Abacavir/lamivudine: Difference between revisions

{{Short description|Combination drug for HIV}}

| Verifiedfields = changed

| verifiedrevid = 448004176

| image = Abacavir and lamivudine.svg

| width = 200

| tradename = Kivexa, Epzicom, others

| Drugs.com = {{drugs.com|ppa|abacavir-and-lamivudine}}

| pregnancy_AU = B3

| pregnancy_category =

| routes_of_administration = [[Oral administration|By mouth]]

| ATC_prefix = J05

| ATC_suffix = AR02

<!-- Legal status -->

| legal_AU = S4

| legal_AU_comment =<ref>{{cite web | title=CAVADEXA , ABADINE, ABALAMID HETERO , BACAMID, LAMAVIR 600/300 (Hetero Australia Pty Ltd) | website=Therapeutic Goods Administration (TGA) | date=13 January 2023 | url=https://www.tga.gov.au/resources/prescription-medicines-registrations/cavadexa-abadine-abalamid-hetero-bacamid-lamavir-600300-hetero-australia-pty-ltd | access-date=15 April 2023}}</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_CA_comment =

| legal_DE = <!-- Anlage I, II, III or Unscheduled -->

| legal_DE_comment =

| legal_NZ = <!-- Class A, B, C -->

| legal_NZ_comment =

| legal_UK_comment =

| legal_US_comment =

| legal_EU = Rx-only

| legal_EU_comment = <ref>{{cite web | title=Kivexa EPAR | website=[[European Medicines Agency]] | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/kivexa | access-date=16 November 2020}}</ref>

| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->

| legal_UN_comment =

| legal_status = <!-- For countries not listed above -->

| CAS_number_Ref = {{cascite|correct|CAS}}

| CAS_number =  136470-78-5

| CAS_number2_Ref = {{cascite|correct|CAS}}

| CAS_number2 = 134678-17-4

| DrugBank_Ref =

| DrugBank =

| UNII_Ref = {{fdacite|correct|FDA}}

| UNII = WR2TIP26VS

| UNII2_Ref = {{fdacite|correct|FDA}}

| UNII2 = 2T8Q726O95

| KEGG = D08775

| NIAID_ChemDB = 225604

<!-- Definition and medical uses -->

'''Abacavir/lamivudine''', sold under the brand name '''Kivexa''' among others, is a [[fixed-dose combination]] [[antiretroviral medication]] used to treat [[HIV/AIDS]].<ref name=PI2016/> It contains [[abacavir]] and [[lamivudine]].<ref name=PI2016/> It is generally recommended for use with other [[antiretrovirals]].<ref name=PI2016/> It is commonly used as part of the preferred treatment in children.<ref name=WHO2015Use>{{cite book | vauthors = ((World Health Organization)) | year = 2015 | title = The selection and use of essential medicines. Twentieth report of the WHO Expert Committee 2015 (including 19th WHO Model List of Essential Medicines and 5th WHO Model List of Essential Medicines for Children) | publisher = World Health Organization | location = Geneva | author-link = World Health Organization | hdl = 10665/189763 | id = WHO technical report series;994 | hdl-access=free | isbn = 9789241209946 | issn = 0512-3054 |pages=45–46 }}</ref> It is taken by mouth as a tablet.<ref name=PI2016>{{cite web|title=Abacavir and Lamivudine Tablets|url=https://www.drugs.com/pro/abacavir-and-lamivudine-tablets.html|publisher=Teva Pharmaceuticals USA|access-date=28 November 2016|url-status=live|archive-url=https://web.archive.org/web/20170206022505/https://www.drugs.com/pro/abacavir-and-lamivudine-tablets.html|archive-date=6 February 2017}}</ref>

<!-- Side effects and mechanism -->

Common side effects include [[Insomnia|trouble sleeping]], [[headache]], [[Depression (mood)|depression]], [[Fatigue|feeling tired]], [[nausea]], [[rash]], and fever.<ref name=PI2016/> Serious side effects may include [[lactic acidosis|high blood lactate levels]], [[allergic reaction]]s, and [[hepatomegaly|enlargement of the liver]].<ref name=PI2016/> It is not recommended in people with a specific [[gene]] known as [[HLA-B*5701]].<ref name=PI2016/> Safety in [[pregnancy]] has not been well studied but it appears to be okay.<ref>{{cite web|title=Abacavir / lamivudine (Epzicom) Use During Pregnancy|url=https://www.drugs.com/pregnancy/abacavir-lamivudine.html|website=www.drugs.com|access-date=4 December 2016|url-status=live|archive-url=https://web.archive.org/web/20161220201915/https://www.drugs.com/pregnancy/abacavir-lamivudine.html|archive-date=20 December 2016}}</ref> Lamivudine and abacavir are both [[nucleoside reverse transcriptase inhibitor]]s (NRTI).<ref name=PI2016/>

<!--History and culture -->

Abacavir/lamivudine was approved for medical use in the United States in 2004.<ref name=PI2016/> It is on the [[WHO Model List of Essential Medicines|World Health Organization's List of Essential Medicines]].<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>

==Society and culture==

===Names===

It is marketed as Kivexa in most countries except for the United States, where it is branded as Epzicom.<ref>{{Cite web|url=https://viivhealthcare.com/viiv-hiv-medicines/|archiveurl=https://web.archive.org/web/20091207235357/http://www.viivhealthcare.com/en/products/epzicom-kivexa.aspx|url-status=dead|title=Our HIV medicines|archivedate=7 December 2009|website=viivhealthcare.com|accessdate=15 April 2023}}</ref> It is marketed by [[ViiV Healthcare]].{{cn|date=January 2023}}

===Legal challenges===

[[Teva Pharmaceuticals]] and [[Lupin Ltd]] both filed [[abbreviated new drug application]]s (ANDAs) relating to the treatments of HIV using various combinations of abacavir, lamivudine and AZT, and challenging various patents. In 2013 the US District Court for the District of Delaware upheld the validity of a patent covering Epzicom and Tizivir. Other matters were subject to appeal or litigation as of 20 November 2014.<ref>{{Cite web|publisher=Glaxosmithkline|url=http://www.gsk.com/media/560424/gsk-novartis-circular.pdf|title=PROPOSED MAJOR TRANSACTION WITH NOVARTIS AG:Circular to Shareholders and Notice of General Meeting|date=20 November 2014|url-status=dead|archive-url=https://web.archive.org/web/20150203213849/http://www.gsk.com/media/560424/gsk-novartis-circular.pdf|archive-date=2015-02-03|access-date=2015-02-03}}</ref>

==See also==

* [[Abacavir/lamivudine/zidovudine]], brand name Trizivir

* [[Abacavir/dolutegravir/lamivudine]], brand name Triumeq

==External links==

* {{cite web | url = https://druginfo.nlm.nih.gov/drugportal/name/abacavir%20mixture%20with%20lamivudine | publisher = U.S. National Library of Medicine | work = Drug Information Portal | title = Abacavir mixture with lamivudine }}

{{Antiretroviral drug}}

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{{DEFAULTSORT:Abacavir Lamivudine}}

[[Category:Fixed dose combination (antiretroviral)]]

[[Category:Hepatotoxins]]

[[Category:Wikipedia medicine articles ready to translate]]

[[Category:Drugs developed by GSK plc]]

[[Category:World Health Organization essential medicines]]