EVALUATION OF THE QUALITY-OF-LIFE ASSOCIATED WITH ZIDOVUDINE TREATMENT IN ASYMPTOMATIC HUMAN-IMMUNODEFICIENCY-VIRUS INFECTION

Background. Zidovudine therapy is recommended for asymptomatic patient s infected with the human immunodeficiency virus (HIV) who have fewer than 500 CD4+ cells per cubic millimeter. An analysis of the quality o f life associated with therapy that integrated both the effects of adv erse events and the benefits of delayed disease progression might infl uence this recommendation. Methods. We applied a survival analysis adj usted for the quality of life to data from a randomized trial conducte d by the AIDS Clinical Trials Group, The trial compared treatment with 500 mg of zidovudine per day, 1500 mg of zidovudine per day, and plac ebo (Protocol 019) in 1338 asymptomatic HIV-infected patients. Results . The average time with neither a progression of disease nor an advers e event (symptom or laboratory finding) was 15.7, 15.6, and 14.8 month s for patients receiving placebo, 500 mg of zidovudine, and 1500 mg of zidovudine, respectively. The incidence of severe symptoms was 13.8 p ercent 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-m g group gained an average of 0.5 month without disease progression, as compared with the placebo group, but had severe adverse events an ave rage of 0.6 month sooner. The 500-mg group had more quality-of-life-ad justed time than the placebo group only if the time lived after the pr ogression of disease was considered by a patient to have less value th an 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 approxima tely equals the increase in the quality of life associated with a dela y in the progression of HIV disease.