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BORDERNETwork Training on. P ost- E xposure- P rophylaxis. Dr. med. Wolfgang Güthoff / Alexander Leffers, M.A. www.bordernet.eu. www.aidshilfe-potsdam.de.

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BORDERNETwork Training on

Post-Exposure-Prophylaxis

Dr. med. Wolfgang Güthoff /

Alexander Leffers, M.A.

www.bordernet.eu

www.aidshilfe-potsdam.de


This presentation arises from the BORDERNETwork project which has received funding from the European Union, in the framework of the Health Program, and co-funding of the Ministry of Environment, Health and Consumer Protection of the Federal State of Brandenburg. The sole responsibility of any use that may be made of the information lies with the authors (SPI, AIDS-Hilfe Potsdam e.V.)


Table of Contents which has received funding from the European Union, in the framework of the Health Program, and co-funding of the Ministry of Environment, Health and Consumer Protection of the Federal State of Brandenburg. T

Transmission

Conditions for PEP

Guidelines on PEP

Blood Control

Problems with PEP


PEP HIV - Exposure which has received funding from the European Union, in the framework of the Health Program, and co-funding of the Ministry of Environment, Health and Consumer Protection of the Federal State of Brandenburg. T

When?

Injury with HIV contaminated instruments

Wetting of open wounds and mucosa with HIV contaminated fluids

Unprotected sex with an HIV infected person

Use of HIV contaminated needles (needle sharing)

Transfusion of HIV contaminated blood or blood products

Postexpositionelle Prophylaxe der HIV-Infektion. Gemeinsame Empfehlung der Deutschen AIDS-Gesellschaft (DAIG e.V. und der Österreichischen AIDS-Gesellschaft (ÖAG) et al., in: Dtsch Med. Wochenschr 2009; 134: S 16-S 33.


PEP - Guidelines which has received funding from the European Union, in the framework of the Health Program, and co-funding of the Ministry of Environment, Health and Consumer Protection of the Federal State of Brandenburg. T

  • The ultimate goal of PEP is:

    • to suppress any viral replication that may occur,

    • to shift the biological advantage to the host cellular immune system to prevent or abort early infection

http://www.who.int/hiv/pub/guidelines/PEP/en/

http://www.hivguidelines.org/wp-content/uploads/2009/05/pep_card.pdf

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5011a1.htm


Occupational PEP Probability which has received funding from the European Union, in the framework of the Health Program, and co-funding of the Ministry of Environment, Health and Consumer Protection of the Federal State of Brandenburg. T

of Transmission

Factors influencing transmission:

Kind of transmitting material (Viral concentration is highest in the blood)

Kind of exposure:

Hollow needle

Cut injury

Open wound

Exposure of mucosa

Viral concentration from index person

Postexpositionelle Prophylaxe der HIV-Infektion. Gemeinsame Empfehlung der Deutschen AIDS-Gesellschaft (DAIG e.V. und der Österreichischen AIDS-Gesellschaft (ÖAG) et al., in: Dtsch Med. Wochenschr 2009; 134: S 16-S 33.


Occupational PEP Probability which has received funding from the European Union, in the framework of the Health Program, and co-funding of the Ministry of Environment, Health and Consumer Protection of the Federal State of Brandenburg. T

of Transmission

Average risk:

  • Percutaneous 0.3%

  • Mucous membrane 0.1%

  • Non-intact skin <0.1%

  • Blood transmission 100%

    (non occupational course – unprotected sex 0,03 – 7,5%)

Postexpositionelle Prophylaxe der HIV-Infektion. Gemeinsame Empfehlung der Deutschen AIDS-Gesellschaft (DAIG e.V. und der Österreichischen AIDS-Gesellschaft (ÖAG) et al., in: Dtsch Med. Wochenschr 2009; 134: S 16-S 33.


Risk for an HIV-Transmission depending on Exposure in Relation to Average Risk

Postexpositionelle Prophylaxe der HIV-Infektion. Gemeinsame Empfehlung der Deutschen AIDS-Gesellschaft (DAIG e.V. und der Österreichischen AIDS-Gesellschaft (ÖAG) et al., in: Dtsch Med. Wochenschr 2009; 134: S 16-S 33.


Occupational PEP Probability Relation to Average Risk

of Transmission

  • High Risk

    • deep parenteral inoculation via hollow needle

    • parenteral inoculation with high viral titers

  • Less Risk

    • injuries via non-hollow needle

    • mucosal exposure/non-intact skin exposure

  • Risk not identified

    • intact skin exposure

    • exposure to urine, saliva, tears, sweat


Exposure Risk Relation to Average Risk

Little information on efficacy of PEP in humans

Seroconversion infrequent following occupational exposure to HIV-infected blood

Use of Zidovudine (ZDV) was associated with an 81% decrease in the risk for HIV infection

limitations include a small number of cases, and that cases and controls came from different cohorts (Cardo et al, NEJM 1997;337:1485-90.)


PEP - Conditions Relation to Average Risk

  • contact with relevant risk of transmission between an HIV-negative Person and an HIV- infected Person (Index person)

  • Negative HIV-Test in exposed Person is a condition for PEP

  • HIV- Rapid Test of Index person

    • HIV Rapid Test available?


PEP - Relation to Average RiskCounselling and Decision(two physicians should get knowledge and experience in this field in every hospital)

Estimation of risk

Decision for PEP:

strongly encourage

recommend

offer

do nothing (counselling is important that the exposed person is assured)

Watch problem situations, discussion of such cases with Dr. Ninfa Ken

or Dr. Pedro Arriaga

Counselling for PEP encloses:

no blood donation for 12 month

safer sex until getting final HIV test after six month

drugs do not have an apply for this indication

written confirmation


Occupational PEP Relation to Average RiskImmediate Measures

  • Measurements at cut injuries or needle sticks

    • disinfection, wash it with soap and water

  • Mucosa membrane exposure

    • Douche of oral cavity with 70% alcohol: mouth wash 5 times for 15 seconds Attention!: state of drunkenness will occur

    • Douche of eyes with running water

  • Non intact skin

    • Wash with soap, water and antiseptic

  • Postexpositionelle Prophylaxe der HIV-Infektion. Gemeinsame Empfehlung der Deutschen AIDS-Gesellschaft (DAIG e.V. und der Österreichischen AIDS-Gesellschaft (ÖAG) et al., in: Dtsch Med. Wochenschr 2009; 134: S 16-S 33.


    Post exposure Prophylaxis (PEP) Relation to Average Risk

    PEP after occupational HIV-Exposition

    Transdermal injury with contaminated hollow needle  strongly encourage

    Superficial injury (f. e. with surgery needle)  offer

    Contact of damaged skin with blood  offer

    Contamination of intact skin  do not recommend

    Contamination of mucosa membrane with blood  recommend

    Contamination of mucosa membrane with urine or saliva  do not recommend

    Postexpositionelle Prophylaxe der HIV-Infektion. Gemeinsame Empfehlung der Deutschen AIDS-Gesellschaft (DAIG e.V. und der Österreichischen AIDS-Gesellschaft (ÖAG) et al., in: Dtsch Med. Wochenschr 2009; 134: S 16-S 33.


    PEP – when to start and time limits Relation to Average Risk

    • Entry and Fusion 2h

    • DNA-Integration in nucleus 12h

    • Viral replication after another 12h

    • PEP within 24h (best - start within first 2h)

    • >72h after Exposition: PEP is not practical

    Replication of HIV and Targets of Therapy

    Postexpositionelle Prophylaxe der HIV-Infektion. Gemeinsame Empfehlung der Deutschen AIDS-Gesellschaft (DAIG e.V. und der Österreichischen AIDS-Gesellschaft (ÖAG) et al., in: Dtsch Med. Wochenschr 2009; 134: S 16-S 33.


    Medications for PEP Relation to Average Risk(German – Austrian Guidelines)

    Postexpositionelle Prophylaxe der HIV-Infektion. Gemeinsame Empfehlung der Deutschen AIDS-Gesellschaft (DAIG e.V. und der Österreichischen AIDS-Gesellschaft (ÖAG) et al., in: Dtsch Med. Wochenschr 2009; 134: S 16-S 33.


    European Guidelines Relation to Average Risk

    • HIV- rapid test from Index person

    • If Index person’s HIV-RNA > 1000 copies/ml – testing of drug resistance

    • Start PEP if possible within 4h and not later then 48h

    • Duration: 4 weeks

    • Medication:

      • Truvada (TDF/FTC)1 x 1 pillAlternative: Combivir (ZDV/3TC) 2 x 1 pill

        +

      • Kaletra (LPVr) 2 x 2 pillsAlternative: Invirase 500(SQV) 2 x2 capsules and Norvir (RTV) 2 x 100mg

    Postexpositionelle Prophylaxe der HIV-Infektion. Gemeinsame Empfehlung der Deutschen AIDS-Gesellschaft (DAIG e.V. und der Österreichischen AIDS-Gesellschaft (ÖAG) et al., in: Dtsch Med. Wochenschr 2009; 134: S 16-S 33.


    Blood Controls Relation to Average Risk

    Serologic control (HIV, possible HBV, HCV):

    • at the start

    • after 6 weeks,

    • after 3 month

    • after 6 month

      Laboratory tests:

    • at the start, after 2 weeks and after 4 weeks:

      Blood count, liver enzymes, kidney function,

      blood sugar, urine


    Problems regarding HIV – PEP Relation to Average Risk

    Pregnancy and lactation period

    No substance is harmless!

    PEP only at high risk

    Experience only with Retrovir and Epivir

    Sustiva (Efavirenz) is contraindicated!


    Problems regarding HIV – PEP Relation to Average Risk

    • Period between exposition and starting PEP not longer than 24 h


    Problems regarding HIV – PEP Relation to Average Risk

    • High risk through massive inoculation ofinfections material


    Problems regarding HIV – PEP Relation to Average Risk

    • Strong side effects of HAART (mental – Efavirenz)


    Problems regarding HIV – PEP Relation to Average Risk

    • Index person gets HAART and drug resistance is probable

      • Course of CD4 cells

      • Opportunistic infections (OI)


    PEP - Index person Relation to Average Risk

    • HIV-Infection known?

    • How fast is an HIV-test possible?

    • HIV- rapid tests every time for every physician available?


    Treatment Algorithm Relation to Average Risk

    Did an exposure to a potentially HIV-infected fluid occur?

    • No indication of PEP

    • No follow-up needed

    Stop PEP

    Continue PEP for

    4 weeks

    NO

    YES

    • Serological test of source patient is confirmed HIV negative

    • no evidence of acute retroviral syndrome

    • Serological test of source patient is confirmed HIV positive

    • Evidence of acute retroviral syndrome occurs

    • Source patient is unknown, unwilling etc.

    • No indication of PEP

    • No follow-up needed

    Did a significant risk of transmission of HIV occur?

    (Contact of a HIV negative person with an HIV positive person (index person/source patient)

    NO

    YES

    • PEP not indicated

    • Follow-up

    • HIV testing

    Is the patient presenting within ideally 2 hours, not later than 72 hours of the exposure?

    NO

    • Initiation of PEP regimen:

    • PEP within 24h (best - start within first 2h)

    • HIV monitoring

    YES

    Can the source patient be interviewed?

    If yes: Individual

    benefit-risk assessment

    If yes: interview on HIV status or infection risk, resp. test/rapid test on HIV

    If no: belongs the source patient to a high risk group (with high prevalence)

    If no: PEP not indicated

    Adopted from: New York State Department of Health/ AIDS Institute: Recommendations for HIV Postexposure Prophylaxis (PEP)

    URL: http://www.hivguidelines.org/wp-content/uploads/2009/05/pep_card.pdf

    Adopted from: Postexpositionelle Prophylaxe der HIV-Infektion. Gemeinsame Empfehlung der Deutschen AIDS-Gesellschaft (DAIG e.V.)

    und der Österreichischen AIDS-Gesellschaft (ÖAG) et al. in: Dtsch Med. Wochenschr 2009; 134: S 16-S 33.


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