SUMMARY:

In May 2018, the FDA approved daily oral antiretroviral preexposure prophylaxis (PrEP) with Truvada (tenofovir plus emtricitabine) for adolescents and adults who weigh at least 35 kg (77 lbs). The CDC has published guidelines on the use of PrEP – a powerful tool to reduce HIV risk in those at high risk.

USPSTF Guidance (June 2019)

The USPSTF recommends offering PrEP with effective antiretroviral therapy 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

• PrEP: Tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg (TDF/FTC) tablet taken daily
  • Offer to those who are HIV-negative and at substantial risk for HIV
  • One pill per day is 92% effective at preventing HIV in those at high risk
  • Use of condoms offers even more protection

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 (manage appropriately)
  • 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
  • Assess side effects, if necessary
• At 3 months and every 6 months after, assess renal function
• 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:

Sexual Transmission Risk

Anyone who recently tested HIV-negative is not in a mutually monogamous (no outside partner) relationship with a partner and

• Gay or bisexual man who
  • Has a sexual partner with HIV
  • Recent (past 6 months) bacterial STD
  • High number of sex partners
  • History of inconsistent or no condom use, especially anal sex
  • Commercial sex work
• Heterosexual man or woman who
  • Has a sexual partner with HIV
  • Had a recent bacterial STD
  • Had a high number of sex partners
  • Has a history of inconsistent or no condom use, especially partners of unknown HIV status who are at substantial risk of HIV infection (e.g., people who inject drugs or have bisexual male partners)
  • Has a history of commercial sex work
  • Lives in a high-prevalence area or network
• Note: The USPSTF also cautions that “Transgender women and men who are sexually active may be at increased risk of HIV acquisition and should be considered for PrEP based on the criteria outlined above. Transgender women are at especially high risk of HIV acquisition.”

HIV-discordant couples

• One sexual partner is HIV-positive and the other is HIV-negative especially when HIV-positive partner
  • Is not taking antiretroviral medications or
  • Does not have an undetectable viral load
• CONCEPTION & PREGNANCY
  • 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
  • For PrEP, 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.

Illicit Drug Injection

• Those who have injected illicit drugs in the past 6 months and
  • Have shared injection equipment or
  • Been in drug treatment for injection drug use in the past 6 months

Note: 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)

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 Provider Information Sheet – PrEP During Conception, Pregnancy, and Breastfeeding

CDC PEP Guidelines

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?