Field effectiveness of new visceral leishmaniasis regimens after 1 year following treatment within public health facilities in Bihar, India.
BACKGROUND:An earlier open label, prospective, non-randomized, non-comparative, multi-centric study conducted within public health facilities in Bihar, India (CTRI/2012/08/002891) measured the field effectiveness of three new treatment regimens for visceral leishmaniasis (VL): single dose AmBisome (...
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Online Access: | https://doi.org/10.1371/journal.pntd.0007726 https://doaj.org/article/4c6a3645983c46a0b7cc724da5da08b2 |
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ftdoajarticles:oai:doaj.org/article:4c6a3645983c46a0b7cc724da5da08b2 2023-05-15T15:15:32+02:00 Field effectiveness of new visceral leishmaniasis regimens after 1 year following treatment within public health facilities in Bihar, India. Vishal Goyal Sakib Burza Krishna Pandey Shambhu Nath Singh Ravi Shankar Singh Nathalie Strub-Wourgaft Vidya Nand Rabi Das Caryn Bern Allen Hightower Suman Rijal Temmy Sunyoto Fabiana Alves Nines Lima Pradeep Das Jorge Alvar 2019-09-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0007726 https://doaj.org/article/4c6a3645983c46a0b7cc724da5da08b2 EN eng Public Library of Science (PLoS) https://doi.org/10.1371/journal.pntd.0007726 https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0007726 https://doaj.org/article/4c6a3645983c46a0b7cc724da5da08b2 PLoS Neglected Tropical Diseases, Vol 13, Iss 9, p e0007726 (2019) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2019 ftdoajarticles https://doi.org/10.1371/journal.pntd.0007726 2022-12-31T07:51:24Z BACKGROUND:An earlier open label, prospective, non-randomized, non-comparative, multi-centric study conducted within public health facilities in Bihar, India (CTRI/2012/08/002891) measured the field effectiveness of three new treatment regimens for visceral leishmaniasis (VL): single dose AmBisome (SDA), and combination therapies of AmBisome and miltefosine (AmB+Milt) and miltefosine and paromomycin (Milt+PM) up to 6 months follow-up. The National Vector Borne Disease Control Program (NVBDCP) recommended an extended follow up at 12 months post-treatment of the original study cohort to quantify late relapses. METHODS:The 1,761 patients enrolled in the original study with the three new regimens were contacted and traced between 10 and 36 months following completion of treatment to determine their health status and any occurrence of VL relapse. RESULTS:Of 1,761 patients enrolled in the original study, 1,368 were traced at the extended follow-up visit: 711 (80.5%), 295 (83.2%) and 362 (71.5%) patients treated with SDA, AmB+Milt and Milt+PM respectively. Of those traced, a total of 75 patients were reported to have relapsed by the extended follow-up; 45 (6.3%) in the SDA, 25 (8.5%) in the AmB+Milt and 5 (1.4%) in the Milt+PM arms. Of the 75 relapse cases, 55 had already been identified in the 6-months follow-up and 20 were identified as new cases of relapse at extended follow-up; 7 in the SDA, 10 in the AmB+Milt and 3 in the Milt+PM arms. CONCLUSION:Extending follow-up beyond the standard 6 months identified additional relapses, suggesting that 12-month sentinel follow-up may be useful as a programmatic tool to better identify and quantify relapses. With limited drug options, there remains an urgent need to develop effective new chemical entities (NCEs) for VL. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLOS Neglected Tropical Diseases 13 9 e0007726 |
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Open Polar |
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Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
language |
English |
topic |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
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Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Vishal Goyal Sakib Burza Krishna Pandey Shambhu Nath Singh Ravi Shankar Singh Nathalie Strub-Wourgaft Vidya Nand Rabi Das Caryn Bern Allen Hightower Suman Rijal Temmy Sunyoto Fabiana Alves Nines Lima Pradeep Das Jorge Alvar Field effectiveness of new visceral leishmaniasis regimens after 1 year following treatment within public health facilities in Bihar, India. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
BACKGROUND:An earlier open label, prospective, non-randomized, non-comparative, multi-centric study conducted within public health facilities in Bihar, India (CTRI/2012/08/002891) measured the field effectiveness of three new treatment regimens for visceral leishmaniasis (VL): single dose AmBisome (SDA), and combination therapies of AmBisome and miltefosine (AmB+Milt) and miltefosine and paromomycin (Milt+PM) up to 6 months follow-up. The National Vector Borne Disease Control Program (NVBDCP) recommended an extended follow up at 12 months post-treatment of the original study cohort to quantify late relapses. METHODS:The 1,761 patients enrolled in the original study with the three new regimens were contacted and traced between 10 and 36 months following completion of treatment to determine their health status and any occurrence of VL relapse. RESULTS:Of 1,761 patients enrolled in the original study, 1,368 were traced at the extended follow-up visit: 711 (80.5%), 295 (83.2%) and 362 (71.5%) patients treated with SDA, AmB+Milt and Milt+PM respectively. Of those traced, a total of 75 patients were reported to have relapsed by the extended follow-up; 45 (6.3%) in the SDA, 25 (8.5%) in the AmB+Milt and 5 (1.4%) in the Milt+PM arms. Of the 75 relapse cases, 55 had already been identified in the 6-months follow-up and 20 were identified as new cases of relapse at extended follow-up; 7 in the SDA, 10 in the AmB+Milt and 3 in the Milt+PM arms. CONCLUSION:Extending follow-up beyond the standard 6 months identified additional relapses, suggesting that 12-month sentinel follow-up may be useful as a programmatic tool to better identify and quantify relapses. With limited drug options, there remains an urgent need to develop effective new chemical entities (NCEs) for VL. |
format |
Article in Journal/Newspaper |
author |
Vishal Goyal Sakib Burza Krishna Pandey Shambhu Nath Singh Ravi Shankar Singh Nathalie Strub-Wourgaft Vidya Nand Rabi Das Caryn Bern Allen Hightower Suman Rijal Temmy Sunyoto Fabiana Alves Nines Lima Pradeep Das Jorge Alvar |
author_facet |
Vishal Goyal Sakib Burza Krishna Pandey Shambhu Nath Singh Ravi Shankar Singh Nathalie Strub-Wourgaft Vidya Nand Rabi Das Caryn Bern Allen Hightower Suman Rijal Temmy Sunyoto Fabiana Alves Nines Lima Pradeep Das Jorge Alvar |
author_sort |
Vishal Goyal |
title |
Field effectiveness of new visceral leishmaniasis regimens after 1 year following treatment within public health facilities in Bihar, India. |
title_short |
Field effectiveness of new visceral leishmaniasis regimens after 1 year following treatment within public health facilities in Bihar, India. |
title_full |
Field effectiveness of new visceral leishmaniasis regimens after 1 year following treatment within public health facilities in Bihar, India. |
title_fullStr |
Field effectiveness of new visceral leishmaniasis regimens after 1 year following treatment within public health facilities in Bihar, India. |
title_full_unstemmed |
Field effectiveness of new visceral leishmaniasis regimens after 1 year following treatment within public health facilities in Bihar, India. |
title_sort |
field effectiveness of new visceral leishmaniasis regimens after 1 year following treatment within public health facilities in bihar, india. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2019 |
url |
https://doi.org/10.1371/journal.pntd.0007726 https://doaj.org/article/4c6a3645983c46a0b7cc724da5da08b2 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 13, Iss 9, p e0007726 (2019) |
op_relation |
https://doi.org/10.1371/journal.pntd.0007726 https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0007726 https://doaj.org/article/4c6a3645983c46a0b7cc724da5da08b2 |
op_doi |
https://doi.org/10.1371/journal.pntd.0007726 |
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PLOS Neglected Tropical Diseases |
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13 |
container_issue |
9 |
container_start_page |
e0007726 |
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