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

Abstract

Monthly doses of rifampin, ofloxacin, and minocycline (ROM) are expected to be effective treatment for multi-bacillary leprosy. Patients with MB leprosy received ROM (n = 10) or World Health Organization multi-drug therapy (MDT) (n = 11). Treatment with ROM was given as 24 consecutive monthly observed doses of rifampin (600 mg), ofloxacin (400 mg), and minocycline (100 mg). Treatment with MDT was given as 24 consecutive monthly observed doses of rifampin (600 mg) and clofazimine (300 mg), and unobserved daily dapsone (100 mg) and clofazimine (50 mg). Twenty patients completed the 24-month regimens with > 99% compliance. Treatments with ROM and MDT were safe, tolerable, and caused similar improvements in lesions, bacterial indices, and histology. All MDT recipients developed clofazimine-induced pigmentation. Six ROM and nine MDT recipients assessed at five or more years after completion of treatment had no evidence of relapse. Twenty-four months of treatment with ROM is a safe, well-tolerated, and convenient regimen that may provide an alternate therapy to MDT for MB leprosy. Larger trials with sufficient follow-up would better define the role of ROM.

The Analysis of the Mycobacterium Leprae Resistance Against Ofloxacin After the Rifampicin Ofloxacin Minocycline (ROM) Therapy

“…(11) Research conducted by Haryanto et al have shown a significant correlation between adherence to treatment MDT with laboratory test results. (12) ROM regimens has a high level of compliance because it is not taken daily regimens and shorter treatment duration (13) Based on morphology index shows only 1 (4.8%) samples with MI of 0.5%, whereas 20 (95.2%) samples with MI 0. In lepromatous leprosy, morphology index fell from a starting point of about 5-20% to zero after 5-6 months of uninterrupted treatment with dapsone, or after about five weeks of combination therapy regimens using rifampicin.…”

Comparison of Effectiveness between Rifampicin Ofloxin-Minocycline Regimen and Multidrug Therapy-World Health Organization in Multibacillary Leprosy Patients

“…The drug price may become a differentiating factor in choosing the drug regimen for the leprosy patients despite the side effect and drug consumption frequency. 9 The ROM regimen has a higher price with less side effects (nausea and vomiting), with once in a month drug consumption, making it more simple for the patients compare to MDT-WHO regimen which needs to be consumed every day with more side effects (skin hyperpigmentation, hemolytic anemia, methemoglobinemia, hypersensitivity reaction), but given freely. 10 Based on those considerations, occupations might be considered as an influencing factor in choosing leprosy medication regimen, therefore a further study needs to be conducted to prove this.…”

“…Both regimens showed the same result on both groups in every aspects examined such as clinical, bacteriological, and histopathological examination. 9 Additionally, Lockwood et al 4 suggested that a study comparing both regimens on MB type leprosy patients for 12 months to increase patient compliance, is needed. 4 This study was conducted to compare the effectiveness between ROM and MDT-WHO regimen for the first 12 months based on the MI score in MB type leprosy patients.…”

“…6 Evaluation of leprosy treatment can be performed by evaluating skin the slit smear examination, especially the morphological index (MI) of acid-fast bacilli (AFB) that might give useful information about medication response. 7 Furthermore, Villahermosa et al 9 conducted a study comparing the effectiveness between ROM and MDT-WHO regimen for 24 months in MB type leprosy patients in the Philippines. Both regimens showed the same result on both groups in every aspects examined such as clinical, bacteriological, and histopathological examination.…”

Hansen's disease in Portugal: multibacillary patients treated between 1988 and 2003

“…2,3 In 1998, with mounting evidence that less than 24 months of therapy was effective, recommended duration was reduced to 1 year. 4,5 Significant controversy was recently generated following a proposal for a reduction in the length of treatment to 6 months with a standardized MDT regimen for all Hansen's disease patients. 6 Despite the WHO declaration that Hansen's disease would be eliminated as a public health problem (defined as a registered prevalence rate of less than 1 case per 10 000 population) by 2000, new cases continue to be diagnosed even outside endemic areas, 8,9 and the illness remains far from being eradicated.…”