Human immunodeficiency virus type 1 RNA level and CD4 count as prognostic markers and surrogate end points: A meta-analysis

摘要: Objective: To evaluate treatment-mediated changes in HIV-1 RNA and CD3 count as prognostic markers surrogate end points for disease progression (AIDS/death). Methods: Data from 13,045 subjects all 16 randomized trials comparing nucleoside analogue reverse transcriptase inhibitors having measurements at 24 weeks were obtained. A total of 3146 had determinations after starting treatment. Results: At Week 24, the percentage experiencing an decrease >1 log(10) copies/ml or a CD4 increase >33% was similar (22% vs 25%). Changes both mere significant independent predictors AIDS/death: across trials, average reduction hazard 51% per 1 (95% confidence interval: 41%, 59%) 20% 33% (17%, 24%). In univariate analyses, ratio AIDS/death treatment comparisons significantly associated with differences between treatments mean area under curve to Weeks 8 (AUCMB) change but, multivariate analysis, only significant. Conclusions: Change RNA, particularly using AUCMB, should be measured aid patient management evaluation activity clinical trials. However, short-term these are imperfect long-term outcome because two may show marker but not AIDS/death.