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To the Editor: Dr Gallant and colleagues¹ compared the proportion of patients with HIV RNA levels less than 400 copies/mL at week 48 in antiretroviral-naive patients who randomly received either tenofovir or stavudine, in combination with efavirenz and lamivudine. The authors stated in their methods that "the study was designed as a noninferiority trial (ie, equivalence)." However, noninferiority and equivalence hypotheses are not identical.

In the intent-to-treat analysis, the lower 2-sided 95% confidence interval (CI) weighted difference exceeded their predefined 10% limit. However, in a 1-sided statistical context such as noninferiority, the 1-sided lower limit may be preferred. Of note, the 1-sided lower bound of the nonweighted 95% CI difference of the primary end point is –9.3, which would indicate noninferiority of the tenofovir-based regimen. Although the authors could not demonstrate equivalence, tenofovir is certainly not virologically inferior to stavudine by more than 10% at week 48.

The choice of . . . [Full Text of this Article]

Jean-Jacques Parienti, MD
parienti-jj@chu-caen.fr
Côte de Nacre University Hospital
Caen, France

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