guideline summary updated us public health service guidelines for the management of occupational...

Guideline SummaryGuideline SummaryUpdated US Public Health Service Guidelines for the

Management of Occupational Exposures to HIV and Recommendations

for Postexposure Prophylaxis

Published August 2013

AETC NRC Slide Set

August 2013 www.aidsetc.org

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Users are cautioned that, because of the rapidly changing field of HIV care, this information could become out of date quickly.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

About This PresentationAbout This Presentation

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Updated Guidelines for the Updated Guidelines for the Management of Occupational Management of Occupational Exposures to HIVExposures to HIVand Recommendations forand Recommendations forPostexposure ProphylaxisPostexposure Prophylaxis

Developed by the Public Health Service Interagency Working Group, convened by the CDC

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Guidelines OutlineGuidelines 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

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Guidelines Outline Guidelines Outline (2)(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

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What the Guidelines EmphasizeWhat 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

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Principal Changes from Previous PEP Principal Changes from Previous PEP GuidelinesGuidelines

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

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Health Care Personnel: DefinitionHealth Care Personnel: Definition

HCP: all paid and unpaid persons working in healthcare setting who have the potential for exposure to infectious materials

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Occupational Risk Exposures in HCPOccupational Risk Exposures in HCP

Percutaneous injury (needlestick, cut)

OR

Contact of mucous membrane or nonintact skin

WITH:

•Blood•Tissue•Other body fluids that are potentially infectious(cerebrospinal, synovial, pleural, pericardial, peritoneal, or amniotic fluids; semen or vaginal secretions)

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NOT Considered Infectious for HIV NOT Considered Infectious for HIV Unless Unless Visibly BloodyVisibly Bloody

Feces Nasal Secretions Saliva Sputum

Sweat Tears Urine Vomitus

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Risk of Occupational Transmission of HIVRisk 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

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Factors Associated with Increased RiskFactors 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.

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Toxicity of PEP RegimensToxicity 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

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Interactions of ARV AgentsInteractions 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

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Selection of HIV PEP Regimens: Rationale Selection of HIV PEP Regimens: Rationale for Current Recommendationsfor 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

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Selection of HIV PEP Regimens: Rationale Selection of HIV PEP Regimens: Rationale for Current Recommendations for Current Recommendations (2)(2)

To encourage HCP to complete the PEP regimen: Optimize side effect and toxicity profiles Optimize dosing convenience

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Resistance to ARVsResistance 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

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ARVs during Pregnancy and LactationARVs 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

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ARVs during Pregnancy and Lactation ARVs during Pregnancy and Lactation (2)(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

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ARVs during Pregnancy and Lactation ARVs during Pregnancy and Lactation (3)(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

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Management of Occupational Exposure by Management of Occupational Exposure by Emergency PhysiciansEmergency 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

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Management of HCP Potentially Exposed Management of HCP Potentially Exposed to HIVto 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

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Source Patient HIV TestingSource 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

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Source Patient HIV Testing Source Patient HIV Testing (2)(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

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Timing and Duration of PEPTiming 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

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Selection of HIV PEP DrugsSelection 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

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Selection of HIV PEP Drugs Selection of HIV PEP Drugs (2)(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

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Selection of HIV PEP Drugs Selection of HIV PEP Drugs (3)(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

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PEP RegimensPEP Regimens

Preferred HIV PEP regimen:

Raltegravir 400 mg BID + TDF/FTC (Truvada) 1 QD

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PEP Regimens PEP Regimens (2)(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)

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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

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ARV agents generally not recommended for PEP: Didanosine Nelfinavir Tipranavir

ARV agents contraindicated as PEP:

Nevirapine

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Selection of Drugs for PEP: Selection of Drugs for PEP: Consultation Is Part of the GuidelinesConsultation Is Part of the Guidelines

“Regular consultation with experts in antiretroviral therapy and HIV transmission is strongly recommended.”

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Resources for ConsultationResources for Consultation

Local experts (eg, HIV or ID consultant, hospital epidemiologist)

National HIV/AIDS Clinicians’ Postexposure Prophylaxis Hotline (PEPline) 24-hour telephone consultation

service: 888-448-4911

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Situations in Which Expert Consultation Situations in Which Expert Consultation Is AdvisedIs 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

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Situations in Which Expert Consultation Situations in Which Expert Consultation Is Advised Is Advised (2)(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

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Situations in Which Expert Consultation Situations in Which Expert Consultation Is Advised Is Advised (3)(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

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Follow-Up of Exposed HCPFollow-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

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Follow-Up of Exposed HCP Follow-Up of Exposed HCP (2)(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

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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

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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.

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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 (404-639-2050)

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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

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Other Occupational and Other Occupational and Nonoccupational ExposuresNonoccupational Exposures

Managing exposure to hepatitis B and C(see previous guideline: CDC. MMWR 2001;50(RR-11); online at http://www.cdc.gov/mmwr/PDF/rr/rr5011.pdf

Nonoccupational HIV exposure (see separate guideline: CDC. MMWR 2005;54(RR-9); online at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5409a1.htm

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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: http://www.aidsetc.org, or on AIDSinfo: http://aidsinfo.nih.gov

About This Slide SetAbout This Slide Set

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