BORDERNETwork Training on

BORDERNETwork Training on

Post-Exposure-Prophylaxis Dr. med. Wolfgang Güthoff / Alexander Leffers, M.A.

www.bordernet.euwww.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

Transmission

Conditions for PEP

Guidelines on PEP

Blood Control

Problems with PEP

PEP HIV - Exposure

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

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

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





Occupational PEP Probability 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


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%)



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

Kind of Exposure Exposition Risk in Relation to Average Risk

Very deep injury 16 : 1

Visible blood at instrument 5 : 1

Index person has high viral load 6 : 1

Exposure of mucosa 1 : 10

Exposure of damaged skin 1 : 10



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

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

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 - Counselling 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 PEPImmediate 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


Post exposure Prophylaxis (PEP)

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


PEP – when to start and time limits

Entry and Fusion 2h

DNA-Integration in nucleus12h

Viral replication after another12h

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

>72h after Exposition: PEP is not practical

Replication of HIV and Targets of Therapy

HIV

HIV- entryund Fusion

Reverse Transkriptase

Integrase

Protease

HIV

HIV

HIV

CD4 - cell

Replication of HIV and Targets of Therapy


Medications for PEP(German – Austrian Guidelines)

Tenofovir 300mg plusEmtricitabin 200mg

as combination product (Truvada 1x1 pill)

combinedwith

Kaletra (Lopinavir + Ritonavir) 2 x 400/100mg or

Sustiva 1 x 600mg

Alternative:

Combivir 2 x 1 pill(Zidovudin + Lamivudin)

Alternative:Invirase (2 x 1000mg plus Ritonavir 2 x 100mg) or

FosamprenavirIndinavir


European Guidelines

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 pill

Alternative: Combivir (ZDV/3TC)2 x 1 pill +

• Kaletra (LPVr) 2 x 2 pills

Alternative: Invirase 500(SQV) 2 x2 capsules and Norvir (RTV) 2 x 100mg


Blood Controls

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

Pregnancy and lactation period

No substance is harmless!

PEP only at high risk

Experience only with Retrovir and Epivir

Sustiva (Efavirenz) is contraindicated!

Period between exposition and starting PEP not longer than 24 h



High risk through massive inoculation ofinfections material


Strong side effects of HAART (mental – Efavirenz)


Index person gets HAART and drug resistance is probable

• Course of CD4 cells

• Opportunistic infections (OI)

HIV-Infection known?

How fast is an HIV-test possible?

HIV- rapid tests every time for every physician available?

PEP - Index person

Treatment AlgorithmDid an exposure to a potentially HIV-infected fluid occur?

Did a significant risk of transmission of HIV occur?(Contact of a HIV negative person with an HIV positive person (index person/source patient)

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

Can the source patient be interviewed?

Initiation of PEP regimen:• PEP within 24h

(best - start within first 2h)• HIV monitoring

YES

YES

YES

NO

NO

NO

• No indication of PEP

• No follow-up needed

• No indication of PEP

• No follow-up needed

• PEP not indicated

• Follow-up• HIV testing

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.pdfAdopted 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.

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 yes: Individual benefit-risk assessment

If no: PEP not indicated

• 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.

Stop PEP Continue PEP for4 weeks

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