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 fumarate Nucleotide analog reverse-transcriptase inhibitor
Clinical data
Trade names Complera, Eviplera
Legal status
Routes of
administration		 Oral
Identifiers
ATC code J05AR08 (WHO)
  (verify)

Emtricitabine/rilpivirine/tenofovir (trade names Complera, Eviplera) is a fixed dose combination of antiretroviral drugs for the treatment of HIV.[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 Europe it is commercialized 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. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  2. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  3. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  4. ↑ Complera/Eviplera (Rilpivirine + emtricitabine + tenofovir), aidsinfonet.org
  5. ↑ 5.0 5.1 5.2 5.3 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. ↑ 7.0 7.1 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. Accessed October 29, 2014.
  8. ↑ Lua error in package.lua at line 80: module 'strict' not found.
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