Emtricitabine/rilpivirine/tenofovir

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.

For the combination drug Emtricitabine/rilpivirine/tenofovir alafenamide, see Tenofovir alafenamide.
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
    Routes of
    administration    		Oral
    ATC code
    Legal status
    Legal status
    • AU: S4 (Prescription only)
    • US: ℞-only
    • In general: ℞ (Prescription only)
    Identifiers
    ChemSpider
    • none
    KEGG
      (verify)

    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. 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. 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. Shah, Krupa; Gleason, Lauren; Luque. "Polypharmacy in the HIV-infected older adult population". Clinical Interventions in Aging: 749. doi:10.2147/CIA.S37738. PMC 3693722.
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