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{{Short description|Drug combination for HIV/AIDS prophylaxis and treatment}}
{{Drugbox
{{About|the combination medication emtricitabine/tenofovir ''disoproxil''|the combination medication emtricitabine/tenofovir ''alafenamide''|Tenofovir alafenamide#combinations}}
| verifiedrevid = 410040945
{{Use dmy dates|date=June 2024}}

{{cs1 config |name-list-style=vanc |display-authors=6}}
<!--Combo data-->
{{Infobox drug
| verifiedrevid = 447540265
| type = combo | type = combo
| component1 = Tenofovir | image = Tenofovir disoproxil and emtricitabine.svg
| image_class = skin-invert-image
| class1 = Nucleotide analogue ]
| width = 250
| component2 = Emtricitabine
| image2 = Truvada.JPG
| class2 = ] ]
| alt =


<!--Clinical data--> <!-- Combo data -->
| component1 = Emtricitabine
| tradename =
| class1 = ] reverse transcriptase inhibitor
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| component2 = Tenofovir disoproxil
| pregnancy_US = B
| class2 = Nucleotide analogue ]
| legal_AU = <!-- Unscheduled / S2 / S3 / S4 / S5 / S6 / S7 / S8 / S9 -->
| legal_CA = <!-- / Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_UK = POM
| legal_US = Rx-only
| routes_of_administration = Oral


<!--Identifiers--> <!-- Clinical data -->
| pronounce =
| tradename = Truvada, others
| Drugs.com = {{Drugs.com|monograph|emtricitabine-and-tenofovir-disoproxil-fumarate}}
| MedlinePlus = a612036
| DailyMedID = Truvada
| pregnancy_AU = B3
| pregnancy_AU_comment = <ref name="Drugs.com Pregnancy" />
| pregnancy_category=
| routes_of_administration = ]
| ATC_prefix = J05 | ATC_prefix = J05
| ATC_suffix = AR03 | ATC_suffix = AR03
| ATC_supplemental =
| PubChem = 11954236


| legal_AU = S4
<!--Chemical data-->
| legal_AU_comment = <ref>{{cite web | title=Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017 | website=Therapeutic Goods Administration (TGA) | date=21 June 2022 | url=https://www.tga.gov.au/resources/publication/publications/prescription-medicines-registration-new-generic-medicines-and-biosimilar-medicines-2017 | access-date=30 March 2024}}</ref>
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F-->
| legal_BR_comment =
| legal_CA = Rx-only
| legal_UK = POM
| legal_US = Rx-only
| legal_EU = Rx-only
| legal_EU_comment = <ref>{{cite web | title=Truvada EPAR | website=European Medicines Agency | date=21 February 2005 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/truvada | access-date=13 June 2024}}</ref>
| legal_status = Rx-only

<!-- Identifiers -->
| CAS_number = 731772-45-5
| CAS_supplemental =
| PubChem = 11954236
| IUPHAR_ligand =
| DrugBank =
| ChemSpiderID =
| UNII =
| KEGG = D02297
| ChEBI =
| ChEMBL =
| NIAID_ChemDB = 214126
| synonyms = Emtricitabine/tenofovir disoproxil fumarate
}} }}


<!-- Definition and treatment -->
'''Tenofovir/emtricitabine''', trademark '''Truvada''', is a ] of two ]s used for the treatment of ]. It consists of 300 milligrams of ] and 200 milligrams of ]. By combining the two agents into one tablet, it reduces the ] and increases ] with antiretroviral therapy. The drug has also found some potential as a preventative measure if taken daily or weekly leading up to exposure, though human clinical trials are ongoing.<ref name="SFGate-Nov-24-2010">, SFGate.com .</ref>
'''Emtricitabine/tenofovir''', sold under the brand name '''Truvada''' among others, is a ] ] used to treat and prevent ].<ref name="Drugs2016Over">{{cite web|title=Truvada|url=https://www.drugs.com/truvada.html|website=Drugs.com|access-date=12 December 2016|url-status=live|archive-url=https://web.archive.org/web/20161220233315/https://www.drugs.com/truvada.html|archive-date=20 December 2016}}</ref><ref name="UKlabel2016">{{cite web|title=UK label Truvada film-coated tablets|url=https://www.medicines.org.uk/emc/medicine/15826|publisher=Electronic Medicines Compendium|date=August 2016|url-status=live|archive-url=https://web.archive.org/web/20161220171148/https://www.medicines.org.uk/emc/medicine/15826|archive-date=20 December 2016}}</ref> It contains the ] ] and ].<ref name="Truvada FDA label" /> For treatment, it must be used in combination with other ]s.<ref name="Truvada FDA label" /><ref name=WHO2008>{{cite book | title = WHO Model Formulary 2008 | year = 2009 | isbn = 9789241547659 | vauthors = ((World Health Organization)) | veditors = Stuart MC, Kouimtzi M, Hill SR | hdl = 10665/44053 | author-link = World Health Organization | publisher = World Health Organization |page=160 }}</ref><!-- Quote = HIV infection alone as a complete regimen or in combination with other antiretroviral medicines --> For ], in those who are at high risk, it is recommended along with ] practices.<ref name="Truvada FDA label" /> It does not cure HIV/AIDS.<ref name=Drugs2016Over/> Emtricitabine/tenofovir is taken ].<ref name="Truvada FDA label" />


<!-- Side effects and mechanism -->
==Clinical studies==
Common side effects include headache, tiredness, trouble sleeping, abdominal pain, weight loss, and rash.<ref name=Drugs2016Over/> Serious side effects may include ] and ].<ref name="Truvada FDA label" /> Use of this medication during ] does not appear to harm the fetus, but this has not been well studied.<ref name="Drugs.com Pregnancy">{{cite web | title=Emtricitabine / tenofovir Pregnancy and Breastfeeding Warnings | website=Drugs.com | date=1 August 2018 | url=https://www.drugs.com/pregnancy/emtricitabine-tenofovir.html | archive-url=https://web.archive.org/web/20191010041222/https://www.drugs.com/pregnancy/emtricitabine-tenofovir.html | archive-date=10 October 2019 | url-status=live | access-date=10 October 2019}}</ref>
The HEAT study (randomized, double-blind, placebo-matched, multicentre) showed that once-daily emtricitabine/tenofovir plus lopinavir/ritonavir or boosted atazanavir or efavirenz were effective in the initial treatment of patients with HIV-1 infection (with screening plasma HIV-1 RNA levels of ≥1,000,000 copies/mL in ACTG 5202).<ref name="emtri">Perry CM..Drugs 2009;69(7):843-857.doi: 10.2165/00003495-200969070-00005.</ref>


<!-- History and culture -->
In other randomized studies, emtricitabine/tenofovir DF 200&nbsp;mg/300&nbsp;mg once daily was an effective backbone for boosted PI-based regimens in the initial treatment of HIV-1 infection.<ref name="emtri"/><ref>{{cite journal|author= Jon Cohen |title= A Powerful and Perplexing New HIV Prevention Tool |journal=Science|pages= 1298 |volume= 330| doi = 10.1126/science.330.6009.1298 |date= 3 December 2010}}</ref>
Emtricitabine/tenofovir was approved for medical use in the United States in 2004.<ref name=Drugs2016Over/> It is on the ].<ref name="WHO21st">{{cite book | vauthors = ((World Health Organization)) | title = World Health Organization model list of essential medicines: 21st list 2019 | year = 2019 | hdl = 10665/325771 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO | hdl-access=free }}</ref> In the United States, emtricitabine/tenofovir was under patent by ] until 2020, but is now available as a generic worldwide.<ref name=AOC2019>{{cite web |title=AOC asks pharma CEO why $2,000 HIV drug costs just $8 in Australia |url=https://www.independent.co.uk/news/world/americas/us-politics/aoc-hiv-drug-cost-us-australia-ceo-gilead-video-a8919316.html |website=The Independent |access-date=15 November 2019 |language=en |date=17 May 2019}}</ref> In 2020, it was the 278th most commonly prescribed medication in the United States, with more than 1{{nbsp}}million prescriptions.<ref>{{cite web | title = The Top 300 of 2020 | url = https://clincalc.com/DrugStats/Top300Drugs.aspx | website = ClinCalc | access-date = 7 October 2022}}</ref><ref>{{cite web | title = Emtricitabine; Tenofovir Disoproxil - Drug Usage Statistics | website = ClinCalc | url = https://clincalc.com/DrugStats/Drugs/EmtricitabineTenofovirDisoproxil | access-date = 7 October 2022}}</ref>


== Medical uses ==
Emtricitabine/tenofovir DF in combination with various boosted PIs was generally well tolerated by adults with HIV-1 infection.<ref name="emtri"/>
Emtricitabine/tenofovir is used both to treat and to prevent HIV/AIDS.<ref name=Drugs2016Over/> The U.S. ] (NIH) recommends antiretroviral therapy (ART) for all people with HIV/AIDS.<ref>{{cite web|url=https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf|title=Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV|date=July 2019|website=AIDSinfo Clinical Guidelines|access-date=30 October 2019|archive-date=4 December 2016|archive-url=https://web.archive.org/web/20161204180634/https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf|url-status=dead}}</ref>


===HIV prevention===
Truvada was developed by ] and approved by the ] in 2004.
The Centers for Disease Control and Prevention (CDC) recommends the use of emtricitabine/tenofovir for ] (PrEP) for uninfected, HIV-1 negative individuals that may be at risk for HIV-1 infection.<ref>{{cite web | title=PrEP | website=] (CDC) | date=17 October 2019 | url=https://www.cdc.gov/hiv/basics/prep.html | archive-url=https://web.archive.org/web/20191031230000/https://www.cdc.gov/hiv/basics/prep.html | archive-date=31 October 2019 | url-status=live | access-date=31 October 2019}} {{PD-notice}}</ref><ref name="Truvada FDA label">{{cite web | title=Truvada- emtricitabine and tenofovir disoproxil fumarate tablet, film coated label | website=DailyMed | date=18 May 2018 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e82b13-a037-49ed-b4b3-030b37c0ecdd | archive-url=https://web.archive.org/web/20191031230542/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e82b13-a037-49ed-b4b3-030b37c0ecdd | archive-date=31 October 2019 | url-status=live | access-date=31 October 2019}}</ref> A ] ] found a 51% ] of contracting HIV with both tenofovir alone and the tenofovir/emtricitabine combination.<ref name="Ok2012">{{cite journal |vauthors=Okwundu CI, Uthman OA, Okoromah CA|s2cid=35672491 |title=Antiretroviral pre-exposure prophylaxis (PrEP) for preventing HIV in high-risk individuals |journal=Cochrane Database Syst Rev |volume= 7|issue=7 |pages=CD007189 |year=2012 |doi=10.1002/14651858.CD007189.pub3 |pmid=22786505 |pmc=11324012 }}</ref> A ] systematic review found a similar relative risk reduction of 54% on average and greater reduction with greater ].<ref>{{cite journal |vauthors=Chou R, Evans C, Hoverman A, Sun C, Dana T, Bougatsos C, Grusing S, Korthuis PT |date=11 June 2019 |title=Preexposure Prophylaxis for the Prevention of HIV Infection: Evidence Report and Systematic Review for the US Preventive Services Task Force |journal=JAMA |volume=321 |issue=22 |pages=2214–2230 |doi=10.1001/jama.2019.2591 |pmid=31184746 |s2cid=184485546 |issn=0098-7484|doi-access=free }}</ref> It was approved for PrEP against HIV infection in the United States in 2012.<ref>{{cite news |date=16 July 2012 |title=FDA approves first pill to help prevent HIV | last=Perrone | first=Matthew |newspaper=] |url=http://seattletimes.nwsource.com/html/businesstechnology/2018699860_apushivdrugfda.html |url-status=live |archive-url=https://web.archive.org/web/20120719082458/http://seattletimes.nwsource.com/html/businesstechnology/2018699860_apushivdrugfda.html |archive-date=19 July 2012 |agency=Associated Press }}</ref>


The CDC recommends PrEP be considered for the following high-risk groups:<ref>{{cite web|url=https://www.cdc.gov/hiv/prevention/research/prep/|title=Pre-Exposure Prophylaxis (PrEP) |access-date=4 June 2015|archive-url=https://web.archive.org/web/20150605164822/http://www.cdc.gov/hiv/prevention/research/prep/|archive-date=5 June 2015}}{{PD-notice}}</ref>
A combination pill containing Truvada and ] (Sustiva) is also available and is marketed as ].
* Individuals in an ongoing sexual relationship with an HIV-positive partner
* Gay or bisexual men who either have had anal sex without a condom or been diagnosed with an STD in the past six months
* Heterosexual men or women who do not regularly use condoms during sex with partners of unknown HIV status who are substantial risk
* Injection of drugs in the last six months with sharing of equipment
* ] heterosexual and homosexual partners, where one partner is HIV-positive and the other HIV-negative


The consideration of utilizing emtricitabine/tenofovir as a reduction strategy involves discussion with a health professional who can help the patient navigate the benefits and risks. Patients are advised to discuss any history of bone issues, kidney issues, or hepatitis B infection with their healthcare provider.<ref>{{cite web | title=Administration of pre-exposure prophylaxis against HIV infection | website=UpToDate | url=https://www.uptodate.com/contents/administration-of-pre-exposure-prophylaxis-against-hiv-infection | access-date=31 October 2019 | archive-date=1 November 2019 | archive-url=https://web.archive.org/web/20191101012946/https://www.uptodate.com/contents/administration-of-pre-exposure-prophylaxis-against-hiv-infection | url-status=dead }}</ref> Effectiveness of PrEP for prevention of infection is reliant on an individual's ability to take the medication consistently.<ref>{{cite web|url=https://www.nice.org.uk/advice/esnm78/chapter/Key-points-from-the-evidence#product-overview|title=Pre-exposure prophylaxis of HIV in adults at high risk: Truvada (emtricitabine/tenofovir disoproxil)|date=5 October 2016 }}</ref>
==References==
{{Reflist}}


Emtricitabine/tenofovir is also used for HIV ]. People who start taking emtricitabine/tenofovir see HIV reduction benefits up to 72 hours after starting, but the medicine must be taken for thirty days after a high-risk sexual event to ensure HIV transmission levels are optimally reduced.<ref>{{cite journal |vauthors=Panlilio AL, Cardo DM, Grohskopf LA, Heneine W, Ross CS |title=Updated U.S. Public Health Service guidelines for the management of occupational exposures to HIV and recommendations for postexposure prophylaxis |journal=MMWR Recomm Rep |volume=54 |issue=RR-9 |pages=1–17 |date=September 2005 |pmid=16195697 |url=https://www.cdc.gov/mmwr/PDF/rr/rr5409.pdf }}</ref><ref>{{cite journal |vauthors=Kuhar DT, Henderson DK, Struble KA, Heneine W, Thomas V, Cheever LW, Gomaa A, Panlilio AL | title=Updated US Public Health Service guidelines for the management of occupational exposures to human immunodeficiency virus and recommendations for postexposure prophylaxis | journal=Infection Control and Hospital Epidemiology | date=September 2013 | volume=34 | issue=9 | pages=875–92 | doi=10.1086/672271 | pmid=23917901 | s2cid=17032413 | url=http://stacks.cdc.gov/view/cdc/20711/cdc_20711_DS1.pdf |id=20711 }}{{PD-notice}}</ref>
==External links==
*, run by Gilead Sciences
*


Emtricitabine/tenofovir as PrEP should not be used for individuals who are positive for HIV-1.<ref name="Truvada FDA label" />
{{HIVpharm}}


=== HIV treatment ===
Emtricitabine/tenofovir has been approved in the United States as part of antiretroviral combination therapy for the treatment of ].<ref name="Truvada FDA label" /> The combination therapy is suggested as one of the options for adults who have not received any prior treatment for HIV infection.<ref>{{cite web|url=https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf|title=Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV|access-date=30 October 2019|archive-date=4 December 2016|archive-url=https://web.archive.org/web/20161204180634/https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf|url-status=dead}}</ref>


=== Hepatitis B ===
Both emtricitabine and tenofovir are indicated for the treatment of ], with the added benefit that they can target HIV for those with co-infection.<ref>{{cite web|url=https://www.aasld.org/sites/default/files/2019-06/HBVGuidance_Terrault_et_al-2018-Hepatology.pdf|title=Update on Prevention, Diagnosis, and Treatment of Chronic Hepatitis B: AASLD 2018 Hepatitis B Guidance|access-date=20 November 2019|archive-date=25 January 2020|archive-url=https://web.archive.org/web/20200125221107/https://www.aasld.org/sites/default/files/2019-06/HBVGuidance_Terrault_et_al-2018-Hepatology.pdf|url-status=dead}}</ref> Emtricitabine/tenofovir may also be considered for some antiviral resistant ] infections.<ref>{{cite web |title=Emtricitabine and Tenofovir Disoproxil Fumarate (Professional Patient Advice) |url=https://www.drugs.com/ppa/emtricitabine-and-tenofovir-disoproxil-fumarate.html |website=Drugs.com |access-date=31 October 2019 }}</ref>


=== Pregnancy and breastfeeding ===
{{DEFAULTSORT:Tenofovir/Emtricitabine}}
In the United States, it is recommended that all pregnant HIV-infected women start ] (ART) as early in pregnancy as possible to reduce the risk of transmission. ART generally does not increase risk of birth defects with exception of ], which is not recommended during first trimester of pregnancy only due to potential risk of ]s.<ref>{{cite web|url=https://aidsinfo.nih.gov/guidelines/brief-html/3/perinatal/224/whats-new-in-the-guidelines|title=Brief What's New in the Guidelines Perinatal|website=AIDSinfo|access-date=23 October 2019|archive-date=23 October 2019|archive-url=https://web.archive.org/web/20191023125908/https://aidsinfo.nih.gov/guidelines/brief-html/3/perinatal/224/whats-new-in-the-guidelines|url-status=dead}}</ref>
<!--Categories-->
]
]
]


Emtricitabine/tenofovir is secreted in breast milk.<ref>{{cite web|title=Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States|url=http://aidsinfo.nih.gov/contentfiles/lvguidelines/perinatalgl.pdf|publisher=] (NIH) |access-date=21 October 2014|url-status=live|archive-url=https://web.archive.org/web/20140412004422/http://aidsinfo.nih.gov/contentfiles/lvguidelines/perinatalgl.pdf|archive-date=12 April 2014}}</ref> In developed countries, HIV-infected mothers are generally recommended to not breastfeed due to slight risk of mother-to-children HIV transmission.<ref>{{cite web |title=Emtricitabine / tenofovir Use During Pregnancy |url=https://www.drugs.com/pregnancy/emtricitabine-tenofovir.html |website=Drugs.com |access-date=23 October 2019 }}</ref><ref name="LacMed2019">{{cite journal |title=Tenofovir |url=https://www.ncbi.nlm.nih.gov/books/NBK501549/ |website=Drugs and Lactation Database (LactMed) |publisher=National Library of Medicine (US) |access-date=23 October 2019 |date=2006|pmid=30000609 }}</ref> In developing countries, where avoiding breastfeeding may not be an option, the World Health Organization recommends a triple drug regimen of tenofovir, efavirenz, and either lamivudine or emtricitabine.<ref name=LacMed2019/>
<!--Other languages-->


==Side effects==
]

]
Emtricitabine/tenofovir is generally well tolerated. Some of its side effects include:<ref name="Truvada FDA label" />
]
* Rare: ], liver dysfunction, worsening of ] infection
]
* Common: headache, abdominal pain, decreased weight, nausea, diarrhea, and decreased bone density

Fat redistribution and accumulation (]) has been observed in people receiving antiretroviral therapy, including fat reductions in the face, limbs, and buttocks and increases in ] of the abdomen and accumulations in the upper back.<ref name="Truvada FDA label" /> When used as pre-exposure prophylaxis (PrEP) this effect may not be present.<ref>{{cite news|url=http://www.aidsmap.com/PrEP-does-not-raise-lipids-or-alter-body-fat-safety-study-finds/page/3216046/|title=PrEP does not raise lipids or alter body fat, safety study finds|access-date=16 February 2018}}</ref> Weight changes have however been linked to the medication.<ref>{{cite journal |vauthors=Glidden DV, Mulligan K, McMahan V, Anderson PL, Guanira J, Chariyalertsak S, Buchbinder SP, Bekker LG, Schechter M, Grinsztejn B, Grant RM |title=Metabolic Effects of Preexposure Prophylaxis With Coformulated Tenofovir Disoproxil Fumarate and Emtricitabine |journal=Clin. Infect. Dis. |volume=67 |issue=3 |pages=411–419 |date=July 2018 |pmid=29415175 |pmc=6051460 |doi=10.1093/cid/ciy083 }}
* {{lay source |template = cite news|url = https://www.healio.com/infectious-disease/hiv-aids/news/online/%7B7ac9ae5c-e02a-433d-8632-82f6d7244211%7D/truvada-as-hiv-prep-not-associated-with-net-fat-increase|title = Truvada as HIV PrEP not associated with net fat increase|date = 13 February 2018 |website= Healio }}</ref>

==Drug interactions==
{| class="wikitable"
|+Drug-drug interactions<ref name="Truvada FDA label" />
! colspan="2" |Drug-drug Interaction
!Coadministration
|-
| rowspan="4" |Tenofovir
|]
|
* May increase didanosine concentration and risk of didanosine toxicity (e.g. ], neuropathy).
* Discontinue didanosine if patient develops didanosine-associated adverse events.
* For patients who weigh more than 60&nbsp;kg, didanosine dose should be reduced to 250&nbsp;mg; there is no available data to recommend didanosine dose adjustments in patients who weigh less than 60&nbsp;kg.
|-
|]
|
* May decrease atazanavir and increase tenofovir concentrations.
* Atazanavir should only be taken together with emtricitabine/tenofovir with ritonavir.
* Monitor for tenofovir toxicity.
|-
|], atazanavir coadministered with ritonavir & darunavir coadministered with ritonavir
|
* May increase tenofovir concentrations.
|-
|]
|
* May increase tenofovir concentrations.
* Consider alternative ] antiviral or antiretroviral therapy.
* Monitor for tenofovir toxicity.
|-
| rowspan="4" |Emtricitabine/tenofovir
|] and breast cancer resistance protein (BCRP) transporters inhibitors
|
* May increase absorption of emtricitabine/tenofovir.
|-
|Drugs may decrease renal function (e.g. ], ], dipivoxil, ], ], ], ], ]s, etc.)
|
* May increase emtricitabine and/or tenofovir concentrations.
|-
|High-dose or multiple ]
|
* May increase the risk of ].
|-
|]
|
* May inhibit the absorption of emtricitabine/tenofovir and result in loss of viral control.<ref>{{cite web|url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5bbdc95b-82a1-4ba5-8185-6504ff68cc06|title=DailyMed - XENICAL- orlistat capsule|website=dailymed.nlm.nih.gov|access-date=30 October 2019}}</ref>
* Monitor HIV viral load frequently while the patient is taking orlistat.
* Discontinue orlistat if HIV viral load increases.
|}
Other drugs with adverse reactions include ], ], and ]. Dabigatran etexilate used with ] inducers requires monitoring of decreased levels and effects of dabigatran. Lamivudine may increase the adverse or toxic effect of emtricitabine. Vincristine used with P-glycoprotein/ABCB1 inducers can decrease the serum concentration of vincristine.<ref>{{cite journal|vauthors=Ramanathan S, Shen G, Cheng A, Kearney BP|date=July 2007|title=Pharmacokinetics of emtricitabine, tenofovir, and GS-9137 following coadministration of emtricitabine/tenofovir disoproxil fumarate and ritonavir-boosted GS-9137|journal=J. Acquir. Immune Defic. Syndr.|volume=45|issue=3|pages=274–9|doi=10.1097/QAI.0b013e318050d88c|pmid=17414929|s2cid=31756102|doi-access=free}}</ref>

==Society and culture==

The patent for the drug combination is owned by ] in some regions. The ] EP0915894B1<ref>{{cite web|title=EP0915894B1 - NUCLEOTIDE ANALOGS|url=https://worldwide.espacenet.com/publicationDetails/biblio?CC=EP&NR=0915894B1&KC=B1&FT=D&ND=4&date=20030514# |website=Espacenet|access-date=13 December 2017}}</ref> expired in July 2018, Gilead Sciences wished the patent to be extended, however "four rival labs—Teva, Accord Healthcare, Lupin and Mylan—had sought to have that overturned in the courts in Britain", the High Court of England and Wales invalidated Gilead's patent,<ref>{{cite web|url=https://www.fiercepharma.com/pharma/u-k-court-invalidates-gilead-s-truvada-patent-extension-allowing-prep-generics|title=U.K. Court invalidates Gilead's Truvada patent extension, allowing PrEP generics|date=19 September 2018 }}</ref> however the company appealed <ref>{{cite web|url=https://pharmaphorum.com/news/truvada-ruling-could-allow-cheap-hiv-prevention-in-the-uk/|title = Truvada ruling could allow cheap HIV prevention in the UK -|date = 19 September 2018}}</ref> and the UK referred the case to the ] who refused to extend the patent.<ref>{{cite web|url=https://medicalxpress.com/news/2018-07-eu-door-version-aids-medicine.html|title = EU door opens for generic version of AIDS medicine Truvada}}</ref> An Irish court rejected an injunction request to prevent the launch of generic Emtricitabine/tenofovir prior to the resolution of the case.<ref>{{cite news|title=Gilead loss of generic HIV drug battle a boost for gay community|url=https://www.irishtimes.com/business/health-pharma/gilead-loss-of-generic-hiv-drug-battle-a-boost-for-gay-community-1.3284747|newspaper=]|access-date=18 May 2018}}</ref><ref>{{cite news|title=Gilead in row with generics manufacturers over HIV drug in Ireland|url=https://www.irishtimes.com/business/health-pharma/gilead-in-row-with-generics-manufacturers-over-hiv-drug-in-ireland-1.3144610|newspaper=]|access-date=30 October 2017}}</ref> Despite the expiration of the Gilead Sciences patent, as of 2021, there are still widespread challenges to the availability and uptake of generic PrEP throughout Europe.<ref>{{cite web|url=https://www.aidsmap.com/news/jan-2021/european-prep-programmes-face-two-big-issues-how-get-more-people-coming-forward-and|title = European PrEP programs face two big issues: How to get more people coming forward, and how to serve them if they do| date=27 January 2021 }}</ref>

In 2019, Gilead Sciences challenged the validity of patents granted to the United States after 2015 for using the drug combination for HIV PrEP and post-exposure prophylaxis (PEP).<ref>{{cite news | last=Rowland | first=Christopher | title=Gilead defied a government HIV patent. The Justice Department has opened a review. | newspaper=] | date=24 April 2019 | url=https://www.washingtonpost.com/business/economy/gilead-defied-a-government-hiv-patent-the-justice-department-has-opened-a-review/2019/04/24/16e4e20e-62bc-11e9-bfad-36a7eb36cb60_story.html | archive-url=https://web.archive.org/web/20191101010542/https://www.washingtonpost.com/business/economy/gilead-defied-a-government-hiv-patent-the-justice-department-has-opened-a-review/2019/04/24/16e4e20e-62bc-11e9-bfad-36a7eb36cb60_story.html | archive-date=1 November 2019 | url-status=live | access-date=31 October 2019 }}</ref><ref>{{cite news | last=Rowland | first=Christopher | title=Gilead files challenge to government patents for HIV prevention pill | newspaper=] | date=21 August 2019 | url=https://www.washingtonpost.com/business/economy/gilead-files-challenge-to-government-patents-for-hiv-prevention-pill/2019/08/21/43baa61e-c43d-11e9-b5e4-54aa56d5b7ce_story.html | archive-url=https://web.archive.org/web/20191101011634/https://www.washingtonpost.com/business/economy/gilead-files-challenge-to-government-patents-for-hiv-prevention-pill/2019/08/21/43baa61e-c43d-11e9-b5e4-54aa56d5b7ce_story.html | archive-date=1 November 2019 | url-status=live | access-date=29 October 2019 }}</ref><ref>{{cite press release | title=Petitions to US Patent and Trademark Office on HIV PrEP Patents | website=] | date=21 August 2019 | url=https://www.gilead.com/news-and-press/company-statements/petitions-to-us-patent-and-trademark-office-on-hiv-prep-patents | archive-url=https://web.archive.org/web/20191030023128/https://www.gilead.com/news-and-press/company-statements/petitions-to-us-patent-and-trademark-office-on-hiv-prep-patents | archive-date=30 October 2019 | url-status=live | access-date=29 October 2019}}</ref> In July 2024, The ] appealed the jury finding that ruled in favor of ] verdict that the U.S. government's patents are invalid.<ref>{{cite news |last1=Silverman |first1=Ed |title=Biden administration appeals jury finding in battle over patents for HIV prevention pills |url=https://www.statnews.com/pharmalot/2024/07/08/gilead-hiv-aids-truvada-descovy-patents-biden/ |access-date=8 July 2024 |publisher=STAT News |date=8 July 2024}}</ref>

In the United States, most healthcare plans are required to cover PrEP without any copay or other ]. This is due to a ] recommendation that gave PrEP a grade A rating. Under the ], this recommendation requires all non-grandfathered private health plans to cover PrEP without cost sharing.<ref>{{cite journal |title=New Guidance On PrEP: Support Services Must Be Covered Without Cost-Sharing {{!}} Health Affairs Forefront |url=https://www.healthaffairs.org/do/10.1377/forefront.20210728.333084/full/ |access-date=4 August 2022 |journal=Health Affairs Forefront |year=2021 |language=en |doi=10.1377/forefront.20210728.333084|last1=Keith |first1=Katie }}</ref><ref>{{cite web |date=19 July 2021 |title=FAQS ABOUT AFFORDABLE CARE ACT IMPLEMENTATION PART 47 |url=https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-47.pdf |access-date=4 August 2022 |website=Centers for Medicare & Medicaid Services}}</ref>

In the United Kingdom, PrEP is widely available to all at-risk groups following the Department for Health and Social Care's decision to make it available across England in 2020. Wales, Scotland, and Northern Ireland made it available in 2017 and 2018.<ref>{{cite web|url=https://www.gov.uk/government/news/hiv-drug-prep-to-be-available-across-england|title = HIV drug PrEP to be available across England}}</ref><ref>{{cite web|url=https://www.iwantprepnow.co.uk/prep-on-the-nhs/|title = Free PrEP on the NHS}}</ref>

==References==
{{Reflist}}

{{Antiretroviral drug}}
{{Portal bar | Medicine | Viruses }}

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