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Long-term incidence of relapse and post-kala-azar dermal leishmaniasis after three different visceral leishmaniasis treatment regimens in Bihar, India.
PLoS Negl Trop Dis. 2020 07; 14(7):e0008429.PN

Abstract

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.

Authors+Show Affiliations

Drugs for Neglected Diseases initiative (DNDi), New York, United States of America.Division of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (RMRI), Patna, Bihar, India.Sadar Hospital Chapra, Saran, Bihar, India.Sadar Hospital Chapra, Saran, Bihar, India.Division of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (RMRI), Patna, Bihar, India.Division of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (RMRI), Patna, Bihar, India.Independent consultant, Bangkok, Thailand.Drugs for Neglected Diseases initiative (DNDi), New Delhi, India.Division of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (RMRI), Patna, Bihar, India.Drugs for Neglected Diseases initiative (DNDi), Geneva, Switzerland.School of Medicine, University of California San Francisco, San Francisco, California, United States of America.Drugs for Neglected Diseases initiative (DNDi), Geneva, Switzerland.

Pub Type(s)

Clinical Trial, Phase IV
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32687498

Citation

Goyal, Vishal, et al. "Long-term Incidence of Relapse and Post-kala-azar Dermal Leishmaniasis After Three Different Visceral Leishmaniasis Treatment Regimens in Bihar, India." PLoS Neglected Tropical Diseases, vol. 14, no. 7, 2020, pp. e0008429.
Goyal V, Das VNR, Singh SN, et al. Long-term incidence of relapse and post-kala-azar dermal leishmaniasis after three different visceral leishmaniasis treatment regimens in Bihar, India. PLoS Negl Trop Dis. 2020;14(7):e0008429.
Goyal, V., Das, V. N. R., Singh, S. N., Singh, R. S., Pandey, K., Verma, N., Hightower, A., Rijal, S., Das, P., Alvar, J., Bern, C., & Alves, F. (2020). Long-term incidence of relapse and post-kala-azar dermal leishmaniasis after three different visceral leishmaniasis treatment regimens in Bihar, India. PLoS Neglected Tropical Diseases, 14(7), e0008429. https://doi.org/10.1371/journal.pntd.0008429
Goyal V, et al. Long-term Incidence of Relapse and Post-kala-azar Dermal Leishmaniasis After Three Different Visceral Leishmaniasis Treatment Regimens in Bihar, India. PLoS Negl Trop Dis. 2020;14(7):e0008429. PubMed PMID: 32687498.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term incidence of relapse and post-kala-azar dermal leishmaniasis after three different visceral leishmaniasis treatment regimens in Bihar, India. AU - Goyal,Vishal, AU - Das,Vidya Nand Rabi, AU - Singh,Shambhu Nath, AU - Singh,Ravi Shankar, AU - Pandey,Krishna, AU - Verma,Neena, AU - Hightower,Allen, AU - Rijal,Suman, AU - Das,Pradeep, AU - Alvar,Jorge, AU - Bern,Caryn, AU - Alves,Fabiana, Y1 - 2020/07/20/ PY - 2019/11/26/received PY - 2020/05/28/accepted PY - 2020/07/30/revised PY - 2020/7/21/pubmed PY - 2020/8/22/medline PY - 2020/7/21/entrez SP - e0008429 EP - e0008429 JF - PLoS neglected tropical diseases JO - PLoS Negl Trop Dis VL - 14 IS - 7 N2 - 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. SN - 1935-2735 UR - https://www.unboundmedicine.com/medline/citation/32687498/Long_term_incidence_of_relapse_and_post_kala_azar_dermal_leishmaniasis_after_three_different_visceral_leishmaniasis_treatment_regimens_in_Bihar_India_ L2 - https://dx.plos.org/10.1371/journal.pntd.0008429 DB - PRIME DP - Unbound Medicine ER -