Madison Clinic
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HIV PEP Guidelines after Sexual Assault

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Initial risk assessment and discussion with patient about risk and PEP is by
clinician who does exam (SANE, Ob-Gyn resident, pediatrics resident.) 

ED Medicine attending meets with all patients in “Low to moderate risk”
category, and with any patient in other risk categories who wishes to talk
about or consider HIV PEP.

Follow-up: All patients who start PEP will have follow-up through Madison
Clinic. 
HCSATS (SAC) PCC will coordinate with Madison Clinic PCC who will arrange appointment.

Medication:  Patient needs 5 days of medication in hand when leaving ED.
Should be dispensed from Pyxis

 
Lowest risk
Very low risk
Low to moderate risk

 

HIV PEP not indicated

Option of PEP should be discussed with patient by medical provider (SANE)  PEP may be prescribed if patient wishes after full discussion of risks/benefits

Recommendation for PEP should be discussed with patient, with full discussion of risks and benefits

 

Risk factors of assailant

 

Assailant is:
Man who has sex with women OR
Unknown risk factors

Note: man who has been in prison has same risk as general male population (1%)

Assailant is:
Man known or suspected HIV positive (most important factor)
Man who has sex with men (HIV prevalence 12-15%)
Known IV drug use (HIV prevalence 2%)

Risk factors of contact

Prior recent unprotected sexual contact (e.g. intimate partner)
No semen to mucosal or wound contact

Semen to mucosal contact, one assailant

Semen to mucosal contact, 2 or more assailants
Victim is man assaulted by man
Victim has grossly visible vaginal or anal tears
Exposure semen to rectum
Exposure blood to mucosa
Exposure blood to open wound

Time since contact

 

PEP must be initiated within 3 days of exposure

HIV PEP Regimen

PEP not indicated

Basic regimen
Truvada x 5 days. 1 tab po qd. Full course is 28 days
Reevaluate at Madison Clinic. Follow-up

Basic Regimen
Truvada x 5 days 1 tab po qd
Expanded regimen - primarily when assailant in  high risk group (e.g. known HIV+ or MSM,)
Truvada x 5 days 1 tab po qd
 + Atazanavir 300 qd* x 5 days
 + Ritonavir 100 mg qd* x 5 days
  (see drug interactions next page)
Alternative expanded regimen Truvada + Kaletra 2 tab po bid
Full course is 28 days
Re-evaluate at Madison Clinic follow-up

Patient Ed

Use “Information about HIV for Patients” attached
Use condoms for consensual relations for 6 months

Discussion with patient

Advise:
HIV serology may be obtained at f/u medical, 6 wks, 3 and 6 months

ED medicine attending meets patient to discuss PEP if patient is interested
Advise: HIV serology should be obtained at, 6 wks, 3 and 6 months

ED medicine attending meets all patients in this risk category to  discuss HIV PEP

If patient is appropriate candidate for medication, discuss: 

  • 28 days medication course needed.
  • 5 days of medication will be provided in ED. 
  • Must come to Madison Clinic appointment  within 4 days for evaluation
    of medication and decision to complete course (see below for how to arrange appt)
  • Costs:   Crime Victims Compensation may cover cost medication, but
    only if patient applies for CVC (to qualify pt must cooperate with law enforcement, assault must have occurred in Washington state.).  
    Patient may qualify for charity care, or insurance may cover costs. Med should be obtained at HMC unless pt has insurance.

Baseline labs if patient starts PEP

  • Pregnancy test – if positive, Truvada,  Atazanavir, Ritonavir, and
    Kaletra are safe in pregnancy.  Weigh the risks and benefits
  • Urine NAAT for Chlamydia gonorrhea
  • HIV serology
  • CBC platelets
  • Creatinine
  • Liver function panel (Hepatic panel A)
  • RPR

Medications

Prescribe usual post-exposure medications:  Azithromycin 1 gm,
Cefixime 400mg, and Hepatitis B vaccine if not previously fully immunized.  Levonorgestrel emergency contraception as indicated. 

Basic regimen: Truvada 1 tablet daily (tenofovir 300 mg + emtricitabine 200 mg)
  • Generally well-tolerated
  • May cause nausea, vomiting, diarrhea, flatulence, headache, renal impairment
  • Rare but serious lactic acidosis and hepatic steatosis
  • Safe in pregnancy (Category B)

Expanded regimen: Truvada 1 tablet daily + Atazanavir 300 mg qday + Ritonavir 100 mg qday)

  • Don’t use with omeprazole, pantoprazole, lansoprazole, cisapride, or
    other PPI
  • Dose 12 hours apart from H2 blockers such as ranitidine
  • Don’t use with midazolam, triazolam, ergots, cisapride, or pimozide St. John’s Wort or lovastatin.
  • There are potential significant interactions with rifampin, lovastatin, simvastatin, fluticasone, anticonvulsants, and garlic (not a comprehensive list)
  • May cause diarrhea, nausea, vomiting
  • Safe in pregnancy

Consult with infectious disease specialist to choose alternate meds if source patient is taking antiretroviral.

Alternative Expanded regimen: Truvada 1 tablet daily  +
Kaletra 2 tablets bid (lopinavir 400 mg + ritonavir 100 mg bid)

  • Don’t use with midazolam, triazolam, ergots, cisapride, or pimozide St. John’s Wort or lovastatin.
  • There are potential significant interactions with rifampin, lovastatin, simvastatin, fluticasone, anticonvulsants, and garlic
    (not a comprehensive list)
  • If using oral contraceptives, use back-up barrier birth control till
    2 weeks after stopping Kaletra
  • May cause diarrhea, nausea, vomiting
  • Safe in pregnancy

Consult with infectious disease specialist to choose alternate meds if source patient is taking antiretroviral.

Providing initial doses

  • Provide initial 5-day supply from ED Pyxis.  Both basic and expanded regimen are stocked there.

Follow-up

For sexual assault patients only

  • HCSATS PCC will coordinate Madison and HCSATS follow-up visits
  • Medical follow-up will be at Madison (initially in 2-4 days, and
    then 2, 6, 12, and 24 weeks)
  • All patients will get social work outreach call from HCSATS
  • Counseling follow-up will be at HCSATS (if patient wishes)

Resources on drug interactions: Harborview Madison Clinic Pharmacy
(206-731-5151) http://depts.washington.edu/madclin/pharmacy/drugs/index.html,
and http://www.hiv-druginteractions.org/

This guideline was developed and approved by:

Amy Baernstein MD   Attending physician Emergency Department
Harborview Medical Center.  Associate Professor, Medicine/General Internal Medicine University of Washington.

Shireesha Dhanireddy MD  Attending physician Madison Clinic
Harborview Medical Center Assistant Professor, Allergy & Infectious Diseases, University of Washington.

Robert Harrington MD   Professor Allergy and Infectious Disease University of Washington, Madison Clinic Harborview Medical Center

Naomi Sugar MD   Medical Director, Harborview Center for Sexual Assault and Traumatic Stress. Clinical Professor Pediatrics, University of Washington.

Information for Providers

Risk of Transmision

Do not over-prescribe HIV PEP
Do not prescribe PEP if blood contacted only intact skin.
Do not prescribe PEP for exposures to:

  • Saliva (unless visibly bloody)           
  • Tears                                                      
  • Feces                                                     
  • Nasal secretions
  • Sweat
  • Vomit
  • Urin

(even if these contacted mucous membrane or non-intact skin).

Do not prescribe PEP for bites, unless source person’s mouth was bloody
AND exposed person’s skin was visibly broken.


Estimated per-act for acquisition of HIV from HIV + source, by
exposure route 1
                                     
Action
Predicted conversions per 10,000 acts
Blood transfusion 9000
Needle sharing  67 (0 .67 per 100 exposures with HIV+ source)
Receptive anal intercourse  50
Needle stick   30
Receptive penile- vaginal intercourse  10 (0.1 per 100 exposures with HIV + source)
Blood to mucous membranes    9
Insertive anal intercourse    6.5
Insertive penile vaginal intercourse  5
Receptive oral intercourse  1 (.01 per 100 exposures with HIV+ source)  
Man receiving oral sex      0.5

Risk that source patient is HIV+ (for King County)

  • General population: < 1%
  • Incarcerated men    ~ 1%
  • Injection drug users  2-3%
  • Men who have sex with men: 12-15%
  • Man who has sex with men and and injection drug use: 25%

References

  1. CDC Antiretroviral Postexposure Prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States.  MMWR Reports and recommendations 2005; 54 (No. RR-2).
  2. CDC  Updated U.S. Public Health Service Guidelines for the Management
    of Occupational Exposures
  3. to HIV and Recommendations for Postexposure Prophylaxis 2005 ;
    Vol. 54 (No. RR-9)
  4. Garcia MT, Figueriredo RM, Moretti ML, Resende MR, Bedoni AJ, Papaiordanou.  Postexposure prophylaxis after sexual assaults:  a prospective cohort study.  Sex Transm Dis. 2005 Apr; 32(4):214-9.
  5. Wiebe ER, Comay SE, McGregor M, Ducceschi S. Offering HIV prophylaxis
    to people who have been sexually assaulted: 16 months' experience in a sexual assault service. CMAJ. 2000 Mar 7;162(5):641-5.

Case Examples

1. Woman assaulted by male acquaintance, risk factors of male unknown. Penile vaginal and penile oral contact, no condom, no visible genital anal injuries. Assessment: Very low risk Action: Option of PEP should be discussed with
patient Who: By medical provider (SANE), ED medicine attending if patient
wishes medication. Treatment: PEP may be prescribed if patient wishes after
full discussion of risks/benefits. Basic regimen.

2. Woman assaulted by male acquaintance, risk factors of male unknown. Penile vaginal, oral, and anal contact, no condom, no visible genital anal injuries. Assessment: Low to moderate risk. Action: Recommendation for PEP should be discussed with patient, with full discussion of risks and benefits. Who: Initial discussion by primary examiner, ED Medicine attending should meet with patient to discuss. Treatment: Basic regimen is appropriate, depending on clinician judgment and patient preference.

3. Woman assaulted by male acquaintance, Man thought to be an IV drug
user, unknown other risk factors. Penile vaginal contact only Assessment:
Low to moderate risk Action: Recommendation for PEP should be discussed"
with patient, with full discussion of risks and benefits. Who: Initial discussion
by primary examiner, ED Medicine attending should meet with patient to discuss. Treatment: Basic regimen OR expanded regimen may be appropriate, depending on clinician judgment and patient preference.

4. Woman assaulted by 2 males 4 days prior to exam Assessment: outside of time frame for HIV PEP Action: Discuss with patient Who: Initial discussion by primary examiner, ED Medicine attending should meet with patient to discuss if further questions Treatment: No HIV PEP medication. Recommend baseline, 6 weeks 3 months and 6 month HIV serology. Baseline serology can be done at HCSATS follow-up.

5. Woman assaulted by male 24 hours ago. Penile-oral and penile-vaginal
contact, condom used. Visible posterior fourchette tear. Assessment:
Low to moderate risk Action: Recommendation for PEP should be discussed
with patient, with full discussion of risks and benefits. Who: Initial discussion
by primary examiner, ED Medicine attending should meet with patient to
discuss. Treatment: Basic regimen appropriate,

6. Male assaulted by male stranger. Unknown other risk factors. Penile-oral contact only. No mouth lesions. Assessment: Low to moderate risk (although contact is very low risk, but assailant is likely MSM, risk of HIV in assailant is higher than average) Assessment: Low to moderate risk Action:
Recommendation for PEP should be discussed with patient, with full
discussion of risks and benefits. Who: Initial discussion by primary
examiner, ED Medicine attending should meet with patient to discuss.
Treatment: Basic regimen OR expanded regimen may be appropriate,
depending on clinician judgment and patient preference.

7. Male assaulted by male stranger. Risk factors unknown. Penile oral and
penile anal contact. Assessment: Low to moderate risk.
Action: Recommendation for PEP should be discussed with patient, with full discussion of risks and benefits. Who: Initial discussion by primary examiner,
ED Medicine attending should meet with patient to discuss. Treatment: Basic regimen OR expanded regimen may be appropriate, depending on clinician judgment and patient preference.

INFORMATION ABOUT HIV FOR PATIENTS

HIV (human immunodeficiency virus) is the virus which can cause AIDS.  
Getting HIV is often a fear that people have after a sexual assault. 
For most individuals the risk of getting HIV from a sexual assault in
Washington State is extremely low.

  • For women the risk is less than 1 in 1000.
  • An assailant must be infected with HIV in order to transmit it. If the assailant were HIV-infected, it is estimated that there is a less than 3% chance of transmitting it during sexual assault.
  • In the Pacific Northwest, the rate of HIV infection in the male population
    is about 1 to 2 %.  Most men who have HIV are homosexually active.
    The rate of HIV infection in injection drug users is 3-4%.
  • Medicines are available which can decrease the risk of acquiring HIV.  The medicines must be started within 72 hours of the exposure and taken for 28 days month in order to be effective. These medications can cause mild gastrointestinal symptoms (nausea, diarrhea, fatigue, and muscle aches) and are not recommended in very low risk situations. 
  • For men who have been sexually assaulted by men there is a higher, although still small chance of getting HIV.  About 1 in 7 gay men in
    Seattle are HIV+, but the risk of HIV transmission, even without
    condoms is around 1%.  Under these circumstances, the risks and
    benefits of preventive medicine should be discussed with a health care provider.

The risk of HIV infection is quite low.  But this was not a risk that you chose to take. 

If you wish, you can get blood testing for HIV at your follow-up appointment. 
A repeat test is needed 6 weeks and 3 months later in order to know for
certain that you have not been infected, and a final test can be done 6
months after the assault.  During this time, it is important to use condoms
for all voluntary sexual relations.

 

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