Tags

Type your tag names separated by a space and hit enter

Risk factors for visceral leishmaniasis relapse in immunocompetent patients following treatment with 20 mg/kg liposomal amphotericin B (Ambisome) in Bihar, India.
PLoS Negl Trop Dis. 2014; 8(1):e2536.PN

Abstract

BACKGROUND

A proportion of all immunocompetent patients treated for visceral leishmaniasis (VL) are known to relapse; however, the risk factors for relapse are not well understood. With the support of the Rajendra Memorial Research Institute (RMRI), Médecins Sans Frontières (MSF) implemented a program in Bihar, India, using intravenous liposomal amphotericin B (Ambisome) as a first-line treatment for VL. The aim of this study was to identify risk factors for VL relapse by examining the characteristics of immunocompetent patients who relapsed following this regimen.

METHODS AND PRINCIPAL FINDINGS

This is an observational retrospective cohort study of all VL patients treated by the MSF program from July 2007 to August 2012. Intravenous Ambisome was administered to 8749 patients with VL in four doses of 5 mg/kg (for a total dose of 20 mg/kg) over 4-10 days, depending on the severity of disease. Out of 8588 patients not known to be HIV-positive, 8537 (99.4%) were discharged as initial cures, 24 (0.3%) defaulted, and 27 (0.3%) died during or immediately after treatment. In total, 1.4% (n = 119) of the initial cured patients re-attended the programme with parasitologically confirmed VL relapse, with a median time to relapse of 10.1 months. Male sex, age <5 years and ≥45 years, a decrease in spleen size at time of discharge of ≤0.5 cm/day, and a shorter duration of symptoms prior to seeking treatment were significantly associated with relapse. Spleen size at admission, hemoglobin level, nutritional status, and previous history of relapse were not associated with relapse.

CONCLUSIONS

This is the largest cohort of VL patients treated with Ambisome worldwide. The risk factors for relapse included male sex, age <5 and ≥45 years, a smaller decrease in splenomegaly at discharge, and a shorter duration of symptoms prior to seeking treatment. The majority of relapses in this cohort occurred 6-12 months following treatment, suggesting that a 1-year follow-up is appropriate in future studies.

Authors+Show Affiliations

Médecins Sans Frontières, New Delhi, India.Rajendra Memorial Research Institute of Medical Sciences, Patna, Bihar, India.Médecins Sans Frontières, New Delhi, India.Médecins Sans Frontières, Barcelona, Spain.Médecins Sans Frontières, New Delhi, India.Rajendra Memorial Research Institute of Medical Sciences, Patna, Bihar, India.No affiliation info availableACCESS Campaign, Geneva, Switzerland.Rajendra Memorial Research Institute of Medical Sciences, Patna, Bihar, India.

Pub Type(s)

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

Language

eng

PubMed ID

24392166

Citation

Burza, Sakib, et al. "Risk Factors for Visceral Leishmaniasis Relapse in Immunocompetent Patients Following Treatment With 20 Mg/kg Liposomal Amphotericin B (Ambisome) in Bihar, India." PLoS Neglected Tropical Diseases, vol. 8, no. 1, 2014, pp. e2536.
Burza S, Sinha PK, Mahajan R, et al. Risk factors for visceral leishmaniasis relapse in immunocompetent patients following treatment with 20 mg/kg liposomal amphotericin B (Ambisome) in Bihar, India. PLoS Negl Trop Dis. 2014;8(1):e2536.
Burza, S., Sinha, P. K., Mahajan, R., Lima, M. A., Mitra, G., Verma, N., Balasegaram, M., Balsegaram, M., & Das, P. (2014). Risk factors for visceral leishmaniasis relapse in immunocompetent patients following treatment with 20 mg/kg liposomal amphotericin B (Ambisome) in Bihar, India. PLoS Neglected Tropical Diseases, 8(1), e2536. https://doi.org/10.1371/journal.pntd.0002536
Burza S, et al. Risk Factors for Visceral Leishmaniasis Relapse in Immunocompetent Patients Following Treatment With 20 Mg/kg Liposomal Amphotericin B (Ambisome) in Bihar, India. PLoS Negl Trop Dis. 2014;8(1):e2536. PubMed PMID: 24392166.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Risk factors for visceral leishmaniasis relapse in immunocompetent patients following treatment with 20 mg/kg liposomal amphotericin B (Ambisome) in Bihar, India. AU - Burza,Sakib, AU - Sinha,Prabhat K, AU - Mahajan,Raman, AU - Lima,María Angeles, AU - Mitra,Gaurab, AU - Verma,Neena, AU - Balasegaram,Manica, AU - Balsegaram,Manica, AU - Das,Pradeep, Y1 - 2014/01/02/ PY - 2013/08/03/received PY - 2013/09/30/accepted PY - 2014/1/7/entrez PY - 2014/1/7/pubmed PY - 2014/9/10/medline SP - e2536 EP - e2536 JF - PLoS neglected tropical diseases JO - PLoS Negl Trop Dis VL - 8 IS - 1 N2 - BACKGROUND: A proportion of all immunocompetent patients treated for visceral leishmaniasis (VL) are known to relapse; however, the risk factors for relapse are not well understood. With the support of the Rajendra Memorial Research Institute (RMRI), Médecins Sans Frontières (MSF) implemented a program in Bihar, India, using intravenous liposomal amphotericin B (Ambisome) as a first-line treatment for VL. The aim of this study was to identify risk factors for VL relapse by examining the characteristics of immunocompetent patients who relapsed following this regimen. METHODS AND PRINCIPAL FINDINGS: This is an observational retrospective cohort study of all VL patients treated by the MSF program from July 2007 to August 2012. Intravenous Ambisome was administered to 8749 patients with VL in four doses of 5 mg/kg (for a total dose of 20 mg/kg) over 4-10 days, depending on the severity of disease. Out of 8588 patients not known to be HIV-positive, 8537 (99.4%) were discharged as initial cures, 24 (0.3%) defaulted, and 27 (0.3%) died during or immediately after treatment. In total, 1.4% (n = 119) of the initial cured patients re-attended the programme with parasitologically confirmed VL relapse, with a median time to relapse of 10.1 months. Male sex, age <5 years and ≥45 years, a decrease in spleen size at time of discharge of ≤0.5 cm/day, and a shorter duration of symptoms prior to seeking treatment were significantly associated with relapse. Spleen size at admission, hemoglobin level, nutritional status, and previous history of relapse were not associated with relapse. CONCLUSIONS: This is the largest cohort of VL patients treated with Ambisome worldwide. The risk factors for relapse included male sex, age <5 and ≥45 years, a smaller decrease in splenomegaly at discharge, and a shorter duration of symptoms prior to seeking treatment. The majority of relapses in this cohort occurred 6-12 months following treatment, suggesting that a 1-year follow-up is appropriate in future studies. SN - 1935-2735 UR - https://www.unboundmedicine.com/medline/citation/24392166/Risk_factors_for_visceral_leishmaniasis_relapse_in_immunocompetent_patients_following_treatment_with_20_mg/kg_liposomal_amphotericin_B__Ambisome__in_Bihar_India_ L2 - https://dx.plos.org/10.1371/journal.pntd.0002536 DB - PRIME DP - Unbound Medicine ER -