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Five-year field results and long-term effectiveness of 20 mg/kg liposomal amphotericin B (Ambisome) for visceral leishmaniasis in Bihar, India.
PLoS Negl Trop Dis. 2014; 8(1):e2603.PN

Abstract

BACKGROUND

Visceral Leishmaniasis (VL; also known as Kala-azar) is an ultimately fatal disease endemic in Bihar. A 2007 observational cohort study in Bihar of 251 patients with VL treated with 20 mg/Kg intravenous liposomal amphotericin B (Ambisome) demonstrated a 98% cure rate at 6-months. Between July 2007 and August 2012, Médecins Sans Frontières (MSF) and the Rajendra Memorial Research Institute (RMRI) implemented a VL treatment project in Bihar, India-an area highly endemic for Leishmania donovani-using this regimen as first-line treatment.

METHODS AND PRINCIPAL FINDINGS

Intravenous Ambisome 20 mg/kg was administered in four doses of 5 mg/kg over 4-10 days, depending on the severity of disease. Initial clinical cure at discharge was defined as improved symptoms, cessation of fever, and recession of spleen enlargement. This observational retrospective cohort study describes 8749 patients with laboratory-confirmed primary VL treated over a 5-year period: 1396 at primary healthcare centers, 7189 at hospital, and 164 at treatment camps. Initial clinical cure was achieved in 99.3% of patients (8692/8749); 0.3% of patients (26/8749) defaulted from treatment and 0.4% (31/8749) died. Overall, 1.8% of patients (161/8749) were co-infected with HIV and 0.6% (51/8749) with tuberculosis. Treatment was discontinued because of severe allergic reactions in 0.1% of patients (7/8749). Overall, 27 patients (0.3%) were readmitted with post Kala-azar dermal leishmaniasis (PKDL). Risk factors for late presentation included female sex, age >15 years and being from a scheduled caste. In 2012, a long-term efficacy survey in the same area of Bihar determined relapse rates of VL after 5 years' intervention with Ambisome. Of 984 immunocompetent patients discharged between September 2010 and December 2011, 827 (84.0%) were traced in order to determine their long-term outcomes. Of these, 20 patients (2.4%) had relapsed or received further treatment for VL. Of those completing 6, 12, and 15 month follow-up, 0.3% (2/767), 3.7% (14/383), and 2.4% (4/164), respectively, had relapsed. The mean ±SD time-to-relapse was 9.6±3.0 months.

SIGNIFICANCE

This is the largest cohort of VL patients treated with 20 mg/kg Ambisome worldwide. The drug has high initial and long-term efficacy, and a low rate of adverse reactions when administered under field conditions in Bihar, India. Although challenging, its use as first line treatment in rural settings in Bihar is safe and feasible.

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

24392168

Citation

Burza, Sakib, et al. "Five-year Field Results and Long-term Effectiveness of 20 Mg/kg Liposomal Amphotericin B (Ambisome) for Visceral Leishmaniasis in Bihar, India." PLoS Neglected Tropical Diseases, vol. 8, no. 1, 2014, pp. e2603.
Burza S, Sinha PK, Mahajan R, et al. Five-year field results and long-term effectiveness of 20 mg/kg liposomal amphotericin B (Ambisome) for visceral leishmaniasis in Bihar, India. PLoS Negl Trop Dis. 2014;8(1):e2603.
Burza, S., Sinha, P. K., Mahajan, R., Lima, M. A., Mitra, G., Verma, N., Balasegaram, M., Balasegarem, M., & Das, P. (2014). Five-year field results and long-term effectiveness of 20 mg/kg liposomal amphotericin B (Ambisome) for visceral leishmaniasis in Bihar, India. PLoS Neglected Tropical Diseases, 8(1), e2603. https://doi.org/10.1371/journal.pntd.0002603
Burza S, et al. Five-year Field Results and Long-term Effectiveness of 20 Mg/kg Liposomal Amphotericin B (Ambisome) for Visceral Leishmaniasis in Bihar, India. PLoS Negl Trop Dis. 2014;8(1):e2603. PubMed PMID: 24392168.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Five-year field results and long-term effectiveness of 20 mg/kg liposomal amphotericin B (Ambisome) for visceral leishmaniasis 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 - Balasegarem,Manica, AU - Das,Pradeep, Y1 - 2014/01/02/ PY - 2013/08/03/received PY - 2013/11/07/accepted PY - 2014/1/7/entrez PY - 2014/1/7/pubmed PY - 2014/9/10/medline SP - e2603 EP - e2603 JF - PLoS neglected tropical diseases JO - PLoS Negl Trop Dis VL - 8 IS - 1 N2 - BACKGROUND: Visceral Leishmaniasis (VL; also known as Kala-azar) is an ultimately fatal disease endemic in Bihar. A 2007 observational cohort study in Bihar of 251 patients with VL treated with 20 mg/Kg intravenous liposomal amphotericin B (Ambisome) demonstrated a 98% cure rate at 6-months. Between July 2007 and August 2012, Médecins Sans Frontières (MSF) and the Rajendra Memorial Research Institute (RMRI) implemented a VL treatment project in Bihar, India-an area highly endemic for Leishmania donovani-using this regimen as first-line treatment. METHODS AND PRINCIPAL FINDINGS: Intravenous Ambisome 20 mg/kg was administered in four doses of 5 mg/kg over 4-10 days, depending on the severity of disease. Initial clinical cure at discharge was defined as improved symptoms, cessation of fever, and recession of spleen enlargement. This observational retrospective cohort study describes 8749 patients with laboratory-confirmed primary VL treated over a 5-year period: 1396 at primary healthcare centers, 7189 at hospital, and 164 at treatment camps. Initial clinical cure was achieved in 99.3% of patients (8692/8749); 0.3% of patients (26/8749) defaulted from treatment and 0.4% (31/8749) died. Overall, 1.8% of patients (161/8749) were co-infected with HIV and 0.6% (51/8749) with tuberculosis. Treatment was discontinued because of severe allergic reactions in 0.1% of patients (7/8749). Overall, 27 patients (0.3%) were readmitted with post Kala-azar dermal leishmaniasis (PKDL). Risk factors for late presentation included female sex, age >15 years and being from a scheduled caste. In 2012, a long-term efficacy survey in the same area of Bihar determined relapse rates of VL after 5 years' intervention with Ambisome. Of 984 immunocompetent patients discharged between September 2010 and December 2011, 827 (84.0%) were traced in order to determine their long-term outcomes. Of these, 20 patients (2.4%) had relapsed or received further treatment for VL. Of those completing 6, 12, and 15 month follow-up, 0.3% (2/767), 3.7% (14/383), and 2.4% (4/164), respectively, had relapsed. The mean ±SD time-to-relapse was 9.6±3.0 months. SIGNIFICANCE: This is the largest cohort of VL patients treated with 20 mg/kg Ambisome worldwide. The drug has high initial and long-term efficacy, and a low rate of adverse reactions when administered under field conditions in Bihar, India. Although challenging, its use as first line treatment in rural settings in Bihar is safe and feasible. SN - 1935-2735 UR - https://www.unboundmedicine.com/medline/citation/24392168/Five_year_field_results_and_long_term_effectiveness_of_20_mg/kg_liposomal_amphotericin_B__Ambisome__for_visceral_leishmaniasis_in_Bihar_India_ DB - PRIME DP - Unbound Medicine ER -