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Dr.Sujnanendra Mishra MD (O&G)
What is PEP.
   PEP is a medical response given to prevent the
    transmission of pathogens after potential exposure.
   PEP for HIV refers to a set of comprehensive services
    to prevent HIV infection in exposed individuals.
   These services include, first aid care, counseling and
    risk assessment
EXPOSURES
   Occupational exposure to HIV-
    “an occupational exposure is defined as a percutaneous,
    mucous membrane or non-intact skin exposure to blood or
    body fluids that occurs during the course of an individual’s
    employment. This applies to health care workers (HCW) and to
    non-health workers.”
   Non-occupational exposure to HIV--
    Non-occupational exposure is any direct mucosal, percutaneous
    or intravenous contact with potentially infectious body fluids
    that occurs outside perinatal or occupational situations
Components of nPEP
Evaluation
 HIV risk assessment
 HIV and STD testing and treatment
 Prevention and risk-reduction
  counseling
 Clinicians able to prescribe
  antiretroviral therapy
 Timely access to care and initiation
  of PEP
Assessing Risk
   Consider the following:
     Risk of HIV acquisition based on type of exposure
     Possibility that the source is HIV-infected
     Circumstances leading to HIV exposure
   Provide risk-reduction and primary prevention
    counseling
   nPEP not indicated for negligible or low risk of HIV
    infection
Risk Behavior
   PEP recommended in situations of:
     Isolated exposure (sexual, needle, trauma)
     Lapse in previous risk-reduction practices
     When patients express interest in behavioral
     change
   Repeated high-risk behavior or
    presentation for repeat courses of PEP
     Opportunity for intensification of education &
      prevention
     Attempt behavioral change
*Risk of Acquisition
   The average risk after a percutaneous exposure to HIV-infected blood has
    been estimated to be approximately 0.23% (95% confidence interval (CI) =
    0.00–0.46%) .
   The average risk after a mucous membrane exposure is estimated to be
    approximately 0.09% (CI = 0.006–0.5%) .
   Factors associated with an increased likelihood of transmission include:
    ° deep (intramuscular) injury
    ° injury caused by a device that enters a blood vessel
    ° injury with a hollow-bore needle
    ° a source patient with a high viral load (VL).
   Episodes of HIV transmission have also been documented after non-intact
    skin exposure. It is estimated to be much less than the risk for mucous
    membrane exposures.
   The risk for transmission after exposure to HIV-infected fluids or tissues other
    than blood has not been quantified either, but it is considered probably
    lower than for blood exposure.
Situation Needing PEP
PEP recommended, if source HIV PEP NOT recommended
+ or at risk of HIV
*Unprotected receptive &           *Kissing, or oral-oral contact & no
insertive vaginal or anal          mucosal damage
intercourse                        *Bites without blood
                                   *Needles/sharps exposure not in contact
*Unprotected receptive penile-     with HIV + or at-risk person
oral contact with ejaculation      *Mutual masturbation – intact skin
*Oral-vaginal contact with blood   *Oral-anal contact
exposure                           *Receptive penile-oral contact without
*Needle-sharing                    ejaculation
                                   *Insertive penile-oral contact
*Injury with blood exposure
                                   *Oral-vaginal – no blood exposure
  - needle stick, bite, accident
Estimated Transmission Risk
Exposure Type if Source HIV-    Estimated Risk
infected
Needle-sharing exposure         0.67% (1/150)1
Receptive anal intercourse      0.5% (1/200) to 3% (6/200)2,3
Receptive vaginal intercourse   0.1% (1/1000)3,4
Insertive anal intercourse      0.065% (1/1500)3,4
Insertive vaginal intercourse   0.05% (1/2000)3,4
Oral sex with ejaculation       Conflicting data, but felt to be low-
                                risk. PEP recommended for
                                performer of oral sex who receives
                                ejaculate.5,6
References for HIV
Transmission Risk
   1) Kaplan EH et al. J Acquir Immune Defic
    Syndr 1992;5:1116-1118.
   2) DeGruttola V et al. J Clin Epidemiol
    1989;42:849-856.
   3) Varghese B et al. Sex Transm Dis
    2002;29:38-43.
   4) European Study Group. BMJ 1992;304:809-
    813.
   5) Dillon B et al. 7th CROI, San Francisco, CA
    2000; abstract 473.
   6) Page-Shafer K et al. AIDS 2002;16:2350-
    2352.
Community Needlestick
Injuries
    Consider:
      HIV prevalence in the community or
       facility
      Surrounding prevalence of injection drug
       use
  DO NOT TEST discarded needles for
   HIV
  Consider tetanus vaccination if
   puncture wound
Bites
 Estimated 250,000 bites annually in the U.S.
 HIV levels in saliva very low
 Documented transmission has involved
  blood-tinged saliva 1,2
 Consider PEP when:
     Blood exposure to biter
     Blood exposure to bitten person (e.g. source
      has bleeding gums or lesions)
     Blood exposure to both parties
    1 Vidmar L et al. Lancet 1996;347:1762-1763.
    2 Pretty I et al. Am J Forensic Med Pathol 1999;20:232-239.
Considering HIV Status of
Exposure Source

   If HIV-positive source, consider their:
       CD4+ cell count
       Viral load
       Antiretroviral medication history
       Antiretroviral resistance history
   If anonymous or unknown status
    source:
     Consider potential risk of HIV infection,
        including information on regional
        prevalence
Contraindications to nPEP
 Prophylaxis for pregnancy attempts
  with an HIV-infected male partner
 Prophylaxis for persons planning to
  engage in high-risk behavior
Risk of HIV transmission
=risk/single exposure
multiplied by the risk of
source being HIV positive.
Transmission Risk from the
Exposure
   Determine the specific sexual,
    injection drug use, or other behavior
    that led person to seek nPEP (see
    Estimated Per-Act Risk by Exposure
    Route)

   Determine relative risk for HIV
    exposure using algorithm for
    evaluation and treatment and per-
    act risk for acquisition of HIV


                        AETC National Resource Center, www.aidsetc.org
Estimated Per-Act Risk for Acquisition of
HIV by Exposure Route

             Exposure Route                        Risk per 10,000
                                                     exposures
   Blood transfusion                                                       9,000
   Needle-sharing injection drug use                                             67
   Receptive anal intercourse                                                    50
   Percutaneous needle stick                                                     30
   Receptive penile-vaginal intercourse                                          10
   Insertive anal intercourse                                                   6.5
   Insertive penile-vaginal intercourse                                          10
   Receptive oral intercourse                                                         1
   Insertive oral intercourse                                                   0.5


              March 2008             AETC National Resource Center, www.aidsetc.org
RISK communication
Risk                                                Term
1 in 1 to 1 in 10                                Very high
1 in 10 to 1 in 100                              High
1 in 100 to 1 in 1000                             Moderate
1 in 1000 to 1 in 10,000                          Low
1 in 10,000 to 1 in 100,000                       Very low
1 in 100,000 to 1 in 1000,000                      Minimal
1 in 1000,000 to 1 in 1 billion/trillion          Negligible



            Communicable Disease Control Branch (CDCB) South Australia
Risk of HIV acquisition when the source is
KNOWN to be HIV infected




        Communicable Disease Control Branch (CDCB) South Australia
* Risk of HIV acquisition by exposure to a
   non-IDU heterosexual source with HIV
                      status UNKNOWN




        Communicable Disease Control Branch (CDCB) South Australia
Assessing Risk of HIV Exposure
      Substantial Risk                             Negligible Risk
      of HIV Exposure                              of HIV Exposure
Exposure of:                            Exposure of:
 vagina, rectum, eye, mouth or          vagina, rectum, eye, mouth
other mucous membrane, non-             or other mucous membrane,
intact skin, or percutaneous            intact or nonintact skin, or
contact                                 percutaneous contact
With:                                   With:
 blood, semen, vaginal                  urine, nasal secretions, saliva,
secretions, rectal secretions,          sweat, or tears if not visibly
breast milk, or any body fluid          contaminated with blood
visibly contaminated with blood
       When the source is                    Regardless of the known or
    known to be HIV infected                   suspected HIV status
                                                   of the source

                                  AETC National Resource Center, www.aidsetc.org
Recommendations for Use of ARVs for nPEP

                                               Substantial                   Negligible
                                              exposure risk                 exposure risk


                           < 72 hours since                   >72 hours since
                              exposure                           exposure


               Source patient           Source patient of
                known to be              unknown HIV                      nPEP not
                   HIV+                      status                     recommended



                   nPEP                   Case-by-case
               recommended                determination

The Centers for Disease Control and Prevention (CDC) flow diagram for nonoccupational post exposure prophylaxis
(nPEP) decision making, CDC, Morb Mortal Wkly Rep, 2005.
PEP should be initiated within hours of
Timing of Initiation   exposure – ideally within 2 hours and not later
                       than 72 hours
                       after exposure and should not be delayed
                       while waiting for tests results.
                       A 28 days course of
 Duration of
                       nPEP is
treatment
                       recommended


         Follow-Up
Two ARV drug regimens

Two-drug ARV regimens


Preferred                          ZDV + 3TC or FTC (a)


Alternatives                       TDF + FTC or 3TC(b)
                                   or
                                   d4T + 3TC

 a The combination ZDV + 3TC is available as a fixed-dose combination
 (FDC) (Combivir), one tablet twice daily (BID).
 b The combination TDF + FTC is available as an FDC (Truvada), one
 tablet once daily (OD).



               March 2008           AETC National Resource Center, www.aidsetc.org
Three-drug ARV regimens

Recommended for exposures that pose an increased risk of transmission
or that involve a source in whom antiretroviral drug resistance is likely.
Preferred                                             ZDV + 3TC or FTC (a)


Alternatives                                          TDF + FTC or 3TC (b)
                                                      or
                                                      d4T + 3TC

a The combination of ZDV + 3TC is available as an FDC (Combivir), one tablet BID.
b The combination of TDF + FTC is available as an FDC (Truvada), one tablet OD.
ARV dosages (Adults)
        • ZDV: 300 mg per os (PO), BID with food
        • 3TC: 150 mg PO, BID or 300 mg PO, OD
        • FTC: 200 mg, PO, OD
        • TDF: 300 mg, PO, OD
        • d4T: 30 mg PO, BID
        • LPV/r: 400 mg/100 mg PO, BID with food
        • SQV/r: 1000 mg/100 mg PO, BID
        • ATV/r: 300 mg/100 mg PO, OD
        • FPV/r: 700 mg/100 mg PO, BID


  Children who need PEP, dosages should
  be adjusted by body weight
Follow-Up
  People who have been potentially exposed to HIV, whether
  occupationally or non-occupationally, should receive follow-
  up treatment.
  • Counseling, post-exposure testing and medical evaluation
  should be provided to all exposed
  people, regardless of whether they receive PEP or not.
  • If taking ARVs patients should be followed up for
  adherence and possible side-effects of ARVs
  (e.g. nausea or diarrhoea) should be managed
  symptomatically without changing the regimen.
Final Words
    Advice on safe practices
• Safe sex.
• Safe needle use.
• Safe Work practices.
• Safe infant feeding.
• Safe Blood/Organ donation.
 A person with a possible exposure to HIV should be advised not
 to donate blood, skin, or organs for the six month following the
 exposure.

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Non occupational post-exposure prophylaxis (n pep) for hiv

  • 2. What is PEP.  PEP is a medical response given to prevent the transmission of pathogens after potential exposure.  PEP for HIV refers to a set of comprehensive services to prevent HIV infection in exposed individuals.  These services include, first aid care, counseling and risk assessment
  • 3. EXPOSURES  Occupational exposure to HIV- “an occupational exposure is defined as a percutaneous, mucous membrane or non-intact skin exposure to blood or body fluids that occurs during the course of an individual’s employment. This applies to health care workers (HCW) and to non-health workers.”  Non-occupational exposure to HIV-- Non-occupational exposure is any direct mucosal, percutaneous or intravenous contact with potentially infectious body fluids that occurs outside perinatal or occupational situations
  • 4. Components of nPEP Evaluation  HIV risk assessment  HIV and STD testing and treatment  Prevention and risk-reduction counseling  Clinicians able to prescribe antiretroviral therapy  Timely access to care and initiation of PEP
  • 5. Assessing Risk  Consider the following:  Risk of HIV acquisition based on type of exposure  Possibility that the source is HIV-infected  Circumstances leading to HIV exposure  Provide risk-reduction and primary prevention counseling  nPEP not indicated for negligible or low risk of HIV infection
  • 6. Risk Behavior  PEP recommended in situations of:  Isolated exposure (sexual, needle, trauma)  Lapse in previous risk-reduction practices  When patients express interest in behavioral change  Repeated high-risk behavior or presentation for repeat courses of PEP  Opportunity for intensification of education & prevention  Attempt behavioral change
  • 7. *Risk of Acquisition  The average risk after a percutaneous exposure to HIV-infected blood has been estimated to be approximately 0.23% (95% confidence interval (CI) = 0.00–0.46%) .  The average risk after a mucous membrane exposure is estimated to be approximately 0.09% (CI = 0.006–0.5%) .  Factors associated with an increased likelihood of transmission include: ° deep (intramuscular) injury ° injury caused by a device that enters a blood vessel ° injury with a hollow-bore needle ° a source patient with a high viral load (VL).  Episodes of HIV transmission have also been documented after non-intact skin exposure. It is estimated to be much less than the risk for mucous membrane exposures.  The risk for transmission after exposure to HIV-infected fluids or tissues other than blood has not been quantified either, but it is considered probably lower than for blood exposure.
  • 8. Situation Needing PEP PEP recommended, if source HIV PEP NOT recommended + or at risk of HIV *Unprotected receptive & *Kissing, or oral-oral contact & no insertive vaginal or anal mucosal damage intercourse *Bites without blood *Needles/sharps exposure not in contact *Unprotected receptive penile- with HIV + or at-risk person oral contact with ejaculation *Mutual masturbation – intact skin *Oral-vaginal contact with blood *Oral-anal contact exposure *Receptive penile-oral contact without *Needle-sharing ejaculation *Insertive penile-oral contact *Injury with blood exposure *Oral-vaginal – no blood exposure - needle stick, bite, accident
  • 9. Estimated Transmission Risk Exposure Type if Source HIV- Estimated Risk infected Needle-sharing exposure 0.67% (1/150)1 Receptive anal intercourse 0.5% (1/200) to 3% (6/200)2,3 Receptive vaginal intercourse 0.1% (1/1000)3,4 Insertive anal intercourse 0.065% (1/1500)3,4 Insertive vaginal intercourse 0.05% (1/2000)3,4 Oral sex with ejaculation Conflicting data, but felt to be low- risk. PEP recommended for performer of oral sex who receives ejaculate.5,6
  • 10. References for HIV Transmission Risk  1) Kaplan EH et al. J Acquir Immune Defic Syndr 1992;5:1116-1118.  2) DeGruttola V et al. J Clin Epidemiol 1989;42:849-856.  3) Varghese B et al. Sex Transm Dis 2002;29:38-43.  4) European Study Group. BMJ 1992;304:809- 813.  5) Dillon B et al. 7th CROI, San Francisco, CA 2000; abstract 473.  6) Page-Shafer K et al. AIDS 2002;16:2350- 2352.
  • 11. Community Needlestick Injuries  Consider:  HIV prevalence in the community or facility  Surrounding prevalence of injection drug use  DO NOT TEST discarded needles for HIV  Consider tetanus vaccination if puncture wound
  • 12. Bites  Estimated 250,000 bites annually in the U.S.  HIV levels in saliva very low  Documented transmission has involved blood-tinged saliva 1,2  Consider PEP when:  Blood exposure to biter  Blood exposure to bitten person (e.g. source has bleeding gums or lesions)  Blood exposure to both parties 1 Vidmar L et al. Lancet 1996;347:1762-1763. 2 Pretty I et al. Am J Forensic Med Pathol 1999;20:232-239.
  • 13. Considering HIV Status of Exposure Source  If HIV-positive source, consider their:  CD4+ cell count  Viral load  Antiretroviral medication history  Antiretroviral resistance history  If anonymous or unknown status source:  Consider potential risk of HIV infection, including information on regional prevalence
  • 14. Contraindications to nPEP  Prophylaxis for pregnancy attempts with an HIV-infected male partner  Prophylaxis for persons planning to engage in high-risk behavior
  • 15. Risk of HIV transmission =risk/single exposure multiplied by the risk of source being HIV positive.
  • 16. Transmission Risk from the Exposure  Determine the specific sexual, injection drug use, or other behavior that led person to seek nPEP (see Estimated Per-Act Risk by Exposure Route)  Determine relative risk for HIV exposure using algorithm for evaluation and treatment and per- act risk for acquisition of HIV AETC National Resource Center, www.aidsetc.org
  • 17. Estimated Per-Act Risk for Acquisition of HIV by Exposure Route Exposure Route Risk per 10,000 exposures Blood transfusion 9,000 Needle-sharing injection drug use 67 Receptive anal intercourse 50 Percutaneous needle stick 30 Receptive penile-vaginal intercourse 10 Insertive anal intercourse 6.5 Insertive penile-vaginal intercourse 10 Receptive oral intercourse 1 Insertive oral intercourse 0.5 March 2008 AETC National Resource Center, www.aidsetc.org
  • 18. RISK communication Risk Term 1 in 1 to 1 in 10 Very high 1 in 10 to 1 in 100 High 1 in 100 to 1 in 1000 Moderate 1 in 1000 to 1 in 10,000 Low 1 in 10,000 to 1 in 100,000 Very low 1 in 100,000 to 1 in 1000,000 Minimal 1 in 1000,000 to 1 in 1 billion/trillion Negligible Communicable Disease Control Branch (CDCB) South Australia
  • 19. Risk of HIV acquisition when the source is KNOWN to be HIV infected Communicable Disease Control Branch (CDCB) South Australia
  • 20. * Risk of HIV acquisition by exposure to a non-IDU heterosexual source with HIV status UNKNOWN Communicable Disease Control Branch (CDCB) South Australia
  • 21. Assessing Risk of HIV Exposure Substantial Risk Negligible Risk of HIV Exposure of HIV Exposure Exposure of: Exposure of:  vagina, rectum, eye, mouth or  vagina, rectum, eye, mouth other mucous membrane, non- or other mucous membrane, intact skin, or percutaneous intact or nonintact skin, or contact percutaneous contact With: With:  blood, semen, vaginal  urine, nasal secretions, saliva, secretions, rectal secretions, sweat, or tears if not visibly breast milk, or any body fluid contaminated with blood visibly contaminated with blood When the source is Regardless of the known or known to be HIV infected suspected HIV status of the source AETC National Resource Center, www.aidsetc.org
  • 22. Recommendations for Use of ARVs for nPEP Substantial Negligible exposure risk exposure risk < 72 hours since >72 hours since exposure exposure Source patient Source patient of known to be unknown HIV nPEP not HIV+ status recommended nPEP Case-by-case recommended determination The Centers for Disease Control and Prevention (CDC) flow diagram for nonoccupational post exposure prophylaxis (nPEP) decision making, CDC, Morb Mortal Wkly Rep, 2005.
  • 23. PEP should be initiated within hours of Timing of Initiation exposure – ideally within 2 hours and not later than 72 hours after exposure and should not be delayed while waiting for tests results. A 28 days course of Duration of nPEP is treatment recommended Follow-Up
  • 24. Two ARV drug regimens Two-drug ARV regimens Preferred ZDV + 3TC or FTC (a) Alternatives TDF + FTC or 3TC(b) or d4T + 3TC a The combination ZDV + 3TC is available as a fixed-dose combination (FDC) (Combivir), one tablet twice daily (BID). b The combination TDF + FTC is available as an FDC (Truvada), one tablet once daily (OD). March 2008 AETC National Resource Center, www.aidsetc.org
  • 25. Three-drug ARV regimens Recommended for exposures that pose an increased risk of transmission or that involve a source in whom antiretroviral drug resistance is likely. Preferred ZDV + 3TC or FTC (a) Alternatives TDF + FTC or 3TC (b) or d4T + 3TC a The combination of ZDV + 3TC is available as an FDC (Combivir), one tablet BID. b The combination of TDF + FTC is available as an FDC (Truvada), one tablet OD.
  • 26. ARV dosages (Adults) • ZDV: 300 mg per os (PO), BID with food • 3TC: 150 mg PO, BID or 300 mg PO, OD • FTC: 200 mg, PO, OD • TDF: 300 mg, PO, OD • d4T: 30 mg PO, BID • LPV/r: 400 mg/100 mg PO, BID with food • SQV/r: 1000 mg/100 mg PO, BID • ATV/r: 300 mg/100 mg PO, OD • FPV/r: 700 mg/100 mg PO, BID Children who need PEP, dosages should be adjusted by body weight
  • 27. Follow-Up People who have been potentially exposed to HIV, whether occupationally or non-occupationally, should receive follow- up treatment. • Counseling, post-exposure testing and medical evaluation should be provided to all exposed people, regardless of whether they receive PEP or not. • If taking ARVs patients should be followed up for adherence and possible side-effects of ARVs (e.g. nausea or diarrhoea) should be managed symptomatically without changing the regimen.
  • 28. Final Words Advice on safe practices • Safe sex. • Safe needle use. • Safe Work practices. • Safe infant feeding. • Safe Blood/Organ donation. A person with a possible exposure to HIV should be advised not to donate blood, skin, or organs for the six month following the exposure.