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.

This article is about the combination medication emtricitabine/rilpivirine/tenofovir disoproxil. For the combination medication emtricitabine/rilpivirine/tenofovir alafenamide, see Tenofovir alafenamide § combinations.

Emtricitabine/rilpivirine/tenofovir
Combination of
EmtricitabineNucleoside analog reverse-transcriptase inhibitor
RilpivirineNon-nucleoside reverse transcriptase inhibitor
Tenofovir disoproxilNucleotide analog reverse-transcriptase inhibitor
Clinical data
Trade namesComplera, Eviplera
AHFS/Drugs.comMultum Consumer Information
MedlinePlusa616021
License data
Pregnancy
category
  • AU: B3
Routes of
administration		By mouth
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • US: ℞-only[1][2]
  • EU: Rx-only[3]
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
ChemSpider
  • none
KEGG
  (verify)

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][10]

  • Diarrhea
  • Nausea
  • Vomiting
  • Insomnia
  • Abnormal dreams
  • Dizziness
  • Headache
  • Rash
  • Weakness
  • Decreased appetite

Serious[8][10]

  • 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]

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. Archived from the original on 24 May 2013. Retrieved 29 January 2012.
  6. "FDA approves Gilead-J&J HIV pill Complera". Business Week. 10 August 2011. Archived from the original on 10 September 2011.
  7. Complera/Eviplera (Rilpivirine + emtricitabine + tenofovir) Archived 9 August 2017 at the Wayback Machine, 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: http://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf Archived 1 November 2016 at the Wayback Machine. Accessed 29 October 2014.
  11. Gleason LJ, Luque AE, Shah K (2013). "Polypharmacy in the HIV-infected older adult population". Clinical Interventions in Aging. 8: 749–63. doi:10.2147/CIA.S37738. PMC 3693722. PMID 23818773.
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