Risk of Early Virological Failure of Once‐Daily Tenofovir‐Emtricitabine plus Twice‐Daily Nevirapine in Antiretroviral Therapy–Naive HIV‐Infected Patients

Comparative Outcomes of Tenofovir-Based and Zidovudine-Based Antiretroviral Therapy Regimens in Lusaka, Zambia

“…12 In another interim analysis, Lapadula and colleagues found that, in combination with TDF and FTC, NVP was associated with higher virologic failure (3 of 7) compared to atazanavir/ritonavir (0 of 7). 13 These clinical trials results are supported by observational data from Nigeria (n= 2,987), where a nearly two-fold increase in virologic failure was demonstrated when TDF+3TC+NVP was compared to ZDV+3TC+NVP (16.1% vs. 9.5%; p< 0.001). 14 However, not all studies agree.…”

“…Early interim analyses of two randomized studies – with 71 and 14 patients respectively – found that patients on TDF- and NVP-containing ART had higher rates of treatment failure. 12, 13 Work by Scarsi and colleagues demonstrated an increased risk for virologic failure (adjusted odds ratio [OR]: 1.7; 95% confidence interval [CI]: 1.3–2.3) when NVP-based regimens containing TDF were compared to analogous combinations with zidovudine (ZDV). 14 Each of these studies had limitations (e.g., small sample size, missing data), but the potential interaction between TDF and NVP is nevertheless cause for concern, especially in resource-constrained settings.…”

Treatment Outcomes of Recommended First-Line Antiretroviral Regimens in Resource-Limited Clinics

“…[5][6][7][8][9][10][11][12][13][14][15][16] Yet 2 small studies comprising less than 42 patients did suggest that the combination of TDF + NVP and emtricitabine or lamivudine (XTC) has higher virologic failure rates than anticipated. [17][18][19] Despite the lack of difference in the primary endpoints between the NVP/TDF/emtricitabine (FTC) and the atazanavir/r + TDF + FTC arms in the ARTEN trial, there were more participants in the NVP arms than the atazanavir/ritonavir arm who discontinued study drugs because of adverse events (13.6% vs. 2.6%) or lack of efficacy (8.4% vs. 1.6%). 11 The 2011 US DHHS guidelines list NVP as an acceptable but not a preferred or an alternative first-line drug and continue to place a warning on combination of NVP and TDF.…”

A randomised comparison of safety and efficacy of nevirapine vs. atazanavir/ritonavir combined with tenofovir/emtricitabine in treatment-naïve patients

“…Previous reports from three small trials had raised questions regarding the efficacy of the specific combination of NVP, TDF and FTC (or the closely related 3TC) after noting high rates of virologic failure among several patients (6)(7)(8). However, these conclusions were based on results that arose from early, unplanned data analyses.…”