July 10, 1996

Serum HIV-1 RNA Levels and Time to Development of AIDS in the Multicenter Hemophilia Cohort Study

Author Affiliations

for the Multicenter Hemophilia Cohort Study
From the Viral Epidemiology Branch, National Cancer Institute, Public Health Service, US Department of Health and Human Services, Rockville, Md (Drs O'Brien, Blattner, and Goedert); PRI, Frederick, Md (Dr Waters and Mr Miley); Milton S. Hershey Medical Center, Hershey, Pa (Dr Eyster); Cornell Medical Center, New York, NY (Dr Hilgartner); Children's Hospital of Philadelphia (Pa) (Dr Cohen); Children's Hospital National Medical Center, Washington, DC (Dr Luban); Athens (Greece) University Medical School (Dr Hatzakis); Mount Sinai Medical Center, New York (Dr Aledort); Biostatistics Branch, National Cancer Institute, Rockville (Dr Rosenberg); and Research Triangle Institute, Rockville (Dr Kroner).

JAMA. 1996;276(2):105-110. doi:10.1001/jama.1996.03540020027025

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 levels define persons with a high probability of long-term AIDS-free survival.