1. Guideline Summary
Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Postexposure Prophylaxis
Published August 2013
AETC NRC Slide Set

2. About This Presentation
These slides were developed using the September 2013 updated guidelines on postexposure prophylaxis (PEP) following occupational exposure to HIV. The intended audience is clinicians involved in the care of health care personnel (HCP) with occupational exposure to HIV.
Users are cautioned that, because of the rapidly changing field of HIV care, this information could become out of date quickly. Finally, it is intended that these slides be used as prepared, without changes in either content or attribution. Users are asked to honor this intent.
– AETC NRC

3. Updated Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Postexposure Prophylaxis
Developed by the Public Health Service Interagency Working Group, convened by the CDC

4. Guidelines Outline Principal changes from previous PEP guidelines
Health care personnel and exposure
Risk of occupational transmission of HIV
ARV toxicities and interactions
Selection of HIV PEP regimens
Resistance to ARVs
ARV drugs during pregnancy and lactation
Management by emergency physicians

5. Guidelines Outline (2)
Recommendations for the management of HCP potentially exposed to HIV
HIV PEP
Source patient testing
Timing and duration of PEP
Selection of PEP drugs
Follow-up of exposed HCP
Postexposure testing
Monitoring and management of PEP toxicity

6. What the Guidelines Emphasize
Prompt management of occupational exposures
Selection of effective and tolerable PEP regimens
Potential toxicities and interactions of PEP drugs
Consultation with experts for postexposure management strategies
Counseling and follow-up of exposed personnel

7. Principal Changes from Previous PEP Guidelines
Elimination of risk stratification for exposure incidents
3-drug (or more) PEP regimen for all
Expanded list of ARVs for PEP
Emphasis on tolerability and convenience of PEP regimen
New recommendations for follow-up HIV testing

8. Health Care Personnel: Definition
HCP: all paid and unpaid persons working in healthcare setting who have the potential for exposure to infectious materials
An exposure that might place HCP at risk for HIV infection
is defined as a percutaneous injury (e.g., a needlestick or
cut with a sharp object) or contact of mucous membrane or
nonintact skin (e.g., exposed skin that is chapped, abraded,
or afflicted with dermatitis) with blood, tissue, or other body
fluids that are potentially infectious. In addition to blood and
visibly bloody body fluids, semen and vaginal secretions also
are considered potentially infectious. Although semen and
vaginal secretions have been implicated in the sexual transmission
of HIV, they have not been implicated in occupational
transmission from patients to HCP. The following fluids
also are considered potentially infectious: cerebrospinal fluid,
synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid,
and amniotic fluid. The risk for transmission of HIV infection
from these fluids is unknown; the potential risk to HCP
from occupational exposures has not been assessed by epidemiologic
studies in health-care settings. Feces, nasal secretions,
saliva, sputum, sweat, tears, urine, and vomitus are not considered
potentially infectious unless they are visibly bloody;
the risk for transmission of HIV infection from these fluids
and materials is low (7).
Any direct contact (i.e., contact without barrier protection)
to concentrated virus in a research laboratory or production
facility requires clinical evaluation. For human bites, clinical
evaluation must include the possibility that both the person
bitten and the person who inflicted the bite were exposed to
bloodborne pathogens. Transmission of HIV infection by this
route has been reported rarely, but not after an occupational
exposure (8–12).

9. Occupational Risk Exposures in HCP
WITH:
Blood
Tissue
Other body fluids that are potentially infectious (cerebrospinal, synovial, pleural, pericardial, peritoneal, or amniotic fluids; semen or vaginal secretions)
Percutaneous injury (needlestick, cut) OR
Contact of mucous membrane or nonintact skin
An exposure that might place HCP at risk for HIV infection
is defined as a percutaneous injury (e.g., a needlestick or
cut with a sharp object) or contact of mucous membrane or
nonintact skin (e.g., exposed skin that is chapped, abraded,
or afflicted with dermatitis) with blood, tissue, or other body
fluids that are potentially infectious. In addition to blood and
visibly bloody body fluids, semen and vaginal secretions also
are considered potentially infectious. Although semen and
vaginal secretions have been implicated in the sexual transmission
of HIV, they have not been implicated in occupational
transmission from patients to HCP. The following fluids
also are considered potentially infectious: cerebrospinal fluid,
synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid,
and amniotic fluid. The risk for transmission of HIV infection
from these fluids is unknown; the potential risk to HCP
from occupational exposures has not been assessed by epidemiologic
studies in health-care settings. Feces, nasal secretions,
saliva, sputum, sweat, tears, urine, and vomitus are not considered
potentially infectious unless they are visibly bloody;
the risk for transmission of HIV infection from these fluids
and materials is low .
Any direct contact (i.e., contact without barrier protection)
to concentrated virus in a research laboratory or production
facility requires clinical evaluation. For human bites, clinical
evaluation must include the possibility that both the person
bitten and the person who inflicted the bite were exposed to
bloodborne pathogens. Transmission of HIV infection by this
route has been reported rarely, but not after an occupational
exposure .

10. NOT Considered Infectious for HIV Unless Visibly Bloody
Feces
Nasal Secretions
Saliva
Sputum
Sweat
Tears
Urine
Vomitus

11. Risk of Occupational Transmission of HIV
Following percutaneous exposure: approximately 0.3%
Following mucous membrane exposure: approximately 0.09%
Risk following nonintact skin exposure estimated to be <0.09%
Risk following exposure to fluids or tissues other than HIV-infected blood estimated to be “considerably lower” than for blood exposure

12. Factors Associated with Increased Risk
Visible contamination of device (such as needle) with patient’s blood
Needle having been placed directly into vein or artery
Hollow-bore (vs solid) needle
Deep injury
Source patient with terminal illness
High viral load*
* Risk of transmission via occupational exposure to a source patient with undetectable viral load is thought to be very low but not impossible; PEP should be offered.

13. Toxicity of PEP Regimens
PEP should be taken for a full 4 weeks
Substantial proportion of HCP taking earlier ARVs as PEP did not complete full course of PEP
Side effects of ARV drugs are common, and a major reason for not completing PEP regimens
Regimens that are tolerable for short-term use should be selected
Potential side effects should be discussed, and treatment for anticipated side effects should be prescribed preemptively, if indicated

14. Interactions of ARV Agents
ARVs can have serious interactions with other drugs
Before prescribing PEP, carefully evaluate concomitant medications, including over-the-counters, supplements, and herbals
Consult package inserts or other resources on ARV drug-drug interactions; consult with experts
Avoid interacting drugs and monitor carefully, as appropriate

15. Selection of HIV PEP Regimens: Rationale for Current Recommendations
Guidelines recommend use of ≥3 ARVs for treatment of HIV infection
Optimal number of ARVs needed for HIV PEP is unknown
Newer ARVs are better tolerated and have better toxicity profiles than agents previously used for PEP
Thus, PEP regimens comprising 3 (or more) tolerable ARVs now recommended for all occupational exposures to HIV

16. Selection of HIV PEP Regimens: Rationale for Current Recommendations (2)
To encourage HCP to complete the PEP regimen:
Optimize side effect and toxicity profiles
Optimize dosing convenience

17. Resistance to ARVs
Resistance of the source virus to ARVs, particularly to 1 or more that may be included in a PEP regimen, may reduce PEP efficacy
Occupational transmission of drug-resistant HIV strains, despite PEP, has been reported
If source patient is known or suspected to harbor drug-resistant HIV, consult with experts for PEP selection
Do not delay initiation of PEP; use ARVs to which the source virus is unlikely to be resistant
Resistance testing at time of exposure is not practical, given length of time required for results
If resistance test results become available during PEP, consider possible modification of PEP regimen if indicated

18. ARVs during Pregnancy and Lactation
Decision to offer PEP based on same considerations as in other HCP
Risk of HIV transmission during pregnancy or breast-feeding is markedly increased in acute HIV infection
Potential risks of ARVs for pregnant women, fetuses, and infants
Expert consultation recommended in all cases

19. ARVs during Pregnancy and Lactation (2)
Potential toxicities of ARVs during pregnancy and lactation depend on timing and duration of exposure, and on number and type of ARVs
Special considerations during pregnancy
Efavirenz: 1st-trimester exposure may increase risk of CNS defects
Avoid efavirenz during 1st trimester
If efavirenz-based PEP is used, do pregnancy test to rule out early pregnancy; counsel nonpregnant women to avoid pregnancy until after completing PEP
Stavudine + didanosine
Not recommended; increased risk of lactic acidosis

20. ARVs during Pregnancy and Lactation (3)
Special considerations in breast-feeding
Counsel lactating HIV-exposed HCP to weigh risks and benefits of continued breast-feeding both while taking PEP and while being monitored for HIV seroconversion
Breast-feeding is not a contraindication to PEP, especially given high risk of HIV transmission through breast milk should acute HIV infection occur
3-drug ARV regimens given to HIV-infected breast-feeding women has been shown to decrease risk of transmission to their infants
Consider stopping breast-feeding to eliminate risk of HIV transmission

21. Management of Occupational Exposure by Emergency Physicians
Institutions are recommended to develop clear protocols for management of occupational exposures, indicating:
Formal expert consultation mechanism (eg, in-house ID consultant or PEPline)
Appropriate initial source patient and exposed HCP laboratory testing
Procedures for counseling exposed HCP
Identifying and having an initial HIV PEP regimen available
Mechanism for outpatient HCP follow-up

22. Management of HCP Potentially Exposed to HIV
Recommendations reflect expert opinion; limited data on safety, tolerability, efficacy, and toxicity of PEP
Consider potential benefits and risks of PEP (including possible toxicity and drug interactions)
Consult with experts
Reevaluate exposed HCP within 72 hours after exposure, especially as additional information about the exposure or source person becomes available

23. Source Patient HIV Testing
If possible, determine the HIV status of exposure source patient to guide appropriate use of PEP
For sources whose HIV status is unknown, rapid HIV testing facilitates decisions about need to initiate or continue PEP
Investigation of whether a source patient might be in the window period before HIV seroconversion is not necessary, unless acute retroviral syndrome is suspected
4th-generation HIV Ag/Ab tests allow identification of most HIV infections during the window period

24. Source Patient HIV Testing (2)
PEP initiation should not be delayed while waiting for HIV test results
If the source is found to be HIV negative, PEP should be discontinued, and no follow-up HIV testing for HCP is needed

25. Timing and Duration of PEP
PEP is most effective when begun soon after the exposure, less effective as time increases (animal studies)
PEP should be started as soon as possible after the exposure, preferably within hours
Point at which no benefit may be gained is not defined; in animal studies less effective if started >72 hours after exposure
Optimal duration unknown; 4 weeks appeared protective in occupational and animal studies
PEP should be taken for 4 weeks, if tolerated

26. Selection of HIV PEP Drugs
Stratifying severity of exposure to determine the number of PEP drugs to be given is no longer recommended
PEP regimen of 3 (or more) ARVs is recommended for all occupational HIV exposures
Typically, 2-NRTI backbone + integrase inhibitor, ritonavir-boosted protease inhibitor, or NNRTI
Other ARV classes may be indicated (eg, if resistant virus), but consult with experts

27. Selection of HIV PEP Drugs (2)
No definitive data show increased efficacy of 3-drug vs 2-drug PEP regimens; current recommendation based on:
Superior efficacy of 3 ARVs in reducing HIV RNA in HIV-infected persons
Concerns about source patient drug resistance to ARVs
Safety and tolerability of newer ARVs
Potential for improved PEP adherence with newer ARVs

28. Selection of HIV PEP Drugs (3)
Choose ARVs with favorable side effect profile and convenient dosing schedule, to facilitate adherence and completion of 4 weeks of PEP
PEP not justified for exposures that pose negligible risk of HIV transmission
Reevaluate and modify PEP regimen whenever additional information about the source is obtained (eg, treatment history or ARV resistance)
Consultation with experts is recommended, but should not delay PEP initiation

29. PEP Regimens Preferred HIV PEP regimen:
Raltegravir 400 mg BID + TDF/FTC (Truvada) 1 QD

30. PEP Regimens (2)
Alternative regimens (combine 1 drug or drug pair from left column with 1 NRTI pair from right column):
Raltegravir
Darunavir + ritonavir
Etravirine
Rilpivirine
Atazanavir + ritonavir
Lopinavir/ritonavir
Tenofovir + emtricitabine
Tenofovir + lamivudine
Zidovudine + lamivudine
Zidovudine + emtricitabine
Elvitegravir/cobicistat/tenofovir/emtricitabine (Stribild)

31. PEP Regimens (3)
Alternative ARV agents for use as PEP (only with expert consultation):
Abacavir¹
Efavirenz²
Enfuvirtide
Fosamprenavir
Maraviroc
Saquinavir
Stavudine
1 Use only with expert consultation, and in persons tested negative for HLA B5701
2 Avoid during first trimester of pregnancy

32. PEP Regimens (4) ARV agents generally not recommended for PEP:
Didanosine
Nelfinavir
Tipranavir
ARV agents contraindicated as PEP:
Nevirapine

33. Selection of Drugs for PEP: Consultation Is Part of the Guidelines
“Regular consultation with experts in antiretroviral therapy and HIV transmission is strongly recommended.”

34. Resources for Consultation
Local experts (eg, HIV or ID consultant, hospital epidemiologist)
National HIV/AIDS Clinicians’ Postexposure Prophylaxis Hotline (PEPline)
24-hour telephone consultation service:

35. Situations in Which Expert Consultation Is Advised
Delayed exposure report (ie, >72 hours)
Interval after which benefit from PEP undefined
Unknown source (eg, needle in sharps disposal container or laundry)
Use of PEP to be decided on case-by-case basis
Consider severity of exposure and epidemiologic likelihood of HIV exposure
Do not test needles or other sharp instruments for HIV
Known or suspected pregnancy in the exposed person
Provision of PEP should not be delayed while awaiting consultation

36. Situations in Which Expert Consultation Is Advised (2)
Breast-feeding in the exposed person
Provision of PEP should not be delayed while awaiting consultation
Known or suspected resistance of the source virus to ARVs
If source person’s virus is known or suspected to be resistant to ≥1 of the drugs considered for PEP, selection of drugs to which the source person’s virus is unlikely to be resistant is recommended
Initiation of PEP should not be delayed while awaiting any results of resistance testing

37. Situations in Which Expert Consultation Is Advised (3)
Toxicity of the initial PEP regimen
Symptoms (eg, GI symptoms) often manageable without changing PEP regimen by prescribing antiemetic or antimotility agents
Counseling and support for management of side effects is very important
Serious medical illness in the exposed person
Significant illness (eg, renal disease) or coadministration of multiple medications may increase risk of drug toxicity and drug-drug interactions

38. Follow-Up of Exposed HCP
All exposed HCP should receive the following, regardless of whether they receive PEP:
Counseling
Early reevaluation after exposure
Follow-up testing and appointments

39. Follow-Up of Exposed HCP (2)
Postexposure counseling
Exposed HCP should be advised to use precautions (eg, use latex barriers during sex; avoid blood or tissue donations, pregnancy, and, if possible, breast-feeding) to prevent secondary transmission, especially during the first 6-12 weeks postexposure
For PEP recipients, provide information on:
Need for adherence to PEP, importance of completing PEP regimen
Possible drug toxicities
Possible drug interactions
Symptoms to report to health care provider

40. Follow-Up of Exposed HCP (3)
Postexposure counseling (cont’d)
Psychological impact of occupational exposure to HIV may be substantial; psychological counseling should be an essential component of the management and care of exposed HCP

41. Follow-Up of Exposed HCP (4)
Early reevaluation after exposure
Reevaluate exposed HCP within 72 hours after exposure, regardless of whether on PEP
Gives additional opportunity for evaluation, counseling, to reinforced adherence, identify and manage early side effects, improve likelihood of follow-up serologic testing, etc.

42. Follow-Up of Exposed HCP (5)
Follow-up testing
HIV testing at baseline, 6 weeks, 12 weeks, and 6 months after exposure
If 4th-generation p24 Ag/HIV Ab test is used: HIV testing at baseline, 6 weeks, 12 weeks, and 4 months after exposure
HIV testing for any exposed HCP with symptoms compatible with acute retroviral syndrome, regardless of interval since exposure
If HIV infection is identified, refer for HIV care
Report case to state health department and to CDC COPHI coordinator ( )

43. Follow-Up of Exposed HCP (6)
Monitoring and management of PEP toxicity:
Evaluation and laboratory testing at baseline and 2 weeks after starting PEP; additionally if symptoms develop
Laboratory tests: CBC, renal and hepatic function tests
Other tests depending on specific toxicities of the drugs in the PEP regimen and on the medical conditions of the HCP
Advise HCP of symptoms that require urgent evaluation (eg, rash, fever, abdominal pain, icterus)
If toxicity noted, consult with expert; consider modification of PEP regimen

44. Other Occupational and Nonoccupational Exposures
Managing exposure to hepatitis B and C
(see previous guideline: CDC. MMWR 2001;50(RR-11); online at
Nonoccupational HIV exposure (see separate guideline: CDC. MMWR 2005;54(RR-9); online at

45. About This Slide Set
This presentation was prepared by Susa Coffey, MD, for the AETC National Resource Center in August 2013
See the most current version of this presentation on the AETC NRC website: or on AIDSinfo: