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Decline in Clinical Efficacy of Oral Miltefosine in Treatment of Post Kala-azar Dermal Leishmaniasis (PKDL) in India.
PLoS Negl Trop Dis. 2015; 9(10):e0004093.PN

Abstract

BACKGROUND

Recent studies have shown significant decline in the final cure rate after miltefosine treatment in visceral leishmaniasis. This study evaluates the efficacy of miltefosine in the treatment of post kala-azar dermal leishmaniasis (PKDL) patients recruited over a period of 5 years with 18 months of follow-up.

METHODOLOGY

In this study 86 confirmed cases of PKDL were treated with two different dosage regimens of miltefosine (Regimen I- 50mg twice daily for 90 days and Regimen II- 50 mg thrice for 60 days) and the clinical outcome assessed monthly. Cure/relapse was ascertained by clinical and histopathological examination, and measuring parasite burden by quantitative real-time PCR. In vitro susceptibility of parasites towards miltefosine was estimated at both promastigote and amastigote stages.

RESULTS

Seventy three of eighty six patients completed the treatment and achieved clinical cure. Approximately 4% (3/73) patients relapsed by the end of 12 months follow-up, while a total of 15% (11/73) relapsed by the end of 18 months. Relapse rate was significantly higher in regimen II (31%) compared to regimen I (10.5%)(P<0.005). Parasite load at the pre-treatment stage was significantly higher (P<0.005) in cases that relapsed compared to the cases that remained cured. In vitro susceptibility towards miltefosine of parasites isolated after relapse was significantly lower (>2 fold) in comparison with the pre-treatment isolates (P<0.005).

CONCLUSION

Relapse rate in PKDL following miltefosine treatment has increased substantially, indicating the need of introducing alternate drugs/ combination therapy with miltefosine.

Authors+Show Affiliations

Dermatology Department, Safdarjung Hospital and Vardhman Mahavir Medical College (VMMC), New Delhi, India.National Institute of Pathology (ICMR), Safdarjung Hospital Campus, New Delhi, India.National Institute of Pathology (ICMR), Safdarjung Hospital Campus, New Delhi, India.National Institute of Pathology (ICMR), Safdarjung Hospital Campus, New Delhi, India.National Institute of Pathology (ICMR), Safdarjung Hospital Campus, New Delhi, India.National Institute of Pathology (ICMR), Safdarjung Hospital Campus, New Delhi, India.National Institute of Pathology (ICMR), Safdarjung Hospital Campus, New Delhi, India.

Pub Type(s)

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

Language

eng

PubMed ID

26492039

Citation

Ramesh, V, et al. "Decline in Clinical Efficacy of Oral Miltefosine in Treatment of Post Kala-azar Dermal Leishmaniasis (PKDL) in India." PLoS Neglected Tropical Diseases, vol. 9, no. 10, 2015, pp. e0004093.
Ramesh V, Singh R, Avishek K, et al. Decline in Clinical Efficacy of Oral Miltefosine in Treatment of Post Kala-azar Dermal Leishmaniasis (PKDL) in India. PLoS Negl Trop Dis. 2015;9(10):e0004093.
Ramesh, V., Singh, R., Avishek, K., Verma, A., Deep, D. K., Verma, S., & Salotra, P. (2015). Decline in Clinical Efficacy of Oral Miltefosine in Treatment of Post Kala-azar Dermal Leishmaniasis (PKDL) in India. PLoS Neglected Tropical Diseases, 9(10), e0004093. https://doi.org/10.1371/journal.pntd.0004093
Ramesh V, et al. Decline in Clinical Efficacy of Oral Miltefosine in Treatment of Post Kala-azar Dermal Leishmaniasis (PKDL) in India. PLoS Negl Trop Dis. 2015;9(10):e0004093. PubMed PMID: 26492039.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Decline in Clinical Efficacy of Oral Miltefosine in Treatment of Post Kala-azar Dermal Leishmaniasis (PKDL) in India. AU - Ramesh,V, AU - Singh,Ruchi, AU - Avishek,Kumar, AU - Verma,Aditya, AU - Deep,Deepak Kumar, AU - Verma,Sandeep, AU - Salotra,Poonam, Y1 - 2015/10/22/ PY - 2015/01/23/received PY - 2015/08/29/accepted PY - 2015/10/23/entrez PY - 2015/10/23/pubmed PY - 2016/3/29/medline SP - e0004093 EP - e0004093 JF - PLoS neglected tropical diseases JO - PLoS Negl Trop Dis VL - 9 IS - 10 N2 - BACKGROUND: Recent studies have shown significant decline in the final cure rate after miltefosine treatment in visceral leishmaniasis. This study evaluates the efficacy of miltefosine in the treatment of post kala-azar dermal leishmaniasis (PKDL) patients recruited over a period of 5 years with 18 months of follow-up. METHODOLOGY: In this study 86 confirmed cases of PKDL were treated with two different dosage regimens of miltefosine (Regimen I- 50mg twice daily for 90 days and Regimen II- 50 mg thrice for 60 days) and the clinical outcome assessed monthly. Cure/relapse was ascertained by clinical and histopathological examination, and measuring parasite burden by quantitative real-time PCR. In vitro susceptibility of parasites towards miltefosine was estimated at both promastigote and amastigote stages. RESULTS: Seventy three of eighty six patients completed the treatment and achieved clinical cure. Approximately 4% (3/73) patients relapsed by the end of 12 months follow-up, while a total of 15% (11/73) relapsed by the end of 18 months. Relapse rate was significantly higher in regimen II (31%) compared to regimen I (10.5%)(P<0.005). Parasite load at the pre-treatment stage was significantly higher (P<0.005) in cases that relapsed compared to the cases that remained cured. In vitro susceptibility towards miltefosine of parasites isolated after relapse was significantly lower (>2 fold) in comparison with the pre-treatment isolates (P<0.005). CONCLUSION: Relapse rate in PKDL following miltefosine treatment has increased substantially, indicating the need of introducing alternate drugs/ combination therapy with miltefosine. SN - 1935-2735 UR - https://www.unboundmedicine.com/medline/citation/26492039/Decline_in_Clinical_Efficacy_of_Oral_Miltefosine_in_Treatment_of_Post_Kala_azar_Dermal_Leishmaniasis__PKDL__in_India_ L2 - https://dx.plos.org/10.1371/journal.pntd.0004093 DB - PRIME DP - Unbound Medicine ER -