High frequency of serious side effects from meglumine antimoniate given without an upper limit dose for the treatment of visceral leishmaniasis in human immunodeficiency virus type-1-infected patients.

Organic pentavalent antimonials are one of the mainstays of treatment for visceral leishmaniasis (VL). Few data are available on the toxicity and efficacy of these drugs at the dosing schedule recommended by the Centers for Disease Control and Prevention (CDC) (Atlanta, GA). We analyzed 25 VL episodes in human immunodeficiency virus (HIV)-infected patients who were treated with meglumine antimoniate (MA) at the CDC-recommended dose in southern Spain. Adverse effects were observed in 14 (56%) VL episodes. In 7 (28%), treatment with MA was permanently discontinued due to serious adverse effects that included acute pancreatitis, acute renal failure, and leukopenia. Three (12%) patients died during therapy due to severe acute pancreatitis attributable to MA. The dosing regimen of MA currently recommended for treating VL is associated with a high rate of serious side effects in HIV- 1-infected patients. Visceral leishmaniasis (VL) caused by Leishmania infantum is endemic in countries bordering the Mediterra- nean basin. It has been increasingly recognized that it affects human immunodeficiency virus type-1 (HIV-1)-infected pa- tients, not only in this endemic area 1 , but also in non-endem- ic western countries. 2,3 Organic pentavalent antimonials (Sb V ) are one of the first-line drugs recommended by the Word Health Organization (WHO) for treating VL in the Mediterranean area. 4 In 1982, WHO (unpublished data) ad- vocated treatment with 20 mg of Sb V /kg of body weight, with a maximum dose of 850 mg/day. The Centers for Dis- ease Control (CDC) (Atlanta, GA) recommended in 1992 to remove the upper limit dose. 5 Data that supported this rec- ommendation stemmed from clinical trials with patients not infected with HIV. 5 It was reported that higher daily doses without an upper limit resulted in better responses. Side ef- fects were regarded as reversible and rarely severe. Patients with VL coinfected with HIV have a poor re- sponse to Sb