What is the recommended treatment for leprosy?

From the Guidelines

The recommended treatment for leprosy is a multidrug therapy (MDT) that combines dapsone, rifampin, and clofazimine, with clofazimine being a crucial component, as evidenced by its effectiveness in treating leprosy and its inclusion in the WHO's "other core second-line agents" for building a treatment regimen 1.

Key Components of Leprosy Treatment

• Dapsone: used in combination with rifampin for paucibacillary leprosy and with rifampin and clofazimine for multibacillary leprosy
• Rifampin: used monthly in combination with dapsone for paucibacillary leprosy and with dapsone and clofazimine for multibacillary leprosy
• Clofazimine: used daily in combination with dapsone and rifampin for multibacillary leprosy, with a recommended dose of 2–3 mg/kg per day (maximum dose, 100 mg daily) for children, as supported by its use in a leprosy trial of 422 children in China and India, where it was well tolerated 1

Treatment Regimens

• Paucibacillary leprosy: daily dapsone (100mg) and monthly rifampin (600mg) for 6 months
• Multibacillary leprosy: daily dapsone (100mg), daily clofazimine (50mg), and monthly rifampin (600mg) plus clofazimine (300mg) for 12-24 months

Monitoring and Complications

• Patients should be monitored for complications like leprosy reactions, which may require additional anti-inflammatory medications such as prednisone
• Completing the full course of therapy is essential for cure, even if symptoms improve earlier

Special Considerations

• Children receive adjusted doses based on weight
• Treatment should begin immediately after diagnosis to prevent disability and reduce transmission
• MDT is highly effective because it targets Mycobacterium leprae from multiple angles, with rifampin killing most bacteria rapidly, while dapsone and clofazimine eliminate remaining organisms and suppress bacterial resistance 1

From the FDA Drug Label

In order to reduce secondary Dapsone resistance, the WHO Expert Committee on Leprosy and the USPHS at Carville, LA, recommended that Dapsone should be commenced in combination with one or more anti-leprosy drugs In the multidrug program Dapsone should be maintained at the full dosage of 100 mg daily without interruption (with corresponding smaller doses for children) and provided to all patients who have sensitive organisms with new or recrudescent disease or who have not yet completed a two year course of Dapsone monotherapy For bacteriologically negative tuberculoid and indeterminate disease, the recommendation is the coadministration of Dapsone 100 mg daily with six months of Rifampin 600 mg daily In lepromatous and borderline lepromatous patients, the recommendation is the coadministration of Dapsone 100 mg daily with two years of Rifampin 600 mg daily

The recommended treatment for leprosy is a multidrug regimen that includes:

• Dapsone 100 mg daily
• Rifampin 600 mg daily for 6 months for tuberculoid and indeterminate disease, or 2 years for lepromatous and borderline lepromatous patients
• Optional: a third anti-leprosy drug, such as Clofazamine 50 to 100 mg daily or Ethionamide 250 to 500 mg daily 2

From the Research

Leprosy Treatment Overview

• The World Health Organization (WHO) recommends multidrug therapy (MDT) for the treatment of paucibacillary and multibacillary forms of leprosy, also known as Hansen's disease (HD) 3, 4, 5.
• MDT combinations of dapsone, rifampin, and clofazimine have reduced the prevalence of the disease but are not without adverse effects impacting regimen adherence 3, 4, 6.

Alternative Treatment Regimens

• A case series of 10 patients with HD treated with monthly rifampin, moxifloxacin, and minocycline (RMM) showed that all patients completed the RMM regimen without treatment interruptions and none experienced significant side effects 3.
• A uniform multidrug therapy regimen for leprosy patients was evaluated in a single-arm open trial, which found low relapse rates, minimal adverse drug reactions, and high compliance 4.
• A network meta-analysis of 60 controlled clinical trials and 9256 patients found that MDT was effective for treating leprosy and multibacillary leprosy, but may not be effective enough, and that pefloxacin and ofloxacin may be good adjunct drugs for increasing MDT efficacy 5.

Drug Interactions and Metabolism

• Rifampicin induces the metabolism of dapsone, resulting in decreased plasma half-life of dapsone and its metabolites, and also induces its own metabolism and decreases its half-life during monotherapy 6.
• Clofazimine lacks significant induction of any drug-metabolizing enzyme, including CYP family, and does not interact with dapsone metabolism 6.
• Clarithromycin was found to be as effective as rifampicin in combination with dapsone and clofazimine regimen in multibacillary leprosy patients, and can be considered as an alternative therapy for leprosy patients who are resistant and/or allergic to rifampicin 7.

Treatment Efficacy and Safety

• The efficacy and safety of antileprosy drugs have been evaluated in several studies, which found that MDT is effective for treating leprosy and multibacillary leprosy, but may have adverse effects such as skin hyperpigmentation and neuritis 3, 4, 5.
• The safety profile of alternative treatment regimens, such as RMM, has been found to be improved compared to traditional MDT regimens 3.