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Single High Dose of Liposomal Amphotericin B in Human Immunodeficiency Virus/AIDS-Related Disseminated Histoplasmosis: A Randomized Trial

医学 组织胞浆菌病 内科学 胃肠病学 伊曲康唑 低钾血症 随机对照试验 毒性 两性霉素B 利巴韦林 养生 外科 免疫学 病毒 皮肤病科 丙型肝炎病毒 抗真菌
作者
Alessandro C. Pasqualotto,Daiane Dalla Lana,Cássia Silva Miranda Godoy,Terezinha do Menino Jesus Silva Leitão,Mônica Baumgardt Bay,Lisandra Serra Damasceno,Renata Ba Soares,Roger Kist,Larissa R. Silva,Denusa Wiltgen,Marineide Melo,Taiguara F Guimarães,Marilia R Guimarães,Hareton Teixeira Vechi,Jacó Ricarte Lima de Mesquita,Glória Regina de Góis Monteiro,Antoine Adenis,Nathan C Bahr,Andrej Spec,David R. Boulware,Dennis Israelski,Tom Chiller,Diego Rodrigues Falci
出处
期刊:Clinical Infectious Diseases [Oxford University Press]
卷期号:77 (8): 1126-1132 被引量:8
标识
DOI:10.1093/cid/ciad313
摘要

Histoplasmosis is a major AIDS-defining illness in Latin America. Liposomal amphotericin B (L-AmB) is the drug of choice for treatment, but access is restricted due to the high drug and hospitalization costs of the conventional long regimens.Prospective randomized multicenter open-label trial of 1- or 2-dose induction therapy with L-AmB versus control for disseminated histoplasmosis in AIDS, followed by oral itraconazole therapy. We randomized subjects to: (i) single dose 10 mg/kg of L-AmB; (ii) 10 mg/kg of L-AmB on D1, and 5 mg/kg of L-AmB on D3; (iii) 3 mg/kg of L-AmB daily for 2 weeks (control). The primary outcome was clinical response (resolution of fever and signs/symptoms attributable to histoplasmosis) at day 14.A total of 118 subjects were randomized, and median CD4+ counts, and clinical presentations were similar between arms. Infusion-related toxicity, kidney toxicity at multiple time-points, and frequency of anemia, hypokalemia, hypomagnesemia, and liver toxicity were similar. Day 14 clinical response was 84% for single-dose L-AmB, 69% 2-dose L-AmB, and 74% for control arm (P = .69). Overall survival on D14 was 89.0% (34/38) for single-dose L-AmB, 78.0% (29/37) for 2-dose L-AmB, and 92.1% (35/38) for control arm (P = .82).One day induction therapy with 10 mg/kg of L-AmB in AIDS-related histoplasmosis was safe. Although clinical response may be non-inferior to standard L-AmB therapy, a confirmatory phase III clinical trial is needed. A single induction dose would markedly reduce drug-acquisition costs (>4-fold) and markedly shorten and simplify treatment, which are key points in terms of increased access.
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