Bibliographic information
Recommendation
Post-kala-azar dermal leishmaniasis (PKD)L in eastern Africa. A combination of paromomycin plus miltefosine is suggested rather than a combination of liposomal amphotericin B (LAmB) and miltefosine
Recommended in favor
Conditional
Certainty of evidence
Low
Notes and Remarks
Dose of paromomycin sulfate (20 mg/kg [equivalent to 15 mg/kg/day paromomycin base] once a day IM for 14 days) and miltefosine (allometric dose orally BID for 42 days). Dose of LAmB 5 mg/kg per day IV on days 1, 3, 5, and 7 (total dose, 20 mg/kg) and miltefosine (allometric dose orally BID for 28 days)
⸋ PKDL cases are reservoirs of infection. Although the majority of cases heal spontaneously, the GDG considered that, whenever possible, every patient should be offered treatment, in line with the VL elimination initiative in eastern Africa. ⸋ Patients should be counselled about the disease, the benefits and risks of treatment and available alternatives, which should adhere to the national patient safety policies and strategies of countries. ⸋ Miltefosine is potentially teratogenic. Its use in pregnancy is contraindicated. It should not be used in women of childbearing potential for whom pregnancy cannot be ruled out,and adequate contraception cannot be assured for the duration of treatment and for 2 months (for shorter miltefosine regimens, e.g. 5, 7 or 10 days) or for 5 months (for 28-day or longer miltefosine regimens) post-treatment (67). ⸋ The availability and the acceptability of contraception (oral versus injectable) should be taken into account before prescription. Miltefosine is potentially teratogenic. Its use in pregnancy is contraindicated. ⸋ Children: Monitoring of ocular side-effects might be particularly difficult in children; therefore, the shorter (LAmB plus miltefosine) regimen is preferred. ⸋ Severely malnourished patients: LAmB plus miltefosine might be preferred to paromomycin plus miltefosine due to the shorter treatment and the safety profile of LAmB plus miltefosine in such patients. In addition, the absence of food to accompany miltefosine intake might increase gastrointestinal side-effects, reducing compliance with therapy. ⸋ Improvement in skin lesions before the end of treatment might compromise adherence, especially to the longer (paromomycin plus miltefosine) regimen. Patient education is therefore important. ⸋ A test dose of LAmB of 1 mg should be given by infusion, followed by a full dose. ⸋ People with pre-existing ocular conditions should be excluded, and risk mitigation for miltefosinerelated ocular adverse events is essential with both regimens. (Follow advice as described in Annex 1.) ⸋ Regular eye examinations (every 2 weeks) should be conducted during and after treatment. ⸋ Educate patients to recognize symptoms.