López Cortés Luis F, Martínez Esteban, von Wichmann Miguel Ángel
Unidad Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva, Hospital Universitario Virgen del Rocío, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Sevilla, España.
Enferm Infecc Microbiol Clin. 2013 Jun;31 Suppl 2:6-11. doi: 10.1016/S0213-005X(13)70137-X.
Currently available data on the safety and tolerability of rilpivirine come from the product information document, a phase IIb, dose-finding clinical trial (TMC278-C204), the phase III ECHO and THRIVE clinical trials, and the preliminary data from the STaR and SPIRIT clinical trials, with a total of 1,728 patients. The comparator has usually been efavirenz. All studies have found a lower incidence and severity of neuropsychiatric adverse effects, a better lipid profile, and a lower number of patients with subclinical transaminase elevation in patients treated with rilpivirine. However, because of the relatively low number of patients coinfected with hepatitis B or C virus, definitive conclusions cannot be drawn. Similarly, experience in patients with mild or moderate liver failure is limited and there are no safety data in patients with advanced liver failure.
目前关于利匹韦林安全性和耐受性的可用数据来自产品信息文件、一项IIb期剂量探索性临床试验（TMC278-C204）、III期ECHO和THRIVE临床试验，以及STaR和SPIRIT临床试验的初步数据，涉及总共1728名患者。对照药物通常为依非韦伦。所有研究均发现，接受利匹韦林治疗的患者神经精神不良反应的发生率和严重程度较低，血脂情况较好，亚临床转氨酶升高的患者数量较少。然而，由于合并感染乙型或丙型肝炎病毒的患者数量相对较少，无法得出明确结论。同样，轻度或中度肝功能衰竭患者的经验有限，晚期肝功能衰竭患者尚无安全性数据。
