title: Effectiveness of enfuvirtide in a cohort of highly antiretroviral-experienced HIV-1-infected patients in Mexico.
abstract: BACKGROUND
  Treatments in patients with multidrug resistance often involve the use of multiple agents with partial antiviral activity and overlapping metabolic toxicities. Enfuvirtide is therefore a welcome addition to the antiretroviral management of patients with multiclass resistant virus, given the low risk of systemic toxicities and novel mechanism of action relative to existing drug classes. The aim of this study was to evaluate the effectiveness of ENF plus optimized background regimen (OBR) in a Mexican cohort of highly HIV-1 ARV-experienced patients.
  
  
  METHODS
  Prospective cohort of treatment-experienced HIV-1-infected adults with virological failure who started therapy with an ENF-containing regimen. The effectiveness of ENF treatment was evaluated with percentages of undetectable HIV-1 RNA viral load after 24 and 48 weeks of treatment, and changes in CD4+ cell counts.
  
  
  RESULTS
  Forty patients >18 years were included. After 24 weeks of treatment, 91% of patients had HIV-1 RNA viral load <400 copies/mL and 65.8% had <50 copies/mL. At week 48 of treatment, 81.4% of the patients had HIV-1 RNA <400 copies/mL and 55.5% had <50 copies/mL; in both cases p <0.0001 compared to baseline. Increase CD4+ cells were also statistically significant at weeks 24 and 48 with respect to the baseline. Pain at the site of injection was the main adverse event in 100% of patients.
  
  
  CONCLUSIONS
  Our study provides clinically important evidence of the effectiveness and safety of ENF in highly ARV-experienced HIV-1-infected patients. These findings strengthen the results of previous randomized controlled trials with this agent.
authors.affiliation: Departamento de Infectología Pediátrica, Hospital de Pediatría, Centro Médico Nacional "Siglo XXI", IMSS, México City (Distrito Federal), México ; Servicio de Infectología, Hospital de Pediatría Centro Médico Nacional Siglo XXI, Avenida Cuauhtémoc 330, Cuauhtémoc, Doctores, Ciudad de México, DF 06720 México.
authors.forename: Gloria
authors.initials: G
authors.lastname: Huerta-García
authors.affiliation: Unidad Médica de Alta Especialidad No. 25, IMSS, Monterrey, Nuevo León México.
authors.forename: Marcelino
authors.initials: M
authors.lastname: Chavez-García
authors.affiliation: Departamento de Infectología adultos, Hospital de Infectología, Centro Médico Nacional "La Raza", IMSS, México City (Distrito Federal), México.
authors.forename: José Antonio
authors.initials: JA
authors.lastname: Mata-Marín
authors.affiliation: Departamento de Infectología adultos, Hospital de Infectología, Centro Médico Nacional "La Raza", IMSS, México City (Distrito Federal), México.
authors.forename: Jorge
authors.initials: J
authors.lastname: Sandoval-Ramírez
authors.affiliation: Departamento de Infectología adultos, Hospital de Infectología, Centro Médico Nacional "La Raza", IMSS, México City (Distrito Federal), México.
authors.forename: Juan
authors.initials: J
authors.lastname: Domínguez-Hermosillo
authors.affiliation: Departamento de Infectología adultos, Hospital de Infectología, Centro Médico Nacional "La Raza", IMSS, México City (Distrito Federal), México.
authors.forename: Ana Lourdes
authors.initials: AL
authors.lastname: Rincón-Rodríguez
authors.affiliation: Departamento de Infectología adultos, Hospital de Infectología, Centro Médico Nacional "La Raza", IMSS, México City (Distrito Federal), México.
authors.forename: Jesús
authors.initials: J
authors.lastname: Gaytán-Martínez
keywords: Drug tolerability; Enfuvirtide; HIV; Treatment- experienced; Virologic suppression