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
Legal status
Routes Oral
Identifiers
CAS number  YesY
ATC code J05AR08
 YesY (what is this?)  (verify)

Emtricitabine/rilpivirine/tenofovir (trade name 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 (Eviplera),[2] for patients who have not previously been treated for HIV.[3] It is available as a once-a-day single tablet.

Medical uses[edit]

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”).[4][5]

Side effects[edit]

Common Side Effects[4][6]

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

Serious Side Effects[4][6]

  • 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 (eg. Immune Reconstitution Syndrome)

Drug-Drug interactions[edit]

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:[4][7]

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

References[edit]

  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. 
  4. ^ a b c d Complera [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2014. Accessed October 28, 2014
  5. ^ Eviplera [package leaflet]. County Cork, Ireland: Gilead Sciences Limited.; 2013. Accessed October 28, 2014.
  6. ^ a b 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.
  7. ^ Shah, Krupa; Gleason, Lauren; Luque. "Polypharmacy in the HIV-infected older adult population". Clinical Interventions in Aging: 749. doi:10.2147/CIA.S37738.