Article Figures & Data
Tables
- 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.
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 thereafter6,34 HBV, hepatitis B virus; PrEP, 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.
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
PrEP, preexposure prophylaxis.
- 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 PrEP, preexposure prophylaxis; DAP, drug assistance program.
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 MSM, men who have sex with men; PEP, postexposure prophylaxis; PrEP, preexposure prophylaxis.