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.

  •   Table of Contents

Download Guidelines

Nucleoside and Nucleotide Analogue Reverse Transcriptase Inhibitors (NRTIs)

Lamivudine

Last Updated: May 22, 2018; Last Reviewed: May 22, 2018

Lamivudine (3TC, Epivir)
Lamivudine (3TC, Epivir)
For additional information see Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/
Formulations
Pediatric Oral Solution:
  • 10 mg/mL [Epivir]
  • 5 mg/mL [Epivir HBVa]
Tablets:
  • 150 mg (scored) and 300 mg [Epivir]
  • 100 mg [Epivir HBVa]
Generic Formulations:
Tablets: 100 mg, 150 mg, and 300 mg

Fixed-Dose Combination Tablets:
  • [Combivir and Generic] Lamivudine 150 mg plus zidovudine 300 mg
  • [Epzicom] Abacavir 600 mg plus lamivudine 300 mg
  • [Symfi Lo] Efavirenz 400 mg plus lamivudine 300 mg plus tenofovir disoproxil fumarate (TDF) 300 mg
  • [Trizivir] Abacavir 300 mg plus lamivudine 150 mg plus zidovudine 300 mg
  • [Triumeq] Abacavir 600 mg plus dolutegravir 50 mg plus lamivudine 300 mg
Dosing Recommendations Selected Adverse Events
Note: See Antiretroviral Management of Newborns with Perinatal HIV Exposure or Perinatal HIV and Table 12 for information about preventing perinatal transmission.

Neonate (≥32 Weeks Gestation at Birth) and Infant (Birth to <4 Weeks) Treatment Dose:
  • 2 mg/kg twice daily (oral solution)
Pediatric Dose
Note: In infants and young children being treated with liquid formulations of lamivudine, initiation with once-daily lamivudine is not recommended. Patients can be transitioned to once-daily treatment with the oral solution when they have been stable on twice-daily treatment for 36 weeks and are aged ≥3 years. Please see the note below and refer to the text for more detail.
Aged ≥4 Weeks to <3 Months:
  • 4 mg/kg twice daily of the oral solution
Aged ≥3 Months to <3 Years:
  • 5 mg/kg twice daily of the oral solution, up to 150 mg
Aged ≥3 Years:
  • 5 mg/kg twice daily of the oral solution, up to 150 mg; or
  • 10 mg/kg once daily of the oral solution, up to 300 mg
Weighing ≥14 kg and Able to Swallow Pills:
  • Weight-band dosing (see table below; dose approximate lamivudine 5 mg/kg/day twice daily or 10 mg/kg once daily)
Weight-Band Dosing (Children Weighing ≥14 kg)
Scored 150-mg Tablet
Weight Twice-Daily AM Dose Twice-Daily PM Dose Once-Daily Dose
14 kg to <20 kg ½ tablet (75 mg) ½ tablet (75 mg) 1 tablet (150 mg)
≥20 kg to <25 kg ½ tablet (75 mg) 1 tablet (150 mg) 1½ tablets (225 mg)
≥25 kg 1 tablet (150 mg) 1 tablet (150 mg) 2 tablets (300 mg)
Note: The scored tablet is the preferred formulation for pediatric patients weighing ≥14 kg who can swallow a solid-dosage form.

Note: The Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV (the Panel) supports switching children to once-daily dosing of lamivudine (oral solution or tablets) from twice-daily dosing in children aged ≥3 years, who have been clinically stable for 36 weeks with an undetectable viral load and stable CD4 T lymphocyte count. Clinicians should use a reasonable, once-daily regimen with the once-daily dose of lamivudine indicated above (approximately 10 mg/kg to a maximum of 300 mg once daily).

Child, Adolescent (Weighing ≥25 kg), and Adult Dose:
  • 150 mg twice daily, or
  • 300 mg once daily
[Combivir and Generic] Lamivudine plus Zidovudine
Adolescent (Weighing ≥30 kg) and Adult Dose:
  • One tablet twice daily
[Trizivir and Generic] Abacavir plus Lamivudine plus Zidovudine
Adolescent (Weighing ≥40 kg) and Adult Dose:
  • One tablet twice daily
[Epzicom] Abacavir plus Lamivudine
Adolescent (Weighing ≥25 kg) and Adult Dose:
  • One tablet once daily
[Triumeq] Abacavir plus Dolutegravir plus Lamivudine
Adolescent (Weighing ≥40 kg) and Adult Dose:
  • One tablet once daily
  • For use in patients who are antiretroviral (ARV) treatment-naive or treatment-experienced (but integrase strand transfer inhibitor-naive) and who are not being treated with UGT1A1/CYP3A inducers.
[Symfi Lo] Efavirenz plus Lamivudine plus TDF
Pediatric (Weighing ≥35 kg) and Adult Dose:
  • One tablet once daily on an empty stomach

Note: The new fixed-dose combination (Symfi Lo) with a lower dose of efavirenz has not yet been discussed by the Panel. The Panel will address its use in children in a later update.
  • Exacerbation of hepatitis has been reported after discontinuation of lamivudine in the setting of chronic hepatitis B virus (HBV) infection.
Special Instructions
  • Lamivudine can be given without regard to food.
  • Store lamivudine oral solution at room temperature.
  • Screen patients for HBV infection before administering lamivudine.
  • When using fixed-dose combinations, see other drug sections for special instructions and additional information about the individual drug components.
Metabolism/Elimination
  • Dose adjustment required in patients with renal insufficiency.
  • Fixed-dose combination tablets should not be used in patients who are on dialysis or who have creatinine clearance <50 mL/min or impaired hepatic function.
a Epivir HBV oral solution and tablets contain a lower amount of lamivudine than Epivir oral solution and tablets. The amount of lamivudine in the Epivir HBV solution and tablet was based on dosing for treatment of HBV infection (in people without HIV coinfection). If Epivir HBV is used in patients with HIV, the higher dose indicated for HIV therapy should be used as part of an appropriate combination regimen. The Epivir HBV tablet is appropriate for use in children who require a dose of lamivudine 100 mg for treatment of HIV.

Download Guidelines