Getting PrEP to the patients who need it

,; ,; ,

doi:doi: 10.12788/jfp.0686

Applied Evidence

Getting PrEP to the patients who need it

J Fam Pract. 2023 November;72(9):E1-E7 | doi: 10.12788/jfp.0686

PDF Download

References

1. CDC. Estimated HIV incidence and prevalence in the United States 2017–2021. HIV Surveill Supplemental Rep. 2023;28. Accessed October 23, 2023. https://www.cdc.gov/hiv/library/reports/hiv-surveillance/vol-28-no-3/index.html

2. CDC. Core indicators for monitoring the Ending the HIV Epidemic initiative (preliminary data): National HIV Surveillance System data reported through March 2023; and preexposure prophylaxis (PrEP) data reported through December 2022. HIV Surveill Data Tables. 2023;4. Published June 2023. Accessed October 23, 2023. https://www.cdc.gov/hiv/library/reports/surveillance-data-tables/

3. CDC. Division of HIV Prevention, National Center for HIV, Viral Hepatitis, STD, and TB Prevention. PrEP effectiveness. Updated June 2022. Accessed October 23, 2023. https://www.cdc.gov/hiv/basics/prep/prep-effectiveness.html

4. US Preventive Services Task Force. Prevention of acquisition of HIV: preexposure prophylaxis. Final recommendation statement. August 22, 2023. Accessed October 23, 2023. https://uspreventiveservicestaskforce.org/uspstf/recommendation/prevention-of-human-immunodeficiency-virus-hiv-infection-pre-exposure-prophylaxis

5. CDC. Preexposure prophylaxis for the prevention of HIV infection in the United States—2021 update: a clinical practice guideline. Accessed October 23, 2023. www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf

6. Mugwanya KK, Wyatt C, Celum C, et al. Changes in glomerular kidney function among HIV-1-uninfected men and women receiving emtricitabine-tenofovir disoproxil fumarate preexposure prophylaxis: a randomized clinical trial. JAMA Intern Med. 2015;175:246-254. doi: 10.1001/jamainternmed.2014.6786

7. Havens PL, Stephensen CB, Van Loan MD, et al. Decline in bone mass with tenofovir disoproxil fumarate/emtricitabine is associated with hormonal changes in the absence of renal impairment when used by HIV-uninfected adolescent boys and young men for HIV preexposure prophylaxis. Clin Infect Dis. 2017;64:317-325. doi: 10.1093/cid/ciw765

8. Pilkington V, Hill A, Hughes S, et al. How safe is TDF/FTC as PrEP? A systematic review and meta-analysis of the risk of adverse events in 13 randomised trials of PrEP. J Virus Erad. 2018;4:215-224.

9. 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. doi: 10.1016/S0140-6736(20)31065-5

10. Liegeon G, Ghosn, J. Long-acting injectable cabotegravir for PrEP: a game-changer in HIV prevention. HIV Med. 2022;24:653-663. doi: 10.1111/hiv.13451

11. Molina JM, Capitant C, Spire B, et al. On-demand preexposure prophylaxis in men at high risk for HIV-1 infection. N Engl J Med. 2015;373:2237-2246. doi: 10.1056/NEJMoa1506273

12. Molina JM, Ghosn J, Assoumou L, et al. Daily and on-demand HIV pre-exposure prophylaxis with emtricitabine and tenofovir disoproxil (ANRS PREVENIR): a prospective observational cohort study. Lancet HIV. 2022;9:e554-e562. doi: 10.1016/S2352-3018(22)00133-3

13. Dimitrov D, Moore JR, Wood D, et al. Predicted effectiveness of daily and nondaily preexposure prophylaxis for men who have sex with men based on sex and pill-taking patterns from the Human Immuno Virus Prevention Trials Network 067/ADAPT Study. Clin Infect Dis. 2020;71:249-255. doi: 10.1093/cid/ciz799

14. Saag MS, Gandhi RT, Hoy JF, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2020 recommendations of the International Antiviral Society-USA Panel. JAMA. 2020;324:1651-1669. doi: 10.1001/jama.2020.17025

15. Havens PL, Perumean-Chaney SE, Patki A, et al. Changes in bone mass after discontinuation of preexposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine in young men who have sex with men: extension phase results of Adolescent Trials Network Protocols 110 and 113. Clin Infect Dis. 2020;70:687-691. doi: 10.1093/cid/ciz486

16. Neilan AM, Salvant Valentine S, Knopf AS. Case 27-2021: a 16-year-old boy seeking human immunodeficiency virus prophylaxis. N Engl J Med. 2021;385:1034-1041. doi: 10.1056/NEJMcpc1909626

17. Thomson KA, Hughes J, Baeten JM, et al. Increased risk of HIV acquisition among women throughout pregnancy and during the postpartum period: a prospective per-coital-act analysis among women with HIV-infected partners. J Infect Dis. 2018;218:16-25. doi: 10.1093/infdis/jiy113

18. Dettinger JC, Kinuthia J, Pintye J, et al. Perinatal outcomes following maternal pre-exposure prophylaxis (PrEP) use during pregnancy: results from a large PrEP implementation program in Kenya. J Int AIDS Soc. 2019;22:e25378. doi: 10.1002/jia2.25378

19. Moodley D, Lombard C, Govender V, et al. Pregnancy and neonatal safety outcomes of timing of initiation of daily oral tenofovir disoproxil fumarate and emtricitabine pre-exposure prophylaxis for HIV prevention (CAP016): an open-label, randomised, non-inferiority trial. Lancet HIV. 2023;10:e154-e163. doi: 10.1016/S2352-3018(22)00369-1

20. CDC. HIV Infection, Risk, Prevention, and Testing Behaviors Among Transgender Women—National HIV Behavioral Surveillance, 7 U.S. Cities, 2019–2020. HIV Surveillance Special Report 27. April 2021. Accessed October 23, 2023. www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-special-report-number-27.pdf

21. Wilson EC, Turner CM, Arayasirikul S, et al. Disparities in the PrEP continuum for trans women compared to MSM in San Francisco, California: results from population-based cross-sectional behavioural surveillance studies. J Int AIDS Soc. 2020;23:e25539. doi: 10.1002/jia2.25539

22. Poteat T, Wirtz A, Malik M, et al. A gap between willingness and uptake: findings from mixed methods research on HIV prevention among Black and Latina transgender women. J Acquir Immune Defic Syndr. 2019;82:131-140. doi: 10.1097/QAI.0000000000002112

23. Cottrell ML, Prince HM, Schauer AP, et al. Decreased tenofovir diphosphate concentrations in a transgender female cohort: implications for human immunodeficiency virus preexposure prophylaxis. Clin Infect Dis. 2019;69:2201-2204. doi: 10.1093/cid/ciz290

24. Hess KL, Hu X, Lansky A, et al. Lifetime risk of a diagnosis of HIV infection in the United States. Ann Epidemiol. 2017;27:238-243. doi: 10.1016/j.annepidem.2017.02.003

25. Kanny D, Jeffries WL 4th, Chapin-Bardales J, et al. Racial/ethnic disparities in HIV preexposure prophylaxis among men who have sex with men—23 urban areas, 2017. MMWR Morb Mortal Wkly Rep. 2019;68:801-806. doi: 10.15585/mmwr.mm6837a2

26. CDC. Core indicators for monitoring the Ending the HIV Epidemic initiative (early release): National HIV Surveillance System data reported through December 2020; and preexposure prophylaxis (PrEP) data reported through September 2020. HIV Surveill Data Tables. 2021;2. Accessed October 23, 2023. www.cdc.gov/hiv/pdf/library/reports/surveillance-data-tables/vol-2-no-2/cdc-hiv-surveillance-tables-vol-2-no-2.pdf

27. CDC. Diagnoses of HIV infection in the United States and dependent areas 2021: special focus profiles. Updated May 23, 2023. Accessed October 23, 2023. www.cdc.gov/hiv/library/reports/hiv-surveillance/vol-34/content/special-focus-profiles.html

28. Walters SM, Frank D, Van Ham B, et al. PrEP care continuum engagement among persons who inject drugs: rural and urban differences in stigma and social infrastructure. AIDS Behav. 2021;26:1308-1320. doi: 10.1007/s10461-021-03488-2

29. Foutz J, Artiga S, Garfield R. The role of Medicaid in rural America [issue brief]. April 25, 2017. Accessed August 16, 2023. www.kff.org/medicaid/issue-brief/the-role-of-medicaid-in-rural-america/

30. Baugher AR, Finlayson T, Lewis R, et al. Health care coverage and preexposure prophylaxis (PrEP) use among men who have sex with men living in 22 US cities with vs without Medicaid expansion, 2017. Am J Public Health. 2021;111:743-751. doi: 10.2105/AJPH.2020.306035

PrEP use in specific populations

Adolescents

Truvada, Descovy, and Apretude all are now approved for use in adolescents weighing ≥ 35 kg. Two important considerations when prescribing to this population are the effects of Truvada on bone health and the unique barriers to access.

In studies of adolescent MSM using Truvada for PrEP, bone mineral density declined, especially among those ages 15 to 19 years.¹⁵ As such, the clinical impact of decreased bone mineral density should be weighed against the risk for HIV acquisition; however, bone mineral density monitoring is not recommended in the current guidelines. CDC guidelines suggest considering Descovy for male adolescents given its potential lower impact on bone mineral density.⁵

Confidentiality and legal issues exist when prescribing PrEP to minors. In terms of parental/guardian involvement, clinicians who are prescribing PrEP for patients younger than 18 years should consult the CDC website for guidance on local and state regulations that govern prescribing and confidentiality (www.cdc.gov/hiv/policies/law/states/minors.html).

CDC guidelines suggest considering Descovy for male adolescents given its potential lower impact on bone mineral density.

Insurance billing statements may lead to inadvertent disclosure of a minor’s decision to take PrEP to their legal guardian.¹⁶ Generic Truvada costs less than $100 for a 3-month supply when using goodrx.com, which may offer an alternative to insurance for medication payment.

Peripartum patients

The increased risk for HIV acquisition in the peripartum period for female patients is well documented.¹⁷ Guidelines recommend offering PrEP with Truvada to female patients at risk for conception, currently pregnant, or breastfeeding when that patient’s partner has HIV and the partner’s viral load is unknown or detectable. Descovy is not recommended for pregnant or breastfeeding patients.⁵Cabotegravir-containing regimens (Apretude) have not been approved by the FDA for pregnant or breastfeeding patients.⁵

Continue to: Data on the impact of...