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SAFE-TA Webinar Series
 This project was supported by Grant No. 2005-WI-AX- K004 awarded by the
Office on Violence Against Women, U.S. Department of Justice. The opinions,
findings, conclusions, and recommendations expressed in this presentation are
those of the authors and do not necessarily reflect the views of the Department
of Justice, Office on Violence Against Women.
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Speakers for Today’s Discussion
 Edith Swann, RN, Ph.D, Vaccine Clinical Research
Branch/DAIDS, NIH, Bethesda, MD
 Ecoee Rooney, MSN, RN, SANE-A, Interim LSU Public
Hospital, New Orleans, LA
 Terri Hamrick, BA, MNM, WVLSW, Executive
Director, Survivors, Inc.
 Kim Day, RN, SANE-A, moderator
www.safeta.org
Edith M. Swann
RN, Ph.D.
Vaccine Clinical Research Branch/DAIDS
NIH, Bethesda, MD
www.safeta.org
PEP Defined
 The use of therapeutic agents to prevent infection
following exposure to a pathogen
 The immediate use of antiretroviral (ARV) drugs to prevent
HIV sero conversion after exposure to potentially HIVinfected blood or body fluids.
(UNAIDS)
 Occupational Exposure (Health care workers-
percutaneous (needlestick), splash, bite, etc.)
 Non-occupational Exposure (sexual assault, IVDU
exposure, etc)
www.safeta.org
CDC Guidelines for Nonoccupational
exposures
 Are not applicable for occupational exposures
 Based on data from:
 Animal transmission models (suggest less effectiveness beyond 24-36 hours)
 Perinatal clinical trials (Prevention of Mother to Child Transmission)
 Occupational exposures (health care workers- usually receive PEP within a few hours
of exposure < 4hrs)
 Observational studies
• Evidence of cost-effectiveness: when the partner (assailant) source is
known to be
•
HIV-infected or
• after unprotected receptive anal intercourse with homosexual or bisexual man of
unknown status.
• Recommendations may be established by State/local jurisdictions
MMWR, 2005, 54, RR-2
www.safeta.org
State and International Guidelines
(Fisher et al., 2006; Miles et al., 2001; NY State Dept of Health, 2008; www.unaids.org/en/policyandpractice/prevention/HIVPEP)
State
Initiation
Considerations
Preferred
Regimen
Follow-up
NY (2008)
Within 2 hrs, no
later than 36 hrs.
Risk behavior, degree of
transmission, exposure
source. Not to be used as
pre-exposure prophylactics.
3 drug regimen:
AZT
+3TC(Combivir),
and TDF, or AZT +
FTC +TDF for 28
days
Continued testing at
1, 3 and 6 months
CA (2001)
Initiated as soon as
possible, not
offered > 72 hrs
>12 yrs of age,
degree of risk (measurable,
possible, no risk), assailants
status, treatments of STD’s
PEP not offered in offered in
every county.
AZT + 3TC
(Combivir) or
3TC + d4T for 28
days
Follow-up testing at
8wks and 14 wks
WHO (2005)
Initiated as soon as
possible, but < 72
hrs
Source exposure, significant
exposure. Special
considerations for children
and pregnant women.
AZT + 3TC, or RDF
+ 3TC or d4T + 3TC
for 28 days. 3 drug:
source is HIV+,
ARV resistance,
status unknown.
Follow-up testing 3-6
months.
UK (2006)
Initiated in < 72
hrs
Risk vs benefit of PEP, risk
of transmission, risk of
source, willingness to start
ARV’s
AZT + 3TC, d4T +
3TC, or TDF + 3TC,
or TDF + FTC for
28 days
Testing at 3 months
and 6 months
www.safeta.org
HIV Exposure Risk/Incidence following
Sexual Assault
 Exposure risk is extremely low (rough estimates only)
 Less than those projected for consensual sex
 Increased risk with repeated sexual exposures
 Specific Circumstances/Considerations
 Trauma/tearing of mucosal tissue
 Bleeding/presence of blood
 Penetration (vaginal/anal)
 Site of exposure to ejaculate
 Viral load measures
 Presence of STD’s/genital lesions
 Risk behaviors of assailant (MSM, IDU)
 Multiple assailants
(CDC STD Treatment Guidelines, 2006; Garcia et al., 2005, Roland, et al. 2005 )
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Estimated Per-Act Risk for Acquisition of
HIV by Exposure Route
Exposure Route
Blood transfusion (1 unit)
Needle-sharing injection drug use
Risk %
90-100%
0.67%
Receptive anal intercourse
0.1-3.0%
Percutaneous needle stick
0.3%
Receptive vaginal intercourse
Insertive anal intercourse
Insertive vaginal intercourse
Receptive oral intercourse
Mucosal Membrane Exposure
0.1-0.2%
0.06%
0.03-0.09%
0-0.04%
0.09%
(AETC National Resource Center 2008, www.aidsetc.org, Fisher et al., 2006)
Nonoccupational
PEP: Evaluation
& Treatment
Algorithm
MMWR January 21, 2005, Vol 54, No. RR-2
Situations for which expert consultation for HIV
post-exposure prophylaxis (PEP) is advised
 Resistance of the source virus to antiretroviral agents




•
Influence of drug resistance on transmission risk unknown
If source person’s virus is known or suspected to be resistant to one or more of the drugs
considered for PEP, selection of drugs to which the source person’s virus is unlikely to be resistant
recommended
Resistance testing of the source person’s virus at the time of the exposure not recommended
Initiation of PEP not to be delayed while awaiting results of resistance testing
Toxicity of the initial PEP regimen
•
•
•
Adverse symptoms (nausea, diarrhea)
Management of symptoms (antimotility or antiemetic agents)
Modifying dose intervals may assist in the management of adverse symptoms
• Delayed exposure report
•
Interval after which lack of benefit from PEP undefined
(MMWR 2005; 54(No. RR-9)
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Situations for which expert consultation for HIV
post-exposure prophylaxis (PEP) is advised (cont.)
 Unknown source
 Use of PEP to be decided on a case-by-case basis
 Consider severity of exposure and likelihood of exposure
 Known or suspected pregnancy in the exposed person
 Use of optimal PEP regimens not precluded
 PEP not denied solely on basis of pregnancy
 Breastfeeding in the exposed person
 Use of optimal PEP regimens not precluded
 PEP not denied solely on basis of breast feeding
(MMWR 2005; 54(No. RR-9)
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Challenges of implementing PEP
following Sexual Assault
 Differing guidelines (country, state)





Type and number of ARV’s to use (availability, toxicity, effectiveness)
Lab monitoring
Access and cost of ARV’s
Follow-up
Confidentiality and Reporting requirements
 Determining status of the assailant
 Cost Effectiveness
 American Academy of Pediatrics has issued nPEP for pediatric patients
(MMWR , 54 (RR-2),2005, Roland, 2007)
www.safeta.org
When should PEP be started?
benefits of PEP
risks of PEP
time
exposure
www.safeta.org
HIV-1Transmission Event
Established Infection
Virus Concentration in Extracellular Fluid
or
Plasma (Copies/ml)
108
Symptoms
107
106
Set Point
105
104
eclipse
103
102
101
Reservoir
Virus
dissemination
0
10-1
10-2
Limit of detection of
assay for plasma
virus
Transit
10-3
10-4
10-5
0
Transmission
5
10
15
20
25
30
35
40
45
50
55
60
65
70
Time Post Exposure (days)
Adapted from Johnston & Fauci, NEJM 2007
PEP Regimens: Basic regimens
 Two NRTIs
 Simple dosing, fewer side effects
 Preferred basic regimens:
zidovudine (AZT) OR tenofovir (TDF)
plus
lamivudine (3TC) OR emtricitabine (FTC)
 Alternative basic regimens:
stavudine (d4T) OR didanosine (ddI)
plus
lamivudine (3TC) OR emtricitabine (FTC)
(Cochrane Collaboration, 2009, MMWR 2005;54(No. RR-9).
Expanded PEP Regimens
 Basic regimen plus a third agent
 Rationale: 3 drugs may be more
effective than 2 drugs, though
direct evidence is lacking
 Consider for more serious
exposures or if resistance in the
source patient is suspected
 Adherence more difficult
 More potential for toxicity
 Preferred Expanded Regimen:
 Basic regimen plus
lopinavir/ritonavir (Kaletra)
 Alternate Expanded Regimens:
 Basic regimen plus one of the
following:






Atazanavir* +/- ritonavir
Fosamprenavir +/- ritonavir
Indinavir +/- ritonavir
Saquinavir (hgc; Invirase) +
ritonavir
Nelfinavir
Efavirenz
(MMWR 2005; 54(RR-9)
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Considerations for PEP in
Pregnancy
• Most ARV’s are pregnancy class B or C
• Antiretroviral Pregnancy Registry
 Avoid Efavirenz due to potential teratogenicity in
pregnant or women of childbearing age at risk for
becoming pregnant (anacephaly in monkeys)
 Avoid prolonged use of Stavudine (d4T)-potential for
mortality attributed to lactic acidosis
 Avoid Amprenavir (ossification defects in rabbits), and
Indinavir in late term (hyperbilirubinemia)
(Garcia et al. ICAAC, December 2001, MMWR, 54 (RR-2), 2005)
Duration of PEP
 In animal model, 28 days more
effective than 10 days or 3 days
of PEP
 4 weeks (28 days) used in case-
control study and
recommended by CDC
guidelines
100
90
80
70
60
50
 Treatment of STD’s must be
considered separate from PEP
40
30
20
10
0
3 days PEP
10 days PEP
28 days PEP
50
25
0
seroconversion rate (%)
www.safeta.org
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Ongoing and Planned PrEP Trials
Study
Location
Sponsor
Population
iPrEX (Brazil,
NIH, Gates
Foundation
Equador, SA,
Thailand, US)
Partners
PrEP Study
Intervention
Arms
PrEP
strategies
Status
3,000 Gay
men, MSM
1
TDF + FTC
Enrolling
(2010)
Gates
Foundation
3,900
serodiscordant
couples
2
TDF; TDF +
FTC
Enrolling
(2012)
MTN, NIH
4,200 sexually
active women
3
TDF; TDF
+FTC; TDF
gel
Planning
Phase
(anticipate
2Q/2009)
FHI,
USAID
3,900 high-risk
women
1
TDF + FTC
Planning
Phase
(Kenya, Uganda)
VOICE
Study (South
Africa)
FEMPrEP
(Kenya, Malawi,
SA, Tanzania)
(anticipate
2Q/2009)
Microbicide Trial
(HPTN 035: 4 arm study)
Pro 2000 Gel (0.5%)
 Synthetic polymer- acts by blocking
attachment of HIV to host cell.
 Pre-clinical-In Vitro: prevents HIV,
active against HSV-2, N.gonorrhea
Buffer Gel (Carbopol 974P)
• Gelling agent that:
 Showed protection in macaque SIV
challenge model.
•
 Phase I study showed no safety
concerns, good acceptability.
•
 No serious adverse events/toxicity.
•
•
www.safeta.org
• Enhances body’s natural
defenses
• Maintains low vaginal pH
In Vitro: inactivated STD pathogens
and sperm, semen inflammatory
cells
Well documented safety profile in
animals
Phase I safety and acceptability
Phase III trial showed good safety
and contraceptive efficacy when
used w/diaphragm.
Trial Conclusion
 PRO 2000 was 30% effective in preventing HIV (effect was
not statistically significant).
 Buffer Gel did not alter the risk of HIV infection.
 Placebo Gel had no impact on risk of HIV acquisition
(similar in the No Gel arm).
 Both Buffer Gel and PRO 2000 were:
 Safe for intravaginal use for extended period of time
 Not contraceptive
 Not effective against STI’s: BV, Chlamydia, HSV-2, gonorrhea,
genital ulcer disease, trichomoniasis.
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Current Observational Cohort
Studies
Study/
Location
Sponsor
Population
HVTN 906 (NY,
HVTN, NIH
High Risk
Women +
Partners
Observational
Open
HVTN, NIH
High Risk
Women-CSW
Observational
Open
HPTN
High Risk
Women
Observational
Open
Philly, Chicago)
HVTN 907
(Haiti, PR, DR)
HPTN 064
(ISIS)
www.safeta.org
Intervention
Status
Additional Studies
Study/
Location
Sponsor
Population
Intervention
Status
JHU- Baltimore
Network
intervention for
reducing sexual risk.
CDC
African
American MSM
CognitiveBehavioral,
counseling
Open
(7/08-9/09)
Behavioral
Counseling —
UCSF
NIMH
HIV –
Men
Specialized
Cognitive-Behavioral
Counseling- to
reduce transmission
in MSM
Sept. 2005Dec 2010
RV 217
USMHRP,
NIH
High Risk
(males +
females)
Acute Infection
Anticipate
6/09
www.safeta.org
Resources
 National PEP Registry
1-877-HIV-1PEP
www.hivpepregistry.org
 National Clinicians’ Post-Exposure Prophylaxis
Hotline (PEPline)
 (888) HIV-4911
www.safeta.org
References
MMWR-CDC (2005), Antiretroviral Postexposure Prophylaxis After
Sexual, Injection-Drug Use, or Other Nonoccupational Exposure to
HIV in the United States. January, 21, 2005, Vol. 54, No. RR-2
New York State Department of Health (2008). HIV prophylaxis following
non-occupational exposure including sexual assault. New York (NY)
State Department of Health.
San Francisco Department of Public Health (2001). Offering HIV
Prophylaxis Following Sexual Assault: Recommendations for the State
of California. The California HIV PEP after Sexual assault Task Force
in conjunction with The California State Office of AIDS.
Fisher, M., Benn, P., Evans, B. et al. (2006). UK Guidelines for the use of
post-exposure prophylaxis for HIV following sexual exposure.
International Journal of STD & AIDS, 17; 81-92.
www.safeta.org
References
UNAIDS (2006). HIV Post-Exposure prophylaxis. Obtained 4/7/09 from:
www.unaids.org/en/PolicyAndPractice/Prevention/HIVPEP/
Centers for Disease Control (CDC) (2008). CDC’s Clinical Studies of PreExposure Prophylaxis for HIV Prevention. Obtained 4/10/09 from :
www.cdc.gov/hiv
Pinkerton, S., Martin, J., Roland, M. et al., (2004). Cost-effectiveness of
HIV postexposure prophylaxis following sexual or injection drug
exposure in 96 metropolitan areas in the United States. AIDS, 18;
2065-2073.
The Cochrane Collaboration (2009). Antiretroviral post-exposure
prophylaxis (PEP) for occupational HIV exposure (Review). Wiley &
Sons Ltd, issue 2.
www.safeta.org
References
Garcia, M., Figueiredo, R., Moretti, M. et al., (2005). Postexposure
Prophylaxis After Sexual Assaults: A Prospective Cohort Study.
Sexually Transmitted Diseases, April, 32 (4), 214-219.
Roland, M. (2007). Postexposure prophylaxis after sexual exposure to
HIV. Current Opinion in Infectious Diseases, 20, 39-46.
Roland. M., Neilands, T., Krone, M. et al., (2005). Seroconversion
Following Nonoccupational Postexposure Prophylaxis against HIV.
Clinical Infectious Diseases, 41, 1507-13.
Cohen, M., Kaleebu, P., Coates, T. (2008). Prevention of the sexual
transmission of HIV-1:preparing for success. Journal of the
International AIDS Society 11:4.
www.safeta.org
Non-occupational Post Exposure
Delivery Systems:
Sexual Assault Patients
Ecoee Rooney, MSN, RN, SANE-A
Interim LSU Public Hospital
New Orleans, LA
• The Interim LSU Public Hospital has
offered HIV prophylaxis to patients
reporting sexual assault since the
program’s inception in the Spring of 2000.
• The initial protocol model used was from
the British Columbia guidelines, until new
guidelines were adopted by the Centers
for Disease Control in 2004.
www.safeta.org
Components of an effective nPEP
delivery system
• Include:
– a patient-centered approach
– sexual assault forensic examiners that are aware of nPEP
options
– careful evaluation of risks versus benefits to identify appropriate
candidates
– thorough discussion and education with the patient regarding
options and medications
– availability of nPEP drugs thorough, clear and concise oral and
written discharge instructions
– a clear transition to an HIV or infectious disease (ID) clinic for
follow-up at 5 days and throughout the treatment period.
www.safeta.org
Patient-Centered Approach
• In addressing the possible nPEP needs of patients who
have been sexually assaulted, there are psychological
issues that factor into the discussion of nPEP, patient
understanding and adherence to an nPEP regimen.
• Patients may have an emotional reaction (whether made
apparent to the provider or not) to the discussion of HIV
prophylaxis after having been sexually assaulted –anger,
fear, frustration or sadness – because it evokes the
thought of a possible HIV infection.
• A compassionate response, preparation for a possibly
emotional reaction to the discussion, and patience are all
required competencies in addressing nPEP in this
context.
www.safeta.org
Sexual assault forensic examiners
that are aware of nPEP options
• SANEs must be able to discuss nPEP
options, in tandem with other involved care
providers (physicians, pharmacists)
• Use of HIV Hotline when needed
www.safeta.org
Careful evaluation of risks vs benefits to
identify appropriate nPEP candidates
• SANEs must be able to discuss nPEP
options, in tandem with other involved care
providers (physicians, pharmacists), to
carefully evaluate the risks versus benefits
to identify appropriate candidates.
www.safeta.org
Thorough discussion and education with
the patient regarding options/medications
• Consideration of the fact that often
patients who have been sexually
assaulted have been traumatized and are
in need of tools
– clear, concise written information in large print
or diagrams
– concise and thorough discharge information
• including provider and medical records department
contact numbers
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Availability of nPEP drugs is
tantamount to providing prophylaxis
• access to the initial dose
• a plan for providing the interim 5 day dose
– the dose the patient will take until they see follow up
care providers in the ID or HIV clinic
• a plan for providing the final 23 day course that
will carry them through the full 28 day regimen.
• There are a variety of models to provide this
medication
– through contracts with the health department,
sponsorships, or grants.
www.safeta.org
Clear transition to an HIV or infectious
disease (ID) clinic for follow-up
• Critical piece to ensuring patients have the follow up they
will need.
• Simple, streamlined process to get them from the acute
provider to the follow up appointment.
– The SAFE can meet them at the appointment to introduce them
to their HIV/ID care provider.
• The HIV/ID care provider should have already obtained
their medical record to minimize the need to repeat what
has already been done for the patient.
• The HIV/ID provider should also know to minimize retraumatizing the patient with seeking to obtain any
unnecessary information.
www.safeta.org
Patient-Centered nPEP Delivery
System Model for Patients
Reporting Sexual Assault
nPEP drugs
(5 day supply onsite
and method for patient
to procure rest of
23 day supply)
Thorough
Thorough,
clear and concise
oral and written
discharge
instructions
discussion/
education
and transition to
with patient regarding
options and meds
Patient
HIV or
ID clinic
follow up at
Careful
evaluation of
risks vs
benefits
SAFE
Provider
Aware of nPEP
options
5 days and
throughout
treatment
period
© Rooney, Dumestre, Travis
Sample Non-Occupational Post
HIV Exposure Follow up Protocol
Patient treated in ED with post-exposure HIV prophylaxis
Baseline serum HIV test, RPR, Hepatitis ABC, UPT, CMP,
CBC, GC C/S, Chlamydia in ED
1st dose Combivir 1 tablet & Kaletra (200/50) 2 tablets PO in
ED & 5 days of meds from outpt pharmacy
Follow Up appointment faxed to outpatient ID/HIV Clinic.
Appointment card given to patient.
SANE Patient: Met by SANE at Outpatient HIV/ID Clinic
for initial visit
•Even if PEP declined, HIV testing schedule is
the same, except without monitoring CBC and
LFTs.
•Use of trade names and commercial sources is
for identification only and does not imply
endorsement by the author.
Weekly followup at Outpatient HIV/ID Clinic for medication
adherence and side effects
Week 2 Monitoring CBC, LFTs
Week 4 Monitoring CBC, LFTs, HIV Serology
Month 3 Monitoring: HIV, RPR, Hepatitis panel test (if
previously nonreactive)
Month 6 Monitoring:
HIV test, if previously nonreactive
References
• Centers for Disease Control and Prevention.
Antiretroviral postexposure prophylaxis after sexual,
injection-drug use, or nonoccupational exposure to HIV
in the United States: recommendations from the U.S.
Department of Health and Human Services. MMWR
2005; 54 (No. RR-2): [11-12]
• Rooney, E., Dumestre, J., Travis, D. (2008) SANE
Dialogues: Focus group on use of nPEP in SANE
programs.
www.safeta.org
HIV Risk Assessment, Sexual Assault,
and the Critical Role of the Advocate
Terri Hamrick, BA, MNM, WVLSW
Executive Director, Survivors, Inc.
www.safeta.org
 Role
of the Advocate
 Discussion of HIV Risk for the Victim
 Case Management, Access to
Services and Follow-up
www.safeta.org
 Providing
information, education and
support if the face of HIV infection
concerns
 HIV
Transmission and Testing Options
 Window Period/HIV Antibodies
 Baseline at point of SART kit
 Impact on Victim and Prosecution
 Anonymous versus Confidential Testing
 To advocate on behalf of the Victim

Understanding HIV Transmission



Assessing risk




3 fluids transmit- blood, vaginal secretions, semen and breast milk
Vaginal, Anal, Oral and other contact risk
Knowledge of assailant(s) and assailant’s risk factors
Type of assault- penetration and receptive partner?
In case of Incest, Marital Rape, or other repeated Sexual Assault over
time- often risk is under assessed and may be under reported
Creating a plan

Does the Victim have support on two levels
•
•

Sexual Assault
Support for the HIV PEP Process
•
•
Partnering with HIV Programs in advance is crucial- proactive rather than reactive
Agency policy for HIV/AIDS should include PEP and relevant partnerships
The Victim is the expert, and makes the ultimate decision to access
PEP!
www.safeta.org
 Development
and maintenance of a
relationship with the AIDS Service
Organization and/or Ryan White Funded
HIV Specialist serving the community
 Anonymous
Testing Sites
 HIV Prevention Case Management
 Part B and C (formerly known as Title II and
III Ryan White Funded Service Providers)
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Stay tuned for Q&A
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What are the risks to the patient of changing
to a different medication regimen midstream during the 28-day cycle?
www.safeta.org
Circumcision was listed on the behavior
prevention strategies, what is the data on
percentage of decrease in the risk of
transmission or reception of HIV?
www.safeta.org
Are there samples of written information or
does anyone have any suggestions about the
dialogue to have with patients about risk
and the discharge instructions
that are on nPEP?
www.safeta.org
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With Ryan White funded HIV specialty
services, can victims remain anonymous?
www.safeta.org
If someone lives in an area where there is very
low incidence of HIV, should they still offer
nPEP?
www.safeta.org
Should every patient receive, regardless of the
risk apparent in their assault, have a
discussion regarding HIV prophylaxis, their
risk, and advisability of receiving postexposure prophylaxis?
www.safeta.org
Ecoee, would you be willing to share any of
the information that you have that you share
with your patients?
www.safeta.org
Should all the patients leaving the sexual
assault exam with post-exposure prophylaxis
also receive Hepatitis B vaccine, when there
is no clear history of Hepatitis B series in
their lives?
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Polling questions – N/A to online viewers –
please wait
www.safeta.org
Do you refer patients primarily to local health
departments/AIDS programs for follow-up
even if they have insurance so that there’s
good continuity about education and
medication profiles?
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Polling questions – N/A to online viewers –
please wait
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There are some legislative reps that want to
test perpetrators – comments
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Pediatric patients – discussion
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Victims that report post 72-hours, what do we
do with them?
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What would be the reason for opposition to
perpetrator testing?
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Thank You!
For more information, visit:
www.safeta.org and www.iafn.org