Single-dose liposomal amphotericin B in the treatment of visceral leishmaniasis in India: a multicenter study.
Widespread antimony resistance renders conventional amphotericin B the only option for the treatment of visceral leishmaniasis (VL) in North Bihar, India. Because of its excellent safety profile, a large dose (7.5 mg/kg) of liposomal amphotericin B (L-AmB) was given to each of 203 patients with VL at 4 treatment centers, and the patients were discharged the next day. At initial clinical and parasitological follow-up, performed on day 30 after treatment, evidence of a cure was seen in 195 (96%) of 203 patients (95% CI, 92-98); 4 patients experienced treatment failure. Two patients were lost to follow-up, 2 died (one due to progressive disease and another, 5 months after treatment, due to an unrelated illness), and 12 experienced relapses during follow-up. Thus, 183 patients (90%; 95% CI, 85-94) had obtained final cure 6 months after treatment. Very few adverse events (fever with rigor, in 9.8% of patients) were seen. Single-dose L-AmB (7.5 mg/kg) treatment is safe and effective, and it may be used for the mass treatment of VL in India.
Sundar
S
S
Kala-azar Medical Research Center, Banaras Hindu University, Varanasi, 221 005, India. shyam_vns@satyam.net.in
Jha
T K
TK
Thakur
C P
CP
Mishra
M
M
Singh
V P
VP
Buffels
R
R
D000293:Adolescent; D000328:Adult; D000666:Amphotericin B / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D000818:Animals; D000981:Antiprotozoal Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D002648:Child; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D007898:Leishmaniasis, Visceral / Q000188:drug therapy*; D008081:Liposomes / Q000737:chemistry*; D008297:Male; D008875:Middle Aged; D010715:Phosphatidylglycerols / Q000737:chemistry; D016896:Treatment Outcome
D000981:Antiprotozoal Agents; D008081:Liposomes; D010715:Phosphatidylglycerols; D000666:Amphotericin B