1. Non-Occupational Post Exposure Prophylaxis NPEP Jude Armishaw Victorian NPEP Service The Alfred

2. What is PEP? Post-exposure prophylaxis (PEP) –A treatment following an exposure to an infection –Aim is to prevent the infection from becoming established in the host HIV PEP –Use of antiretroviral medications to reduce the risk of transmission of HIV –Same drugs as used to treat HIV infection –Started with 72 hours of exposure –Taken for one month (28 days)

3. NPEP Non occupational post-exposure prophylaxis –Use of PEP outside the healthcare setting –Sexual exposure –Injecting drug use exposure

4. HIV Transmission Risk = RISK CARRIED BY THE EXPOSURE X RISK THAT THE SOURCE IS HIV POSITIVE

5. Risk of HIV Transmission - Source HIV Positive EXPOSURE ROUTE SOURCE HIV INFECTED Estimated per act risk Receptive anal intercourse 1/120 Needle sharing injecting drug use 1/150 Occupational needlestick injury 1/333 Insertive anal intercourse 1/1000 Receptive and insertive vaginal intercourse 1/1000 Receptive oral intercourse with ejaculation Not measurable Insertive oral intercourse Not measurable

6. HIV Transmission Risk Risk estimates only HIV transmission heterogeneous Per-contact risk for any individual may be considerably higher than the average More useful for assessing population based risk rather than absolute risk for an individual

7. Cofactors increasing HIV transmission High plasma viral load in the source partner Presence of STI, especially genital ulcer disease and symptomatic gonorrhoea in source or exposed person Source ~ increases viral load Exposed ~ increases dendritic cells A breach in mucosal integrity of exposed person (e.g. scratch, cut) through which host dendritic cells capture HIV

8. Role of dendritic cells in HIV transmission

9. What is the risk where the partner’s HIV status is unknown? Most common presentation for NPEP is MSM following unprotected anal sex with an anonymous partner How do we assess risk where source HIV status unknown? Seroprevalence

10. HIV Transmission Risk = RISK CARRIED BY THE EXPOSURE X RISK THAT THE SOURCE IS HIV POSITIVE

11. HIV Sero-prevalence Community GroupHIV Seroprevalence MSM – Melbourne10% ( Gay Periodic survey) Injecting Drug users –MSM –All others Up to 32% (may vary locally) 1% Heterosexuals –Blood donors –STI clinic attendees –Commercial sex workers 0.0005% <0.2% 0.1% Selected other regions –Oceania, W & central Europe, N Africa & Middle East, E Asia, NZ –Latin America, N America, S & SE Asia, E Europe & Central Asia –Caribbean –Sub-Saharan Africa ≤0.4% 0.3-0.9% 1.0% 5.0%

12. HIV Transmission Risk & Recommendations EXPOSURE ROUTE ESTIMATED PER ACT RISK Source HIV + Source unknown MSM Source unknown Heterosexual Receptive anal intercourse1/120 R31/1 200 R21/120 000 Needle sharing IDU1/150 R31/880 R21/15,000 C2 Insertive anal intercourse1/1000 R31/10,000 C2* STI, trauma blood 1/1 000 000 Receptive vaginal intercourse 1/1000 R3 1/1 000 000* Insertive vaginal intercourse 1/1000 R3 1/1 000 000* Receptive oral intercourse with ejaculation Not measurable C2* oral mucosa not intact Not measurable Insertive oral intercourseNot measurable

13. Efficacy and evidence Animal data Start within 72 hours of exposure Sooner the better Taken for 28 days Completion of course with good compliance HCW case control study and MTC Reduces HIV transmission by up to 80%

14. Recommended NPEP Regimens 2- drug regimen Truvada (Tenofovir 300mg/Emtricitabine 200mg) One tablet daily for 28 days Or Combivir (Zidovudine 300mg/Lamivudine 150mg) One tablet twice daily for 28 days 3- drug regimen One of the above 2 drug combinations Plus Kaletra (Lopinavir 200mg/Ritonavir 50mg) Two tablets twice daily for 28 days

15. Addition of 3 rd drug Higher risks (RAI, IAI, RVI, IVI, IDU w pos source) –But … no data to show 3 drug NPEP regimen more efficacious than 2 drug regimen –Based on evidence that 3 drugs is more effective in treating established HIV (HAART) Source ARV Hx –Where resistance genotype indicates drug resistance tailor NPEP regimen

16. Side effects Side effects in 45-75% NPEP patients –Nausea –Headache –Fatigue & lethargy –Diarrhoea Adherence to full 28 day course important Completing a 2 drug regimen may exceed the benefit of a poorly tolerated 3 drug regimen

17. NPEP Service Service commenced Aug 2005Service commenced Aug 2005 Alfred Hospital, VAC and DHSAlfred Hospital, VAC and DHS Hub and Spoke ModelHub and Spoke Model Hub is Alfred HospitalHub is Alfred Hospital –0.8 FTE Clinical Nurse Consultant (CNC) –0.3 I.D. Physician –0.3 Clinical Psychologist –5 Registered Nurses on-call 24/7 for 1800 number

18. NPEP spoke clinics in Metropolitan & Rural Vic Metropolitan –Prahran Market Clinic –Centre Clinic –Carlton Clinic –MSHC –Northside Clinic –Recreation Medical Centre –Alfred ED (A/H only) –The Alfred ID Clinic –Middle Park Clinic –Richmond Hill Medical Centre –Monash Medical Centre –Royal Melbourne Rural BendigoBendigo SheppartonShepparton GeelongGeelong WodongaWodonga WarrnamboolWarrnambool

19. Telephone Information Line 1800 889 887 (24 hours Fri – Mon and 0830 to midnight Tue – Thurs) Staffed by RNs on rotating rosterStaffed by RNs on rotating roster RNs trained inRNs trained in –HIV –Sexual Health –NPEP –Telephone Counselling Skills

20. Community exposure to HIV  Call 1800 889 887  Nurse assess and refer to spoke clinic if need NPEP  Patient go to spoke clinic  Given starter pack (7 days)  Paperwork faxed to NPEP Service and remainder packs sent to clinic for patient to collect  Patient return at week 1 for remaining 21 days medication  Patient return for week 4 and 12 follow-up

21. Case 1 A young man tells you that he was in a sauna last night and had insertive anal sex with an anonymous partner. He did not use a condom. > What is his risk of getting HIV from this exposure? > What factors need to be assessed? > Is NPEP recommended?

22. Case 2 A heterosexual man tells you that he went to see a female sex worker in Melbourne yesterday and had insertive penile-vaginal sex. He used a condom, but when he withdrew he noticed that the condom had broken. > What is his risk of getting HIV from this exposure? > Would you recommend that he take NPEP? > Would the risk be any different if it had happened in Thailand?

23. Case 3 A woman tells you she was walking along St Kilda beach and felt a sharp sting in her foot. When she looked down she saw that she had stepped on a needle. > What is the risk of getting HIV from this exposure? > Is NPEP recommended? > What are the other factors that need to be assessed?

24. Case 4 A man tells you that he had unprotected receptive anal sex 2 days ago with a casual partner that he met on the internet. Last night this partner told him that he has HIV. > What is his risk of getting HIV from this exposure? > Is NPEP recommended? > What other factors would you need to assess?

25. Case 5 A young man is very distressed that he had unprotected receptive oral sex last night with an anonymous partner that he met at a bar. The partner ejaculated into his mouth. > What is the risk of HIV from this exposure? > Is NPEP recommended? > What other factors would you need to assess?

26. Feedback

27. Final Questions and Thankyou