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1.
N Engl J Med ; 376(24): 2329-2340, 2017 06 15.
Artigo em Inglês | MEDLINE | ID: mdl-28614691

RESUMO

BACKGROUND: Talaromyces marneffei infection is a major cause of human immunodeficiency virus (HIV)-related death in South and Southeast Asia. Guidelines recommend initial treatment with amphotericin B deoxycholate, but this drug has substantial side effects, a high cost, and limited availability. Itraconazole is available in oral form, is associated with fewer unacceptable side effects than amphotericin, and is widely used in place of amphotericin; however, clinical trials comparing these two treatments are lacking. METHODS: In this open-label, noninferiority trial, we randomly assigned 440 HIV-infected adults who had talaromycosis, confirmed by either microscopy or culture, to receive either intravenous amphotericin B deoxycholate (amphotericin) (219 patients), at a dose of 0.7 to 1.0 mg per kilogram of body weight per day, or itraconazole capsules (221 patients), at a dose of 600 mg per day for 3 days, followed by 400 mg per day, for 11 days; thereafter, all the patients received maintenance therapy with itraconazole. The primary outcome was all-cause mortality at week 2. Secondary outcomes included all-cause mortality at week 24, the time to clinical resolution of talaromycosis, early fungicidal activity, relapse of talaromycosis, development of the immune reconstitution inflammatory syndrome (IRIS), and the side-effect profile. RESULTS: The risk of death at week 2 was 6.5% in the amphotericin group and 7.4% in the itraconazole group (absolute risk difference, 0.9 percentage points; 95% confidence interval [CI], -3.9 to 5.6; P<0.001 for noninferiority); however, the risk of death at week 24 was 11.3% in the amphotericin group and 21.0% in the itraconazole group (absolute risk difference, 9.7 percentage points; 95% CI, 2.8 to 16.6; P=0.006). Treatment with amphotericin was associated with significantly faster clinical resolution and fungal clearance and significantly lower rates of relapse and IRIS than itraconazole. The patients who received amphotericin had significantly higher rates of infusion-related reactions, renal failure, hypokalemia, hypomagnesemia, and anemia than patients in the itraconazole group. CONCLUSIONS: Amphotericin was superior to itraconazole as initial treatment for talaromycosis with respect to 6-month mortality, clinical response, and fungicidal activity. (Funded by the Medical Research Council and others; IVAP Current Controlled Trials number, ISRCTN59144167 .).


Assuntos
Infecções Oportunistas Relacionadas com a AIDS/tratamento farmacológico , Anfotericina B/uso terapêutico , Antifúngicos/uso terapêutico , Ácido Desoxicólico/uso terapêutico , Itraconazol/uso terapêutico , Micoses/tratamento farmacológico , Talaromyces , Infecções Oportunistas Relacionadas com a AIDS/mortalidade , Administração Oral , Adulto , Anfotericina B/efeitos adversos , Antifúngicos/efeitos adversos , Creatinina/metabolismo , Ácido Desoxicólico/efeitos adversos , Combinação de Medicamentos , Feminino , Humanos , Quimioterapia de Indução/efeitos adversos , Infusões Intravenosas/efeitos adversos , Itraconazol/efeitos adversos , Masculino , Micoses/mortalidade , Talaromyces/isolamento & purificação
2.
AIDS ; 34(13): 1875-1882, 2020 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-32910061

RESUMO

OBJECTIVE: We assessed the association between methamphetamine use and lack of viral suppression among a cohort of HIV-seropositive persons who inject drugs (PWID) in Hai Phong, Vietnam. DESIGN: Cohort study with random effects logit modeling and mediation analysis for antiretroviral therapy (ART) adherence. METHODS: PWID were recruited from October 2016 to October 2017; HIV-seropositive PWID were enrolled in a cohort to assess HIV viral loads, changes in drug use, risk behaviors, and ART adherence during 24-month follow-up. Methamphetamine use in last 30 days was divided into three categories: 0 days (no use), 1-19 days (intermediate), and 20 or more days (heavy). Bivariate and a multivariable random effects logit models were used to assess the relationship between methamphetamine use and not being virally suppressed. We also assessed self-reported ART adherence as a mediating factor. RESULTS: A total of 645 HIV-seropositive PWID were included at baseline; 95% male, average age 40 (SD = 6.4). At baseline, methamphetamine use in last 30 days was 64% no use, 32% intermediate use, 4% heavy use. Approximately 74% of PWID reported high/complete adherence; 76% were at viral suppression. In random effects analysis, recent methamphetamine use was associated with not being virally suppressed during follow-up (adjusted odds ratio: 1.84, 95% confidence interval: 1.06, 3.17); the effect was not explained by a mediating effect of self-reported adherence to ART. CONCLUSION: Recent methamphetamine use is associated with not being virally suppressed among PWID. The results of this study indicate the need for targeted interventions for methamphetamine use with special focus on those with HIV infection.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Usuários de Drogas/psicologia , Infecções por HIV , Metanfetamina/uso terapêutico , Abuso de Substâncias por Via Intravenosa/complicações , Adulto , Terapia Antirretroviral de Alta Atividade , Estudos de Coortes , Feminino , Infecções por HIV/complicações , Infecções por HIV/tratamento farmacológico , Humanos , Masculino , Adesão à Medicação/estatística & dados numéricos , Metanfetamina/efeitos adversos , Pessoa de Meia-Idade , Assunção de Riscos , Abuso de Substâncias por Via Intravenosa/epidemiologia , Cooperação e Adesão ao Tratamento , Resultado do Tratamento , Vietnã/epidemiologia , Carga Viral
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