CCC Guidance for Pediatric HIV PEP Outside of the Perinatal Period

Transcription

1 CCC Guidance for Pediatric HIV PEP Outside of the Perinatal Period There are currently no published guidelines for post-exposure prophylaxis from the CDC/PHS specific to the pediatric population. This guidance for pediatric post-exposure prophylaxis (PEP) regimens for known or possible exposures to HIV-infected body fluids can be used pending release of updated non-occupational exposure guidelines that will include pediatric dosing. The following guidance was developed by experts within the Clinician Consultation Center (CCC), based on the 2003 statement on pediatric PEP from the American Academy of Pediatrics 1, the 2005 CDC non-occupational guidelines 2, and interim recommendations from the New York Department of Health for pediatric PEP 5. The decision to start PEP in the pediatric population should be based on consideration of the following: o Type of exposure? o What was timing of exposure? o Was this a one-time exposure or repeated exposure? o Source patient status and can he or she be tested? o Age & weight of patient. o Ability to swallow pills? o How are parents feeling? o Will exposed patient be able to take 28 days worth of PEP? Most pediatric exposures are considered low risk, e.g. found needles in the community setting. There has never been a documented transmission of HIV from a found needle in the community setting 1. Generally for these situations, CCC s consensus opinion is to discourage the use of PEP. Standard occupational PEP regimens contain 3 drugs. There may be instances where 2 drug PEP is acceptable. The decision to use 2 vs 3 drug PEP has to take into consideration a variety of factors which may include, but are not limited to, the risk of the exposure, access to the drugs, cost, pill burden, and tolerability. Consultation with an expert is recommended. Duration of PEP is for 28 days or until the source person tests negative for HIV, whichever is sooner. Monitoring for toxicities include CBC, LFTs and renal function is recommended at baseline and two weeks into treatment. The following tables assume that a decision to give PEP has been made by the provider and parent(s)/guardian(s) of the exposed child.

2 **** NOTE: This document does not address possible drug toxicities, drug-drug interactions, and baseline and follow-up serologies for bloodborne pathogens. Comprehensive management of an exposure should include consideration of these aspects. We encourage consultation to support a thorough workup of the exposure. PEP REGIMEN OPTIONS Standard occupational PEP regimens contain 3 drugs. There may be instances where 2-drug PEP is acceptable. The decision to use 2 vs 3 drug PEP must take into consideration a variety of factors which may include, but are not limited to, the risk of the exposure, access to the drugs, cost, pill burden, and tolerability. NOTE: AZT * +3TC or TDF+FTC are options to 2-drug PEP. For 3-drug PEP, add either LPV/r or RAL. Age/Weight Preferred Alternatives Ages 0-2 AZT+3TC # PLUS LPV/r (for ages >2 weeks) OR AZT+3TC # PLUS RAL (for ages >4 weeks) Ages 2-12 AND < 40 kg Ages 12 & above OR >40kg TDF+3TC # PLUS RAL AZT+3TC # PLUS LPV/r TDF/FTC PLUS RAL AZT/3TC # PLUS RAL or LPV/r * For all medication acronyms, please see the PEP dosage tables on the following pages. # FTC can be used in place used interchangeably with 3TC

3 *Tenofovir (TDF, Viread): PEDIATRIC DOSING FOR PEP MEDICATIONS Powder 40 mg/g Tablets (film coated) 150, mg Dosing recommendations based on body weight if using the oral powder - Note: One level scoop of powder = 40 mg tenofovir. To administer oral powder, manufacturer recommends sprinkling TDF oral powder on the soft food. Stir with a spoon until well mixed. Give the entire dose right away after mixing to avoid a bad taste. Children 2 to <12 years: 8 mg/kg once daily (maximum: 300 mg once daily. Note: for pediatric patients weighing greater than or equal to 17 kg who can swallow an intact tablet, one TDF tablet (150, 200, 250 or 300 mg based on body weight) once daily taken orally. Body Weight (kg) 10 to <12 80 mg once daily 12 to < mg once daily 14 to < mg once daily 17 to < mg once daily 19 to < mg once daily 22 to < mg once daily 24 to < mg once daily 27 to < mg once daily 29 to < mg once daily 32 to < mg once daily 34 to < mg once daily mg once daily *Emtricitabine (FTC, Emtriva) Capsule: Children >33 kg: 200 mg once daily Solution: 3 mg/kg once daily (0 to <3 months) 6 mg/kg once daily ( 3 months to 17 years; maximum: 240 mg/day) *Zidovudine (AZT, Retrovir) Oral syrup: 50mg / 5mL Capsule 100 mg (to be swallowed) Tablet 300 mg (to be swallowed) Weight (kg) 4 to 9 12 mg/kg/dose BID up to 300mg / dose 9 to 30 9 mg/kg/dose BID up to 300mg / dose > mg BID (adult dose)

4 *Lamivudine (3TC, Epivir) Tablets: 100mg, 150mg, 300mg Oral solution: 50mg / 5mL Body Weight (kg) < 50 4 mg/kg/dose BID up to 300mg /day > mg/dose BID (adult dose) *Raltegravir (RAL, Isentress) Tablet: 400 mg (film-coated, to be swallowed) Chewable Tablets: 25 mg, 100 mg Oral Suspension: Single-use packet of 100 mg If at least 25 kg: One 400 mg film-coated tablet orally, twice daily. If unable to swallow a tablet, consider the chewable tablet, as specified in Table 1, below. Table 1: Alternate with RAL chewable tablets for pediatric patients weighing at least 25 kg Body Weight (kg) Number of Chewable Tablets 25 to less than mg twice daily 1.5 X 100 mg twice daily 28 to less than mg twice daily 2 X 100 mg twice daily At least 40 kg 300 mg twice daily 3X 100 mg twice daily The weight-based dosing recommendation for the chewable tablet is based on approximately 6 mg/kg/dose twice daily. The 100 mg chewable tablet can be divided into equal halves. If at least 4 weeks of age and weighing at least 3 kg but less than 25 kg: Weight-based dosing, as specified in Table 2, below. For patients weighing between 11 and 20 kg, either the chewable tablet or oral suspension can be used, as specified in Table 2. Patients can remain on the oral suspension as long as their weight is below 20 kg. Refer to Table 2 for appropriate dosing. Table 2: Recommended for RAL oral suspension and chewable tablets in Pediatric Patients who weigh <25 kg Body Weight (kg) Volume () of Suspension Number of Chewable Tablets 3 to less than 4 1 ml (20 mg) BID 4 to less than mgl (30 mg) BID 6 to less than 8 2 ml (40 mg) BID 8 to less than 11 3 ml (60 mg) BID 11 to less than 14 4 ml (80 mg) BID 3 X 25 mg BID 14 to less than 20 5 ml (100 mg) BID 1 X 100 mg BID 20 to less than X 100 mg BID

5 *Kaletra (lopinavir/ritonavir, LPV/r) : Oral solution: 80 mg LPV/20mg RTV per 1 ml Tablets 100 mg LPV/25 mg RTV; 200 mg LPV/50 mg RTV Body Surface Area Dosing For children 2 weeks to 12 months of age, < 1 year old, LPV/r should be administered as 300mg/75mg per m2 per dose twice daily. For children > 12 months of age, LPV/r can be administered as 230mg/75 mg per m2 per dose twice daily. The following tables provide weight band dosing at this dose. Weight-Band Dosing of Oral Solution (230mg/75mg per m2) Body Weight (kg) < mg LPV/kg/dose BID >15 to mg LPV/kg/dose BID > 40 (Adult dose) 400mg LPV BID Weight-Band Dosing of Tablet (230mg/75mg per m2) Body Weight (kg) Body Surface Area (m 2 ) Recommended number of 100/25 mg BID 15 to to < >25 to to < > (or 2 X 200/50 mg tablets) This material is intended for educational purposes for healthcare providers only. It is not intended as a substitute for professional medical care or advice, nor to replace a healthcare professionals' clinical judgment regarding their individual patient care.

6 References 1. Havens, P. & the Committee on Pediatric AIDS. Postexposure Prophylaxis in Children and Adolescents for Nonoccupational Exposure to Human Immunodeficiency Virus. American Academy of Pediatrics Clinical Report: Guidance for the Clinician in Rendering Pediatric Care. Pediatrics. 2003; 111(6): Accessed at: 2. Centers for Disease Control and Prevention. Recommendations and Reports: Antiretroviral Postexposure Prophylaxis After Sexual, Injection-Drug Use, or Other Nonoccupational Exposure to HIV in the United States. Recommendations from the U.S. Department of Health and Human Services. MMWR Accessed at: 3. Kaufman, M. & The Committee on Adolescence. Care of the Adolescent Sexual Assault Victim. American Academy of Pediatrics Clinical Report. Pediatrics. 2008; 122: Accessed at: 4. Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2010: Sexual Assault and STDs. Accessed at: 5. New York State Department of Health AIDS Institute. HIV Post-Exposure Prophylaxis for Children Beyond the Perinatal Period. Accessed at: