• 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]

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.

• Human immunodeficiency virus (HIV) infection
• Hepatitis B virus infection
• Hepatitis C virus infection
• Sexually transmitted diseases
• Sexual assault

Counseling
Diagnosis
Evaluation
Management
Prevention
Risk Assessment
Treatment

Allergy and Immunology
Emergency Medicine
Family Practice
Infectious Diseases
Pediatrics
Preventive Medicine
Psychiatry
Psychology

Advanced Practice Nurses
Health Care Providers
Nurses
Physician Assistants
Physicians
Psychologists/Non-physician Behavioral Health Clinicians
Public Health Departments
Social Workers

To help medical providers identify and treat pediatric patients with potential human immunodeficiency virus (HIV) exposures

Children beyond the perinatal period with potential human immunodeficiency virus (HIV) exposures

Initial Evaluation/Risk Assessment

1. Risk assessment to determine whether post-exposure prophylaxis for human immunodeficiency virus (HIV) is indicated
2. Cleansing of wound or irrigation of mouth and eyes, as appropriate
3. Notification of parent or guardian
4. Referral of child to medical facility or emergency room for further evaluation
5. Confidential baseline HIV antibody tests
6. Assessment of risk for other pathogens
7. Blood count (CBC)
8. Liver function tests

Evaluation and Management of Sexual Assault

1. Inclusion of a Sexual Assault Forensic Examiner (SAFE) trained in pediatric examinations on evaluation team
2. Availability of appropriate resources to address medical, psychosocial, and legal issues
3. Assessment of child for risk of sexually transmitted disease, with laboratory evaluation and antimicrobial prophylaxis as appropriate

Treatment/Management/Counseling

1. Discussing benefits and risks of post-exposure prophylaxis with family and child
2. Parental or legal guardian consent
3. Post-exposure prophylaxis for HIV:
   • Children/adolescents 13 years and older:
     • Recommended regimen: zidovudine, lamivudine, and tenofovir
     • Alternative regimen: zidovudine, lamivudine, and nelfinavir
   • Children 13 years or younger:
     • Recommended regimen: zidovudine, lamivudine, and nelfinavir
   • Other medications considered, but not recommended: nevirapine, efavirenz, abacavir
4. Clinical follow-ups to include toxicity assessment, complete blood count, liver function tests, and HIV testing
5. Assessment of psychosocial status and obtaining referrals if needed
6. Post-exposure prophylaxis following exposure to other infectious agents:
   • Hepatitis B vaccine series
   • Hepatitis B immune globulin
   • Determination of serostatus if child has been previously vaccinated
   • Determination of hepatitis C serologic status in cases of percutaneous exposure
   • Assessment of tetanus vaccination status in cases of percutaneous exposure and administration of tetanus toxoids and tetanus immune globulin if vaccination status is not up-to-date
   • Cleansing of bite wounds and administration of antibiotics, as appropriate

Prevention/Counseling

1. Home and school instruction about avoiding potentially risky exposures
2. Age-appropriate discussions between physician and child concerning reduction of risky behaviors

• Risk and incidence of human immunodeficiency virus (HIV) transmission after exposure to HIV and after prophylaxis
• Incidence of post-exposure transmission of hepatitis B virus (HBV)
• Adverse effects of HIV post-exposure prophylaxis

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

Not stated

Not stated

Expert Consensus (Committee)

Not applicable

Review

Not stated

Expert Consensus

The Human Immunodeficiency Virus (HIV) Guidelines Program works directly with committees composed of HIV Specialists to develop clinical practice guidelines. These specialists represent different disciplines associated with HIV care, including infectious diseases, family medicine, obstetrics and gynecology, among others. Generally, committees meet in person three to four times per year, and otherwise conduct business through monthly conference calls.

Committees meet to determine priorities of content, review literature, and weigh evidence for a given topic. These discussions are followed by careful deliberation to craft recommendations that can guide HIV primary care practitioners in the delivery of HIV care. Decision making occurs by consensus. When sufficient evidence is unavailable to support a specific recommendation that addresses an important component of HIV care, the group relies on their collective best practice experience to develop the final statement. The text is then drafted by one member, reviewed and modified by the committee, edited by medical writers, and then submitted for peer review.

Not applicable

A formal cost analysis was not performed and published cost analyses were not reviewed.

Peer Review

Not stated

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.

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

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.

Overall Potential Benefits

These guidelines are intended to help medical providers identify and treat pediatric patients with potential human immunodeficiency virus (HIV) exposures. Early identification and treatment may reduce the risk and rate of HIV transmission and viral replication.

• 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. There are no clinical trials in the pediatric age group to guide decision-making in the management of pediatric post-exposure prophylaxis (PEP) for HIV, and consultation with a pediatric HIV Specialist is recommended.
• No clinical studies are available to determine the best regimens for prophylaxis. The guideline committee's recommendations for drug choices and dosages follow current NYSDOH recommendations for occupational and non-occupational PEP and take into account the current antiretroviral (ARV) therapy recommendations in the NYDOH's Pediatric Antiretroviral Therapy. The recommended regimen for children/adolescents 13 years and older provides potent antiviral activity with a low pill burden and minimal side effects; however, tenofovir has not yet been US Food and Drug Administration (FDA)-approved for children under age 18.
• Although in general the NYSDOH recommends a three-drug regimen for PEP, the Committee did not reach consensus. Some believed that the issues of toxicity and poorer adherence with a three-drug regimen warranted use of a two-drug regimen in some cases. Others believed that a three-drug regimen was always preferable. More recently available formulations of medications include combination pills and once daily dosing that are more convenient. These have not been extensively studied in the context of PEP but have been proven effective in the treatment of HIV infection.

Following the development and dissemination of guidelines, the next crucial steps are adoption and implementation. Once practitioners become familiar with the content of guidelines, they can then consider how to change the ways in which they take care of their patients. This may involve changing systems that are part of the office or clinic in which they practice. Changes may be implemented rapidly, especially when clear outcomes have been demonstrated to result from the new practice such as prescribing new medication regimens. In other cases, such as diagnostic screening or oral health delivery, however, barriers emerge which prevent effective implementation. Strategies to promote implementation, such as through quality of care monitoring or dissemination of best practices, are listed and illustrated in the companion document to the original guideline (HIV clinical practice guidelines, New York State Department of Health; 2003), which portrays New York's HIV Guidelines Program. The general implementation strategy is outlined below.

• Statement of purpose and goal to encourage adoption and implementation of guidelines into clinical practice by target audience
• Define target audience (providers, consumers, support service providers).
  • Are there groups within this audience that need to be identified and approached with different strategies (e.g., HIV Specialists, family practitioners, minority providers, professional groups, rural-based providers)?
• Define implementation methods.
  • What are the best methods to reach these specific groups (e.g., performance measurement consumer materials, media, conferences)?
• Determine appropriate implementation processes.
  • What steps need to be taken to make these activities happen?
  • What necessary processes are internal to the organization (e.g., coordination with colleagues, monitoring of activities)?
  • What necessary processes are external to the organization (e.g., meetings with external groups, conferences)?
  • Are there opinion leaders that can be identified from the target audience that can champion the topic and influence opinion?
• Monitor progress.
  • What is the flow of activities associated with the implementation process and which can be tracked to monitor the process?
• Evaluate.
  • Did the processes and strategies work?
  • Were the guidelines implemented?
  • What could be improved in future endeavors?

Staying Healthy

Effectiveness
Patient-centeredness
Timeliness

• 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]

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

2002 Mar (revised 2004)

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

New York State Department of Health

Committee for the Care of Children and Adolescents with HIV Infection

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

Not stated

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.

None available

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).