Post Exposure Prophylaxis Post Exposure Prophylaxis (PEP/oPEP)(PEP/oPEP)

Dr Don Ajith Karawita Dr Don Ajith Karawita MBBS (PERA), PgD Ven (COL), MD Venereology (COL)MBBS (PERA), PgD Ven (COL), MD Venereology (COL)

(Senior Registrar in Venereology)(Senior Registrar in Venereology)

National STD/AIDS Control Programme National STD/AIDS Control Programme

CDC Guidelines 2001.CDC Guidelines 2001.

CDC CDC headquarters headquarters in Atlantain Atlanta

Standard Precautions

1. Hand washing

2. Gloves

3. Personal protective equipment (PPE)

4. Patient care equipments– Cleaning of instruments

5. Environmental control– Management of spills

6. Linen management

7. Occupational health and blood borne pathogens– Handling of sharps– Prevention of mucous

membrane exposures– Management of needle

stick accident or mucous membrane exposure

– Collection and transport of specimens

8. Patient isolation

Additional Precautions

1. Transmission based precautions– Airborne precautions (droplet nuclei < 5µm)– Droplet precautions (droplet nuclei > 5µm)– Contact precautions / isolation

2. Strict isolation

3. Aseptic precautions• Cleaning of entry site of the body• Hands of the staff must be disinfected and

gloved.

Choice of methodChoice of method

RISK GROUP EXAMPLES CHOICE OF PROCESSING

High risk (Critical)Direct contact with a break in skin or mucous membrane or entering a sterile body area.

Surgical instruments, Needles, Syringes, cystoscopes, Laparoscopes, Surgical dressings.

Must be sterileHeat sterilization (autoclaving), chemical

sterilants

Intermediate risk (Semi-critical)Direct contact with mucous membranes or non-intact skin

Endoreacheal tubes, Gastroscopes & other endoscopes.

High level disinfection acceptable, liquid chemicals.

Low risk (Non-critical)Items in contact with intact skin.

Stethoscopes, BP apparatus, bed pans, urinals

Low level disinfection or through cleaning with detergent acceptable

Disinfectant / AntisepticDisinfectant / Antiseptic

• Alcohol– Surgical spirit

(60% isopropyl alcohol)

– 70% ethyl alcohol– Alcohol hand rub

(Isopropyl alcohol with glycerol)

• Aldehydes– Cidex

(2% glutaraldehyde solution)

• Chlorhexidines– Hibisol

(0.5% chlorhexidine in 70% alcohol

– Hibitane

(4% chlorhexidine gluconate

– Hibiscrub

(4% chlorhexidine gluconate with a detergent)

• Chlorine releasing Chlorine releasing agentsagents– TCL, Bleaching powder

(Calcium hypochiorite 35% w/w of available chlorine)

– Sodium hypochlorite liquid form

• 5% stock solution

• 1% (10,000ppm)

• 0.1%(1000ppm)

• 0.01% (125ppm) Milton

• IodophorsIodophors

– Betadine, Wokadine (10% solution, available iodine 1%)

– Betadine scrub, Wokadine scrub (7.5% Povidone iodine scrub, avilable iodine 0.75%

• Peracetic acidPeracetic acid

– Perasafe (Peracetic acid)

• Phenolic disinfectantsPhenolic disinfectants

– Lysol (2%, 5% solutions)

Disinfectant / AntisepticDisinfectant / Antiseptic

Hospital waste

Hazardous waste General or Non-hazardous waste

1. Infectious waste (incinaration/ Burial)

2. Pathologicl waste (incinaration/ Burial)

3. Chemical waste (Returned to supplier/ MSD)

4. Pharmaceutical waste (Returned to supplier/ MSD)

5. Radioactive waste (Keep for radioactive decay→Dispose as non hazardous waste)

1. Sharps

Dispose to common

garbage site/bin

Collected by local authorities

Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human Immunodeficiency Virus (HIV)and Human Immunodeficiency Virus (HIV)

• Bloodborne viruses

• Can produce chronic infection

• Transmissible in healthcare settings

• Data from multiple sources (e.g., surveillance, observational studies, serosurveys) used to assess risk of occupational transmission

Risk of Bloodborne Virus Transmission after Risk of Bloodborne Virus Transmission after Occupational Percutaneous ExposureOccupational Percutaneous Exposure

Source Risk

HBV

HBeAg +

HBeAg -

22.0-30.0%

1.0-6.0%

HCV 1.8%

HIV 0.3%

Patient

1.Exposure2. Exposure Substance

Health care worker (HCW)

PercutaneousPercutaneous

Severe, Less severe

Mucous Mucous membrane/Non membrane/Non intact skinintact skin

Small volume, Large volume.

Blood, Bloody fluid, OPIM

3. Determine Infectious Status of Source

4. Determine Susceptibility of Exposed Person

Evaluation - Occupational exposure to infectious materials

Elements of Postexposure Management

• Wound management & Exposure reporting → Step 1

• Risk Assessment → Step 2– (1) blood borne infection status of source source

personperson

– (2) Infectious materialInfectious material

– (3) type and severity of exposureexposure

– (4) Susceptibility of HCWSusceptibility of HCW

• Appropriate treatment → Step 3• Follow-up, and counseling → Step 4

Step 1Step 1 Provide immediate care to the Provide immediate care to the exposure siteexposure site

• Post exposure Wound Management:Post exposure Wound Management: – Wash wounds and skin with soap and water– Flush mucous membranes with water– No evidence of benefit for:

• application of antiseptics or disinfectants• squeezing (“milking”) puncture sites

• Avoid use of bleach and other agents caustic to skin

• Inform authorities → Infection control unit.

Management of sharps accidentsManagement of sharps accidents

WHO / SEAR 1999

WHO / SEAR 1999

Elements of Postexposure Management

• Wound management & Exposure reporting → Step 1

• Risk Assessment → Step 2– (1) blood borne infection status of source source

personperson

– (2) Infectious materialInfectious material

– (3) type and severity of exposureexposure

– (4) Susceptibility of HCWSusceptibility of HCW

• Appropriate treatment → Step 3• Follow-up, and counseling → Step 4

Postexposure Management: Postexposure Management: Risk Assessment Risk Assessment (Seek expert advice)(Seek expert advice)

Infectious status of the source person (SC)

– presence of HBsAg

– presence of HCV antibody

– presence of HIV antibody

– if source unknown, assess epidemiologic and clinical evidence (Do not test discarded

needles)

Body substance– blood– bloody fluid– Other potentially infectious

materials (OPIM)(semen, vaginal secretions and CSF, synovial, pleural, peritoneal, pericardial and amniotic fluids) or tissue

Type of exposure (EC)

– percutaneous

– mucous membrane

– non-intact skin

– bites resulting in blood exposure

Determine susceptibility of exposed person (HCW)

– Hepatitis B vaccine status

– HBV immune status if vaccine response status in unknown

– Anti-HCV and ALT

– HIV antibody

Elements of Postexposure Management

• Wound management & Exposure reporting → Step 1

• Risk Assessment → Step 2– (1) blood borne infection status of source source

personperson

– (2) Infectious materialInfectious material

– (3) type and severity of exposureexposure

– (4) Susceptibility of HCWSusceptibility of HCW

• Appropriate treatment → Step 3• Follow-up, and counseling → Step 4

Step 3Step 3 Give PEP for exposures posing Give PEP for exposures posing risk of infection transmissionrisk of infection transmission

• HBV– Give oPEP as soon as possible within 24 hours.– PEP can be given to pregnant women

• HCV– PEP not recommended

• HIV– Initiate PEP within hours of exposure (2-72 Hours)– Offer pregnancy testing to all women of child bearing age

not known to be pregnant.– Seek expert consultation if viral resistance suspected.– Administer PEP for 4 weeks if tolerated.

oPEPoPEPHepatitis B Hepatitis B InfectionInfection

Concentration of HBV in Body FluidsConcentration of HBV in Body Fluids

High Moderate Low/Not

Detectable

Blood Semen Urine Serum Vaginal Fluid Feces Wound exudates Saliva Sweat

TearsBreast Milk

Vaccination and antibody response status of exposed

worker*

Treatment when source is found to be:

HBsAg positiveHBsAg negative

Source unknown

or not available

for testing

Unvaccinated HBIG x1 and initiate Hepatitis B vaccine series.

Initiate hepatitis B vaccine series

Initiate hepatitis B vaccine series

Previously vaccinated

Known responder No treatment No treat. No treatment

Known non-responder

HBIGx1 and initiate re-vaccination or HBIGx2

No treatment

If known high risk source, treat as if source were HBsAg positive

Antibody response unknown

Test exposed person for anti-HBs

1. If adequate, no treatment.

2. If inadequate, HBIGx1 and vaccine booster.

No treatment

Test exposed person for

anti-HBs: 1. If adequate,

no Treatment

2. If inadequate, vaccine

booster and recheck titer

in 1-2 months.

• Persons who have previously been infected with HBV are immune to reinfection and do not require PEP.

• Hepatitis B immunoglobulin: dose 0.06ml/kg im• A responder is a person with adequate levels of serum

antibody to HBsAg (i.e. anti-HBs > 10mIU/ml): a non-responder is a person with inadequate response to vaccination (i.e. serum anti-HBs antibody< 10mIU/ml)

• The option of giving one dose of HBIG and reinitiating the vaccine series is preferred for non-responders who have not completed a second 3-dose vaccine series. For those who previously completed a second vaccine series but failed to respond, 2doses of HBIG are preferred. Give one dose at time of exposure, and the second dose one month later.

Regimen Prevention of HBV Infection

Multiple doses of HBIG alone when 1st dose initiated within 1 week

70-75%

Hepatitis B vaccine series alone 70-75%

Combination of HBIG and vaccine series 85-95%

* Estimated for adults, based on perinatal data

Efficacy of HBV PEP*

Hepatitis B Vaccine: Long-Term Efficacy

• Anti-HBs titers decline to <10 mIU/mL in 30-50% of adults within 8-10 years after vaccination

• Exposure to HBV results in anamnestic anti-HBs response that prevents clinically significant HBV infection

• Immune memory remains intact for at least 20 years after immunization

• Chronic HBV infection rarely documented among vaccine responders

• Booster doses currently not recommended

oPEPoPEPHepatitis C Hepatitis C InfectionInfection

oPEPoPEPHepatitis C InfectionHepatitis C Infection

Not recommendedNot recommended

oPEPHIV Infection

AIDS

Clinical stage 4

AIDS Defining illnesses

Overview of the HIV clinical disease

75%Clinical stage 2

Clinical stage 3

Clinical stage 1

8 to 12 years1-4wks 3wks

HIV Seroconversio

n illness

33%

Natural History of HIV Infection

Percutaneous injuries

Exposure type

Infection status of the sourceHIV-positive, class 1

Aymptomatic HIV infection or known low viral load (e.g. <1500)

HIV-positive, class 2

Symptomatic HIV infection, AIDS, Acute seroconversion, or known high viral load

Source of unknown HIV status

(e.g deceased source person with no samples available for HIV testing)

Unknown source

(e.g. a needle from a sharps disposal container)

HIV negative

Less severe (e.g. solid needle, superficial injury)

Recommend basic 2-drug PEP

Recommend expanded 3-drug PEP.

Generally, no PEP

Generally, no PEP

No PEP

More severe

(e.g. large-bore hollow needle, deep puncture, visible blood on device or needle used in patient’s artery or vein)

Recommend expanded 3-drug PEP.

Recommend expanded 3-drug PEP.

Generally, no PEP

Generally, no PEP

No PEP

Mucous membrane exposures and non-intact skin exposures.

Exposure type

Infection status of the source

HIV-positive, class 1

Asymptomatic HIV infection or known low viral load (e.g. <1500)

HIV-positive, class 2

Symptomatic HIV infection, AIDS, acute seroconversion, or known high viral load

Source of unknown HIV status

(e.g. deceased source person with no samples available for HIV testing)

Unknown source

(e.g. splash from inappropriately disposed blood)

HIV-Negative

Small volume (e.g. few drops)

Consider basic 2-drug PEP

Recommend basic 2-drug PEP

Generally, No PEP

Generally, No PEP

No PEP

Large volume (e.g. major blood splash)

Recommend basic 2-drug PEP

Recommend expanded 3-drug PEP

Generally, No PEP

Generally, No PEP

No PEP

• If drug resistance is a concern, obtain expert consultation. Initiation of PEP should not be delayed pending expert consultation and, because expert consultation alone cannot substitute for face-to-face counseling, resource should be available to provide immediate evaluation and follow-up care for all exposures.

• The designation “consider PEP” indicates that PEP is optional and should be based on as individualized decision between the exposed person and the treating clinician. However, consider basic 2-drug PEP for a source with HIV risk factors, or occurs in a setting where exposure to HIV-infected persons is likely.

• If PEP is offered and taken, and the source is later determined to be HIV negative, PEP should be discontinued.

• For skin exposures, follow-up is indicated only if there is evidence of compromised skin integrity (e.g. dermatitis, abrasion, or open wound)

Risk of Adverse Effects

Risk of Transmission

Considerations When Using PEP Considerations When Using PEP

PEP

Basic Regimen

Zidovudine (ZDV)

Lamivudine (3TC)

200 mg tid (300 mg PO bid)

150 mg bid

Alternate Basic Regimens

Didanosine (ddI)

Stavudine (d4T)

Stavudine (d4T) Lamivudine (3TC)

200 mg bid (125 mg bid if <60 kg)

40 mg bid (30 mg bid if <60 kg)

40 mg bid (30 mg bid if <60 kg)

150 mg bid

Postexposure Management: HIV PEP Postexposure Management: HIV PEP Basic RegimenBasic Regimen

Expanded Regimen

Basic regimen plus one of the following

Indinavir (IDV) 800 mg q8h

Nelfinavir (NFV) 750 mg tid or 1250 mg bid

Efavirenz (EFV) 600 mg daily

Abacavir (ABC) 300 mg bid

Postexposure Management: HIV Postexposure Management: HIV Expanded RegimenExpanded Regimen

Elements of Postexposure Management

• Wound management & Exposure reporting → Step 1

• Risk Assessment → Step 2– (1) blood borne infection status of source source

personperson

– (2) Infectious materialInfectious material

– (3) type and severity of exposureexposure

– (4) Susceptibility of HCWSusceptibility of HCW

• Appropriate treatment → Step 3• Follow-up, and counseling → Step 4

HBV Infection HCV infection HIV InfectionAdvice exposed persons to seek medical evaluation for any acute any acute illnessillness occurring during follow-up

Advice exposed persons to seek medical evaluation for any acute any acute illnessillness occurring during follow-up

Perform HIV antibody testing for illness compatible with an acute acute retroviral syndrome.retroviral syndrome.

Test for anti-HBs 1-2 months after last dose of vaccine if only if only vaccine vaccine given. given. ((anti-HBsanti-HBs response to vaccine cannot be ascertained if HBIG received in the previous 3-4 months)

Perform testing for anti-HCV and ALT 4-6 months after exposure

Evaluate exposed persons taking PEP within 72 hours after exposure and monitor for drug toxicity for at least 2 weeks.

Follow-up not indicated if exposed person immune to HBV or received HBIG PEP

Perform HCV RNA testing at 4-6 weeks if earlier diagnosis of HCV infection desired

Perform HIV-antibody testing for at least 6 months postexposure (e.g. at baseline, 6 weeks, 3 months, and 6 months)

Prevent secondary transmissionrevent secondary transmission on during the follow-up period. Refrain from donating blood, plasma, organs, tissue, or semen.

No need for: modification of sexual practices or patient care, refraining from conception

Confirm repeatedly reactive anti-HCV EIA with supplemental test

Prevent secondary Prevent secondary transmissiontransmission on during the follow-up period.

Step 4 Perform follow up testing and provide counselingStep 4 Perform follow up testing and provide counseling

Preventing Transmission of Preventing Transmission of Blood borne VirusesBlood borne Viruses

in Healthcare Settingsin Healthcare Settings

Frequency of Percutaneous Injury in Frequency of Percutaneous Injury in Healthcare PersonnelHealthcare Personnel

• Based on CDC estimates, 384,325 (95% CI 311,091-463,922) percutaneous injuries are sustained by healthcare personnel in US hospitals annually*

• The number of injuries sustained outside of hospital settings is unknown

• Frequency of percutaneous injury varies by occupational group and healthcare setting

* Panlilio, AL, et. al. Estimate of the Annual Number of Percutaneous Injuries in U.S. Healthcare Workers. 4th Decennial Conference, March 5-9, 2000

Preventing Transmission of Bloodborne VirusesPreventing Transmission of Bloodborne Virusesin Healthcare Settingsin Healthcare Settings

• Promote hepatitis B vaccination• Treat all patients as potentially

infectious• Use barriers to prevent

blood/body fluid contact• Prevent percutaneous injuries