Download HIV Post Exposure Prophylaxis following non

Antiretroviral Postexposure
Prophylaxis After Sexual, Injection
Drug-Use or Other Nonoccupational
exposure to HIV
Gonzalo Bearman MD, MPH
Assistant Professor of Internal Medicine and Public Health
Divisions of Quality Health Care & Infectious Diseases
Associate Hospital Epidemiologist
VCU Health System
Outline
• Definition of nonoccupational exposure to HIV
• What is the estimated risk based on the exposure type?
• What is the HIV status of the source and exposed patient?
– Signs and symptoms of acute retroviral syndrome
– Rapid HIV testing
• Data supporting the uses on nPEP for HIV
• CDC nPEP protocol algorithm
• Antiretrovirals of choice
– Side effects
– Maximizing adherence
– Special considerations
• Follow-up of the patient
• Expected impact of the nPEP
• Conclusion
Antiretroviral Postexposure
Prophylaxis After Sexual,
Injection-Drug Use, or Other
Nonoccupational Exposure to HIV
in the United States
Recommendations from the U.S. Department
of Health and Human Services
MMWR January 21, 2005 / 54(RR02);1-20
nPEP is Not Intended for:
• “Persons who engage in behaviors that
result in frequent, recurrent exposures that
would require sequential or nearcontinuous courses of antiretroviral
medications (e.g., discordant sex partners
who rarely use condoms or injection-drug
users who often share injection equipment)
should not take nPEP.”
MMWR January 21, 2005 / 54(RR02);1-20
DHHS Recommendations for nPEP
• DHHS recommends the prompt initiation of nPEP
with HAART when persons seek care within 72
hours after exposure, the source is known to be
HIV infected, and the exposure event presents a
substantial risk for transmission.
• When the HIV status of the source is not known
and the patient seeks care within 72 hours after
exposure, DHHS does not recommend for or
against nPEP but encourages clinicians and
patients to weigh the risks and benefits on a caseby-case basis.
MMWR January 21, 2005 / 54(RR02);1-20
What Constitutes a Nonoccupational
Exposure to HIV?
Has exposure of vagina, rectum, eye,
mouth, non-intact skin, or percutaneous
contact with blood, semen, vaginal
secretions, rectal secretions, breast milk,
or any visibly bloody body fluid
occurred?
MMWR January 21, 2005 / 54(RR02);1-20
What is the Estimated Risk?
MMWR January 21, 2005 / 54(RR02);1-20
Efficacy of nPEP
• Current studies suggest that nPEP might reduce
the risk of infection with HIV after sexual
exposures
– However:
• participants were not randomly assigned and sample sizes were
too small for statistically significant conclusions.
• For ethical and logistical reasons, a randomized,
placebo-controlled clinical trial of nPEP probably
will never be completed.
– High quality data may never be available for NPEP
MMWR January 21, 2005 / 54(RR02);1-20
Observational Study Data-nPEP
• High-risk HIV incidence cohort in Brazil,
nPEP
– 4-day starter packs of zidovudine/lamivudine
were administered to 200 homosexual and
bisexual men.
• In men taking nPEP after a self-identified high-risk
exposure
– Seroincidence was 0.7 per 100 person-years (one
seroconversion) among men who took nPEP and 4.1 per
100 person-years among men who did not take nPEP (11
seroconversions)
Harrison LH, Do Lago RF, Moreira RI, Schechter M. Demand for post-sexual-exposure chemoprophylaxis for the prevention of HIV infection in Brazil
[abstract 492]. Presented at the 7th Conference on Retroviruses and Opportunistic Infections, San Francisco, California, January 30--February 2,
2000.
Observational Study Data
• Ffficacy of postexposure prophylaxis is a
case-control study of needlestick injuries to
health-care workers.
– The prompt initiation of zidovudine was
associated with an 81% decrease in the risk for
acquiring HIV.
N Engl J Med 1997;337:1485--90
MMWR January 21, 2005 / 54(RR02);1-20
HIV Status of the Potentially
Exposed Person?
• Baseline HIV testing should be performed
on all persons seeking evaluation for
potential nonoccupational HIV exposure.
– FDA-approved rapid test kit
• If rapid tests are not available:
– Assume that the potentially exposed patient is
not infected
MMWR January 21, 2005 / 54(RR02);1-20
HIV Status of the Source?
• If the HIV status of the source is unknown, it
should be determined whether the source is
available for interview and HIV testing.
– Risk factors for HIV infection; signs and symptoms of
acute retroviral syndrome.
• If the risk associated with the exposure is
considered substantial
– nPEP can be started pending HIV testing of the source
and then stopped if the source is determined to be
noninfected.
MMWR January 21, 2005 / 54(RR02);1-20
Acute Retroviral Syndrome
Common signs and symptoms of acute retroviral
syndrome (occurring in >50% of patients):
• fever
• adenopathy
• pharyngitis
• rash
• myalgias arthralgia
• less common:
• diarrhea, headache, nausea, weight loss,
thrush
MMWR January 21, 2005 / 54(RR02);1-20
Reveal:Rapid HIV Test
MedMira Laboratories
• Rapid HIV test performed on patient serum
– HIV antibody test
• SENSITIVITY: 99.8%
– All positive tests are confirmed by western blot
• Processing time for the test (upon receipt by the
laboratory) is about 20-30 minutes.
– It is critical that the the source blood be drawn
immediately and delivered to the laboratory in
an expeditious manner
VCU nPEP Protocol
Has exposure of vagina, rectum, eye, mouth, non-intact skin,
or percutaneous contact with blood, semen, vaginal secretions,
rectal secretions, breast milk, or any visibly bloody body fluid
occurred?
PEP not indicated.
Refer to follow-up
clinic for hepatitis B
& C testing
No
Yes
No
Did exposure occur <72 hours ago?
Yes
Send rapid HIV serum test on source patient (2
serum separator tubes) to Microbiology Lab.
Is the source patient HIV+
or at high risk of HIV
infection?
No
Is the source patient present?
Yes
No
Yes
Begin Combivir® 1 tablet twice daily + Kaletra®
3 capsules twice daily
oObtain 1st day doses from Blue ED Omnicell; complete
pre-printed prescriptions & place in Omnicell return bin
oWrite Rx for 10 day supply of drugs (reduced pricing
available in AD Williams Pharmacy).
Is the source patient HIV infected by rapid testing?
Yes
No
Does source patient have signs/ symptoms of
acute retroviral syndrome?*
Yes
No
Check AST, ALT, BUN, creatinine, CBC/diff,
pregnancy test (if tests abnormal, page ID fellow)
Follow-up clinic for hepatitis B & C follow-up.
Preferred Antiretroviral Therapy
A 28-day course of HAART is recommended for persons who have had
nonoccupational exposure to blood, genital secretions, or other
potentially infected body fluids of a persons known to be HIV infected
when that exposure represents a substantial risk for HIV transmission
MMWR January 21, 2005 / 54(RR02);1-20
Maximizing Adherence nPEP
• Decrease Pill burden:
– prescribing medications with fewer doses and
fewer pills per dose
• Educate patients about the importance of
adherence and about potential side effects
• Offer ancillary medications for side effects
(e.g., anti-emetics and anti-diarrheals)
• Provide ongoing encouragement and
consultation by phone or office visit
MMWR January 21, 2005 / 54(RR02);1-20
Adverse Effects of PEP
Adverse effects of combivir + kaletra:
•diarrhea, nausea, vomiting, headache,
insomnia, myopathy, transaminases,
pancreatitis, anemia, neutropenia
Special Considerations
• When the source-person is available for
interview:
– His or her history of antiretroviral medication
use and most recent viral load measurement
should be considered when selecting
antiretroviral medications for nPEP.
• This may help avoid prescribing antiretroviral
medications to which the source-virus is likely to be
resistant.
MMWR January 21, 2005 / 54(RR02);1-20
Follow-up Testing and Care
• Test the exposed patient to HIV antibodies at
baseline and at 4--6 weeks, 3 months, and 6
months after exposure to determine whether HIV
infection has occurred.
• Testing for sexually transmitted diseases:
– hepatitis B and C
• Pregnancy testing should be offered
• Follow patient for signs of acute-retroviral
seroconversion syndrome
MMWR January 21, 2005 / 54(RR02);1-20
What is the Expected Public Health
Impact of this New Guideline?
• Although 40,000 new HIV infections occur in the
United States each year, the impact on nPEP may
be limited
– Few exposed persons seek care after nonoccupational
exposure
– Many people have frequently recurring exposures and
would not benefit from nPEP.
– Clinicians and exposed patients are unaware of the
availability of nPEP
– Financial means of paying for nPEP might limit it’s use
• 28 days of Combivir/Kaletra - $1200
MMWR January 21, 2005 / 54(RR02);1-20
Conclusion
• DHHS recommends nPEP with HAART when persons
seek care within 72 hours after exposure, the source is
known to be HIV infected, and the exposure event presents
a substantial risk for transmission.
• If the HIV status of the source is not known and the patient
seeks care within 72 hours after exposure, DHHS does not
recommend for or against nPEP but encourages clinicians
and patients to weigh the risks and benefits on a case-bycase basis.
• The prompt initiation of HAART (within 72 hours)
following substantial nonoccupational HIV exposure and
it’s continuation for 28 days may reduce the likelihood of
transmission.