Pre and Post Exposure Prophylaxis. Laila AL Dabal MD FRCP MSc Infectious Diseases Unit Dubai Health Authority 15 March 2018

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1 Pre and Post Exposure Prophylaxis Laila AL Dabal MD FRCP MSc Infectious Diseases Unit Dubai Health Authority 15 March 2018

2 Indications for Pre and Post Exposure Prophylaxis: occupational and non-occupational exposure Legal aspects of occupational and non-occupational exposure And should it be mandatory for HCP? Is prophylaxis always justified? Updated guidelines: when to give, what to give, for how long and monitoring- Case scenarios Rashid Hospital data

3 The essence of ID and IC : how to prevent before exposure and how to control after exposure

4 Relevant factors when assessing for PrEP and PEP Immunity of exposed person:age,immunesupressing disease or medication Vaccine-preventable diseases vaccination history Specific immune globulin- Medical chemoprophylaxis-signs/symptoms of active infection Risk assessment /stratification /checklists Baseline tests ( active and latent infections, renal/hepatic profiles, pregnancy/breast feeding, concomitant medication ) Counseling

5 Non-occupational ( community) exposure Sexual: known or unknown partner Respiratory route ( airborne and droplet) Mucosal and Contact transmission Needle stick and sharp objects exposure Human and animals bites Spectrum: HIV, HBV,STD VZV, TB, meningococcal, influenza, measles, VHF, Rabies, Tetanus,

6 Occupational exposure Needle stick and sharp objects exposure Mucosal and Contact transmission Respiratory route ( airborne and droplet) Bites and scratches Spectrum: BBV: HBV/HCV/HIV VZV, TB-MDR TB, influenza,measles,meningococcal, Brucellosis VHF,

7 Pre and post exposure vaccines what is relevant to HCW BCG HAV Typhoid Cholera MMR Tetanus Meningococcal Pertussis Diphtheria HBV VZV Influenza

8 Specific immunoglobulin HAV HBV Rabies CMV VZV Tetanus German Measles (Rubella)

9 Efficacy and safety data Any form of PrEP or PEP is not 100% effective in preventing the development of active infection post exposure. Several factors are linked to efficacy like route of transmission, inoculum size, time to prophylaxis, PEP regimen potency, PrEP and PEP are not always safe and there can be drug-related SE and toxicities as in other situations

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11 At Dubai Government level

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13 Administrative support At DHA level Medical Fitness Department-DHA and community Preventive Medicine Department- community Occupational Health Department Central Infection Control and prevention committee Pharmacy, Laboratory, Quality offices, Staff clinics, employee health clinics, IDU in Rashid Hospital, IC teams, IPC committees in hospitals and Primary Health Care clinics with Policies and Procedures plus pathways in place.

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15 RH data Staff clinic/quality office Type of injury NS and sharp object injury Mucous membrane exposure Other Infectious diseases exposure Number of exposed staff

16 Ward 4 ( Infectious Diseases Unit) data F: Blood splash from HIV pt. into her eyes PEP No conversions F:Needle prick from HIV pt. PEP No conversions M : NSI while inserting Central line PEP No conversion F: non bloody Secretion splash from HIV pt. on her hands M: Saliva from HIV positive on non intact skin No PEP No PEP No conversion No conversion M: Sneezing on face by MDR,PTB pt. No PEP Did not develop active disease 37/52 pregnant nurse exposed to H1N1 +VE case Female nurse exposed to VZV case M: nurse had a spit on his face by HIV/HBV positive patient F: nurse had a CCVHF patient vomitus on her hand Oseltamivir VZV vaccine series No PEP Ribavirin PEP Did not develop active disease Did not develop active disease No follow up No conversion

17 Most recent consults: 3 OB/GY young female doctors had emergency surgery for ovarian torsion case. After closure, they were informed that the patient was HIV positive A young CID police officer had a bite from an aggressive? HIV positive lady ( sex worker) A young UAE male with recent travel to Thailand had un-protected exposure while there to unknown sex worker

18 Scenario 1 A 39 yr old female, working in ward 4, and while collecting ABG samples at 1700 on Thursday for a newly diagnosed advanced AIDS patient with HIV VL of > 100,000 copies per ml and pending HIV genotype test, she had eye splashes with blood. She stopped immediately, washed her eyes and went to ER. The immediate action to be taken by ER physician would be to: 1- reassure her as the risk of mucosal transmission of HIV is very low and no need for Post Exposure Prophylaxis 2- check her baseline status and start PEP as standards immediately 3- ask her to go to staff clinic on Sunday 4- call ID on call immediately

19 Scenario 2 3 ob./gyn doctors were involved in emergency surgery in Dubai Hospital for an un-booked patient. They has variable degrees of undocumented exposure with one only wearing double gloves. After wound closure, they were told that she is HIV positive with high titers on ELISA test. The ID on call is contacted 33 hours after exposure. What would be the best action to take now? 1- Start PEP for all three pending WB confirmation and HIV PCR for the patient 2- Individualize PEP decision based on history of exposure and risk of transmission 3- Do not start PEP to any as it is too late to be effective ( more than 24 hrs) 4- council the doctors and reassure that risk of exposure is very low and her HIV is not confirmed yet

20 Scenario 4 A 32 year old lady is married to HIV positive patient, he is on ART for the last 3/12 and his HIV VL is zero on Rx. She is planning to become pregnant. What advise would you give her? 1- She should be on protected sex and start pre exposure prophylaxis till he is maintaining zero viremia for at least 6/12 2- She should be on life long prophylaxis plus protected sex as there is a risk of virologic failure in her husband 3- She can have un-protected sex and no need for PrEP as he has zero viremia 4- They should try IVF to avoid the risk of HIV transmission

21 HIV PrEP

22 HIV PrEP at IDU-RH Used in few discordant couples Main indication is for female partner planning for natural methods of pregnancy Majority of our discordant couples are not on PrEP: monitored every 6/12 and counseled about transmission reduction methods with maintenance of zero viremia in positive partner.

23 Occupational BBV: HIV,HBV,HCV

24 For transmission of blood borne pathogens (HIV, HBV and HCV) to occur, an exposure must include both of the following: Infectious body fluid Blood, semen, vaginal fluid, amniotic fluid, breast milk, cerebrospinal fluid, pericardial fluid, peritoneal fluid, pleural fluid and synovial fluid can transmit HIV, HBV and HCV. Saliva, vomitus, urine, feces, sweat, tears and respiratory secretions do not transmit HIV (unless visibly bloody). The risk of HBV and HCV transmission from non-bloody saliva is negligible. A portal of entry (percutaneous, mucous membrane, cutaneous with non-intact skin). If both of these factors are not present, there is no risk of transmission and further evaluation is not required.

25 Risk of HBV, HCV and HIV transmission after occupational percutaneous exposure Role of 30,3 and 0.3% HBV risk varies depending on e-antigen: If e-antigen positive, risk is up to 30% If e-antigen negative, risk is 1-6% HCV risk is 1.8% (range of 0-7%) HIV risk is 0.3% (range of %)

26 Average Risk of HIV Infection to Healthcare Personnel by Exposure Route

27 Occupations of US Healthcare Personnel with Documented/Possible Occupational AIDS/HIV Infection

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30 What is the time frame for using PEP? Efficacy is time sensitive: first dose should be given as soon as possible. Optimal time to start PEP is within hours of exposure, rather than days. Do not wait for SP test results (unless results will be available within an hour or two) to proceed with a PEP decision and initiation, when indicated. 72 hours post-exposure as the outer limit of opportunity to initiate PEP; however, a delay of that scale is believed to compromise PEP efficacy. The 72-hour outside limit recommendation is based on animal studies; no human data are available.

31 SEXUAL ASSAULT? Yes No Assailant known? Yes No TESTING AND MEDICAL HISTORY Previous Baseline Following Current Exposure Condition Result Date Result Date Other results HIV +ve -ve +ve -ve Biochemistry/liver function tests Hepatitis C +ve -ve +ve -ve Pregnancy +ve -ve Syphilis +ve -ve +ve -ve Current and past medical history, e.g. renal disease: Other STIs +ve -ve +ve -ve HBsAg +ve -ve +ve -ve All medications and drug allergies: Anti-HBs +ve -ve +ve -ve Anti-HBc +ve -ve +ve -ve Psychiatric history: Hepatitis A IgG +ve -ve Drug and alcohol history: CHARACTERISTICS OF EXPOSURE Date of exposure / / Time of exposure am/pm Place of exposure: Sexual contact Sharps exposure Receptive anal sex: ejaculation withdrawal Occupational Non-occupational Insertive anal sex: circumcised uncircumcised Reuse of injecting equipment Other needle-stick injury Receptive vaginal sex Hollow bore needle Solid bore needle Solid sharp Insertive vaginal sex: circumcised uncircumcised Other exposure Receptive oral sex Insertive oral sex Mucous membrane: occupational non-occupational Other risks Blood splash: Condoms used? Yes No superficial non-intact skin mucous membrane Condom: broke slipped removed by source Under the influence of alcohol or drugs? Yes No RISK CHARACTERISTICS OF SOURCE Sex Male Female Non-binary HIV positive Antiretroviral use Source HIV risk Partner +ve -ve Unknown known no ARV MSM regular HBV suspected unknown Injecting drug use casual HCV unknown past ARV High prevalence other STIs Last viral load: Date: current ARV country Which STIs, if any: TRIAGE AND PEP ASSESSMENT Date / / Time am/pm Location Management Post exposure prophylaxis for HIV recommended? Yes No Hepatitis B immunoglobulin / / Regimen commenced? Yes No Hepatitis B vaccine / / Has patient taken PEP in the last 12 months? Yes No Was patient referred to counselling? Yes No Did patient consent to receive PEP? Yes No Reason not referred? Date PEP was received / / Time: am/pm Was PrEP discussed? Yes No Follow-up date / / & Location GP SHC Other Was PrEP recommended? Yes No Drug prescribed Dose Frequency Contraception given? Yes No I confirm that the above patient has had an exposure incident that may be a risk for HIV transmission. The result of the assessment for eligibility for HIV PEP is documented and drugs prescribed. Prescriber s signature Prescriber s name Provider number Contact details Telephone

32 Recommended PEP regimens 1- Emtricitabine/Tenofovir + Dolutegravir 2-Emtricitabine/Tenofovir + Raltegravir 3- Emtricitabine/Tenofovir + boosted Darunavir

33 Baseline tests and follow up Baseline Exposed staff HIV Ag/Ab, HBS Ag, HBS Ab, HCV Ab, CBC, LFT, renal profile Inform the lab that your sending post exposure samples for rapid TAT Exposure source HIV Ag/Ab-PCR if known HIV positive HBS Ag HCV Ab, PCR 72 hrs. Assessment for adherence and early SE Check lab results If HIV negative: stop PEP 14 days Assessment + blood tests Check lab results If HIV negative: stop PEP 28 days Assessment+ blood tests Check lab results If HIV negative: stop PEP 6-8 weeks HIV Ag/Ab-HIV PCR is not indicated Window period assessment in high risk groups only 16 weeks HIV Ag/Ab- stop if using COMBO test Check lab results if indicated 6 months HIV Ag/Ab, Check lab results if indicated 1 year HIV Ag/Ab- if HCV co-infection

34 Occupational HBV exposure

35 Concentration of HBV in Body Fluids

36 PEP for Exposure to HBV Unvaccinated Previously vaccinated Antibody response unknown HBIG x 1 and initiate hepatitis B vaccine series Test exposed person for anti-hbs 1. If adequate, no treatment 2. If inadequate, HBIG x 1 and vaccine booster

37 Efficacy of HBV PEP Regimen Multiple doses of HBIG alone when 1st dose initiated within 1 week Prevention of HBV Infection 70-75% Hepatitis B vaccine series alone Combination of HBIG and vaccine series 70-75% 85-95%

38 HCV work up and? PEP

39 Occupational Transmission of HCV Inefficiently transmitted by occupational exposures Average incidence 1.8% (range 0-7%) following percutaneous exposure from HCV-positive source Case reports of transmission from blood splash to mucous membrane

40 Recommendations Baseline testing Initial follow-up Final follow-up HCV+ SP or SP has potential HCV risk factors 6 weeks HCV RNA (HCV viral load) PEPline 2017 SP HCV status unknown or SP is known and has no known HCV risk factors HCV Ab Optional: 6 week HCV RNA 6 months HCV Ab CDC 2016 All source persons HCV Ab 3 weeks HCV RNA Optional: 6 month HCV Ab

41 CCVHF PEP Exposure assessment Baseline blood tests ( Pregnancy test if indicated) Ribavirin for 10-14? 21 days at 400 mg bd dose Check CCVHF PCR on day 5-if asymptomatic and negative PCR- stop ribavirin prophylaxis

42 Counselling Avoid blood /organ donation until informed that no active infection occurred Protected sex or refrain till advised Discuss pregnancy plans No job restrictions for occupational exposure while on PEP or under follow up

43 Process map mucosal exposure from viremic HIV/HBV/HCV positive + MDR-TB patient into unprotected eyes Exposure at 0830 Incident report in AMAN at minutes Staff clinic Registration and evaluation 0900 Lab for baseline test 1045

44 Challenges Lack of awareness in both occupational and community exposure on importance of PrEP and PEP whenever applicable Taking occupational exposure too easy or too serious to the degree on denial ( no tests done, delay in initialing PEP, not complaint with PrEP, no compliance with PEP, no time) Fear of stigma and legal consequences if diagnosed with serious infectious diseases ( TB, HIV) Lack of timely reporting and incidence documentation ( can have legal consequences) No access to PrEP or PEP including vaccines and immunoglobulin (availability, cost, no system in place)

45 In summary Assess exposure with understanding of core transmission principles Perform baseline tests- exposed and exposure source if available Decide if prophylaxis is indicated or not Decide what to give and for how long Follow up on prophylaxis and post completion In case of occupational exposure: timely reporting is crucial

46 Thank you