Lamivudine
EPIVIR
What it isCytidine-analog reverse-transcriptase inhibitor; HIV and chronic hepatitis B.
Why this oneIts signature HIV-resistance mutation develops quickly but impairs viral fitness, so the drug may remain useful in a failing regimen.
What limits itStopping can trigger a severe hepatitis B flare; resistance emerges quickly when it is used alone for hepatitis B.
FDA-approved for
- HIV-1 infection (1995)
- chronic hepatitis B
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Chronic hepatitis B | Adults | 100 mg QD | 100 mg QD | 100 mg QD |
| Chronic hepatitis B | Pediatric 2-17 yr | 3 mg/kg QD (max 100 mg) | 3 mg/kg QD (max 100 mg) | 100 mg QD |
Renal Adjust by CrCl: 30-49 mL/min 100 mg first dose then 50 mg QD; 15-29 100 mg then 25 mg QD; 5-14 35 mg then 15 mg QD; <5 35 mg then 10 mg QD
Hepatic Undefined
Instructions
- May be taken with or without food
- Do not use with other lamivudine- or emtricitabine-containing products
- Oral solution available for pediatric patients requiring <100 mg or unable to swallow tablets
- Monitor hepatic function for several months after discontinuation
Cautions
- Exacerbations of hepatitis after discontinuation
- Risk of HIV-1 resistance if unrecognized/untreated HIV-1
- Emergence of resistance-associated HBV substitutions
- Lactic acidosis and severe hepatomegaly with steatosis (nucleoside analogues)
Adverse reactions
- Ear/nose/throat infections
- Sore throat
- Diarrhea
Pregnancy APR data show no substantial difference in major birth defects vs background; pregnancy registry available
Lactation Present in human milk; weigh benefits of breastfeeding against maternal need
⚠ BOXED WARNING
- Severe acute exacerbation of hepatitis B on discontinuation
Cost, est. cash$10–$500/month
Generic entry2011
Classes and tags
Clinical profile
Legacy pregnancy categoryUnknown / historical label unavailable
Defining liabilityAgent-specific renal, hepatic, hematologic, metabolic and drug-interaction toxicity.
Mechanism of action: Lamivudine ballicule
