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)

Lamivudine

Last Updated: April 16, 2019; Last Reviewed: April 16, 2019

Lamivudine (3TC, Epivir)
Lamivudine (3TC, Epivir)
For additional information see Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/
Formulations
Pediatric Oral Solution:
  • [Epivir] 10 mg/mL
  • [Epivir HBV]a 5 mg/mL
Tablets:
  • [Epivir] 150 mg (scored) and 300 mg
  • [Epivir HBV]a 100 mg
Generic Formulations:
  • 100 mg,150 mg, and 300 mg tablets
  • Fixed-dose combination tablet containing lamivudine 150 mg/zidovudine 300 mg
Fixed-Dose Combination Tablets:
  • [Cimduo] Lamivudine 300 mg/tenofovir disoproxil fumarate (TDF) 300 mg
  • [Combivir] Lamivudine 150 mg/zidovudine 300 mg
  • [Delstrigo] Doravirine 100 mg/lamivudine 300 mg/TDF 300 mg
  • [Epzicom] Abacavir 600 mg/lamivudine 300 mg
  • [Symfi] Efavirenz 600 mg/lamivudine 300 mg/TDF 300 mg
  • [Symfi Lo] Efavirenz 400 mg/lamivudine 300 mg/TDF 300 mg
  • [Temixys] Lamivudine 300 mg/TDF 300 mg
  • [Triumeq] Abacavir 600 mg/dolutegravir 50 mg/lamivudine 300 mg
  • [Trizivir] Abacavir 300 mg/lamivudine 150 mg/zidovudine 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 using lamivudine for the prevention of perinatal HIV transmission.

Neonate (≥32 Weeks Gestation at Birth) and Infant (Birth to <4 Weeks) Dose:
Oral Solution:
  • Lamivudine 2 mg/kg twice daily

Infant and Child 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:

  • Lamivudine 4 mg/kg twice daily of the oral solution
Aged ≥3 Months to <3 Years:
  • Lamivudine 5 mg/kg twice daily of the oral solution (maximum 150 mg per dose)
Aged ≥3 Years:
  • Lamivudine 5 mg/kg twice daily of the oral solution (maximum 150 mg per dose); or
  • 10 mg/kg once daily of the oral solution (maximum 300 mg per dose)
Weighing ≥14 kg and Able to Swallow Pills:
  • Weight-band dosing (see table below; dose is approximately lamivudine 5 mg/kg/day twice daily or lamivudine 10 mg/kg once daily)
Weight-Band Dosing for the Scored, 150-mg Lamivudine Table in Children Weighing ≥14 kg 
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 tablet.

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

Child and Adolescent (Weighing ≥25 kg) and Adult Dose:
  • Lamivudine 150 mg twice daily, or
  • Lamivudine 300 mg once daily
[Cimduo] Lamivudine/TDF
Child and Adolescent (Weighing >35 kg) and Adult Dose:
  • One tablet once daily
[Combivir and Generic] Lamivudine/Zidovudine
Child and Adolescent (Weighing ≥30 kg) and Adult Dose:
  • One tablet twice daily
[Delstrigo] Doravirine/Emtricitabine/TDF
Adult Dose:
  • One tablet once daily
  • Not studied in children or adolescents (see doravirine section)
[Epzicom] Abacavir/Lamivudine
Child and Adolescent (Weighing ≥25 kg) and Adult Dose:
  • One tablet once daily
[Symfi] Efavirenz 600 mg/Lamivudine/TDF
Child and Adolescent (Weighing ≥40 kg) and Adult Dose:
  • One tablet once daily on an empty stomach
[Symfi Lo] Efavirenz 400 mg/Lamivudine/TDF
Child and Adolescent (Weighing ≥35 kg) and Adult Dose:
  • One tablet once daily on an empty stomach

Note: Symfi Lo has not been studied in children (sexual maturity rating [SMR] 1 to 3) and major inter-individual variability in efavirenz plasma concentrations has been found in pediatric patients in a multi-ethnic setting. The 400 mg dose of efavirenz may be too low in children or adolescents with SMRs 1 to 3 weighing ≥40 kg. Therapeutic drug monitoring is suggested by some Panel members when Symfi Lo is used in pediatric patients weighing ≥40 kg. See the efavirenz section for more information.

[Temixys] Lamivudine/TDF
Child and Adolescent (Weighing ≥35 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 fixed-dose combination (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 FDA-approved dose for pediatric patients is one tablet once daily for patients weighing >40 kg.
[Trizivir and Generic] Abacavir/Lamivudine/Zidovudine
Child and Adolescent (Weighing ≥30 kg) and Adult Dose:
  • One tablet once daily 
  • Severe exacerbation of hepatitis can occur in patients with hepatitis B virus (HBV) and HIV coinfection who discontinue lamivudine.
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 FDC tablets, see other drug sections of the Drug Appendix for special instructions and additional information about the individual components of the FDC.
Metabolism/Elimination
  • Dose adjustment required in patients with renal insufficiency.
  • FDC 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.

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