minimum inhibitory concentration of Mycobacterium ulcerans[4] resulting in cure of Buruli ulcer in nearly all patients [5,6]. However, the CLA dosage can safely be doubled to 15 mg/kg, and administered once-daily with an extended release formulation, which is likely to give therapeutic plasma concentrations, even in the presence of CYP3A4 induction; this approach is currently utilized in an ongoing WHO-sponsored clinical trial in West Africa (http://www.clinicaltrials.gov/ct2/show/NCT01659437 NLM Identifier: NCT01659437). Next, the authors argue that the combination of MFX and RIF would be better suited to treat a possible concurrent tuberculosis (TB)-infection. Though theoretically possible, Buruli ulcer-TB co-infection is uncommon as O’Brien et al.[1] admit; indeed, no single case of Buruli ulcer-TB-HIV co-infection has ever been reported in the literature. Buruli ulcer is a predominantly rural disease, whereas TB is more prevalent in urban areas. Should an HIV-positive patient present with both manifest TB and Buruli ulcer, we propose that initial therapy be directed at TB and HIV only. In such extremely rare cases, a MFX and RIF containing anti-TB regimen will indeed likely suffice to treat Buruli ulcer as well; the larger risk for patients with this triple infection would clearly be HIV and TB, not Buruli ulcer. Treatment with MFX and RIF for 8 weeks is not an established therapy for the treatment of latent TB and certainly not for the treatment of active TB. We rather propose that latent TB in HIV-infected patients is viewed as a separate entity, which needs proper diagnosis and treatment according to local and WHO guidelines. The authors mention the risk of the development of resistance of Mycobacterium tuberculosis during treatment with MFX. Other concerns with the use of MFX instead of CLA are the high costs, low availability and development of resistance amongst Gram-negative bacteria. In addition, it is contra-indicated in those under 18 years, the age group most affected by Buruli ulcer. In conclusion, we believe that there is currently no compelling reason to introduce MFX as a first-line drug for the treatment of HIV-positive Buruli ulcer patients. Priorities in research and treatment in Buruli ulcer cannot be copied from TB. Antimicrobial treatment is only part of the treatment in Buruli ulcer. Considering the median time to healing of 12–20 months [5,6], most of the healing takes place in the period after drug treatment, when local wound care and possibly, surgical interventions are important – not drug treatment. The need to start with combination antiretroviral therapy (cART) during the first 8 weeks of drug treatment for Buruli ulcer should be balanced with the risk of compliance problems and increased risks of side-effects. Vertical control programs may further limit the early start of cART in many Buruli ulcer centers. We propose that the pharmacokinetics of extended release CLA at 15 mg/kg in combination with RIF and EFV be studied in a small series of Buruli ulcer-HIV co-infected patients, and that the available research funding is directed at firmly establishing the efficacy and safety of the combination of RIF and CLA as oral therapy for Buruli ulcer. Acknowledgements Conflicts of interest There are no conflicts of interest." @default.
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• W2321880263 date "2014-03-13" @default.
• W2321880263 modified "2023-10-14" @default.
• W2321880263 title "Oral treatment for patients with Buruli ulcer co-infected with HIV" @default.
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• W2321880263 doi "https://doi.org/10.1097/qad.0000000000000146" @default.
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