RESUMEN
BACKGROUND: The most effective highly active antiretroviral therapy (HAART) to prevent mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) in pregnancy and its efficacy during breast-feeding are unknown. METHODS: We randomly assigned 560 HIV-1-infected pregnant women (CD4+ count, > or = 200 cells per cubic millimeter) to receive coformulated abacavir, zidovudine, and lamivudine (the nucleoside reverse-transcriptase inhibitor [NRTI] group) or lopinavir-ritonavir plus zidovudine-lamivudine (the protease-inhibitor group) from 26 to 34 weeks' gestation through planned weaning by 6 months post partum. A total of 170 women with CD4+ counts of less than 200 cells per cubic millimeter received nevirapine plus zidovudine-lamivudine (the observational group). Infants received single-dose nevirapine and 4 weeks of zidovudine. RESULTS: The rate of virologic suppression to less than 400 copies per milliliter was high and did not differ significantly among the three groups at delivery (96% in the NRTI group, 93% in the protease-inhibitor group, and 94% in the observational group) or throughout the breast-feeding period (92% in the NRTI group, 93% in the protease-inhibitor group, and 95% in the observational group). By 6 months of age, 8 of 709 live-born infants (1.1%) were infected (95% confidence interval [CI], 0.5 to 2.2): 6 were infected in utero (4 in the NRTI group, 1 in the protease-inhibitor group, and 1 in the observational group), and 2 were infected during the breast-feeding period (in the NRTI group). Treatment-limiting adverse events occurred in 2% of women in the NRTI group, 2% of women in the protease-inhibitor group, and 11% of women in the observational group. CONCLUSIONS: All regimens of HAART from pregnancy through 6 months post partum resulted in high rates of virologic suppression, with an overall rate of mother-to-child transmission of 1.1%. (ClinicalTrials.gov number, NCT00270296.)
Asunto(s)
Terapia Antirretroviral Altamente Activa , Lactancia Materna , Infecciones por VIH/transmisión , VIH-1 , Transmisión Vertical de Enfermedad Infecciosa/prevención & control , Complicaciones Infecciosas del Embarazo/tratamiento farmacológico , Adulto , Terapia Antirretroviral Altamente Activa/efectos adversos , Recuento de Linfocito CD4 , Femenino , Estudios de Seguimiento , Infecciones por VIH/tratamiento farmacológico , Inhibidores de la Proteasa del VIH/uso terapéutico , VIH-1/genética , VIH-1/aislamiento & purificación , Humanos , Lactante , Recién Nacido , Masculino , Neutropenia/inducido químicamente , Nevirapina/uso terapéutico , Cooperación del Paciente , Embarazo , ARN Viral/sangre , Factores de Riesgo , Carga Viral/efectos de los fármacos , Adulto Joven , Zidovudina/uso terapéuticoRESUMEN
BACKGROUND: The safety and efficacy of nevirapine (NVP) and efavirenz (EFV) based highly active antiretroviral treatment (ART) with concurrent anti-tuberculosis treatment in sub-Saharan Africa has not been well established. METHODS: We performed a retrospective study comparing human immunodeficiency virus (HIV) infected adults exposed and not exposed to tuberculosis (TB) treatment with similar baseline HIV-1 RNA levels who were started on ART as part of Botswana's ART Programme. ART regimens, HIV-1 RNA, CD4+ cell count, and liver function tests were reviewed for 12 months following ART initiation. RESULTS: Among 155 patients on ART only and 155 exposed to TB treatment, there was no difference in virologic or immunologic response throughout the first year of ART. Furthermore, there remained no differences in virologic or immunologic outcomes when NVP and EFV groups were stratified by TB treatment exposure status. While more hepatotoxic events occurred in the group exposed to TB treatment than in those not exposed (9% vs. 3%, P = 0.05), there was no difference between patients treated with NVP and those treated with EFV. CONCLUSIONS: Patients co-infected with HIV and TB in Botswana can be treated effectively with either NVP- or EFV-based ART and TB treatment. As hepatotoxic events were more common in the group exposed to TB treatment, liver function tests should be monitored closely.