Preexposure Prophylaxis (PrEP) for HIV Prevention: The Primary Care Perspective

Article Figures & Data

Table 1. Indications for the Use of Preexposure Prophylaxis Among Adult Patients with No Acute or Established HIV Infection

MSM and transgender females	Any male sex partner in the past 6 months AND
	not in a monogamous relationship with a recently tested HIV-negative partner AND
	one of the following: any anal sex without condoms (receptive or insertive) in the past 6 months OR any STI reported or diagnosed in the past 6 months OR is in an ongoing relationship with an HIV-positive man
Patients who inject drugs	Any injection of drugs (not prescribed) in the past 6 months AND
	one of the following: any sharing of drug injection or preparation equipment in the past 6 months OR treated in a methadone, buprenorphine, or suboxone program in the past 6 months OR meets sexual risk criteria described above or below
Heterosexual men and women	Any sex with opposite-sex partners in the past 6 months AND
	not in a monogamous relationship with a recently tested HIV-negative partner AND
	one of the following: is a man who has sex with both men and women^* OR uses condoms infrequently with a partner known to be bisexual or use IV drugs OR is in an ongoing relationship with an HIV-positive partner

From ref. 6.
↵* That is, who is behaviorally bisexual; please also see the criteria for men who have sex with men (MSM).
IV, intravenous; STI, sexually transmitted infection.

Table 2. Laboratory Evaluation and Monitoring for Use of Preexposure Prophylaxis

What to Assess	How to Assess	When to Assess
HIV serostatus	Antibody (serum or point-of-care) or nucleic acid testing³⁷	No more than 7 days before starting PrEP and every 3 months thereafter⁶
HBV serostatus	HBsAb, HBsAg, HBcAb	Before starting PrEP,⁶ and can be considered thereafter, depending on behavioral risks or potential exposures
Renal function	Creatinine clearance	Before starting PrEP, at 3 months, and every 3–6 months thereafter, depending on baseline function⁶
Pregnancy	Qualitative pregnancy test	Before starting PrEP and every 3 months thereafter^6,34

Table 3. Patient Assessments and Counseling Topics for Use of Preexposure Prophylaxis

Screening/Counseling	Rationale
Behavioral risk reduction	Effective use of PrEP depends on synergy with motivational interviewing or multifaceted interventions to reduce high-risk sexual practices and/or injection drug use.³⁸
STI screening	Activities that increase risk for HIV also increase risk for other STIs, and screening for STI symptoms may be appropriate.⁶
Pregnancy intent and contraception	While PrEP is FDA approved for use during pregnancy and is potentially a valuable tool in preventing transmission during that time, the safety of PrEP for the developing fetus is not well studied; this should be discussed with any patient hoping to conceive.^6,34
Alcohol and drug abuse (including inhaled stimulants and amyl nitrate)	These may increase risk of renal and hepatic side effects and decrease adherence to the PrEP regimen.⁶
Use of renally cleared medications	TDF/FTC is renally cleared, and drug concentrations will be higher when used with other renally cleared medications, including acyclovir and other antiretrovirals.³⁹
Risk for bone loss (including possible measurement of bone density)	Bone loss without fracture was noted in some studies.^7,9

FDA, US Food and Drug Administration; PrEP, preexposure prophylaxis; STI, sexually transmitted infection; TDF/FTC, tenofovir/emtricitabine.

Table 4. Side Effects of Tenofovir/Emtricitabine^{7–11,21,22,39,42–45}

When studied as PrEP	Abdominal pain Nausea Weight loss Headache Dizziness Back pain Bone loss without associated fracture risk Elevated creatinine
When studied as part of a multidrug HIV treatment regimen	Lactic acidosis Severe hepatomegaly with steatosis Posttreatment exacerbation of hepatitis B New or worsening renal failure Decreased serum phosphorus Bone loss without associated fracture risk

Table 5. Patient Assistance Programs for Those without Insurance Coverage or with Other Barriers to Access to Preexposure Prophylaxis

Name	Organization	Description	URL
Gilead U.S. Advancing Access Program	Gilead Sciences, Inc.	Manufacturer's patient assistance program for those with no or incomplete insurance coverage	http://www.truvada.com/truvada-patient-assistance
PrEP DAP	Washington State Department of Health	Drug assistance program for Washington state residents who are eligible for PrEP	http://www.doh.wa.gov/YouandYourFamily/IllnessandDisease/HIVAIDS/HIVCareClientServices/PrEPDAP
NYC Patient Assistance Program	New York City Department of Health and Mental Hygiene	Patient assistance program to help uninsured patients in New York City pay for PrEP	http://www.nyc.gov/html/doh/html/living/prep-pep-resources.shtml
Fact sheet: Pharmaceutical Company Patient Assistance Programs and Co-Payment Assistance Programs for Pre-exposure Prophylaxis (PrEP) and Post-exposure Prophylaxis (PEP)	National Alliance of State and Territorial AIDS Directors	List of pharmaceutical company patient assistance programs	https://www.nastad.org/sites/default/files/PrEP-and-PEP-PAP-fact-sheet.pdf

Table 6. Resources for Prescribing Preexposure Prophylaxis in a Clinic Setting

Resource	Organization	Description	URL
Preexposure prophylaxis for the prevention of HIV infection—2014: clinical providers' supplement	Centers for Disease Control and Prevention	Patient and provider information sheets related to PrEP, HIV risk index for MSM, coding information, and practice quality measures	http://stacks.cdc.gov/view/cdc/23108
PrEPline	Clinical Consultation Center at the University of California–San Francisco	PrEP support hotline for clinicians available Monday through Friday from 11:00 am to 6:00 pm EST	http://nccc.ucsf.edu/clinician-consultation/prep-pre-exposure-prophylaxis1-855-448-77371-855-HIV-PREP
Truvada checklist for prescribers	Gilead	Checklist for providers before prescribing PrEP	http://start.truvada.com/hcp/truvadaprep-checklist
Guidance for the Use of Pre-Exposure Prophylaxis (PrEP) to Prevent HIV Transmission	New York State Department of Health AIDS Institute	Checklists for clinicians to use before and during PrEP prescription to guide laboratory testing and patient counseling	http://www.hivguidelines.org/clinical-guidelines/pre-exposure-prophylaxis/guidance-for-the-use-of-pre-exposure-prophylaxis-prep-to-prevent-hiv-transmission/
PrEP and PEP pocket card	Florida/Caribbean AIDS Education and Training Center	Pocket card that summarizes important points about the use of PrEP, along with protocols for post-exposure prophylaxis for HIV, hepatitis A, and hepatitis B	http://www.fcaetc.org/files/Pocket_Guides/PrEPPEP.pdf