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 known about the relationship between changes in surrogate markers and health-related quality of life (HRQOL) outcomes. This study investigated how changes in CD4/mm3 and viral burden (RNA copies/mL) are related to changes in HRQOL as indexed by the Medical Outcomes Study HIV Health Survey (MOS-HIV-30).


METHODS
Subjects were HIV-1-infected patients with CD4 counts <300/mm3 enrolled 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 (MHS) summary scores were used for analyses. HRQOL and surrogate marker data assessed up to 2 years after randomization were analyzed for a total of 1,112 patients.


RESULTS
Individual patients' initial status (intercepts) and rates of change (slopes) over time for log CD4, log RNA, PHS, and MHS were estimated with the use of empirical Bayes. Early response to treatment correlated with HRQOL better for RNA than for CD4. However, the relationship between weekly change and HRQOL was stronger for CD4 than for RNA.


CONCLUSIONS
Surrogate markers are significantly associated with HRQOL outcomes. Improvements in HRQOL over time are associated with lower initial viral load and with increases in CD4 counts. Limitations concerning the restricted variability of the change scores are addressed.
Weinfurt
K P
KP
Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina 27715, USA. weinf001@mc.duke.edu
Willke
R J
RJ
Glick
H A
HA
Freimuth
W W
WW
Schulman
K A
KA
D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D020008:Delavirdine / Q000627:therapeutic use; D016049:Didanosine / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000175:diagnosis* / Q000188:drug therapy / Q000523:psychology; D015497:HIV-1; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012367:RNA, Viral / Q000097:blood; D019562:Viral Load
D019380:Anti-HIV Agents; D012367:RNA, Viral; D020008:Delavirdine; D016049:Didanosine