FDA Analyses of Maraviroc Safety Data

AST and/or ALT Elevation During Double-Blind Period
Studies 1027 and 1028

1 (<1%)

6 (1%)

3 (1%)

> 10 x ULN

10 (5%)

21 (5%)

21 (5%)

> 5 x ULN

21 (10%)

56 (13%)

43 (10%)

> 3 x ULN

139 (67%)

269 (63%)

249 (60%)

> ULN

Placebo

(n=209)

MVC BID

(n=426)

MVC QD

(n=414)

AST and/or ALT