Effectiveness and safety of liposomal amphotericin B for visceral leishmaniasis under routine program conditions in Bihar, India.
We evaluated, through the prospective monitoring of 251 patients at Sadar Hospital in Bihar, India, the effectiveness and safety of 20 mg/kg body weight of liposomal amphotericin B for the treatment of visceral leishmaniasis. The treatment success rates for the intention-to-treat, per protocol, and intention-to-treat worse-case scenario analyses were 98.8%, 99.6%, and 81.3%, respectively. Nearly one-half of patients experienced mild adverse events, but only 1% developed serious but non-life-threatening lips swelling. The lost to follow-up rate was 17.5%. Our findings indicate that the 20 mg/kg body weight treatment dosage is effective and safe under routine program conditions. Given that the exorbitant cost of liposomal amphotericin B is a barrier to its widespread use, we recommend further study to monitor and evaluate a lowered dosage and a shorter treatment course.
Sinha
Prabhat K
PK
Rajendra Memorial Research Institute of Medical Science, Patna, Bihar, India.
Roddy
Paul
P
Palma
Pedro Pablo
PP
Kociejowski
Alice
A
Lima
María Angeles
MA
Rabi Das
Vidya Nand
VN
Gupta
Jitendra
J
Kumar
Nawin
N
Mitra
Gaurab
G
Saint-Sauveur
Jean-François
JF
Seena
Siju
S
Balasegaram
Manica
M
Parreño
Fernando
F
Pandey
Krishna
K
D000293:Adolescent; D000328:Adult; D000666:Amphotericin B / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D000981:Antiprotozoal Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D005260:Female; D006801:Humans; D007194:India; D007898:Leishmaniasis, Visceral / Q000188:drug therapy*; D008081:Liposomes; D008297:Male; D008875:Middle Aged; D055815:Young Adult
D000981:Antiprotozoal Agents; D008081:Liposomes; C068538:liposomal amphotericin B; D000666:Amphotericin B