Article Text

Download PDFPDF
CP-054 Off-label use of Emtricitabine/Rilpivirine/Tenofovir
  1. R Castaño,
  2. V Torres,
  3. C Garcia,
  4. C Cortés,
  5. S Chavernas,
  6. D Amar,
  7. E Torres
  1. University Hospital of Ceuta, Pharmacy, Ceuta, Spain


Background Emtricitabine/rilpivirine/tenofovir (FTC/RPV/TDF) was initially approved for the treatment of human immunodeficiency virus type 1 in treatment-naïve adult patients with a viral load ≤ 100,000 copies/mL.

Purpose To evaluate the effectiveness and safety of off-label use of FTC/RPV/TDF after this drug was included in our hospital’s formulary.

Material and methods This retrospective observational study included all patients for whom FTC/RPV/TDFwasdispensed from our university hospital’s pharmacy department from October 2013 to March 2014. We collected the following information from medical records: age, sex, drug history, prior antiretroviral treatment, reasons for treatment change, viral load, CD4 count and atherogenic index at the start and end of the study period, adherence, side effects and reasons for discontinuing treatment.

Results We included 19 consecutive patients (14 men and 5 women; mean age, 44.7 years). All patients were treatment-experienced; 78% had previously been treated with efavirenz/emtricitabine/tenofovir. The most frequent reasons for changing antiretroviral treatment were hyperlipidaemia (38.8%) and interaction with methadone (22%). The viral load was <50 copies/mL in 10 patients. The mean CD4 count was 634.6/mm3 at baseline and 596.4/mm3 at study end (normal range: 450–1400/mm3). The mean atherogenic index, recorded in 16 patients, was 4.5 (normal range: 0–5) at both the beginning and end of the study. No side effects were documented. Two patients discontinued treatment for reasons unrelated to the antiretroviral (pregnancy and death). We detected no non-adherence to the treatment.

Conclusion In our centre, changing treatment to FTC/RPV/TDF is mostly due to side effects and interactions in the previous treatment. Although our preliminary data preclude definitive conclusions, FTC/RPV/TDF seems safe and effective.

References and/or Acknowledgements

  1. Molina JM, et al. Lancet 2011;378:238–46

  2. Nelson M, et al. Multicentre Open-Label Study of Switching from Atripla to Eviplera for Possible Efavirenz Associated CNS Toxicity. 2013

  3. Enferm Infecc Microbiol Clin 2013;31:604–13

References and/or AcknowledgementsNo conflict of interest.

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.