Safety and effectiveness of meglumine antimoniate in the treatment of Ethiopian visceral leishmaniasis patients with and without HIV co-infection.

In sub-Saharan Africa, visceral leishmaniasis (VL) is treated with either Pentostam(TM) (sodium antimony gluconate) or generic sodium stibogluconate (SSG), except in Uganda where Glucantime(®) (meglumine antimoniate) has been in use for at least a decade. Between January 2008 and February 2009, 54 Ethiopian VL patients were treated with Glucantime. The medical charts of these patients were reviewed to assess the effectiveness and safety profile of Glucantime in a routine healthcare setting. None of the patients from south Ethiopia (n=24) and 46.4% of the patients from north Ethiopia (n=30) were HIV co-infected. At completion of treatment (Day 31), cure rates were 78.6% (95% CI 59.0-91.7%) in north Ethiopia and 100% (95% CI 85.8-100%) in south Ethiopia. Thirty-three non-serious and six serious adverse events (two pancreatitis, one renal failure and three deaths) were observed in 26 patients. One-third of the non-serious adverse events were due to biochemical pancreatitis. During treatment, a case-fatality rate of 10.0% in north Ethiopia and 0.0% in south Ethiopia was noted. These data show that Glucantime can be as effective as Pentostam or SSG in HIV-negative patients. The data also point to clinical pancreatitis as a safety concern, especially in patients with HIV co-infection.