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{{Short description|Combination drug for HIV}}
{{Short description|Combination drug for HIV}}
{{About|the combination medication emtricitabine/rilpivirine/tenofovir ''disoproxil''|the combination medication emtricitabine/rilpivirine/tenofovir ''alafenamide''|Tenofovir alafenamide#combinations}}
{{About|the combination medication emtricitabine/rilpivirine/tenofovir ''disoproxil''|the combination medication emtricitabine/rilpivirine/tenofovir ''alafenamide''|Tenofovir alafenamide#combinations}}
{{Use dmy dates|date=June 2024}}
{{Infobox drug
{{Infobox drug
| verifiedrevid = 444331164
| verifiedrevid = 444331164
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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]].<ref>{{cite web |title=Approval of Complera: emtricitabine/rilpivirine/tenofovir DF fixed dose combination |url=https://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm267592.htm |publisher=U.S. [[Food and Drug Administration]] (FDA) |date=August 10, 2011 }}</ref> 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,<ref name="Eviplera EPAR" /><ref>{{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=2012-01-29 |archive-date=2013-05-24 |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 }}</ref> for patients who have not previously been treated for HIV.<ref>{{cite web |url=http://www.businessweek.com/ap/financialnews/D9P1ERH80.htm |title=FDA approves Gilead-J&J HIV pill Complera |date=August 10, 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=2011-09-10 }}</ref> It is available as a once-a-day single tablet.
'''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]].<ref>{{cite web |title=Approval of Complera: emtricitabine/rilpivirine/tenofovir DF fixed dose combination |url=https://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm267592.htm |publisher=U.S. [[Food and Drug Administration]] (FDA) |date=10 August 2011 }}</ref> 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,<ref name="Eviplera EPAR" /><ref>{{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 }}</ref> for patients who have not previously been treated for HIV.<ref>{{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 }}</ref> 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.<ref>[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=2017-08-09 }}, aidsinfonet.org</ref>
In the European Union it is marketed as Eviplera and in the US as Complera.<ref>[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</ref>


== Medical uses ==
== 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]]”).<ref name="complera">Complera [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2014. Accessed October 28, 2014</ref><ref name="eviplera">Eviplera [package leaflet]. County Cork, Ireland: Gilead Sciences Limited.; 2013. Accessed October 28, 2014.</ref>
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]]”).<ref name="complera">Complera [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2014. Accessed 28 October 2014</ref><ref name="eviplera">Eviplera [package leaflet]. County Cork, Ireland: Gilead Sciences Limited.; 2013. Accessed 28 October 2014.</ref>


== Side effects ==
== Side effects ==
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* Decreased appetite
* Decreased appetite


'''Serious'''<ref name="complera" /><ref name="SE">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 {{Webarchive|url=https://web.archive.org/web/20161101202407/https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf |date=2016-11-01 }}. Accessed October 29, 2014.</ref>
'''Serious'''<ref name="complera" /><ref name="SE">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 {{Webarchive|url=https://web.archive.org/web/20161101202407/https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf |date=1 November 2016 }}. Accessed 29 October 2014.</ref>
* [[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
* [[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
* 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

Revision as of 06:54, 20 June 2024

This article is about the combination medication emtricitabine/rilpivirine/tenofovir disoproxil. For the combination medication emtricitabine/rilpivirine/tenofovir alafenamide, see Tenofovir alafenamide § combinations.

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
AHFS/Drugs.comMultum Consumer Information
MedlinePlusa616021
License data
Pregnancy
category
  • AU: B3
Routes of
administration		By mouth
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • US: ℞-only[1][2]
  • EU: Rx-only[3]
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
ChemSpider
  • none
KEGG
  (verify)

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.

In the European Union it is marketed as Eviplera and in the US as Complera.[7]

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”).[8][9]

Side effects

Common[8][10]

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

Serious[8][10]

  • 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:[8][11]

References

  1. ^ "Complera- emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate tablet, film coated". DailyMed. 26 March 2021. Retrieved 20 June 2024.
  2. ^ "Complera Access - emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate tablet, film coated". DailyMed. 20 February 2024. Retrieved 20 June 2024.
  3. ^ a b "Eviplera EPAR". European Medicines Agency. 28 November 2011. Retrieved 20 June 2024.
  4. ^ "Approval of Complera: emtricitabine/rilpivirine/tenofovir DF fixed dose combination". U.S. Food and Drug Administration (FDA). 10 August 2011.
  5. ^ "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.
  6. ^ "FDA approves Gilead-J&J HIV pill Complera". Business Week. 10 August 2011. Archived from the original on 10 September 2011.
  7. ^ Complera/Eviplera (Rilpivirine + emtricitabine + tenofovir) Archived 9 August 2017 at the Wayback Machine, aidsinfonet.org
  8. ^ a b c d Complera [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2014. Accessed 28 October 2014
  9. ^ Eviplera [package leaflet]. County Cork, Ireland: Gilead Sciences Limited.; 2013. Accessed 28 October 2014.
  10. ^ 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.
  11. ^ 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.
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