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

(1)

HIV Postexposure Prophylaxis

for Occupational and Non

for Occupational and

Non--occupational Exposure

occupational Exposure

VtSHP Annual Meeting VtSHP Annual Meeting 4/10/10 4/10/10 Deborah Kutzko FNP Deborah Kutzko FNP

"Financial support for this program has been provided by the New England AIDS Education and Training "Financial support for this program has been provided by the New England AIDS Education and Training

Center

Center--NEHEC/MAI project, Funded by the US Department of Health Resources and Services NEHEC/MAI project, Funded by the US Department of Health Resources and Services

Administration,(HRSA) and sponsored regionally by Commonwealth Medicine. UMass Medical School, Administration,(HRSA) and sponsored regionally by Commonwealth Medicine. UMass Medical School,

Worcester, MA; Federal Grant Award # 6 H4AHA00050 Worcester, MA; Federal Grant Award # 6 H4AHA00050--0808--00" 00"

First Let’s Look at Some Numbers

National National Vermont Vermont

(2)

Vermont HIV/AIDS Prevalence

Total: 358 Total: 358

131* Vermont diagnosed 131* Vermont diagnosed residents living with HIV residents living with HIV (2008)

(2008)

227 Vermont diagnosed 227 Vermont diagnosed residents living with AIDS residents living with AIDS (2008)

(2008)

Vermont Department of Health STD/HIV Program

Populations living with HIV/AIDS: 2008

More men than women were living with More men than women were living with HIV/AIDS (83% of the cases are men) HIV/AIDS (83% of the cases are men) 86% of all HIV and AIDS cases diagnosed 86% of all HIV and AIDS cases diagnosed in Vermont are among white Non

in Vermont are among white Non--Hispanic

Hispanic

In Vermont, 36% of people newly In Vermont, 36% of people newly diagnosed with HIV/AIDS are 40+ diagnosed with HIV/AIDS are 40+

Exposure and Risk in 2008 of HIV Exposure and Risk in 2008 of HIV

HIV Transmission Categories (VT): HIV Transmission Categories (VT):

–

–Men: MSM (77% of PLWHIV through 2008)Men: MSM (77% of PLWHIV through 2008)

–

–Women: heterosexual contact (56%)Women: heterosexual contact (56%)

Post

Post--Exposure Prophylaxis

Exposure Prophylaxis

(PEP)

the use of therapeutic agents to prevent the use of therapeutic agents to prevent infection following exposure to a infection following exposure to a pathogen

pathogen

types of exposures include percutaneous types of exposures include percutaneous (needlestick), splash, bite, sexual

(needlestick), splash, bite, sexual for health

for health--care workers, PEP commonly care workers, PEP commonly considered for exposures to HIV and considered for exposures to HIV and Hepatitis B

Hepatitis B

Occupational Risk Exposures

in Health Care Personnel

Percutaneous injury Percutaneous injury (needlestick, cut) (needlestick, cut) OR OR Contact of mucous Contact of mucous membrane or membrane or nonintact skin nonintact skin WITH: WITH: •• BloodBlood •• TissueTissue

•• Other body fluids that Other body fluids that are potentially are potentially infectious infectious (cerebrospinal, (cerebrospinal, synovial, pleural, synovial, pleural, pericardial, pericardial, peritoneal, or peritoneal, or amniotic fluids; amniotic fluids; semen or vaginal semen or vaginal secretions) secretions)

NOT Considered Infectious

for HIV, unless

for HIV, unless Visibly

Visibly

Bloody

Feces Feces Nasal Secretions Nasal Secretions Saliva Saliva Sputum Sputum Sweat Sweat Tears Tears Urine Urine Vomitus Vomitus

(3)

Risk of HIV Infection following

Occupational Exposure to HIV

Occupational Exposure to

HIV--Infected Blood

Infected Blood

Approximately 0.3% following Approximately 0.3% following percutaneous exposure percutaneous exposure Approximately 0.09% following Approximately 0.09% following mucous membrane exposure mucous membrane exposure

Factors Associated with

Increased Risk

Visible contamination of device (such as needle) Visible contamination of device (such as needle) with patient’s blood

with patient’s blood

Needle having been placed directly into vein or Needle having been placed directly into vein or artery

artery Hollow

Hollow--bore (vs solid) needlebore (vs solid) needle Deep injury

Deep injury

Source patient with terminal illness Source patient with terminal illness High viral load

High viral load

(not established in occupational exposure) (not established in occupational exposure)

Exposure Risks (average, per

episode, involving HIV

episode, involving HIV--infected

infected

source patient)

24% 24% Vertical (no prophylaxis)

Vertical (no prophylaxis)1010

0.67% 0.67% IDU needle sharing

IDU needle sharing99

4 case reports 4 case reports Female

Female--female orogenitalfemale orogenital88

0.06% 0.06% Receptive oral (male)

Receptive oral (male)77

0.03 0.03 –– 0.14%0.14% Insertive vaginal intercourse

Insertive vaginal intercourse66

0.1 0.1 –– 0.2%0.2% Receptive vaginal intercourse

Receptive vaginal intercourse55

0.06% 0.06% Insertive anal intercourse

Insertive anal intercourse44

1% 1% Receptive anal intercourse

Receptive anal intercourse33

0.09% 0.09% Mucocutaneous (blood) Mucocutaneous (blood)22 0.3% 0.3% Percutaneous (blood) Percutaneous (blood)11

Tolerability of HIV PEP in

Health Care Workers

0 10 20 30 40 50 60 70 80 90 100

Nausea Fatigue Headache Vomiting Diarrhea Myalgias

P e rc e n t o f H C W s

Wang SA. Infect Control Hosp Epidemiol 2000;231:780-5.

Incidence of Common Side Effects

When should PEP be started?

efficacy of PEP thought to wane with time efficacy of PEP thought to wane with time at what point is PEP “no longer worth it”? at what point is PEP “no longer worth it”?

benefits of PEP

risks of PEP

time

Timing of PEP: what’s the

evidence?

animal models and animal PEP studies: animal models and animal PEP studies: suggest substantially less effective beyond suggest substantially less effective beyond 24

24 -- 36 hours36 hours1,21,2

case

case--control study: most subjects in each control study: most subjects in each group received PEP within 4 hours group received PEP within 4 hours33

analysis of PEP failures does not suggest analysis of PEP failures does not suggest a clear cut

a clear cut--offoff44

(4)

How Long Should PEP be

Administered?

N = 24 macaques

N = 24 macaques inoculated with SIV inoculated with SIV intravenously intravenously

PMPA for PEP initiated PMPA for PEP initiated 24 hours post

24 hours post--inoculation inoculation

PEP administered for PEP administered for 3, 10, or 28 days 3, 10, or 28 days 50 25 0 0 10 20 30 40 50 60 70 80 90 100 seroconversion rate (%) 3 days PEP 10 days PEP 28 days PEP

Tsai C-C et al. J Virol 1998;72:4265-73.

Duration of PEP

in animal model, 28 days more effective in animal model, 28 days more effective than 10 days or 3 days of PEP

than 10 days or 3 days of PEP11

4 weeks (28 days) used in case

4 weeks (28 days) used in case--control control study

study22_{and recommended by CDC}_{and recommended by CDC}

guidelines guidelines33

1. Tsai C-C et al. J Virol 1998;72:4265-73. 2. Cardo DM et al. NEJM 1997;337:1485-90. 3. MMWR June 29, 2001:50(RR11);1-42.

Review of Vermont PEP Protocol

Criteria for Recommending HIV Post

Criteria for Recommending HIV Post--Exposure Exposure Prophylaxis (PEP)

Prophylaxis (PEP) After Sexual Assault (Adult After Sexual Assault (Adult

))

NOTE: This algorithm is for use with ADULTS only. For NOTE: This algorithm is for use with ADULTS only. For consultation about PEP for children (as determined by consultation about PEP for children (as determined by stage on the Tanner Scale), call an infectious disease stage on the Tanner Scale), call an infectious disease specialist

specialist::

At Fletcher Allen Health Care: At Fletcher Allen Health Care: Comprehensive Care Clinic (1

Comprehensive Care Clinic (1--800800--639639--2480) or 2480) or Pediatric infectious disease specialist William Pediatric infectious disease specialist William

Raszka, M.D. (1

Raszka, M.D. (1--800800--639639--2480)2480) At Dartmouth

At Dartmouth--Hitchcock Medical Center:Hitchcock Medical Center: Infectious Disease Clinic (1

Infectious Disease Clinic (1--603603--650650--6060 or after 6060 or after hours at 1

hours at 1--603603--650650--5000)5000)

))

1.

1. Rape exam is performed.Rape exam is performed.

2.

2. Was there significant mucosal exposure?Was there significant mucosal exposure?

unprotected receptive anal intercourse unprotected receptive anal intercourse unprotected insertive anal intercourse unprotected insertive anal intercourse unprotected receptive vaginal intercourse unprotected receptive vaginal intercourse unprotected insertive vaginal intercourse unprotected insertive vaginal intercourse receptive fellatio with ejaculation. receptive fellatio with ejaculation.

3 IF YES:

3 IF YES: continue on with PEP algorithmcontinue on with PEP algorithm

IF NO: IF NO: stopstop

4 Did the survivor present within 48 hours of the assault? 4 Did the survivor present within 48 hours of the assault?

IF WITHIN 48 HOURS:

IF WITHIN 48 HOURS: continue with PEP algorithm continue with PEP algorithm

IF AFTER 48 HOURS:

IF AFTER 48 HOURS: stop PEP algorithm and proceed to stop PEP algorithm and proceed to HIV testing algorithm

HIV testing algorithm

))

Is the perpetrator’s HIV status known? Is the perpetrator’s HIV status known? IF PERPETRATOR KNOWN TO BE HIV POSITIVE:

IF PERPETRATOR KNOWN TO BE HIV POSITIVE: call Infectious Disease call Infectious Disease Specialist.

Specialist.

IF HIV STATUS OF PERPETRATOR UNKNOWN

IF HIV STATUS OF PERPETRATOR UNKNOWN: call Infectious Disease : call Infectious Disease Specialist.

Specialist.

Infectious disease specialists at the Fletcher Allen Health Care Infectious disease specialists at the Fletcher Allen Health Care

Comprehensive Care Clinic and at the Dartmouth

Comprehensive Care Clinic and at the Dartmouth--Hitchcock Medical Hitchcock Medical Center Infectious Disease Clinic are available for consultation about PEP. Center Infectious Disease Clinic are available for consultation about PEP. Consultation with DHMC is appropriate for survivors (primarily from Consultation with DHMC is appropriate for survivors (primarily from Orange and Windsor counties) who prefer to receive follow Orange and Windsor counties) who prefer to receive follow--up care in up care in Lebanon, NH.

Lebanon, NH.

FAHC Comprehensive Care Clinic: 1

FAHC Comprehensive Care Clinic: 1--800800--639639--2480 (24 hours/day)2480 (24 hours/day) DHMC Infectious Disease Clinic: 1

(5)

))

If PEP is recommended and the survivor agrees to take the medications: If PEP is recommended and the survivor agrees to take the medications:

Counsel survivor on possible side

Counsel survivor on possible side--effects of PEP.effects of PEP. Administer initial dose and provide short

Administer initial dose and provide short--term supply of PEP medications.term supply of PEP medications. On the next working day, survivor must receive follow

On the next working day, survivor must receive follow--up for postup for post--medication blood work, baseline HIV test, and prescription for balance of medication blood work, baseline HIV test, and prescription for balance of PEP drugs with infectious disease specialists from a site affiliated with PEP drugs with infectious disease specialists from a site affiliated with the specialist that has provided consultation.

the specialist that has provided consultation. Comprehensive Care Clinic has four sites: Burlington

Comprehensive Care Clinic has four sites: Burlington ---- 11--800800--639639--2480; 2480; Rutland

Rutland ---- 747747--1830; St. Johnsbury 1830; St. Johnsbury ---- 751751--7603; Brattleboro 7603; Brattleboro ---- 257257--8860.8860. DHMC Infectious Disease Clinic

DHMC Infectious Disease Clinic ---- 11--603603--650650--6060. 6060. Survivor may call Comprehensive Care Clinic or DHMC Infectious Survivor may call Comprehensive Care Clinic or DHMC Infectious Disease Clinic with questions about PEP at any time. Disease Clinic with questions about PEP at any time.

))

If PEP is recommended and the survivor does not want to If PEP is recommended and the survivor does not want to

take the medications take the medications::

Survivor should be tested for HIV as soon as possible, then Survivor should be tested for HIV as soon as possible, then again at 6, 12, and 36 weeks. Survivor with Hepatitis C, again at 6, 12, and 36 weeks. Survivor with Hepatitis C, test again at 36 weeks.

test again at 36 weeks.

Give survivor list of HIV test sites and AIDS hotline number Give survivor list of HIV test sites and AIDS hotline number (1

(1--800800--882882--2437).*2437).*

IF SURVIVOR IS ACCOMPANIED TO HOSPITAL BY IF SURVIVOR IS ACCOMPANIED TO HOSPITAL BY RAPE CRISIS ADVOCATE:

RAPE CRISIS ADVOCATE: advocate offers survivor follow advocate offers survivor follow up phone the next day to reassess decision.

up phone the next day to reassess decision.

IF SURVIVOR IS UNACCOMPANIED BY RAPE CRISIS IF SURVIVOR IS UNACCOMPANIED BY RAPE CRISIS ADVOCATE:

ADVOCATE: SANE offers survivor followSANE offers survivor follow--up phone call to up phone call to reassess decision.

reassess decision.

))

If PEP is not recommended

If PEP is not recommended survivor survivor should be tested for HIV as soon as should be tested for HIV as soon as possible, then again at 6, 12, and 36 possible, then again at 6, 12, and 36 weeks. Survivor with Hepatitis C, test weeks. Survivor with Hepatitis C, test again at 36 weeks.

again at 36 weeks.

Give survivor list of HIV test sites and Give survivor list of HIV test sites and AIDS hotline number (1

AIDS hotline number (1--800800--882882--2437).* 2437).*

Criteria for Recommending HIV Test for Criteria for Recommending HIV Test for

Sexual Assault Survivor Sexual Assault Survivor Presenting More Than 48 Hours After Presenting More Than 48 Hours After

Sexual Assault Sexual Assault

Is the perpetrator known to be infected with HIV? Is the perpetrator known to be infected with HIV?

IF YES

IF YES: survivor should call FAHC Comprehensive Care : survivor should call FAHC Comprehensive Care Clinic

Clinic (1

(1--800800--639639--2480) or DHMC Infectious Disease Clinic (12480) or DHMC Infectious Disease Clinic (1--603

603--650

650--6060) without delay.6060) without delay.

IF STATUS OF PERPETRATOR IS UNKNOWN IF STATUS OF PERPETRATOR IS UNKNOWN: survivor : survivor should be tested for HIV as soon as possible, then again at 6, 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 12 and 36 weeks. Survivor with Hepatitis C, test again at 36 weeks.

weeks.

Give survivor list of anonymous and confidential HIV test Give survivor list of anonymous and confidential HIV test sites.

sites.

Medications

Medications –

– a moving target

a moving target

Medications

Medications –

– a moving target

a moving target

Old standard

Old standard –– Combivir based Combivir based Easy to take

Easy to take –– one pill 2 x a dayone pill 2 x a day Contains AZT

Contains AZT -- bone marrow toxicitybone marrow toxicity New NNRTI based

New NNRTI based CDC suggestion

CDC suggestion –– Atripla Atripla Once a day

(6)

Interactions of ARV

Agents

ARVs can have serious interactions with other ARVs can have serious interactions with other drugs

drugs

Carefully evaluate concomitant medications, Carefully evaluate concomitant medications, including over

including over--thethe--counters, supplements, and counters, supplements, and herbals before prescribing PEP

herbals before prescribing PEP

Consult package inserts or other resources on Consult package inserts or other resources on ARV drug

ARV drug--drug interactionsdrug interactions

Avoid interacting drugs and monitor carefully, Avoid interacting drugs and monitor carefully, as appropriate as appropriate

Resistance to

ARVs

Resistant virus may be present in a treatment Resistant virus may be present in a treatment--experienced source patient

experienced source patient

Resistance testing at time of exposure is not Resistance testing at time of exposure is not practical, because results will not be available practical, because results will not be available to influence choice of initial PEP regimen to influence choice of initial PEP regimen No data suggest that modifying regimen when No data suggest that modifying regimen when resistance test results become available resistance test results become available (typically 1

(typically 1--2 weeks) will improve PEP efficacy2 weeks) will improve PEP efficacy Expert consultation is recommended Expert consultation is recommended

Medications

Medications –

– a moving target

a moving target

Current thought at FAHC

Truvada (emtricitabine/tenofovir) 1 pill qd Truvada (emtricitabine/tenofovir) 1 pill qd Atazanivir (200 mg) 2 pills qd

Atazanivir (200 mg) 2 pills qd Ritonavir (100 mg) 1 pill qd Ritonavir (100 mg) 1 pill qd Four pills once a day

Four pills once a day Side effects

Side effects –– nausea, fatiguenausea, fatigue

Medications

Medications –

– a moving target

a moving target

Atripla (SustivaTM (efavirenz) 600mg + Atripla (SustivaTM (efavirenz) 600mg + TruvadaTM (tenofovir 300mg +

TruvadaTM (tenofovir 300mg + emtricitabine 200mg) one tablet HS emtricitabine 200mg) one tablet HS Total number of tablets per day = one Total number of tablets per day = one Note: Sustiva is contraindicated in Note: Sustiva is contraindicated in pregnancy

pregnancy

May cause nightmares May cause nightmares

Medications

Medications –

– a moving target

a moving target

Still a good idea

Combivir (AZT/3TC) 1 pill BID Combivir (AZT/3TC) 1 pill BID

Kaletra (Lopinavir/Ritonavir) 3 pills BID Kaletra (Lopinavir/Ritonavir) 3 pills BID 4 pills BID

4 pills BID

Side effects nausea/fatigue/amenia Side effects nausea/fatigue/amenia

Post

Post--Exposure Prophylaxis:

Exposure Prophylaxis:

Core Principles

Evidence is limited Evidence is limited Balancing of risks vs Balancing of risks vs benefits benefits

Timing: the sooner the Timing: the sooner the better, but interval beyond better, but interval beyond which there is no benefit is which there is no benefit is unclear

(7)

Post

Post--Exposure Prophylaxis:

Exposure Prophylaxis:

Core Principles

Optimal duration unclear, 28 days is Optimal duration unclear, 28 days is recommended

recommended

Decision making can get very complex Decision making can get very complex when resistance in SP suspected when resistance in SP suspected Offering SEXPEP is reasonable for Offering SEXPEP is reasonable for risky exposures, and does not appear risky exposures, and does not appear to increase unsafe sexual behavior for to increase unsafe sexual behavior for most recipients most recipients

At the Clinic

1 1stst_visit_visit Asses risk Asses risk

Asses desire for medications Asses desire for medications Review risk/benefit

Review risk/benefit Meet with Social Worker Meet with Social Worker

Lab for CBC/dif Complete metabolic panel Lab for CBC/dif Complete metabolic panel Lab for HIV, HCV

Lab for HIV, HCV

At the Clinic

2

2ndnd_visit_{visit –}_{– 1 week after the first}_{1 week after the first}

Asses risk Asses risk Asses sx

Asses sx –– how are you feelinghow are you feeling Review labs from last week Review labs from last week Asses desire for medications Asses desire for medications Review risk/benefit

Lab for CBC/dif Complete metabolic panel Lab for CBC/dif Complete metabolic panel

At the Clinic

3rd visit

3rd visit –– 1 week after the second1 week after the second Asses risk

Asses risk Asses sx

At the Clinic

4th visit

4th visit –– 1 week after the third1 week after the third Asses risk

Asses risk Asses sx

Review risk/benefit Discuss end of therapy Discuss end of therapy Meet with Social Worker Meet with Social Worker

At the Clinic

5 visit

5 visit –– 6 weeks after assault6 weeks after assault Asses sx

Asses sx ––how are you feelinghow are you feeling Meet with Social Worker Meet with Social Worker Lab for HIV

(8)

At the Clinic

6

6thth_visit_{visit –}_{– 1 week after the fifth}_{1 week after the fifth}

Give HIV test results Give HIV test results

At the Clinic

Last visits

6 months after assault

6 months after assault –– HIV/HCV testsHIV/HCV tests 2 weeks later for test results