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Pipeline Plus

In the Crowded HIV Market, There’s Room for Innovation

Marion Clark PharmD, RPh
Kunj Gohil PharmD, RPh

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

Tables

Future Therapies

Drug
Manufacturer
Status Regimen Information Pivotal Studies Expected Approval Notes
Remune (HIV-1 immunogen) Immune Response BioPharma, Inc. Pending at FDA 10 units IM injection NCT00002359 2015 First HIV vaccine
Elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide Gilead Sciences, Inc. 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 Gilead Sciences, Inc. 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 U.S. Army Medical Research and Materiel Command Phase 3 IM injection HVTN 100 After 2017 Combination of two previously failed vaccines
Emtricitabine/ rilpivirine/ tenofovir alafenamide Gilead Sciences, Inc. 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 Johnson & Johnson 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 Therapiesa

Drug
Manufacturer
Approval Date Indicationb Regimen Informationc Cost of Course of Therapy per Yeard
Evotaz (atazanavir/cobicistat) Bristol-Myers Squibb January 29, 2015 HIV-1 infection One FDC tablet orally once daily (ATV 300 mg, COBI 150 mg) $20,494
Prezcobix (darunavir/cobicistat) Janssen January 29, 2015 HIV-1 infection One FDC tablet orally once daily (DRV 800 mg, COBI 150 mg) $20,997
Triumeq (abacavir/ dolutegravir/ lamivudine) Viiv Healthcare 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) Gilead Sciences, Inc. 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) Gilead Sciences, Inc. 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) Gilead Sciences, Inc. July 12, 2006 HIV-1 infection One FDC tablet orally once daily (EFV 600 mg, FTC 200 mg, TDF 300 mg) $32,342
Epzicom (abacavir/lamivudine) GlaxoSmithKline 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) Gilead Sciences, Inc. August 2, 2004 HIV-1 infection One FDC tablet orally once daily (FTC 200 mg, TDF 300 mg) $20,028
Trizivir (abacavir/lamivudine/ zidovudine) Viiv Healthcare 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
Combivir (lamivudine/zidovudine) Viiv Healthcare 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

Author bio: 
Dr. Clark is a Post-Doctoral Fellow with Medical Services at MediMedia Managed Markets in South San Francisco, California. Dr. Gohil is Central Services Manager with Medical Services at MediMedia Managed Markets in Yardley, Pennsylvania.

References

  1. GlobalData. HIV Global Drug Forecast and Market Analysis to 2022: Event-Driven Update March 2013;
  2. 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.
  3. 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.
  4. GlobalData. PharmaFocus: HIV—R&D Strategies Towards Cure and Prevention August 2013;
  5. 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.
  6. Immune Response BioPharma, Inc. Remune: HIV/AIDS vaccine. Available at: http://www.immuneresponsebiopharma.com/Pages/REMUNEVaccine.aspx. Accessed April 7, 2015.
  7. 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.