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FDA-Approved HIV Medicines

March 19, 2018

Treatment with HIV medicines is called antiretroviral therapy (ART). ART is recommended for everyone with HIV. People on ART take a combination of HIV medicines (called an HIV regimen) every day. A person's initial HIV regimen generally includes three HIV medicines from at least two different drug classes.

ART can’t cure HIV, but HIV medicines help people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission.

The following table lists HIV medicines approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in the United States. 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 AIDSinfo Drug Database. Or download the AIDSinfo Drug Database app to view the information on your Apple or Android devices.

To see a timeline of all FDA approval dates for HIV medicines, view the AIDSinfo FDA Approval of HIV Medicines infographic.

FDA-Approved HIV Medicines
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)
Ziagen December 17, 1998
Emtriva July 2, 2003
Epivir November 17, 1995
tenofovir disoproxil

(tenofovir DF, TDF)
Viread October 26, 2001
(azidothymidine, AZT, ZDV)
Retrovir March 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.
Sustiva September 17, 1998
January 18, 2008
(extended-release nevirapine, NVP)
June 21, 1996
Viramune XR (extended release)
March 25, 2011
(rilpivirine hydrochloride, RPV)
Edurant May 20, 2011
Protease Inhibitors (PIs)
PIs block HIV protease, an enzyme HIV needs to make copies of itself
(atazanavir sulfate, ATV)
Reyataz June 20, 2003
(darunavir ethanolate, DRV)
Prezista June 23, 2006
(fosamprenavir calcium, FOS-APV, FPV)
Lexiva October 20, 2003

*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 HIV-1-Infected Adults and Adolescents and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.

March 1, 1996
(saquinavir mesylate, SQV)
December 6, 1995
June 22, 2005
Fusion Inhibitors
Fusion inhibitors block HIV from entering the CD4 cells of the immune system.
March 13, 2003
CCR5 Antagonists
CCR5 antagonists block CCR5 coreceptors on the surface of certain immune cells that HIV needs to enter the cells.
August 6, 2007
Integrase Inhibitors
Integrase inhibitors block HIV integrase, an enzyme HIV needs to make copies of itself.
August 13, 2013
(raltegravir potassium, RAL)

Isentress HD
October 12, 2007

May 26, 2017
Post-Attachment Inhibitors
Post-attachment inhibitors block CD4 receptors on the surface of certain immune cells that HIV needs to enter the cells.
(Hu5A8, IBA, Ibalizumab-uiyk, TMB-355, TNX-355)
March 6, 2018
Pharmacokinetic Enhancers
Pharmacokinetic enhancers are used in HIV treatment to increase the effectiveness of an HIV medicine included in an HIV regimen.
September 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)
August 2, 2004
abacavir, dolutegravir, and lamivudine
(abacavir sulfate / dolutegravir sodium / lamivudine, ABC / DTG / 3TC)
Triumeq August 22, 2014
abacavir, lamivudine, and zidovudine
(abacavir sulfate / lamivudine / zidovudine, ABC / 3TC / ZDV)
November 14, 2000
atazanavir and cobicistat
(atazanavir sulfate / cobicistat, ATV / COBI)
January 29, 2015
bictegravir, emtricitabine, and tenofovir alafenamide
(bictegravir sodium / emtricitabine / tenofovir alafenamide fumarate, BIC / FTC / TAF)
February 7, 2018
darunavir and cobicistat
(darunavir ethanolate / cobicistat, DRV / COBI)
January 29, 2015
dolutegravir and rilpivirine
(dolutegravir sodium / rilpivirine hydrochloride, DTG / RPV)
November 21, 2017
efavirenz, emtricitabine, and tenofovir disoproxil fumarate
(efavirenz / emtricitabine / tenofovir DF, EFV / FTC / TDF)
Atripla July 12, 2006
elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide fumarate
(elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide, EVG / COBI / FTC / TAF)
Genvoya November 5, 2015
elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate
Stribild August 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)
Odefsey March 1, 2016
emtricitabine, rilpivirine, and tenofovir disoproxil fumarate
(emtricitabine / rilpivirine hydrochloride / tenofovir disoproxil fumarate, emtricitabine / rilpivirine / tenofovir, FTC / RPV / TDF)
Complera August 10, 2011
emtricitabine and tenofovir alafenamide
(emtricitabine / tenofovir AF, emtricitabine / tenofovir alafenamide fumarate, FTC / TAF)
Descovy April 4, 2016
emtricitabine and tenofovir disoproxil fumarate
(emtricitabine / tenofovir DF, FTC / TDF)
Truvada August 2, 2004
lamivudine and zidovudine
(3TC / ZDV)
Combivir September 27, 1997
lopinavir and ritonavir
(ritonavir-boosted lopinavir, LPV/r, LPV / RTV)
Kaletra September 15, 2000

This fact sheet is based on information from the following sources:

[Note from This article was created by AIDSinfo, who last updated it on March 19, 2018. We have cross-posted it with their permission.]

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