Nevirapine (NVP) vs ritonavir-boosted atazanavir (ATV/r) combined with tenofovir/emtricitabine (TDF/FTC) in first-line therapy: NEWART 48-week data
© DeJesus et al; licensee BioMed Central Ltd. 2010
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 .
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
Outcome Measure (48 wks)
NVP 200 mg BID (n=75)
ATV/r 300/100 QD (n=77)
Difference (95% CI) from model
adjusting for screening VL and CD4+
Virologic Response (VR)
-4.1% (-18.3% to 10.1%)
Virologic Failure (VF), Protocol Defined
-2.6% (-13.1% to 7.9%)
- due to investigator-defined VF
- due to adverse events
- due to other reason
Mean Change in TC/HDLc [baseline to week 48 (LOCF)]
-0.33 (-0.64 to -0.02)
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.
- Soriano V, Köppe S, Migrone H, et al: International AIDS Society - 5th Conference on HIV Pathogenesis. Treatment & Prevention. 2009Google Scholar
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