Single tablet regimens are associated with reduced Efavirenz withdrawal in antiretroviral therapy naïve or switching for simplification HIV-infected patients
Efavirenz (EFV) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) which has shown good efficacy for the treatment of HIV infection [ 1 – 4
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Open Access 01.12.2014 | Research article

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

verfasst von: Massimiliano Fabbiani, Mauro Zaccarelli, Pierfrancesco Grima, Mattia Prosperi, Iuri Fanti, Manuela Colafigli, Alessandro D’Avino, Annalisa Mondi, Alberto Borghetti, Massimo Fantoni, Roberto Cauda, Simona Di Giambenedetto

Erschienen in: BMC Infectious Diseases | Ausgabe 1/2014

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Abstract

Background

Efavirenz (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.

Methods

Patients 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.

Results

Overall, 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.

Conclusions

In 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.

Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1471-2334-14-26) contains supplementary material, which is available to authorized users.

Competing interests

MF received speakers’ honoraria from Abbott Virology, Merck Sharp & Dohme and Janssen-Cilag. MZ received speakers’ honoraria from Abbott Virology, Gilead Science, Merck Sharp & Dohme and Janssen-Cilag. MP is supported by University of Manchester’s Health Research Center (HeRC) under the Medical Research Council grant MR/K006665/1. MC has been a paid consultant for Merck Sharp & Dohme, Italy and has been employed by Bristol-Myers-Squibb, Italy since May 10th, 2010 to Feb 28th 2011. RC has been advisor for Gilead and Janssen-Cilag, received speakers’ honoraria from ViiV, Bristol-Myers Squibb, Merck Sharp and Dohme and Janssen-Cilag, and research support from “Fondazione Roma”. SDG received speakers’ honoraria and support for travel meetings from Gilead, Bristol-Myers Squibb, Abbott, Boehringer Ingelheim, Janssen-Cilag, and GlaxoSmithKline. All the other authors have nothing to declare.

Authors’ contributions

MF contributed to study design, data interpretation and article writing; MZ contributed to study design, data interpretation/analysis and article writing; PG, IF, MC, AD, AM, AB contributed to data collection; MP contributed to data interpretation and analysis; MF, RC and SDG coordinated the project and contributed to the interpretation of data. All authors reviewed the manuscript during preparation, provided critical feedback and approved the final manuscript.

Abkürzungen

STR

Single tablet regimen.