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- 1. Standard Precautions(SP) and Post Exposure Prophylaxis (PEP) Unit 16 HIV Care and ART: A Course for Pharmacists by Salahadin M.Ali
- 2. 2 Learning Objectives Identify the risks of HIV, HCV, and HBV seroconversion following accidental occupational exposures Describe the basic principles and procedures of standard precautions List the management steps of occupational exposure Describe the principles of HIV post-exposure prophylaxis Describe measures taken to maximize the effectiveness of post-exposure prophylaxis (PEP)
- 3. 3 Case study Abebech is a 32 year-old nurse. She came to the ART clinic after she sustained a needle stick while providing an injection to a hospitalized patient. She thinks that the patient is HIV positive and she is requesting HIV post- exposure prophylaxis What measures are important for preventing this problem in the future? What further information is needed to manage this client?
- 5. 5 . Estimated Pathogen-Specific Seroconversion Rate Per Exposure for Occupational Needle stick Injury AETC http://depts.washington.edu/hivaids
- 6. 6 AETC http://depts.washington.edu/hivaids Type of Exposure Involved in Transmission of HIV to Health Care Workers
- 7. 7 Source of HIV Involved in HIV Transmission to Health Care Worker AETC http://depts.washington.edu/hivaids
- 8. 8 Risk Factors for HIV Transmission with Occupational Exposure to HIV-Infected Blood
- 9. 9 Other Possible Risk Factors Hollow bore vs solid bore No documented cases to date of seroconversion from suture needles Glove use 50% decrease in volume of blood transmitted Mucous membrane exposure
- 10. 10 HIV in the Environment How long does HIV live outside the body? HIV does not survive well in the environment When HIV-infected blood or body fluids dry, the theoretical risk of environmental transmission is essentially zero No reports of environmental transmission
- 12. 12 Standard Precautions Definition Standards developed to prevent exposure and transmission of disease in occupational setting Provide guidance for the safe handling of infectious material Formerly referred to as Universal Precautions. “Universal” means everyone, everywhere, always
- 13. 13 Components of Standard Precautions Hand washing – Key step in limiting nosocomial spread of disease Use protective barriers when indicated Gloves: mucus membranes, body fluids, broken skin Goggles: procedures Gowns/masks: procedures
- 14. 14 Components of Standard Precautions (2) Sharps and waste - handle with gloves and dispose in designated containers Needles Scalpels Suture material Bandages Dressings Anything contaminated with any body fluid
- 15. 15 Rules to Follow While Disposing Sharps Do not recap needles! Put containers within arms reach Use adequate light source when treating patients Wear heavy-duty gloves when transporting sharps Incinerate used needles to a sufficient temperature to melt Keep sharps out of reach of children
- 16. 16 Components of Standard Precautions (3) Re-usable instruments - must be thoroughly disinfected Speculums Surgical tools Thermometers Immunizations Hepatitis A and B
- 17. 17 Recommended Antiseptic Solutions Ethyl alcohol, 70% Chlorhexidine, 2-4% (e.g. Hibtane, Hibiscrub) Chlorhexidine gluconate and cetrimide, at least 2% (e.g. Savlon*) Iodine tincture, 3% Iodophores, 7.5-10% (e.g. Betadine) Chlorozylenol in alcohol, 0.5-3.75%, (e.g. Dettol*) *Use undiluted
- 18. 18 Recommended Disinfectants Chlorine, 0.5% (Barkina) Sedex and Ghion brands contain 5% Chlorine, dilute for use Glutaraldehyde, 2-4% (e.g. Cidex) Formaldehyde, 8% Hydrogen peroxide, 6% Soak the instrument for 20 minutes after decontamination and cleaning
- 20. 20 Wound Care Gently wash wounds with soap and water (don’t scrub vigorously) Allow wounds to bleed freely Irrigate exposed mucosal surfaces with sterile saline
- 21. 21 Post Exposure Prophylaxis Definition: Use of therapeutic agent to prevent establishment of infection following exposure to pathogen Comprises a set of services that provide to manage the specific aspect of exposure to HIV and to help prevent HIV infection in a person exposed to the risk of getting infected by HIV Roles in Occupational Exposure: HIV prevention HBV prevention
- 22. 22 Post Exposure Prophylaxis Rationale: Ultimate goals of PEP are to maximally suppress any limited viral replication that may occur and to shift the biologic advantage to the host cellular immune system to prevent or abort early infection, Several clinical studies have demonstrated that HIV transmission can be significantly reduced by the administration of antiretroviral (ARV) agents
- 23. 23 Rational for HIV PEP Considerations that influence the rationale and recommendations for PEP include 1.The pathogenesis of HIV infection, particularly the time course of early infection; 2.The biological plausibility that infection can be prevented or ameliorated by using antiretroviral drugs; 3.Direct or indirect evidence of the efficacy of specific agents used for prophylaxis; and 4.The risk and benefit of PEP to exposed HCP
- 24. 24 Cell free HIV CD40—CD40 Skin or mucosa 24 hours 48 hours 1. HIV co-receptors, CD4 + chemokine receptor CC5 Immature Dendritic cell 3. Mature Dendritic cell in regional LN undergoes a single replication, which transfers HIV to T- cell Via lymphatics or circulation T-cell PEP Burst of HIV replication 2. Selective of macrophage- tropic HIV Why PEP as soon as possible: The Early Stages of HIV Infection
- 25. 25 HIV PEP for Occupational Exposure Overview Limited data (animal) Better to err on side of treatment Exposed patient must be tested for HIV prior to PEP Start immediately after exposure not later than 72 hours Duration 28 days
- 26. 26 Establishing eligibility for PEP Evaluating client eligibility for HIV PEP involves assessing the following: The timing of the potential exposure The persons HIV status The nature and risk of exposure; and The HIV status of the source of the potential exposure
- 27. 27 Assessment of exposure risk Low-risk exposure • Exposure to small volume of blood or blood contaminated body fluid • Exposure to saliva, tears, sweat, or non-bloody urine or feces (don’t require PEP) • Following injury with a solid needle • Asymptomatic source patient
- 28. 28 Assessment of exposure risk cont. High-risk exposure Exposure to large volume of blood from a patient with clinical AIDS or acute HIV infection Other potentially infectious source fluid that carry meaningful risk (e.g. semen; vaginal secretions; and cerebrospinal, synovial, pleural, peritoneal, pericardial, and amniotic fluids) Injury with a hollow needle Needles used in source patient artery or vein Visible blood on device
- 29. 29 Does This Patient Need HIV PEP?
- 30. 30 PEP is not indicated If the exposed patient is HIV positive from previous exposure In chronic exposure Any exposure to non-infectious body fluids (such as faces, saliva, urine and sweet) Exposure to body fluids from a person known to be HIV- negative ,unless this person is identified as being at risk for recent infection and thus likely to be within the window period If the exposure occurred more than 72 hours previously
- 31. 31 PEP indication Individuals are eligible for HIV PEP if: If exposure occurred within the past 72 hours The potentially exposed individual is not infected or not known to be infected with HIV; Mucous membrane or non-intact skin was significantly exposed to a potentially infectious body fluid The source of HIV-infected or the HIV status is unknown
- 32. 32 Recommendation of PEP Site of exposure HIV status of source patient unknown positive Low risk High risk Mucosal splash/non intact skin Recommend 2-drug regimen Recommend 2-drug regimen Recommend 3-drug regimen Percutaneou s (sharps) Recommend 2-drug regimen Recommend 2-drug regimen Recommend 3-drug regimen
- 33. 33 Possible ARV regimens for PEP ARV drug Regimen Dose Frequency Duration 2- drug regimen Zidovudin (AZT) + lamivudine(3TC) Alternative: Stavudin + lamivudine Tenofovir + lamivudine AZT 300mg 3TC 150mg D4T30 or 40 mg 3TC150 mg TDF 300mg 3TC150 mg Twice daily (b.i.d) Twice daily (b.i.d) Once daily (qd) Twice daily (b.i.d) 28 days 28 days 28 days 3-drug regimen Zidovudine(AZT) + lamivudine(3TC) + EFV or TDF AZT 300 mg 3TC 150 mg EFZ 600mg or TDF300mg Twice daily (b.i.d) Twice daily (b.i.d) Daily (qd) Daily (qd) 28 days
- 34. 34 Recommended ARV regimens for PEP ARV drug Regimen Dose Frequency Duration 2- drugs regimens AZT + 3TC AZT 300 mg 3TC 150 mg Twice daily (b.i.d) 28 days TDF +3TC TDF 300mg 3TC150 mg Once daily (qd) Twice daily (b.i.d) 28 days 3-drugs regimens AZT + 3TC +TDF AZT 300 mg 3TC 150 mg TDF 300mg Twice daily (b.i.d) Twice daily (b.i.d) Daily (qd) 28 days AZT+3TC+LPV/r AZT 300 mg 3TC 150 mg LPV/r 400mg Twice daily (b.i.d) Twice daily (b.i.d) Daily (qd)
- 35. 35 Important Note (1) Do not use NEVIRAPINE containing regimen for PEP, as the risk of hepatotoxicity Do not give EFAVIRENZE for PREGNANT Or CHILDBIRING AGE WOMEN(TERATOGENIC ) Before administering PEP to a pregnant woman, the clinician should discuss the potential benefits and risks to her and to the fetus..
- 36. 36 Important Note (2) PEP is indicated at any time during pregnancy when a significant exposure has occurred, despite possible risk to the woman and the fetus with expert consultation. Drugs to avoid during pregnancy EFV, ddi +d4T and unboosted IDV because 1. Efavirenz, associated with teratogenicity 2. The combination of didanosine and stavudine should be avoided due to an increased risk of mitochondrial toxicity in pregnant women. 3. Unboosted indinavir should not be used in pregnant women in the second or third trimester due to a substantial decrease in antepartum indinavir plasma concentrations. Consider resistance potential of source patient
- 37. 37 Important Note (3) Timing and Duration of PEP. PEP should be initiated as soon as possible. The optimal duration of PEP is unknown. Because 4 weeks of ZDV appeared protective in occupational and animal studies, PEP probably should be administered for 4 weeks, if tolerated. Do not consider PEP beyond 72 hours post exposure (commence as soon as possible with in 1 to 2 hours, post exposure)
- 38. 38 Universal Precautions and PEP Non- occupational PEP Substantial exposure risk Negligible Case-by-case nPEP nPEP not recommended ? 72 hrs since exposure > 72 hrs since exposure SP known SP of unknown to be HIV + HIV status recommended determination exposure risk
- 39. 39 Sexual assault and PEP women 14 years and older presenting to a health facility after potential exposure to HIV during sexual assault Should be counselled by the examining health care worker about the potential risk of HIV infection. Parents/guardian of traumatized children should be counselled and informed Risk of HIV infection after sexual assault.
- 40. 40 Post-rape prophylaxis should be carefully monitored and evaluated for: Psychosocial and legal support Screening for conventional STIs and follow up management Drug adverse effects Seroconversion
- 41. 41 Points to be covered in the counselling The exact risk of transmission is not known, but it exists It is important to know the victim’s HIV status prior to any antiretroviral treatment It is the patient’s choice to have immediate HIV testing, this can be delayed until 72 hours post examination visit*
- 42. 42 PEP recommendation PEP is not recommended if victim presents More than 72 hours after exposure Following condom leak or tear Recommended regimen AZT/ 3TC/EFV or d4T/3TC/ EFV for 28 days. Alternatively, LPV/r can substitute for EFV.
- 43. 43 Subsequent follow- up They should be instructed to return at 6 weeks and 3 months post sexual assault for voluntary counselling and HIV testing.
- 44. 44 Case Study 1 27 year-old female nurse presents to OPD for evaluation of needle stick injury 2 days ago from a diabetic lancet Source patient (SP): 35 year-old male, HIV+ Discussion: What do we need to know about the source patient and exposure in order to manage this nurse? Would you offer her PEP? If so, which agents?
- 45. 45 Additional Information The SP has been taking AZT/3TC/NVP (1st regimen) for one year. He was WHO stage II prior to starting ART, and is currently in good health The SP’s most recent CD4 count was 200; his initial CD4 before starting ART was 180 Viral load 2 months ago was 60,000 How does this information influence the choice of PEP regimen?
- 46. 46 Case Study 1 - Questions What is her risk for contracting HIV? What factors influence this risk? Is it too late to start PEP? Which regimen (s) should be considered? What follow-up should be arranged?
- 47. 47 Case Study 1: PEP Options Source patient’s high-level viremia despite HAART suggests that he is either not taking his medications, or that he has developed resistance to his regimen Resistance assay is not performed in Ethiopia – therefore must reason around patterns of anticipated resistance to SP’s regimen If resistance has developed, would suspect resistance to lamivudine and zidovudine May have NNRTI cross resistance as well
- 48. 48 Case Study 1: PEP Options High viral load of source patient would warrant use of a three drug PEP regimen One reasonable PEP regimen: ABC + tenofovir + lopinavir/ritonavir OR ADC + ddi + lopinavir/ritonavir
- 49. 49 Case Study 2 24 year-old dental technician splashed in the eye during dental procedure 3 hours ago Source patient: 33 year-old male, co-infected with HIV and HCV What else do you need to know?
- 50. 50 Which Fluids are Potentially Infectious for HIV? Blood? Saliva? Sweat? Feces? Spinal fluid? Pleural fluid? Pus? Urine?
- 51. 51 Case Study 2 – cont. Saliva was visibly bloody - in fact, it was mostly blood that splashed her She rinsed out her eye immediately Source patient has never taken antiretrovirals, has a CD4 count of “about 500” and a viral load of 20,000 last time it was checked. The exposed patient is 8 weeks pregnant
- 52. 52 Case Study 2 – Questions Discuss: What are your PEP recommendations? How does her pregnancy affect your decision making?
- 53. 53 PEP in Pregnancy Antiretroviral Pregnancy Registry has not detected increased teratogenic risk for ARVs in humans general, nor specifically for AZT and 3TC, in the first trimester 1 Avoid efavirenz (anencephaly in monkeys), amprenavir (ossification defects in rabbits), and, in late term, indinavir (hyperbilirubinemia) Avoid combination d4T and ddI Theoretically higher risk of vertical transmission with primary HIV infection
- 54. 54 Case Study 2 - cont. The patient starts AZT/3TC/TDF 3 days later she calls complaining of headache, congestion, an itchy rash, and URI symptoms What further information is needed for managing this patient?
- 55. 55 Case 2 – cont. Exam: VS: T 99.0 R 14 P 78 BP 134/76 Gen - alert, tired-appearing, no acute distress HEENT - hyperemic nasal mucosa with frontal sinus tenderness; pharynx is also red Neck - 3 cm. left ant cervical lymph node Lungs, cardiac, abdomen: normal Neuro: normal Skin: urticarial rash on trunk and legs; no ulcerations
- 56. 56 Case 2 – Questions What is the most likely diagnosis? How would you manage this patient?
- 57. 57 Primary HIV Infection Flu-like or mono-like illness often accompanied by a rash1 Onset typically 2-6 weeks following exposure, but high variability Symptoms generally resolve spontaneously in 1- 3 wks (corresponding with VL reduction) Treatment of PHI with antiretroviral therapy may have significant long-term benefit
- 58. 58 PHI: Diagnostic Testing 1 mil 100,000 10,000 1,000 100 10 + _ HIV RNA HIV-1 Antibodies Exposure 0 14 21 28 Symptoms Days HIV RNA Ab 7 Image courtesy of The Center for AIDS Information & Advocacy, www.centerforaids.org
- 59. 59 Could She Have Primary HIV Infection? Primary HIV Infection less likely Only three days since the exposure Presence of nasal congestion Rash is urticarial However, would not be unreasonable to check an HIV viral load to rule out PHI
- 60. 60 Follow-up HIV Testing CDC recommendations: HIV Ab testing at 6 weeks, 3 months, 6 months following exposure Extended HIV Ab testing at 12 months recommended if health care worker contracts HCV from a source patient co-infected with HIV and HCV VL testing not recommended unless Primary HIV Infection (PHI) suspected MMWR June 29, 2001 / 50(RR11);1-42.
- 61. 61 Role of pharmacist Determining who should receive prophylaxis and which drugs are most appropriate Discontinuing PEP medication if their initial HIV test is positive Continuing PEP medication for four weeks once initiated Making aware on the common adverse effects that may be experienced while taking PEP medicine Emphasizing the importance of adherence to medicine
- 62. 62 Role of pharmacist… cont. Explaining on the risk of stopping PEP medicine Noting that PEP medicine can be taken during pregnancy Stressing on counseling, post exposure management and follow- up Accessing ARVs for PEP for 24 hours and 7days of a week Documenting & reporting the use of ARVs for PEP
- 63. 63 Key Points UPs should be implemented and practiced at all times by all health care providers and caregivers in all settings (hospital, clinic, community settings, and patient homes). The most effective infection control measure that can be performed by health care workers is hand washing with soap and water before and after patient contact. Risk factors for seroconversion vary according to the type of injury, viral load of source patient, glove use, type of needle, and drying conditions.
- 64. 64 Key points (2) PEP is the use of therapeutic agents to prevent infection following exposure to a pathogen PEP should be initiated as soon as possible (within hours) and continued for four weeks. Consider resistance potential of source patient Basic PEP regimen involves 2 NRTIs while the expanded regimen includes an NNRTI or PI.
Editor's Notes
- NOTES: Unit 16 should take approximately 1 hour and 30 minutes to implement Step 1: Overview of Unit Learning Objectives and Introductory Case Study (Slide 1-3) – 5 minutes Step 2: Occupational Exposure Risk (Slides 4-10) – 10 minutes Step 3: Standard Precautions (Slides 11-18) – 10 minutes Step 4: Management of occupational Exposure (Slides 19-43) – 35 minutes Step 5: Case Studies (Slides 44 – 63) – 25 minutes Step 6: Key Points (Slide 64-65) – 5 minutes
- Note: Step 1: Overview of Unit Learning Objectives and Introductory Case Study (Slide 1-3) – 5 minutes
- Note: This is not an uncommon situation. As described later in this section, occupational exposures can be reduced by use of universal precautions. The evaluation of this patient client includes assessment of both the exposure type and the source patient client.
- Note: Step 2: Occupational Exposure Risk (Slides 4-10) – 10 minutes
- Notes: This slide illustrates the risk of transmission of HIV, which is much less than that of Hepatitis B or Hepatitis C. Source: AETC at http://depts.washington.edu/hivaids (table adapted from Centers for Disease Control & Prevention. MMWR 2001;50(RR-11):1-52.)
- Notes: Most occupational exposures are due to contaminated sharp injuries. Percutaneous rout is an important rout of transmission. The mucous membrane rote of exposure is often much overlooked. This is also the route of exposure but less than percutaneous rout. Cutaneous exposure is much less likely to transmit HIV. Source: AETC at http://depts.washington.edu/hivaids (table adapted from Centers for Disease Control & Prevention. MMWR 2001;50(RR-11):1-52.)
- Note: Source: AETC at http://depts.washington.edu/hivaids (table adapted from Centers for Disease Control & Prevention. MMWR 2001;50(RR-11):1-52.)
- Note: Analysis of the characteristics of an exposure associated with occupational acquisition of HIV has shown a hierarchical RR and found statistical significant in different studies Source: New York State Department of Health AIDS Institute: www.hivguidelines.org
- Notes: Type of exposure – or route of exposure is important. Hollow bore needles are more likely than solid needles to cause seroconversion because they can contain and transmit a larger volume of blood. Similarly, large diameter needles are associated with trend towards increased risk (though not significant; p = 0.08). Glove material reduced the transferred blood volume by 46%-86% in one study (“Efficacy of gloves in reducing blood volumes transferred during simulated needle stick injury.” Mast ST, Woolwine JD, Gerberding JL. Department of Medicine and Infectious Diseases, University of California, San Francisco). HIV may be transmitted by mucous membrane exposure, though this is much less common. Simple cutaneous exposure is unlikely to transmit HIV; in fact not a single case of transmission has been ascribed to this route.
- Notes: Source: CDC, Division of AIDS prevention. http://www.cdc.gov/hiv/pubs/facts/transmission.htm
- Note: Step 3: Standard Precautions (Slides 11-18) – 10 minutes
- Notes: Most patient care does not involve any risk of HIV transmission, and most HIV-infected health care workers are infected through sexual contact. Occupational exposure is unusual and can be minimized by adopting appropriate accident prevention procedures. Universal Precautions were developed by CDC in 1985 to help address the concern of risk faced by healthcare workers when providing care to patients with HIV and other blood borne pathogens like Hepatitis B and C. These precautions are designed to guide safe handling of infectious material including blood and body fluids. The name has recently been changed to Standard Precautions, to show that they are the standard for health care practice.
- Notes: Protective barriers and hand washing are important components of SP. The single most important personal action that the healthcare worker can take to limit nosocomial spread of disease is hand washing with soap and water before and after all procedures.
- Notes: Proper handling of sharps and waste is probably the most important factor in limiting occupational exposure to blood borne pathogens like HIV.
- Notes: Immunizations against hepatitis A and B are recommended for all health care workers as a component of standard precautions.
- Notes: Antiseptic solutions are chemicals that are applied to skin or other living tissues to inhibit or kill transient or resident microorganisms. Don’t dilute Savlon or Dettol. Don’t use Hexachlorophene, Benzalkonium chloride and mercury containing compounds as antiseptics.
- Note: Disinfectants are chemicals that are applied on non-living and non critical surfaces such as walls, floors, and furniture.
- Note: Step 4: Management Of Occupational Exposure (Slides 19-43) – 35 minutes
- Notes: The service comprises first aid, counseling including the assessment of risk of exposure to the infection, HIV testing, and depending on the outcome of the exposure assessment, the prescription of a 28-day course of antiretroviral drugs, with appropriate support and follow-up. Post-exposure prophylaxis may be administered to prevent infection after potential exposure to other viruses (such as hepatitis B with the injection of immunoglobulin and vaccine).
- Notes: There are evidences that show the decline of transmission of HIV by administering ARVs after exposure and dramatic decline in the vertical transmission of HIV(MTCT) ARVs for PEP are administered when the benefit outweighs the toxicity hence proper rule out of the pts are critical
- Note: Role of Pathogenesis in Considering Antiretroviral Prophylaxis. Information about primary HIV infection indicates that systemic infection does not occur immediately, leaving a brief window of opportunity during which post exposure antiretroviral intervention might modify or prevent viral replication. Theoretically, initiation of antiretroviral PEP soon after exposure might prevent or inhibit systemic infection by limiting the proliferation of virus in the initial target cells or lymph nodes.
- Notes: The rational for starting PEP as soon as possible is based on the pathophysiology depicted here. From time of crossing the skin or mucous membrane it takes only about 48 hours to establish HIV infection. The free HIV viron is first taken up the immature dendritic cell and travels to the T-cell where in a single replication it transfers HIV to the T-cell. It is during this time that it is possible to interrupt early replication (less than 48 hours).
- Notes: According to the result of animal studies, initiating PEP within 12, 24 or 36 hours of exposure is more effective than initiating it 48 or 72 hours following exposure Such studies have also established that PEP is not effective when given more than 72 hours following exposure As in all things, it is important to balance the benefit against the risk of therapy. Don’t forget to test the exposed patient for HIV before committing to a course of PEP; however, sometimes the first dose of PEP might be given prior to this test because of logistical difficulties in obtaining a rapid test. PEP should be started as soon as possible, at least within 72 hours. studies suggest better efficacy with 28 days of PEP when compared with shorter duration of therapy
- Notes: PEP should be initiated as soon as possible after exposure, with in the first hours and no later than 72 hours after exposure. PEP should not be offered beyond 72 hours exposure. A first dose or, even better, a start pack of PEP drugs should be made readily available to potentially exposed individuals and given according to national policy and local protocols. An HIV test should normally not be a condition of initiating PEP, nor should PEP be delayed until the result of an HIV test become available (unless rapid testing is used ). Post-exposure prophylaxis is intended for HIV- negative individuals only. The possibility that the exposed individual has pre-existing HIV infection should always be explored as part of the process of assessing eligibility. PEP providers should be aware that both occupationally exposed workers and people who have been sexually assaulted may have other ongoing risks for HIV infection. Potentially exposed people who are known or found to be HIV infected should not receive PEP.
- Notes: The low risk mightn’t require PEP in most cases but it depends on the evaluation of the physician The low risk i.e. Exposure to saliva, tears, sweat, or non-bloody urine or feces really don’t require PEP at all
- Notes: The initial step - not shown here - is to determine the status of the exposed person. If this person is seronegative (and the exposure was not simply cutaneous) then: 1.Determine the status of the source patient 2. If the source patient’s status is unknown or the patient is unwilling to get tested, assess the background risk of the patient. In general, hospitalized patients in Ethiopia are high risk (>2.3% background prevalence for 2009) 3. If the source patient is positive or comes from a high risk background, PEP is indicated
- Notes: Post-exposure prophylaxis is not appropriate in the context of chronic exposure to HIV. However, high-risk single or episodic exposure such as rape by a strange or needle stick injury ) may occur against a background of potential chronic exposure, such as regular and ongoing unprotected sex with an intimate partner. In these case, the high risk episodic exposure should be treated as such and PEP offered if the person is HIV-negative. However, the importance off reducing the ongoing risk within the intimate relationship should be emphasized as part of the counseling process.
- Notes: The standard PEP regimen should comprise two nucleoside-analogue reverse- transcriptase inhibitors. Three –drug regimens, comprising two nucleoside-analogue reverse-transcriptase inhibitors plus a boosted protease inhibitor, can be considered in situations where antiretroviral therapy resistance is known or suspected A regimen comprising two nucleoside-analogue reverse-transcriptase inhibitors is recommended if: • the HIV status of the source person is unknown; and • the background prevalence of resistance to antiretroviral therapy in the community is less than 15%; and • the source person has never used antiretroviral therapy; or • the source person is unlikely to have HIV infection resistant to antiretroviral therapy, based on antiretroviral therapy and adherence history. A regimen comprising two nucleoside-analogue reverse-transcriptase inhibitors plus a boosted protease inhibitor can be considered if: the source person is HIV positive, taking antiretroviral therapy and is known to have signs of, personal history of or proven antiretroviral therapy resistance; or • the source person’s HIV status is unknown; and • the background prevalence of resistance to antiretroviral therapy in the community exceeds 15% (where this is known).
- Note: Refer: to adult and adolescent OI guideline march 2008
- Notes: Don’t use NVP because of high risk of liver toxicity in patients with preserved immune function. When available, the resistance profile of the source person is helpful in selecting the ARV regimen. Although there is no human data regarding optimal timing of PEP, animal studies suggest that the optimal time to begin PEP is immediately after the exposure. The benefits of PEP decrease after 24 to 36 hours. This highlights the importance of having a PEP program in all high risk areas to ensure prompt assessment and management of the exposed person. Efavirenze should not be given to women who are pregnant or are of childbearing age because it is teratogenic.
- Note: Initiation of PEP: The interval within which PEP should be initiated for optimal efficacy is not known. Animal studies have demonstrated the importance of starting PEP soon after an exposure. Although animal studies suggest that PEP probably is substantially less effective when started more than 24--36 hours post exposure, the interval after which no benefit is gained from PEP for humans is undefined.
- Note: Ref –national OI ART guideline march 2008.
- Note: Ref –national OI ART guideline march 2008
- Note: *management guidelines on sexual assault provides for a 3-day starter pack for those who prefer not to test immediately, or those that are not ready to receive results immediately Ref –national OI ART guideline march 2008
- Notes: Ref –national OI ART guideline march 2008 Recommended post-exposure prophylaxis eligibility criteria among people who have been sexually assaulted (1) less than 72 hours has elapsed since exposure; and (2) the exposed individual is not known to be HIV infected; and (3) the person who is the source of exposure is HIV infected or has unknown HIV status; and (4) a defined risk of exposure, such as: receptive vaginal or anal intercourse without a condom or with a condom that broke or slipped; or contact between the perpetrator’s blood or ejaculate and mucous membrane or non-intact skin during the assault; or receptive oral sex with ejaculation; or the person who was sexually assaulted was drugged or otherwise unconscious at time of the alleged assault and is uncertain about the nature of the potential exposure; or the person was gang raped.
- Notes: Step 5 – Case Studies (Slides 44 – 63) – 25 minutes There are two case study exercises. It is not necessary to separate into small groups for this exercise. Follow along with the slides and additional information, and then discuss the questions together as a group. The case studies are used as a foundation for discussion and for presenting further more detailed information related to PEP as the cases develop. Use this time to practice risk assessment of the source patient and exposure type to decide what the PEP recommendation for this case should be.
- Notes: The patient’s detectable viral load and non-significant increase in CD4 count after one year of therapy suggests treatment failure. This may be due to suboptimal drug levels (non-adherence, malabsorption, unfavorable pharmacokinetics), drug resistance, or combination of all of these. Therefore, choosing a 3 drug regimen that differs from that of the source patient would be appropriate
- Note: There may be some need to know about the depth of exposure, signs of visible blood. Be sure to communicate that the risk of contracting of HIV is based on many factors.
- Notes: Although resistance testing genotype, phenotype, and virtual phenotype are helpful in determining ARV selection, it is only recently that we have had this luxury. Even with the availability of ARV testing, it is essential to take an ARV drug history. In that history it would be important to find out which drugs, when they were taken (dates started – date finished), and why they were stopped. By using this information and what you know about ARVs, it may be possible to predict resistance to ARV and cross resistance.
- Note: In high risk exposure it may be prudent to use a three drug PEP regimen. Inclusion of a PI in the high risk PEP may be expensive, but it is not unreasonable.
- Notes: In this case there are two considerations: Hepatitis C and HIV. Classify the level of risk for the exposure as well as information about the source patient. Additionally, be sure to ask about the stage of disease, viral load, CD4, ARV, OI as related to HIV. In this case there is also co-infection with Hepatitis C which also presents a risk factor for the healthcare worker. Although treatment is unusual even in developed countries it would be appropriate to ask about the serotype of Hepatitis C, treatment, and stage of Hepatitis C disease as well as a confirmation of the disease. While the risk for transmission of HIV (via sharps injury) is 0.3% the risk for Hepatitis C is 1.8%. If available quantitative HCV RNA tests should be done in those who are Hepatitis C positive. There is NO prophylaxis with IG or with antiviral.
- Notes: Ask participants about each fluid and the risks associated with each. This is a VERY IMPORTANT slide. Go over common client questions and misconceptions. e.g. “The man on the bus had HIV and he was sweating and some of it touched me can I get AIDS?” You must know which fluids are inherently infectious with HIV and which ones are not and the conditions under which fluids may become infectious.
- Notes: There are many questions about this case both for the event and the source person. Discuss each of these concerns. Local care – Did it get in her eye? Was she wearing goggles, corrective lens or a face shield? The pregnancy may affect our selection of ARV. Source patient – has given a lot of information. It is important to verify this and to complete the history of this “splash.”
- Note: There are no safe drugs in pregnancy, but using our risk benefit equation these are some medications (including retrovirals) that are safer than others.
- Notes: EXAMINE the patient. Determine whether this is a drug side adverse effect. The differential should include acute HIV.
- Notes: This exam is consistent with a simple viral syndrome, with pharyngitis and possibly sinusitus. The differential diagnosis includes acute viral syndrome associated with HIV seroconversion- Why? Why not? Ask participants to brainstorm why each could be possible.
- Note: Ddx: Herpes simplex with erythema multiforme.
- Notes: Acute seroconversion to HIV positive is a diagnosis that is easy miss or misdiagnose. These patients are symptomatic, but are seldom diagnosed with acute HIV disease. Observe carefully for patients with a flu-like illness with a rash. These symptoms can be confused with “any viral syndrome” and disappear in a few days to a week or so. If the diagnosis can be made via PCR antiretrovirals may be of benefit in preventing vertical transmission as well as in lowering the “viral set point” and improving the course of HIV disease over the long term.
- Notes: Typical Sequence of Events in Primary HIV Event Day Infection 0 Entry of virus into bloodstream 3-7 Detectable HIV-1 RNA 7-14 Detectable p24 antigen 12-19 Onset of symptoms 14-28 Antibody seroconversion 30-60 Within two to eight weeks after the symptoms of primary HIV infection it should be possible to obtain a positive antibody test for HIV via EIA and Western blot or any of the rapid antibody tests in use. P24 antigen and HIV PCR would be positive BEFORE these symptoms occur.
- Note: In Ethiopia, it may be some time before all of these laboratory tests are widely available, but it is nevertheless important to know of their existence.
- Notes: They can stop taking PEP medicine at any time, but if they do so, they will probably not get the full benefit of PEP if the source to which they were exposed was HIV positive; • PEP medicine can be taken during pregnancy and may protect the mother from getting HIV infection after exposure; They can continue to breastfeed while taking PEP is safe, although if women get infected by HIV while breastfeeding ,the risk of transmitting HIV through breastfeeding is higher at early stage of infection; appropriate counseling should discuss safe alternatives to breastfeeding if they are acceptable, feasible, affordable and sustainable Exclusive breast feeding is strongly recommended whenever alternatives are not possible
- Note: Step 6: Key Points (Slide 64-65) – 5 minutes