Volume 13 Supplement 4

Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection

Open Access

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

  • E DeJesus1,
  • A Mills2,
  • L Bhatti3,
  • C Conner4 and
  • S Storfer4
Journal of the International AIDS Society201013(Suppl 4):P4

DOI: 10.1186/1758-2652-13-S4-P4

Published: 8 November 2010

Purpose of study

Until recently, few prospective data existed to indicate safety/efficacy of NVP with entry CD4 count restricted to <250 (women) or <400 (men) cells/mm3. Two phase IV trials, ARTEN and NEWART, compared virologic safety/efficacy of NVP vs ATV/r on a background of TDF/FTC in HIV+ patients within these CD4 ranges. NEWART (US) was designed to be confirmatory of ARTEN and to supplement ARTEN data [1].

Methods

In NEWART, treatment naïve patients were randomized to open-label NVP 200mg BID (lead-in dose 200mg QD x 14 days) or ATV/r (300/100mg) plus TDF/FTC (300/200mg). Women had CD4 counts (cells/mm3) <250; men <400. Primary endpoint was virologic response prior to and at week 48 defined as confirmed HIV viral load (VL) <50 copies/mL without subsequent rebound or therapy change. A point estimate of -6.5% or higher for difference in proportion of responders (NVP-ATV/r) was considered consistent with a successful ARTEN study.

Summary of results

152 patients were treated: 89% male, 68% White, 31% Black. At baseline, mean log10 VL was 4.9 and median CD4 count (cells/mm3) was 176 (NVP) and 193 (ATV/r). Table 1 summarizes key outcome measures. Mean plasma lipid (mg/dL) changes from baseline through 48 weeks (last observation carried forward) were as follows (NVP and ATV/r arms, respectively): total cholesterol (TC) 18.2 and 13.8 (P=0.73); HDL cholesterol (HDLc) 9.6 and 3.5 (P=0.016); LDL cholesterol (LDLc) 8.7 and 6.9 (P=0.93); and triglycerides -4.7 and 8.4 (P=0.36).

Table 1

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)

*NVP arm: 1 DAIDS grade 3 hepatobiliary AE (viral hepatitis); no grade 3/4 rash †2 deaths: 1-NVP (suicide); 1-ATV/r (lymphoma)

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%)].

Conclusions

NVP + TDF/FTC was noninferior to ATV/r + TDF/FTC. Although trial discontinuations were greater in the NVP arm, VR was similar because of less documented VF. HDLc increased and TC/HDLc decreased significantly more for NVP than for ATV/r.

Authors’ Affiliations

(1)
Orlando Immunology Center
(2)
Anthony Mills MD Inc., Los Angeles
(3)
AIDS Healthcare Foundation, Los Angeles
(4)
Boehringer Ingelheim Pharmaceuticals Inc.

References

  1. Soriano V, Köppe S, Migrone H, et al: International AIDS Society - 5th Conference on HIV Pathogenesis. Treatment & Prevention. 2009Google Scholar

Copyright

© DeJesus et al; licensee BioMed Central Ltd. 2010

This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Advertisement