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

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

Research output: Contribution to journalArticle

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.

Original languageEnglish
Article number26
JournalBMC Infectious Diseases
Volume14
Issue number1
DOIs
Publication statusPublished - Jan 13 2014

Keywords

  • Adherence
  • Combination antiretroviral therapy
  • Discontinuation
  • STR
  • Toxicity

ASJC Scopus subject areas

  • Infectious Diseases
  • Medicine(all)

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    Fabbiani, M., Zaccarelli, M., Grima, P., Prosperi, M., Fanti, I., Colafigli, M., D'Avino, A., Mondi, A., Borghetti, A., Fantoni, M., Cauda, R., & Di Giambenedetto, S. (2014). Single tablet regimens are associated with reduced Efavirenz withdrawal in antiretroviral therapy naïve or switching for simplification HIV-infected patients. BMC Infectious Diseases, 14(1), [26]. https://doi.org/10.1186/1471-2334-14-26