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Table 1

From: Nevirapine (NVP) vs ritonavir-boosted atazanavir (ATV/r) combined with tenofovir/emtricitabine (TDF/FTC) in first-line therapy: NEWART 48-week data

Outcome Measure (48 wks)

NVP 200 mg BID (n=75)

ATV/r 300/100 QD (n=77)

P value

Difference (95% CI) from model

adjusting for screening VL and CD4+

Virologic Response (VR)

46 (61.3%)

50 (64.9%)

0.71

-4.1% (-18.3% to 10.1%)

Virologic Failure (VF), Protocol Defined

10 (13.3%)

12 (15.6%)

0.63

-2.6% (-13.1% to 7.9%)

Early withdrawals†

24

18

  

- due to investigator-defined VF

5

0

  

- due to adverse events

9*

9

  

- due to other reason

10

9

  

Mean Change in TC/HDLc [baseline to week 48 (LOCF)]

-0.38

-0.02

0.038

-0.33 (-0.64 to -0.02)

  1. *NVP arm: 1 DAIDS grade 3 hepatobiliary AE (viral hepatitis); no grade 3/4 rash †2 deaths: 1-NVP (suicide); 1-ATV/r (lymphoma)
  2. For NEWART and ARTEN (combined), VR for NVP 200mg BID was 65% (171/263) vs 65% for ATV/r (176/270) [P=0.75 (CI= -7.7% to 10.7%)].