Purpose: To compare changes in health-related quality of life (HR-QOL) over 3 months in a cohort of patients who were initiating their first antiretroviral therapy (naive patients) and patients who had been previously treated with two nucleoside analogues and who switched to HAART (pretreated patients).
Method: One hundred thirty-eight patients initiating or changing to HAART (indinavir plus two nucleoside analogues) were recruited from 23 Spanish hospitals. Patients' HR-QOL was evaluated by administering the Medical Outcome Study HIV Health Survey (MOS-HIV) questionnaire at baseline and after 3 months of treatment. Clinical changes and changes in HR-QOL were measured after 3 months of treatment. The size of changes in HR-QOL scores was calculated at 3 months using the effect size (ES).
Results: On entering the study, both groups showed similar characteristics except in viral load and number of symptoms. The naive group presented an average viral load 2.5 times greater than the pretreated group and had 1.5 more symptoms per patient. The pretreated group began treatment with higher scores (better QOL) than the naive group in 7 of the 11 HR-QOL dimensions and in the two health summary scores (p <.05). After 3 months of treatment, significant differences appeared between both groups in terms of the percentage of patients with viral loads that decreased by more than 1 log (78.9% naive group, 54.3% pretreated group; p <.01); plasma HIV-1 viral load was not detectable in 33.3% of naive patients versus 13.5% of pretreated patients (p <.01). At 3 months, no statistically significant differences in changes in HR-QOL were found between naive and pretreated patients.
Conclusion: After 3 months of therapy with a HAART regimen, including two nucleoside analogues plus indinavir, naive patients presented a greater virological response but no significant differences in changes in HR-QOL when compared to pretreated patients. Both naive patients and patients previously treated with two nucleoside analogues showed improvement in clinical variables and in HR-QOL after this period of time.