title: Ethiopian visceral leishmaniasis: generic and proprietary sodium stibogluconate are equivalent; HIV co-infected patients have a poor outcome.
abstract: We evaluated generic sodium stibogluconate (SSG) (International Dispensary Association, Amsterdam) versus Pentostam (sodium stibogluconate, GlaxoWellcome, London) under field conditions in Ethiopian patients with visceral leishmaniasis (VL; kala-azar). The 199 patients were randomly assigned to Pentostam (n = 104) or SSG (n = 95) in 1998/99; both drugs were given at 20 mg/kg intra-muscularly for 30 days. A clinical cure after 30-days treatment was achieved in 70.2% (Pentostam) and 81.1% (SSG). There were no significant differences between the 2 drugs for the following parameters: frequency of intercurrent events (vomiting, diarrhoea, bleeding or pneumonia) or main outcome (death during treatment and death after 6-month follow-up; relapse or post kala-azar dermal leishmaniasis at 6-months follow-up). Twenty-seven patients had confirmed co-infection with HIV. On admission, HIV co-infected VL patients were clinically indistinguishable from HIV-negative VL patients. The HIV co-infected VL patients had a higher mortality during treatment (33.3% vs 3.6%). At 6-month follow-up, HIV-positive patients had a higher relapse rate (16.7% vs 1.2%), a higher death rate during the follow-up period (14.3% vs 2.4%), and more frequent moderate or severe post kala-azar dermal leishmaniasis (27.3% vs 13.3%). Only 43.5% of the HIV-positive patients were considered cured at 6-months follow-up vs 92.1% of the HIV-negative patients. HIV-positive patients relapsing with VL could become a reservoir of antimonial-resistant Leishmania donovani.
authors.affiliation: Médecins sans Frontières-Holland, P.O. Box 10014, 1001 EA Amsterdam, The Netherlands. koert_ritmeijer@amsterdam.msf.org
authors.forename: K
authors.initials: K
authors.lastname: Ritmeijer
authors.forename: H
authors.initials: H
authors.lastname: Veeken
authors.forename: Y
authors.initials: Y
authors.lastname: Melaku
authors.forename: G
authors.initials: G
authors.lastname: Leal
authors.forename: R
authors.initials: R
authors.lastname: Amsalu
authors.forename: J
authors.initials: J
authors.lastname: Seaman
authors.forename: R N
authors.initials: RN
authors.lastname: Davidson
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000150:complications / Q000188:drug therapy*; D000328:Adult; D000967:Antimony Sodium Gluconate / Q000627:therapeutic use*; D000981:Antiprotozoal Agents / Q000627:therapeutic use*; D016568:Drugs, Generic / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007273:Injections, Intramuscular; D007898:Leishmaniasis, Visceral / Q000150:complications / Q000188:drug therapy*; D008297:Male; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: D000981:Antiprotozoal Agents; D016568:Drugs, Generic; D000967:Antimony Sodium Gluconate