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In the Crowded HIV Market, There’s Room for Innovation
Human immunodeficiency virus (HIV) is one of the most challenging infectious diseases that the world has ever seen. In 2013, approximately 35 million people were living with HIV globally, and an estimated 2.1 million new cases occurred that year.1,2 Only about half of HIV-infected patients received antiretroviral therapy (ART) to manage their disease.
A highly saturated HIV market yielded $12.2 billion in global sales in 2012, including $9.3 billion in the U.S., but sales are expected to decline to $11 billion globally in 2022, with $8.6 billion in the U.S., as a result of patent expirations and decreased incidence rates through more efficacious regimens.1
Current medications use a host of mechanisms to manage viral load; with an extremely complicated treatment algorithm, ART requires various combinations of these therapies. Fixed-dose combinations have become increasingly preferred because they minimize pill burden and are easy for patients to use.3 Unfortunately, patients continue to experience treatment failure due to the development of resistance or toxicity.1,3
Despite the large number of drugs approved for HIV, distinct unmet needs exist for an efficacious medication with a strong safety profile that offers simple regimens and dosing frequency.4 Researchers’ focus has shifted to fixed-dose, single-tablet combination regimens because they can utilize various mechanisms of action without complicated administration schedules, which may increase adherence.1,4
The near-term HIV pipeline includes fixed-dose combinations with a new form of tenofovir disoproxil fumarate, tenofovir alafenamide; the new prodrug formulation is associated with decreased toxicity.5 The most novel additions to the HIV pipeline are vaccines in development for HIV-1 infection. Administration of a vaccine will stimulate immune responses in the body, slowing virus replication.6,7
|Remune (HIV-1 immunogen)
||Pending at FDA||10 units IM injection||NCT00002359||2015||First HIV vaccine|
|Elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide
||Pending at FDA||Single FDC tablet daily orally (EVG 150 mg, COBI 150 mg, FTC 200 mg, and TAF 10 mg)||NCT01797445 NCT01780506||2015||New formulation of tenofovir included; successor to Stribild|
|Emtricitabine/ tenofovir alafenamide
||Phase 3||Single FDC tablet daily orally (FTC 200 mg, TAF 10 mg or 25 mg)||NCT02121795||After 2016||New formulation of tenofovir; successor to Truvada|
|ALVAC-HIV vCP1521 + AIDSVAX B/B
||Phase 3||IM injection||HVTN 100||After 2017||Combination of two previously failed vaccines|
|Emtricitabine/ rilpivirine/ tenofovir alafenamide
||Phase 3||Single FDC tablet daily orally (FTC 200 mg, RPV 25 mg, TAF 25 mg)||NCT02345226 NCT02345252||After 2017||New formulation of tenofovir; successor to Complera|
|Darunavir/ cobicistat/ emtricitabine/ tenofovir alafenamide
||Phase 3||Single FDC tablet daily orally (DRV 800 mg, COBI 150 mg, FTC 200 mg, TAF 10 mg)||NCT02269917||After 2017||New formulation of tenofovir|
COBI = cobicistat; DRV = darunavir; EVG = elvitegravir; FDC = fixed-dose combination; FTC = emtricitabine; HIV = human immunodeficiency virus; IM = intramuscular; RPV = rilpivirine; TAF = tenofovir alafenamide
Sources: FDA; GlobalData; company websites; ClinicalTrials.gov; National Institutes of Health
Current Combination Therapies
||January 29, 2015||HIV-1 infection||One FDC tablet orally once daily (ATV 300 mg, COBI 150 mg)||$20,494|
||January 29, 2015||HIV-1 infection||One FDC tablet orally once daily (DRV 800 mg, COBI 150 mg)||$20,997|
|Triumeq (abacavir/ dolutegravir/ lamivudine)
||August 22, 2014||HIV-1 infection||One FDC tablet orally once daily (ABC 600 mg, DTG 50 mg, 3TC 300 mg)||$37,634|
|Stribild (elvitegravir/cobicistat/ emtricitabine/ tenofovir disoproxil fumarate)
||August 27, 2012||HIV-1 infection||One FDC tablet orally once daily (EVG 150 mg, COBI 150 mg, FTC 200 mg, TDF 300 mg)||$32,228|
|Complera (emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate)
||August 10, 2011||HIV-1 infection||One FDC tablet orally once daily (FTC 200 mg, RBV 27.5 mg, TDF 300 mg)||$32,039|
|Atripla (efavirenz/emtricitabine/ tenofovir disoproxil fumarate)
||July 12, 2006||HIV-1 infection||One FDC tablet orally once daily (EFV 600 mg, FTC 200 mg, TDF 300 mg)||$32,342|
||August 2, 2004||HIV-1 infection||One FDC tablet orally once daily (ABC 600 mg, 3TC 300 mg)||$17,232|
|Truvada (emtricitabine/tenofovir disoproxil fumarate)
||August 2, 2004||HIV-1 infection||One FDC tablet orally once daily (FTC 200 mg, TDF 300 mg)||$20,028|
|Trizivir (abacavir/lamivudine/ zidovudine)
||November 14, 2000||HIV-1 infection||One FDC tablet orally twice daily (ABC 300 mg, 3TC 150 mg, ZDV 300 mg)||$23,502 generic, $21,151|
||September 26, 1997||HIV-1 infection||One FDC tablet orally twice daily (3TC 150 mg, ZDV 300 mg)||$13,161 (generic, $10,681)|
aThis list is not all-inclusive; additional therapies may be available for this disease state.
bAbbreviated indication provided; for full indication, please refer to prescribing information.
cRegimens based on the recommended dosage and maintenance phases from prescribing information; typical doses and titration schedules may vary based on patient-specific requirements.
dCosts calculated using average wholesale price and regimen provided and rounded to the nearest dollar.
Sources: Red Book; Drugs@FDA; and prescribing information for all medications
ABC = abacavir; ATV = atazanavir; COBI = cobicistat; DRV = darunavir; DTG = dolutegravir; EFV = efavirenz; EVG = elvitegravir; FDC = fixed-dose combination; FTC = emtricitabine; HIV-1 = human immunodeficiency virus type 1; RPV = rilpivirine; TDF = tenofovir disoproxil fumarate; 3TC = lamivudine; ZDV = zidovudine
GlobalData. HIV Global Drug Forecast and Market Analysis to 2022: Event-Driven Update March 2013;
- Kaiser Family Foundation. The global HIV/AIDS epidemic. December
12014;Available at: https://www.kff.org/global-health-policy/fact-sheet/the-global-hivaids-epidemic/. Accessed April 7, 2015.
- AIDS.gov. Overview of HIV treatments. August
72009;Available at: https://www.hiv.gov/hiv-basics/staying-in-hiv-care/hiv-treatment/hiv-treatment-overview. Accessed April 7, 2015. GlobalData. PharmaFocus: HIV—R&D Strategies Towards Cure and Prevention August 2013;
- HIVandHepatitis.com. HIV drugs: few new approvals, but pipeline looks promising. January
122015;Available at: http://www.hivandhepatitis.com/hiv-treatment/approved-hiv-drugs/5001-6-hiv-drugs-fewnew-approvals-but-pipeline-looks-promising. Accessed April 7, 2015.
- Immune Response BioPharma, Inc. Remune: HIV/AIDS vaccine. Available at: http://www.immuneresponsebiopharma.com/Pages/REMUNEVaccine.aspx. Accessed April 7, 2015.
- National Institutes of Health. NIH-sponsored HIV vaccine trial launches in South Africa. February
182015;Available at: https://www.niaid.nih.gov/news-events/newsroom. Accessed April 7, 2015.