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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Published in:PLoS neglected tropical diseases 2020-07, Vol.14 (7), p.e0008429-e0008429
Main Authors: Goyal, Vishal, Das, Vidya Nand Rabi, Singh, Shambhu Nath, Singh, Ravi Shankar, Pandey, Krishna, Verma, Neena, Hightower, Allen, Rijal, Suman, Das, Pradeep, Alvar, Jorge, Bern, Caryn, Alves, Fabiana
Format: Article
Language:English
Subjects:
Biology and Life Sciences
Causes of
Clinical medicine
Complications and side effects
Density
Development and progression
DNA
Drug dosages
Drug therapy
Funding
Lesions
Medicine
Medicine and Health Sciences
Microscopy
Miltefosine
Nucleotide sequence
Parasitic diseases
Paromomycin
Patient outcomes
Patients
PCR
Recurrence (Disease)
Risk analysis
Risk factors
Skin
Skin diseases
Software
Statistical models
Tropical diseases
Vector-borne diseases
Visceral leishmaniasis
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Summary: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
ISSN:1935-2735
1935-2727
1935-2735
DOI:10.1371/journal.pntd.0008429