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Pre-Exposure Prophylaxis
Pre-Exposure Prophylaxis for the Prevention of HIV Infection
(PrEP), Non-Occupational
Centers for Disease Control and Prevention (CDC) and Department of Health and Human Services. U.S. Public Health Service. Clinical
Post-Exposure Prophylaxis
Practice Guideline: Pre-Exposure Prophylaxis for the Prevention of HIV Infection in the United States – 2014.
Available at
(nPEP) and Occupational
CDC and DHHS. U.S. Public Health Service. Clinical Providers’ Supplement: Pre-Exposure Prophylaxis for the Prevention of HIV Infection in
PEP (oPEP)
the United States – 2014. Available at Both accessed December 8, 2014.
BEFORE INITIATING PrEP
February 2015
Recommendations for PrEP
Editors:
Jeffrey Beal, MD, AAHIVS
• PrEP is recommended for men who have sex with men (MSM), intravenous drug users (IDUs) and heterosexual adults who do not have acute or established
Lynn Deitrick, RN, PhD
Providing state-of-the-art HIV education, consultation, and resource
HIV infection, but are at high risk for acquiring HIV infection
Jennifer Janelle, MD, AAHIVS
materials to healthcare professionals throughout the region.
• Risks and benefits of PrEP for adolescents should be weighed carefully in the context of local laws and regulations as the data on efficacy and safety of PrEP
Joanne J. Orrick, PharmD, AAHIVP
for adolescents are insufficient
Chart Reviews
Clinical Consultation
• Sexual PrEP Indications (men who have sex with men and/or women, heterosexual men or women, transgender men or women):
Managing Editor:
Kimberly Tucker, MEd
◦ Adult person
F/C AETC - Project ECHO
®
HIV CareLink Newsletter
Layout:
Adrian Green, BS
◦ Without acute or established HIV infection
HIV Updates
Preceptorships
◦ Any sex in past 6 months
◦ Not in a mutually monogamous partnership with a recently tested HIV-negative partner AND ≥ 1 of the following:
This resource summarizes the guidelines for the management of occupational
Treatment Guideline Resources
Web-Based Education
▪ Ongoing sex with HIV-positive partner or
and non-occupational exposures to the human immunodeficiency virus (HIV),
▪ Any STI diagnosed or reported in past 6 months or
hepatitis B (HBV), and hepatitis C (HCV), including recommendations for pre-
▪ High number of different sexual partners or
exposure prophylaxis (PrEP) for the prevention of HIV in men who have sex with
▪ History of inconsistent or no condom use or
men (MSM), injecting drug users (IDUs), and heterosexually active adults at high
▪ Commercial sex work
866.FLC.AETC (866.352.2382)
risk for acquiring HIV. Post-exposure prophylaxis (PEP) is also summarized. This
NOTE: Sexual activity in high HIV prevalence areas may increase risk of HIV acquisition (see
or ).
resource is intended to guide initial decisions about PrEP/PEP and should be
• IDUs indications:
Clinical Consultation Services
used in conjunction with other guidance provided in the full reports. View the full
◦ Risk of sexual acquisition (see above)
reports at websites listed throughout this resource.
◦ Sharing of injection or drug preparation equipment in the past 6 months or in a methadone, buprenorphine, or suboxone tx program in the past 6 months
/consultation
Management of Non-Occupational Exposures
Available to clinicians in Florida, Puerto Rico, and the U.S. Virgin Islands
• Tenofovir/emtricitabine (TDF/FTC, Truvada
®
) is the only agent that is FDA-approved for prevention of HIV via PrEP for all populations at risk listed above.
• Evaluate Exposure - See inside of card
Tenofovir (TDF, Viread
®
) alone is an alternative option for heterosexual or IDU’s but not for MSM, as efficacy has not been studied in the MSM population. See
• Start non-occupational post-exposure prophylaxis (nPEP) when indicated
guidelines for more information.
Online Consultation
• Sexual exposure requires evaluation for sexually transmitted infections (STIs)
Consultation on the diagnosis, prevention, and treatment of HIV/AIDS and
Determine Eligibility
• For IDUs, assess access to clean needles/syringes
related conditions
• Negative HIV antibody test immediately (i.e., within one week) before starting PrEP medication. Anonymous tests, patient-self reported test results or oral
• Women at risk for unintended pregnancy should be offered emergency
rapid tests (less sensitive) should not be used to screen for HIV infection when considering PrEP.
contraception
Resistance Testing Consultation
• HIV viral load if symptoms of acute HIV infection present or if patient (pt) has had at-risk sexual exposure with an HIV-infected person in the last 30 days and/
• Refer as appropriate to counseling for risk-reduction, mental health,
Consultation on the interpretation of resistance test results
or ongoing injection drug use. Delay initiating PrEP until pt is confirmed to be HIV-negative.
substance abuse, and domestic violence
◦ See Figure on Documenting HIV Status in the PrEP Guidelines available at
• Victims of sexual assault should be referred for additional evaluation and
- - - If outside our region, please consult the national services below - - -
counseling
• Assess for pregnancy or breastfeeding and discuss pregnancy plans
◦ See the New York State Department of Health AIDS Institute guidelines
• Confirm that pt is at substantial, ongoing, high risk for acquiring HIV infection
National Consultation Services
for victims of sexual assault at
• A sexual history is recommended for all pts. If sexual partner(s) are known HIV-positive, assess if they are in care and on antiretroviral (ARV) therapy and
Clinician Consultation Center
guidelines/post-exposure-prophylaxis/hiv-prophylaxis-for-victims-of-
assist if needed.
Online Consultation:
nccc.ucsf.edu
sexual-assault/
• Perform estimated creatinine clearance (CrCL). Do not initiate if estimated CrCL is < 60 mL/min. If pt has mild renal insufficiency or risk factors for renal
◦ National Sexual Assault Online Hotline 1.800.656.HOPE (656.4673)
dysfunction obtain CrCL, phosphorus, urine glucose and urine protein prior to initiating PrEP. Please visit
Pre-Exposure Prophylaxis
855.448.7737
cfm
for a glomeruar filtration rate calculator to estimate renal function.
Management of Occupational Exposures
Advice to clinicians on providing antiretroviral drug therapy to HIV
• Consider bone mineral density in pts with risk factors for osteoporosis or bone loss or history of pathologic fracture
Requires immediate reporting so exposed person can be evaluated, tested,
uninfected persons to prevent HIV infection
Other Recommended Actions
and provided with appropriate occupational post-exposure prophylaxis (oPEP)
Call 11 am - 6 pm EST, Monday - Friday
• Screen for hepatitis B infection; vaccinate if appropriate, or treat if active infection identified whether or not PrEP prescribed. Because TDF/FTC treats
if indicated
Post-Exposure Prophylaxis
888.448.4911
hepatitis B, it is important to recognize if this infection is present as flare of hepatitis B is possible if infection is not recognized and Truvada
is discontinued.
®
• Treatment (tx) of Exposure Site
• Screen pt for alcohol and illicit drug use, including the use of injectable drugs as these substances may affect sexual risk behavior. Refer for substance abuse
Timely answers for urgent exposure management
◦ Wash wounds and skin sites with soap and water
Call 9 am - 2 am EST, 7 days a week or see the online PEP Quick Guide
◦ Flush mucous membranes with water
tx if indicated. For IDUs, assess access to clean needles/syringes.
for urgent PEP decision-making
◦ Use of antiseptics-not contraindicated, but no evidence that it will further
• Sexually transmitted infection (STI) screening including oral or rectal STI testing and tx as appropriate
reduce risk of transmission. Avoid use of caustic agents (e.g., bleach).
• Educate all pts on the importance of practicing safer sex consistently, using condoms correctly, and the need for 100% adherence to PrEP medications if
Perinatal HIV/AIDS
888.448.8765
• Evaluate Exposure - See inside of card
prescribed. Educate women on the following:
Rapid perinatal HIV consultation
• Start oPEP when indicated
◦ The safety of PrEP medication exposure to infants during pregnancy has not been fully assessed but no harm reported to date
Call 24 hours a day, 7 days a week
◦ PrEP should not be prescribed for breastfeeding women
Exposure to other blood-borne pathogens (e.g., hepatitis B and C) should be
HIV/AIDS Management
800.933.3413
BEGINNING PrEP MEDICATION REGIMEN
considered in addition to HIV. See sections on hepatitis B and C provided in
Peer-to-peer advice on HIV/AIDS management
this resource. Clients should be counseled to initiate or resume preventive
Call 9 am - 8 pm EST, Monday - Friday
• Pts taking PrEP should be informed of side effects of these medications and possible signs and symptoms requiring urgent medical evaluation
behaviors to prevent additional exposure and to prevent possible secondary
Voicemail 24 hours a day, 7 days a week
• Provide pt with a medication fact sheet listing dosing instructions and side effects
transmission while receiving PEP.
• Reinforce the fact that PrEP is not always effective in preventing HIV infection particularly if used inconsistently. The consistent use of PrEP together with other
prevention methods (consistent condom use, discontinuing drug injection or never sharing injection equipment) confers very high levels of protection.
This publication is made possible by AETC grant award H4AHA00049 from the HIV/
• Review important prescribing considerations
1
AIDS Bureau (HAB) of the Health Resources Services Administration (HRSA), U.S.
• Review “Agreement Form for Initiating TRUVADA
®
for Pre-Exposure Prophylaxis (PrEP) of Sexually Acquired HIV-1 Infection” with your pt
2
Department of Health and Human Services (HHS). The University of South Florida
• Prescribe Truvada
®
(300 mg tenofovir [TDF]/200 mg emtricitabine [FTC]) po once daily and educate pt on proper use of medication
3
Center for HIV Education and Research operates an AIDS Education and Training
Center (AETC) that strengthens the capacity of healthcare professionals to care for
• Prescribe no more than a 90-day supply, and renew only if HIV antibody test or fourth generation antigen/antibody test confirms that pt remains HIV-uninfected
people living with HIV/AIDS through training and technical assistance. The information
• Assess pregnancy intent and perform pregnancy test. Assure the pt has been informed about the benefits and risk of use should pregnancy occur as well as
presented is the consensus of HIV/AIDS specialists within the Florida/Caribbean AETC
the need to avoid breastfeeding.
and does not necessarily represent the official views of HRSA/HAB.
• Consider using TDF/FTC for both tx of active hepatitis B infection and HIV prevention
• Provide risk-reduction (consistent condom use, discontinuing drug injection, never sharing injection equipment) and PrEP medication adherence counseling
and condoms
• Make sure pt has a follow up appointment date
1. Gilead Sciences, Inc. TRUVADA
®
for a Pre-exposure Prophylaxis (PrEP) Indication: Risk Evaluation and Mitigation Strategy (REMS). June, 2014. Available at
An up-to-date and downloadable PDF file is available online at /treatment. To order additional printed copies,
Accessed: December 8, 2014.
please email . If you require an alternate format to accommodate a disability,
2. Gilead Sciences, Inc. Agreement Form for Initiating TRUVADA
for Pre-exposure Prophylaxis (PrEP) of Sexually Acquired HIV-1 Infection. June, 2014. Available
®
please email
or call 866.352.2382.
at Accessed: December 8, 2014.
3. Use of this drug for prevention of parenteral HIV acquisition in those without sexual risk is “off label”. MMWR. 2013; 62(23);463-465.
ALSO AVAILABLE FOR ORDER AND DOWNLOAD:
NOTE: 100% adherence is essential for PrEP to be effective.
PrEP is not always effective in preventing HIV infection particularly if used inconsistently.
ARV Therapy in Adults & Adolescents
Post-Exposure Prophylaxis (PEP)
in Pediatrics/Adolescents
FOLLOW-UP AT LEAST EVERY 90 DAYS WHILE PATIENT TAKING PrEP
ARV Therapy in Pediatrics
Treatment of Sexually Transmitted Diseases (STDs)
• Repeat HIV and pregnancy tests every 3 months
Hepatitis in HIV/AIDS
in HIV-Infected Patients
• Document negative (blood or serum) HIV antibody test or fourth generation antigen/antibody test
Opportunistic Infections (OIs) in HIV/AIDS
• Document negative pregnancy test; if pregnant, discuss ongoing PrEP (unknown risks) with pt and prenatal care provider and report exposure to antiretroviral
Treatment of Tuberculosis (TB) in HIV/AIDS
pregnancy registry ( )
Oral Manifestations Associated with HIV/AIDS
• Assess side effects, adherence and HIV acquisition risk behaviors. Consider more frequent follow-up visits if inconsistent adherence is identified
• Provide support for risk-reduction strategies and the consistent and correct use of condoms. Respond to new questions and provide any new information
about PrEP use.
Report Adverse Events and Pregnancy Exposures
• STI symptoms assessment and testing and tx as indicated at each follow-up visit; at 6 month intervals screen for STIs (syphilis, gonorrhea and chlamydia)
Clinician Consultation Center
without regard to symptoms.
Post Exposure Prophylaxis Consultation
• FDA MedWatch:
• Assess for signs/symptoms of acute HIV infection and if present, discontinue PrEP until testing confirms that pt is HIV-negative.
• Three months after PrEP initiation, and at least every 6 months thereafter, evaluate serum creatinine and estimated creatinine clearance
(
Report unusual or severe toxicity to antiretrovirals
(PEPline)
professionals/kdoqi/gfr_calculator.cfm). If pt has mild renal insufficiency or risk factors for renal dysfunction obtain CrCL, phosphorus, urine glucose and urine
protein prior to initiating PrEP. If CrCL falls to < 60 mL/min while on PrEP, re-assess the risk vs. benefits of PrEP and dose adjust TDF/FTC per package insert
888.HIV.4911 (448.4911)
800.FDA.1088 (332.1088)
if PrEP continued.
• At least every 12 months, evaluate the need to continue PrEP as a component of HIV prevention
• Antiretroviral Pregnancy Registry:
ON DISCONTINUING PrEP
A voluntary prospective, exposure-registration, observational
The information contained in this publication is intended for medical
professionals, as a quick reference to the national guidelines. This resource
study designed to collect and evaluate data on the outcomes of
• Document reasons for discontinuing PrEP
does not replace nor represent the comprehensive nature of the published
pregnancy exposures to antiretroviral products.
• Perform blood (or serum) HIV antibody test or fourth generation HIV antigen/antibody test
guidelines. Recognizing the rapid changes that occur in this field, clinicians
• If HIV-positive, baseline HIV genotype and linkage to care
are encouraged to consult with their local experts or research the literature
• If HIV-negative, assure continued risk-reduction support services as indicated
800.258.4263
for the most up-to-date information to assist with individual treatment
• If active hepatitis B is diagnosed, assure continued hepatitis B tx
decisions for their patient. If your patient should experience a serious adverse
• If pregnant, inform prenatal care provider of TDF/FTC use in early pregnancy
event, please report the event to the FDA (
SPECIAL THANKS TO:
HowToReport/default.htm) to help increase patient safety.
Michael C. Willig, MSN, RN
Visit
/treatment
for the most up-to-date version of this resource.
for his contributions to the March 2014 edition of this resource
Post-Exposure Prophylaxis (PEP) for Hepatitis B Virus (HBV)
CDC. Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis. MMWR, 2001;50(RR-11): 1-53. Available at
CDC. CDC Guidance for Evaluating Health-Care Personnel for Hepatitis B Virus Protection and for Administering Postexposure Management. MMWR, 2013;62(RR-10); 1-19. Available at
Both accessed: December 8, 2014.
Management of Exposures to HBV
• Any blood or body fluid exposure to an unvaccinated person should lead to the initiation of the hepatitis B vaccine series, unless they have not responded after a second complete vaccination series (after two 3-dose series)
◦ Recombivax HB
10 mcg or Engerix-B
20 mcg IM at 0, 1, and 6 months (Consider 40 mcg dose if exposed person is on dialysis or is immunocompromised)
®
®
• When Hepatitis B Immune Globulin (HBIG) is indicated, it should be administered as soon as possible after the exposure (preferably within 24 hours, but is recommended up to 1 week following an occupational exposure)
◦ HBIG can be administered simultaneously with the Hepatitis B vaccine, but at a separate site
• Test for Hepatitis B surface antibody (HBsAb) 1-2 months after last dose of vaccine series or booster, adequate HBsAb ≥ 10 mIU/mL (>0.99 index value)
• Exposed persons with HBsAb < 10 mlU/mL, or unvaccinated/incompletely vaccinated, and exposure from a source pt HBsAg (+) or unknown HBsAg status: baseline HBV testing [hepatitis B surface antibody (HBsAb), hepatitis B surface antigen (HBsAg)
and hepatitis B core antibody (HBcAb) total] and at 6 months retest with HBsAG and HBcAb total
EXPOSED PERSON’S
TREATMENT
IMMUNE STATUS
Source HBsAg (+), HBsAg (unknown) or Not Available for Testing
Source HBsAg (-)
Unvaccinated or Incomplete Vaccination
HBIG (0.06 mL/kg IM) x 1 and vaccinate
Vaccinate
Vaccinated-responder (HBsAb ≥ 10 mIU/mL)
No PEP
No PEP
After first vaccination series- HBIG (0.06 mL/kg IM) x 1 and revaccinate
4
Revaccinate
4
Vaccinated-nonresponder
(HBsAb < 10 mIU/mL)
After second vaccination series- HBIG (0.06 mL/kg IM) x 2 doses (one at time of exposure and one 1 month after exposure)
No PEP
Test exposed person for HBsAb. If HBsAb ≥ 10 mIU/mL, no PEP necessary.
No PEP
Vaccination Completed
(HBsAb response unknown)
Test exposed person for HBsAb. If HBsAb < 10 mIU/mL, administer HBIG x 1 and revaccinate.
4
Revaccinate
4
4. Give vaccine booster dose; check antibody response (HBsAb quantitative) 1-2 months later; give additional 2 doses (for total of 6 doses) if HBsAb remains < 10 mIU/mL and repeat HBsAb 1-2 months later.

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