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Primary Care
CMECNE

CDC Guidelines on Daily Oral Antiretroviral Preexposure Prophylaxis to Prevent HIV in Those at High Risk

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Learning Objectives and CME/Disclosure Information

This activity is intended for healthcare providers delivering care to women and their families.

After completing this activity, the participant should be better able to:

1. List the recommended clinical tests that should be ordered and reviewed before prescribing PrEP in an HIV-negative individual
2. Discuss who is eligible for PrEP

Estimated time to complete activity: 0.25 hours

Faculty:

Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.

Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.

Method of Participation and Request for Credit

Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from July 6 2018 through July 6 2021, participants must read the learning objectives and faculty disclosures and study the educational activity.

If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.

For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.

Joint Accreditation Statement

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Physician Continuing Medical Education

Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Continuing Nursing Education

The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.

Designated for 0.2 contact hours of pharmacotherapy credit for Advance Practice Registered Nurses.

Read Disclaimer & Fine Print

SUMMARY:

Currently, there are two approved daily oral antiretroviral preexposure prophylaxis (PrEP) medications. The CDC has published guidelines on the use of PrEP – a powerful pharmacologic approach to reduce HIV risk in those at high risk. PrEP should be offered to adults and adolescents who weigh at least 35 kg (77 lb) and meet ‘at risk’ criteria (see below).

USPSTF Guidance (June 2019)

The USPSTF recommends offering PrEP to persons at high risk of HIV acquisition. This recommendation is Grade A, which means that PrEP should be offered or provided in the appropriate clinical settings (see below). In addition, the USPSTF document states that while associated with “small harms” (e.g., kidney and GI events), overall

The USPSTF found convincing evidence that PrEP is of substantial benefit for decreasing the risk of HIV infection in persons at high risk of HIV infection, either via sexual acquisition or through injection drug use. The USPSTF also found convincing evidence that adherence to PrEP is highly correlated with its efficacy in preventing the acquisition of HIV infection.

What is PrEP

  • Emtricitabine (F) 200 mg and tenofovir disoproxil fumarate (TDF) 300 mg (F/TDF) tablet taken daily
  • Emtricitabine (F) 200 mg tenofovir alafenamide  (TAF) 25 mg tablet (F/TAF) taken daily
    • F/TDF is recommended to prevent HIV infection among all persons at risk through sex or injection drug use
    • F/TAF is recommended to prevent HIV infection among persons at risk through sex, excluding people at risk through receptive vaginal sex because due to lack of studies for this indication
  • Offer to those who are HIV-negative and at substantial risk for HIV
  • Effectiveness estimates
    • Sexual transmission route: approximately 99% effective
    • Injection drug use: 74 to 84% effective (based on tenofovir alone and may be higher with combination pill)
    • Effectiveness strongly related to adherence to PrEP

Clinical Actions

  • Clinical eligibility
    • Receive HIV testing to confirm negative status before starting PrEP
    • No signs/symptoms of acute HIV infection
    • Normal renal function
    • No contraindication to medications
    • Documented hepatitis B virus infection and vaccination status | Hepatitis B is not a contraindication but discontinuation of emtricitabine and tenofovir can result in rebound hepatitis and therefore patient must be monitored careful if PrEP is stopped
    • Document pregnancy intention
    • Screen/treat STDs
  • Recommend regular monitoring of HIV infection status, side effects, adherence, and sexual or injection risk behaviors
  • Reinforce the importance of adherence and HIV risk reduction, including encouraging condom use for additional protection
  • Patients on PrEP should return to their health care provider every 3 months for a repeat HIV test and
    • Write a prescription refill if appropriate
    • Offer counseling about medication adherence and risk reduction
    • Test for STDs
    • Test for pregnancy
    • Assess side effects, if necessary
  • At 3 months and every 6 months after, assess renal function using Cockcroft-Gault formula
    • F/TDF: Approved for use in persons with a eCrCl >60 ml/min
    • F/TAF: Approved for use in persons with eCrCl ≥30 ml/min
  • Every 6 months test for bacterial STDs
  • Stop PrEP if
    • Patient requests to stop
      • Counsel regarding other preventative measures
    • Patient now HIV positive (manage and refer)

Dosage Regimen

  • Daily, continuing, oral doses of TDF/FTC (Truvada), ≤90 day supply
  • Side Effects in clinical trials
    • Early side effects: Upset stomach or loss of appetite that were mild and usually went away within the first month
    • Some people experienced mild headache
    • No serious side effects were seen in trials, however
      • The medication may impair renal function and therefore renal function studies are required on follow up
      • Liver function can be adversely affected and patients should report symptoms (e.g. tea colored urine, light colored stool etc.)

KEY POINTS:

Who Should be Offered PrEP?

  • Sexually active gay and bisexual men without HIV
  • Sexually active heterosexual men and women without HIV
  • Sexually active transgender persons without HIV
  • Persons without HIV who inject drugs
  • Persons who have been prescribed non-occupational post-exposure prophylaxis (PEP) and report continued risk behavior, or who have used multiple courses of PEP

Definitions

  • Sexually-Active Adults and Adolescents
    • Anal or vaginal sex in the past 6 months and
      • HIV-positive sexual partner (especially if partner has unknown or detectable viral load) or
      • Recent (past 6 months) bacterial STI or
      • History of inconsistent or no condom use with sexual partner(s)
  • Persons Who Inject Drugs
    • HIV-positive injecting partner or
    • Shares drug preparation or injection equipment
  • Note: The USPSTF states that “It is important to note that men who have sex with men and heterosexually active persons are not considered to be at high risk if they are in a mutually monogamous relationship with a partner who has recently tested negative for HIV”

HIV-discordant Couples and Pregnancy

  • Conception and pregnancy
    • PrEP is one of several options to protect the partner who is HIV-negative (see related ‘ObG Topics, below) in a couple considering pregnancy
    • Data on use of the PrEP medication has not shown increased risk of birth defects nor risk to breastfeeding children

 Breastfeeding

  • The CDC states that “F/TDF as PrEP is considered generally safe for pregnant and breastfeeding women”
  • For F/TDF, the FDA label states

The developmental and health benefits of breastfeeding and the mother’s clinical need for TRUVADA for HIV-1 PrEP should be considered along with any potential adverse effects on the breastfed child from TRUVADA and the risk of HIV-1 acquisition due to nonadherence and subsequent mother to child transmission

Women should not breastfeed if acute HIV-1 infection is suspected because of the risk of HIV-1 transmission to the infant.

PrEP vs PEP

  • PrEP is only for people who are at ongoing substantial risk of HIV infection
  • For a single high-risk event of potential HIV exposure (e.g., unprotected sex, needle-sharing injection drug use, or sexual assault—use postexposure prophylaxis (PEP) option , or PEP within 72 hours of exposure (see ‘Learn More – Primary Sources’ below)

Learn More – Primary Sources:

CDC: Pre-Exposure Prophylaxis (PrEP)

NIH: Pre-Exposure Prophylaxis (PrEP)

Preexposure Prophylaxis for the Prevention of HIV Infection: US Preventive Services Task Force Recommendation Statement (JAMA) 

USPSTF: Prevention of Human Immunodeficiency Virus (HIV) Infection: Pre-Exposure Prophylaxis (USPSTF)

ACOG Committee Opinion 595: Preexposure Prophylaxis for the Prevention of Human Immunodeficiency Virus

CDC PEP Guidelines

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Related ObG Topics:

Screening & Treatment of Gynecologic infections in the HIV-Positive Woman
Cervical Cytology and HPV Screening in the HIV Positive Woman
CDC Recommends Conception Strategies When an Uninfected Woman’s Male Partner is HIV Positive
Optimizing Contraception for the HIV-positive Woman
Does Amniocentesis or CVS Increase the risk of HIV Vertical Transmission?

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This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

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