Emtricitabine/rilpivirine/tenofovir
{{Short description|Combination drug for HIV}}
{{About|the combination medication emtricitabine/rilpivirine/tenofovir disoproxil|the combination medication emtricitabine/rilpivirine/tenofovir alafenamide|Tenofovir alafenamide#combinations}}
{{Use dmy dates|date=June 2024}}
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{{Infobox drug
| verifiedrevid = 444331164
| type = combo
| component1 = Emtricitabine
| class1 = Nucleoside analog reverse-transcriptase inhibitor
| component2 = Rilpivirine
| class2 = Non-nucleoside reverse transcriptase inhibitor
| component3 = Tenofovir disoproxil
| class3 = Nucleotide analog reverse-transcriptase inhibitor
| tradename = Complera, Eviplera
| Drugs.com = {{drugs.com|mtm|emtricitabine-rilpivirine-and-tenofovir}}
| MedlinePlus = a616021
| DailyMedID = Emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil
| pregnancy_AU = B3
| pregnancy_AU_comment =
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| routes_of_administration = By mouth
| ATC_prefix = J05
| ATC_suffix = AR08
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| legal_AU = S4
| legal_AU_comment =
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| legal_US = Rx-only
| legal_US_comment = {{cite web | title=Complera- emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate tablet, film coated | website=DailyMed | date=26 March 2021 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d637cfab-f1e8-4eb3-a1b3-f85ca3bec612 | access-date=20 June 2024}}{{cite web | title=Complera Access - emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate tablet, film coated | website=DailyMed | date=20 February 2024 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9176bf31-c889-47bd-861c-f2d3fc37ab8d | access-date=20 June 2024}}
| legal_EU = Rx-only
| legal_EU_comment = {{cite web | title=Eviplera EPAR | website=European Medicines Agency | date=28 November 2011 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/eviplera | access-date=20 June 2024}}
| legal_UN =
| legal_UN_comment =
| legal_status = Rx-only
| CAS_number = 1436864-99-1
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| ChemSpiderID = none
| UNII =
| KEGG = D10571
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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.{{cite web |title=Approval of Complera: emtricitabine/rilpivirine/tenofovir DF fixed dose combination |url=https://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm267592.htm |archive-url=https://web.archive.org/web/20110818180513/http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm267592.htm |url-status=dead |archive-date=18 August 2011 |publisher=U.S. Food and Drug Administration (FDA) |date=10 August 2011 }} 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,{{cite web |url=http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002312/human_med_001514.jsp&mid=WC0b01ac058001d124 |title=Eviplera; summary of the European public assessment report |publisher=European Medicines Agency |date=November 2011 |access-date=29 January 2012 |archive-date=24 May 2013 |archive-url=https://web.archive.org/web/20130524144857/http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002312/human_med_001514.jsp&mid=WC0b01ac058001d124 |url-status=dead }} for patients who have not previously been treated for HIV.{{cite web |url=http://www.businessweek.com/ap/financialnews/D9P1ERH80.htm |title=FDA approves Gilead-J&J HIV pill Complera |date=10 August 2011 |work=Business Week |url-status=dead |archive-url=https://web.archive.org/web/20110910182000/http://www.businessweek.com/ap/financialnews/D9P1ERH80.htm |archive-date=10 September 2011 }} It is available as a once-a-day single tablet.
In the European Union it is marketed as Eviplera and in the US as Complera.[http://www.aidsinfonet.org/fact_sheets/view/471 Complera/Eviplera (Rilpivirine + emtricitabine + tenofovir)] {{Webarchive|url=https://web.archive.org/web/20170809184246/http://aidsinfonet.org/fact_sheets/view/471 |date=9 August 2017 }}, aidsinfonet.org
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”).Complera [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2014. Accessed 28 October 2014Eviplera [package leaflet]. County Cork, Ireland: Gilead Sciences Limited.; 2013. Accessed 28 October 2014.
Side effects
- Diarrhea
- Nausea
- Vomiting
- Insomnia
- Abnormal dreams
- Dizziness
- Headache
- Rash
- Weakness
- Decreased appetite
SeriousPanel 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 {{Webarchive|url=https://web.archive.org/web/20161101202407/https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf |date=1 November 2016 }}. Accessed 29 October 2014.
- 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:{{cite journal | vauthors = Gleason LJ, Luque AE, Shah K | title = Polypharmacy in the HIV-infected older adult population | journal = Clinical Interventions in Aging | volume = 8 | pages = 749–63 | year = 2013 | pmid = 23818773 | pmc = 3693722 | doi = 10.2147/CIA.S37738 | doi-access = free }}
- carbamazepine, oxcarbazepine, phenobarbital, phenytoin
- rifampicin, rifapentine
- omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole
- systemic dexamethasone (more than a single dose)
- St John's wort
References
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{{DEFAULTSORT:Emtricitabine Rilpivirine Tenofovir Disoproxil}}