Relationship between CD4 count, viral burden, and quality of life over time in HIV-1-infected patients

BACKGROUND. Although surrogate markers such as CD4 counts and viral burden (HIV-1 RNA) are predictive of AIDS-related disease progression, little is k nown about the relationship between changes in surrogate markers and health -related quality of life (HRQOL) outcomes. This study investigated how chan ges in CD4/mm(3) and viral burden (RNA copies/mL,) are related to changes i n HRQOL as indexed by the Medical Outcomes Study HIV Health Survey (MOS-HIV -30), METHODS. Subjects were HIV-infected patients with CD4 counts <300/mm(3) enr olled in a double-blind, randomized clinical trial of delavirdine. As part of the clinical protocol, patients completed the MOS-HIV-30, from which the Physical Health (PHS) and Mental Health (NIHS) summary scores were used fo r analyses. HRQOL and surrogate marker data assessed up to 2 years after ra ndomization were analyzed for a total of 1,112 patients. RESULTS. Individual patients' initial status (intercepts) and rates; of cha nge (slopes) over time for log CD4, log RNA, PHS and MHS were estimated wit h the we of empirical Bayes, Early response to treatment correlated with HR QOL better for RNA than. for CD4, However; the relationship between weekly change and HRQOL tvas stronger for CD4 than for RNA. CONCLUSIONS, Surrogate markers ape significantly associated with HRQOL, out comes, Improvements in HRQOL, over time are associated with lower initial v iral load and with increases in CD4: counts, Limitations concerning the res tricted variability of the change scores are addressed.