Emtricitabine/rilpivirine/tenofovir

Emtricitabine/rilpivirine/tenofovir, sold under the brand name Complera among others, is a fixed-dose combination of antiretroviral drugs for the treatment of HIV/AIDS.[4] The drug was co-developed by Gilead Sciences and Johnson & Johnson's Tibotec division and was approved by the US Food and Drug Administration (FDA) in August 2011, and by the European Medicines Agency in November 2011,[3][5] for patients who have not previously been treated for HIV.[6] It is available as a once-a-day single tablet.

In the European Union it is marketed as Eviplera and in the US as Complera.[7]

Medical uses

Emtricitabine/rilpivirine/tenofovir is indicated for treatment of HIV-1 in adults naïve to HIV-1 medications (where the virus has not developed resistance to these anti-HIV medications) and who have no more than 100,000 copies per mL of HIV-1 RNA in their blood (“viral load”).[8][9]

Side effects

Common[8]

Serious[8][10]

  • Diarrhea
  • Nausea
  • Vomiting
  • Insomnia
  • Abnormal dreams
  • Dizziness
  • Headache
  • Rash
  • Weakness
  • Decreased appetite
  • Lactic acidosis (excess lactic acid in blood) is a rare and potentially fatal side effect. It is characterized by the following symptoms: deep and rapid breathing, tiredness or weakness, nausea, vomiting, abnormal muscle pain, dizziness or drowsiness
  • Serious liver problems, such as hepatomegaly (enlarged liver) and steatosis (fatty liver). Presentation typically includes: skin or the white part of the eyes turning yellow (jaundice), dark “tea-colored” urine, light-colored bowel movements, loss of appetite, nausea, stomach pain
  • Worsening of hepatitis B (HBV) infection. Patients also diagnosed with HBV who stop taking Emtricitabine/rilpivirine/tenofovir may suddenly exacerbate their hepatitis.
  • New or worsening kidney problems, including kidney failure
  • Onset of depressive disorders or mood changes
  • Changes in bone such as osteonecrosis (breakdown and death of bone)
  • Increases or redistribution of body fat
  • Immune system changes (e.g. Immune Reconstitution Syndrome)

Interactions

Contraindications

Use of emtricitabine/rilpivirine/tenofovir with the following medicines is contraindicated, as they lead to reduced blood levels of rilpivirine and in turn reduce the effectiveness of emtricitabine/rilpivirine/tenofovir:[8][11]

  • carbamazepine, oxcarbazepine, phenobarbital, phenytoin
  • rifampicin, rifapentine
  • omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole
  • systemic dexamethasone (more than a single dose)
  • St John's wort

References

  1. Complera- emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate tablet, film coated DailyMed, 26 March 2021, retrieved 20 June 2024^
  2. Complera Access - emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate tablet, film coated DailyMed, 20 February 2024, retrieved 20 June 2024^
  3. Eviplera EPAR European Medicines Agency, 28 November 2011, retrieved 20 June 2024^
  4. Approval of Complera: emtricitabine/rilpivirine/tenofovir DF fixed dose combination U.S. Food and Drug Administration (FDA), 10 August 2011^
  5. Eviplera; summary of the European public assessment report European Medicines Agency, November 2011, retrieved 29 January 2012^
  6. FDA approves Gilead-J&J HIV pill Complera Business Week, 10 August 2011^
  7. Complera/Eviplera (Rilpivirine + emtricitabine + tenofovir), aidsinfonet.org^
  8. Complera [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2014. Accessed 28 October 2014^
  9. Eviplera [package leaflet]. County Cork, Ireland: Gilead Sciences Limited.; 2013. Accessed 28 October 2014.^
  10. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Department of Health and Human Services [updated 1 May 2014]. Available from:. Accessed 29 October 2014.^
  11. Polypharmacy in the HIV-infected older adult population Clinical Interventions in Aging, 2013^