Single tablet regimens are associated with reduced Efavirenz withdrawal in antiretroviral therapy naïve or switching for simplification HIV-infected patients

Abstract

BackgroundEfavirenz (EFV) administration is still controversial for its high rates of interruption mainly related to central nervous system side effects (CNS-SE). Aim of the study was to define if single tablet regimen (STR) as compared to bis-in-die (BID) or once-daily (OD) with ≥2 pills-a-day EFV formulations reduced the risk of interruption.MethodsPatients starting any cART regimen including EFV + 2NRTIs or switching to EFV + 2NRTIs for simplification after virological suppression were retrospectively selected. Incidence, probability and prognostic factors of interruption by different causes were assessed by survival analysis and Cox regression model.ResultsOverall, 553 patients starting EFV-containing regimens were included: 38.2% started BID regimen, 44.5% OD regimens ≥2 pills and 17.4% STR. The overall proportion of EFV interruption was 37.4% at 4 years; at the same time point, interruptions for virological failure and toxicity were 8.8% and 16.5% (8% for CNS-SE), respectively. Starting EFV co-formulated in STR was associated with lower proportion of overall interruption at 4 years (17.1% vs. 40.6%, p < 0.01). Only one virological failure was observed with STR up to 4 years (1.1% vs. 10.3% in non-STR, p = 0.051). STR also accounted for lower proportion of interruption by patient decision (1.5% vs. 11.8%, p = 0.01). No differences of interruption by overall toxicity and CNS-SE were observed. In multivariable analysis, STR and male gender were associated with lower risk of EFV interruption, while higher CD4 nadir and IDU with higher risk.ConclusionsIn our experience, starting EFV co-formulated in STR was associated with lower virological failure and higher adherence, despite a similar proportion of CNS toxicity, thus reducing the risk of treatment interruption.

Adverse events in Chinese human immunodeficiency virus (HIV) patients receiving first line antiretroviral therapy

“…However, Chen et.al reported that the allelic frequency of CYP2B6 polymorphisms in Chinese population is 0.16 [23], which is different from other populations [24]. Previous studies have demonstrated that Efavirenzbased regimens can lead to adverse effects impacting the central nervous system [25]. Consistently, nervous system AEs were the most commonly reported AE in our study.…”

3-Year Efficacy and Durability of Simplification to Single Tablet Regimens: A Comparison between Co-Formulated Efavirenz/Emtricitabine/Tenofovir and Rilpivirine/Emtricitabine/Tenofovir

“…virological suppression, increase patients' satisfaction and appear to decrease health-care costs in some contexts [4][5][6][7][8]. On the other hand, STR use offers very few disadvantages over multiple tablet regimens: STR are not available for single drug dosage adjustment in case of renal impairment and higher costs are expected for some of the newest compounds, especially when compared to the prescription of generic drugs.…”

Antiretroviral pill count and clinical outcomes in treatment‐naïve patients with HIV infection

“…Our results could be used to evaluate any premium paid for other STRs over multiple‐pill formulations of the same regimen by assuming that our results represent a best case scenario. Deliberate nonadherence (rather than accidental) could explain why most of the reduction in the risk of AIDS or death in this study came from using a one‐pill regimen rather than a two‐pill regimen . With a one‐pill regimen, patients cannot take just part of their regimen; with two‐ or three‐pill regimens, patients can avoid taking efavirenz while still taking the other drugs.…”