For Patients

HIV/AIDS Historical Time Line 2010 - 2017

2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017

2017

Changes in Labeling

  • Multiple medical products 

New Approval

  • Juluca (dolutegravir and rilpivirine)

Generic Drug Approval

  • emtricitabine and tenofovir disoproxil fumarate Tablets, 200 mg/300 mg

Fixed-Dose Combination Approval

  • Tablet containing lamivudine/zidovudine 150 mg/300 mg

New Indication and Usage

  • Stribild (elvitegravir, cobicistat, emtrictiabine, tenofovir disoproxil fumarate) 

     

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2016
 

Changes in Labeling

  • Multiple medical products

New Indication and Usage

  • Selzentry (maraviroc)

  • Truvada (emtricitabine/tenofovir disoproxil fumarate)

Request for Community and Expert Input

  • Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products
  • Regarding Risk Factor Elicitation for the Transfusion-Transmissible Infection Monitoring System

Fixed-Dose Combination Approvals

  • Descovy (emtricitabine (FTC) and tenofovir alafenamide (TAF))

  • ODEFSEY (emtricitabine, rilpivirine, & tenofovir alafenamide)
     

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2015
 

New Drugs

  • Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide)

  • Reyataz (atazanavir)

  • Prezcobix (darunavir and cobicistat)

New Drug Tentative Approvals

  • Dutrebis (lamivudine and raltegravir)

  • Evotaz (atazanavir and cobicistat)

Changes in Labeling

  • multiple medical products

Other Notable Events

  • Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.

  • Approved diagnostic test to differentiate between types of HIV infection

Guidance for Industry

  • HIV-1 Infection: Developing Antiretroviral Drugs for Treatment

  • Draft Blood donor deferral policy for men who have had sex with another man (MSM)

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2014

New Drugs

  • Vitekta (elvitegravir)

  • Tybost (cobicistat)

  • Triumeq (abacavir sulfate, dolutegravir, lamivudine)

New Drug Tentative Approvals

  • emtricitabine and tenofovir disoproxil fumarate

  • efavirenz, lamivudine and tenofovir disoproxil fumarate

  • Lamivudine and Zidovudine

  • atazanavir sulfate and ritonavir

  • lamivudine and tenofovir disoproxil fumarate FDC tablets

  • emtricitabine and tenofovir disoproxil fumarate tablets

  • atazanavir sulfate capsules

Changes in Labeling

  • multiple medical products

Generic Drug Approvals

  • lamivudine and zidovudine tablets

Other Notable Events

  • Advisory Committee Meeting:  Blood donor deferral policy for men who have had sex with another man (MSM)

Guidance for Industry

  • FDA’s blood donor deferral policy for men who have sex with men

  • Microbicide Development for the Prevention of HIV Infection

Pediatric Labeling Updates

  • Reyataz (atazanavir)

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2013

New Drugs:

  • Tivicay (dolutegravir)

New Drug Tentative Approvals

  • efavirenz, lamivudine and tenofovir disoproxil fumarate tablets
  • lamivudine and tenofovir disoproxil fumarate fixed-dose combination tablets
  • emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg
  • efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, 600 mg/300 mg/300 mg
  • lamivudine and tenofovir disoproxil fumarate tablets, 300 mg/300 mg
  • efavirenz, emtricitabine and tenofovir Disoproxil fumarate tablets, 600 mg/200 mg/300 mg

New Dosage Form

  • Isentress (raltegravir) oral suspension

Changes in Labeling

  • multiple medical products

Generic Drug Approvals

  • efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet

Other Notable Events

  • Reopening of Comment Period: HIV-Focused Drug Development and HIV Cure Research

  • First rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies approved

  • July 25, 2013 webinar on Draft Guidance: Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment

  • January 17, 2013 webinar “ Draft Guidance Vaginal Microbicides: Development for the Prevention of HIV Infection"

Guidance for Industry

  • New Guidance for Industry Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment


Pediatric Labeling Updates

  • Sustiva (efavirenz)
  • Prezista (darunavir) tablet and oral suspension

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2012

 

New Drugs

  • Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy

  • New fixed dose combination, Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate)

New Drug Tentative Approvals

  • Fixed dose efavirenz, lamivudine and tenofovir disoproxil fumarate fixed-dose tablets

  • Fixed dose lamivudine and tenofovir disoproxil fumarate

  • Lamivudine, nevirapine and zidovudine fixed dose combination

  • Lamivudine, Nevirapine and Zidovudine Fixed Dose Combination Scored Tablets for Oral Suspension

  • Lopinavir and ritonavir Oral Solution, 80 mg/20 mg per mL

  • Efavirenz tablets, 600 mg

  • Lopinavir and ritonavir tablets 200 mg/50 mg

  • Nevirapine tablets 200 mg

  • Nevirapine tablets for oral suspension, 50 mg and 100 mg for pediatric use

  • Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets, 600 mg/200 mg/300 mg

  • Abacavir sulfate and lamivudine tablets 60mg/30mg for pediatric patients

Changes in Labeling

  • multiple medical products

Generic Drug Approvals

  • Abacavir tablets, 300 mg

  • Nevirapine formulations

  • Lamivudine and zidovudine tablets USP, 150 mg/300 mg

Other Notable Events

  • World AIDS Day

  • Hepsera (adefovir dipivoxil) package insert updated 

  • Prezista (darunavir) availability of 800 mg tablet strength

  • Truvada approved to reduce the risk of sexually transmitted HIV in people who are not infected with the virus

  • First In-Home rapid HIV antibody test kit

  • Updated HHS Adult and Adolescent Antiretroviral Treatment Guidelines available

Guidance for Industry

  • Draft guidance on vaginal microbicides for the prevention of HIV infection

New Drug Tentative Approvals for PEPFAR purchase eligibility  

  • More than 150 antiretroviral drugs available through PEPFAR for worldwide HIV/AIDS relief

  • Lamivudine for PEPFAR

  • Lamivudine, nevirapine, and zidovudine fixed dose combination / PEPFAR

  • Efavirenz Capsules USP, 50 mg, and 200 mg for PEPFAR

Advisory Committee Meetings

  • Truvada for Pre-Exposure Prophylaxis (PrEP)

  • Fixed-dose combination tablet of elvitegravir/cobicistat/emtricitabine/ tenofovir disoproxil fumarate

  • Intelence (etravirine): pediatric dosing recommendations and new scored 25 mg tablet for pediatric dosing

  • FDA advisory committee meeting: Truvada for Pre-Exposure Prophylaxis (PrEP) 

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 2011

New Drug Approvals

  • Complera (emtricitabine/rilpivirine/tenofovir DF) fixed dose combination tablets, 200mg/25mg/300mg , a new complete regimen for treatment naïve patients

  • Edurant (rilpivirine) 25 mg tablets, a new NNRTI for treatment naïve adult patients

  • Viramune XR (nevirapine) tablet, 400 mg, a new extended release formulation NNRTI for use in combination with other antiretrovirals

New Drug Tentative Approvals for PEPFAR purchase eligibility

  • Notable this year are the multiple combination fixed-dose drugs that allow for improved dosing schedules and the solutions/suspension drug formulations that offer additional options for patients who have difficulty swallowing tablets.

  • lamivudine and zidovudine fixed-dose combination tablets, 30 mg/60 mg

  • lamivudine and tenofovir DF fixed-dose combination tablets, 300mg/300mg

  • tenofovir disoproxil fumarate tablets, 300 mg

  • emtricitabine capsules, 200 mg

  • abacavir sulfate oral solution, 20 mg (base)/mL

  • abacavir sulfate scored tablets for oral suspension, 60 mg

  • abacavir sulfate and lamivudine fixed-dose combination scored tablets, 60 mg/30 mg, for pediatric dosing

  • lamivudine and tenofovir DF fixed-dose combination tablets, 300 mg/300 mg, co-packaged with nevirapine tablets, 200 mg

New Diagnostic Test Approvals

  • The GS HIV Combo Ag/Ab EIA, the second “Fourth Generation" HIV diagnostic assay which allows for the detection of HIV p24 antigen and antibodies to HIV-1 groups M and O as well as HIV-2 

Generic Drug Approvals

  • lamivudine and zidovudine fixed dose combination tablets, 150 mg/300 mg

  • zidovudine water-dispersible tablets, 100 mg, intended for use in pediatrics and all patients unable to swallow tablets

Labeling Changes

  • multiple medical products

Other notable events

  • Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents released updated Adult HIV Treatment Guidelines

  • The 30th Anniversary of the initial report in the Centers for Disease Control and Prevention’s MMRW of what would later become known as HIV/AIDS 

2010

New Drug Approvals

  • Egrifta (tesamorelin) to treat lipodystrophy

  • New tablet formulation of Norvir (ritonavir)

Generic Drug Approvals

  •  zidovudine injection, 10 mg/mL

  • didanosine delayed-release capsules, 125 mg, 200 mg, 250 mg, and 400 mg

Tenative Approvals for PEPFAR

  • Abacavir sulfate tablets, 60 mg

  • Abacavir Sulfate Tablets, 300 mg

  • Lamivudine, nevirapine, and stavudine fixed dose combination tablets, 150 mg/200 mg/30 mg

  • Atazanavir sulfate capsules, 300 mg

  • Lamivudine and stavudine Fixed Dose Combination tablets 150mg/30mg

  • Fixed dose combination lamivudine, nevirapine, and zidovudine tablets for Oral Solution, 30 mg/50 mg/60 mg

  • Tenofovir disoproxil fumarate tablets, 300 mg

  • Nevirapine tablets for oral suspension, 50 mg

  • Efavirenz cross-scored tablets, 200 mg

Changes in labeling:

  • multiple medical products

Aprpoval of new HIV testing assays:

  • Rapid INSTI HIV-1 60 second Antibody Test

  • Fourth Generation HIV Diagnostic Test Approved, permitting earlier detection of infection

Guidance for Industry:

  • New Guidance for Industry: Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination

  • Draft guidance re: development of antivirals for Chronic Hepatitis C, including coinfection with HIV

Advisory Committee Meetings:

  • HHS Blood Safety and Availability Advisory Committee meeting re: policy on deferral of donors with high-risk exposure to HIV

  • FDA Endocrinologic and Metabolic Drugs Advisory Committee re: application for Egrifta (tesamorelin acetate) to treat lipodystrophy 

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Page Last Updated: 01/08/2018
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