1. Post Exposure Prophylaxis For Management of Occupational Exposure Dr A.K. Gupta MD (Pediatrics) Additional Project Director Delhi State AIDS Control Society Govt of Delhi

2. Definitions Occupational exposure refers to exposure to potential blood-borne infections (HIV, HBV and HCV) during performance of duties. Non-occupational exposure refers to exposure to potential blood-borne infections (HIV, HBV, HCV) outside work setting- e.g. sexual assault /rape/sodomy etc Post exposure prophylaxis (PEP) refers to the comprehensive management given to minimize the risk of infection following potential exposure to blood-borne pathogens (HIV, HBV, HCV). 2

3. 3 Exposures which place health personnel at risk of blood borne infection – A percutaneous injury e.g. Needle stick injury (NSI) or cut with a sharp instrument Contact with the mucous membrane of eye or mouth Contact with non-intact skin (abraded skin or with dermatitis) Contact with intact skin when the duration of contact is prolonged with blood or other potential infected body fluids

4. Exposed Person Exposed person is the person who is at risk of acquiring HIV/HBV/HCV infection through exposure to blood or body fluids. Who is at Risk ? - Nursing Staff Emergency Care Providers Labor & delivery room personnel Surgeons and operation theater staff Lab Technicians Dentists Health cleaning/ mortuary staff / Waste Handlers 4

5. 5 Potentially infectious body fluids - Exposure to body fluids considered at risk Exposure to body fluids considered not at risk unless they contain visible blood Blood, Semen, Vaginal secretions, CSF, Synovial, Pleural and Pericardial fluid, Amniotic fluid & other body fluids contaminated with visible blood Tears, Sweat, Urine and faeces, Saliva, Sputum and vomitus

6. . Occupational Blood-Borne Exposures Relative Risk of Sero-conversion with Percutaneous Injury Mucous membrane splash to eye, oro nasal 0.09%

7. 7 Work Practices which Increase the Risk of Needle Stick Injury Recapping needles (Most important) Performing activities involving needles and sharps in a hurry Handling and passing needles or sharp after use Failing to dispose of used needles properly in puncture-resistant sharps containers Poor healthcare waste management practices Ignoring Universal Work Precautions

8. Risk Factors for HIV Seroconversion in HCWs Risk Factor Adjusted Odds Ratio* Deep Injury 15.0 Visible Blood on Device 6.2 Terminal Illness in Source Patient 5.6 Needle in Source Vein/Artery 4.3 From: NEJM 1997;337:1485- 90. *All Risk Factors were significant (P < 0.01)

9. Supreme Court Directive To Ensure PEP Drugs in All Govt Hospitals 1.Universal Work Precautions (UWP) and PEP guidelines should be followed by HCPs to prevent occupational transmission of HIV, Hepatitis B and hepatitis C. 2.This will develop confidence in HCPs while working with patients some of whom might be infected with HIV/HBV/HCV. 3.PEP drugs should be available in all Govt Hospitals to enable protection of HCPs dealing with potentially infected patients to make sure that no patients suffering from HIV be denied treatment/surgery/ procedures etc 4.Availability of UWP and PEP can minimize the stigma and discrimination against PLHIVs in Health Care facilities.

10. 10 Post Exposure Prophylaxis (PEP) It refers to the comprehensive management to minimize the risk of infection following potential exposure to blood borne pathogens (HIV, HBV, HCV ).It includes –  First Aid  Risk Assessment  Counseling  PEP drugs (4Weeks) depending upon risk assessment  Relevant Lab Investigation on informed consent of the source and exposed person  Follow up and support

11. 11 Management of exposed person 1 st step: Management of exposed site - First Aid  Skin: Do not squeeze the wound to bleed it, do not put the pricked finger in mouth. Wash with soap & water, don’t scrub, no antiseptics or skin washes (bleach, chlorine, alcohol, betadine).  Eye: wash with water/ normal saline/ don’t remove contact lens immediately if wearing, no soap or disinfectant.  Mouth: spit fluid immediately, repeatedly rinse the mouth with water and spit / no soap/ disinfectant.

12. 12 2 nd step: Establish eligibility for PEP Evaluation must be made rapidly so as to start treatment as soon as possible-ideally within 2hours but certainly within 72 hours of exposure. However all exposed cases don’t require prophylactic treatment. Factors determining the requirement of PEP-  Nature/Severity of exposure and risk of transmission  HIV status of the source of exposure  HIV status of the exposed individual

13. 13 A. Categories of exposure CategoryDefinition and Example Mild exposure Mucous membrane/non-intact skin with small volumes e.g. a superficial wound with a low caliber needle, contact with eyes or mucous membrane, subcutaneous injections with a low caliber needle. Moderate exposure Mucous membrane/non-intact skin with large volumes or percutaneous superficial exposure with solid needle e.g. a cut or needle stick injury penetrating gloves. Severe exposure percutaneous exposure with large volumes e.g. an accident with a high caliber needle visibly contaminated with blood, a deep wound, an accident with material that has been previously been used intravenously or intra-arterially

14. 14 Exposure with discarded sharps / needles, contaminated for over 48hrs, the risk for HIV is negligible but risk for HBV remains significant as HBV survives longer outside the body.

15. 15 B. Assessment of HIV status of the source of exposure  A baseline rapid HIV testing should be done before stating PEP. Further initiation of PEP where indicated should not be delayed for want of report.  A + HIV test result can help taking a decision but a negative test result does not exclude HIV infection as the source may be in the window period.  When the status of source is unknown or the sample is not available for testing the risk is based on the HIV prevalence in the geographical area. C. Assessment of the exposed individual Exposed individual should be tested for pre-existing HIV infection. HIV + cases should not receive PEP and should be referred to ART centre for eligibility of ART and further management.

16. 16 Information to exposed person includes - 1.The risk of acquiring HIV infection from specific exposure. 2.PEP is provided to prevent potential transmission of HIV virus. It is not 100% effective and should be given preferably within 2 hours but certainly within 72 hours if eligible. 3.Baseline HIV testing is important. PEP medicines will be discontinued if the initial baseline HIV test is positive. In that case further assessment for initiating ART would be done. 4.Duration of course of medicine is 4 weeks. Importance of adhering to medication once started. Medicines can be stopped at any time but benefit of PEP will not be obtained. 5.Common side effects of medicines. 6.After exposure the person should not have unprotected sexual intercourse until it is confirmed 6 months after the exposure that he/she is not HIV infected. Condom use is essential 7.The PEP drugs are usually safe during pregnancy. If the lady gets HIV due to exposure during pregnancy, the baby will have some risk of becoming HIV infected. 8.The PEP drugs are usually safe during breast feeding but the lady may consider stopping breast feeding if PEP is indicated. 9.Symptoms and signs of early HIV sero conversion 10.Risk of Hepatitis B and Hepatitis C after needle stick exposure and available prophylaxis for this. 3 rd step – Counseling for PEP

17. 17 There are 2 types of regimen Basic - 2 drug combination Expanded regimen - 3 drug combination 4 th step – Prescribe PEP Drug2 drug regimen3 drug regimen Zidovudine(AZT) Or Stavudine (d4T) + Lamivudine (3TC) Protease inhibitors If Protease inhibitors is not available 300 mg twice a day or 30 mg twice a day + 150 mg twice a day Nil 300 mg twice a day or 30 mg twice a day + 150 mg twice a day + 1 st choice: Lopinavir/ ritonavir 400mg/100mg twice a day or 2 nd choice: Nelfinavir 1250 mg twice a day Efavirenz (EFV) 600 mg once a day

18. 18 Exposure Status of source HIV+ and asymptomatic HIV+ and symptomatic HIV status not known MildConsider 2 drug PEP Start 2 drug PEP Usually no PEP or Consider 2 drug PEP ModerateStart 2 drug PEP Start 3 drug PEP Usually no PEP or Consider 2 drug PEP SevereStart 3 drug PEP Usually no PEP or Consider 2 drug PEP HIV testing of source should not delay the decision of starting PEP. Start 2 drugs first if required then obtain consultation. Prophylaxis needs to be continued for 4 weeks. For a female under consideration of PEP a pregnancy test is recommended. Efavirenz is contraindicated in first 3months and Indinavir during Pre natal time. It is recommended to begin with basic regimen and if 3 rd drug is required then add Nelfinavir.

19. Tolerability of HIV PEP in HCWs From: Wang SA. Infect Control Hosp Epidemiology 2000;231:780-5.

20. Protection Against Hepatitis B 20

21. 21 5 th step - Laboratory Evaluation Reason for testing soon after exposure is to establish “baseline’ against which to compare future test results. TimingIn persons on PEPIn persons not on PEP Baseline (with in 8 days of exposure) HIV, anti- HCV, HBsAg, Complete blood counts Transaminases HIV,HCV,HBV 6 th step – Follow up Clinical – Monitoring for appearance of signs of HIV sero conversion Use precautions to prevent secondary transmission (Blood donation, Breast feeding,Pregnancy, Unprotected Sexual relations especially during 6-12 wks following exposure. Condom use is essential. Drug adherence Psychological support

22. 22 Lab follow up for HIV and Hepatitis – TimingIn persons taking PEP Weeks 2 & 4 Transaminases Complete blood counts Week 6HIV-Ab Month 3HIV-Ab, anti - HCV, HBsAg, Transaminases Month 6HIV-Ab, anti –HCV, HBsAg, Transaminases Exposed persons should have post PEP HIV test. Testing at end of PEP may give indication of sero conversion. To diagnose all persons who sero convert testing at 3 and 6 months is recommended.

23. 23 Availability of PEP at Healthcare facility It is recommended that PEP drugs be kept available round-the-clock in any of the three locations - Emergency room, Labor room and ICU. Drug Stock at the Healthcare facility PEP kit comprises of 2 drug regimen: Zidovudine(AZT) 300mg + Lamivudine (3TC) 150 mg as a fixed dose combination 3 rd Drug (PI) can be purchased from chemist near RML Hospital, Lok Nayak Hospital or AIIMS & amount will be reimbursed by DSACS.

24. 24 hour PEP Helpline PEP guidelines on web site of DSACS. www.delhisacs.org

25. 25 Thanks