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.

Adults: Tuberculoid (TT & BT) (WHO classification Paucibacillary, “PB”)

Agent	Dose	Duration
Dapsone	100 mg daily	12 months, and then therapy discontinued
Rifampicin	600 mg daily	12 months, and then therapy discontinued

Adults: Lepromatous (LL, BL, BB) (WHO classification Multibacillary, “MB”)

Agent	Dose	Duration a
Dapsone	100 mg daily	24 months, and then therapy discontinued
Rifampicin	600 mg daily	24 months, and then therapy discontinued
Clofazimine b	50 mg daily	24 months, and then therapy discontinued

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.

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 and a curriculum vitae to the NHDP. A packet of information including the form 1572 as well as consent forms, etc., will be provided. An Institutional Review Board (IRB) of the Centers for Disease Control and Prevention has agreed to act as the central IRB for the use of Clofazimine for Hansen's Disease, so that individual physicians do not need to arrange this themselves. For further information, or to request investigator status to use Clofazimine, please call the NHDP at 1-800-642-2477.

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.

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.

Treatment for children: Tuberculoid (TT & BT) (WHO Paucibacillary, “PB”)

Agent	Dose	Duration
Dapsone	1 mg/ Kg daily	12 months, and then therapy discontinued
Rifampicin	10-20 mg/ Kg daily (not > 600)	12 months, and then therapy discontinued

Treatment for children: Lepromatous (LL, BL, BB) (WHO Multibacillary, “MB”)

Agent	Dose	Duration
Dapsone	1 mg/ Kg daily	24 months, and then therapy discontinued
Rifampicin	10-20 mg/ Kg daily (not > 600)	24 months, and then therapy discontinued
Clofazimine	1.0 mg/ Kg dailyc	24 months, and then therapy discontinued

3. As there is no formulation less than 50 mg, and the capsule should never be cut open, alternate day dosing may be used at 2 mg/kg.

Laboratory Monitoring

I. Recommended Laboratory Tests and Frequency

	Initial visit	2nd visit (1-2 months)	3m	6m	12m	18m	24m
CBC + platelets	X	X	X	X	X	X	X
AST	X		X	X	X	X	X
ALT	X		X	X	X	X	X
Ca	X
BUN	X
Creatinine	X
Bilirubin	X
G6PD	X
Hepatitis B*
Hepatitis C*

*Screen for these or other co-morbidities if patient requires prednisone for reaction

II. Other tests

1. UA should be done annually with these studies for all patients.
2. PCR Assay (Polymerase Chain Reaction)
   PCR is performed routinely on all biopsies sent to NHDP. For questions call 1-800-642-2477.