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 These slides were developed using the September 2013 updated guidelines on postexposure prophylaxis PE ID: 750439
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Slide1
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 SetSlide2
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Users are cautioned that, because of the rapidly changing field of HIV care, this information could become out of date quickly.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 PresentationSlide3
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 CDCSlide4
Guidelines Outline
Principal changes from previous PEP guidelines
Health care personnel and exposureRisk of occupational transmission of HIVARV toxicities and interactionsSelection of HIV PEP regimensResistance to ARVsARV drugs during pregnancy and lactationManagement by emergency physiciansSlide5
Guidelines Outline
(2)
Recommendations for the management of HCP potentially exposed to HIVHIV PEPSource patient testingTiming and duration of PEPSelection of PEP drugsFollow-up of exposed HCPPostexposure testingMonitoring and management of PEP toxicitySlide6
What the Guidelines Emphasize
Prompt management of occupational exposures
Selection of effective and tolerable PEP regimensPotential toxicities and interactions of PEP drugsConsultation with experts for postexposure management strategiesCounseling and follow-up of exposed personnelSlide7
Principal Changes
from
Previous PEP GuidelinesElimination of risk stratification for exposure incidents3-drug (or more) PEP regimen for all Expanded list of ARVs for PEPEmphasis on tolerability and convenience of PEP regimenNew recommendations for follow-up HIV testing Slide8
Health Care Personnel: Definition
HCP: all paid and unpaid persons working in healthcare setting who have the potential for exposure to infectious materialsSlide9
Occupational Risk Exposures in HCP
Percutaneous injury (needlestick, cut)
ORContact of mucous membrane or nonintact skinWITH:BloodTissueOther body fluids that are potentially infectious(cerebrospinal, synovial, pleural, pericardial, peritoneal, or amniotic fluids; semen or vaginal secretions)Slide10
NOT Considered Infectious for HIV Unless
Visibly Bloody
FecesNasal SecretionsSalivaSputumSweat TearsUrine VomitusSlide11
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 exposureSlide12
Factors Associated with Increased Risk
Visible contamination of device (such as needle) with patient’s blood
Needle having been placed directly into vein or arteryHollow-bore (vs solid) needleDeep injurySource patient with terminal illnessHigh 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.Slide13
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 PEPSide effects of ARV drugs are common, and a major reason for not completing PEP regimensRegimens that are tolerable for short-term use should be selectedPotential side effects should be discussed, and treatment for anticipated side effects should be prescribed preemptively, if indicated Slide14
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 expertsAvoid interacting drugs and monitor carefully, as appropriateSlide15
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 unknownNewer ARVs are better tolerated and have better toxicity profiles than agents previously used for PEPThus, PEP regimens comprising 3 (or more) tolerable ARVs now recommended for all occupational exposures to HIVSlide16
Selection of HIV PEP Regimens: Rationale for Current Recommendations
(2)
To encourage HCP to complete the PEP regimen:Optimize side effect and toxicity profilesOptimize dosing convenienceSlide17
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 reportedIf source patient is known or suspected to harbor drug-resistant HIV, consult with experts for PEP selectionDo not delay initiation of PEP; use ARVs to which the source virus is unlikely to be resistantResistance testing at time of exposure is not practical, given length of time required for resultsIf resistance test results become available during PEP, consider possible modification of PEP regimen if indicatedSlide18
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 infectionPotential risks of ARVs for pregnant women, fetuses, and infants Expert consultation recommended in all casesSlide19
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 ARVsSpecial considerations during pregnancyEfavirenz: 1st-trimester exposure may increase risk of CNS defectsAvoid efavirenz during 1st trimesterIf efavirenz-based PEP is used, do pregnancy test to rule out early pregnancy; counsel nonpregnant women to avoid pregnancy until after completing PEPStavudine + didanosineNot recommended; increased risk of lactic acidosisSlide20
ARVs during Pregnancy and Lactation
(3)
Special considerations in breast-feedingCounsel lactating HIV-exposed HCP to weigh risks and benefits of continued breast-feeding both while taking PEP and while being monitored for HIV seroconversionBreast-feeding is not a contraindication to PEP, especially given high risk of HIV transmission through breast milk should acute HIV infection occur3-drug ARV regimens given to HIV-infected breast-feeding women has been shown to decrease risk of transmission to their infantsConsider stopping breast-feeding to eliminate risk of HIV transmissionSlide21
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 testingProcedures for counseling exposed HCPIdentifying and having an initial HIV PEP regimen available Mechanism for outpatient HCP follow-upSlide22
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 expertsReevaluate exposed HCP within 72 hours after exposure, especially as additional information about the exposure or source person becomes availableSlide23
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 periodSlide24
Source Patient HIV Testing
(2)
PEP initiation should not be delayed while waiting for HIV test resultsIf the source is found to be HIV negative, PEP should be discontinued, and no follow-up HIV testing for HCP is neededSlide25
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 hoursPoint at which no benefit may be gained is not defined; in animal studies less effective if started >72 hours after exposureOptimal duration unknown; 4 weeks appeared protective in occupational and animal studiesPEP should be taken for 4 weeks, if toleratedSlide26
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 NNRTIOther ARV classes may be indicated (eg, if resistant virus), but consult with expertsSlide27
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 personsConcerns about source patient drug resistance to ARVsSafety and tolerability of newer ARVsPotential for improved PEP adherence with newer ARVsSlide28
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 PEPPEP not justified for exposures that pose negligible risk of HIV transmissionReevaluate 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 initiationSlide29
PEP Regimens
Preferred HIV PEP regimen:
Raltegravir 400 mg BID + TDF/FTC (Truvada) 1 QDSlide30
PEP Regimens
(2)
Alternative regimens (combine 1 drug or drug pair from left column with 1 NRTI pair from right column):RaltegravirDarunavir + ritonavirEtravirine +
Rilpivirine
Atazanavir
+ ritonavir
Lopinavir/ritonavir
Tenofovir
+ emtricitabine
Tenofovir + lamivudine
Zidovudine + lamivudine
Zidovudine + emtricitabine
Elvitegravir/
cobicistat
/tenofovir/emtricitabine (
Stribild
)Slide31
PEP Regimens
(3)
Alternative ARV agents for use as PEP (only with expert consultation):Abacavir¹Efavirenz²EnfuvirtideFosamprenavirMaravirocSaquinavirStavudine
1
Use only with expert consultation, and in persons tested negative for HLA B5701
2
Avoid during first trimester of pregnancySlide32
PEP Regimens
(4)
ARV agents generally not recommended for PEP:DidanosineNelfinavirTipranavirARV agents contraindicated as PEP:NevirapineSlide33
Selection of Drugs for PEP: Consultation Is Part of the Guidelines
“Regular consultation with experts in antiretroviral therapy and HIV transmission is strongly recommended.”Slide34
Resources for Consultation
Local experts (
eg, HIV or ID consultant, hospital epidemiologist)National HIV/AIDS Clinicians’ Postexposure Prophylaxis Hotline (PEPline)24-hour telephone consultationservice: 888-448-4911Slide35
Situations in Which Expert Consultation Is Advised
Delayed exposure report (ie, >72 hours)
Interval after which benefit from PEP undefinedUnknown source (eg, needle in sharps disposal container or laundry)Use of PEP to be decided on case-by-case basisConsider severity of exposure and epidemiologic likelihood of HIV exposureDo not test needles or other sharp instruments for HIVKnown or suspected pregnancy in the exposed personProvision of PEP should not be delayed while awaiting consultationSlide36
Situations in Which Expert Consultation Is Advised
(2)
Breast-feeding in the exposed personProvision of PEP should not be delayed while awaiting consultationKnown or suspected resistance of the source virus to ARVsIf 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 recommendedInitiation of PEP should not be delayed while awaiting any results of resistance testingSlide37
Situations in Which Expert Consultation Is Advised
(3)
Toxicity of the initial PEP regimenSymptoms (eg, GI symptoms) often manageable without changing PEP regimen by prescribing antiemetic or antimotility agentsCounseling and support for management of side effects is very importantSerious medical illness in the exposed personSignificant illness (eg, renal disease) or coadministration of multiple medications may increase risk of drug toxicity and drug-drug interactionsSlide38
Follow-Up of Exposed HCP
All exposed HCP should receive the following, regardless of whether they receive PEP:
CounselingEarly reevaluation after exposureFollow-up testing and appointmentsSlide39
Follow-Up of Exposed HCP
(2)
Postexposure counselingExposed 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 postexposureFor PEP recipients, provide information on:Need for adherence to PEP, importance of completing PEP regimen Possible drug toxicities Possible drug interactionsSymptoms to report to health care provider Slide40
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 HCPSlide41
Follow-Up of Exposed HCP
(4)
Early reevaluation after exposureReevaluate exposed HCP within 72 hours after exposure, regardless of whether on PEPGives additional opportunity for evaluation, counseling, to reinforced adherence, identify and manage early side effects, improve likelihood of follow-up serologic testing, etc.Slide42
Follow-Up of Exposed HCP
(5)
Follow-up testing HIV testing at baseline, 6 weeks, 12 weeks, and 6 months after exposureIf 4th-generation p24 Ag/HIV Ab test is used: HIV testing at baseline, 6 weeks, 12 weeks, and 4 months after exposureHIV testing for any exposed HCP with symptoms compatible with acute retroviral syndrome, regardless of interval since exposureIf HIV infection is identified, refer for HIV careReport case to state health department and toCDC COPHI coordinator (404-639-2050)Slide43
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 developLaboratory tests: CBC, renal and hepatic function testsOther tests depending on specific toxicities of the drugs in the PEP regimen and on the medical conditions of the HCPAdvise HCP of symptoms that require urgent evaluation (eg, rash, fever, abdominal pain, icterus)If toxicity noted, consult with expert; consider modification of PEP regimenSlide44
Other Occupational and
Nonoccupational
ExposuresManaging 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.pdfNonoccupational HIV exposure (see separate guideline: CDC. MMWR 2005;54(RR-9); online at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5409a1.htmSlide45
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: http://www.aidsetc.org, or on
AIDSinfo
:
http://aidsinfo.nih.gov