Entecavir
BARACLUDE
What it isGuanosine analog that inhibits viral reverse transcriptase; chronic hepatitis B.
Why this oneResistance is uncommon unless lamivudine resistance is already present, distinguishing it from older agents.
What limits itTake on an empty stomach. Stopping can trigger a severe hepatitis flare; adjust for renal impairment.
FDA-approved for
- chronic hepatitis B (2005)
FDA label
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| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Chronic HBV, nucleoside-naive, compensated liver disease | >=16 yr | 0.5 mg QD | 0.5 mg QD | 0.5 mg QD |
| Chronic HBV, lamivudine-refractory / known resistance | >=16 yr | 1 mg QD | 1 mg QD | 1 mg QD |
| Chronic HBV, decompensated liver disease | adult | 1 mg QD | 1 mg QD | 1 mg QD |
| Chronic HBV (>=2 yr and >=10 kg) | pediatric | Weight-based (oral solution if <30 kg); naive vs lamivudine-experienced | Per Table 1 by weight | 0.5 mg (naive) / 1 mg (lamivudine-exp) at >30 kg |
Renal CrCl <50 mL/min (incl. hemodialysis/CAPD): reduce dose or extend interval (e.g., 0.25 mg QD or 0.5 mg q48h for the 0.5 mg dose).
Hepatic No adjustment needed
Instructions
- Take on an empty stomach (>=2 h after and >=2 h before a meal)
- Do not discontinue abruptly; monitor hepatic function for several months if stopped
- Offer HIV testing before starting
Cautions
- Severe acute HBV exacerbation after discontinuation
- HIV nucleoside-resistance risk if unrecognized/untreated HIV coinfection
- Lactic acidosis and severe hepatomegaly with steatosis
Adverse reactions
- Headache
- Fatigue
- Dizziness
- Nausea
Pregnancy Insufficient human data (Antiretroviral Pregnancy Registry); animal studies show no adverse developmental effects at clinically relevant exposures.
Lactation Undefined
⚠ BOXED WARNINGS
- Severe acute exacerbation of hepatitis B on discontinuation
- Lactic acidosis and hepatomegaly
Cost, est. cash$10–$500/month
Generic entry2014
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: Entecavir ballicule
