title: [Safety profile of rilpivirine: general and neuropsychiatric tolerability, safety in patients with hepatitis B or C viruses, and lipid profile].
abstract: 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.
authors.affiliation: 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. Electronic address: lflopez@us.es.
authors.forename: Luis F
authors.initials: LF
authors.lastname: López Cortés
authors.forename: Esteban
authors.initials: E
authors.lastname: Martínez
authors.forename: Miguel Ángel
authors.initials: MÁ
authors.lastname: von Wichmann
mesh_terms: D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active; D001288:Attention / Q000187:drug effects; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology; D002986:Clinical Trials as Topic; D004244:Dizziness / Q000139:chemically induced; D003875:Drug Eruptions / Q000209:etiology; D050171:Dyslipidemias / Q000139:chemically induced* / Q000209:etiology; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy; D006261:Headache / Q000139:chemically induced; D006509:Hepatitis B / Q000150:complications; D006526:Hepatitis C / Q000150:complications; D006801:Humans; D017093:Liver Failure / Q000209:etiology / Q000378:metabolism; D019964:Mood Disorders / Q000139:chemically induced; D015337:Multicenter Studies as Topic; D009325:Nausea / Q000139:chemically induced; D009422:Nervous System Diseases / Q000139:chemically induced*; D009570:Nitriles / Q000009:adverse effects* / Q000627:therapeutic use; D011743:Pyrimidines / Q000009:adverse effects* / Q000627:therapeutic use; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D000068696:Rilpivirine; D012893:Sleep Wake Disorders / Q000139:chemically induced
chemical_list: D019380:Anti-HIV Agents; D009570:Nitriles; D011743:Pyrimidines; D018894:Reverse Transcriptase Inhibitors; D000068696:Rilpivirine
keywords: Coinfección; Coinfection; Rilpivirina; Rilpivirine; Safety; Seguridad; Tolerabilidad; Tolerability