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49. The Panel suggests that clinicians closely monitor persons with
asymptomatic visceral infection and generally initiate therapy only if
clinical manifestations of VL develop (W-VL).
50. For an immunocompetent person with VL, treatment with liposomal
amphotericin B (L-AmB) is recommended. The FDA-approved dosage
regimen is 3 mg/kg/day IV on days 1–5, 14, and 21 (total dose,
21 mg/kg) (Table 3) (S-H).
Remarks: Multiple regimens in which the total L-AmB dose is 18–21 mg/kg have
been used effectively in regions other than East Africa.
Doses of 40 mg/kg or more may be necessary in persons with VL acquired in East
Africa. Other lipid-associated formulations of amphotericin B, such as amphotericin
B lipid complex and amphotericin B colloidal dispersion, are not generally
recommended: they have not been approved by FDA for treatment of VL; and they
have been less well studied in VL treatment trials (ie, bioequivalence has not been
established).
51. For an immunocompetent person with VL caused by L. donovani,
acquired in the Indian subcontinent (South Asia), who is >12 years
of age, weighs >30 kg, and is not pregnant or breastfeeding,
treatment with the oral agent miltefosine, 2.5 mg/kg per day
(maximum, 150 mg, in 3 divided doses) for 28 days, is a possible
alternative to L-AmB, particularly in persons weighing <75 kg (see
Recs. 78–79 and Table 3) (S-M).
52. Pentavalent antimonial therapy (20 mg SbV/kg/day IV or IM for
28 days) is a recommended therapy for immunocompetent persons
with VL acquired in areas where the prevalence of antimony-resistant
Leishmania species is low (<10%) (S-H).
53. The Panel does NOT recommend switching to amphotericin B
deoxycholate in persons with contraindications to, or substantial
toxicity with, L-AmB, with the exception of persons who develop
liposome-induced complement activation-related pseudoallergy
(CARPA). Amphotericin B lipid complex is a consideration in this
situation (S-L).
Response Assessment
54. Clinical parameters correlate well with parasitologic responses to VL
treatment and should be used to monitor the response (S-L).
55. Parasitologic confirmation of response (such as by repeat bone
marrow aspiration for microscopy and culture after treatment) is
NOT recommended in a patient showing a timely clinical response.
Antibody levels fall but over many months or longer (S-M).
Treatment
