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
Pregnancy
category
  • AU: B3
Routes of
administration		Oral
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • US: ℞-only
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
ChemSpider
  • none
KEGG
  (verify)

Emtricitabine/rilpivirine/tenofovir (trade names Complera, Eviplera) is a fixed-dose combination of antiretroviral drugs for the treatment of HIV/AIDS.[1] The drug was co-developed by Gilead Sciences and Johnson & Johnson's Tibotec division and was approved by the Food and Drug Administration in August 2011, and by the European Medicines Agency in November 2011,[2] for patients who have not previously been treated for HIV.[3] 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.[4]

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”).[5][6]

Side effects

Common[5][7]

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

Serious[5][7]

  • 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:[5][8]

References

  1. ↑ "Approval of Complera: emtricitabine/rilpivirine/tenofovir DF fixed dose combination". Food and Drug Administration. August 10, 2011.
  2. ↑ "Eviplera; summary of the European public assessment report". European Medicines Agency. November 2011.
  3. ↑ "FDA approves Gilead-J&J HIV pill Complera". Business Week. August 10, 2011. Archived from the original on 2011-09-10.
  4. ↑ Complera/Eviplera (Rilpivirine + emtricitabine + tenofovir) Archived 2017-08-09 at the Wayback Machine, aidsinfonet.org
  5. 1 2 3 4 Complera [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2014. Accessed October 28, 2014
  6. ↑ Eviplera [package leaflet]. County Cork, Ireland: Gilead Sciences Limited.; 2013. Accessed October 28, 2014.
  7. 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 May 1, 2014]. Available from: http://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf Archived 2016-11-01 at the Wayback Machine. Accessed October 29, 2014.
  8. ↑ 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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