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My Child Found a Needle and. Management of Potential Nonoccupational Exposures to Blood Borne Viruses. Sheryl L. Henderson, MD., Ph.D. Pediatric Infectious Disease Emory University School of Medicine July 20. 2005. Case 1 The needle in the pocket. 8 year old boy
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Management of Potential Nonoccupational Exposures to Blood Borne Viruses Sheryl L. Henderson, MD., Ph.D. Pediatric Infectious Disease Emory University School of Medicine July 20. 2005
Case 1The needle in the pocket • 8 year old boy • Received a used pair of jeans 3 hours before presentation to ED, • Put his hand in the pocket and…
Postexposure evaluation and management • Blood borne viruses-- HIV, HBV, HCV • Causes of chronic infection • HIV and HBV--prophylaxis available
Source HBV HBeAg + HBeAg - HCV HIV Risk 22.0-30.0% 1.0-6.0% 1.8% 0.3% Risk of Bloodborne Virus Transmission after Occupational Percutaneous Exposure
HIV Postexposure evaluation and management • HIV -- most anxiety producing, • No controlled trials evaluating transmission risk, • Data from multiple sources (e.g., surveillance, observational studies, registrys, serosurveys) used to assess risk of transmission.
Antiretroviral Postexposure Prophylaxis After Sexual, Injection-Drug Use, or Other Nonocccupational Exposure to HIV in the United States MMWR 54: No. RR-2, January 21, 2005
Efficacy of HIV Prophylaxis • Animal Studies (macaque model) • Postexposure prophylaxis in the newborn • Occupational exposures
Macaque studies • PMPA (tenofovir) most effective when given within 24 hours and continued for 28 days after intravenous inoculation with SIV. (Tsai et. al., J Virol, 1998) • Animals inoculated vaginally with HIV-2 were protected by PMPA given up to 72 hours. (Otten et. al, J Virol, 1999) • Small numbers of animals in the studies.
Human Studies of HIV PEP:Prevention of Perinatal Transmission • ZDV administered during pregnancy, labor, and delivery reduced transmission by 67% (Connor EM, et al. N Engl J Med 1994;331:1173-80.) • Protective effect observed when ZDV given only to newborn within the first 48-72 hours of life (Wade NA, et al. N Engl J Med 1998;339:1409-14.) • PACTS mutlicenter study demonstrated reduced perinatal transmission by 48% when only infant prophylaxis within 24 hours. (Bulterys, et. al., 1999
Timing and Duration • Studies suggest there is a period of hours before the virus is fully integrated during which time infection can be interrupted with the use of postexposure prophylaxis. • Duration of treatment, more effective, the longer administered. (28 days)
Postexposure Management:Wound Care • Clean wounds with soap and water • Flush mucous membranes with water • No evidence of benefit for: • application of antiseptics or disinfectants • squeezing (“milking”) puncture sites • Avoid use of bleach and other agents caustic to skin • Evaluate tetanus immune status
Considerations When Using PEP Risk of Transmission Risk of Adverse Effects PEP
Factors to consider in evaluating risk • Potential that the source fluid is infected, • Timing of the exposure, • Nature of the exposure (e.g., blood-mucous membrane)? • Amount of bodily fluid exposed to, • Risk of transmission based on the nature of the exposure.
Factors to consider in evaluating risk • Potential that the source fluid is infected, • Timing of the exposure, • Nature of the exposure (e.g., blood-mucous membrane)? • Amount of bodily fluid exposed to, • Risk of transmission based on the nature of the exposure.
Assessing the source • Source-known or unknown? • If known, what is the HIV infection status? • If unknown, what is the likelihood of infection? • HIV test (rapid or EIA) if source is present
Postexposure Management: Unknown or Untestable Source • Consider information about exposure • where and under what circumstances • prevalence of HIV in the population group or the environment • Testing of needles and other sharp instruments not recommended • unknown reliability and interpretation of findings • hazard of handling sharp instrument
Factors to consider in evaluating risk • Potential that the source fluid is infected, • Timing of the exposure, • Nature of the exposure (e.g., blood-mucous membrane, deep or superficial)? • Amount of bodily fluid exposed to, • Risk of transmission based on the nature of the exposure.
Timing • Viability of virus • How long has the body fluid been present on object before exposure? • 8% viability in syringe at room temp for 3 weeks, and <1% at higher temps for 1 week (Abdala et. al, Subst Use and Misue, 2000) • Efficacy of prophylaxis
Factors to consider in evaluating risk • Potential that the source fluid is infected, • Timing of the exposure, • Nature of the exposure (e.g., blood-mucous membrane, deep or superficial)? • Amount of bodily fluid exposed to, • Risk of transmission based on the nature of the exposure.
Risk of Occupational PercutaneousExposure • CDC surveillance--1,440 HCW with percutaneous exposures to HIV+ blood (0.28% seroconversion) • 23 aggregate studies 20 of 6,202 (0.32%) seroconversion.
Risk of Occupational PercutaneousExposure • Case-control study of HIV seroconversion in HCW (33 cases/665 controls) in U.S, U.K., Europe • Use of zidovudine (ZDV) was associated with an 81% decrease in the risk for HIV infection • limitations include a small number of cases, and that cases and controls came from different cohorts (Cardo et al, NEJM 1997;337:1485-90.) • Evaluation of risk factors
Risk Factors for HIV Transmission After Percutaneous Exposure to HIV-Infected Blood: CDC Case-Control Study* Risk Factor Adjusted OR ratio (95% CI) Deep injury 15 (6.0-41) Visible blood on device 6.2 (2.2-21) Procedure involving needle 4.3 (1.7-12) placed in artery or vein Terminal illness in source patient 5.6 (2.0-16) Postexposure use of zidovudine 0.19 (0.06-0.52) *Cardo et al., New Engl J Med 1997;337:1485-90.
Factors to consider in evaluating risk • Potential that the source fluid is infected, • Timing of the exposure, • Nature of the exposure (e.g., blood-mucous membrane, deep or superficial)? • Amount of bodily fluid exposed to, • Risk of transmission based on the nature of the exposure.
Estimated per-act risk for acquisition of HIV by exposure route.
Risks of Sexual HIV Transmission • Studies of risk evaluation of HIV discordant couples. • Risks evaluated include type of sex act, frequency and use of condoms. • Mathematical modeling of studies was used to quantify per act risk on the basis of choice of partner, sex act, and condom use. (Varghese et. al., Sex Transm Dis 2002:29:38-43)
Estimated per-act risk for acquisition of HIV by exposure route.
HIV Risk after Sexual Assault • Studies in women—higher rates of genital trauma relative to consensual sex acts, • Men and boys also victims of rape, • Three documented cases of HIV serconversion after sexual assault in literature among women, • In children (1998) 26 with AIDS and h/o sexual assault (Lindegren, Pediatrics 1998:102:e46)
Risks after found needle exposure • Source of needle often unknown • Unknown period of time • Small bore needle • Small amounts of fluid, if any • Likely low risk of HIV transmission
Decision Algorithm for Management of nonoccupational HIV exposuresMMWR 54:No. RR-2, January 21, 2005
Case 1--needle found in pocket • More information gathered • Blood visible in needle • Family member stated they would be concerned that this was from an IDU • No further information on the source, or length of time needle had been in the pocket.
Considerations When Using PEP Risk of Transmission Risk of Adverse Effects PEP
Antiretroviral Medications have significant side effects • Important to counsel patient about side effects, • Most common side effects, occurring in >50% of patients on some of the regimens: • Nausea • Fatigue • Diarrhea • Anorexia • Among HCW <50% complete Px
Reported Cases of Toxicity Associated with Nevirapine for PEP* • Fulminant liver failure (one requiring liver transplantation) and hypersensitivity reaction have been reported in healthcare personnel taking nevirapine for PEP • FDA has received 22 reports of serious adverse events related to nevirapine taken for PEP • hepatotoxicity (12 cases) • skin rash (14 cases) • rhabdomyolysis (1 case) *MMWR 2001;49:1153-1155
Nevirapine not used as PEP • Recent FDA updates that nevirapine not be started as initial therapy in HIV-infected individuals with relatively good immune systems.
Important Concepts about HIV PEP • Determining which and how many agents to use for PEP is largely empiric • Professional judgement should be used based on local knowledge and experience in treating HIV • Regimens should be tolerable to the exposed person
HIV PEP • Depending on risk of transmission, some experts may decide to use 2 vs. 3 medications (never monotherapy). • If there is information about an HIV positive source, prophylaxis may be selected based on the source’s medication regimen and viral resistance pattern.
Antiretroviral medications • Continued increase in the number of medications available for treatment and prophylaxis • Select medications that are readily available. • 3 drug regimen available at CHOA: AZT/3TC=Combivir PLUS Lopinavir/Ritonavir=Kaletra
Side effects of PEP drugs Signs and symptoms of acute HIV infection fever rash flu-like illness Prevention of secondary transmission sexual abstinence or condom use no blood/tissue donation Postexposure Management:HIV Postexposure Counseling No work restriction indicated
Management of Exposure • Obtain baseline HIV EIA, HBV sAg and HBV sAb (to determine if vaccine responder), HCV Ab. • If sexual assault, w/u for STD’s, pregnancy in women (prior to initiating PEP).
Re-evaluation of HIV-Exposed Person Consider re-evaluation of the exposed person within 72 hours • additional information about the source person may become available • if the source person has a negative HIV antibody test, stop PEP
Postexposure Management:Follow-up HIV Testing of Exposed Person • If source HIV positive or unknown, test at 6 weeks, 3 months, 6 months • EIA standard test • direct virus assays not recommended • Testing of CBC and Chemistry panel at 2 weeks to assess for side effects of medications.
Elements of Postexposure Management • Wound management • Assessment of infection risk • Baseline testing • Appropriate treatment, follow-up, and counseling
Resources Emory Pediatric Infectious Disease First Call Pager: PIC #50174 Office: (404) 727-5642
HIV PEPline • National Clinicians’ Post-Exposure Prophylaxis Hotline (PEPline) • Free consultation for clinicians treating occupational exposures to HIV and other bloodborne pathogens. • 24 hours a day • 7 days a week • 1-888-HIV-4911 • http://www.ucsf.edu/hivcntr/ • a joint program of UCSF/SFGH CPAT / EPI Center supported by HRSA and CDC
CASE 2 THE BITE
CASE 2 • 11 year old in PMD office • He had bitten another boy 24 hours before • Child bitten is known HIV+