Serum HIV-1 RNA levels and time to development of AIDS in the multicenter hemophilia cohort study

Objective.-To determine if the long-term incidence of the acquired immunodeficiency syndrome (AIDS) is related to human immunodeficiency virus type 1 (HIV-1) RNA levels measured early in HIV-1 infection. Design.-Epidemiologic cohort study. Setting.-Five hemophilia treatment centers in the United States. Subjects.-A total of 165 subjects with hemophilia and HIV-1 infection (age at HIV-1 seroconversion, 1-66 years) followed from 1979 to 1995. Methods.-The HIV-1 RNA level was measured by polymerase chain reaction over a range of 200 to 1 million or more HIV-1 RNA copies/mL. in archived serum specimens collected 12 to 36 months (median, 27 months) after the estimated date of HIV-1 seroconversion. Kaplan-Meier methods were used to examine the risk of AIDS and proportional hazards models were used to estimate relative hazards. Results.-The HIV-1 RNA values were similar in subjects younger than 17 years at seroconversion (median, 5214 copies/mL) and those 18 to 34 years old (median, 4693 copies/mL), but higher in those 35 years or older (median, 12 069 copies/mL) (P=.02 compared with each younger group). At 10 years after seroconversion, the proportions of subjects with AIDS were 72% among subjects with 100 000 or more HIV-1 RNA copies/mL measured 12 to 36 months after HIV-1 seroconversion (n=9), 52% among subjects with 10 000 to 99 999 copies/mL (n=55), 22% among subjects with 1000 to 9999 copies/mL (n=82), and 0% among subjects with fewer than 1000 copies/mL (n=19) (P<.001). The age-adjusted relative hazard for AIDS for subjects with 10 000 or more copies/mL was 14.3 (95% confidence interval, 1.9-105.6) compared with subjects with fewer than 1000 copies/mL. Conclusions.-The HIV-1 RNA level during early chronic HIV-1 infection is a strong, age-independent predictor of clinical outcome; low revels define persons with a high probability of long-term AIDS-free survival.