Long-term incidence of relapse and post-kala-azar dermal leishmaniasis after three different visceral leishmaniasis treatment regimens in Bihar, India.
Background Few prospective data exist on incidence of post kala-azar dermal leishmaniasis (PKDL) and visceral leishmaniasis (VL) relapse after different treatment regimens. Methodology/principal findings A Phase IV trial included 1761 VL patients treated between 2012-2014 with single dose AmBisome (...
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ftdoajarticles:oai:doaj.org/article:b22b4f7e4946414e9077e0e3b5079fd0 2023-05-15T15:12:48+02:00 Long-term incidence of relapse and post-kala-azar dermal leishmaniasis after three different visceral leishmaniasis treatment regimens in Bihar, India. Vishal Goyal Vidya Nand Rabi Das Shambhu Nath Singh Ravi Shankar Singh Krishna Pandey Neena Verma Allen Hightower Suman Rijal Pradeep Das Jorge Alvar Caryn Bern Fabiana Alves 2020-07-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0008429 https://doaj.org/article/b22b4f7e4946414e9077e0e3b5079fd0 EN eng Public Library of Science (PLoS) https://doi.org/10.1371/journal.pntd.0008429 https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0008429 https://doaj.org/article/b22b4f7e4946414e9077e0e3b5079fd0 PLoS Neglected Tropical Diseases, Vol 14, Iss 7, p e0008429 (2020) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2020 ftdoajarticles https://doi.org/10.1371/journal.pntd.0008429 2022-12-31T07:36:44Z Background Few prospective data exist on incidence of post kala-azar dermal leishmaniasis (PKDL) and visceral leishmaniasis (VL) relapse after different treatment regimens. Methodology/principal findings A Phase IV trial included 1761 VL patients treated between 2012-2014 with single dose AmBisome (SDA; N = 891), miltefosine-paromomycin (Milt-PM; n = 512), or AmBisome-miltefosine (AmB-Milt; n = 358). Follow-up for PKDL and VL relapse was scheduled for 6, 12 and 24 months after treatment, lasting until 2017. Patients with lesions consistent with PKDL were tested by rK39 rapid test, and if positive, underwent skin-snip sampling, smear microscopy and PCR. Probable PKDL was defined by consistent lesions and positive rK39; confirmed PKDL required additional positive microscopy or PCR. PKDL and relapse incidence density were calculated by VL treatment and risk factors evaluated in Cox proportional hazards models. Among 1,750 patients who completed treatment, 79 had relapse and 104 PKDL. Relapse incidence density was 1.58, 2.08 and 0.40 per 1000 person-months for SDA, AmB-Milt and Milt-PM, respectively. PKDL incidence density was 1.29, 1.45 and 2.65 per 1000 person-months for SDA, AmB-Milt and Milt-PM. In multivariable models, patients treated with Milt-PM had lower relapse but higher PKDL incidence than those treated with SDA; AmB-Milt rates were not significantly different from those for SDA. Children <12 years were at higher risk for both outcomes; females had a higher risk of PKDL but not relapse. Conclusions/significance Active surveillance for PKDL and relapse, followed by timely treatment, is essential to sustain the achievements of VL elimination programs in the Indian sub-continent. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Azar ENVELOPE(-63.733,-63.733,-64.983,-64.983) Indian PLOS Neglected Tropical Diseases 14 7 e0008429 |
institution |
Open Polar |
collection |
Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
topic |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
spellingShingle |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Vishal Goyal Vidya Nand Rabi Das Shambhu Nath Singh Ravi Shankar Singh Krishna Pandey Neena Verma Allen Hightower Suman Rijal Pradeep Das Jorge Alvar Caryn Bern Fabiana Alves Long-term incidence of relapse and post-kala-azar dermal leishmaniasis after three different visceral leishmaniasis treatment regimens in Bihar, India. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
Background Few prospective data exist on incidence of post kala-azar dermal leishmaniasis (PKDL) and visceral leishmaniasis (VL) relapse after different treatment regimens. Methodology/principal findings A Phase IV trial included 1761 VL patients treated between 2012-2014 with single dose AmBisome (SDA; N = 891), miltefosine-paromomycin (Milt-PM; n = 512), or AmBisome-miltefosine (AmB-Milt; n = 358). Follow-up for PKDL and VL relapse was scheduled for 6, 12 and 24 months after treatment, lasting until 2017. Patients with lesions consistent with PKDL were tested by rK39 rapid test, and if positive, underwent skin-snip sampling, smear microscopy and PCR. Probable PKDL was defined by consistent lesions and positive rK39; confirmed PKDL required additional positive microscopy or PCR. PKDL and relapse incidence density were calculated by VL treatment and risk factors evaluated in Cox proportional hazards models. Among 1,750 patients who completed treatment, 79 had relapse and 104 PKDL. Relapse incidence density was 1.58, 2.08 and 0.40 per 1000 person-months for SDA, AmB-Milt and Milt-PM, respectively. PKDL incidence density was 1.29, 1.45 and 2.65 per 1000 person-months for SDA, AmB-Milt and Milt-PM. In multivariable models, patients treated with Milt-PM had lower relapse but higher PKDL incidence than those treated with SDA; AmB-Milt rates were not significantly different from those for SDA. Children <12 years were at higher risk for both outcomes; females had a higher risk of PKDL but not relapse. Conclusions/significance Active surveillance for PKDL and relapse, followed by timely treatment, is essential to sustain the achievements of VL elimination programs in the Indian sub-continent. |
format |
Article in Journal/Newspaper |
author |
Vishal Goyal Vidya Nand Rabi Das Shambhu Nath Singh Ravi Shankar Singh Krishna Pandey Neena Verma Allen Hightower Suman Rijal Pradeep Das Jorge Alvar Caryn Bern Fabiana Alves |
author_facet |
Vishal Goyal Vidya Nand Rabi Das Shambhu Nath Singh Ravi Shankar Singh Krishna Pandey Neena Verma Allen Hightower Suman Rijal Pradeep Das Jorge Alvar Caryn Bern Fabiana Alves |
author_sort |
Vishal Goyal |
title |
Long-term incidence of relapse and post-kala-azar dermal leishmaniasis after three different visceral leishmaniasis treatment regimens in Bihar, India. |
title_short |
Long-term incidence of relapse and post-kala-azar dermal leishmaniasis after three different visceral leishmaniasis treatment regimens in Bihar, India. |
title_full |
Long-term incidence of relapse and post-kala-azar dermal leishmaniasis after three different visceral leishmaniasis treatment regimens in Bihar, India. |
title_fullStr |
Long-term incidence of relapse and post-kala-azar dermal leishmaniasis after three different visceral leishmaniasis treatment regimens in Bihar, India. |
title_full_unstemmed |
Long-term incidence of relapse and post-kala-azar dermal leishmaniasis after three different visceral leishmaniasis treatment regimens in Bihar, India. |
title_sort |
long-term incidence of relapse and post-kala-azar dermal leishmaniasis after three different visceral leishmaniasis treatment regimens in bihar, india. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2020 |
url |
https://doi.org/10.1371/journal.pntd.0008429 https://doaj.org/article/b22b4f7e4946414e9077e0e3b5079fd0 |
long_lat |
ENVELOPE(-63.733,-63.733,-64.983,-64.983) |
geographic |
Arctic Azar Indian |
geographic_facet |
Arctic Azar Indian |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 14, Iss 7, p e0008429 (2020) |
op_relation |
https://doi.org/10.1371/journal.pntd.0008429 https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0008429 https://doaj.org/article/b22b4f7e4946414e9077e0e3b5079fd0 |
op_doi |
https://doi.org/10.1371/journal.pntd.0008429 |
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PLOS Neglected Tropical Diseases |
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14 |
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7 |
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e0008429 |
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1766343438409662464 |