Can we prevent infection after an exposure? The world of post-exposure prophylaxis (PEP)
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Can we prevent infection after an exposure? The world of post-exposure
prophylaxis (PEP)
James WiltonProject CoordinatorBiomedical Science of HIV Prevention [email protected]
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HIV/AIDS in Canada
• Number of people living with HIV• 57,000 in 2005• 65,000 in 2008
• 2,200 to 4,200 infected in 2005• 2,300 to 4,300 infected in 2008
• MSM (44%)• People who use injection drugs (17%)• Women (26%)• Aboriginal (12.5%)
Source: Public Health Agency of Canada
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Improving HIV prevention
1. Do better with the strategies that we already have
2. Develop new biomedical technologies to prevent HIV
3. Adopt a more comprehensive approach to HIV/AIDS prevention
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What is post-exposure prophylaxis (PEP)?
• Post After
• Exposure When a fluid containing HIV comes into contact with mucous membranes or non-intact skin
• Prophylaxis An action taken to prevent infection or disease
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What is PEP to prevent HIV infection?
• The use of a combination of antiretrovirals by HIV-negative individuals for a short period of time after a suspected or known exposure to HIV
• Must be started as soon as possible but within 48-72 hours after the exposure
• Must be taken everyday for 28 days• Must avoid additional exposures while taking
PEP
• Types of exposures• Occupational• Non-occupational
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Occupational vs. non-occupational exposures
Occupational• Work-related exposures to HIV• Needle-stick injuries• Sharp objects
• “Standard of care”
Non-occupational (nPEP)• Exposures outside of the workplace• Non-consensual sex• Consensual sex• Needle sharing
• Not “standard of care”
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Does PEP work?
• No randomized controlled studies
• Observational studies• Studies with control groups• Evaluations of PEP programs
• Indirect evidence• Non-human primate (monkey) studies • Prevention of mother-to-child transmission
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How does PEP work?
• Infection does not occur instantly after an exposure to HIV• The virus needs to spread
throughout the body • This may take up to 3 days after the
exposure
• The “window of opportunity” for PEP• The brief period of time - after an
exposure - where infection has not yet occurred
• During this time, PEP may be able to stop HIV from causing an infection
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How well does PEP work?
• We don’t know how protective PEP is
• We know it is not 100% protective• People have become infected despite using PEP
• Protection likely depends on: • Starting PEP quickly• Being adherent• The risk of transmission from the exposure • Avoiding additional exposures• The number and type of antiretrovirals used
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Does occupational PEP work?
• Study details• 712 healthcare workers exposed to HIV-infected
blood
• Study findings• 256 did use PEP
– 9 became infected • 456 did not use PEP
– 24 became infected
PEP reduced the risk of HIV transmission by 81%
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Does non-occupational PEP work?
• Study details• 200 gay men in Brazil given a 4-day starter-pack of
PEP• Followed for over 2 years
• Study findings• 68 men did use PEP after a high risk exposure
– 1 became infected• 86 men did not use PEP after a high risk exposure
– 10 became infected
Study did not calculate effectiveness of nPEP
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Failure of nPEP to prevent infection is rare
It is difficult to interpret how protective PEP is… • Would people have remained uninfected
without using PEP?• Among those who became infected, was
PEP used correctly?
# People who used nPEP # HIV infections
Amsterdam 261 5France 776 1Denmark 374 1Australia 1552 0Switzerland 710 0San Francisco
702 6
Montreal ~900 6
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What’s involved in taking PEP?
1. Assessment
2. Counseling
3. Prescription
4. Follow-up
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What’s involved in taking PEP?
1. Assessment• Was the exposure within the last 72 hours?• Is the exposed person HIV-negative? • Was the exposure high-risk?
• What activity led to the exposure?• What was the HIV status of the source person?
2. Counseling
3. Prescription
4. Follow-up
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Guidelines for non-occupational PEP
• When is PEP recommended?
• Example, the CDC nPEP guidelines
• Is there a substantial risk from the activity?
– No PEP not recommended
• If yes, was the exposure to someone who was HIV-positive?
– No PEP not recommended– Unknown Case-by-case basis– Yes PEP recommended
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What’s involved in taking PEP?
1. Assessment
2. Counseling• What are the risks and benefits of starting
PEP?• Is the exposed person ready to start PEP?• Adherence and risk-reduction counseling
3. Prescription
4. Follow-up
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What’s involved in taking PEP?
1. Assessment
2. Counseling
3. Prescription• What antiretrovirals? How many?• Starter-packs
4. Follow-up
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Guidelines for non-occupational PEP
USA Australia WHO UK EuropeTiming of PEP Within 72 hours Within 48
hours
Number of antiretrovirals
2 or 3 3
What antiretrovirals?
Two NRTIsTwo NRTIs + PI/NNRTITwo NRTIs + tenofovir
Two NRTIsTwo NRTIs + PI
Truvada + Kaletra
Duration 28 daysBarber and Benn 2010
NRTI = nucleoside reverse transcriptase inhibitorNNRTI = non-nucleoside reverse transcriptase inhibitorPI = protease inhibitorTruvada = tenofovir + emtricitabineKaletra = Lopinavir
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What’s involved in taking PEP?
1. Assessment
2. Counseling
3. Prescription
4. Follow-up • Ongoing risk-reduction and adherence
counseling • Monitoring/management of side-effects and
toxicity• HIV testing
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Why do so few people use nPEP in Canada?
• People may not think they are at risk
• Lack of national and provincial guidelines
• Use of nPEP is not promoted
• Only available in some emergency departments and urgent care clinics
• Cost is only covered by some provincial and private insurance plans
• Side-effects, adherence, monitoring, counseling
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Why is there reluctance to make nPEP more widely available?
• Feasibility
• Cost-effectiveness
• Risk compensation
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Why is there reluctance to make nPEP more widely available?
• Feasibility• Research suggests that nPEP programs are feasible
but challenges exists
• Cost-effectiveness• Research suggests that targeted nPEP programs are
cost-effective
• Risk compensation• Research shows that there is little evidence of risk
compensation
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Enhancing the potential benefit of PEP• Access to PEP provides an opportunity to offer
additional services to people at high risk of infection
• Research study• Study details
– In addition to PEP, participants received either:1. Standard risk-reduction counseling (2-sessions)2. Enhanced risk-reduction counseling (5-sessions)
– Participants followed for a year after initiating PEP
• Study findings– Standard counseling 12.3% became infected– Enhanced counseling 2.4% became infected
• Combining PEP with enhanced risk-reduction counseling can make it a more effective prevention tool
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A comprehensive approach to PEP
• Integration into a comprehensive prevention program
• Targeted outreach and educational campaigns
• Prevention, care and support services• Adherence counseling and support• Risk-reduction counseling • Psychological counseling and trauma support• Mental health and addiction services
• Advocacy to improve access
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Clinique l’Actuel: 9 years experience with nPEP• Sexual health clinic in Montreal, Quebec
• Over 1,139 consultations• Prescribed to over 900 people• Majority of PEP users are gay men• 80% first time using PEP• Average time to consultation after exposure - 29 hours
• Challenges• 68% complained of side-effects• 50% completed follow-up
• 6 HIV infections• Many reported ongoing exposures
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CATIE’s Programming Connection
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CATIE Resources: PEP factsheet and article
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Thank you!