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Previous Volume 330:738-743 March 17, 1994 Number 11 Next

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ABSTRACT

Background Zidovudine therapy is recommended for asymptomatic patients infected with the human immunodeficiency virus (HIV) who have fewer than 500 CD4+ cells per cubic millimeter. An analysis of the quality of life associated with therapy that integrated both the effects of adverse events and the benefits of delayed disease progression might influence this recommendation.

Methods We applied a survival analysis adjusted for the quality of life to data from a randomized trial conducted by the AIDS Clinical Trials Group. The trial compared treatment with 500 mg of zidovudine per day, 1500 mg of zidovudine per day, and placebo (Protocol 019) in 1338 asymptomatic HIV-infected patients.

Results The average time with neither a progression of disease nor an adverse event (symptom or laboratory finding) was 15.7, 15.6, and 14.8 months for patients receiving placebo, 500 mg of zidovudine, and 1500 mg of zidovudine, respectively. The incidence of severe symptoms was 13.8 percent in the placebo group, 15.2 percent in the 500-mg group, and 19.9 percent in the 1500-mg group (P = 0.038). After 18 months, the 500-mg group gained an average of 0.5 month without disease progression, as compared with the placebo group, but had severe adverse events an average of 0.6 month sooner. The 500-mg group had more quality-of-life-adjusted time than the placebo group only if the time lived after the progression of disease was considered by a patient to have less value than the time after the occurrence of a severe symptom.

Conclusions For asymptomatic patients treated with 500 mg of zidovudine, a reduction in the quality of life due to severe side effects of therapy approximately equals the increase in the quality of life associated with a delay in the progression of HIV disease.

Source Information

From the Statistical and Data Analysis Center, AIDS Clinical Trials Group, Harvard School of Public Health (W.R.L., R.D.G., D.J.C., M.A.T.), Dana-Farber Cancer Institute (R.D.G., B.F.C., A.G.), Harvard Medical School (R.D.G., D.J.C.), and Beth Israel Hospital (D.J.C.) -- all in Boston; and the University of California, San Francisco, and San Francisco General Hospital (P.A.V.).

Address reprint requests to Dr. Lenderking at the Department of Biostatistics, Harvard School of Public Health, 665 Huntington Ave., Boston, MA 02115.

Full Text of this Article

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Zidovudine and the Quality of Life
Berman D. S., Wenglin B. D., Lenderking W. R., Gelber R. D., Cotton D. J.
Extract | Full Text  
N Engl J Med 1994; 331:332-333, Aug 4, 1994. Correspondence

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