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 or by schedule (injections).
A person's initial HIV treatment regimen generally includes three HIV medicines from at least two different HIV drug classes. In many cases, different oral medicines may be combined into a single pill or capsule. Some people are eligible to receive newer long-acting medicines in the form of injections every one or two months.
The following table lists HIV medicines recommended for the treatment of HIV infection in the United States, based on the HIV Clinical Practice Guidelines at Clinicalinfo.HIV.gov.
These drugs have been approved by the U.S. Food and Drug Administration (FDA). Some drugs were approved by the FDA but later discontinued, either as brand-name and/or generic versions. Discontinued drugs are listed in the table below for historical reference.
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.
To see a timeline of all FDA approval dates for HIV medicines, view the HIVinfo FDA Approval of HIV Medicines infographic. To learn more about how each drug class prevents HIV from spreading in the body, view the HIV Life Cycle fact sheet.
*Although some brand-name HIV medicines have been discontinued, generic versions of the same drug formulation remain available.
FDA Approved HIV Medicines – Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
NRTIs block reverse transcriptase, an enzyme HIV needs to make copies of itself.
Generic Name | Brand Name | FDA Approval Date |
|---|---|---|
| abacavir (abacavir sulfate, ABC) | Ziagen | December 17, 1998 |
| emtricitabine (FTC) | Emtriva | July 2, 2003 |
| lamivudine (3TC) | Epivir | November 17, 1995 |
| tenofovir disoproxil fumarate (tenofovir DF, TDF) | Viread | October 26, 2001 |
(tenofovir AF, TAF) | Vemlidy | November 10, 2016 |
| zidovudine (azidothymidine, AZT, ZDV) | Retrovir | March 19, 1987 |
FDA Approved HIV Medicines – Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)
NNRTIs block reverse transcriptase, an enzyme HIV needs to make copies of itself.
Generic Name | Brand Name | FDA Approval Date |
|---|---|---|
| doravirine (DOR) | Pifeltro | August 30, 2018 |
| efavirenz (EFV) | Sustiva (discontinued)* | September 17, 1998 |
| etravirine (ETR) | Intelence | January 18, 2008 |
| nevirapine (NVP) | Viramune (discontinued)* | June 21, 1996 |
Viramune XR (extended-release) (discontinued)* | March 25, 2011 | |
| rilpivirine (rilpivirine hydrochloride, RPV) | Edurant | May 20, 2011 |
Edurant PED (discontinued) | March 15, 2024 |
FDA Approved HIV Medicines – Integrase Strand Transfer Inhibitors (INSTIs)
INSTIs block HIV integrase, an enzyme HIV needs to make copies of itself.
| Generic Name (Other names and acronyms) | Brand Name | FDA Approval Date |
|---|---|---|
| cabotegravir (cabotegravir sodium, CAB) | Apretude (injection) | December 20, 2021 |
| Vocabria (tablet) | January 22, 2021 | |
| dolutegravir (dolutegravir sodium, DTG) | Tivicay | August 12, 2013 |
| Tivicay PD | June 12, 2020 | |
| raltegravir (raltegravir potassium, RAL) | Isentress | October 12, 2007 |
| Isentress HD | May 26, 2017 |
FDA Approved HIV Medicines – Protease Inhibitors (PIs)
PIs block HIV protease, an enzyme HIV needs to make copies of itself.
Generic Name | Brand Name | FDA Approval Date |
|---|---|---|
| atazanavir (atazanavir sulfate, ATV) | Reyataz | June 20, 2003 |
| darunavir (darunavir ethanolate, DRV) | Prezista | June 23, 2006 |
| fosamprenavir (fosamprenavir calcium, FOS-APV, FPV) | Lexiva (discontinued)* | October 20, 2003 |
| ritonavir (RTV) | Norvir | March 1, 1996 |
| tipranavir (TPV) | Aptivus | June 22, 2005 |
Note: 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.
FDA Approved HIV Medicines – Fusion Inhibitors
Fusion inhibitors block HIV from entering the CD4 T lymphocytes (CD4 cells) of the immune system.
Generic Name | Brand Name | FDA Approval Date |
|---|---|---|
| enfuvirtide (T-20) | Fuzeon (discontinued) | March 13, 2003 |
FDA Approved HIV Medicines – CCR5 Antagonists
CCR5 antagonists block CCR5 coreceptors on the surface of certain immune cells that HIV needs to enter the cells.
Generic Name | Brand Name | FDA Approval Date |
|---|---|---|
| maraviroc (MVC) | Selzentry | August 6, 2007 |
FDA Approved HIV Medicines – Attachment Inhibitors
Attachment inhibitors bind to the gp120 protein on the outer surface of HIV, preventing HIV from entering CD4 cells.
Generic Name | Brand Name | FDA Approval Date |
|---|---|---|
| fostemsavir (fostemsavir tromethamine, FTR) | Rukobia | July 2, 2020 |
FDA Approved HIV Medicines – Post-Attachment Inhibitors
Post-attachment inhibitors block CD4 receptors on the surface of certain immune cells that HIV needs to enter the cells.
Generic Name | Brand Name | FDA Approval Date |
|---|---|---|
| ibalizumab-uiyk (IBA, Hu5A8, TMB-355, TNX-355) | Trogarzo | March 6, 2018 |
FDA Approved HIV Medicines – Capsid Inhibitors
Capsid inhibitors interfere with the HIV capsid, a protein shell that protects HIV's genetic material and enzymes needed for replication.
Generic Name | Brand Name | FDA Approval Date |
|---|---|---|
| lenacapavir (LEN, GS-6207, GS-HIV, GS-CA2, GS-CA1) | Sunlenca | December 22, 2022 |
FDA Approved HIV Medicines – Pharmacokinetic Enhancers
Pharmacokinetic enhancers are used in HIV treatment to increase the effectiveness of an HIV medicine included in an HIV treatment regimen.
Generic Name | Brand Name | FDA Approval Date |
|---|---|---|
| cobicistat (COBI, c) | Tybost | September 24, 2014 |
FDA Approved HIV Medicines – Combination HIV Medicines
Combination HIV medicines contain two or more HIV medicines from one or more drug classes.
Generic Name | Brand Name | FDA Approval Date |
|---|---|---|
| abacavir and lamivudine (abacavir sulfate / lamivudine, ABC / 3TC) | Epzicom (discontinued)* | August 2, 2004 |
| abacavir, dolutegravir, and lamivudine (abacavir sulfate / dolutegravir sodium / lamivudine, ABC / DTG / 3TC) | Triumeq | August 22, 2014 |
| Triumeq PD | March 30, 2022 | |
| abacavir, lamivudine, and zidovudine (abacavir sulfate / lamivudine / zidovudine, ABC / 3TC / ZDV) | Trizivir (discontinued)* | November 14, 2000 |
| atazanavir and cobicistat (atazanavir sulfate / cobicistat, ATV / COBI) | Evotaz | January 29, 2015 |
| bictegravir, emtricitabine, and tenofovir alafenamide (bictegravir sodium / emtricitabine / tenofovir AF, BIC / FTC / TAF) | Biktarvy | February 7, 2018 |
| cabotegravir and rilpivirine (cabotegravir / rilpivirine, CAB / RPV, CAB plus RPV, Cabenuva kit, cabotegravir extended-release injectable suspension and rilpivirine extended-release injectable suspension) | Cabenuva | January 22, 2021 |
| darunavir and cobicistat (darunavir ethanolate / cobicistat, DRV / COBI) | Prezcobix | January 29, 2015 |
| darunavir, cobicistat, emtricitabine, and tenofovir alafenamide (darunavir ethanolate / cobicistat / emtricitabine / tenofovir AF, DRV / COBI / FTC / TAF) | Symtuza | July 17, 2018 |
| dolutegravir and lamivudine (dolutegravir sodium / lamivudine, DTG / 3TC) | Dovato | April 8, 2019 |
| dolutegravir and rilpivirine (dolutegravir sodium / rilpivirine hydrochloride, DTG / RPV) | Juluca | November 21, 2017 |
| doravirine, lamivudine, and tenofovir disoproxil fumarate (doravirine / lamivudine / tenofovir DF, DOR / 3TC / TDF) | Delstrigo | August 30, 2018 |
| efavirenz, emtricitabine, and tenofovir disoproxil fumarate (efavirenz / emtricitabine / tenofovir DF, EFV / FTC / TDF) | Atripla (discontinued)* | July 12, 2006 |
| efavirenz, lamivudine, and tenofovir disoproxil fumarate (efavirenz / lamivudine / tenofovir DF, EFV / 3TC / TDF) | Symfi | March 22, 2018 |
| Symfi Lo | February 5, 2018 | |
| elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (elvitegravir / cobicistat / emtricitabine / tenofovir AF, EVG / COBI / FTC / TAF) | Genvoya | November 5, 2015 |
| elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (elvitegravir / cobicistat / emtricitabine / tenofovir DF, EVG / COBI / FTC / TDF) | Stribild | August 27, 2012 |
| emtricitabine, rilpivirine, and tenofovir alafenamide (emtricitabine / rilpivirine hydrochloride / tenofovir AF, FTC / RPV / TAF) | Odefsey | March 1, 2016 |
| emtricitabine, rilpivirine, and tenofovir disoproxil fumarate (emtricitabine / rilpivirine hydrochloride / tenofovir DF, FTC / RPV / TDF) | Complera | August 10, 2011 |
| emtricitabine and tenofovir alafenamide (emtricitabine / tenofovir AF, FTC / TAF) | Descovy | April 4, 2016 |
| emtricitabine and tenofovir disoproxil fumarate (emtricitabine / tenofovir DF, FTC / TDF) | Truvada | August 2, 2004 |
| lamivudine and tenofovir disoproxil fumarate (lamivudine / tenofovir DF, 3TC / TDF) | Cimduo | February 28, 2018 |
| lamivudine and zidovudine (lamivudine / zidovudine, 3TC / ZDV) | Combivir (discontinued)* | 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:
From FDA:
From the National Library of Medicine:
- Drug information from the DailyMed website
Also see the HIV Source collection of HIV links and resources.