Emtricitabine/rilpivirine/tenofovir

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Emtricitabine/rilpivirine/tenofovir
Combination of
Emtricitabine Nucleoside analog reverse-transcriptase inhibitor
Rilpivirine Non-nucleoside reverse transcriptase inhibitor
Tenofovir disoproxil Nucleotide analog reverse-transcriptase inhibitor
Clinical data
Trade names Complera, Eviplera
AHFS/Drugs.com Multum Consumer Information
MedlinePlus a616021
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)

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.

Contents

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]

Serious [8] [10]

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. 1 2 "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. Archived from the original on 18 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. 1 2 3 4 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. 1 2 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. 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.