Original Research5 July 2016
    Author, Article, and Disclosure Information
    Background:

    The total population health benefits and costs of HIV preexposure prophylaxis (PrEP) for people who inject drugs (PWID) in the United States are unclear.

    Objective:

    To evaluate the cost-effectiveness and optimal delivery conditions of PrEP for PWID.

    Design:

    Empirically calibrated dynamic compartmental model.

    Data Sources:

    Published literature and expert opinion.

    Target Population:

    Adult U.S. PWID.

    Time Horizon:

    20 years and lifetime.

    Intervention:

    PrEP alone, PrEP with frequent screening (PrEP+screen), and PrEP+screen with enhanced provision of antiretroviral therapy (ART) for individuals who become infected (PrEP+screen+ART). All scenarios are considered at 25% coverage.

    Outcome Measures:

    Infections averted, deaths averted, change in HIV prevalence, discounted costs (in 2015 U.S. dollars), discounted quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios.

    Results of Base-Case Analysis:

    PrEP+screen+ART dominates other strategies, averting 26 700 infections and reducing HIV prevalence among PWID by 14% compared with the status quo. Achieving these benefits costs $253 000 per QALY gained. At current drug prices, total expenditures for PrEP+screen+ART could be as high as $44 billion over 20 years.

    Results of Sensitivity Analysis:

    Cost-effectiveness of the intervention is linear in the annual cost of PrEP and is dependent on PrEP drug adherence, individual transmission risks, and community HIV prevalence.

    Limitation:

    Data on risk stratification and achievable PrEP efficacy levels for U.S. PWID are limited.

    Conclusion:

    PrEP with frequent screening and prompt treatment for those who become infected can reduce HIV burden among PWID and provide health benefits for the entire U.S. population, but, at current drug prices, it remains an expensive intervention both in absolute terms and in cost per QALY gained.

    Primary Funding Source:

    National Institute on Drug Abuse.

    References

    • 1. Centers for Disease Control and Prevention. Estimated HIV incidence in the United States, 2007–2010. HIV Surveillance Supplemental Report 2012;17(No. 4). Accessed at www.cdc.gov/hiv/pdf/statistics_hssr_vol_17_no_4.pdf on 12 August 2014. Google Scholar
    • 2. Friedman SRTempalski BCooper HPerlis TKeem MFriedman Ret alEstimating numbers of injecting drug users in metropolitan areas for structural analyses of community vulnerability and for assessing relative degrees of service provision for injecting drug users. J Urban Health2004;81:377-400. [PMID: 15273263] CrossrefMedlineGoogle Scholar
    • 3. Centers for Disease Control and Prevention (CDC)Integrated prevention services for HIV infection, viral hepatitis, sexually transmitted diseases, and tuberculosis for persons who use drugs illicitly: summary guidance from CDC and the U.S. Department of Health and Human Services. MMWR Recomm Rep2012;61:1-40. [PMID: 23135062] MedlineGoogle Scholar
    • 4. Spiller MWBroz DWejnert CNerlander LPaz-Bailey GCenters for Disease Control and Prevention (CDC)HIV infection and HIV-associated behaviors among persons who inject drugs—20 cities, United States, 2012. MMWR Morb Mortal Wkly Rep2015;64:270-5. [PMID: 25789742] MedlineGoogle Scholar
    • 5. Grant RMLama JRAnderson PLMcMahan VLiu AYVargas Let aliPrEx Study TeamPreexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med2010;363:2587-99. [PMID: 21091279] doi:10.1056/NEJMoa1011205 CrossrefMedlineGoogle Scholar
    • 6. Murnane PMCelum CMugo NCampbell JDDonnell DBukusi Eet alPartners PrEP Study TeamEfficacy of preexposure prophylaxis for HIV-1 prevention among high-risk heterosexuals: subgroup analyses from a randomized trial. AIDS2013;27:2155-60. [PMID: 24384592] doi:10.1097/QAD.0b013e3283629037 CrossrefMedlineGoogle Scholar
    • 7. Baeten JMDonnell DNdase PMugo NRCampbell JDWangisi Jet alPartners PrEP Study TeamAntiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med2012;367:399-410. [PMID: 22784037] doi:10.1056/NEJMoa1108524 CrossrefMedlineGoogle Scholar
    • 8. Choopanya KMartin MSuntharasamai PSangkum UMock PALeethochawalit Met alBangkok Tenofovir Study GroupAntiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet2013;381:2083-90. [PMID: 23769234] doi:10.1016/S0140-6736(13)61127-7 CrossrefMedlineGoogle Scholar
    • 9. Centers for Disease Control and Prevention, U.S. Public Health Service. Preexposure prophylaxis for the prevention of HIV infection in the United States–2014: A Clinical Practice Guideline. 2014. Accessed at www.cdc.gov/hiv/pdf/prepguidelines2014.pdf on 12 June 2014. Google Scholar
    • 10. Paltiel ADFreedberg KAScott CASchackman BRLosina EWang Bet alHIV preexposure prophylaxis in the United States: impact on lifetime infection risk, clinical outcomes, and cost-effectiveness. Clin Infect Dis2009;48:806-15. [PMID: 19193111] doi:10.1086/597095 CrossrefMedlineGoogle Scholar
    • 11. Juusola JLBrandeau MLOwens DKBendavid EThe cost-effectiveness of preexposure prophylaxis for HIV prevention in the United States in men who have sex with men. Ann Intern Med2012;156:541-50. [PMID: 22508731]. doi:10.7326/0003-4819-156-8-201204170-00001 LinkGoogle Scholar
    • 12. U.S. Department of Veterans Affairs. National Acquisition Center (CCST). Accessed at www1.va.gov/nac/ on 1 April 2015. Google Scholar
    • 13. Broz DWejnert CPham HTDiNenno EHeffelfinger JDCribbin Met alNational HIV Behavioral Surveillance System Study GroupHIV infection and risk, prevention, and testing behaviors among injecting drug users — National HIV Behavioral Surveillance System, 20 U.S. cities, 2009. MMWR Surveill Summ2014;63:1-51. [PMID: 24990587] MedlineGoogle Scholar
    • 14. Centers for Disease Control and Prevention (CDC)Prevalence and awareness of HIV infection among men who have sex with men—21 cities, United States, 2008. MMWR Morb Mortal Wkly Rep2010;59:1201-7. [PMID: 20864920] MedlineGoogle Scholar
    • 15. Centers for Disease Control and Prevention (CDC)HIV testing and risk behaviors among gay, bisexual, and other men who have sex with men - United States. MMWR Morb Mortal Wkly Rep2013;62:958-62. [PMID: 24280915] MedlineGoogle Scholar
    • 16. Centers for Disease Control and Prevention. HIV Surveillance Report, 2013. Volume 25. February 2015. Accessed at www.cdc.gov/hiv/library/reports/surveillance/ on July 15, 2015. Google Scholar
    • 17. Hall HIGreen TAWolitski RJHoltgrave DRRhodes PLehman JSet alEstimated future HIV prevalence, incidence, and potential infections averted in the United States: a multiple scenario analysis. J Acquir Immune Defic Syndr2010;55:271-6. [PMID: 20634702] doi:10.1097/QAI.0b013e3181e8f90c CrossrefMedlineGoogle Scholar
    • 18. Centers for Disease Control and Prevention. HIV/AIDS: Infographics and Posters. Accessed at www.cdc.gov/hiv/library/infographics.html?s_cid=bb-dhap-hiv-ngmhaad-001 – ngmhaad on June 29, 2015. Google Scholar
    • 19. Weinstein MCO'Brien BHornberger JJackson JJohannesson MMcCabe Cet alISPOR Task Force on Good Research Practices—Modeling StudiesPrinciples of good practice for decision analytic modeling in health-care evaluation: report of the ISPOR Task Force on Good Research Practices—Modeling Studies. Value Health2003;6:9-17. [PMID: 12535234] CrossrefMedlineGoogle Scholar
    • 20. Gold MPanel on cost-effectiveness in health and medicine. Med Care1996;34:DS197-9. [PMID: 8969326] MedlineGoogle Scholar
    • 21. Tempalski BPouget ERCleland CMBrady JECooper HLHall HIet alTrends in the population prevalence of people who inject drugs in US metropolitan areas 1992-2007. PLoS One2013;8:e64789. [PMID: 23755143] doi:10.1371/journal.pone.0064789 CrossrefMedlineGoogle Scholar
    • 22. Centers for Disease Control and Prevention (CDC)HIV infection and HIV-associated behaviors among injecting drug users - 20 cities, United States, 2009. MMWR Morb Mortal Wkly Rep2012;61:133-8. [PMID: 22377843] MedlineGoogle Scholar
    • 23. Central Intelligence Agency. The World Factbook: United States. Accessed at www.cia.gov/library/publications/the-world-factbook/geos/us.html on 12 August 2014. Google Scholar
    • 24. Degenhardt LHall WWarner-Smith MUsing cohort studies to estimate mortality among injecting drug users that is not attributable to AIDS. Sex Transm Infect2006;82 Suppl 3:iii56-63. [PMID: 16735295] MedlineGoogle Scholar
    • 25. Arias EUnited States life tables, 2010. Natl Vital Stat Rep2014;63:1-63. [PMID: 25383611] MedlineGoogle Scholar
    • 26. Samji HCescon AHogg RSModur SPAlthoff KNBuchacz Ket alNorth American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) of IeDEAClosing the gap: increases in life expectancy among treated HIV-positive individuals in the United States and Canada. PLoS One2013;8:e81355. [PMID: 24367482] doi:10.1371/journal.pone.0081355 CrossrefMedlineGoogle Scholar
    • 27. Wada NJacobson LPCohen MFrench APhair JMuñoz ACause-specific mortality among HIV-infected individuals, by CD4(+) cell count at HAART initiation, compared with HIV-uninfected individuals. AIDS2014;28:257-65. [PMID: 24105030] doi:10.1097/QAD.0000000000000078 CrossrefMedlineGoogle Scholar
    • 28. Spire BLucas GMCarrieri MPAdherence to HIV treatment among IDUs and the role of opioid substitution treatment (OST). Int J Drug Policy2007;18:262-70. [PMID: 17689374] CrossrefMedlineGoogle Scholar
    • 29. Sanders GDBayoumi AMSundaram VBilir SPNeukermans CPRydzak CEet alCost-effectiveness of screening for HIV in the era of highly active antiretroviral therapy. N Engl J Med2005;352:570-85. [PMID: 15703422] CrossrefMedlineGoogle Scholar
    • 30. MacArthur GJMinozzi SMartin NVickerman PDeren SBruneau Jet alOpiate substitution treatment and HIV transmission in people who inject drugs: systematic review and meta-analysis. BMJ2012;345:e5945. [PMID: 23038795] doi:10.1136/bmj.e5945 CrossrefMedlineGoogle Scholar
    • 31. Zaric GSBarnett PGBrandeau MLHIV transmission and the cost-effectiveness of methadone maintenance. Am J Public Health2000;90:1100-11. [PMID: 10897189] CrossrefMedlineGoogle Scholar
    • 32. Sullivan LEMoore BAChawarski MCPantalon MVBarry DO'Connor PGet alBuprenorphine/naloxone treatment in primary care is associated with decreased human immunodeficiency virus risk behaviors. J Subst Abuse Treat2008;35:87-92. [PMID: 17933486] CrossrefMedlineGoogle Scholar
    • 33. Cipriano LEZaric GSHolodniy MBendavid EOwens DKBrandeau MLCost effectiveness of screening strategies for early identification of HIV and HCV infection in injection drug users. PLoS One2012;7:e45176. [PMID: 23028828] doi:10.1371/journal.pone.0045176 CrossrefMedlineGoogle Scholar
    • 34. Kral AHLorvick JCiccarone DWenger LGee LMartinez Aet alHIV prevalence and risk behaviors among men who have sex with men and inject drugs in San Francisco. J Urban Health2005;82:i43-50. [PMID: 15738321] CrossrefMedlineGoogle Scholar
    • 35. Pollack HAD'Aunno THIV testing and counseling in the nation's outpatient substance abuse treatment system, 1995-2005. J Subst Abuse Treat2010;38:307-16. [PMID: 20171038] doi:10.1016/j.jsat.2009.12.004 CrossrefMedlineGoogle Scholar
    • 36. Sanchez TFinlayson TDrake ABehel SCribbin MDinenno Eet alCenters for Disease Control and Prevention (CDC)Human immunodeficiency virus (HIV) risk, prevention, and testing behaviors—United States, National HIV Behavioral Surveillance System: men who have sex with men, November 2003-April 2005. MMWR Surveill Summ2006;55:1-16. [PMID: 16826162] MedlineGoogle Scholar
    • 37. National Institutes of Health. Starting antiretroviral treatment early improves outcomes for HIV-infected individuals [press release]. 27 May 2015. Accessed at www.nih.gov/news/health/may2015/niaid-27.htm on 15 July 2015. Google Scholar
    • 38. Westergaard RPAmbrose BKMehta SHKirk GDProvider and clinic-level correlates of deferring antiretroviral therapy for people who inject drugs: a survey of North American HIV providers. J Int AIDS Soc2012;15:10. [PMID: 22360788] doi:10.1186/1758-2652-15-10 CrossrefMedlineGoogle Scholar
    • 39. Zule WABobashev GVWechsberg WMCostenbader ECCoomes CMBehaviorally bisexual men and their risk behaviors with men and women. J Urban Health2009;86 Suppl 1:48-62. [PMID: 19513854] doi:10.1007/s11524-009-9366-3 CrossrefMedlineGoogle Scholar
    • 40. Montgomery JPMokotoff EDGentry ACBlair JMThe extent of bisexual behaviour in HIV-infected men and implications for transmission to their female sex partners. AIDS Care2003;15:829-37. [PMID: 14617504] CrossrefMedlineGoogle Scholar
    • 41. Wejnert CLe BRose CEOster AMSmith AJZhu JGabriela Paz-Bailey for the NHBS Study GroupHIV infection and awareness among men who have sex with men-20 cities, United States, 2008 and 2011. PLoS One2013;8:e76878. [PMID: 24194848] doi:10.1371/journal.pone.0076878 CrossrefMedlineGoogle Scholar
    • 42. Kapadia FLatka MHHudson SMGolub ETCampbell JVBailey Set alDUIT Study TeamCorrelates of consistent condom use with main partners by partnership patterns among young adult male injection drug users from five US cities. Drug Alcohol Depend2007;91 Suppl 1:S56-63. [PMID: 17329041] CrossrefMedlineGoogle Scholar
    • 43. Long EFBrandeau MLOwens DKThe cost-effectiveness and population outcomes of expanded HIV screening and antiretroviral treatment in the United States. Ann Intern Med2010;153:778-89. [PMID: 21173412]. doi:10.7326/0003-4819-153-12-201012210-00004 LinkGoogle Scholar
    • 44. Semaan SNeumann MSHutchins KD'Anna LHKamb MLProject RESPECT Study GroupBrief counseling for reducing sexual risk and bacterial STIs among drug users—results from project RESPECT. Drug Alcohol Depend2010;106:7-15. [PMID: 19720471] doi:10.1016/j.drugalcdep.2009.07.015 CrossrefMedlineGoogle Scholar
    • 45. Sionean CLe BCHageman KOster AMWejnert CHess KLet alNHBS study groupHIV Risk, prevention, and testing behaviors among heterosexuals at increased risk for HIV infection—National HIV Behavioral Surveillance System, 21 U.S. cities, 2010. MMWR Surveill Summ2014;63:1-39. [PMID: 25522191] MedlineGoogle Scholar
    • 46. Davis KRWeller SCThe effectiveness of condoms in reducing heterosexual transmission of HIV. Fam Plann Perspect1999;31:272-9. [PMID: 10614517] CrossrefMedlineGoogle Scholar
    • 47. Public Health Agency of Canada. HIV transmission risk: a summary of the evidence. Feburary 2013. Accessed at www.catie.ca/sites/default/files/HIV-TRANSMISSION-RISK-EN.pdf on 9 February 2015. Google Scholar
    • 48. Hollingsworth TDAnderson RMFraser CHIV-1 transmission, by stage of infection. J Infect Dis2008;198:687-93. [PMID: 18662132] doi:10.1086/590501 CrossrefMedlineGoogle Scholar
    • 49. Pilcher CDTien HCEron JJVernazza PLLeu SYStewart PWet alQuest StudyBrief but efficient: acute HIV infection and the sexual transmission of HIV. J Infect Dis2004;189:1785-92. [PMID: 15122514] CrossrefMedlineGoogle Scholar
    • 50. Castilla JDelRomero JHernando VMarincovich BGarcía SRodríguez CEffectiveness of highly active antiretroviral therapy in reducing heterosexual transmission of HIV. J Acquir Immune Defic Syndr2005;40:96-101. [PMID: 16123689] CrossrefMedlineGoogle Scholar
    • 51. Marrazzo JMRamjee GRichardson BAGomez KMgodi NNair Get alVOICE Study TeamTenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med2015;372:509-18. [PMID: 25651245] doi:10.1056/NEJMoa1402269 CrossrefMedlineGoogle Scholar
    • 52. U.S. Bureau of Labor StatisticsConsumer Price Index. Washington, DC: U.S. Department of Labor; 2014. Google Scholar
    • 53. New York State Department of Health. Pre-exposure prophylaxis (PrEP) to prevent HIV infection: questions and answers. December 2012. Accessed at www.health.ny.gov/publications/0265/ on February 9, 2015. Google Scholar
    • 54. Paltiel ADWeinstein MCKimmel ADSeage GRLosina EZhang Het alExpanded screening for HIV in the United States—an analysis of cost-effectiveness. N Engl J Med2005;352:586-95. [PMID: 15703423] CrossrefMedlineGoogle Scholar
    • 55. Goldhaber-Fiebert JDStout NKOrtendahl JKuntz KMGoldie SJSalomon JAModeling human papillomavirus and cervical cancer in the United States for analyses of screening and vaccination. Popul Health Metr2007;5:11. [PMID: 17967185] CrossrefMedlineGoogle Scholar
    • 56. Karnon JVanni TCalibrating models in economic evaluation: a comparison of alternative measures of goodness of fit, parameter search strategies and convergence criteria. Pharmacoeconomics2011;29:51-62. [PMID: 21142278] doi:10.2165/11584610-000000000-00000 CrossrefMedlineGoogle Scholar
    • 57. Stinnett AAPaltiel ADEstimating CE ratios under second-order uncertainty: the mean ratio versus the ratio of means. Med Decis Making1997;17:483-9. [PMID: 9343807] CrossrefMedlineGoogle Scholar
    • 58. Henry J. Kaiser Family Foundation. U.S. federal funding for HIV/AIDS: the President's FY 2016 budget request. April 2015. Accessed at http://kff.org/global-health-policy/fact-sheet/u-s-federal-funding-for-hivaids-the-presidents-fy-2016-budget-request/ on 4 September 2015. Google Scholar
    • 59. Gilead Sciences, Inc. Gilead expands initiatives providing access to new HIV therapy Truvada in United States and abroad. 18 August 2004. Accessed at www.gilead.com/news/press-releases/2004/8/gilead-expands-initiatives-providing-access-to-new-hiv-therapy-truvada-in-united-states-and-abroad on 1 April 2015. Google Scholar
    • 60. Livoti C. HIV drugs to be uniquely shielded from generic pricing pressure in public payer scheme. Financial Times. 28 February 2013. Accessed at www.ft.com/cms/s/2/286774b4-81be-11e2-b050-00144feabdc0.html#axzz43viyCqtY on 1 April 2015. Google Scholar
    • 61. Holtgrave DRPinkerton SDJones TSLurie PVlahov DCost and cost-effectiveness of increasing access to sterile syringes and needles as an HIV prevention intervention in the United States. J Acquir Immune Defic Syndr Hum Retrovirol1998;18 Suppl 1:S133-8. [PMID: 9663636] CrossrefMedlineGoogle Scholar
    • 62. Kwon JAAnderson JKerr CCThein HHZhang LIversen Jet alEstimating the cost-effectiveness of needle-syringe programs in Australia. AIDS2012;26:2201-10. [PMID: 22914579] doi:10.1097/QAD.0b013e3283578b5d CrossrefMedlineGoogle Scholar
    • 63. Blankenship KMSmoyer ABBray SJMattocks KBlack-white disparities in HIV/AIDS: the role of drug policy and the corrections system. J Health Care Poor Underserved2005;16:140-56. [PMID: 16327113] CrossrefMedlineGoogle Scholar
    • 64. Lehman DABaeten JMMcCoy COWeis JFPeterson DMbara Get alPartners PrEP Study TeamRisk of drug resistance among persons acquiring HIV within a randomized clinical trial of single- or dual-agent preexposure prophylaxis. J Infect Dis2015;211:1211-8. [PMID: 25587020] doi:10.1093/infdis/jiu677 CrossrefMedlineGoogle Scholar
    • 65. Supervie VBarrett MKahn JSMusuka GMoeti TLBusang Let alModeling dynamic interactions between pre-exposure prophylaxis interventions & treatment programs: predicting HIV transmission & resistance. Sci Rep2011;1:185. [PMID: 22355700] doi:10.1038/srep00185 CrossrefMedlineGoogle Scholar
    • 66. Basu SAndrews JComplexity in mathematical models of public health policies: a guide for consumers of models. PLoS Med2013;10:e1001540. [PMID: 24204214] doi:10.1371/journal.pmed.1001540 CrossrefMedlineGoogle Scholar
    • 67. Alistar SSOwens DKBrandeau MLEffectiveness and cost effectiveness of oral pre-exposure prophylaxis in a portfolio of prevention programs for injection drug users in mixed HIV epidemics. PLoS One2014;9:e86584. [PMID: 24489747] doi:10.1371/journal.pone.0086584 CrossrefMedlineGoogle Scholar
    • 69. Koblin BAChesney MAHusnik MJBozeman SCelum CLBuchbinder Set alEXPLORE Study TeamHigh-risk behaviors among men who have sex with men in 6 US cities: baseline data from the EXPLORE Study. Am J Public Health2003;93:926-32. [PMID: 12773357] CrossrefMedlineGoogle Scholar
    • 70. Bellis DJReduction of AIDS risk among 41 heroin addicted female street prostitutes: effects of free methadone maintenance. J Addict Dis1993;12:7-23. [PMID: 8381030] CrossrefMedlineGoogle Scholar
    • 72. Barnett PGChow AJoyce VRBayoumi AMGriffin SCSun Het alEffect of management strategies and clinical status on costs of care for advanced HIV. Am J Manag Care2014;20:e129-37. [PMID: 25326927] MedlineGoogle Scholar
    • 73. Tengs TOLin THA meta-analysis of utility estimates for HIV/AIDS. Med Decis Making2002;22:475-81. [PMID: 12458977] CrossrefMedlineGoogle Scholar
    • 74. Quinn TCWamer MJSewankambo NSerwadda DLi CWabwire-Mangen Fet alViral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. N Engl J. Med2000;345:921-9. [PMID: 10738050] CrossrefMedlineGoogle Scholar