Treatment of visceral leishmaniasis in HIV-infected patients: a randomized trial comparing meglumine antimoniate with amphotericin B

Laguna, Fernando Ballester; López‐Vélez, Rogelio; Pulido, Federico; Salas, Ana María Nápoles; Torre-Cisneros, J; Torres, Ebert; Medrano, Francisco J.; Sanz, Jaime; Picó, Guillermo; Gómez-Rodrigo, J.; Pasquau, Juan; Alvar, Jorge

doi:10.1097/00002030-199906180-00009

Cited by 107 publications

(67 citation statements)

References 16 publications

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“…Experiences with HIV/VL coinfection in the Mediterranean region, most frequently caused by L. infantum, suggest that CD4-deficient individuals tend to relapse frequently (90). In randomized controlled trials in Spain, cure rates in both antimonial-and amphotericin B-treated coinfected patients were as low as 66% and 62%, respectively, compared with Ͼ90% cure rates in non-HIV patients (89). Similar figures have been reported in Ethiopia.…”

Section: Host Factors Host Immune Statussupporting

confidence: 63%

Drug Resistance in Leishmaniasis

2006

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SUMMARY Leishmaniasis is a complex disease, with visceral and cutaneous manifestations, and is caused by over 15 different species of the protozoan parasite genus Leishmania. There are significant differences in the sensitivity of these species both to the standard drugs, for example, pentavalent antimonials and miltefosine, and those on clinical trial, for example, paromomycin. Over 60% of patients with visceral leishmaniasis in Bihar State, India, do not respond to treatment with pentavalent antimonials. This is now considered to be due to acquired resistance. Although this class of drugs has been used for over 60 years for leishmaniasis treatment, it is only in the past 2 years that the mechanisms of action and resistance have been identified, related to drug metabolism, thiol metabolism, and drug efflux. With the introduction of new therapies, including miltefosine in 2002 and paromomycin in 2005-2006, it is essential that there be a strategy to prevent the emergence of resistance to new drugs; combination therapy, monitoring of therapy, and improved diagnostics could play an essential role in this strategy.

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Section: Host Factors Host Immune Statussupporting

confidence: 63%

Drug Resistance in Leishmaniasis

2006

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“…Leishmania/HIV co-infected patients have low cure rates and almost all patients are known to relapse with any form of treatment. 14,15 Risk factors for mortality in VL patients have been related to anaemia, severe malnutrition and long duration of illness. 16 A significant association with treatment failure was also seen in patients presenting with a large spleen at presentation, reflecting more advanced disease.…”

Section: Introductionmentioning

confidence: 99%

Clinical risk factors for therapeutic failure in kala-azar patients treated with pentavalent antimonials in Nepal

Rijal

Bhandari

Koirala

et al. 2010

Transactions of the Royal Society of Tropical Medicine and Hygi

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a b s t r a c tDrug-related factors and parasite resistance have been implicated in the failure of pentavalent antimonials (Sb v ) in the Indian subcontinent; however, little information is available on host-related factors. Parasitologically confirmed kala-azar patients, treatment naïve to Sb v , were prospectively recruited at a referral hospital in Nepal and were treated under supervision with 30 doses of quality-assured sodium stibogluconate (SSG) 20 mg/kg/day and followed for 12 months to assess cure. Analysis of risk factors for treatment failure was assessed in those receiving ≥25 doses and completing 12 months of follow-up. One hundred and ninety-eight cases were treated with SSG and the overall cure rate was 77.3% (153/198). Of the 181 cases who received ≥25 doses, 12-month follow-up data were obtained in 169, comprising 153 patients (90.5%) with definite cure and 16 (9.5%) treatment failures. In the final logistic regression model, increased failure to SSG was significantly associated with fever for ≥12 weeks [odds ratio (OR) = 7.4], living in districts bordering the high SSG resistance zone in Bihar (OR = 6.1), interruption of treatment (OR = 4.3) and ambulatory treatment (OR = 10.2). Early diagnosis and supervised treatment is of paramount importance to prevent treatment failures within the control programme.

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“…Antimonials are not an ideal drug; they have to be administered parenterally over a period of 28-30 days, generally requiring hospitalization. Antimonials have shown rare but serious side effects, such as cardio, pancreas and liver toxicity (Gasser et al 1994;Sundar et al 1998c;Thakur et al 1998;Rijal et al 2003), whose importance increases if the patient is coinfected with HIV (Delgado et al 1999;Laguna et al 1999). Resistance to antimonials has been reported in up to 65% of patients in some villages of Bihar, India (Sundar 2001).…”

Section: Introductionmentioning

confidence: 99%

Drug policy for visceral leishmaniasis: a cost‐effectiveness analysis

Vanlerberghe

Diap

Guérin³

et al. 2007

Tropical Med Int Health

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Summaryobjective To facilitate the choice of the best visceral leishmaniasis (VL) treatment strategy for first-line health services in (VL)-endemic areas, we compared in a formal decision analysis the cost and the costeffectiveness of the different available options.methods We selected four drug regimens for VL on the basis of frequency of use, feasibility and reported efficacy studies. The point estimates and the range of plausible values of effectiveness and cost were retrieved from a literature review. A decision tree was constructed and the strategy minimizing the cost per death averted was selected.results Treatment with amphotericin B deoxycholate was the most effective approach in the baseline analysis and averted 87.2% of all deaths attributable to VL. The least expensive and the most costeffective treatment was the miltefosine regimen, and the most expensive and the least cost-effective was AmBisome Ò treatment. The cost of drug and medical care are the main determinants of the costeffectiveness ranking of the alternative schemes. Sensitivity analysis showed that antimonial was competitive with miltefosine in the low-resistance regions.conclusion In areas with >94% response rates to antimonials, generic sodium stibogluconate remains the most cost-effective option for VL treatment, mainly due to low drug cost. In other regions, miltefosine is the most cost-effective option of treatment, but its use as a first-line drug is limited by its teratogenicity and rapid resistance development. AmBisome in mono-or combination therapy is too expensive to compete in cost-effectiveness with the other regimens.keywords visceral leishmaniasis, drug policy, cost-effectiveness analysis

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Treatment of visceral leishmaniasis in HIV-infected patients: a randomized trial comparing meglumine antimoniate with amphotericin B

Abstract: Treatment of VL with meglumine antimoniate or amphotericin B was shown to have similar efficacy and toxicity rates in Spanish HIV-infected patients. The differences in the toxicity patterns could be useful in choosing one of these agents as first-line treatment.

Cited by 107 publications

References 16 publications

Drug Resistance in Leishmaniasis

Drug Resistance in Leishmaniasis

Clinical risk factors for therapeutic failure in kala-azar patients treated with pentavalent antimonials in Nepal

Drug policy for visceral leishmaniasis: a cost‐effectiveness analysis

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