Liposomal amphotericin B (Fungisome TM ) for the treatment of cryptococcal meningitis in HIV/AIDS patients in India: A multicentric, randomized controlled trial

• Published in: Journal of postgraduate medicine (Bombay) 2010-04, Vol.56 (2), p.71-75
• Main Authors: Jadhav, M. P, Bamba, A, Shinde, V. M, Gogtay, N, Kshirsagar, N. A, Bichile, L. S, Mathai, D, Sharma, A, Varma, S, Digumarathi, R
• Format: Article
• Language: English
• Subjects: AIDS patients; Amphotericin B; Amphotericin B, cryptococcal meningitis, HIV/Acquired immune deficiency syndrome, liposomes; Cryptococcal meningitis; Dosage and administration; Drug therapy; Liposomes
• ISSN: 0022-3859; 0972-2823
• DOI: 10.4103/0022-3859.65276

Background : There is need to investigate the use of liposomal amphotericin B in cryptococcal meningitis in India. Aims : To compare the efficacy, safety, duration of treatment and cost of two doses of liposomal amphotericin B (Amp B) (Fungisome TM ) in cryptococcal meningitis in HIV/AIDS patients. Settings and Design : Prospective, randomized, multicenter study in tertiary care hospitals across India. Materials and Methods : Adult patients with culture-proven cryptococcal meningitis with HIV/AIDS were randomized to receive either 1 (Group A) or 3 mg/kg/day of Fungisome (Group B). Clinical efficacy and tolerability, laboratory evaluations and mycological response were assessed daily, twice weekly and weekly respectively. The patients were assessed at four and eight-week follow-up. Statistics : We calculated average and standard deviation for the various parameters. Results : The time to show clinical response was 13.66 days (1 mg) and 9.55 days (3 mg). In Group B (n=6 complete response), 50% patients responded within one week by microbial conversion, 83% in two weeks and 100% in three weeks. Patients with 1 mg dose (n=4 complete response), none showed microbial conversion within one week, 75% responded in two weeks, whereas one patient took four weeks. The average duration of treatment was 36.5±14.4 and 26.5±5.89 (S.D.) days in 1 and 3 mg/kg/day respectively. Drug was tolerated with little renal, hepatic or hematological toxicity. The cost was found to be 3.81 lacs and 1.74 lacs with 3mg/kg/day and 1mg/kg/day respectively. Conclusion : Higher dose showed better efficacy and quicker microbial conversion of Cerebrospinal fluid (CSF) (cerebrospinal fluid) than 1 mg/kg/day. It shortened the duration of treatment in days by 27% while drug cost almost doubled (Clinical trial registration number: ISRTCN 52812742)