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Open Access Research article

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

Massimiliano Fabbiani1, Mauro Zaccarelli25*, Pierfrancesco Grima3, Mattia Prosperi4, Iuri Fanti1, Manuela Colafigli1, Alessandro D’Avino1, Annalisa Mondi1, Alberto Borghetti1, Massimo Fantoni1, Roberto Cauda1 and Simona Di Giambenedetto1

Author Affiliations

1 Institute of Clinical Infectious Diseases, Catholic University of Sacred Heart, Rome, Italy

2 Viral Immunodeficiency Unit, National Institute for Infectious Diseases “Lazzaro Spallanzani”, Rome, Italy

3 Infectious Diseases Unit, S. Caterina Novella Hospital, Galatina, Lecce, Italy

4 Centre for Health Informatics, University of Manchester, Manchester, UK

5 National Institute for Infectious Diseases “Lazzaro Spallanzani, Clinical Department, Via Portuense 292, 00149 Roma, Italy

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BMC Infectious Diseases 2014, 14:26  doi:10.1186/1471-2334-14-26

Published: 13 January 2014

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.

Keywords:
STR; Discontinuation; Combination antiretroviral therapy; Toxicity; Adherence