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Talking to Your Doctor About nPEP

May 2007


Introduction

Please share this with your health provider. If your doctor does not have a great deal of HIV experience, he or she may want to contact a more experienced provider to support making decisions around nPEP. San Francisco General Hospital has a 24-hour PEPline, which offers guidance around occupational HIV PEP. It may also help providers making decisions for non-occupational PEP (nPEP). The phone number is 1-888-448-4911. Provider AIDS Training (PAT) Warm Line (800-933-3413), with skilled staff to support doctors with anti-HIV drug management decisions. These resources are for health care providers only.


A Few Points to Consider

A doctor should be aware of the issues concerning the care of someone with a possible HIV exposure. A few points to consider include:

  • If the exposure involves a small cut or puncture, encourage bleeding and then wash with soap and water.

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  • If the exposure does not involve open sores, wash with soap and water.

  • If the exposure is due to anal or vaginal sex, refrain from douching.

  • If the exposure is oral, rinse thoroughly with water. Don't brush teeth as it might result in tearing and possibly increase the risk of infection.

  • If the exposure is in the eyes, rinse gently but thoroughly with water or normal saline.

  • If clothing was exposed to blood or blood products, find other clothing and shower if necessary or possible.

  • If sexual assault, rape or domestic violence is suspected, get counseling and referrals.

  • An evaluation for sexually transmitted infections (STI), hepatitis and emergency contraception may be necessary and should be a routine part of HIV PEP screening. This should include screening and treating STIs as needed and consider of hepatitis B PEP or vaccination.


Discussion Points and Comments

Step One

Did the possible HIV exposure occur within the past 72 hours? Can anti-HIV therapy be started within those 72 hours?

  • If no, nPEP is not a reasonable option. Describe acute infection syndrome to the patient. (Not all seroconverters experience this.) Screen for HIV using standard antibody test in 4-6 weeks. Confirm negative results with follow-up tests in 3 and 6 months. Discuss and develop an HIV prevention plan.1

  • If yes, nPEP might be a reasonable option.


Step Two

Are you currently HIV-positive?

  • If no, confirm it with an HIV antibody test.

  • If unknown, screen with an antibody test.

  • If yes, nPEP should NOT be started. Treat HIV disease according to Federal Guidelines, available at www.aidsinfo.nih.gov.


Step Three

Conduct a risk assessment. What is the chance that the activity(ies) that put you at risk resulted in an HIV exposure or infection?

  • If low to no risk, nPEP is generally discouraged.

  • If moderate risk, nPEP might be considered.

  • If high to highest risk, nPEP is a reasonable option.

  • If the exposure is not isolated and future incidents are highly likely because of regular high-risk activity, nPEP is generally discouraged according to CDC recommendations.


Step Four

What is the chance that the source (like a sexual partner or needle) was HIV-infected?

  • If low to no risk, nPEP is discouraged regardless of risk assessment.

  • If moderate risk, nPEP might be considered if warranted by risk assessment.

  • If high to highest risk, nPEP is reasonable if warranted by risk assessment.


Step Five

Based on the risk and source assessment, is nPEP reasonable to consider?

  • If no, describe acute infection syndrome to patient. (Not all seroconverters experience this.) Screen for HIV using standard antibody test in 4-6 weeks. Confirm negative results with follow-up tests in 3 and 6 months. Discuss and develop an HIV prevention plan.

  • If yes, consider if nPEP is a desirable option.


Choosing an nPEP Regimen

Step One

Is the person seeking nPEP a woman?

  • If no, continue to the next section.

  • If yes, is she pregnant? (Do a pregnancy test.)

    • If no, continue to consider nPEP and discuss the drug interactions between nPEP and hormonal birth control.

    • If yes, continue to consider nPEP, but counsel her on the unknown risk of using medications during pregnancy. Do not consider Sustiva (efavirenz) for nPEP, as it may cause birth defects. Do not consider Videx + Zerit (ddI + d4T) due to possibly lethal side effects. Consider risks of anti-HIV therapy known to raise billirubin levels. Provide referrals for prenatal care.2

  • If yes, is she lactating or breast-feeding a child?

    • If no, continue to consider nPEP.

    • If yes, continue to consider nPEP, but counsel her on the unknown risk of using medications while breast-feeding. Consider whether nPEP therapies are excreted in breast milk and the possible harm to her nursing infant if she is actually newly infected with HIV.


Step Two

Is the HIV status of the sex partner or source of exposure known?

  • If no, consider two drugs for nPEP (two NRTIs).

  • If yes, is anything known about the anti-HIV drug history, viral load, resistance profile, CD4+ cell count of the source?

    • If no, consider two or three drugs for nPEP.

    • If yes, conduct an anti-HIV drug assessment of the source.

  • The regimen that an individual is offered will likely include drugs that the source does not have resistance to and/or has not used recently. If a provider is not familiar with anti-HIV drugs, s/he should seek guidance from the National PEPline.


Step Three

Once a regimen is chosen, discuss side effects, adherence and monitoring

  • Describe the regimen: the number of pills and when to take them each day. If the patient doesn't think that he or she can comply, consider another or simpler regimen or discourage nPEP.3

  • Describe the possible side effects of each drug and how to check for them. Describe the schedule of follow-up visits to check for drug side effects (like lab work and physical exams).

  • Describe possible interactions between anti-HIV drugs and other drugs the patient is taking. Work with a pharmacist to modify the drug doses as needed. Note: Some anti-HIV drugs, particularly Norvir (ritonavir), may have lethal interactions with street drugs. Conduct a thorough assessment of legal, over-the-counter and street drugs.

  • Develop an adherence plan.


Step Four

If nPEP remains a desired option ...

  • Screen for HIV with standard antibody test. Start nPEP within 72 hours of exposure.

  • See suggested follow-up schedule on page 4. Describe acute infection syndrome to patient. (Not all seroconverters experience this.) Screen for HIV using standard antibody test in 4-6 weeks. Confirm negative results with follow-up tests in 3 and 6 months. Discuss and develop a post exposure HIV prevention plan.


Step Five

If nPEP is no longer a desired option ...

  • Describe acute infection syndrome to patient. (Not all seroconverters experience this.) Screen for HIV using standard antibody test in 4-6 weeks. Confirm negative results with follow-up tests in 3 and 6 months. Discuss and develop an HIV prevention plan.


Suggested Schedule for nPEP

The CDC has funded a 24-hour national PEP registry for non-occupational HIV exposure: 1-877-448-1737 and www.HIVpepregistry.org. Its purpose is to collect information about the use and impact of nPEP among people at risk for HIV. The registry is entirely anonymous and no names or personal identifiers are collected.


Visit #1: Medical Evaluation

  • Conduct risk assessment of patient.

  • Conduct assessment of source if known (HIV status, CD4+ cell count, medication and viral load history including resistance test results).

  • Gather information about patient's medical history, including current medications, allergies, alcohol and drug use, previous exposure to HIV, HBV and HCV and earlier use of nPEP.

  • Conduct physical exam.

  • Conduct appropriate lab work (see table of recommended evaluation, below)

    • Women: pregnancy test (discuss contraception plans).

    • Screen and treat STIs as needed.

    • Any other blood tests (EKG, CXR, etc.) if indicated by medical history and exam.

  • A 3-5 day supply of medication provided or prescribed initially.

  • Discuss an HIV prevention and risk reduction plan.

  • If the patient is a victim of a rape, sexual assault or domestic violence, provide referrals to rape crisis or domestic violence counseling and other referrals as appropriate.

Note: HIV RNA tests are NOT recommended for diagnosing HIV infection. The false positive rate is high and may cause undue anxiety for the patient.


Visit #2: Week 1

  • Patient returns for lab work and HIV antibody test results. (Conduct post-test counseling.)

  • Review any side effects or other problems.

  • If antibody test is negative, labs are normal, and there are no serious side effects from nPEP, dispense remaining three weeks' medication.

  • If antibody test is positive, consult Federal Guidelines for treating HIV disease.


Visit #3: 1 Month

  • Review side effects or other problems.


Visit #4: 6 Weeks

  • Follow-up HIV antibody screening. (Conduct pre-test counseling.)

  • If antibody test is negative, confirm results at visit 5.

  • If antibody test is positive, consult Federal Guidelines for treating HIV disease.


Visit #5: 3 Months

  • Follow-up HIV antibody screening. (Conduct pre-test counseling.)

  • If antibody test is negative, confirm results at visit 6.

  • If antibody test is positive, consult Federal Guidelines for treating HIV disease.


Visit #6: 6 Months

  • Confirm HIV-negative test results. (Conduct pre- and post-test counseling.)

  • If antibody test is negative, revisit prevention and risk reduction plan.

  • If antibody test is positive, consult Federal Guidelines for treating HIV disease.


Recommended Lab Evaluation for nPEP of HIV Infection


Test Baseline During nPEP* 4-6 Wks After Exposure 3 Mos After Exposure 6 Mos After Exposure

  HIV antibody test

E†, S§

 

E

E

E

  CBC with differential

E

E

     

  Serum liver enzymes

E

E

     

  Blood urea nitrogen/creatinine

E

E

     

  STD screen

E, S

   

  Hepatitis B serology

E, S

 

 

  Hepatitis C serology

E, S

   

E

E

  Pregnancy test

E

   

  HIV viral load

S

 

E**

E**

E**

  HIV resistance test

S

 

E**

E**

E**

  CD4+ T lymphocyte count

S

 

E**

E**

E**

* Other specific tests might be indicated dependent on the antiretrovirals prescribed. Literature pertaining to individual agents should be consulted.

† E = exposed patient. S = source.

§ HIV antibody testing of the source patient is indicated for sources of unknown serostatus.

º Additional testing for pregnancy, STDs, and HBV should be done as clinically indicated.

** If determined to be HIV infected on follow-up testing, perform as clinically indicated once diagnosed.


nPEP Resource List

These resources may be useful for people seeking information about nPEP and related issues. While Project Inform provides this publication, it is not an HIV prevention organization and does not answer calls on prevention, high-risk behaviors or risk reduction. Project Inform's Hotline answers questions about HIV disease, its treatments and related conditions. Do not call the Hotline about questions prevention. You will be referred to other resources. Some are listed below.


HIV Prevention

  • National HIV/AIDS Prevention Hotline
    800-458-5231, English and Spanish
    HIV prevention & testing info & referrals

  • HIV Nightline/Crisis Hotline
    415-434-2437; Spanish: 415-989-5212; Deaf: 415-781-2228
    California only: 800-273-2437; Spanish -- California only: 800-303-7432


Domestic Violence and Rape Crisis

  • National Domestic Violence Hotline
    800-799-7233; Deaf: 800-787-3224
    English, Spanish + translators for 139 languages

  • Rape, Abuse and Incest National Network (RAINN)
    800-656-4673, www.rainn.org
    Referrals to local rape crisis centers


HIV/AIDS Treatment Information Resources4


For Physicians Only


PEP Programs And Resources5

  • San Francisco Bay Area, CA
    415-487-5538
    Spanish language translators available

  • Boston, MA
    Fenway Community Health Center
    617-267-0900, nPEP to walk-in clients
    English and Spanish

  • New York, New York
    Bentley-Salick Medical Practice
    212-358-2400, nPEP free of charge


Internet Resources

Several nPEP documents are found on the internet. On most search engines the key words, PEP HIV, will bring up a long list of articles. A few include:


Footnotes

  1. It cannot be concluded that nPEP is not effective when started after 72 hours. Data suggests that the earlier the intervention is started the greater the chances of success. Currently there's no definite time after exposure that nPEP is deemed useless. If the risk of the exposure is very high, it may be reasonable to start nPEP even after 72 hours.

  2. If the woman is pregnant, it's important that both you and she are aware of study results that show the effectiveness of preventing HIV transmission from mother to child. Research centers like the Bay Area Perinatal AIDS Cohort (BAPAC) in San Francisco have reduced mother-to-child transmission rates to near zero. For more information, call the National Perinatal HIV Consultation and Referral Service (www.ucsf.edu) at 1-888-448-8765 (available 24/7).

  3. People may be under a great deal of stress and may not be able to retain information that's provided to them. Consider using starter packs of medication (3-5 days). Schedule a follow-up visit to review lab results and provide counseling, support and medication adjustment, as needed.

  4. For a more complete listing of HIV treatment information and other resources, read Resource Guide.

  5. Please help Project Inform keep this resource list up to date. If you discover a site or clinic in your local area that provides nPEP, please let us know the name of the clinic and/or a contact person. Call 415-558-8669 x212 or email web@projectinform.org.


  
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This article was provided by Project Inform. Visit Project Inform's website to find out more about their activities, publications and services.
 
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