4/15/2010. Vermont Department of Health STD/HIV Program Vermont Department of Health STD/HIV Program. Vermont Department of Health STD/HIV Program

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1 First Let s Look at Some Numbers HIV Postexposure Prophylaxis for Occupational and Non- occupational Exposure National Vermont VtSHP Annual Meeting 4/10/10 Deborah Kutzko FNP "Financial support for this program has been provided by the New England AIDS Education and Training Center-NEHEC/MAI project, Funded by the US Department of Health Resources and Services Administration,(HRSA) and sponsored regionally by Commonwealth Medicine. UMass Medical School, Worcester, MA; Federal Grant Award # 6 H4AHA " 00" 1

2 Vermont HIV/AIDS Prevalence Vermont Department of Health STD/HIV Program Total: * Vermont diagnosed residents living with HIV (2008) 227 Vermont diagnosed residents living with AIDS (2008) Populations living with HIV/AIDS: 2008 More men than women were living with HIV/AIDS (83% of the cases are men) 86% of all HIV and AIDS cases diagnosed in Vermont are among white Non- Hispanic In Vermont, 36% of people newly diagnosed with HIV/AIDS are 40+ Vermont Department of Health STD/HIV Program Exposure and Risk in 2008 of HIV HIV Transmission Categories (VT): Men: MSM (77% of PLWHIV through 2008) Post-Exposure Prophylaxis (PEP) the use of therapeutic agents to prevent infection following exposure to a pathogen Women: heterosexual contact (56%) types of exposures include percutaneous (needlestick), splash, bite, sexual Vermont Department of Health STD/HIV Program for health-care workers, PEP commonly considered for exposures to HIV and Hepatitis B Occupational Risk Exposures in Health Care Personnel Percutaneous injury (needlestick, cut) OR Contact of mucous membrane or nonintact skin WITH: Blood Tissue Other body fluids that are potentially infectious (cerebrospinal, synovial, pleural, pericardial, peritoneal, or amniotic fluids; semen or vaginal secretions) NOT Considered Infectious for HIV, unless Visibly Bloody Feces Nasal Secretions Saliva Sputum Sweat Tears Urine Vomitus 2

3 Risk of HIV Infection following Occupational Exposure to HIV- Infected Blood Approximately 0.3% following percutaneous exposure Approximately 0.09% following mucous membrane exposure Factors Associated with Increased Risk Visible contamination of device (such as needle) with patient s blood Needle having been placed directly into vein or artery Hollow-bore (vs solid) needle Deep injury Source patient with terminal illness High viral load (not established in occupational exposure) Exposure Risks (average, per episode, involving HIV-infected source patient) Percutaneous (blood) 1 Mucocutaneous (blood) 2 Receptive anal intercourse 3 Insertive anal intercourse 4 Receptive vaginal intercourse 5 Insertive vaginal intercourse 6 Receptive oral (male) 7 Female-female orogenital 8 IDU needle sharing 9 Vertical (no prophylaxis) % 0.09% 1% 0.06% % % 0.06% 4 case reports 0.67% 10 24% Percent of HCWs Tolerability of HIV PEP in Health Care Workers Incidence of Common Side Effects Nausea Fatigue Headache Vomiting Diarrhea Myalgias Wang SA. Infect Control Hosp Epidemiol 2000;231: When should PEP be started? efficacy of PEP thought to wane with time at what point is PEP no longer worth it? risks of PEP benefits of PEP Timing of PEP: what s the evidence? animal models and animal PEP studies: suggest substantially less effective beyond hours 1,2 case-control control study: most subjects in each group received PEP within 4 hours 3 analysis of PEP failures does not suggest a clear cut-off 4 exposure time 1. Tsai C-C et al. J Virol 1998;72: Shih CC et al. JID Cardo DM et al. NEJM 1997;337: MMWR June 29, 2001:50(RR11);

4 How Long Should PEP be Administered? N = 24 macaques inoculated with SIV intravenously PMPA for PEP initiated 24 hours post- inoculation PEP administered for 3, 10, or 28 days Tsai C-C et al. J Virol 1998;72: days PEP days PEP days PEP seroconversion rate (%) Duration of PEP in animal model, 28 days more effective than 10 days or 3 days of PEP 1 4 weeks (28 days) used in case-control control study 2 and recommended by CDC guidelines 3 1. Tsai C-C et al. J Virol 1998;72: Cardo DM et al. NEJM 1997;337: MMWR June 29, 2001:50(RR11);1-42. Review of Vermont PEP Protocol NOTE: This algorithm is for use with ADULTS only. For consultation about PEP for children (as determined by stage on the Tanner Scale), call an infectious disease specialist: At Fletcher Allen Health Care: Comprehensive Care Clinic ( ) or Pediatric infectious disease specialist William Raszka, M.D. ( ) At Dartmouth-Hitchcock Medical Center: Infectious Disease Clinic ( or after hours at ) 5000) 1. Rape exam is performed. 2. Was there significant mucosal exposure? unprotected receptive anal intercourse unprotected insertive anal intercourse unprotected receptive vaginal intercourse unprotected insertive vaginal intercourse receptive fellatio with ejaculation. 3 IF YES: continue on with PEP algorithm IF NO: stop 4 Did the survivor present within 48 hours of the assault? IF WITHIN 48 HOURS: continue with PEP algorithm IF AFTER 48 HOURS: stop PEP algorithm and proceed to HIV testing algorithm Is the perpetrator s HIV status known? IF PERPETRATOR KNOWN TO BE HIV POSITIVE: call Infectious Disease Specialist. IF HIV STATUS OF PERPETRATOR UNKNOWN: : call Infectious Disease Specialist. Infectious disease specialists at the Fletcher Allen Health Care Comprehensive Care Clinic and at the Dartmouth-Hitchcock Medical Center Infectious Disease Clinic are available for consultation about PEP. Consultation with DHMC is appropriate for survivors (primarily from Orange and Windsor counties) who prefer to receive follow-up care in Lebanon, NH. FAHC Comprehensive Care Clinic: (24 hours/day) DHMC Infectious Disease Clinic: ( after hours) 4

5 If PEP is recommended and the survivor agrees to take the medications: Counsel survivor on possible side-effects effects of PEP. Administer initial dose and provide short-term term supply of PEP medications. On the next working day, survivor must receive follow-up for post- medication blood work, baseline HIV test, and prescription for balance of PEP drugs with infectious disease specialists from a site affiliated with the specialist that has provided consultation. Comprehensive Care Clinic has four sites: Burlington ; Rutland ; St. Johnsbury ; 7603; Brattleboro DHMC Infectious Disease Clinic Survivor may call Comprehensive Care Clinic or DHMC Infectious Disease Clinic with questions about PEP at any time. If PEP is recommended and the survivor does not want to take the medications: Survivor should be tested for HIV as soon as possible, then again at 6, 12, and 36 weeks. Survivor with Hepatitis C, test again at 36 weeks. Give survivor list of HIV test sites and AIDS hotline number ( ).* 2437).* IF SURVIVOR IS ACCOMPANIED TO HOSPITAL BY RAPE CRISIS ADVOCATE: advocate offers survivor follow up phone the next day to reassess decision. IF SURVIVOR IS UNACCOMPANIED BY RAPE CRISIS ADVOCATE: SANE offers survivor follow-up phone call to reassess decision. If PEP is not recommended survivor should be tested for HIV as soon as possible, then again at 6, 12, and 36 weeks. Survivor with Hepatitis C, test again at 36 weeks. Give survivor list of HIV test sites and AIDS hotline number ( ).* 2437).* Criteria for Recommending HIV Test for Sexual Assault Survivor Presenting More Than 48 Hours After Sexual Assault Is the perpetrator known to be infected with HIV? IF YES: : survivor should call FAHC Comprehensive Care Clinic ( ) or DHMC Infectious Disease Clinic ( ) 6060) without delay. IF STATUS OF PERPETRATOR IS UNKNOWN: : survivor should be tested for HIV as soon as possible, then again at 6, 12 and 36 weeks. Survivor with Hepatitis C, test again at 36 weeks. Give survivor list of anonymous and confidential HIV test sites. Old standard Combivir based Easy to take one pill 2 x a day Contains AZT - bone marrow toxicity New NNRTI based CDC suggestion Atripla Once a day 5

6 Interactions of ARV Agents ARVs can have serious interactions with other drugs Carefully evaluate concomitant medications, including over-the-counters, supplements, and herbals before prescribing PEP Consult package inserts or other resources on ARV drug-drug interactions Avoid interacting drugs and monitor carefully, as appropriate Resistance to ARVs Resistant virus may be present in a treatment- experienced source patient Resistance testing at time of exposure is not practical, because results will not be available to influence choice of initial PEP regimen No data suggest that modifying regimen when resistance test results become available (typically 1-2 weeks) will improve PEP efficacy Expert consultation is recommended Current thought at FAHC Truvada (emtricitabine/tenofovir) 1 pill qd Atazanivir (200 mg) 2 pills qd Ritonavir (100 mg) 1 pill qd Four pills once a day Side effects nausea, fatigue Atripla (SustivaTM (efavirenz) 600mg + TruvadaTM (tenofovir 300mg + emtricitabine 200mg) one tablet HS Total number of tablets per day = one Note: Sustiva is contraindicated in pregnancy May cause nightmares Still a good idea Combivir (AZT/3TC) 1 pill BID Kaletra (Lopinavir/Ritonavir) 3 pills BID 4 pills BID Side effects nausea/fatigue/amenia Post-Exposure Prophylaxis: Core Principles Evidence is limited Balancing of risks vs benefits Timing: the sooner the better, but interval beyond which there is no benefit is unclear 6

7 Post-Exposure Prophylaxis: Core Principles Optimal duration unclear, 28 days is recommended Decision making can get very complex when resistance in SP suspected Offering SEXPEP is reasonable for risky exposures, and does not appear to increase unsafe sexual behavior for most recipients 1 st visit Asses risk Asses desire for medications Review risk/benefit Lab for CBC/dif Complete metabolic panel Lab for HIV, HCV 2 nd visit 1 week after the first Asses risk Asses sx how are you feeling Review labs from last week Asses desire for medications Review risk/benefit Lab for CBC/dif Complete metabolic panel 3rd visit 1 week after the second Asses risk Asses sx how are you feeling Review labs from last week Asses desire for medications Review risk/benefit Lab for CBC/dif Complete metabolic panel 4th visit 1 week after the third Asses risk Asses sx how are you feeling Review labs from last week Asses desire for medications Review risk/benefit Discuss end of therapy Lab for CBC/dif Complete metabolic panel 5 visit 6 weeks after assault Asses sx how are you feeling Lab for HIV 7

8 6 th visit 1 week after the fifth Give HIV test results Last visits 6 months after assault HIV/HCV tests 2 weeks later for test results 8