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 14, 2020; Last Reviewed: April 14, 2020

Lamivudine (3TC, Epivir)
Lamivudine (3TC, Epivir)
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 (FDC) tablet containing lamivudine 150 mg/zidovudine 300 mg
Fixed-Dose Combination Tablets:
  • [Cimduo] Lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg
  • [Combivir] Lamivudine 150 mg/zidovudine 300 mg
  • [Delstrigo] Doravirine 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg
  • [Dovato] Dolutegravir 50 mg/lamivudine 300 mg
  • [Epzicom] Abacavir 600 mg/lamivudine 300 mg
  • [Symfi] Efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg
  • [Symfi Lo] Efavirenz 400 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg
  • [Temixys] Lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg
  • [Triumeq] Abacavir 600 mg/dolutegravir 50 mg/lamivudine 300 mg
  • [Trizivir] Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg
When using 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
Note: See Antiretroviral Management of Newborns with Perinatal HIV Exposure or Perinatal HIV and Table 12 for information about using lamivudine (3TC) to prevent perinatal HIV transmission.

Neonate (≥32 Weeks Gestation at Birth) and Infant (Birth to <4 Weeks) Dose 
Oral Solution:
  • 3TC 2 mg/kg twice daily

Infant and Child Dose:
Once-daily dosing of the 3TC oral solution is not recommended when initiating 3TC oral solution in infants and young children. 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:

  • 3TC 4 mg/kg twice daily of the oral solution
Aged ≥3 Months to <3 Years:
  • 3TC 5 mg/kg twice daily of the oral solution (maximum 150 mg per dose)
Aged ≥3 Years:
  • 3TC 5 mg/kg twice daily of the oral solution (maximum 150 mg per dose); or
  • 3TC 10 mg/kg once daily of the oral solution (maximum 300 mg per dose)
Weight-Band Dosing for the Scored, 10 mg/ml Lamivudine Tablet in Children Weighing ≥3 kg 
Weight Twice-Daily Dose, AM Twice-Daily Dose, PM
3 kg to 5.9 kg 3 ml 3 ml
6 kg to 9.9  kg 4 ml 4 ml
10 kg 13.9 kg 6 ml 6 ml


Weighing ≥14 kg and Able to Swallow Pills:

  • Weight-band dosing (see table below; dose is approximately 3TC 5 mg/kg per day twice daily or 3TC 10 mg/kg once daily)
  • The scored tablet is the preferred formulation for pediatric patients weighing ≥14 kg who can swallow a tablet.
Weight-Band Dosing for the Scored, 150-mg Lamivudine Tablet in Children Weighing ≥14 kg 
Weight Twice-Daily Dose, AM Twice-Daily Dose, PM 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 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 3TC (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 once-daily regimen using the once-daily dose of 3TC indicated above (approximately 3TC 10 mg/kg, with a maximum of 3TC 300 mg once daily).

Child and Adolescent (Weighing ≥25 kg) and Adult Dose:
  • 3TC 150 mg twice daily, or
  • 3TC 300 mg once daily
[Cimduo] Lamivudine/Tenofovir Disoproxil Fumarate (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
  • The use of Delstrigo has not been studied in children or adolescents (see Doravirine section)
[Dovato] Dolutegravir/Lamivudine
Adult Dose:
  • One tablet once daily with or without food as a complete antiretroviral (ARV) regimen in antiretroviral therapy (ART)-naive adults with no known mutations associated with resistance to the individual components of Dovato.
  • Dovato is not approved by the Food and Drug Administration (FDA) or recommended by the Panel for use in children or adolescents as a complete ARV regimen. However, it could be used as part of a three-drug regimen in patients who meet the minimum body weight requirements for each component drug.
[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
  • Symfi Lo has not been studied in children (sexual maturity ratings [SMRs] 1–3), and major interindividual variability in efavirenz (EFV) plasma concentrations has been found in pediatric patients in a multi-ethnic setting. The 400 mg dose of EFV may be too low in children or adolescents with SMRs 1 to 3 who weigh ≥40 kg. The use of therapeutic drug monitoring is suggested by some Panel members when Symfi Lo is used in pediatric patients who weigh ≥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 FDC tablet can be used in patients who are ART-naive or ART-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 (see the Dolutegravir section for more information).
[Trizivir and Generic] Abacavir/Lamivudine/Zidovudine
Child and Adolescent (Weighing ≥30 kg) and Adult Dose:
  • One tablet twice daily 
  • Severe exacerbation of hepatitis can occur in patients with hepatitis B virus (HBV)/HIV coinfection who discontinue 3TC. 
Special Instructions
  • 3TC can be given without regard to food.
  • Store 3TC oral solution at room temperature
  • Screen patients for HBV infection before using 3TC or FDC tablets that contain 3TC. Hepatic function and hepatitis B viral load should be monitored for several months after patients with HBV infection stop taking 3TC. Patients with HBV/HIV coinfection who receive Dovato will require additional treatment for chronic HBV infection.
Metabolism/Elimination
  • Dose adjustment is required for patients with renal insufficiency.
  • FDC tablets should not be used in patients who are on dialysis, patients who have creatinine clearance <50 mL/min, or patients who have impaired hepatic function.
a Epivir HBV oral solution and tablets contain a lower amount of 3TC than Epivir oral solution and tablets. The amount of 3TC in the Epivir HBV solution and tablet was based on dosing for treatment of HBV infection in people without HIV coinfection. Patients with HIV who are taking Epivir HBV as part of their ARV regimen should receive the appropriate amount of oral solution or the appropriate number of tablets to achieve the higher doses of 3TC that are used to treat HIV.

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