title: T20QoL: an observational multicenter cohort study to evaluate the quality of life in HIV-patients treated with enfuvirtide (ENF, T-20) in combination with an optimized background therapy.
abstract: OBJECTIVE
  To evaluate the impact of health-related quality of life (HRQoL) enfuvirtide-based (ENF-based) salvage regimens of treatment-experienced HIV patients, in an observational multicenter cohort study.
  
  
  METHODS
  HRQoL was measured in a cohort of 16 patients over a 6-month follow-up using 2 instruments: the ISSQoL (Istituto Superiore di Sanità Quality of Life), a recently validated HIV-specific questionnaire; the EQ-5D (EuroQol), a generic widely used instrument. ENF was given at standard dosage along with an optimized background regimen.
  
  
  RESULTS
  Most of HRQoL dimensions showed improvement in ENF-treated patients at the post-baseline time points. Social functioning was the only dimension showing a negative effect. Monthly care costs of antiretroviral drugs for HIV patients taking ENF plus an optimized background regimen were approximately euro2,348 per patient-month (range euro382-euro2,940).
  
  
  CONCLUSIONS
  Our results show that the addition of ENF to an optimized background salvage-HAART may positively affect HRQoL not only in clinical trials but also in a sample population of patients used in a routine clinical practice.
authors.affiliation: Istituto Superiore di Sanità, Rome, Italy;
authors.forename: R
authors.initials: R
authors.lastname: Bucciardini
authors.forename: M
authors.initials: M
authors.lastname: Massella
authors.forename: A
authors.initials: A
authors.lastname: Corpolongo
authors.forename: P
authors.initials: P
authors.lastname: Narciso
authors.forename: V
authors.initials: V
authors.lastname: Fragola
authors.forename: M
authors.initials: M
authors.lastname: Mirra
authors.forename: S
authors.initials: S
authors.lastname: Donnini
authors.forename: O
authors.initials: O
authors.lastname: Viganò
authors.forename: S
authors.initials: S
authors.lastname: Costarelli
authors.forename: V
authors.initials: V
authors.lastname: Tozzi
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