Effectiveness and Safety of Liposomal Amphotericin B for Visceral Leishmaniasis under Routine Program Conditions in Bihar, India

Sinha, Prabhat Kumar; Roddy, Paul; Palma, Pedro Pablo; Kociejowski, A; Lima, María Angeles; Das, Vidya Nand Rabi; Gupta, Jitendra; Kumar, Nawin; Mitra, Gaurab; Saint-Sauveur, Jean-François; Seena, Siju; Balasegaram, Manica; Parreño, Fernando; Pandey, Krishna

doi:10.4269/ajtmh.2010.10-0156

Cited by 40 publications

(37 citation statements)

References 24 publications

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“…All patients were admitted to the district hospital for the duration of treatment, and given four doses of Ambisome 5 mg/kg over a 10-day period. The intent-to-treat analysis yielded a treatment effectiveness rate of 98.8% at 6 months, with no relapses and an excellent safety profile [6]. In coordination with the RMRI, MSF shortly thereafter signed an agreement with the State Health Society, Bihar to reinforce the existing programme by identifying VL patients in Vaishali district and treating with Ambisome 20 mg/kg.…”

Section: Introductionmentioning

confidence: 99%

Five-Year Field Results and Long-Term Effectiveness of 20 mg/kg Liposomal Amphotericin B (Ambisome) for Visceral Leishmaniasis in Bihar, India

Burza¹,

Sinha

Mahajan³

et al. 2014

PLoS Negl Trop Dis

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BackgroundVisceral 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 FindingsIntravenous 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.SignificanceThis 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.

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Section: Introductionmentioning

confidence: 99%

Five-Year Field Results and Long-Term Effectiveness of 20 mg/kg Liposomal Amphotericin B (Ambisome) for Visceral Leishmaniasis in Bihar, India

Burza¹,

Sinha

Mahajan³

et al. 2014

PLoS Negl Trop Dis

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“…Non-adherence (patients who were lost to follow-up or did not pick up their drugs for more than 15 days), treatment failure (non-response or failure to decrease the parasitological grade after a 30-day course of the treatment regimen) and death due to visceral leishmaniasis were considered to be poor treatment outcomes [14]. …”

Section: Methodsmentioning

confidence: 99%

Visceral leishmaniasis treatment outcome and its determinants in northwest Ethiopia

2016

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OBJECTIVESPoor treatment outcomes of visceral leishmaniasis (VL) are responsible for the high mortality rate of this condition in resource-limited settings such as Ethiopia. This study aimed to identify the proportion of poor VL treatment outcomes in northwest Ethiopia and to evaluate the determinants associated with poor outcomes.METHODSA hospital-based retrospective study was conducted among 595 VL patients who were admitted to Kahsay Abera Hospital in northwest Ethiopia from October 2010 to April 2013. Data were entered into Epi Info version 7.0 and exported to SPSS version 20 for analysis. Bivariate and multivariate logistic regression models were fitted to identify the determinants of VL treatment outcomes. Adjusted odds ratio (aORs) with 95% confidence intervals (CIs) were used, and p-values <0.05 were considered to indicate statistical significance.RESULTSThe proportion of poor treatment outcomes was 23.7%. Late diagnosis (≥29 days) (aOR, 4.34; 95% CI, 2.22 to 8.46), severe illness at admission (inability to walk) (aOR, 1.63; 95% CI, 1.06 to 2.40) and coinfection with VL and human immunodeficiency virus (HIV) (aOR, 2.72; 95% CI, 1.40 to 5.20) were found to be determinants of poor VL treatment outcomes.CONCLUSIONSPoor treatment outcomes, such as death, treatment failure, and non-adherence, were found to be common. Special attention must be paid to severely ill and VL/HIV-coinfected patients. To improve VL treatment outcomes, the early diagnosis and treatment of VL patients is recommended.

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“…[1] They are responsible for various syndromes in humanKala-azar, cutaneous leishmaniasis, mucosal leishmaniasis, and post kala azar dermal leishmaniasis etc. The Kala-azar is still most important disease of this group.…”

Section: Introductionmentioning

confidence: 99%

Comparison of Toxicity of Intravenous Amphotericin B in Diagnosed Cases of Kala Azar on Daily versus Alternate Day Regimen

Dinkar¹

2017

JMSCR

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Effectiveness and Safety of Liposomal Amphotericin B for Visceral Leishmaniasis under Routine Program Conditions in Bihar, India

Cited by 40 publications

References 24 publications

Five-Year Field Results and Long-Term Effectiveness of 20 mg/kg Liposomal Amphotericin B (Ambisome) for Visceral Leishmaniasis in Bihar, India

Five-Year Field Results and Long-Term Effectiveness of 20 mg/kg Liposomal Amphotericin B (Ambisome) for Visceral Leishmaniasis in Bihar, India

Visceral leishmaniasis treatment outcome and its determinants in northwest Ethiopia

Comparison of Toxicity of Intravenous Amphotericin B in Diagnosed Cases of Kala Azar on Daily versus Alternate Day Regimen

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