title: Health-related quality of life outcomes in HIV-infected patients starting different combination regimens in a randomized multinational trial: the INITIO-QoL substudy.
abstract: The health-related quality of life (HRQoL) outcomes in HIV-infected, treatment-naive patients starting different HAART regimens in a 3-year, randomized, multinational trial were compared. HRQoL was measured in a subgroup of patients enrolled in the INITIO study (153/911), using a modified version of the MOS-HIV questionnaire. The regimens compared in the INITIO trial were composed by two NRTIs (didanosine + stavudine) plus either an NNRTI (efavirenz) or a PI (nelfinavir), or both (efavirenz + nelfinavir). Primary HRQoL outcomes were Physical and Mental Health Summary scores (PHS and MHS, respectively). During follow-up, an increase of PHS score was observed in all treatment arms. The MHS score remained substantially unchanged with the four-drug combination and showed with both NNRTI- and PI-based three-drug regimens a marked trend toward improvement, which became statistically significant when a multiple imputation method was used to adjust for missing data. Overall, starting all the combination regimens compared in the INITIO study was associated with a maintained or slightly improved HRQOL status, consistently with the positive immunological and virological changes observed in the main study. The observed differences in the MHS indicate a possible HRQoL benefit associated to the use of three-drug, two-class regimens and no additional benefit for the use of four-drug, three-class regimens, confirming that three-drug, two-class regimens that include two NRTIs plus either an NNRTI or a PI should be preferred as initial treatment of HIV infection.
authors.affiliation: Department of Drug Research and Evaluation, Istituto Superiore di Sanità, Rome, Italy.
authors.forename: Raffaella
authors.initials: R
authors.lastname: Bucciardini
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Fragola
authors.forename: Maurizio
authors.initials: M
authors.lastname: Massella
authors.forename: Cosimo
authors.initials: C
authors.lastname: Polizzi
authors.forename: Marco
authors.initials: M
authors.lastname: Mirra
authors.forename: Ruth
authors.initials: R
authors.lastname: Goodall
authors.forename: Dianne
authors.initials: D
authors.lastname: Carey
authors.forename: Fleur
authors.initials: F
authors.lastname: Hudson
authors.forename: Roberto
authors.initials: R
authors.lastname: Zajdenverg
authors.forename: Marco
authors.initials: M
authors.lastname: Floridia
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D002985:Clinical Protocols; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000523:psychology* / Q000821:virology; D006801:Humans; D008297:Male; D008603:Mental Health; D008875:Middle Aged; D010809:Physical Fitness; D011788:Quality of Life; D011795:Surveys and Questionnaires
chemical_list: D019380:Anti-HIV Agents