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Assessing the Efficacy and Safety of Liposomal Amphotericin B and Miltefosine in Combination for Treatment of Post Kala-Azar Dermal Leishmaniasis.
J Infect Dis. 2020 02 03; 221(4):608-617.JI

Abstract

BACKGROUND

No satisfactory canonical treatment is available for post-kala-azar dermal leishmaniasis (PKDL), clinical sequela of visceral leishmaniasis. Confined treatment options and substantial increase in relapse rate after miltefosine (MIL) treatment warrant the need to adapt resilient combination therapies. In this study, we assessed the safety and efficacy of combination therapy using liposomal amphotericin B (LAmB) and MIL for treating PKDL.

METHODS

Thirty-two PKDL patients, confirmed by microscopy or quantitative polymerase chain reaction (qPCR), were included in the study. An equal number of cases (n = 16) were put on MIL monotherapy (100 mg/day for 90 days) or MIL and LAmB combination for 45 days (3 injections of LAmB, 5 mg/kg body weight, and 100 mg/day MIL). Parasite load in slit aspirate was monitored using qPCR.

RESULTS

Patients treated with combination therapy demonstrated a rapid decline in parasite load and achieved 100% cure, with no reports of relapse. Those treated with MIL monotherapy attained clinical cure with a gradual decrease in parasite load; however, 25% relapsed within 18 months of follow-up.

CONCLUSIONS

Liposomal amphotericin B and MIL combination for treating PKDL is efficacious and safe, with high tolerability. Furthermore, this study established the utility of minimally invasive slit aspirate method for monitoring of parasite load and assessment of cure in PKDL.

Authors+Show Affiliations

Department of Dermatology, Safdarjung Hospital and Vardhman Mahavir Medical College, New Delhi, India.Indian Council of Medical Research- National Institute of Pathology, Safdarjung Hospital Campus, New Delhi, India. Faculty of Health and Biological Sciences, Symbiosis International (Deemed University), Pune, India.Department of Dermatology, Safdarjung Hospital and Vardhman Mahavir Medical College, New Delhi, India.Indian Council of Medical Research- National Institute of Pathology, Safdarjung Hospital Campus, New Delhi, India.Indian Council of Medical Research- National Institute of Pathology, Safdarjung Hospital Campus, New Delhi, India.

Pub Type(s)

Journal Article
Observational Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31854451

Citation

Ramesh, V, et al. "Assessing the Efficacy and Safety of Liposomal Amphotericin B and Miltefosine in Combination for Treatment of Post Kala-Azar Dermal Leishmaniasis." The Journal of Infectious Diseases, vol. 221, no. 4, 2020, pp. 608-617.
Ramesh V, Dixit KK, Sharma N, et al. Assessing the Efficacy and Safety of Liposomal Amphotericin B and Miltefosine in Combination for Treatment of Post Kala-Azar Dermal Leishmaniasis. J Infect Dis. 2020;221(4):608-617.
Ramesh, V., Dixit, K. K., Sharma, N., Singh, R., & Salotra, P. (2020). Assessing the Efficacy and Safety of Liposomal Amphotericin B and Miltefosine in Combination for Treatment of Post Kala-Azar Dermal Leishmaniasis. The Journal of Infectious Diseases, 221(4), 608-617. https://doi.org/10.1093/infdis/jiz486
Ramesh V, et al. Assessing the Efficacy and Safety of Liposomal Amphotericin B and Miltefosine in Combination for Treatment of Post Kala-Azar Dermal Leishmaniasis. J Infect Dis. 2020 02 3;221(4):608-617. PubMed PMID: 31854451.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Assessing the Efficacy and Safety of Liposomal Amphotericin B and Miltefosine in Combination for Treatment of Post Kala-Azar Dermal Leishmaniasis. AU - Ramesh,V, AU - Dixit,Keerti Kaumudee, AU - Sharma,Neha, AU - Singh,Ruchi, AU - Salotra,Poonam, PY - 2019/07/11/received PY - 2019/11/08/accepted PY - 2019/12/20/pubmed PY - 2020/9/22/medline PY - 2019/12/20/entrez KW - combination therapy KW - liposomal amphotericin B KW - miltefosine KW - post-kala-azar dermal leishmaniasis KW - visceral leishmaniasis SP - 608 EP - 617 JF - The Journal of infectious diseases JO - J Infect Dis VL - 221 IS - 4 N2 - BACKGROUND: No satisfactory canonical treatment is available for post-kala-azar dermal leishmaniasis (PKDL), clinical sequela of visceral leishmaniasis. Confined treatment options and substantial increase in relapse rate after miltefosine (MIL) treatment warrant the need to adapt resilient combination therapies. In this study, we assessed the safety and efficacy of combination therapy using liposomal amphotericin B (LAmB) and MIL for treating PKDL. METHODS: Thirty-two PKDL patients, confirmed by microscopy or quantitative polymerase chain reaction (qPCR), were included in the study. An equal number of cases (n = 16) were put on MIL monotherapy (100 mg/day for 90 days) or MIL and LAmB combination for 45 days (3 injections of LAmB, 5 mg/kg body weight, and 100 mg/day MIL). Parasite load in slit aspirate was monitored using qPCR. RESULTS: Patients treated with combination therapy demonstrated a rapid decline in parasite load and achieved 100% cure, with no reports of relapse. Those treated with MIL monotherapy attained clinical cure with a gradual decrease in parasite load; however, 25% relapsed within 18 months of follow-up. CONCLUSIONS: Liposomal amphotericin B and MIL combination for treating PKDL is efficacious and safe, with high tolerability. Furthermore, this study established the utility of minimally invasive slit aspirate method for monitoring of parasite load and assessment of cure in PKDL. SN - 1537-6613 UR - https://www.unboundmedicine.com/medline/citation/31854451/Assessing_the_Efficacy_and_Safety_of_Liposomal_Amphotericin_B_and_Miltefosine_in_Combination_for_Treatment_of_Post_Kala_Azar_Dermal_Leishmaniasis_ L2 - https://academic.oup.com/jid/article-lookup/doi/10.1093/infdis/jiz486 DB - PRIME DP - Unbound Medicine ER -