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Home Updates

FDA Approved HIV Medicines

FDA Approved HIV Medicines

Nabin Bista by Nabin Bista
January 26, 2023
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FDA-Approved HIV Medicines
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FDA Approved HIV Medicines

Treatment with HIV medicines is called antiretroviral therapy (ART). ART is recommended for everyone with HIV, and people with HIV should start ART as soon as possible. People on ART take a combination of HIV medicines (called an HIV treatment regimen) every day. A person’s initial HIV treatment regimen generally includes three HIV medicines from at least two different HIV drug classes.

The following table lists HIV medicines recommended for the treatment of HIV infection in the United States, based on the U.S. Department of Health and Human Services (HHS) HIV/AIDS medical practice guidelines. All of these drugs are approved by the U.S. Food and Drug Administration (FDA). The HIV medicines are listed according to drug class and identified by generic and brand names. Click on a drug name to view information on the drug from the Clinicalinfo Drug Database.

 

Drug ClassGeneric Name
(Other names and acronyms)
Brand NameFDA Approval Date
Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
NRTIs block reverse transcriptase, an enzyme HIV needs to make copies of itself.abacavir
(abacavir sulfate, ABC)
ZiagenDecember 17, 1998
emtricitabine
(FTC)
EmtrivaJuly 2, 2003
lamivudine
(3TC)
EpivirNovember 17, 1995
tenofovir disoproxil
fumarate

(tenofovir DF, TDF)
VireadOctober 26, 2001
zidovudine
(azidothymidine, AZT, ZDV)
RetrovirMarch 19, 1987
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)
NNRTIs bind to and later alter reverse transcriptase, an enzyme HIV needs to make copies of itself.doravirine
(DOR)
PifeltroAugust 30, 2018
efavirenz
(EFV)
SustivaSeptember 17, 1998
etravirine
(ETR)
IntelenceJanuary 18, 2008
nevirapine
(extended-release nevirapine, NVP)
ViramuneJune 21, 1996
Viramune XR (extended release)March 25, 2011
rilpivirine
(rilpivirine hydrochloride, RPV)
EdurantMay 20, 2011
Protease Inhibitors (PIs)
PIs block HIV protease, an enzyme HIV needs to make copies of itself.atazanavir
(atazanavir sulfate, ATV)
ReyatazJune 20, 2003
darunavir
(darunavir ethanolate, DRV)
PrezistaJune 23, 2006
fosamprenavir
(fosamprenavir calcium, FOS-APV, FPV)
LexivaOctober 20, 2003
ritonavir
(RTV)
*Although ritonavir is a PI, it is generally used as a pharmacokinetic enhancer as recommended in the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
NorvirMarch 1, 1996
tipranavir
(TPV)
AptivusJune 22, 2005
Fusion Inhibitors
Fusion inhibitors block HIV from entering the CD4 T lymphocyte (CD4 cells) of the immune system.enfuvirtide
(T-20)
FuzeonMarch 13, 2003
CCR5 Antagonists
CCR5 antagonists block CCR5 coreceptors on the surface of certain immune cells that HIV needs to enter the cells.maraviroc
(MVC)
SelzentryAugust 6, 2007
Integrase Strand Transfer Inhibitor (INSTIs)
Integrase inhibitors block HIV integrase, an enzyme HIV needs to make copies of itself.cabotegravir
(cabotegravir sodium, CAB)
VocabriaJanuary 22, 2021
dolutegravir
(dolutegravir sodium, DTG)
TivicayAugust 12, 2013
Tivicay PDJune 12, 2020
raltegravir
(raltegravir potassium, RAL)
IsentressOctober 12, 2007
Isentress HDMay 26, 2017
Attachment Inhibitors
Attachment inhibitors bind to the gp120 protein on the outer surface of HIV, preventing HIV from entering CD4 cells.fostemsavir
(fostemsavir tromethamine, FTR)
RukobiaJuly 2, 2020
Post-Attachment Inhibitors
Post-attachment inhibitors block CD4 receptors on the surface of certain immune cells that HIV needs to enter the cells.ibalizumab-uiyk
(Hu5A8, IBA, Ibalizumab, TMB-355, TNX-355)
TrogarzoMarch 6, 2018
Pharmacokinetic Enhancers
Pharmacokinetic enhancers are used in HIV treatment to increase the effectiveness of an HIV medicine included in an HIV treatment regimen.cobicistat
(COBI, c)
TybostSeptember 24, 2014
Combination HIV Medicines
Combination HIV medicines contain two or more HIV medicines from one or more drug classes.abacavir and lamivudine
(abacavir sulfate / lamivudine, ABC / 3TC)
EpzicomAugust 2, 2004
abacavir, dolutegravir, and lamivudine
(abacavir sulfate / dolutegravir sodium / lamivudine, ABC / DTG / 3TC)
TriumeqAugust 22, 2014
Triumeq PDMarch 30, 2022
abacavir, lamivudine, and zidovudine
(abacavir sulfate / lamivudine / zidovudine, ABC / 3TC / ZDV)
TrizivirNovember 14, 2000
atazanavir and cobicistat
(atazanavir sulfate / cobicistat, ATV / COBI)
EvotazJanuary 29, 2015
bictegravir, emtricitabine, and tenofovir alafenamide
(bictegravir sodium / emtricitabine / tenofovir alafenamide fumarate, BIC / FTC / TAF)
BiktarvyFebruary 7, 2018
cabotegravir and rilpivirine
(CAB and RPV, CAB plus RPV, Cabenuva kit, cabotegravir extended-release injectable suspension and rilpivirine extended-release injectable suspension)
CabenuvaJanuary 22, 2021
darunavir and cobicistat
(darunavir ethanolate / cobicistat, DRV / COBI)
PrezcobixJanuary 29, 2015
darunavir, cobicistat, emtricitabine, and tenofovir alafenamide
(darunavir ethanolate / cobicistat / emtricitabine / tenofovir AF, darunavir ethanolate / cobicistat / emtricitabine / tenofovir alafenamide, darunavir / cobicistat / emtricitabine / tenofovir AF, darunavir / cobicistat / emtricitabine / tenofovir alafenamide fumarate, DRV / COBI / FTC / TAF)
SymtuzaJuly 17, 2018
dolutegravir and lamivudine
(dolutegravir sodium / lamivudine, DTG / 3TC)
DovatoApril 8, 2019
dolutegravir and rilpivirine
(dolutegravir sodium / rilpivirine hydrochloride, DTG / RPV)
JulucaNovember 21, 2017
doravirine, lamivudine, and tenofovir disoproxil fumarate
(doravirine / lamivudine / TDF, doravirine / lamivudine / tenofovir DF, DOR / 3TC / TDF)
DelstrigoAugust 30, 2018
efavirenz, emtricitabine, and tenofovir disoproxil fumarate
(efavirenz / emtricitabine / tenofovir DF, EFV / FTC / TDF)
AtriplaJuly 12, 2006
efavirenz, lamivudine, and tenofovir disoproxil fumarate
(EFV / 3TC / TDF)
SymfiMarch 22, 2018
efavirenz, lamivudine, and tenofovir disoproxil fumarate
(EFV / 3TC / TDF)
Symfi LoFebruary 5, 2018
elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide
(elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide fumarate, EVG / COBI / FTC / TAF)
GenvoyaNovember 5, 2015
elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate
(QUAD, EVG / COBI / FTC / TDF)
StribildAugust 27, 2012
emtricitabine, rilpivirine, and tenofovir alafenamide
(emtricitabine / rilpivirine / tenofovir AF, emtricitabine / rilpivirine / tenofovir alafenamide fumarate, emtricitabine / rilpivirine hydrochloride / tenofovir AF, emtricitabine / rilpivirine hydrochloride / tenofovir alafenamide, emtricitabine / rilpivirine hydrochloride / tenofovir alafenamide fumarate, FTC / RPV / TAF)
OdefseyMarch 1, 2016
emtricitabine, rilpivirine, and tenofovir disoproxil fumarate
(emtricitabine / rilpivirine hydrochloride / tenofovir disoproxil fumarate, emtricitabine / rilpivirine / tenofovir, FTC / RPV / TDF)
CompleraAugust 10, 2011
emtricitabine and tenofovir alafenamide
(emtricitabine / tenofovir AF, emtricitabine / tenofovir alafenamide fumarate, FTC / TAF)
DescovyApril 4, 2016
emtricitabine and tenofovir disoproxil fumarate
(emtricitabine / tenofovir DF, FTC / TDF)
TruvadaAugust 2, 2004
lamivudine and tenofovir disoproxil fumarate
(3TC / TDF)
CimduoFebruary 28, 2018
lamivudine and zidovudine
(3TC / ZDV)
CombivirSeptember 27, 1997
lopinavir and ritonavir
(ritonavir-boosted lopinavir, LPV/r, LPV / RTV)
KaletraSeptember 15, 2000

 

Source: https://hivinfo.nih.gov/understanding-hiv/fact-sheets/fda-approved-hiv-medicines



  • WHO Model List of Essential Medicines 22nd List (2021)
  • National List of Essential Medicines Nepal 2021
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