Health-related quality of life in HIV-infected naive patients treated with nelfinavir or nevirapine associated with ZDV/3TC (the COMBINE-QoL substudy).
OBJECTIVE
The aim of the study was to assess differences in health-related quality of life (HRQoL) in HIV-infected naive patients treated with two HAART regimens at 12 months.


METHODS
The MOS-HIV questionnaire was used to measure HRQoL in a subgroup of 127 patients included in the COMBINE study, which was an open-label, randomized, multicenter study comparing zidovudine (ZDV) and lamivudine (3TC) plus nelfinavir (NFV) or nevirapine (NVP) regimens in HIV-infected naive patients. 63 patients were included in the ZDV/3TC/NFV arm and 64 in the ZDV/3TC/NVP arm.


RESULTS
No statistically significant differences were observed at baseline in demographic and clinical variables and HRQoL scores between treatment groups, except that the proportion of homosexual men was higher in the ZDV/3TC/NVP arm. There were no statistically significant differences in HRQoL scores between arms at 12 months and over time; only ZDV/3TC/NVP patients showed statistically significant improvement in Physical Health Summary score (p <.01) and a trend toward a better profile in Mental Health Summary score (p =.07). Overall, patients who were treated with ZDV/3TC/NVP showed greater changes in physical dimensions and patients who were treated with ZDV/3TC/NFV showed greater changes in mental health.


CONCLUSIONS
Differences in HRQoL between study groups at 1 year follow-up were not detected. Nevertheless, a trend toward improvement was observed in summary health scores in ZDV/3TC/NVP-treated patients.
Casado
A
A
University of Barcelona, Barcelona, Spain.
Badia
X
X
Consiglio
E
E
Ferrer
E
E
González
A
A
Pedrol
E
E
Gatell
J M
JM
Azuaje
C
C
Llibre
J M
JM
Aranda
M
M
Barrufet
P
P
Martínez-Lacasa
J
J
Podzamczer
D
D
D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000523:psychology*; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D019888:Nelfinavir / Q000008:administration & dosage / Q000009:adverse effects; D019829:Nevirapine / Q000008:administration & dosage / Q000009:adverse effects; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D013030:Spain; D011795:Surveys and Questionnaires; D015215:Zidovudine / Q000008:administration & dosage / Q000009:adverse effects
D019380:Anti-HIV Agents; D019259:Lamivudine; D015215:Zidovudine; D019829:Nevirapine; D019888:Nelfinavir