Table 1

Weeks on HAART/TDF

480/480

480/336

HIV RNA < 50 (copies/mL) at Week 480 (ITT, M=F)

63%

64%

HIV RNA < 50 (copies/mL) at Week 480 (ITT, M=E)

92%

96%

Change in Mean (SD) CD4, cells/mm³

545 (287)

180 (290)

Drug-related Adverse Events (Grades 1-4)

66%

46%

Change in Mean (SD) Creatinine Clearance, mL/min^β

+2.5 (23.4)

-10.7 (22.6)

Median Limb Fat at Year 10, kg

10.4

7.5

Percent Change in Mean (SD) Spine BMD^χ

-2.44 (5.08)^δ

0.04 (4.72)

Percent Change in Mean (SD) Hip BMD

-2.94 (4.95)^δ

-1.86 (4.67)^δ

Discontinuations during open-label extension

25 (29.1%)

19 (22.4%)

Adverse event

2 (2.3%)

2 (2.4%)

Suboptimal virologic response

5 (5.8%)

1 (1.2%)

LTFU^ε, Nonadherent, Pregnancy, Consent Withdrawn, Death

13 (15.1%)

9 (10.6%)

Other

5 (5.8%)

7 (8.2%)