Different liposomal amphotericin B formulations for visceral leishmaniasis
Authors: Thomas P C Dorlo, Manica Balasegaram
Journal: The Lancet Global Health (2014)

In response to the promising results of a single dose of liposomal amphotericin B (AmBisome) to treat visceral leishmaniasis in Bangladesh, Nilima Kshirsagar (April issue),1Kshirsagar NA Single-dose liposomal amphotericin B for visceral leishmaniasis.Lancet Glob Health. 2014; 2: e203Summary Full Text Full Text PDF PubMed Scopus (2) Google Scholar suggests that an alternative form—Fungisome—might soon qualify for similar use and application. AmBisome was the first formulation of amphotericin B that maximised efficacy in visceral leishmaniasis while minimising toxic effects. Fungisome is the brand name of a liposomal amphotericin B product developed in Kshirsagar's own laboratory2Kshirsagar NA Pandya SK Kirodian GB Sanath S Liposomal drug delivery system from laboratory to clinic.J Postgrad Med. 2005; 51: S5-15PubMed Google Scholar and marketed by LifeCare Innovations. It cannot be considered a generic of AmBisome because the liposomal compositions are not comparable. To transform multilamellar vesicles into small unilamellar vesicles, Fungisome requires sonication for 45 min before administration, which is technically very challenging in programmatic settings for visceral leishmaniasis. Moreover, published evidence on the efficacy and safety of Fungisome in visceral leishmaniasis, either in single-dose or multidose regimens, is very limited.3Mondal S Bhattacharya P Rahaman M Ali N Goswami RP A curative immune profile one week after treatment of Indian kala-azar patients predicts success with a short-course liposomal amphotericin B therapy.PLoS Negl Trop Dis. 2010; 4: e764Crossref PubMed Scopus (35) Google Scholar The phase 2–3 clinical trials that Kshirsagar mentions were actually in fungal infections.2Kshirsagar NA Pandya SK Kirodian GB Sanath S Liposomal drug delivery system from laboratory to clinic.J Postgrad Med. 2005; 51: S5-15PubMed Google Scholar An ongoing phase 2 trial is assessing single-dose Fungisome for visceral leishmaniasis in India.4Gaspani S Milani B Access to liposomal generic formulations: beyond AmBisome and Doxil/Caelyx.Generics Biosimilars Initiative J. 2013; 2: 60-62Crossref Google Scholar Beyond Fungisome, other products could be considered as generics of liposomal amphotericin B. Bioequivalence to AmBisome has to be established then through adapted processes.4Gaspani S Milani B Access to liposomal generic formulations: beyond AmBisome and Doxil/Caelyx.Generics Biosimilars Initiative J. 2013; 2: 60-62Crossref Google Scholar Before any generic product can be used for visceral leishmaniasis, liposomal amphotericin B suppliers should submit their products to the WHO Prequalification Programme, the remit of which has been expanded to liposomal amphotericin B,5WHO11th invitation to manufacturers and suppliers of medicinal products for HIV infection and related diseases to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification of Medicines Programme.http://apps.who.int/prequal/info_applicants/eoi/EOI-HIV-v11.pdfGoogle Scholar to determine which medicines are quality-assured and bioequivalent to AmBisome. This is the only safeguard to avoid exposing visceral leishmaniasis patients to products with an unassessed safety and efficacy profile. We declare that we have no competing interests. Single-dose liposomal amphotericin B for visceral leishmaniasisDinesh Mondal and colleagues (January, p e51)1 investigated the safety and efficacy of single-dose liposomal amphotericin B for treatment of visceral leishmaniasis (also known as kala azar) in Bangladesh. The successful administration of single-dose liposomal amphotericin B at a primary health centre is heartening. In a linked Comment, Prabhat Kumar Sinha and Sujit Bhattacharya2 discussed adverse events reported in the study. Concerns about potential risks of adverse drug reactions and resistance prompted WHO to initiate pharmacovigilance for miltefosine,3 another drug used to treat leishmaniasis, and develop an educational manual for patients and health workers. Full-Text PDF Open Access