Abstract
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 selfadministered 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 (150mg twice daily) or lamivudine (150mg twice daily) plus loviride (100mg 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.
Similar content being viewed by others
References
Hammer SM, Squires KE, Hughes MD, et al. A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. N Engl J Med 1997; 337: 725–33
Gulick RM, Mellors JW, Havlir D, et al. Treatment with indinavir, zidovudine, and lamivudine in adults with human immunodeficiency virus infection and prior antiretroviral therapy. N Engl J Med 1997; 337: 734–9
Wu AW, Revicki DA, Jacobson D, et al. Evidence for reliability, validity and usefulness of the medical outcomes study HIV health survey (MOS-HIV). Q Life Res 1997; 6: 481–93
Wu AW, Mathews WC, Brysk LT, et al. Quality of life in a placebo-controlled trial of zidovudine in patients with AIDS and AIDS-related complex in AIDS clinical trials. J Acquir Immune Defic Syndr Hum Retrovirol 1990; 3: 638–90
Wu AW, Hays RD, Kelly S, et al. Applications of the medical outcomes study health-related quality of life measures in HIV/AIDS. Q Life Res 1997; 6: 531–54
Bozzette SA, Kanouse DE, Berry S, et al. Health status and function with zidovudine or zalcitabine as initial therapy for AIDS: a randomized controlled trial (ACTG 114). JAMA 1995; 273: 295–301
Revicki DA, Swartz C. Quality of life outcomes of saquinavir, zalcitabine, and combination saquinavir-zalcitabine therapy for advanced HIV-infection [abstract]. 4th International Conference on Retroviral and Opportunistic Infections; 1997 Jan 22-26; Washington DC, 266
Nabulsi A, Revicki D, Conway D, et al. Quality of life consequences of adding ritonavir to current anti-viral therapy for advanced HIV patients. XI International Conference on AIDS; 1996 Jul 7-12; Vancouver
Wu AW, Rubin HR, Mathews WC, et al. Functional status and well-being in a placebo-controlled trial of zidovudine in early AIDS-related complex. J AIDS 1993; 6: 452–8
De Boer JB, van Dam FSAM, Sprangers MAG, et al. Longitudinal study on the quality of life of symptomatic HIV-infected patients in a trial of zidovudine and interferon-alpha. AIDS 1993; 7: 947–53
Scott-Lennox JA, Adams JE, Lee JT, et al. Quality of life associated with zidovudine plus lamivudine combination treatment in therapy-naive HIV-infected patients. 3rd International Conference on Retroviral and Opportunistic Infections 1996; Jan 28-Feb 1, 1996: P119
Scott-Lennox JA, Mills RJ, Burt ME. Impact of zidovudine plus lamivudine or zalcitabine on health-related quality of life. Ann Pharmacother 1998 May; 32 (5): 525–30
Randomised trial of addition of lamivudine or lamivudine plus loviride to zidovudine-containing regimens for patients with HIV-1 infection: the CAESAR trial. Lancet 1997; 349: 1413–21
Wu AW, Johns Hopkins University. MOS-HIV health survey — scoring guidelines. Med Outcomes Trust 1996; 297: 1–15
Revicki DA, Sorensen S, Wu AW. Reliability and validity of the physical and mental health summary scores from the Medical Outcomes Study HIV Health Survey. Med Care 1998; 36 (2): 126–37
van Elteren PH. On the combination of independent two-sample tests of Wilcoxon. Bull Int Stat Inst 1958; 37 (Pt 3): 351–61
Wu AW, Jacobson D, Clark B, et al. Quality of life associated with valacyclovir vs high and low dose acyclovir for prophylaxis against cytomegalovirus in AIDS [abstract]. 4th International Conference on Retroviral and Opportunistic Infections; 1997 Jan 22-26; Washington DC, 297
Department of Health and Human Services and Henry J. Kaiser Family Foundation. Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents. MMWR Morb Mortal Wkly Rep 1998; 47 (RR-5): 43–82
USPHS/IDSA Prevention of Opportunistic Infections Working Group. 1997 USPHS/IDSA guidelines for the prevention of opportunistic infections in persons infected with human immunodeficiency virus. MMWR Morb Mortal Wkly Rep 1997; 46 (RR-12): 1–46
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Chatterton, M., Scott-Lennox, J., Wu, A. et al. 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. Pharmacoeconomics 15 (Suppl 1), 67–74 (1999). https://doi.org/10.2165/00019053-199915001-00006
Published:
Issue Date:
DOI: https://doi.org/10.2165/00019053-199915001-00006