The Use of the Restricted Mean Survival Time as a Treatment Measure in HIV/AIDS Clinical Trial: Reanalysis of the ACTG A5257 Trial

Journal of Acquired Immune Deficiency Syndromes : JAIDS
Xianmixikemaier AbuliziPhilippe Flandre

Abstract

The restricted mean survival time (RMST) measures have not been used as primary measure of efficacy in HIV/AIDS clinical trials. In this work, we aim to compare analysis based on the difference in RMST (Δ-RMST) measure and 2 other treatment-effect measures in a recent HIV equivalence trial, and to investigate the performance and characteristics of Δ-RMST-based analysis in a simulation study. We reanalyzed a recent HIV equivalence trial (ACTG A5257 trial) with hazard ratio and Δ-RMST, and then compared the results with the original analysis based on risk difference estimated by Kaplan-Meier curves (RDKM). In a simulation study, we investigated the performance and operating characteristics of Δ-RMST-based analysis in the setting of non-proportional hazards (PH) ratio. In the ACTG A5257 trial, analyses based on Δ-RMST globally led to similar conclusions as the published finding based on RDKM. By contrast, analyses based on hazard ratio provided some discordant equivalence conclusions compared both with the initial analyses based on RDKM and the Δ-RMST. Results of simulation study indicate that the violation of the PH assumption has an impact on Δ-RMST-based analysis regarding the probability of declaring equivalence. Although the ...Continue Reading

References

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Aug 15, 2006·JAMA : the Journal of the American Medical Association·Roy M GulickUNKNOWN AIDS Clinical Trials Group (ACTG) A5095 Study Team
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Jul 2, 2014·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Hajime UnoLee-Jen Wei
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Sep 7, 2017·JAMA Cardiology·Dae Hyun KimLee-Jen Wei
Jan 13, 2018·Journal of Statistical Computation and Simulation·Peter C Austin

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Citations

Jan 1, 2021·Journal of Biopharmaceutical Statistics·Mai Zhou
Jul 14, 2021·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Isabelle R Weir, Sean Wasserman

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