Table 1

Patient characteristicsa

ParameterValue for groupP value for R5 vs non-R5
MOTIVATE-1 and -2 MVC arms overallCurrent study population
Overall study populationPatients with non-R5 genotype by population-based sequencing at failurePatients with R5 genotype by population-based sequencing at failure
No. of patients7941819190
Mean age (yr) (range)46 (17–75)*45 (19–70)45 (19–70)45 (34–69)NS
% male patients (no. of male patients/total no. of patients)89 (745/840)*91 (165/181)93 (85/91)89 (80/90)NS
% female patients (no. of female patients/total no. of patients)11 (95/840)*9 (16/181)7 (6/91)11 (10/90)
% white patients (no. of white patients/total no. of patients)83 (699/840)*80 (145/181)84 (76/91)77 (69/90)NS
% black patients (no. of black patients/total no. of patients)14 (121/840)*19 (34/181)15 (14/91)22 (20/90)
% R5 patients by ESTA at screening (no. of R5 patients/total no. of patients)NA69 (124/181)48 (44/91)89 (80/90)<0.001
% R5 patients by original Trofile assay at failure (no. of R5 patients/total no. of patients)43 (57/133)*42 (76/181)2 (2/91)82 (74/90)<0.001
Median baseline pVL (log) (IQR)4.9 (4.4–5.3)5.1 (4.7–5.5)5.0 (4.6–5.4)5.2 (4.8–5.6)0.03
Median failure pVL (log) (IQR)NA4.1 (3.5–5.0)4.3 (3.6–5.1)4.0 (3.3–4.9)0.06
Median baseline CD4 count (cells/mm3) (IQR)168 (74–289)72 (17–177)64 (15–174)79 (23–182)NS
Median no. of active ARVs (wOBTss) (IQR)1.0 (0–2)0.5 (0–1.0)0.5 (0–1.0)1.0 (0–1.5)0.03
Median geno2pheno FPR at screening (IQR)33.2 (14.7–56.5)31.1 (12.5–55.3)19.6 (6.9–41.4)41.9 (21.8–65.0)<0.001
Median geno2pheno FPR at failure (IQR)NA5.3 (1.1–48.9)1.1 (0.4–1.8)48.9 (21.2–74.0)<0.001
Median % non-R5 variants by deep sequencing (screening, n = 181) (IQR)0 (0–0.3)0.1 (0–3.1)1.4 (0–15.2)0 (0–0.1)<0.001
Median % non-R5 variants by deep sequencing (failure, n = 73) (IQR)NA0.8 (0–99.0)99.5 (94.8–99.9)0 (0–0.2)<0.001
  • a Shown are the baseline patient characteristics in the current study as well as those from the maraviroc (MVC) arms of the MOTIVATE-1 and -2 studies. Most values shown are median values, with the interquartile ranges (IQR) in parentheses, unless otherwise indicated. The data in the MOTIVATE column were derived from a previously reported data set (8) comprising a majority of maraviroc recipients in the MOTIVATE studies (94%; 788/840 patients). Due to the small numbers of patients, those with races/ethnicities other than white or black are not included in the table. pVL, plasma viral load; wOBTss, weighted optimized background therapy susceptibility score; FPR, false-positive rate; ARVs, antiretrovirals. Some values were derived from data reported previously (1, 3) and are marked with asterisks.