A Comparison of Miltefosine and Sodium Stibogluconate for Treatment of Visceral Leishmaniasis in an Ethiopian Population with High Prevalence of HIV Infection

Médecins Sans Frontières-Holland, Amsterdam, The Netherlands.
Clinical Infectious Diseases (Impact Factor: 8.89). 09/2006; 43(3):357-64. DOI: 10.1086/505217
Source: PubMed


Antimonials are the mainstay of visceral leishmaniasis (VL) treatment in Africa. The increasing incidence of human immunodeficiency virus (HIV) coinfection requires alternative safe and effective drug regimens. Oral miltefosine has been proven to be safe and effective in the treatment of Indian VL but has not been studied in Africa or in persons with HIV and VL coinfection.
We compared the efficacy of miltefosine and sodium stibogluconate (SSG) in the treatment of VL in persons in Ethiopia. A total of 580 men with parasitologically and/or serologically confirmed VL were randomized to receive either oral miltefosine (100 mg per day for 28 days) or intramuscular SSG (20 mg/kg per day for 30 days).
The initial cure rate was 88% in both treatment groups. Mortality during treatment was 2% in the miltefosine group, compared with 10% in the SSG group. Initial treatment failure was 8% in the miltefosine group, compared with 1% in the SSG group. Among the 375 patients (65%) who agreed to HIV testing, HIV seroprevalence was 29%. Among patients not infected with HIV, initial cure, mortality, and initial treatment failure rates were not significantly different (94% vs. 95%, 1% vs. 3%, and 5% vs. 1% for the miltefosine and SSG groups, respectively). Initial treatment failure with miltefosine occurred in 18% of HIV-coinfected patients, compared with treatment failure in 5% of non-HIV-infected patients. At 6 months after treatment, 174 (60%) of the 290 miltefosine recipients and 189 (65%) of the 290 SSG recipients experienced cure; 30 (10%) of 290 in the miltefosine group and 7 (2%) of 290 in the SSG group experienced relapse, and the mortality rate was 6% in the miltefosine group, compared with 12% in the SSG group. HIV-infected patients had higher rates of relapse (16 [25%] of 63 patients), compared with non-HIV-infected patients (5 [5%] of 131).
Treatment with miltefosine is equally effective as standard SSG treatment in non-HIV-infected men with VL. Among HIV-coinfected patients, miltefosine is safer but less effective than SSG.

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Available from: Yibeltal Assefa, Jun 30, 2015
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    • "Matema–Humera lowlands are, geographically, an extension of eastern Sudan [8, 15, 17] and have similar rainfall pattern and vegetation [7, 8]. The most kala-azar affected part of Matema–Humera lowlands is the Kafta-Humera district with the annual incidence that range from 1000 to 2000 cases, with higher prevalence (>80%) in labour migrants from Amhara and Tigray highland areas compared to the permanent residents in the area [19]. World Health organization report on leishmaniasis in tropical Africa [20] indicated that 45.6% of Humera population involved in farm activities were positive for leishmanin skin test compared to 8.3% in non-farmers (urban and farm-owning population) with annual sero-conversion rate of 7% and less than 1% respectively. "
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    • "In patients with HIV-1-associated VL, miltefosine treatment appears to be well tolerated, but outcomes are suboptimal. In a study of 107 HIV-1-infected VL patients in Ethiopia, mortality outcomes were similar in miltefosine- and SSG-treated patients (5% versus 7%), but rates of initial treatment failure (17.5% versus 2.3%) and subsequent relapse (25% versus 11%) were higher in those receiving miltefosine.11 However, whether miltefosine can prevent secondary infection is worth exploring. "
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    • "In African data from Ethiopia, poor cure rates were also found, with only 43.5 % of HIV-positive patients being cured at 6-month follow-up [110]. Better results were observed in another two studies performed in Ethiopian populations, with 65.2–78.6 % cure rates, but a higher proportion of non-HIV-infected patients were included in the analysis [29, 42]. "
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