Background: Assessments of health-related quality of life and treatment satisfaction were conducted as part of a randomised, double-blind, placebo-controlled 52-week trial conducted in Canada, Australia, Europe, and South Africa (CAESAR). The Medical Outcomes Study HIV Health Survey (MOS-HIV) was self-administered during 3 scheduled clinic visits (baseline, week 28 and the end-of-treatment/withdrawal visit). A single question was used at the end of treatment to assess patient satisfaction with study medications.
Methods: Patients were randomly allocated to receive placebo, lamivudine (150 mg twice daily) or lamivudine (150 mg twice daily) plus loviride (100 mg 3 times daily) in addition to their current treatment regimen, which could be either zidovudine monotherapy, or zidovudine in combination with didanosine or zalcitabine at standard dosages.
Results: Statistically significant differences across treatment groups were demonstrated for the Physical and Mental Health Summary scores, and for 5 of 10 MOS-HIV subscales (physical functioning, vitality, cognitive functioning, general health perceptions, social functioning). These differences favoured the lamivudine and lamivudine plus loviride groups over the placebo group (p < 0.05). No significant difference was found between the 3 treatment groups with regard to the percentages of patients who were satisfied with their study medication.
Conclusion: The results suggest that, for treatment-experienced patients with HIV infection and CD4+ counts < 250 cells/mm3, the addition of lamivudine or lamivudine plus loviride to antiretroviral regimens containing zidovudine maintained patient-reported mental and physical health.