Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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Nucleoside and Nucleotide Analogue Reverse Transcriptase Inhibitors (NRTIs)

Abacavir

Last Updated: April 14, 2020; Last Reviewed: April 14, 2020

Abacavir (ABC, Ziagen)
Abacavir (ABC, Ziagen)
Formulations
Pediatric Oral Solution: 20 mg/mL
Tablet: 300 mg (scored)

Generic Formulations:
  • 300 mg tablet
  • 20 mg/mL pediatric oral solution
Fixed-Dose Combination Tablets:
  • [Epzicom and generic] Abacavir 600 mg/lamivudine 300 mg
  • [Triumeq] Abacavir 600 mg/dolutegravir 50 mg/lamivudine 300 mg
  • [Trizivir and generic] Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg
When using fixed-dose combination (FDC) tablets, refer to other sections of the Drug Appendix for information about the individual components of the FDC. See also Appendix A, Table 2. Antiretroviral Fixed-Dose Combination Tablets: Minimum Body Weights and Considerations for Use in Children and Adolescents

For additional information, see Drugs@FDA or DailyMed.
Dosing Recommendations Selected Adverse Events
Neonate and Infant Dose:
  • Abacavir (ABC) is not approved for use in infants aged <3 months.
Infant and Child (Aged ≥3 Months) Dose
Oral Solution:
  • ABC 8 mg/kg twice daily (maximum 300 mg per dose) or ABC 16 mg/kg once daily (maximum 600 mg per dose)
  • In infants and young children who are being treated with liquid formulations of ABC, initiation with once-daily ABC is not generally recommended. In older children who can be treated with tablet formulations, therapy can be initiated with once-daily administration. In clinically stable patients who have undetectable viral loads and stable CD4 T lymphocyte cell counts while receiving the liquid formulation of ABC twice daily, the ABC dose can be changed from twice-daily dosing to once-daily dosing with the liquid or tablet formulations (see text below).
Weight-Band Dosing for Children and Adolescents Weighing ≥14 kg
Weight Scored 300-mg Tablet
Twice-Daily Dose, AM Twice-Daily Dose, PM Once-Daily Dose
14 kg to <20 kg ½ tablet (150 mg) ½ tablet (150 mg) 1 tablet (300 mg)
≥20 kg to <25 kg ½ tablet (150 mg) 1 tablet (300 mg) 1½ tablets (450 mg)
≥25 kg 1 tablet (300 mg) 1 tablet (300 mg) 2 tablets (600 mg)

Child and Adolescent (Weighing ≥25 kg) and Adult Dose:
  • ABC 300 mg twice daily or ABC 600 mg once daily
[Epzicom] Abacavir/Lamivudine
Child and Adolescent (Weighing ≥25 kg) and Adult Dose:
  • One tablet once daily
[Triumeq] Abacavir/Dolutegravir/Lamivudine
Child and Adolescent (Weighing ≥25 kg) and Adult Dose:
  • One tablet once daily
  • This FDC tablet can be used in patients who are antiretroviral (ARV)-naive or ARV-experienced (but integrase strand transfer inhibitor-naive) and who are not being treated with uridine diphosphate glucuronosyltransferase 1A1 or cytochrome P450 3A inducers.
  • The Food and Drug Administration-approved dose for pediatric patients is one tablet once daily for patients weighing ≥40 kg (see the Dolutegravir section for more information).
[Trizivir] Abacavir/Lamivudine/Zidovudine
Child and Adolescent (Weighing ≥30 kg) and Adult Dose:
  • One tablet twice daily
  • Hypersensitivity reactions (HSRs) can be fatal. HSRs usually occur during the first few weeks of starting therapy. Symptoms may include fever, rash, nausea, vomiting, malaise or fatigue, loss of appetite, and respiratory symptoms (e.g., cough, shortness of breath).
Special Instructions
  • Test patients for the HLA-B*5701 allele before starting therapy to predict the risk of HSRs. Patients who test positive for the HLA-B*5701 allele should not be given ABC. Patients with no prior HLA-B*5701 testing who are tolerating ABC do not need to be tested.
  • Warn patients and caregivers about the risk of serious, potentially fatal HSRs. Occurrence of an HSR requires immediate and permanent discontinuation of ABC. Do not rechallenge.
  • ABC can be given without regard to food. The oral solution does not require refrigeration.
  • Screen patients for hepatitis B virus (HBV) infection before using Trizivir, Epzicom, and Triumeq (or the generic equivalents of these FDC tablets). These FDC tablets contain lamivudine (3TC), and severe acute exacerbation of HBV infection can occur when 3TC is discontinued. Therefore, hepatic function and hepatitis B viral load should be monitored for several months after therapy with 3TC is stopped in patients with HBV.
Metabolism/Elimination
  • ABC is systemically metabolized by alcohol dehydrogenase and glucuronyl transferase.
  • The majority of ABC is excreted as metabolites in urine.
  • ABC requires a dose adjustment in patients with hepatic insufficiency.
  • Do not use FDC tablets such as Trizivir, Epzicom, and Triumeq (or the generic equivalents of these FDC tablets) in patients with impaired hepatic function, because the dose of ABC cannot be adjusted.
  • Do not use Trizivir, Epzicom, and Triumeq (or the generic equivalents of these FDC tablets) in patients with creatinine clearance <50 mL/min and patients on dialysis, because the dose of 3TC cannot be adjusted.

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