Abstract
Intro: In studies with MVC a numeric increase in CD4 cell count has been observed in the groups receiving MVC vs Placebo or efavirenz. The clinical parameters associated with and clinical significance of the increase in CD4 cell count are unknown. This post hoc analysis of the Wk 48 data combined MOTIVATE 1 and 2 data explores efficacy of MVC by degree of immune deficiency at BL, the clinical relevance of and predictors of the CD4 cell count increase observed in the MVC vs PBO arms. Methods: Descriptive statistics of antiviral efficacy (ITT), time to virologic failure, change in CD4 cell count (LOCF) and time to a Category C event were computed for all patients who received at least one dose of randomized study drug. A multivariate analysis of BL demographic and disease characteristics was conducted to determine parameters of changes in CD4 count at Wk 48. Results: There were no differences at BL among randomized treatment arms in CD4 cell count, viral load, age, gender, race and number of new drugs used in OBT. At all clinically relevant CD4 cell count strata a greater proportion of patients receiving MVC achieved HIV RNA <50 copies/mL at Wk 48 as compared to the PBO arm.TABLE: No Caption AvailableConclusions: Efficacy of MVC was observed in all CD4 strata and CD4 cell increases were greater in patients who received MVC vs PBO independent of viral load change or achieving a viral load <50 copies/mL. Predictors of CD4 count increase, other than MVC use, were similar to what has previously been reported. The higher proportion of patients achieving CD4 cell count >200 cells/mm3 on MVC, and the fact that on treatment CD4+ cells (but not treatment arm) were associated with lower risk of Category C events, suggests a clinical relevance to the CD4 cell count increases on MVC observed in the MOTIVATE studies.
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