Recommended Treatment Regimens

Following are the general NHDP recommendations.  NHDP recommendations are for daily rifampin, and for longer duration of treatment than the WHO recommendations, largely due to WHO’s cost considerations for developing countries.  Treatment that is more intensive and of longer duration is medically preferable.

Treatment guidelines for immunologically competent individuals, (e.g. those without immunodeficiency, immunosuppression, prolonged corticosteroid use, etc.) are as follows.  

1. The recommended durations of treatment are sufficient, even though large numbers of dead bacilli may remain in the tissues for several years, before they are eliminated by physiological processes.  There is no evidence that additional, prolonged treatment hastens the elimination of these dead organisms. 
   
   
2. Clofazimine, used for decades to treat HD around the world, is no longer available on the open market.  Because it is no longer distributed commercially, the only way we can obtain the drug in the U.S. is to once again treat it as an investigational new drug (IND). The NHDP holds this IND for its use in treating HD in the U.S.

In order for physicians to obtain the drug for treating HD, they will have to be registered as an investigator under the NHDP IND.  This will require submitting a signed FDA form 1572, providing a curriculum vitae, and obtaining and maintaining local Institutional Review Board (IRB) approval.  A packet of information will be provided including everything that is needed for submission to the local IRB, e.g. treatment protocol, sample consent form and prescribing information.  The NHDP provides guidance in this process but cannot obtain approval for physicians at any other clinic in the United States.  Further information about this process can be obtained from the NHDP at 1-800-642-2477

For immunologically compromised patients, these protocols may be modified, and consultation with the NHDP is recommended.  

ALTERNATIVE ANTI-MICROBIAL AGENTS

Minocycline, 100 mg daily, can be used as a substitute for Dapsone in individuals who do not tolerate this drug.  It can also be used instead of Clofazimine, although evidence of the efficacy of its anti-inflammatory activity against Type 2 reactions is not as substantial as the evidence for Clofazimine.

Clarithromycin, 500 mg daily is also effective against M. leprae, and can be used as a substitute for any of the other drugs in a multiple drug regimen.  In children, this drug is recommended in place of Clofazimine, since Clofazimine cannot be used in children in the United States. 

Ofloxacin, 400 mg daily, may also be used in place of Clofazimine, for adults.  This is not recommended for children. 

In the United States, the occurrence of leprosy in children is rare.  We strongly recommend contacting the NHDP for management of leprosy in children; the following are general guidelines. 

3. In children, this drug is recommended in place of Clofazimine, since Clofazimine cannot be used in children in the United States.