Understanding PrEP Needs in Women by Integritas Communications

UNDERSTANDING PrEP NEEDS IN WOMEN

HIV Prevention in OB/GYN Practice

Learning Objectives • Demonstrate an understanding of HIV epidemiology among women in the United States • Incorporate HIV risk and PrEP eligibility assessment for all sexually active patients in the OB/GYN setting • Describe key components of PrEP initiation and management for the OB/GYN patient population

HIV Burden Among Women in the United States • 1 in 5 new HIV diagnoses are among women • 84% acquired from heterosexual transmission; 16% IDU1 • Black women in the United States2 – Have 15 times the HIV/AIDS rate compared with white women – Are 15.3 times as likely as white women to die from HIV infection – Are less likely than white women to have acquired HIV through injection drug use3

Burden in Women Seen Across Adulthood

Age at HIV Diagnosis in Women3

Race/Ethnicity of Women With New HIV Diagnoses3

1% 3% 1%

22%

23%

18%

12% 29% 54%

30% 13-24 45-54

25-34 55+

35-44

IDU, injection drug use. 1. CDC. https://www.cdc.gov/hiv/library/reports/hiv-surveillance/vol-34/content/special-focus-profiles.html. Accessed August 20, 2023; 2. US Department of Health and Human Services, Office of Minority Health. HIV/AIDS and African Americans. 2023. https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=21; Accessed August 20, 2023; 3. Kaiser Family Foundation. Black Americans and HIV/AIDS: The Basics. 2020. https://www.kff.org/hivaids/fact-sheet/black-americans-andhivaids-the-basics/. Accessed August 20, 2023.

Women in the South Are Disproportionately Affected In 2020, among individuals newly diagnosed with HIV, 51% of all males and

% of all females

were living in the South.

Midwest

Northeast

South

West

AIDSVu. https://aidsvu.org/resources/deeper-look-south/. Accessed August 20, 2023.

Multiple Factors Concurrently Increase a Woman’s Risk for Acquiring HIV Community Poverty Prevalence, Discrimination, Gender Imbalances, Community Violence, Housing

Network Sex Exchange, Community Social Support, Intimate Partner Violence

MICROSYSTEM

MESOSYSTEM

Dyadic

EXOSYSTEM

A qualitative study of data from the women’s HIV Seroincidence Study (HPTN 064) found that multiple factors contribute to women’s vulnerability to HIV in the US.

Sexual Concurrency, Interpersonal Social Support

Individual

HIV/STI Awareness, Sexual Risk Taking, Substance Use

INTERACTING FACTORS Frew PM, et al. BMC Public Health. 2016;16(1):803.

Having an STI Increases Risk for Acquiring HIV Chlamydia, gonorrhea, and syphilis cases have been increasing for years 2.5 Million New Cases in 2021

Cases, M

Syphilis é 459% Chlamydia é 132% Gonorrhea é 96%

0 2000

2021

• Having an STI such as chlamydia, gonorrhea, and/or syphilis, places people at higher risk for acquiring HIV • The same behaviors and circumstances increase risk for acquiring any STI, including HIV • HIV, substance use, and viral hepatitis affect similar populations as STIs • Opioids and other substance use is linked to increasing STIs and outbreaks of infectious diseases

HIV Is One Part of a Syndemic *Note: 2020 and 2021 data reflect the effect of COVID-19 on STD surveillance trends. CDC. STI Fact Sheet. www.cdc.gov/std/statistics/2021/syndemic-infographic-2023.pdf. Accessed August 9, 2023.

PREEXPOSURE PROPHYLAXIS AS PART OF SEXUAL HEALTH

Importance of Addressing HIV Prevention as Part of Patients’ Sexual Health “Clinicians should initiate a discussion about pre-exposure prophylaxis (PrEP) with ANY sexually active adolescent and adult patient so that it may be considered an option for them.” — Updated 2021 CDC PrEP Guidelines2

• 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.

PrEP Is for Anyone Who… • Has been sexually active in the past 6 months and reports1 – 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.

The Critical Role of Ob/Gyns in HIV Prevention

8 1 out of 5 of new HIV infections in the United States is among women1

However, women make up only 8% of PrEP users2

1. CDC. https://www.cdc.gov/nchhstp/newsroom/fact-sheets/hiv/PrEP-for-hiv-prevention-in-the-US-factsheet.html. Accessed August 30, 2023; 2. AIDSVu. https://aidsvu.org/aidsvu-releases-new-data-highlighting-ongoing-inequities-in-prep-use-among-black-and-hispanic-people-andacross-regions-of-the-county/. Accessed August 30, 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

YES

Unknown or detectable viral load?

Always used condoms?

YES

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

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.

2021 Updated Guidelines Assessing HIV Risk Assess HIV Risk in All PWID Ever injected drugs? YES

Injected in past 6 months?

Prescribe if requested

YES

Shared injection equipment or partner with HIV? YES

Prescribe PrEP

Prescribe if requested

PWID, people who inject drugs. 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.

Expedited Partner Therapy Is… “… treating the sex partners of patients diagnosed with chlamydia or gonorrhea by providing prescriptions or medications to the patient to take to his/her partner without the health care provider first examining the partner.”

CDC. https://www.cdc.gov/std/ept/default.htm. Accessed August 23, 2023.

PrEP CLINICAL ELIGIBILITY AND EVIDENCE

PrEP Includes Both Medication AND Services • 2 FDA-approved medications for PrEP in women – Oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC; Truvada®; available in generic) – Cabotegravir long-acting injectable (CAB LAI; Apretude®)

• Both reduce the risk of sexually acquired HIV • May only be used in persons without HIV • Comprehensive services include – Regular HIV screening – Regular STI screening – Safer sex + risk-reduction counseling • Regular assessment of intimate partner violence (IPV), insurance, housing, etc. FDA, US Food and Drug Administration. 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.

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 • 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; LWH, living with HIV; 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.

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

100

10 0

TDF/ FTC

Overall

Detectable TFV-DP

iPrEx Trial1 (N=2499)

10 0

PWID

90 80

TDF/ FTC

Overall

Detectable TFV-DP

Partners PrEP2 (N=4758 couples)

10 0

TDF/ FTC

Overall

Detectable TFV-DP

Bangkok Tenofovir3 (N=2413)

TFV-DP, tenofovir diphosphate; TGW, transgender women. 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

1.62

0.16

15 Infections

0.3 0.2 0.1 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.

PrEP Efficacy

CAB vs TDF/FTC in Cisgender Women

0.08 0.06 0.04

Participants in the cabotegravir group had an 88% lower risk of HIV infection than those in the TDF/FTC group (HR 0.12; P<0.0001)

0.02

TDF/FTC Cabotegravir

0 0 9 17 25 33 41 49 57 65 73 81 89 97 105 113 121 129 137 145 153

– Both TDF/FTC and cabotegravir were effective, safe, and welltolerated in women – Cabotegravir was superior to TDF/FTC in preventing HIV infection in women

Cumulative HIV Incidence by Study Group

Cumulative Incidence

• The results of the HPTN 084 study showed thata

Time Since Enrollment, Weeks

CAB was statistically superior to TDF/FTC in preventing HIV infection among women. HPTN, HIV Prevention Trials Network; HR, hazard ratio. aN=3224 participants aged 18–45 years who were assigned female sex at birth, and who reported ≥2 episodes of vaginal intercourse in the previous 30 days, were at risk of HIV infection based on an HIV risk score, and agreed to use a long-acting reversible contraceptive method, were randomly assigned 1:1 to active cabotegravir with TDF/FTC placebo (cabotegravir group) or active TDF/FTC with cabotegravir placebo (TDF/FTC group). Delany-Moretlwe S, et al. Lancet. 2022;399(10337):1779-1789.

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

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 CT only 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 (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

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

STI Screen (MSM/TGW)1,a

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

Pregnancy Test (if of childbearing potential)2

Every 6 Mo

Every 12 Mo

When Stopping CAB

CT only

GC/Syphilis only

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 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

Rectal fluid

Unknown

Cervical tissue

Cervicovaginal fluid

Unknown

Penile tissue

Unknown

IDU3

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; 3. CDC. PrEP Effectiveness. https://www.cdc.gov/hiv/basics/prep/prep-effectiveness.html. Accessed August 30, 2023.

Comparing PrEP Options Consider for

TDF/FTC

TAF/FTC

CAB LAI

Renal Function1-4

Bone Mineral Density1,3,4,5

Lipids4-7

Gender-Affirming Hormones4

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

Receptive Vaginal Sex5

On-Demand Use5

Frequency of Dose5

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.

Barriers to PrEP Use in Cisgender Women • Patients may have low perceived risk for HIV1 • Common Concerns2 – Stigma related to using “HIV medicines”— family and friends might suspect they are HIV-positive1 – Expectation of hostile reactions from male partners1 – Bias, stigma, and judgment from providers1 – Clinicians rarely ask about risk behaviors related to HIV acquisition1 – Cost, insurance coverage, and copays1

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!

Turn the conversation to epidemiology: “This is not necessarily about you or your behaviors; this is something that’s out there in the community that you could be exposed to.”1 1. Devarajan S, et al. AIDS Care. 2020;32(3):386-393; 2. Goparaju L. J AIDS Clin Res. 2017;8(9):730; 3. CDC. STI and HIV Infection Risk Assessment. https://www.cdc.gov/std/treatment-guidelines/clinical-risk.htm. Accessed August 30, 2023; 4. National Coalition for Sexual Health. https://nationalcoalitionforsexualhealth.org/tools/for-healthcare-providers/asset/Sexual-Health-Questions-to-Ask-All-Patients.pdf. Accessed August 16, 2023.

Providers Need to Screen For Intimate Partner Violence (IPV), a Barrier to PrEP Use in Women • 1 in 4 women in the United States will experience IPV in their lifetimes – Female survivors of IPV are at higher risk for acquiring HIV than women in nonviolent relationships

• 1 in 2 women with HIV has experienced IPV • PrEP is one part of a comprehensive safety planning strategy for women at increased risk for HIV due to IPV – Many women experiencing IPV may be concerned that violence will escalate if their partners find out they are taking PrEP

• Providers should apply a trauma-informed lens to PrEP initiation and help avoid unintentional disclosure

“If the partner finds out, there will be trouble.” Jeffers NK, et al. AIDS Behav. 2022;26(7):2266-2278.

Use a Trauma-Informed Approach to Care Being trauma-informed is an approach to care and prevention that acknowledges that traumas may have occurred or may even be an active part in a patient’s life, and that those traumas may manifest physically, mentally, and/or behaviorally.1,2 Realize

Recognize

Respond

Realize the widespread impact of trauma and understand paths for recovery

Recognize the signs and symptoms of trauma in patients, families, and staff

Respond by fully integrating knowledge about trauma policies, procedures, and practices

Resist Retraumatization Resist retraumatization of patients and staff

1. Substance Abuse and Mental Health Services Administration (SAMHSA). https://ncsacw.acf.hhs.gov/userfiles/files/SAMHSA_Trauma.pdf. Accessed August 10, 2023; 2. Trauma Informed Care. https://www.traumainformedcare.chcs.org/what-is-trauma-informed-care/. Accessed August 10, 2023.

TDF/FTC PrEP Is Safe During Pregnancy • TDF/FTC PrEP use is not associated with increased risk of adverse outcomes for pregnancy or early infant growth • A study measuring pregnancy outcomes in women not living with HIV showed TDF/FTC PrEP use was not associated with preterm birth or small for gestational age infants Stalter RM, et al. Exp Opin Drug Saf. 2021;20(11):1367-1373.

CAP 016 Study

Safety of TDF/FTC in Pregnant Women • Study: CAP 016, a single-site, open-label, randomized, noninferiority trial in South Africa • Eligibility: Pregnant women aged ≥18 years, not living with HIV, and at 14 to 28 weeks’ gestation at enrollment time • Regimen: 540 pregnant women randomized 1:1 to immediate initiation (n=271) or deferred initiation (n=269) of PrEP until breastfeeding cessation – Immediate PrEP group received a monthly supply of once-daily oral TDF (300 mg) and FTC (200 mg) – Deferred PrEP group received standard of care for HIV prevention

• Primary outcomes: – Occurrence of: Preterm live birth (<37 weeks’ gestational age) and very preterm birth (<34 weeks’ gestational age), determined by menstrual dating – Low birthweight (<2500 g), very low birthweight (<1500 g), stillbirth (≥20 weeks’ gestational age), and small for gestational age (birthweight less than the tenth percentile) – PrEP was not associated with pre-term birth or small for gestational age infants

Data support the use of TDF/FTC for PrEP in pregnancy. CAB use in pregnant women has not been evaluated. Moodley D, et al. Lancet HIV. 2023;10(3):e154-e163.

TDF/FTC May Be Used for PrEP During Breastfeeding A study of 50 breastfeeding women using TDF/FTC for PrEP between 1-24 weeks postpartum (median 13 weeks) showed that1,2 • After 7 days of treatment, tenofovir was undetectable in 94% of infant plasma samples, but FTC was detectable in 96% of infant plasma samples – In these infants, the average FTC plasma concentration was lower than therapeutic doses in infants living with HIV (aged ≤3 months) • Less than 1% of the FTC Cmax observed a therapeutic dose of FTC (3 mg/kg/day)

• There were no serious adverse events. Two infants (4%) experienced mild diarrhea that resolved. Cmax, maximal concentration. 1. Mugwanya KK, et al. PLoS Med. 2016;13(9):e1002132; 2. Drugs@FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021752s061lbl.pdf. Accessed August 30, 2023.

Key Takeaways • Initiate a discussion about PrEP with any sexually active adolescent or adult • PrEP is effective and safe in women, and currently oral TDF/FTC and CAB LAI are approved for use in women • PrEP efficacy depends on adherence • Women who are pregnant or breastfeeding may use PrEP