cabotegravir
Fuentes regulatorias consultadas
Indicaciones aprobadas
- Profilaxis preexposición del VIH-1 en adultos y adolescentes de al menos 35 kg con prueba negativa, como fase oral de inicio o puente del esquema de cabotegravir de acción prolongada.
Contraindicaciones
Absolutas
- Hipersensibilidad a cabotegravir.
- Estado VIH positivo o desconocido para profilaxis preexposición.
- Rifampicina, rifapentina, carbamazepina, oxcarbazepina, fenitoína o fenobarbital
Advertencias clínicas
- Confirma VIH negativo antes de iniciar y antes de cada continuación; usar PrEP durante infección no diagnosticada puede seleccionar resistencia. — CIMA/AEMPS, ficha técnica 1231760001
- Advertencia mayor · Puede causar hepatotoxicidad, hipersensibilidad y trastornos depresivos; suspende y evalúa ante síntomas graves. — CIMA/AEMPS, ficha técnica 1231760001
- Se han notificado síndrome de Stevens-Johnson y necrólisis epidérmica tóxica; suspende inmediatamente y no reinicies cabotegravir ante una reacción cutánea grave. — CIMA/AEMPS, ficha técnica 1231760001
Interacciones medicamentosas
- ModeradaRifampicina, rifapentina, carbamazepina, oxcarbazepina, fenitoína o fenobarbital
Mecanismo: La inducción de UGT1A1/UGT1A9 reduce cabotegravir y puede causar pérdida de eficacia.
Recomendación: No combines.
CIMA/AEMPS, ficha técnica 1231760001
- ModeradaAntiácidos con cationes polivalentes
Mecanismo: Pueden reducir la absorción de cabotegravir oral.
Recomendación: Administra al menos 2 horas antes o 4 horas después.
CIMA/AEMPS, ficha técnica 1231760001
Eventos adversos
Comunes (≥1%)
Cefalea, diarrea, náuseas, fatiga y sueños anormales
Raros pero graves
Hipersensibilidad, hepatotoxicidad y conducta suicida
Embarazo y lactancia
No se recomienda durante el embarazo salvo que el beneficio supere el riesgo. Durante la lactancia, úsalo solo si el beneficio esperado supera el riesgo para el lactante.
Bibliografía reciente (PubMed)
Intramuscular injection of long-acting cabotegravir and rilpivirine is a novel, long-acting antiretroviral therapy (ART) combination approved for use as a fully suppressive regimen for people living with HIV. Long-acting cabotegravir with rilpivirine ART has reduced required dosing frequency from once daily to once every month or every 2 months injections. This new era of long-acting ART, which includes other antiretrovirals and formulations in various stages of clinical development, holds tremendous promise to change the standard of HIV treatment. Although long-acting ART has high potential to be revolutionary in the landscape of HIV care, prevention, and treatment cascade, more data are needed to substantiate its efficacy and cost-effectiveness among patients at risk of non-adherence and across age groups, pregnancy, and post partum. Advocacy efforts and policy changes to optimise a sustained, high-quality, equitable reach of long-acting ART, especially in low-income and middle-income countries where most people living with HIV reside, are needed to realise the full benefits of long-acting ART.
Pre-exposure prophylaxis (PrEP) of human immunodeficiency virus (HIV) represents the most significant breakthrough in the HIV prevention field over the past decade. PrEP is an effective strategy in preventing the transmission of HIV across all populations, providing high adherence. The current PrEP options include oral daily and on-demand tenofovir-based regimens, long-acting injections of cabotegravir, and a 1-month dapivirine vaginal ring. As a component of a multifaceted prevention approach, extensive deployment of PrEP holds the promise to significantly reduce the global HIV epidemic. Nonetheless, barriers still exist in terms of uptake, adherence, and persistence, while disparities in PrEP accessibility remain a concern. Cabotegravir is an antiviral agent that inhibits the human immunodeficiency virus (HIV) integrase and is used in combination with rilpivirine, a non-nucleoside HIV reverse transcription inhibitor, in the treatment of HIV infection and the acquired immunodeficiency syndrome (AIDS). The fixed combination of cabotegravir and rilpivirine is typically given intramuscularly once monthly and has been linked to a low rate of serum aminotransferase elevations during therapy and to rare episodes of acute, clinically apparent liver injury.
- Safety and Efficacy of Long-Acting Injectable Agents for HIV-1: Systematic Review and Meta-Analysis.
HIV-1 infection continues to affect global health. Although antiretrovirals can reduce the viral load or prevent HIV-1 infection, current drugs require daily oral use with a high adherence level. Long-acting antiretrovirals (LA-ARVs) significantly improve medication adherence and are essential for HIV-1 prophylaxis and therapy. This study aimed to investigate the safety and efficacy of long-acting cabotegravir (CAB-LA) and long-acting rilpivirine (RPV-LA) in the prevention and treatment of HIV-1 infection. PubMed, Embase, and the Cochrane Library were searched for studies from database inception to November 12, 2022. We included studies that reported efficacy and safety data on LA-ARV intervention in people living with HIV and excluded reviews, animal studies, and articles with missing or duplicate data. Virological suppression was defined as plasma viral load <50 copies/mL 6 months after antiviral therapy initiation. We extracted outcomes for analysis and expressed dichotomous data as risk ratios (RRs) and continuous data as mean differences. Depending on the heterogeneity assessment, a fixed- or random-effects model was used for data synthesis. We performed subgroup analyses of the partial safety and efficacy outcomes of CAB-LA+RPV-LA. The protocol was registered with the Open Science Framework. We included 12 trials comprising 10,957 individuals, of which 7 were prevention trials and 5 were treatment trials. CAB-LA and RPV-LA demonstrated safety profiles comparable with those of the placebo in terms of adverse event-related withdrawal. Moreover, the efficacy data showed that CAB-LA had a better effect on HIV-1 prevention than tenofovir disoproxil fumarate-emtricitabine (17/5161, 0.33% vs 75/5129, 1.46%; RR 0.21, 95% CI 0.07-0.61; I2=70%). Although CAB-LA+RPV-LA had more drug-related adverse events (556/681, 81.6% vs 37/598, 6.2%; RR 12.50, 95% CI 3.98-39.23; I2=85%), a mild or moderate injection site reaction was the most common reaction, and its frequency decrea