Open AccessA randomised comparison of safety and efficacy of nevirapine vs. atazanavir/ritonavir combined with tenofovir/emtricitabine in treatment‐naïve patients
Author(s) -
DeJesus E.,
Mills A.,
Bhatti L.,
Conner C.,
Storfer S.
Publication year - 2011
Publication title -
international journal of clinical practice
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.756
H-Index - 98
eISSN - 1742-1241
pISSN - 1368-5031
DOI - 10.1111/j.1742-1241.2011.02807.x
Subject(s) - medicine , emtricitabine , nevirapine , atazanavir , ritonavir , clinical endpoint , discontinuation , adverse effect , viral load , lopinavir , gastroenterology , clinical trial , human immunodeficiency virus (hiv) , antiretroviral therapy , immunology
Summary Background: We report data from NEWART, a randomised phase 4 clinical trial comparing virologic efficacy and safety of nevirapine (NVP) vs. ritonavir‐boosted atazanavir (ATV/r) on a background of tenofovir/emtricitabine (TDF/FTC) in HIV‐1‐infected treatment‐naïve patients. This study enrolled patients according to CD4‐based initiation criteria for NVP (<250 cells/mm 3 for women and <400 cells/mm 3 for men), to reduce the likelihood of symptomatic hepatic events. NEWART was designed to support and confirm results from ARTEN, an international trial with similar design and study endpoints. Methods: A total of 152 patients were randomised 1 : 1 to open‐label NVP 200 mg twice daily or ATV/r (300/100 mg) once daily, plus once daily TDF/FTC (300/200 mg). All participants met CD4 + guidelines at entry. The primary endpoint for non‐inferiority was virologic response prior to and at week 48 (confirmed HIV plasma viral load <50 copies/ml, without rebound or change in ARVs). Safety data, including plasma lipids, were recorded throughout the study. Results: The primary endpoint was achieved in 46/75 (61.3%) and 50/77 (64.9%) of patients taking NVP and ATV/r, respectively. Frequency of adverse events (AEs) was similar between arms, with 88.0% of NVP‐treated patients and 94.8% of ATV/r‐treated patients experiencing at least one AE. Nine patients (12%) in each arm experienced an AE that led to discontinuation. At week 48, a significantly greater increase was seen in mean plasma HDL cholesterol (HDL‐C) in the NVP arm (9.6 mg/dl) vs. the ATV/r arm (3.5 mg/dl); p = 0.016. Also, total cholesterol (TC):HDL‐C ratio on‐treatment was −0.38 and −0.02 for the NVP and ATV/r arms, respectively (p = 0.038). Conclusions: Efficacy results were consistent with the ARTEN study demonstrating that NVP was non‐inferior to ATV/r when taken in combination with TDF/FTC. Rates of AEs were similar between the two arms, whereas HDL‐C increased and TC:HDL‐C decreased significantly more in patients taking NVP than ATV/r.