Long-acting injectable cabotegravir (CAB-LA) was recently approved by the U.S. Food and Drug Administration for use as HIV preexposure prophylaxis among men who have sex with men and transgender women in the United States. The authors performed a cost-effectiveness analysis comparing CAB-LA to both branded and generic tenofovir-based regimens.
Background:
The HIV Prevention Trials Network (HPTN) 083 trial demonstrated the superiority of long-acting injectable cabotegravir (CAB-LA) compared with oral emtricitabine–tenofovir disoproxil fumarate (F/TDF) for HIV preexposure prophylaxis (PrEP).
Objective:
To identify the maximum price premium (that is, greatest possible price differential) that society should be willing to accept for the additional benefits of CAB-LA over tenofovir-based PrEP among men who have sex with men and transgender women (MSM/TGW) in the United States.
Design:
Simulation, cost-effectiveness analysis.
Data Sources:
Trial and published data, including estimated HIV incidence (5.32, 1.33, and 0.26 per 100 person-years for off PrEP, generic F/TDF and branded emtricitabine–tenofovir alafenamide (F/TAF), and CAB-LA, respectively); 28% 6-year PrEP retention. Annual base-case drug costs: $360 and $16 800 for generic F/TDF and branded F/TAF. Fewer side effects with branded F/TAF versus generic F/TDF were assumed.
Target Population:
476 700 MSM/TGW at very high risk for HIV (VHR).
Time Horizon:
10 years.
Perspective:
Health care system.
Intervention:
CAB-LA versus generic F/TDF or branded F/TAF for HIV PrEP.
Outcome Measures:
Primary transmissions, quality-adjusted life-years (QALYs), costs (2020 U.S. dollars), incremental cost-effectiveness ratios (ICERs; U.S. dollars per QALY), maximum price premium for CAB-LA versus tenofovir-based PrEP.
Results of Base-Case Analysis:
Compared with generic F/TDF (or branded F/TAF), CAB-LA increased life expectancy by 28 000 QALYs (26 000 QALYs) among those at VHR. Branded F/TAF cost more per QALY gained than generic F/TDF compared with no PrEP. At 10 years, CAB-LA could achieve an ICER of at most $100 000 per QALY compared with generic F/TDF at a maximum price premium of $3700 per year over generic F/TDF (CAB-LA price <$4100 per year).
Results of Sensitivity Analysis:
In a PrEP-eligible population at high risk for HIV, rather than at VHR (n = 1 906 800; off PrEP incidence: 1.54 per 100 person-years), CAB-LA could achieve an ICER of at most $100 000 per QALY versus generic F/TDF at a maximum price premium of $1100 per year over generic F/TDF (CAB-LA price <$1500 per year).
Limitation:
Uncertain clinical and economic benefits of averting future transmissions.
Conclusion:
Effective oral PrEP limits the additional price society should be willing to pay for CAB-LA.
Primary Funding Source:
FHI 360; Eunice Kennedy Shriver National Institute of Child Health and Human Development; National Institute of Allergy and Infectious Diseases; National Heart, Lung, and Blood Institute; National Institute on Drug Abuse; the Reich HIV Scholar Award; and the Steve and Deborah Gorlin MGH Research Scholars Award.
References
- 1.
Landovitz RJ ,Donnell D ,Clement ME ,et al ;HPTN 083 Study Team . Cabotegravir for HIV prevention in cisgender men and transgender women. N Engl J Med. 2021;385:595-608. [PMID:34379922 ] doi:10.1056/NEJMoa2101016 CrossrefMedlineGoogle Scholar - 2.
Landovitz RJ ,Kofron R ,McCauley M . The promise and pitfalls of long-acting injectable agents for HIV prevention. Curr Opin HIV AIDS. 2016;11:122-8. [PMID:26633643 ] doi:10.1097/COH.0000000000000219 CrossrefMedlineGoogle Scholar - 3. Horn T. Drug pricing in the age of generics. Presented at The American Conference for the Treatment of HIV (ACTHIV) 2019: A State-of-the-Science Conference for Frontline Health Professionals, Miami, Florida, 13 April 2019. Accessed at www.acthiv.org/wp-content/uploads/2019/04/Tim_Horn_09_30.pdf on 3 March 2021. Google Scholar
- 4. Hoover KW, Zhu W, Wiener J, et al. Trends in Truvada and Descovy prescriptions for PrEP in the United States, 2014-2020 [Abstract]. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI), Virtual, 3 June to 3 November 2021. Abstract no. 696. Accessed at www.croiconference.org/abstract/trends-in-truvada-and-descovy-prescriptions-for-prep-in-the-united-states-2014-2020 on 21 October 2021. Google Scholar
- 5. U.S. House of Representatives Committee Repository. Hearing: HIV Prevention Drug: Billions in Corporate Profits After Millions in Taxpayer Investments. 16 May 2019. Accessed at https://docs.house.gov/Committee/Calendar/ByEvent.aspx?EventID=109486 on 3 March 2021. Google Scholar
- 6. Medical Practice Evaluation Center. Ordering of patient simulation in CEPAC. Massachusetts General Hospital. Accessed at https://mpec.massgeneral.org/wp-content/uploads/2020/07/Flowcharts-cepac50c.pdf on 22 October 2021. Google Scholar
- 7.
Neumann PJ ,Cohen JT ,Weinstein MC . Updating cost-effectiveness---the curious resilience of the $50,000-per-QALY threshold. N Engl J Med. 2014;371:796-7. [PMID:25162885 ] doi:10.1056/NEJMp1405158 CrossrefMedlineGoogle Scholar - 8.
Walensky RP ,Horn T ,McCann NC ,et al . Comparative pricing of branded tenofovir alafenamide-emtricitabine relative to generic tenofovir disoproxil fumarate-emtricitabine for HIV preexposure prophylaxis: a cost-effectiveness analysis. Ann Intern Med. 2020;172:583-590. [PMID:32150602 ] doi:10.7326/M19-3478 LinkGoogle Scholar - 9. Crepaz N, Song R, Lyss S. Estimated time from HIV infection to diagnosis, 50 U.S. states and the District of Columbia, 2014-2018 [Abstract]. Presented at AIDS 2020: 23rd International AIDS Conference, Virtual, 6 July 2020. Abstract OAC0206. Google Scholar
- 10.
Neilan AM ,Bulteel AJB ,Hosek SG ,et al . Cost-effectiveness of frequent HIV screening among high-risk young men who have sex with men in the United States. Clin Infect Dis. 2021;73:e1927-e1935. [PMID:32730625 ] doi:10.1093/cid/ciaa1061 CrossrefMedlineGoogle Scholar - 11.
Grey JA ,Bernstein KT ,Sullivan PS ,et al . Estimating the population sizes of men who have sex with men in US states and counties using data from the American Community Survey. JMIR Public Health Surveill. 2016;2:e14. [PMID:27227149 ] doi:10.2196/publichealth.5365 CrossrefMedlineGoogle Scholar - 12.
Singh S ,Song R ,Johnson AS ,et al . HIV incidence, prevalence, and undiagnosed infections in U.S. men who have sex with men. Ann Intern Med. 2018;168:685-694. [PMID:29554663 ] doi:10.7326/M17-2082 LinkGoogle Scholar - 13. Williams R Jr, Flanagan TP, Bazerman L. Who does not show up for followup in an HIV PrEP clinic? [Abstract]. Open Forum Infect Dis. 2020;7: S180. Abstract 101. doi:10.1093/ofid/ofaa439.411 Google Scholar
- 14.
Laupacis A ,Keown P ,Pus N ,et al . A study of the quality of life and cost-utility of renal transplantation. Kidney Int. 1996;50:235-42. [PMID:8807593 ] doi:10.1038/ki.1996.307 CrossrefMedlineGoogle Scholar - 15.
Borgström F ,Zethraeus N ,Johnell O ,et al . Costs and quality of life associated with osteoporosis-related fractures in Sweden. Osteoporos Int. 2006;17:637-50. [PMID:16283064 ] doi:10.1007/s00198-005-0015-8 CrossrefMedlineGoogle Scholar - 16. Centers for Medicare & Medicaid Services. 2020 Physician Fee Schedule. 2021. Accessed at www.cms.gov/apps/physician-fee-schedule/search/search-criteria.aspx on 3 March 2021. Google Scholar
- 17. Centers for Medicare & Medicaid Services. Clinical Laboratory Fee Schedule. 2020. Accessed at www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index?redirect=/ClinicalLabFeeSched/01_overview.asp on 3 March 2021. Google Scholar
- 18. Truven Health Analytics. IBM Micromedex RED BOOK. Accessed at http://micromedex.com/redbook on 17 November 2021. Google Scholar
- 19. U.S. Department of Veterans Affairs. National Acquisition Center (CCST): pharmaceutical catalog search. 2020. Accessed at www.vendorportal.ecms.va.gov/NAC/Pharma/List on 3 March 2021. Google Scholar
- 20.
Lundgren JD ,Babiker AG ,Gordin F ,et al ;INSIGHT START Study Group . Initiation of antiretroviral therapy in early asymptomatic HIV infection. N Engl J Med. 2015;373:795-807. [PMID:26192873 ] doi:10.1056/NEJMoa1506816 CrossrefMedlineGoogle Scholar - 21.
Schackman BR ,Goldie SJ ,Freedberg KA ,et al . Comparison of health state utilities using community and patient preference weights derived from a survey of patients with HIV/AIDS. Med Decis Making. 2002;22:27-38. [PMID:11833663 ] doi:10.1177/0272989X0202200103 CrossrefMedlineGoogle Scholar - 22.
Paltiel AD ,Scharfstein JA ,Seage GR ,et al . A Monte Carlo simulation of advanced HIV disease: application to prevention of CMV infection. Med Decis Making. 1998;18:S93-105. [PMID:9566470 ] doi:10.1177/0272989X98018002S11 CrossrefMedlineGoogle Scholar - 23.
Sax PE ,Meyers JL ,Mugavero M ,et al . Adherence to antiretroviral treatment and correlation with risk of hospitalization among commercially insured HIV patients in the United States. PLoS One. 2012;7:e31591. [PMID:22384040 ] doi:10.1371/journal.pone.0031591 CrossrefMedlineGoogle Scholar - 24.
Walmsley SL ,Antela A ,Clumeck N ,et al ;SINGLE Investigators . Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013;369:1807-18. [PMID:24195548 ] doi:10.1056/NEJMoa1215541 CrossrefMedlineGoogle Scholar - 25.
Gallant JE ,DeJesus E ,Arribas JR ,et al ;Study 934 Group . Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV. N Engl J Med. 2006;354:251-60. [PMID:16421366 ] doi:10.1056/NEJMoa051871 CrossrefMedlineGoogle Scholar - 26.
Raffi F ,Rachlis A ,Stellbrink HJ ,et al ;SPRING-2 Study Group . Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study. Lancet. 2013;381:735-43. [PMID:23306000 ] doi:10.1016/S0140-6736(12)61853-4 CrossrefMedlineGoogle Scholar - 27.
Fleishman JA ,Yehia BR ,Moore RD ,et al ;HIV Research Network . Establishment, retention, and loss to follow-up in outpatient HIV care. J Acquir Immune Defic Syndr. 2012;60:249-59. [PMID:22531758 ] doi:10.1097/QAI.0b013e318258c696 CrossrefMedlineGoogle Scholar - 28.
Helleberg M ,Engsig FN ,Kronborg G ,et al . Retention in a public healthcare system with free access to treatment: a Danish nationwide HIV cohort study. AIDS. 2012;26:741-8. [PMID:22156974 ] doi:10.1097/QAD.0b013e32834fa15e CrossrefMedlineGoogle Scholar - 29.
Bozzette SA ,Berry SH ,Duan N ,et al . The care of HIV-infected adults in the United States. HIV Cost and Services Utilization Study Consortium. N Engl J Med. 1998;339:1897-904. [PMID:9862946 ] doi:10.1056/NEJM199812243392606 CrossrefMedlineGoogle Scholar - 30.
Bamezai A ,Melnick G ,Nawathe A . The cost of an emergency department visit and its relationship to emergency department volume. Ann Emerg Med. 2005;45:483-90. [PMID:15855942 ] doi:10.1016/j.annemergmed.2004.08.029 CrossrefMedlineGoogle Scholar - 31. Levinson DR. Medicaid Drug Price Comparisons: Average Manufacturer Price to Published Prices. Department of Health and Human Services. June 2005. Accessed at https://oig.hhs.gov/oei/reports/oei-05-05-00240.pdf on 3 March 2021. Google Scholar
- 32.
Eggman AA ,Feaster DJ ,Leff JA ,et al . The cost of implementing rapid HIV testing in sexually transmitted disease clinics in the United States. Sex Transm Dis. 2014;41:545-50. [PMID:25118967 ] doi:10.1097/OLQ.0000000000000168 CrossrefMedlineGoogle Scholar - 33.
Schackman BR ,Eggman AA ,Leff JA ,et al . Costs of expanded rapid HIV testing in four emergency departments. Public Health Rep. 2016;131:71-81. [PMID:26862232 ] doi:10.1177/00333549161310S109 CrossrefMedlineGoogle Scholar - 34.
Mayer KH ,Molina JM ,Thompson MA ,et al . Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet. 2020;396:239-254. [PMID:32711800 ] doi:10.1016/S0140-6736(20)31065-5 CrossrefMedlineGoogle Scholar - 35.
Komatsu A ,Ikeda A ,Kikuchi A ,et al . Osteoporosis-related fractures in HIV-infected patients receiving long-term tenofovir disoproxil fumarate: an observational cohort study. Drug Saf. 2018;41:843-848. [PMID:29623648 ] doi:10.1007/s40264-018-0665-z CrossrefMedlineGoogle Scholar - 36. Centers for Disease Control and Prevention. Chronic Kidney Disease Surveillance System. Indicator details: incidence of individual CKD stages/eGFR categories. 2019. Accessed at https://nccd.cdc.gov/CKD/detail.aspx?Qnum=Q89 on 3 March 2021. Google Scholar
- 37.
Cahn P ,Fourie J ,Grinsztejn B ,et al . Week 48 analysis of once-daily vs. twice-daily darunavir/ritonavir in treatment-experienced HIV-1-infected patients. AIDS. 2011;25:929-39. [PMID:21346512 ] doi:10.1097/QAD.0b013e328345ee95 CrossrefMedlineGoogle Scholar - 38.
Yazdanpanah Y ,Fagard C ,Descamps D ,et al ;ANRS 139 TRIO Trial Group . High rate of virologic suppression with raltegravir plus etravirine and darunavir/ritonavir among treatment-experienced patients infected with multidrug-resistant HIV: results of the ANRS 139 TRIO trial. Clin Infect Dis. 2009;49:1441-9. [PMID:19814627 ] doi:10.1086/630210 CrossrefMedlineGoogle Scholar - 39. Bernstein L. FDA approves breakthrough injectable HIV medication. The Washington Post. 21 Jan 2021. Accessed at www.washingtonpost.com/health/hiv-injectable-drug/2021/01/22/56a8d8c4-5ce7-11eb-8bcf-3877871c819d_story.html on 3 March 2021. Google Scholar
- 40. Marzinke M, Grinsztejn B, Fogel J, et al. Laboratory analysis of HIV infections in HPTN 083: injectable CAB for PrEP [Abstract]. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI), Virtual, 6 March 2021. Abstract no. 153. Accessed at www.croiconference.org/abstract/laboratory-analysis-of-hiv-infections-in-hptn-083-injectable-cab-for-prep on 9 March 2021. Google Scholar
- 41. Gilead. Gilead Announces Decision Not to Pursue Marketing Authorization for Descovy for Pre-Exposure Prophylaxis in the European Union. 20 October 2021. Accessed at www.gilead.com/news-and-press/company-statements/gilead-announces-decision-not-to-pursue-marketing-authorization-for-descovy-for-pre-exposure-prophylaxis-in-the-european-union on 29 October 2021. Google Scholar
- 42.
Grant RM ,Lama JR ,Anderson PL ,et al ;iPrEx Study Team . Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363:2587-99. [PMID:21091279 ] doi:10.1056/NEJMoa1011205 CrossrefMedlineGoogle Scholar - 43.
Harris NS ,Johnson AS ,Huang YA ,et al . Vital signs: status of human immunodeficiency virus testing, viral suppression, and HIV preexposure prophylaxis - United States, 2013-2018. MMWR Morb Mortal Wkly Rep. 2019;68:1117-1123. [PMID:31805031 ] doi:10.15585/mmwr.mm6848e1 CrossrefMedlineGoogle Scholar - 44.
Finlayson T ,Cha S ,Xia M ,et al ;National HIV Behavioral Surveillance Study Group . Changes in HIV preexposure prophylaxis awareness and use among men who have sex with men - 20 urban areas, 2014 and 2017. MMWR Morb Mortal Wkly Rep. 2019;68:597-603. [PMID:31298662 ] doi:10.15585/mmwr.mm6827a1 CrossrefMedlineGoogle Scholar - 45.
Furukawa NW ,Zhu W ,Huang YA ,et al . National trends in drug payments for HIV preexposure prophylaxis in the United States, 2014 to 2018: a retrospective cohort study. Ann Intern Med. 2020;173:799-805. [PMID:32894696 ] doi:10.7326/M20-0786 LinkGoogle Scholar - 46.
McManus KA ,Powers S ,Killelea A ,et al . Regional disparities in qualified health plans' prior authorization requirements for HIV pre-exposure prophylaxis in the United States. JAMA Netw Open. 2020;3:e207445. [PMID:32492164 ] doi:10.1001/jamanetworkopen.2020.7445 CrossrefMedlineGoogle Scholar - 47.
Nayak RK ,Avorn J ,Kesselheim AS . Public sector financial support for late stage discovery of new drugs in the United States: cohort study. BMJ. 2019;367:l5766. [PMID:31645328 ] doi:10.1136/bmj.l5766 CrossrefMedlineGoogle Scholar - 48.
Conti RM ,David FS . Public research funding and pharmaceutical prices: do Americans pay twice for drugs. F1000Res. 2020;9:707. [PMID:33204410 ] doi:10.12688/f1000research.24934.1 CrossrefMedlineGoogle Scholar - 49. Canadian Agency for Drugs and Technologies in Health (CADTH). Common drug review: Vocabria (cabotegravir) and Cabenuva (cabotegravir/rilpivirine) injection. The ViiV Healthcare ULC. 2020. Accessed at www.cadth.ca/sites/default/files/cdr/pharmacoeconomic/sr0628-vocabria%2Bcabenuva-pharmacoeconomic-review-report.pdf on 3 March 2021. Google Scholar
- 50.
Jenness SM ,Weiss KM ,Goodreau SM ,et al . Incidence of gonorrhea and chlamydia following human immunodeficiency virus preexposure prophylaxis among men who have sex with men: a modeling study. Clin Infect Dis. 2017;65:712-718. [PMID:28505240 ] doi:10.1093/cid/cix439 CrossrefMedlineGoogle Scholar - 51.
Keen P ,Hammoud MA ,Bourne A ,et al . Use of HIV pre-exposure prophylaxis (PrEP) associated with lower HIV anxiety among gay and bisexual men in Australia who are at high risk of HIV infection: results from the flux study. J Acquir Immune Defic Syndr. 2020;83:119-125. [PMID:31935203 ] doi:10.1097/QAI.0000000000002232 CrossrefMedlineGoogle Scholar - 52. mysexpro. What is Sex Pro? Accessed at https://mysexpro.org/en/home on 3 March 2021. Google Scholar
- 53.
Smith DK ,Van Handel ,Grey J . Estimates of adults with indications for HIV pre-exposure prophylaxis by jurisdiction, transmission risk group, and race/ethnicity, United States, 2015. Ann Epidemiol. 2018;28:850-857.e9. [PMID:29941379 ] doi:10.1016/j.annepidem.2018.05.003 CrossrefMedlineGoogle Scholar - 54.
Weiss KM ,Prasad P ,Ramaraju R ,et al . Estimated number of men who have sex with men with indications for HIV pre-exposure prophylaxis in a national sexual network study. J Acquir Immune Defic Syndr. 2020;84:10-17. [PMID:31939869 ] doi:10.1097/QAI.0000000000002300 CrossrefMedlineGoogle Scholar - 55.
Sullivan PS ,Sanchez TH ,Zlotorzynska M ,et al . National trends in HIV pre-exposure prophylaxis awareness, willingness and use among United States men who have sex with men recruited online, 2013 through 2017. J Int AIDS Soc. 2020;23:e25461. [PMID:32153119 ] doi:10.1002/jia2.25461 CrossrefMedlineGoogle Scholar - 56. Centers for Disease Control and Prevention. HIV Infection Risk, Prevention, and Testing Behaviors Among Men Who Have Sex With Men—National HIV Behavioral Surveillance, 23 U.S. Cities, 2017. HIV Surveillance Special Report 22. February 2019. Accessed at www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-special-report-number-22.pdf on 3 March 2021. Google Scholar
- 57.
Becasen JS ,Denard CL ,Mullins MM ,et al . Estimating the prevalence of HIV and sexual behaviors among the US transgender population: a systematic review and meta-analysis, 2006-2017. Am J Public Health. 2019;109:e1-e8. [PMID:30496000 ] doi:10.2105/AJPH.2018.304727 CrossrefMedlineGoogle Scholar - 58. HIV Medicine Association and Ryan White Medical Providers Coalition. Correspondence on the U.S. Preventative Services Task Force's PrEP recommendation [Letter]. 26 December 2018. Accessed at www.hivma.org/globalassets/hivma/news/uspstf-prep-recommendation-hivma-comments-12-26-18.pdf on 3 March 2021. Google Scholar
- 59.
Neilan AM ,Bangs AC ,Hudgens M ,et al . Modeling adherence interventions among youth with HIV in the United States: clinical and economic projections. AIDS Behav. 2021;25:2973-2984. [PMID:33547993 ] doi:10.1007/s10461-021-03169-0 CrossrefMedlineGoogle Scholar - 60.
Ross EL ,Weinstein MC ,Schackman BR ,et al . The clinical role and cost-effectiveness of long-acting antiretroviral therapy. Clin Infect Dis. 2015;60:1102-10. [PMID:25583979 ] doi:10.1093/cid/ciu1159 CrossrefMedlineGoogle Scholar - 61.
Borre ED ,Hyle EP ,Paltiel AD ,et al . The clinical and economic impact of attaining national HIV/AIDS strategy treatment targets in the United States. J Infect Dis. 2017;216:798-807. [PMID:29029344 ] doi:10.1093/infdis/jix349 CrossrefMedlineGoogle Scholar - 62.
Walensky RP ,Horn T ,McCann NC ,et al . Comparative pricing of branded tenofovir alafenamide-emtricitabine relative to generic tenofovir disoproxil fumarate-emtricitabine for HIV preexposure prophylaxis [Letter]. Ann Intern Med. 2020;173:507-508. [PMID:32926822 ] doi:10.7326/L20-0693 LinkGoogle Scholar - 63.
Yacoub R ,Nadkarni GN ,Weikum D ,et al . Elevations in serum creatinine with tenofovir-based HIV pre-exposure prophylaxis: a meta-analysis of randomized placebo-controlled trials [Letter]. J Acquir Immune Defic Syndr. 2016;71:e115-8. [PMID:26627105 ] doi:10.1097/QAI.0000000000000906 CrossrefMedlineGoogle Scholar - 64.
Gu Q ,Koenig L ,Mather RC ,et al . Surgery for hip fracture yields societal benefits that exceed the direct medical costs. Clin Orthop Relat Res. 2014;472:3536-46. [PMID:25091223 ] doi:10.1007/s11999-014-3820-6 CrossrefMedlineGoogle Scholar - 65. U.S. Renal Data System. 2018 ADR reference tables. Section K: healthcare expenditures for ESRD patients. 2018. Accessed at www.usrds.org/previous-adrs/2010-2019 on 22 October 2021. Google Scholar
- 66.
Wawer MJ ,Gray RH ,Sewankambo NK ,et al . Rates of HIV-1 transmission per coital act, by stage of HIV-1 infection, in Rakai, Uganda. J Infect Dis. 2005;191:1403-9. [PMID:15809897 ] doi:10.1086/429411 CrossrefMedlineGoogle Scholar - 67.
Robb ML ,Eller LA ,Kibuuka H ,et al ;RV 217 Study Team . Prospective study of acute HIV-1 infection in adults in East Africa and Thailand. N Engl J Med. 2016;374:2120-30. [PMID:27192360 ] doi:10.1056/NEJMoa1508952 CrossrefMedlineGoogle Scholar - 68.
Daar ES ,Tierney C ,Fischl MA ,et al ;AIDS Clinical Trials Group Study A5202 Team . Atazanavir plus ritonavir or efavirenz as part of a 3-drug regimen for initial treatment of HIV-1. Ann Intern Med. 2011;154:445-56. [PMID:21320923 ] doi:10.7326/0003-4819-154-7-201104050-00316 LinkGoogle Scholar - 69. National Technical Information Center. Multicenter AIDS Cohort Study (MACS) Public Dataset Release PO4. 2021. Google Scholar
- 70. Masciotra S, Luo W, Smith T, et al. Performance evaluation of the Aptima HIV-1 Quant Assay on the Panther System [Abstract]. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI), Boston, Massachusetts, 4 March 2018. Abstract no. 570. Accessed at www.croiconference.org/abstract/performance-evaluation-aptima-hiv-1-quant-assay-panther-system on 3 March 2021. Google Scholar
- 71.
Chavez P ,Wesolowski L ,Patel P ,et al . Evaluation of the performance of the Abbott ARCHITECT HIV Ag/Ab combo assay. J Clin Virol. 2011;52:S51-5. [PMID:21983253 ] doi:10.1016/j.jcv.2011.09.010 CrossrefMedlineGoogle Scholar - 72.
Nasrullah M ,Wesolowski LG ,Meyer WA ,et al . Performance of a fourth-generation HIV screening assay and an alternative HIV diagnostic testing algorithm. AIDS. 2013;27:731-7. [PMID:23135170 ] doi:10.1097/QAD.0b013e32835bc535 CrossrefMedlineGoogle Scholar - 73.
Gebo KA ,Moore RD ,Fleishman JA . The HIV Research Network: a unique opportunity for real time clinical utilization analysis in HIV. Hopkins HIV Rep. 2003;15:5-6. [PMID:14974424 ] MedlineGoogle Scholar - 74. University HealthSystem Consortium. 2006-2008 Cost Data. Chicago: University HealthSystem Consortium; 2009. Google Scholar
Author, Article, and Disclosure Information
Division of General Academic Pediatrics, Division of Infectious Diseases, and Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, and Harvard Medical School, Boston, Massachusetts (A.M.N.)
UCLA Center for Clinical AIDS Research and Education, Los Angeles, and Division of Infectious Diseases, David Geffen School of Medicine at UCLA, Los Angeles, California (R.J.L.)
Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, Massachusetts (M.H.L., N.W.)
Instituto de Pesquisa Clinica Evandro Chagas, Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, Brazil (B.G.)
Division of Infectious Diseases, Medical Practice Evaluation Center, and Division of General Internal Medicine, Massachusetts General Hospital, Boston, Harvard Medical School, Boston, Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, Boston, and Harvard University Center for AIDS Research, Boston, Massachusetts (K.A.F.)
Science Facilitation, FHI 360, Washington, DC (M.M.)
Division of Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina (M.S.C.)
Division of Infectious Diseases and Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, Harvard Medical School, Boston, and Harvard University Center for AIDS Research, Boston, Massachusetts (A.L.C., E.P.H.)
Division of Infectious Diseases, Louisiana State University Health Sciences Center, New Orleans, Louisiana (M.E.C.)
Medical Practice Evaluation Center and Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital, Boston, and Harvard Medical School, Boston, Massachusetts (K.P.R.)
Yale School of Public Health, New Haven, Connecticut (A.D.P.)
Division of Infectious Diseases, Medical Practice Evaluation Center, and Division of General Internal Medicine, Massachusetts General Hospital, Boston, and Harvard Medical School, Boston, Massachusetts, and Centers for Disease Control and Prevention, Atlanta, Georgia (R.P.W.).
Presented in part as an oral abstract at the 2021 Conference on Retroviruses and Opportunistic Infections, Virtual, 6 March to 10 March 2021. The findings in this manuscript have not otherwise been previously presented.
Disclaimer: The findings, conclusions, and views expressed in this report are those of the author(s) and do not necessarily represent the official position of the Centers for Disease Control and Prevention/the Agency for Toxic Substances and Disease Registry, the U.S. Department of Health and Human Services, or the United States.
Acknowledgment: The authors acknowledge Mr. Tim Horn of the National Alliance of State and Territorial AIDS Directors (NASTAD) for his insights related to drug costs. They also thank Mr. Christopher Panella, who assisted with programming; Dr. Fatma Shebl, who reviewed select data derivations; and Ms. Justine Scott, Ms. Guner Ege Eskibozkurt, and Ms. Stephanie Horsfall, who assisted in preparing the manuscript for submission; as well as the Cost-Effectiveness of Preventing AIDS Complications research team in the Medical Practice Evaluation Center at Massachusetts General Hospital for providing feedback on study design and interpretation. Mr. Horn did not receive compensation for his support. Mr. Panella, Dr. Shebl, Ms. Scott, Ms. Eskibozkurt, and Ms. Horsfall contributed as part of their institutional roles.
Grant Support: By grant UM1AI068619 from FHI 360 (Drs. Freedberg and Walensky) and additional support by grant K08 HD094638 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (Dr. Neilan), grants R01 AI093269 (Drs. Walensky and Reddy) and K23 AI137121 (Dr. Clement) from the National Institute of Allergy and Infectious Diseases, grant K01 HL123349 (Dr. Hyle) from the National Heart, Lung, and Blood Institute, grant R37 DA015612 (Dr. Paltiel) from the National Institute on Drug Abuse, the Jerome and Celia Reich HIV Scholar Award (Dr. Hyle), and the Steve and Deborah Gorlin MGH Research Scholars Award (Dr. Walensky).
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M21-1548.
Reproducible Research Statement: Study protocol and statistical code: Not applicable. Model specifications are available at https://mpec.massgeneral.org/cepac-model. Data set: Available at https://giveprepashot.org/may-2020-dsmb-result.
Corresponding Author: Anne M. Neilan, MD, MPH, Medical Practice Evaluation Center, Massachusetts General Hospital, 100 Cambridge Street, Suite 1600, Boston, MA 02114; e-mail, [email protected]
Author Contributions: Conception and design: M.S. Cohen, M.H. Le, A.M. Neilan.
Analysis and interpretation of the data: A.L. Ciaranello, K.A. Freedberg, E.P. Hyle, R.J. Landovitz, M.H. Le, M. McCauley, A.M. Neilan, K.P. Reddy, N. Wattananimitgul.
Drafting of the article: M.H. Le, M. McCauley, A.M. Neilan, N. Wattananimitgul.
Critical revision of the article for important intellectual content: A.L. Ciaranello, M.E. Clement, K.A. Freedberg, B. Grinsztejn, E.P. Hyle, R.J. Landovitz, M.H. Le, A.M. Neilan, A.D. Paltiel, K.P. Reddy, N. Wattananimitgul.
Final approval of the article: A. Ciaranello, M.E. Clement, M.S. Cohen, K.A. Freedberg, B. Grinsztejn, E.P. Hyle, R.J. Landovitz, M.H. Le, M. McCauley, A.M. Neilan, A.D. Paltiel, K.P. Reddy, R.P. Walensky, N. Wattananimitgul.
Provision of study materials or patients: B. Grinsztejn, R.J. Landovitz.
Statistical expertise: A.L. Ciaranello.
Obtaining of funding: M.S. Cohen, K.A. Freedberg, R.J. Landovitz, A.D. Paltiel, K.P. Reddy.
Administrative, technical, or logistic support: M.H. Le, M. McCauley, A.M. Neilan, N. Wattananimitgul.
Collection and assembly of data: M.E. Clement, R.J. Landovitz, A.M. Neilan, N. Wattananimitgul.
This article was published at Annals.org on 1 February 2022.
Submit a Comment
Contributors must reveal any conflict of interest. Comments are moderated. Please see our information for authorsregarding comments on an Annals publication.
*All comments submitted after October 1, 2021 and selected for publication will be published online only.