atazanavir
Fuentes regulatorias consultadas
Indicaciones aprobadas
- Tratamiento combinado de infección por VIH-1 en adultos y población pediátrica desde 6 años.
Contraindicaciones
Absolutas
- Hipersensibilidad; hepatopatía grave; combinaciones CYP3A expresamente contraindicadas, incluidos rifampicina, hipérico, simvastatina/lovastatina, pimozida, quetiapina, midazolam oral, triazolam y derivados del ergot.
Advertencias clínicas
- Puede prolongar PR y causar bloqueo cardíaco; vigila en trastornos de conducción o con otros fármacos que prolongan PR. — CIMA/AEMPS, ficha técnica 84067
- Advertencia mayor · Puede causar hiperbilirrubinemia, nefrolitiasis, colelitiasis y nefropatía crónica; controla bilirrubina y función renal según riesgo. — CIMA/AEMPS, ficha técnica 84067
Interacciones medicamentosas
- SeveraInhibidores de la bomba de protones, antagonistas H2 y antiácidos
Mecanismo: El aumento del pH gastrico reduce la absorcion de atazanavir.
Recomendación: Antiácidos: administra atazanavir 2 h antes o 1 h después. En pacientes sin tratamiento previo, el IBP no debe superar omeprazol 20 mg y se toma unas 12 h antes de atazanavir 300 mg/ritonavir 100 mg; con tratamiento previo no se recomienda IBP. Con antagonista H2 en pacientes previamente tratados, no superes famotidina 20 mg dos veces al día y da atazanavir/ritonavir simultáneamente o al menos 10 h después; sin ritonavir, atazanavir 400 mg al menos 2 h antes y 10 h después, con máximo famotidina 20 mg por dosis y 40 mg/día.
FDA label, set_id 165cff62-b284-4a27-a65d-9ec8a5bfcdd8
- SeveraTenofovir disoproxilo y moduladores CYP3A
Mecanismo: Pueden cambiar la exposición a atazanavir o al fármaco asociado.
Recomendación: Usa la pauta potenciada y los ajustes específicos; revisa todas las combinaciones.
CIMA/AEMPS, ficha técnica 84067
Eventos adversos
Comunes (≥1%)
Hiperbilirrubinemia, náuseas, diarrea, cefalea y erupción
Raros pero graves
Bloqueo cardíaco, hepatotoxicidad, nefrolitiasis, colelitiasis y reacciones cutáneas graves
Embarazo y lactancia
Puede usarse durante el embarazo cuando esté clínicamente indicado con un régimen adecuado. Vigila durante los primeros días a todo neonato expuesto intraútero por riesgo de hiperbilirrubinemia grave. No amamantes si tienes VIH y recibes tratamiento.
Bibliografía reciente (PubMed)
Viruses cause a variety of diseases in the human body. Antiviral agents are used to prevent the production of disease-causing viruses. These agents obstruct and kill the virus's translation and replication. Because viruses share the metabolic processes of the majority of host cells, finding targeted medicines for the virus is difficult. In the ongoing search for better antiviral agents, the USFDA approved EVOTAZ, a new drug discovered for the treatment of Human Immunodeficiency Virus (HIV). It is a once-daily (OD) fixed-dose combination of Cobicistat, a cytochrome P450 (CYP) enzyme inhibitor, and Atazanavir, a protease inhibitor. The combination drug was created in such a way that it can inhibit both CYP enzymes and proteases at the same time, resulting in the virus's death. The drug is not effective in children under the age of 18; however, it is still being studied for various parameters. This review article focuses on EVOTAZ's preclinical and clinical aspects, as well as its efficacy and safety profiles.
Children living with human immunodeficiency virus (HIV) have limited options for second-line antiretroviral therapy (ART). In this open-label trial with a 2-by-4 factorial design, we randomly assigned children with HIV who had first-line treatment failure to receive second-line therapy with tenofovir alafenamide fumarate (TAF)-emtricitabine or standard care (abacavir or zidovudine, plus lamivudine) as the backbone and dolutegravir or ritonavir-boosted darunavir, atazanavir, or lopinavir as the anchor drug. The primary outcome was a viral load of less than 400 copies per milliliter at 96 weeks. We hypothesized that TAF-emtricitabine would be noninferior to standard care, that dolutegravir and ritonavir-boosted darunavir would each be superior to ritonavir-boosted lopinavir and atazanavir analyzed in combination, and that ritonavir-boosted atazanavir would be noninferior to ritonavir-boosted lopinavir. Safety was also assessed. A total of 919 children underwent randomization; 458 were assigned to receive TAF-emtricitabine, and 461 to receive standard care. Assigned anchor drugs were dolutegravir (229 participants), ritonavir-boosted darunavir (232), ritonavir-boosted atazanavir (231), and ritonavir-boosted lopinavir (227). The median age of participants was 10 years, and 497 (54.1%) were male. The median viral load at baseline was 17,573 copies per milliliter. At week 96, TAF-emtricitabine was superior to standard care: the adjusted difference in the percentage of participants with a viral load of less than 400 copies per milliliter was 6.3 percentage points (95% confidence interval [CI], 2.0 to 10.6; P = 0.004). Dolutegravir was superior to ritonavir-boosted lopinavir and atazanavir analyzed in combination (adjusted difference, 9.7 percentage points; 95% CI, 4.8 to 14.5; P<0.001), but ritonavir-boosted darunavir was not (adjusted difference, 5.6 percentage points; 95% CI, 0.3 to 11.0; P = 0.04 [prespecified threshold, P = 0.03]). Ritonavir-boosted atazanavir was noni