PrEP For Teens and Young Adults: Are you Doing Your Part to Prevent HIV in Your Patients?

Learning Objectives • Demonstrate an understanding of HIV epidemiology among teens and young adults in the United States • Incorporate HIV risk and PrEP eligibility assessment for all sexually active patients in the pediatric setting • Describe key components of PrEP initiation and management for the adolescent/young adult population

PrEP, preexposure prophylaxis.

HIV BURDEN

HIV Burden Among Adolescents in the United States • Adolescents 13-24 years account for 19% of new HIV infections in the United States1 – 24% among persons with male-to-male sexual contact1

New HIV Diagnoses by Age, 2021

19

%

1/5

In 2021

of all new HIV diagnoses were among youth ages 13-24.

The rate of new HIV diagnoses in Black youth ages 13-24 was 3.9 times greater than the national average

• High rates continue as the Native Hawaiian/Other Pacific…

11.8 result of insufficient sexual American Indian/Alaskan Native 7.7 Asian 3.1 education and health Multiracial 10.6 2 related inequities White 3.5 Hispanic 13 • Black youth continue to Black/African American 46.6 US Overall 11.9 3.9x Greater disproportionately carry 0 10 20 30 40 50 the burden of HIV2 Rate of New Diagnoses, Per 100,000 1. Centers for Disease Control and Prevention (CDC). www.cdc.gov/hiv/library/reports/hiv-surveillance/vol-34/content/special-focusprofiles.html. Accessed May 23, 2023; 2. AIDSVu.org. aidsvu.org/national-youth-hiv-aids-awareness-day-2023. Accessed August 4, 2023.

Importance of Addressing HIV Prevention as Part of Patients’ Sexual Health “Clinicians should initiate a discussion about preexposure prophylaxis (PrEP) with ANY sexually active adolescent and adult patient so that it may be considered an option for them.”

— Updated 2021 CDC PrEP Guidelines1

• PrEP is medication used for HIV prevention; it also includes services (eg, HIV testing, education, linkage) that help prevent HIV1,2 • According to the CDC1,2 – Everyone between the ages of 13 and 64 years should be tested for HIV at least once as part of routine health care – When taken as prescribed, PrEP reduces the risk of acquiring HIV from sex by about 99% 1. CDC. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2021 Update. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf. Accessed August 20, 2023; 2. CDC. https://www.cdc.gov/hiv/basics/prep/about-prep.html. Accessed August 20, 2023.

Routine HIV Screening The American Academy of Pediatrics recommends routine HIV screening for all youth 15 years or older, at least once, in health care settings.

Hsu KK, Rakhmanina NY. Pediatrics. 2022;149(1):e2021055207.

Importance of Pediatricians and Addressing HIV Risk • Many patients continue to present to pediatricians well after age 18 years; some well into their twenties1 • Low HIV testing, high STI rates, and low HIV prevention use contribute to high HIV rates2,3 – Despite 37% of high school students reporting being sexually active by the 12th grade, only 13% reported having ever been tested for HIV3 – Adolescents and adults younger than 24 years old account for 50% of all STIs, and rates are increasing4 STI, sexually transmitted infection.

1. Hardin AP, et al. Pediatrics. 2017;140(3):e20172151; 2. CDC. www.cdc.gov/std/statistics/2021/syndemic-infographic-2023.pdf. Accessed May 9, 2023; 3. Hsu KK, Rakhmanina NY. Pediatrics. 2022;149(1):e2021055207; 4. CDC. www.cdc.gov/std/life-stages-populations/adolescentsyoungadults.htm. Accessed August 4, 2023.

Low PrEP Uptake • In 2021, PrEP uptake was only 20% among all 16- to 24-year-olds who could benefit from it1 • Only 37% of clinicians who treat adolescents are somewhat/very familiar with PrEP2

PrEP Uptake1 Prescribed PrEP 20%

Eligible, not on PrEP 80%

1. CDC. www.cdc.gov/media/releases/2023/p0523-hiv-declines-among-young-people.html. Accessed June 6, 2023; 2. Hosek S, Henry-Reid L. Pediatrics. 2020;145(1):e20191743.

PREEXPOSURE PROPHYLAXIS AS PART OF SEXUAL HEALTH IN PEDIATRIC CARE

PrEP Is for Anyone Who… • Has been sexually active in the past 6 months and has1 – Inconsistent or no condom use – A sexual partner with HIV, with unknown or detectable viral load – An STI diagnosis in the past 6 months

• Injects drugs or has a partner who injects drugs1,2,3

1. CDC. Deciding to Take PrEP. https://www.cdc.gov/hiv/basics/prep/prep-decision.html. Accessed August 30, 2023; 2. Stewart J, Stekler JD. J Fam Pract. 2019;68(5):254-261; 3. CDC. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2021 Update. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf. Accessed August 30, 2023.

Having Conversations About Sexual Health • Adolescents may be more willing to discuss sensitive topics if pediatricians1: – Establish confidentiality and privacy – Use screening questionnaires – Increase time spent discussing sexual health

• The American Academy of Pediatrics provides the Bright Futures Adolescence Tools for screening questionnaires about sensitive topics for parents and adolescents1,2

CDC’s “5 Ps” of Sexual Risk Assessment Partners Practices Past History of STIs Protection from STIs Pregnancy Plans3 Don’t forget the 6th “P”4: Plus=Pleasure, Problems, and Pride!

www.aap.org/en/practice-management/bright-futures/bright-futures-materials-andtools/bright-futures-tool-and-resource-kit/bright-futures-adolescence-tools/2 1. Hsu KK, Rakhmanina NY. Pediatrics. 2022;149(1):e2021055207; 2. American Academy of Pediatrics. www.aap.org/en/practicemanagement/bright-futures/bright-futures-materials-and-tools/bright-futures-tool-and-resource-kit/bright-futures-adolescence-tools/.

Accessed July 23, 2023; 3. CDC. www.cdc.gov/std/treatment-guidelines/clinical-risk.htm. Accessed July 23, 2023; 4. National Coalition for Sexual Health. nationalcoalitionforsexualhealth.org/tools/for-healthcare-providers/asset/Sexual-Health-Questions-to-Ask-All-Patients.pdf.

Accessed July 23, 2023.

2021 Updated Guidelines Assessing HIV Risk Assess HIV Risk in All Sexually Active Adolescents and Adults Anal or vaginal sex in the past 6 months?

YES 1 or more sex partners of unknown HIV status?

Partner with HIV? YES

NO

NO

YES

NO

Unknown or detectable viral load?

Always used condoms?

YES

NO

Prescribe PrEP

NO Discuss PrEP, prescribe if requested

Prescribe PrEP

Had bacterial STI in the past 6 months?

YES Discuss PrEP, prescribe if requested

YES GC or syphilis

NO Extragenital (oral or anal) chlamydia

NO

YES

Discuss PrEP, prescribe if requested

Prescribe PrEP

NO Discuss PrEP, prescribe if requested

GC, gonococcal.

CDC. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2021 Update. https://www.cdc.gov/hiv/pdf/risk/prep/cdchiv-prep-guidelines-2021.pdf. Accessed August 30, 2023.

PrEP CLINICAL ELIGIBILITY AND EVIDENCE

PrEP Includes Both Medication AND Services • 3 FDA-approved medications for PrEP: – Oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC; Truvada®; available in generic) – Oral tenofovir alafenamide/emtricitabine (TAF/FTC; Descovy®) – Cabotegravir long-acting injectable (CAB LAI; Apretude™)

• May only be used in persons without HIV • Comprehensive services include1:

• All are indicated to reduce the risk of sexually acquired HIV1: – TAF/FTC (unlike TDF/FTC and CAB) is not indicated in individuals having receptive vaginal sex

• Only oral TDF/FTC has been shown to prevent HIV from IDU2

– Regular HIV screening – Regular STI screening – Safer sex + risk-reduction counseling 1. CDC. www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf. Accessed March 30, 2023; 2. Biello KB, et al. AIDS Care.

2019;31(10):1214-1220.

Efficacy of TDF/FTC for Oral PrEP

Reduction in HIV Incidence, TDF/FTC vs Placebo, %

100

Cisgender MSM and TGW 92

Heterosexual Cisgender Men and Women 100

90

100

90

90

80

80

70

70

70

60

60

60

50

50

40

40

40

30

30

30

20

20

20

50

10 0

44

TDF/ FTC

TDF/ FTC

Overall

Detectable TFV-DP

iPrEx Trial1 (N=2499)

10 0

PWID

90 80

75

TDF/ FTC

TDF/ FTC

Overall

Detectable TFV-DP

Partners PrEP2 (N=4758 couples)

10 0

70

49

TDF/ FTC

TDF/ FTC

Overall

Detectable TFV-DP

Bangkok Tenofovir3 (N=2413)

TFV-DP, tenofovir diphosphate; MSM, men who have sex with men; TGW, transgender women; PWID, people who inject drugs.

1. Grant RM, et al. N Engl J Med. 2010;363(27):2587-2599; 2. Baeten JM, et al. N Engl J Med. 2012;367(5):399-410; 3. Choopanya K, et al. Lancet.

2013;381(9883):2083-2090.

PrEP Efficacy

TAF/FTC vs TDF/FTC DISCOVER Trial: HIV Incidence Incidence Rate Ratio (95% CI) FAVORS FTC/TDF NI

NI Margin

0.47 0.19

1.15

0.5 0.4

1

1.62

2

0.16

15 Infections

0.3 0.2 0.1 0

0

0.34

0.6

HIV Incidence Rate/100 PY

FAVORS FTC/TAF

HIV Incidence

7 Infections 4386 PY 4370 PY TAF/FTC (n=2670)

TDF/FTC (n=2665)

Daily TAF/FTC was statistically noninferior to daily TDF/FTC for HIV prevention, with TAF/FTC showing more-favorable effects on BMD and biomarkers of renal safety.

BMD, bone mineral density; CI, confidence interval; NI, noninferiority; PY, patient-years.

Double-blind phase 3 noninferiority trial in 94 community, hospital-associated clinics in Europe and North America among cisgender MSM and TGW who have sex with men, randomly assigned 1:1 TAF/FTC or TDF/FTC (both with matched placebo) tablets daily. Efficacy outcome (HIV infection) assessed when all participants had completed 48 weeks of follow-up and half had completed 96 weeks of follow-up.

Mayer KH, et al. Lancet. 2020;396(10246):239-254.

Data That Led to the Approval of TDF/FTC and TAF/FTC for Oral PrEP in Adolescents • Two Adolescent Medicine Trials Network (ATN) open-label studies demonstrated the acceptability and safety of PrEP among young MSM1: – ATN 113, ages 15 – 17 years2 – ATN 110, ages 18 – 24 years3

• Efficacy and safety data to support the FDA approval of TAF/FTC in adolescents was extrapolated from1: – Data from the DISCOVER trial in adult MSM and TGW – Data from trials of TAF/FTC in adolescents with HIV MSM, men who have sex with men; TGW, transgender women.

1. Hsu KK, Rakhmanina NY. Pediatrics. 2022;149(1):e2021055207; 2. Hosek SG, et al. JAMA Pediatr. 2017;171(11):1063-1071; 3. Hosek SG, et al. J Acquir Immune Defic Syndr. 2017;74(1):21-29.

PrEP Efficacy CAB vs TDF/FTC

HPTN 083 Trial Results FAVORS CAB

HIV Incidence

FAVORS TDF/FTC

0.18 0

0.62 0.75

Noninferiority

0.34a

Superiority

NI Margin

1.00

1.23

2.00

HIV Incidence Rate/100 PY

Hazard Ratio (95% CI) 1.8 1.6 1.4 1.2 1 0.8 0.6 0.4 0.2 0

1.22

39 Infections

0.41

100 PY

13 Infections 100 PY

CAB (n=2282)

TDF/FTC (n=2284)

CAB was statistically superior to TDF/FTC in preventing HIV infection among MSM and TGW. aP<0.0001.

HPTN, HIV Prevention Trials Network; IM, intramuscular.

Double-blind, double-dummy, noninferiority trial to compare LAI CAB at 600 mg IM every 8 weeks with daily oral TDF/FTC in cisgender MSM and TGW who have sex with men, over 153 weeks.

Landovitz RJ, et al. N Engl J Med. 2021;385(7):595-608.

PrEP Efficacy Depends on Adherence A systematic review and metaanalysis of oral PrEP effectiveness, safety, adherence, and risk compensation in all populations showed that: • Efficacy is strongly linked to adherence • On average, a 10% decrease in adherence causes a 13% decrease in efficacy

Murchu EO, et al. BMJ Open. 2022;12(5):e048478.

Trial

Author, Year

Partners PrEP

Baeten, 2012

Bangkok Tenofovir Study

Choopanya, 2013

iPrEx

Grant, 2010

VOICE

Mazzarro, 2015

PROUD

McCormack, 2015

IPERGAY

Molina, 2015

FEM-PrEP

Van Damme, 2012

Clinical Eligibility for PrEP

2021 Updated CDC Practice Guidelines The Following Conditions Must Be Met for Daily Oral PrEP Use: • HIV-1/2 Ag/Ab test result within 1 week before initially prescribing PrEP • No signs/symptoms of AHI • eCrCl ≥60 mL/min/1.73 m2 for TDF/FTC; eCrCl ≥30 mL/min/1.73 m2 for TAF/FTC • No contraindicated medications The Following Conditions Must Be Met for PrEP With CAB LAI: • HIV-1/2 Ag/Ab test result within 1 week before initially prescribing PrEP • No signs/symptoms of AHI • No contraindicated medications

AHI, acute HIV infection; eCrCl, estimated creatinine clearance; Ag/Ab, antigen/antibody.

CDC. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2021 Update. https://www.cdc.gov/hiv/pdf/risk/prep/cdchiv-prep-guidelines-2021.pdf. Accessed August 30, 2023.

HIV and STI Testing for PrEP Initiation • Any patient requiring HIV/STI screening should be offered 3-site testing1 • 3-site STI screening for chlamydia and GC1 – Swab oropharynx, rectum, and test urine or vagina (depending on anatomy) • Genital testing with a swab is preferred for patients with a vagina, but urine is acceptable • Patients can self-swab all sites • Chlamydia/GC often missed with urine/genital testing only

• Blood tests – HIV-1/2 Ag/Ab blood test (preferred), HIV-1 RNA assay, or a rapid, point-of-care, FDA-approved, fingerstick Ag/Ab blood test2 – Syphilis serology1 RNA, ribonucleic acid.

1. CDC. PrEP Clinical Practice Guidelines – 2021 Update. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf. Accessed August 30, 2023; 2. Workowski KA, Bolan GA. MMWR Recomm Rep. 2015;64(RR-03):1-137.

PrEP PRESCRIBING AND MONITORING

Lab Testing for Initiating Oral PrEP Test/Screen HIV Assessment • Signs/symptoms AHI • Discuss whether continued need for PrEP; adherence, side effects, etc

HIV Status • HIV-1/2 Ag/Ab test (lab preferred) • HIV RNA assay

Initiation X (HIV-1/2 Ag/Ab test only)

Renal Status • eCrCl ≥60 mL/min/1.73 m2 (TDF/FTC or TAF/FTC) • eCrCl ≥30 mL/min/1.73 m2 (TAF/FTC) If at baseline >50 yo OR eCrCl <90 mL/min/1.73 m2 (TDF/FTC or TAF/FTC)a STI Screen (for anal sex)b STI Screen (for vaginal insertive or receptive sex)b Lipid Screen (only for persons prescribed TAF/FTC) Hepatitis Screens (HBV and HCV serologies; HAV serology for those having anal sex or if at risk)1,2 Pregnancy Test (if of childbearing potential)2

X X X X X X

CT, chlamydia trachomatis; HAV, hepatitis A virus; HBV, hepatitis B virus; HCV, hepatitis C virus; NAAT, nucleic acid amplification test; yo, years old. aIf at baseline ≥50 yo OR eCrCl <90 mL/min/1.73 m2 test every 6 months (TDF/FTC or TAF/FTC); bSyphilis testing; GC and chlamydia NAATs (all potential exposure sites).

1. CDC: https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf. Accessed August 30, 2023; 2. New York State Department of Health (NYSDOH) AIDS Institute: https://www.hivguidelines.org/home/guideline-slides-and-pocket-guides/. Accessed August 30, 2023.

Prescribing Oral PrEP • Once You’ve Taken the Following Steps1 – Identified patient at risk of HIV infection (or a patient expressed interest in starting PrEP) – Confirmed their interest and clinical eligibility – Verified patient weighs ≥35 kg – Obtained negative HIV test result • Confirmed no HIV exposure event within last 4 weeks • No sign/symptoms of acute HIV infection

– Ordered necessary labs

• You may initiate PrEP as long as there is a negative HIV test; you do not need to withhold PrEP until other tests are back

Prescription

Pill Supply

Daily Oral PrEP2

• 1 fixed-dose combination tablet: 300 mg TDF and 200 mg FTC • 90-day supply TDF/FTC OR • 90-day supply TAF/FTC – Not for those having receptive vaginal sex • Optional: Some clinicians prefer to give a 30-day supply at initiation to enable them to check on the patient sooner

1. CDC. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2021 Update. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf. Accessed August 30, 2023; 2. Drugs@FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021752s061lbl.pdf. Accessed August 30, 2023.

Return for Follow-up Schedule follow-up visit for 30 or 90 days (depending on number of pills supplied)

Safety Considerations

TDF/FTC and TAF/FTC Black Box Warnings1,2 Risk of drug resistance with use of TDF/FTC or TAF/FTC for PrEP in patients with undiagnosed early HIV infection • Use of TDF/FTC and TAF/FTC for PrEP is only for HIV-negative individuals

Posttreatment acute exacerbation of HBV infection • Severe acute exacerbations of HBV have been reported in people with HBV who have discontinued TDF/FTC and may occur with TAF/FTC • Hepatic function should be monitored closely in these patients

1. Drugs@FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021752s061lbl.pdf. Accessed August 30, 2023; 2. Drugs@FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208215s012lbl.pdf. Accessed August 30, 2023.

Monitoring for Oral PrEP Test/Screen HIV Assessment

• Signs/symptoms AHI • Discuss whether continued need for PrEP; adherence, side effects, etc

HIV Status

• HIV-1/2 Ag/Ab test (lab preferred) • HIV RNA assay

Every 3 Mo

Every 6 Mo

Every 12 Mo

X

X

X

Xa

X

X X

X CT only X

X

X

X

Renal Status

• eCrCl ≥60 mL/min/1.73 m2 (TDF/FTC or TAF/FTC) • eCrCl ≥30 mL/min/1.73 m2 (TAF/FTC) If at baseline >50 yo OR eCrCl <90 mL/min/1.73 m2 (TDF/FTC or TAF/FTC)a STI Screen (for anal sex)b STI Screen (for vaginal insertive or receptive sex)b Lipid Screen (only for persons prescribed TAF/FTC)

Hepatitis Screens (HBV and HCV serologies; HAV serology for those having anal sex or if at risk)1,2 Pregnancy Test (if of childbearing potential)2

X

X (if not done at initiation) X

aIf at baseline ≥50 yo OR eCrCl <90 mL/min/1.73 m2 test every 6 months (TDF/FTC or TAF/FTC); bSyphilis testing; GC and chlamydia NAATs (all

potential exposure sites).

1. CDC. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2021 Update. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf. Accessed August 30, 2023; 2. NYSDOH AIDS Institute. Clinical Guidelines Program. 2022. https://www.hivguidelines.org/home/guideline-slides-and-pocket-guides/. Accessed August 30, 2023.

Lab Testing and Monitoring for CAB LAI 1 Mo Every Every Initiation Visit 2 Mo 4 Mo

Test/Screen HIV Assessment1 • Signs/symptoms AHI • Discuss whether continued need for PrEP; adherence, side effects, etc

X

HIV Status1 • HIV-1/2 Ag/Ab test (lab preferred) • HIV RNA assay

X

STI Screen (MSM/TGW)1,a

X

STI Screen (heterosexually active men and women)1,a

X

Pregnancy Test (if of childbearing potential)2

X

X

X

Every 6 Mo

Every 12 Mo

When Stopping CAB

X

X

X

X

X

X

X

X

X

X

CT only

GC/Syphilis only

X

GC/Syphilis only

X

X

X

X

X

Unlike for oral PrEP, renal status, lipid panel, hepatitis screens are not required. aSyphilis testing; GC and chlamydia NAATs (all potential exposure sites).

1. CDC. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2021 Update. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf. Accessed August 30, 2023; 2. NYSDOH AIDS Institute. Clinical Guidelines Program. https://www.hivguidelines.org/home/guideline-slides-and-pocket-guides/. Accessed August 30, 2023.

Prescribing CAB LAI Once You’ve Taken the Following Steps1 • Identified patient at risk of HIV infection (or a patient expressed interest in starting PrEP) • Confirmed patient interest and clinical eligibility • Verified patient weighs ≥35 kg • Obtained negative HIV test result – Confirmed no HIV exposure event within last 4 weeks – Patient not part of, or located in, high-incidence population – No sign/symptoms of AHI

• Ordered necessary labs • You may initiate CAB LAI as long as there is a negative HIV test; you do not need to withhold PrEP until other tests are back

Optional oral lead-in2

MONTH 1

MONTH 2

MONTH ≥4

600 mg initiation dose2

600 mg initiation dose2

600 mg maintenance dose every 2 months2

Oral lead-in dosing may be used for 1 month prior to starting injections to determine tolerability for CAB. CAB may be used by those having receptive vaginal sex.1,2 1. CDC. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2021 Update. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf. Accessed August 30, 2023; 2. Drugs@FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215499s000lbl.pdf. Accessed August 30, 2023.

Safety Considerations CAB LAI Warnings

Black Box Warning: Risk of drug resistance with use of CAB LAI (or oral CAB) for PrEP in patients with undiagnosed HIV infection • Use of CAB LAI for PrEP is only for HIV-negative individuals

Warnings/Precautions: Hypersensitivity reactions have been reported in association with other integrase inhibitors, and hepatotoxicity has been reported in patients receiving oral CAB; discontinue CAB LAI if either of these develop • Depressive disorders have been reported with CAB LAI for PrEP; patients with depressive symptoms should be evaluated promptly

Drugs@FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215499s000lbl.pdf. Accessed August 30, 2023.

How Long Until PrEP Works?

Time to Maximum HIV Protection (Tissue Concentration),

by Mode of HIV Exposure Approximate Time to Maximum Protection (days) Tissue/Fluid

Oral PrEP1

CAB LAI PrEP2

Rectal tissue

7

7

Rectal fluid

Unknown

7

Cervical tissue

21

7

Cervicovaginal fluid

Unknown

7

Penile tissue

Unknown

Unknown

1. CDC. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2021 Update. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf. Accessed August 30, 2023; 2. Shaik JS, et al. Br J Clin Pharmacol.

2022;88(4):1667-1678.

Comparing PrEP Options Consider for

TDF/FTC

TAF/FTC

CAB LAI

Renal Function1-4

ü

ü

Bone Mineral Density1,3,4,5

ü

ü

Lipids4-7

ü

Gender-Affirming Hormones4

ü

ü

ü

Diarrhea (6%); nausea (5%)

Diarrhea (5%); nausea (4%)

Injection-site reaction (32%-81%); mostly mild and greatest initially

Other Considerations Side Effects4 Approved to Prevent HIV From IDU5

ü

Receptive Vaginal Sex5

ü

On-Demand Use5

ü

Frequency of Dose5

1 pill daily

ü

1 pill daily

Injection in buttocks every 2 months

1. Drugs@FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021752s061lbl.pdf. Accessed August 30, 2023; 2. Gandhi M, et al. Lancet HIV. 2016;3(11):e521-e528; 3. Drugs@FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s019lbl.pdf. Accessed August 30, 2023; 4. NYSDOH AIDS Institute. Clinical Guidelines Program. https://www.hivguidelines.org/guideline/hivprep/?mytab=tab_7&mycollection=pep-prep. Accessed August 30, 2023; 5. CDC. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2021 Update. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf. Accessed August 30, 2023; 6. Shah S, et al. AIDS. 2021;35(suppl 2):S189-S195; 7. Wood BR, Huhn GD. Open Forum Infect Dis. 2021;8(12):ofab542.

Shared Decision-Making (SDM) in PrEP • SDM is about collaboration – Goal: develop a treatment plan that considers both the patient’s preferences and the clinician’s medical recommendations – Can lead to greater adherence, and improved health outcomes

• SDM can – Reduce stigma by normalizing conversations about HIV prevention – Promote clinicians’ cultural competence and cultural humility – Increase trust in the patient-provider relationship McNulty MC, et al. Cult Health Sex. 2022;24(8):1033-1046.

Resources About Laws Regarding Minors’ Access to STI Services by State • Guttmacher Institute – Minors’ Access to STI Services – https://www.guttmacher.org/state-policy/explore/minorsaccess-sti-services

• Centers for Disease Control and Prevention – State Laws That Address High-Impact HIV Prevention Efforts – https://www.cdc.gov/hiv/policies/law/states/index.html

Key Takeaways • Initiate a discussion about PrEP with any sexually active adolescent or adult • PrEP is effective and safe in adolescents • PrEP efficacy depends on adherence • Laws regarding minors’ access to STI services vary by state