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Brief Summary

GUIDELINE TITLE

HIV post-exposure prophylaxis for children beyond the perinatal period.

BIBLIOGRAPHIC SOURCE(S)

  • New York State Department of Health. HIV post-exposure prophylaxis for children beyond the perinatal period. New York (NY): New York State Department of Health; 2004. 20 p. [33 references]

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: New York State Department of Health. HIV post-exposure prophylaxis for children beyond the perinatal period. New York (NY): New York State Department of Health; 2002 Mar. 26 p.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • July 24, 2008, Ziagen (abacavir sulfate): The U.S. Food and Drug Administration (FDA) has notified the maker of abacavir and abacavir-containing medications of the need to add information to the current BOXED WARNING about the recommendation to test all patients for the HLA-B*5701 allele before starting or restarting therapy with abacavir or abacavir-containing medications.
  • September 10, 2007, Viracept (nelfinavir mesylate): Pfizer issued a Dear Healthcare Professional Letter to inform healthcare professionals of the presence of ethyl methanesulfonate (EMS), a process-related impurity in Viracept and to provide guidance on the use of Viracept in pregnant women and pediatric patients.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Assessment to Determine Whether Post-Exposure Prophylaxis (PEP) is Indicated

  • Following an exposure, the clinician should ascertain whether the exposure is associated with a potential risk of human immunodeficiency virus (HIV) transmission and whether it has occurred within the previous 36 hours.
  • Types of exposures that should prompt PEP (Table 1 in the original guideline document provides risk calculations for specific exposures):
    • Unprotected vaginal or anal intercourse
    • Oral sex with ejaculation or blood exposure
    • Needle sharing
    • Injuries with exposure to blood from a source known to be HIV-infected
    • Injuries with exposure to blood from a source of unknown HIV status (Including needlesticks, human bites, accidents)
  • Once the clinician has determined that a potential risk exposure has taken place, the clinician should:
    • Clean the HIV-exposed wound with warm water and soap. If the mouth or eyes are involved, they should be irrigated copiously with tap water.
    • Notify the parent or legal guardian unless the child/adolescent refuses parental notification and is deemed competent to make such decisions and can legally request that his/her parents not be notified.
    • Refer the child to a medical facility or emergency department for immediate further evaluation of the risk of exposure and the need for PEP.
    • Obtain a confidential baseline HIV antibody test.
    • Assess the risk of exposure to other pathogens, including hepatitis B virus (HBV) and hepatitis C virus (HCV), tetanus, sexually transmitted diseases, and bacterial infections, and treat as necessary (see section below titled, "PEP Following Exposures to Other Infectious Agents").

Special Considerations For Evaluation Of Sexual Assault Exposures

  • Evaluation of and treatment for sexual assault should be managed by a multidisciplinary team that is experienced in the care of children or adolescents who have been sexually assaulted.
  • A Sexual Assault Forensic Examiner (SAFE) who is trained to perform pediatric examinations should be included on the team whenever possible to assist in the medical examination, coordination of care, and discussions about treatment regimen. A rape crisis counselor and/or child advocacy team should be involved in all cases of sexual assault to assist the child and the family in dealing with the trauma and to assist with referrals.
  • Children and adolescents who are sexually assaulted should be managed in an emergency department or other setting where appropriate resources are available to address the medical, psychosocial, and legal issues of such an offense.
  • Children who are sexually assaulted should be assessed for the risk of acquiring other sexually transmitted diseases, including gonorrhea, syphilis, chlamydia, hepatitis B, herpes simplex virus, human papillomavirus, bacterial vaginosis, and trichomoniasis. Laboratory evaluation and possible antimicrobial prophylaxis should be considered depending on the nature of the assault.

Implementing Post-Exposure Prophylaxis

  • The clinician should discuss key issues about PEP with the family and child as soon as possible. Key issues include:
    • Potential benefits of HIV PEP
    • Potential toxicities associated with medications
    • Instructions on how and when to give the medications
    • Importance of adherence to the medication regimen
    • Nature and duration of medication regimen and monitoring schedule
  • When parental or legal guardian consent cannot be obtained to initiate HIV PEP in a minor, the treatment may be initiated. Parental/legal guardian consent is strongly recommended to continue PEP beyond the first few hours/days. Emancipated minors, married minors, and minors who are parents may provide consent for medical care and treatment.
  • Before initiating PEP, the clinician should obtain complete blood count (CBC) and serum liver enzymes.
  • The prophylactic medication regimen should be started as soon as possible (ideally within two hours and not more than 36 hours following exposure) and should be continued for 28 days.
  • Medications should be made available to the patient in sufficient supply to complete a course of prophylaxis.

Recommended Regimens For Post-Exposure Prophylaxis (please refer to Table 4 in the original guideline document for dosing recommendations)

  • For children/adolescents 13 years or older, the suggested PEP regimen is zidovudine, lamivudine, and tenofovir. An alternative PEP regimen for these patients is zidovudine, lamivudine, and nelfinavir (see Table 4 in the original guideline document).
  • For children 13 years or younger, the suggested PEP regimen is zidovudine, lamivudine, and nelfinavir (see Table 4 in the original guideline document).
  • When the source is known to be HIV-infected and information regarding previous anti-retroviral (ARV) therapy, current level of viral suppression, or genotypic/phenotypic resistance profile is available, the clinician, in consultation with an HIV Specialist, should individualize the regimen to more effectively suppress viral replication.

Follow Up Monitoring for Patients Receiving PEP

  • Initial follow-up of the exposed child should occur within 2 to 3 days to review medication regimen, assess psychosocial status of child and family, and arrange appropriate referrals (e.g., psychosocial counseling after sexual assault).
  • Clinicians should closely monitor patients receiving PEP to detect ARV-induced toxicities. Arrangements should be made for clinical follow-up at 2 weeks and 4 weeks; CBC and serum liver enzymes should be repeated at 4 weeks (see Table 5 in the original guideline document).
  • HIV testing should be repeated at 1, 3 and 6 months after exposure.
  • Because of the complexity and potential adverse effects of the PEP regimens, longitudinal care of the exposed patient should be provided either directly by or in consultation with a pediatric HIV Specialist.

Post-Exposure Prophylaxis Following Exposures To Other Infectious Agents

  • If the exposed child/adolescent is not fully immunized against hepatitis B, the child/adolescent should complete the hepatitis B vaccine series, with the next scheduled dose being given immediately. If the source is known to be hepatitis B surface antigen positive (HBsAg+), the child should receive hepatitis B immune globulin in addition to completing the hepatitis B vaccine series.
  • If the child has been previously vaccinated against hepatitis B, the child's serostatus should be determined. If the child has serologic immunity to hepatitis B, no further action is necessary. If the child does not have serologic immunity but there is documentation of previous vaccination, the clinician should administer a booster vaccine and reevaluate serologic status in 1 month to determine whether full revaccination is necessary.
  • The baseline hepatitis C serologic status of the exposed child should be determined in cases of percutaneous exposure. There are currently no recommendations for prophylaxis for hepatitis C virus (HCV). Repeat testing for hepatitis C serologic status should be performed at 6 months. Repeat testing for hepatitis C serologic status or polymerase chain reaction (PCR) for HCV may be considered at 2 to 4 weeks after exposure.
  • The tetanus vaccination status of the exposed child should be assessed in cases of percutaneous exposure or bite wound. Tetanus toxoids and tetanus immune globulin should be given if the child's vaccination status is not up-to-date.
  • Bite wounds should be cleansed. Antibiotics should be initiated in severe wounds, deep puncture wounds, and wounds to the face, genitals, or extremities.

Preventing Exposures

  • Children should be instructed in school and at home about potentially risky exposures and how to avoid them.
  • The clinician should discuss reduction of potentially risky behaviors with all children in a manner that is appropriate to their age and developmental stage as a routine component of pediatric care.

CLINICAL ALGORITHM(S)

A clinical algorithm on post-exposure prophylaxis (PEP) beyond the perinatal period is provided in the original guideline document.

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

These guidelines are based on best-practice evidence and constitute the opinion of the New York State Department of Health (NYSDOH) Committee for the Care of Children and Adolescents with Human Immunodeficiency Virus (HIV) Infection.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • New York State Department of Health. HIV post-exposure prophylaxis for children beyond the perinatal period. New York (NY): New York State Department of Health; 2004. 20 p. [33 references]

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2002 Mar (revised 2004)

GUIDELINE DEVELOPER(S)

New York State Department of Health - State/Local Government Agency [U.S.]

SOURCE(S) OF FUNDING

New York State Department of Health

GUIDELINE COMMITTEE

Committee for the Care of Children and Adolescents with HIV Infection

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Committee Chair: Jeffrey M. Birnbaum, MD, MPH, Assistant Professor of Pediatrics, SUNY Health Sciences Center at Downstate, Brooklyn, New York, Director, HEAT Program, Kings County Hospital

Committee Vice Chair: Geoffrey A. Weinberg, MD, Director, Pediatric HIV Program, Strong Memorial Hospital, Rochester, NY, Associate Professor of Pediatrics, Division of Infectious Diseases, University of Rochester School of Medicine and Dentistry

Committee Members: Jacobo Abadi, MD, Assistant Professor of Pediatrics, Albert Einstein College of Medicine, Bronx, New York, Jacobi Medical Center; Saroj S. Bakshi, MD, Associate Professor of Clinical Pediatrics, Albert Einstein College of Medicine, Bronx, New York, Chief, Division of Pediatric Infectious Diseases, Bronx-Lebanon Hospital Center; Howard J. Balbi, MD, Associate Professor of Pediatrics, SUNY at Stony Brook School of Medicine, Director, Pediatric Infectious Diseases, Good Samaritan Hospital Medical Center; Joseph S. Cervia, MD, Associate Professor of Clinical Medicine and Pediatrics, Albert Einstein College of Medicine, Bronx, New York, Director, The Comprehensive HIV Care and Research Center, Long Island Jewish Medical Center; Aracelis D. Fernandez, MD, Assistant Professor of Pediatrics, Albany Medical College; Ed Handelsman, MD, Assistant Professor of Pediatrics, SUNY Health Sciences Center at Downstate, Assistant Medical Director of Pediatrics, Office of the Medical Director, AIDS Institute; Sharon Nachman, MD, Chief, Pediatric Infectious Diseases, Professor of Pediatrics, SUNY at Stony Brook; Natalie Neu, MD, Assistant Professor of Pediatrics, Division of Pediatric Infectious Diseases, Columbia University; Catherine J. Painter, MD, PhD, Assistant Professor of Clinical Pediatrics, College of Physicians and Surgeons, Columbia University, New York, New York, Medical Director, Incarnation Children's Center; Roberto Posada, MD, Assistant Professor of Pediatrics, Division of Pediatric Infectious Diseases, Mount Sinai School of Medicine, New York, New York, Director, Pediatric HIV Program, Mount Sinai Hospital; Michael G. Rosenberg, MD, PhD, Associate Professor of Clinical Pediatrics, Albert Einstein College of Medicine, Bronx, New York, Pediatric Consultation Services, Jacobi Medical Center; Pauline Thomas, MD, Assistant Professor, Dept. of OB/GYN and Women's Health, Dept. of Preventive Medicine and Community Health, New Jersey Medical School; Barbara Warren, BSN, MPH, PNP, Assistant Director, Bureau of HIV Ambulatory Care Services, AIDS Institute, New York State Department of Health

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: New York State Department of Health. HIV post-exposure prophylaxis for children beyond the perinatal period. New York (NY): New York State Department of Health; 2002 Mar. 26 p.

GUIDELINE AVAILABILITY

Electronic copies: Available from the New York State Department of Health AIDS Institute Web site.

Print copies: Available from Office of the Medical Director, AIDS Institute, New York State Department of Health, 5 Penn Plaza, New York, NY 10001; Telephone: (212) 268-6108

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

Print copies: Available from Office of the Medical Director, AIDS Institute, New York State Department of Health, 5 Penn Plaza, New York, NY 10001; Telephone: (212) 268-6108

This guideline is available as a Personal Digital Assistant (PDA) download from the New York State Department of Health AIDS Institute Web site.

PATIENT RESOURCES

None available

NGC STATUS

This summary was prepared by ECRI on January 21, 2004. This NGC summary was updated by ECRI on February 3, 2005. This summary was updated by ECRI Institute on October 2, 2007, following the U.S. Food and Drug Administration advisory on Viracept (nelfinavir mesylate). This summary was updated by ECRI Institute on August 11, 2008 following the U.S. Food and Drug Administration advisory on Ziagen (abacavir sulfate).

COPYRIGHT STATEMENT

DISCLAIMER

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