Dr Anton Pozniak Chelsea and Westminster Hospital
London, UK
This open-label study in treatment-naive patients with CCR5-tropic virus showed that a high proportion of patients in the MVC and TDF/FTC treatment groups achieved and maintained viral suppression through 48 weeks of treatment
Low potential for resistance or loss of susceptibility to study drugs at treatment failure
When stratified by plasma HIV-1 RNA concentration at baseline, the number of patients who achieved plasma HIV-1 RNA < 50 c/mL at W48 was higher in the TDF/FTC + ATV/r treatment arm compared with the MVC + ATV/r group
CD4 cell counts increased from baseline in both treatment groups
The frequency of treatment-limiting hyperbilirubinemia was greater than expected
Limitations
Unpowered to establish non-inferiority
Design
Objective
Primary endpoint: % with HIV RNA < 50 c/mL at W48 (ITT, missing, discontinued = failure), not powered to show a difference
Protocol-defined treatment failure: < 1.0 log10 c/mL decrease from baseline in plasma HIV RNA at W4 or thereafter; failure to achieve plasma
HIV RNA < 400 c/mL at W24; or rebound in plasma HIV RNA > 1 000 c/mL
on 2 consecutive measurements ≤ 14 days apart in patients having achieved levels < 400 c/mL on 2 consecutive visits
Baseline characteristics (mean), and disposition
HIV-1 RNA < 50 c/mL at W48, ITT, missing/discontinuation = failure
Genotype analysis : 3 patients in each group with HIV RNA ≥ 500 c/mL at time of discontinuation :
no resistance to any component
no change in tropism in MVC group
Median change from baseline in CD4 cell count/mm 3 at W48: + 173 for MVC vs + 187 for TDF/FTC
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