Standard Precautions and Post Exposure Prophylaxis Unit 17 HIV Care and ART: A Course for Healthcare Professionals

2 Learning Objectives  Describe the basic principles and procedures of standard precautions  Identify the risks of HIV, HCV, and HBV seroconversion following accidental occupational exposures  List the management steps of occupational exposure  Describe the principles of HIV post-exposure prophylaxis

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 patient?

Occupational Exposure Risk

5. Estimated Pathogen-Specific Seroconversion Rate Per Exposure for Occupational Needlestick Injury AETC

6 Type of Exposure Involved in Transmission of HIV to Health Care Workers

7 Source of HIV Involved in HIV Transmission to Health Care Worker AETC

8 Risk FactorOdds Ratio Confidence Interval Deep Injury Visibly Bloody Device Device Used in Artery or Vein Terminally Ill Source Patient Use of Zidovudine for PEP P<0.01 for all associations Risk Factors for HIV Transmission with Occupational Exposure to HIV-Infected Blood

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 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

Standard Precautions

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 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 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 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 Components of Standard Precautions (3)  Re-usable instruments - must be thoroughly disinfected Speculums Surgical tools Thermometers  Immunizations Hepatitis A and B

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, % (e.g. Betadine)  Chlorozylenol in alcohol, %, (e.g. Dettol*) *Use undiluted

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

Management of Occupational Exposure

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 Post Exposure Prophylaxis  Definition: Use of therapeutic agent to prevent establishment of infection following exposure to pathogen  Roles in Occupational Exposure: HIV prevention HBV prevention

22 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 Duration 28 days

23 Decision-making Tools for PEP  Source code (SC) Risk assessment of the source patient SC 1, SC 2, SC Unknown  Exposure code (EC) Risk assessment of exposure type EC 1, EC 2, EC 3

24 Step 1: Does This Patient Need HIV PEP? Source patient HIV +HIV - Unknown / Unwilling to get tested* PEP High back- ground risk Low back- ground risk No PEP *CDC recom: usually PEP unnecessary; consider use if source patient is high risk

25 HIV NegativeHIV Positive Asymptomatic/high CD4 = HIV SC 1 Advanced disease, primary infection or low CD4 =HIV SC 2 HIV Status Unknown or Source Unknown = HIV SC Unknown No PEP Step 2: Determine HIV Status Code of Source (HIV SC)

26 Step 3: Type of Exposure: Determine the Exposure Code Exposure on Mucous membrane or broken skin Exposure on Intact Skin Percutaneous Exposure Determine Volume No PEP Determine Severity Few drops, short duration, SMALL = EC 1 Several drops/long duration/major blood splash LARGE = EC 2 Solid, superficial Scratch LESS SEVERE = EC 2 Hollow needle, deep Puncture MORE SEVERE = EC 3

27 Step 4: Determine PEP Regimen HIV SCECPEP Recommendation 11PEP may not be warranted 21Consider basic regimen 12Recommend basic regimen 22Expanded regimen recommended 1 or 23Expanded regimen recommended UnknownIf EC is 2 or 3 and a risk exists, consider PEP basic regimen

28 Exposure TypeSource Infection Status HIV+ Class 1HIV+ Class 2 Less SevereBasic (2 Drugs)Expanded (3 Drugs) More SevereExpanded (3 Drugs) Step 4: Determine PEP Regimen (2)  Less Severe: Solid needle, superficial injury  More Severe: Large-bore hollow needle, deep punture, visible blood on device, or needle used in patient's artery or vein  HIV Class 1: Asymptomatic or HIV RNA less than 1500 copies/ml  HIV Class 2: Symptomatic HIV infection, AIDS, acute seroconversion, or known high HIV RNA

29 HIV Post Exposure Prophylaxis  2 drug regimen Zidovudine plus lamivudine (combivir) Stavudine plus Lamivudine Tenofovir plus lamivudine  3 drug regimen LPV/r or Indinivr or Nelfinavir plus NRTI backbone Efavirez plus NRTI backbone Consider resistance potential of source patient Don’t use NVP (hepatotoxicity)

30 HIV PEP - When to Start  As soon as possible! U.S. Public Health Service Guidelines recommends prompt initiation of PEP (within hours of exposure), but does not rule out consideration of PEP even if more than 36 hours have elapsed since the exposure  Animal data show no benefit when treatment is delayed hours  Most experts use 72 hour window limit

31 Cell free HIV CD40—CD40 Skin or mucosa 24 hours48 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 The Early Stages of HIV Infection

32 HIV PEP - When to Stop  Timing is unclear  Animal studies suggest better efficacy with 28 days of PEP when compared with shorter duration of therapy

33 Current PEP Policy in Ethiopia  Emphasis is on standard precautions  Individual ART programs may access and distribute PEP free of charge

34 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?

35 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?

36 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?

37 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

38 Case Study 1: PEP Options  High viral load of source patient would warrant use of a three drug PEP regimen  One reasonable PEP regimen: didanosine + tenofovir + lopinavir/ritonavir

39 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?

40 Which Fluids are Potentially Infectious for HIV?  Blood?  Saliva?  Sweat?  Feces?  Spinal fluid?  Pleural fluid?  Pus?  Urine?

41 Which Fluids are Potentially Infectious for HIV? (2)  Blood  Saliva  Sweat  Feces  Spinal fluid  Pleural fluid  Pus  Urine

42 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

43 Case Study 2 – Questions  Discuss: What are your PEP recommendations? How does her pregnancy affect your decision making?

44 PEP in Pregnancy  Most antiretrovirals class B or C in pregnancy  Antiretroviral Pregnancy Registry has not detected increased teratogenic risk for ARVs in general, nor specifically for AZT and 3TC, in the first trimester1  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

45 Case Study 2 - cont.  The patient starts AZT/3TC/Nelfinavir  3 days later she calls complaining of headache, congestion, an itchy rash, and URI symptoms What further information is needed for managing this patient?

46 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

47 Case 2 – Questions  What is the most likely diagnosis?  How would you manage this patient?

48 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 benefit3

49 PHI: Diagnostic Testing 1 mil 100,000 10,000 1, _ HIV RNA HIV-1 Antibodies Exposure Symptoms Days HIV RNA Ab 7 Image courtesy of The Center for AIDS Information & Advocacy,

50 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

51 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.

52 Key Points  Standard precautions should be implemented and practiced by all healthcare providers  The most important infection control method is handwashing  Proper handling of sharps is critical for reducing occupational exposure to blood borne pathogens  Risk of HIV seroconversion after occupational exposure varies depending on source patient and exposure circumstance  When indicated, PEP should be employed immediately (within hours)