Leprosy medical therapy

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: João André Alves Silva, M.D. [2]

Overview

The medical treatment of leprosy is made with a multiple drug regimen, for 6 to 12 months. This drug regimen may include 2 or 3 drugs: rifampicin, dapsone and clofazimine, or rifampicin and dapsone, depending on the class of the disease.

Medical Therapy

Every patient should receive multidrug therapy, and never be treated with a single drug. Multidrug therapy, or MDT, is a safe and effective combination of oral drugs to treat leprosy and prevent drug resistance. To improve adherence to treatment, it is distributed for free. The drug combination is provided in blister packs to facilitate the process.

This treatment regimen is identical, both in adults and children, simply with a change in the dosage of the drugs, and is safe for pregnant women or those breastfeeding.

This treatment does not interfere with the therapy for HIV, nor for TB, however, in this last case, if a leprosy patient is also being treated for tuberculosis with rifampin, then rifampin should be omitted from the MDT regimen.

New cases

• Those who have never received MDT in the past - will receive full course of MDT treatment

Other cases

• Relapsed cases - will repeat previous MDT regimen
• Previous paucibacillary cases, now returning as multibacillary patients - will receive full course of MDT treatment
• Patients who did not complete the due MDT regimen - will receive the same MDT regimen as new cases
• Transferred patients - these should carry a record of the current treatment to date, in order for this to be continued

Antimicrobial therapy

• 1. Multibacillary Leprosy (Skin smear positive)

• Preferred regimen: Dapsone 100 mg/day PO AND Rifampin 600 mg PO 4 times per week AND Clofazimine 50 mg/day PO supplemented by Clofazimine 300 mg PO loading dose monthly
• Pediatric regimen: Dapsone 1-2 mg/kg/day PO AND Rifampin 450 mg PO <35 kg, 300 mg PO <20 kg, 150 mg PO <12 kg
• Length of treatment: 12-24 months

• 2. Paucibacillary Leprosy (Skin Smear negative)

• Preferred regimen: Rifampin 600 mg PO once a month for 6 months AND Dapsone 100 mg/day PO for 6 months

• 3. Erythema Nodosum Leprosum (ENL)

• Continue anti-leprosy drugs throughout
• 3.1 Mild

• Preferred regimen: Rest affect limb, analgesics, follow-up q2wks, check for iridocyclitis; Chloroquine OR Aspirin may be useful

• 3.2 Severe (numerous nodules + fever, ulcerating/pustular ENL, visceral involvement, nodules + neuritis, recurrent ENL)

• Preferred regimen: Prednisolone 30-40 mg/day PO (not to exceed 1 mg/kg) for 1-2 weeks THEN taper over 12 weeks
• Alternative regimen (1): (If unresponsive to corticosteroids or if risk of corticosteroids prevent administration) Start Clofazimine 100 mg PO TID for maximum of 12 weeks, taper the dose to 100 mg PO BID for 12 weeks THEN 100 mg qd for 12-24 weeks
• Alternative regimen (2): (if not contraindicated) Thalidomide 200-400 mg/day PO, reduced to 50-100 mg/day after 1-2 weeks

• 4. Reversal Reaction

• Preferred regimen: Prednisolone start with 40 mg/day PO THEN taper by 10 mg twice a week for 12 weeks

Prophylaxis

• 1. Adult

• 1.1 35 kg and over

• Preferred regimen: Rifampin 600 mg PO single dose

• 1.2 less than 35 kg

• Preferred regimen: Rifampin 450 mg PO single dose

• 2. Pediatric

• 2.1 for children older than 9 yrs

• Preferred regimen: Rifampin 450 mg PO single dose

• 2.2 for children aged 5 to 9 yrs

• Preferred regimen: Rifampin 300 mg PO single dose

Multidrug Therapy

According to the directions of the WHO, the multidrug treatment of leprosy should be:

Multibacillary Leprosy   ▸  Adults   ▸  Children <10 years old   ▸  Children >10 years old Paucibacillary Leprosy   ▸  Adults   ▸  Children <10 years old   ▸  Children >10 years old

Adults Preferred Regimen† ▸ Rifampicin 600 mg once a month PO PLUS ▸ Clofazimine 50 mg/day PO and 300 mg once a month PO PLUS ▸ Dapsone 100 mg/day PO † During 12 months. Children <10 years old Preferred Regimen† ▸ Rifampicin 10 mg/Kg once a month PO PLUS ▸ Clofazimine 1 mg/Kg/day PO and 6 mg/Kg once a month PO PLUS ▸ Dapsone 2 mg/Kg/day PO † During 12 months. Children >10 years old Preferred Regimen† ▸ Rifampicin 450 mg once a month PO PLUS ▸ Clofazimine 50 mg every other day PO and 150 mg once a month PO PLUS ▸ Dapsone 50 mg/day PO † During 12 months. Adults Preferred Regimen† ▸ Rifampicin 600 mg once a month PO PLUS ▸ Dapsone 100 mg/day PO † During 6 months. Children <10 years old Preferred Regimen† ▸ Rifampicin 10 mg/Kg once a month PO PLUS ▸ Dapsone 2 mg/Kg/day PO † During 6 months. Children >10 years old Preferred Regimen† ▸ Rifampicin 450 mg once a month PO PLUS ▸ Dapsone 50 mg/day PO † During 6 months.

The administration of the monthly drugs should be supervised by an health care practitioner at a local clinic. During this visit, it is important to look for potential complications of the disease, such as neuritis, or reactions to the medication.

Patients with high bacterial index may be considered for treatment for more than 12 months. However, this decision should only be made by a specialist at a referral unit after careful evaluation of the clinical scenario.

Leprosy Drug Summary

Rifampicin

Rifampicin is typically used to treat Mycobacterium infections, including tuberculosis and leprae. It inhibits DNA-dependent RNA polymerase in bacterial cells by binding its beta-subunit, thus preventing transcription of messenger RNA (mRNA) and subsequent translation to proteins.

Clofazimine

Clofazimine is a fat-soluble riminophenazine used in combination with rifampicin and dapsone as part of the multidrug therapy (MDT) for the treatment of leprosy. It exerts a slow bactericidal effect on Mycobacterium leprae inhibiting its growth, binding preferentially to mycobacterial DNA. However, its precise mechanisms of action is unknown. Clofazimine also has an anti-inflammatory effect and is used to control the leprosy reaction and erythema nodosum leprosum.

Dapsone

Dapsone (diamino-diphenyl sulphone) is a pharmacological medication mostly used in combination with rifampicin and clofazimine as multidrug therapy (MDT) for the treatment of Mycobacterium leprae infections. As an antibacterial, dapsone inhibits bacterial synthesis of dihydrofolic acid.

References

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