Choice of effect measure in HIV randomized trials.
Comparing the results of HIV trials using different endpoints and scale is a difficult task. The two main primary endpoints are the proportion of patients with HIV-1 RNA less than 50 copies/ml at week 48 and the time to virologic failure. In the A5202 study, the use of the risk difference scale instead of the risk ratio scale would have led to equivalence in the comparisons between efavirenz and atazanavir/ritonavir. We discuss these results and their impact on the design of the A5257, as well as alternative approaches.
aINSERM UMR-S 1136 Pierre Louis Institute of Epidemiology and Public Health bSorbonne Universités, UPMC Univ Paris 06, Paris, France.
Philippe
P
Flandre
D000480:Alkynes; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D000069446:Atazanavir Sulfate / Q000627:therapeutic use; D048588:Benzoxazines / Q000627:therapeutic use; D003521:Cyclopropanes; D023381:Endpoint Determination; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000302:isolation & purification; D006801:Humans; D012367:RNA, Viral / Q000097:blood; D016032:Randomized Controlled Trials as Topic; D019438:Ritonavir / Q000627:therapeutic use; D013995:Time; D016896:Treatment Outcome; D019562:Viral Load
D000480:Alkynes; D044966:Anti-Retroviral Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D012367:RNA, Viral; D000069446:Atazanavir Sulfate; C098320:efavirenz; D019438:Ritonavir