|Emtricitabine||Nucleoside analog reverse-transcriptase inhibitor|
|Rilpivirine||Non-nucleoside reverse transcriptase inhibitor|
|Tenofovir disoproxil fumarate||Nucleotide analog reverse-transcriptase inhibitor|
|Trade names||Complera, Eviplera|
|ATC code||J05AR08 (WHO)|
Emtricitabine/rilpivirine/tenofovir (trade names Complera, Eviplera) is a fixed dose combination of antiretroviral drugs for the treatment of HIV. 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, for patients who have not previously been treated for HIV. It is available as a once-a-day single tablet.
In Europe it is commercialized as Eviplera and in the US as Complera.
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”).
- Abnormal dreams
- Decreased appetite
- 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)
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:
- carbamazepine, oxcarbazepine, phenobarbital, phenytoin
- rifampicin, rifapentine
- omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole
- systemic dexamethasone (more than a single dose)
- St John's wort
- "Approval of Complera: emtricitabine/rilpivirine/tenofovir DF fixed dose combination". Food and Drug Administration. August 10, 2011.
- "Eviplera; summary of the European public assessment report". European Medicines Agency. November 2011.
- "FDA approves Gilead-J&J HIV pill Complera". Business Week. August 10, 2011.
- Complera/Eviplera (Rilpivirine + emtricitabine + tenofovir), aidsinfonet.org
- Complera [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2014. Accessed October 28, 2014
- Eviplera [package leaflet]. County Cork, Ireland: Gilead Sciences Limited.; 2013. Accessed October 28, 2014.
- 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.
- Shah, Krupa; Gleason, Lauren; Luque. "Polypharmacy in the HIV-infected older adult population". Clinical Interventions in Aging: 749. doi:10.2147/CIA.S37738.