Treatment of Hansen’s Disease

Pharmaceutical treatment of Hansen's disease (HD) involves two main factors:

1. Antibiotics for treating the infection
2. Immunomodulators for management of reactions

Antibiotic treatment options

The NHDP Headquarters in Baton Rouge, Louisiana, recognizes there are multiple treatment options for HD. The following options include the treatment regimen that the NHDP Baton Rouge clinic utilizes, as well as other treatment options used by different programs throughout the world. Treatment options were updated February 2025.

While the care of an individual diagnosed with HD involves considerably more than prescribing medication, the appropriate drug combination is the most important step toward curing the infection. Health care providers should emphasize to their patients the importance of taking all medications for the duration of treatment.

The former NHDP regimen with daily rifampin is no longer recommended due to significant drug-drug interactions, which is in line with the WHO (World Health Organization) recommendation that uses monthly doses. The WHO provides prepackaged free multidrug therapy consisting of dapsone, monthly rifampin, and clofazimine* to countries outside the United States. More information about the WHO treatment regimens can be found on their website (who.int).

In 1997, the WHO Expert Committee on Leprosy recommended the following alternative 24 month multidrug therapy regimen (three drugs) for adult patients with multibacillary leprosy, who refuse to take clofazimine: - rifampicin, 600 mg once a month for 24 months, - ofloxacin, 400 mg once a month for 24 months, AND - minocycline, 100 mg once a month for 24 months (WHO monthly regimen, page 14 ). The monthly alternative therapy option is referred to as ROM (Rifampin, Moxifloxacin, Minocycline) in some publications due to the use of ofloxacin instead of moxifloxacin (RMM). The NHDP currently uses the RMM regimen as a treatment option. In 2024 alone, NHDP provided RMM to 213 patients in the United States.

RMM = Rifampin, Moxifloxacin, Minocycline

Each monthly dose of RMM consists of two rifampin 300mg capsules, one moxifloxacin 400mg tablet, and one minocycline 100mg tablet. All three antibiotics should be taken once a month on the same day. The three antibiotics can be taken all at once but are better tolerated when each is taken at least 15 to 45 minutes apart. Some patients prefer to space out the antibiotics with breakfast, lunch, and dinner to prevent GI side effects. This is also acceptable so long as all three antibiotics are taken on the same day.

Treatment of reactions

Many HD patients will experience an acute hypersensitivity or immunological reaction to the M. leprae organism during the course of their disease. Unfortunately, there are no predictors to identify which patients will develop a reaction. Patients who develop reactions should start immunomodulatory treatment and be monitored closely as they are at a higher risk of nerve damage and subsequent disabilities and deformities.

Types of reactions:

1. Reversal reaction: Type 1
2. Erythema nodosum leprosum (ENL): Type 2
3. Lucio's

Detailed information on recognizing and treating each reaction can be found within the NHDP Treatment Guide.

An important part of the management of reactions is providing correct information and listening to the concerns of patients and their families. Patients usually fear that treatment has failed, their disease is getting worse, and they will suffer permanent disability and disfigurement. In chronic reactions, especially ENL, patients often become discouraged. It should be emphasized that a reaction does not indicate a failure of antibacterial treatment or toxicity to drugs. Reactions are due to the immune system reacting to the dead bacteria. Patients can always be reassured that HD and reactions are treatable conditions and that even long-standing reactions will eventually end. In most cases, the long-term prognosis is good and there should not be any further progression of nerve damage or disability after the initiation of treatment. Patients must understand that discontinuing medication is NOT a good option. Patients should contact their physician at the first signs of a reaction.

The management of ENL will vary somewhat depending on whether the reaction is mild or severe and whether it is intermittent or continuous. If the physician is inexperienced in treating this reaction, consider contacting NHDP at 1-800-642-2477 or email HRSANHDPCLINIC@HRSA.GOV.

Summary: Treatment of Reactions

During the prescribed time of treatment, hold all antibiotics during acute phase of reactions. Rifampin reduces the effectiveness of all steroids, including prednisone, so it is necessary to hold rifampin until patient is stable to obtain an optimal therapeutic response to prednisone. Another option is to increase prednisone on the day that rifampin is taken.

A practical guide for the dose of prednisone in neuritis is that the initial doses should be large enough to relieve pain and tenderness in the nerves in 24-48 hours. The maintenance dose should be large enough to prevent recurrence of nerve pain. An exception to this would be patients who have had long-standing neuritis with persistent pain probably due to scarring in and around nerves, but whose nerve function status has been stable for a long period. Prednisone is not usually beneficial in such patients.

Recommended Laboratory Monitoring
Initial: CBC, CMP, CRP, ESR, 25-hydroxy vitamin D, HBsAg, HCV Ab, QuantiFERON-TB Gold

Every three months: CBC with diff, CMP, CRP, ESR, 25-hydroxy vitamin D

*Availability of Clofazimine

Clofazimine is not available commercially in the United States.

Prescribers must complete the required enrollment and training to become a clinical investigator in the NHDP clofazimine protocol. The investigator must enroll their HD patients, obtain informed consent, and comply with the reporting requirements of the clofazimine protocol.

Please contact NHDP for further information regarding clofazimine for HD patient use.

National Hansen's Disease Program
9181 Interline Avenue
Baton Rouge, LA 70809
Email: NHDPRx@hrsa.gov
Phone: 1-800-642-2477

NHDP can provide clofazimine ONLY for Hansen's Disease treatment. Contact the FDA to obtain access to clofazimine for the treatment of non-tuberculous mycobacterial (NTM) infections other than leprosy. (FDA Clofazimine Expanded Access)