Emtricitabine/rilpivirine/tenofovir, sold under the brand name Complera among others, is a fixed-dose combination of antiretroviral drugs for the treatment of HIV/AIDS.[4] The drug was co-developed by Gilead Sciences and Johnson & Johnson's Tibotec division and was approved by the US Food and Drug Administration (FDA) in August 2011, and by the European Medicines Agency in November 2011,[3][5] for patients who have not previously been treated for HIV.[6] It is available as a once-a-day single tablet.
| Combination of | |
|---|---|
| Emtricitabine | Nucleoside analog reverse-transcriptase inhibitor |
| Rilpivirine | Non-nucleoside reverse transcriptase inhibitor |
| Tenofovir disoproxil | Nucleotide analog reverse-transcriptase inhibitor |
| Clinical data | |
| Trade names | Complera, Eviplera |
| AHFS/Drugs.com | Multum Consumer Information |
| MedlinePlus | a616021 |
| License data | |
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| Routes of administration | By mouth |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
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In the European Union it is marketed as Eviplera and in the US as Complera.[7]
Medical uses
editEmtricitabine/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”).[8][9]
Side effects
edit- Diarrhea
- Nausea
- Vomiting
- Insomnia
- Abnormal dreams
- Dizziness
- Headache
- Rash
- Weakness
- 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)
Interactions
editContraindications
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:[8][11]
- carbamazepine, oxcarbazepine, phenobarbital, phenytoin
- rifampicin, rifapentine
- omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole
- systemic dexamethasone (more than a single dose)
- St John's wort
References
edit- ^ "Complera- emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate tablet, film coated". DailyMed. 26 March 2021. Retrieved 20 June 2024.
- ^ "Complera Access - emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate tablet, film coated". DailyMed. 20 February 2024. Retrieved 20 June 2024.
- ^ a b "Eviplera EPAR". European Medicines Agency. 28 November 2011. Retrieved 20 June 2024.
- ^ "Approval of Complera: emtricitabine/rilpivirine/tenofovir DF fixed dose combination". U.S. Food and Drug Administration (FDA). 10 August 2011.
- ^ "Eviplera; summary of the European public assessment report". European Medicines Agency. November 2011. Archived from the original on 24 May 2013. Retrieved 29 January 2012.
- ^ "FDA approves Gilead-J&J HIV pill Complera". Business Week. 10 August 2011. Archived from the original on 10 September 2011.
- ^ Complera/Eviplera (Rilpivirine + emtricitabine + tenofovir) Archived 9 August 2017 at the Wayback Machine, aidsinfonet.org
- ^ a b c d Complera [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2014. Accessed 28 October 2014
- ^ Eviplera [package leaflet]. County Cork, Ireland: Gilead Sciences Limited.; 2013. Accessed 28 October 2014.
- ^ 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 1 May 2014]. Available from: http://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf Archived 1 November 2016 at the Wayback Machine. Accessed 29 October 2014.
- ^ 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.
