Quality-of-life evaluation in a clinical trial of zidovudine therapy in patients with mildly symptomatic HIV infection

Richard D. Gelber, William R. Lenderking, Deborah J. Cotton, Bernard F. Cole, Margaret A Fischl, Aron Goldhirsch, Marcia A. Testa

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Abstract

Objective: To evaluate the effects of zidovudine therapy in patients with mildly symptomatic HIV infection using Q-TWiST (quality-adjusted: Time Without Symptoms and Toxicity). Design: Analysis of a previously reported multicenter, randomized, placebo-controlled clinical trial. Setting: Thirty-two AIDS Clinical Trial units. Patients: A total of 351 patients with mildly symptomatic HIV infection were assigned to placebo, and 360 patients were assigned to zidovudine, 1200 mg/d. Measurements: A modified Q-TWiST method for comparing treatments based on time spent without severe symptomatic adverse events and without disease progression. Zidovudine and placebo were compared in a threshold utility analysis considering reduction in quality of life associated with adverse events and disease progression. Adverse events defined by laboratory findings were distinguished from findings representing symptomatic events. Results: The incidence of severe symptomatic adverse events was 22.8% for the zidovudine group and 15.1% for the placebo group (P = 0.01), but, as previously reported, zidovudine improved progression-free survival relative to placebo (at 18 months, 91% compared with 81%; P = 0.001). In an 18-month period, patients receiving zidovudine went an average of 14.5 months without disease progression or a severe symptomatic adverse event compared with 14.7 months for placebo. The zidovudine group gained 0.9 months without disease progression but lost 1.1 months due to adverse events. Within the 18-month observation period, treatment provided more Q-TWiST than placebo if the quality of life after HIV disease progression was assumed to be 10% to 20% worse than the quality of life after a severe symptomatic adverse event. Conclusions: The Q-TWiST analysis projects that quality-of-life reductions due to severe symptomatic adverse events might be balanced by the quality-of-life benefits of delayed HIV disease progression for patients who receive zidovudine for mildly symptomatic HIV infection. At currently recommended doses (500 to 600 mg/d, half the dose used in this study) zidovudine therapy is likely to yield a more favorable result.

Original languageEnglish
Pages (from-to)961-966
Number of pages6
JournalAnnals of Internal Medicine
Volume116
Issue number12
StatePublished - Jun 15 1992

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Zidovudine
HIV Infections
Quality of Life
Clinical Trials
Disease Progression
Placebos
Therapeutics
HIV
Disease-Free Survival
Acquired Immunodeficiency Syndrome
Randomized Controlled Trials
Observation
Incidence

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Gelber, R. D., Lenderking, W. R., Cotton, D. J., Cole, B. F., Fischl, M. A., Goldhirsch, A., & Testa, M. A. (1992). Quality-of-life evaluation in a clinical trial of zidovudine therapy in patients with mildly symptomatic HIV infection. Annals of Internal Medicine, 116(12), 961-966.

Quality-of-life evaluation in a clinical trial of zidovudine therapy in patients with mildly symptomatic HIV infection. / Gelber, Richard D.; Lenderking, William R.; Cotton, Deborah J.; Cole, Bernard F.; Fischl, Margaret A; Goldhirsch, Aron; Testa, Marcia A.

In: Annals of Internal Medicine, Vol. 116, No. 12, 15.06.1992, p. 961-966.

Research output: Contribution to journalArticle

Gelber, RD, Lenderking, WR, Cotton, DJ, Cole, BF, Fischl, MA, Goldhirsch, A & Testa, MA 1992, 'Quality-of-life evaluation in a clinical trial of zidovudine therapy in patients with mildly symptomatic HIV infection', Annals of Internal Medicine, vol. 116, no. 12, pp. 961-966.
Gelber, Richard D. ; Lenderking, William R. ; Cotton, Deborah J. ; Cole, Bernard F. ; Fischl, Margaret A ; Goldhirsch, Aron ; Testa, Marcia A. / Quality-of-life evaluation in a clinical trial of zidovudine therapy in patients with mildly symptomatic HIV infection. In: Annals of Internal Medicine. 1992 ; Vol. 116, No. 12. pp. 961-966.
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abstract = "Objective: To evaluate the effects of zidovudine therapy in patients with mildly symptomatic HIV infection using Q-TWiST (quality-adjusted: Time Without Symptoms and Toxicity). Design: Analysis of a previously reported multicenter, randomized, placebo-controlled clinical trial. Setting: Thirty-two AIDS Clinical Trial units. Patients: A total of 351 patients with mildly symptomatic HIV infection were assigned to placebo, and 360 patients were assigned to zidovudine, 1200 mg/d. Measurements: A modified Q-TWiST method for comparing treatments based on time spent without severe symptomatic adverse events and without disease progression. Zidovudine and placebo were compared in a threshold utility analysis considering reduction in quality of life associated with adverse events and disease progression. Adverse events defined by laboratory findings were distinguished from findings representing symptomatic events. Results: The incidence of severe symptomatic adverse events was 22.8{\%} for the zidovudine group and 15.1{\%} for the placebo group (P = 0.01), but, as previously reported, zidovudine improved progression-free survival relative to placebo (at 18 months, 91{\%} compared with 81{\%}; P = 0.001). In an 18-month period, patients receiving zidovudine went an average of 14.5 months without disease progression or a severe symptomatic adverse event compared with 14.7 months for placebo. The zidovudine group gained 0.9 months without disease progression but lost 1.1 months due to adverse events. Within the 18-month observation period, treatment provided more Q-TWiST than placebo if the quality of life after HIV disease progression was assumed to be 10{\%} to 20{\%} worse than the quality of life after a severe symptomatic adverse event. Conclusions: The Q-TWiST analysis projects that quality-of-life reductions due to severe symptomatic adverse events might be balanced by the quality-of-life benefits of delayed HIV disease progression for patients who receive zidovudine for mildly symptomatic HIV infection. At currently recommended doses (500 to 600 mg/d, half the dose used in this study) zidovudine therapy is likely to yield a more favorable result.",
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AU - Fischl, Margaret A

AU - Goldhirsch, Aron

AU - Testa, Marcia A.

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N2 - Objective: To evaluate the effects of zidovudine therapy in patients with mildly symptomatic HIV infection using Q-TWiST (quality-adjusted: Time Without Symptoms and Toxicity). Design: Analysis of a previously reported multicenter, randomized, placebo-controlled clinical trial. Setting: Thirty-two AIDS Clinical Trial units. Patients: A total of 351 patients with mildly symptomatic HIV infection were assigned to placebo, and 360 patients were assigned to zidovudine, 1200 mg/d. Measurements: A modified Q-TWiST method for comparing treatments based on time spent without severe symptomatic adverse events and without disease progression. Zidovudine and placebo were compared in a threshold utility analysis considering reduction in quality of life associated with adverse events and disease progression. Adverse events defined by laboratory findings were distinguished from findings representing symptomatic events. Results: The incidence of severe symptomatic adverse events was 22.8% for the zidovudine group and 15.1% for the placebo group (P = 0.01), but, as previously reported, zidovudine improved progression-free survival relative to placebo (at 18 months, 91% compared with 81%; P = 0.001). In an 18-month period, patients receiving zidovudine went an average of 14.5 months without disease progression or a severe symptomatic adverse event compared with 14.7 months for placebo. The zidovudine group gained 0.9 months without disease progression but lost 1.1 months due to adverse events. Within the 18-month observation period, treatment provided more Q-TWiST than placebo if the quality of life after HIV disease progression was assumed to be 10% to 20% worse than the quality of life after a severe symptomatic adverse event. Conclusions: The Q-TWiST analysis projects that quality-of-life reductions due to severe symptomatic adverse events might be balanced by the quality-of-life benefits of delayed HIV disease progression for patients who receive zidovudine for mildly symptomatic HIV infection. At currently recommended doses (500 to 600 mg/d, half the dose used in this study) zidovudine therapy is likely to yield a more favorable result.

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