Quality of life and treatment satisfaction after the addition of lamivudine or lamivudine plus loviride to zidovudine-containing regimens in treatment-experienced patients with HIV infection.
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.


CONCLUSIONS
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.
Chatterton
M L
ML
Glaxo Wellcome, Inc., Research Triangle Park, North Carolina, USA. mary-lou.chatterton@mail.tju.edu
Scott-Lennox
J
J
Wu
A W
AW
Scott
J
J
D000081:Acetamides / Q000627:therapeutic use*; D000098:Acetophenones / Q000627:therapeutic use*; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000523:psychology*; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D017060:Patient Satisfaction; D011788:Quality of Life; D015215:Zidovudine / Q000627:therapeutic use*
D000081:Acetamides; D000098:Acetophenones; D019380:Anti-HIV Agents; D019259:Lamivudine; C080073:loviride; D015215:Zidovudine