Assessing the Efficacy and Safety of Liposomal Amphotericin B and Miltefosine in Combination for Treatment of Post Kala-Azar Dermal Leishmaniasis

2019 ◽  
Vol 221 (4) ◽  
pp. 608-617 ◽  
Author(s):  
V Ramesh ◽  
Keerti Kaumudee Dixit ◽  
Neha Sharma ◽  
Ruchi Singh ◽  
Poonam Salotra

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.

2021 ◽  
Vol 87 ◽  
pp. 34-41
Author(s):  
Krishna Pandey ◽  
Biplab Pal ◽  
Niyamat Ali Siddiqui ◽  
Chandra Shekhar Lal ◽  
Vahab Ali ◽  
...  

Background: Treatment of post-kala-azar dermal leishmaniasis cases is of paramount importance for kala-azar elimination; however, limited treatment regimens are available as of now. Aim: To compare the effectiveness of liposomal amphotericin B vs miltefosine in post-kala-azar dermal leishmaniasis patients. Methodology: This was a randomized, open-label, parallel-group study. A total of 100 patients of post kala azar dermal leishmaniasis, aged between 5 and 65 years were recruited, 50 patients in each group A (liposomal amphotericin B) and B (miltefosine). Patients were randomized to receive either liposomal amphotericin B (30 mg/kg), six doses each 5 mg/kg, biweekly for 3 weeks or miltefosine 2.5 mg/kg or 100 mg/day for 12 weeks. All the patients were followed at 3rd, 6th and 12th months after the end of the treatment. Results: In the liposomal amphotericin B group, two patients were lost to follow-up, whereas four patients were lost to follow-up in the miltefosine group. The initial cure rate by “intention to treat analysis” was 98% and 100% in liposomal amphotericin B and miltefosine group, respectively. The final cure rate by “per protocol analysis” was 74.5% and 86.9% in liposomal amphotericin B and miltefosine, respectively. Twelve patients (25.5%) in the liposomal amphotericin B group and six patients (13%) in the miltefosine group relapsed. None of the patients in either group developed any serious adverse events. Limitations: Quantitative polymerase chain reaction was not performed at all the follow-up visits and sample sizes. Conclusion: Efficacy of miltefosine was found to be better than liposomal amphotericin B, hence, the use of miltefosine as first-line therapy for post-kala-azar dermal leishmaniasis needs to be continued. However, liposomal amphotericin B could be considered as one of the treatment options for the elimination of kala-azar from the Indian subcontinent.


2021 ◽  
Vol 8 (5) ◽  
pp. 69-72
Author(s):  
Pavankumar Narapaka ◽  
Kalpana Katikala

The complication of visceral leishmaniasis is post-kala-azar dermal leishmaniasis (PKDL). PKDL typically occurs as a result of treatment failure or parasite resistance to treatment regimens, as well as poor patient follow-up. In the treatment of visceral leishmaniasis and post-kala-azar dermal leishmaniasis, Liposomal Amphotericin B is considering as first-line therapy. We're going to show you a case where Liposomal Amphotericin B was used to treat it. Keywords: visceral leishmaniasis, post-kala-azar dermal leishmaniasis, PKDL, kala-azar


Author(s):  
Srija Moulik ◽  
Ritika Sengupta ◽  
Manab Kumar Ghosh ◽  
Nilay Kanti Das ◽  
Bibhuti Saha ◽  
...  

Background: Post kala-azar dermal leishmaniasis (PKDL) is thought to be the reservoir of infection for visceral leishmaniasis in South Asia. The development of strategies for the diagnosis and treatment of PKDL are important for the implementation of the visceral leishmaniasis elimination program. Aims: Liposomal amphotericin B (L-AMB) has been an overwhelming success in the treatment of visceral leishmaniasis. However, the empirical three-week regimen of L-AMB proposed for PKDL was shown to be inadequate, especially in the macular variant. This study aimed to delineate response of the different variants of PKDL to L-AMB. Methods: Skin biopsies were collected from PKDL cases at disease presentation and upon completion of treatment with L-AMB. Parasite DNA was detected by Internal Transcribed Spacer-1 PCR (ITS-1 PCR) and quantified by amplification of parasite kDNA. CD68 + macrophages were estimated in tissue sections by immunohistochemistry. Results: Treatment with L-AMB decreased the parasite load by 97% in polymorphic cases but only by 45% in macular cases. The median parasite load (89965 vs 5445 parasites/μg of genomic DNA) as well as infiltration by CD68+ cells before treatment was much greater in the polymorphic cases. Limitations: Although monitoring of the parasite load for 12 months post-treatment would have been ideal, this was not possible owing to logistical issues as well as the invasive nature of biopsy collection procedure. Conclusion: A dramatic decrease in the parasite burden was noted in patients with polymorphic lesions. Although patients with macular disease also had a decrease in parasite burden, this was not as marked as in the polymorphic cases. There was also a significantly greater infiltration of CD68 + macrophages in polymorphic PKDL before therapy.


2003 ◽  
Vol 22 (7) ◽  
pp. 653-656 ◽  
Author(s):  
ZIJU ELANJIKAL ◽  
JAN SÖRENSEN ◽  
HELGA SCHMIDT ◽  
WOLFGANG DUPUIS ◽  
KATHRIN TINTELNOT ◽  
...  

2015 ◽  
Vol 4 (3) ◽  
pp. 222-229
Author(s):  
Can Acıpayam ◽  
Gülnaz Çulha ◽  
Ali Altunay ◽  
Fazilet Akoğlu ◽  
Alkan Yeral ◽  
...  

2008 ◽  
Vol 53 (2) ◽  
pp. 772-775 ◽  
Author(s):  
Ashraf S. Ibrahim ◽  
Teclegiorgis Gebremariam ◽  
Julie A. Schwartz ◽  
John E. Edwards ◽  
Brad Spellberg

ABSTRACT We compared the efficacy of combination posaconazole-liposomal amphotericin B (LAmB) therapy to monotherapy with either drug in diabetic ketoacidotic or neutropenic mice with disseminated zygomycosis caused by Rhizopus oryzae. Combination therapy was no better than LAmB alone, and posaconazole monotherapy did not improve survival or reduce fungal burden versus placebo.


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