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Entecavir: Brands, Price & Uses in Bangladesh
Entecavir is a nucleoside analog antiviral indicated for the treatment of chronic hepatitis B virus (HBV) infection.
About Entecavir
Indications of Entecavir
Entecavir is a nucleoside analog antiviral indicated for the treatment of chronic hepatitis B virus (HBV) infection.
Established / FDA-approved uses
- Chronic hepatitis B infection in adults with evidence of active viral replication and either persistently elevated serum aminotransferases (ALT or AST) or histologically active disease, including patients with compensated and decompensated liver disease.
- Chronic hepatitis B infection in pediatric patients 2 years of age and older with evidence of active viral replication and either persistently elevated ALT or histologically active disease.
- Lamivudine-refractory chronic hepatitis B (known lamivudine- or telbivudine-resistant HBV) - a higher dose of Entecavir is used in this setting.
Important limitation
Entecavir is not indicated for, and is not effective against, HIV infection. It is not a treatment for hepatitis C or hepatitis D. Patients being started on Entecavir should be tested for HIV infection before treatment begins, because Entecavir monotherapy in a patient with unrecognised or untreated HIV/HBV co-infection may lead to the development of HIV resistance.
Dosage & Administration of Entecavir
General principle
Entecavir is taken once daily, by mouth, on an empty stomach (at least 2 hours before or 2 hours after a meal). The dose depends on prior treatment history, hepatic status, and renal function.
| Indication / Patient group | Recommended adult dose |
|---|---|
| Nucleoside-treatment-naive, compensated liver disease | 0.5 mg once daily |
| Lamivudine-refractory or lamivudine/telbivudine-resistant HBV | 1 mg once daily |
| Decompensated liver disease (any treatment history) | 1 mg once daily |
Renal impairment (adults)
| Creatinine clearance (CrCl) | Usual dose (0.5 mg dose group) | Lamivudine-refractory/decompensated (1 mg dose group) |
|---|---|---|
| ≥50 mL/min | 0.5 mg every 24 hours | 1 mg every 24 hours |
| 30 to <50 mL/min | 0.25 mg every 24 hours or 0.5 mg every 48 hours | 0.5 mg every 24 hours |
| 10 to <30 mL/min | 0.15 mg every 24 hours or 0.5 mg every 72 hours | 0.3 mg every 24 hours or 1 mg every 72 hours |
| <10 mL/min, haemodialysis or CAPD | 0.05 mg every 24 hours or 0.5 mg every 7 days | 0.1 mg every 24 hours or 1 mg every 7 days |
For haemodialysis patients, Entecavir should be given after the dialysis session.
Pediatric dosing (2 years and older)
Weight-based dosing using the oral solution (0.05 mg/mL) is used for nucleoside-naive pediatric patients weighing less than 30 kg; patients weighing ≥30 kg may receive a 0.5 mg tablet once daily. Lamivudine-experienced pediatric patients require a higher weight-based dose. See Use in Special Populations for details. Safety and efficacy have not been established in children under 2 years of age.
Hepatic impairment
No dose adjustment of Entecavir is required for patients with hepatic impairment who have not previously received a nucleoside analogue and who do not have decompensated liver disease; decompensated liver disease requires the 1 mg once-daily dose as above.
Duration
Entecavir should be continued for as long as the prescribing physician advises. Do not stop Entecavir without medical guidance - stopping abruptly can trigger a severe flare of hepatitis B (see Precautions and Warnings).
Side Effects of Entecavir
Most patients tolerate Entecavir well. The following adverse effects have been reported:
| Frequency | Effects |
|---|---|
| Common | Headache, fatigue, dizziness, nausea, insomnia, diarrhoea |
| Less common | Vomiting, dyspepsia, elevated liver enzymes, rash |
| Rare but serious | Lactic acidosis and severe hepatomegaly with steatosis (see boxed warning), acute exacerbation of hepatitis B on stopping therapy (see boxed warning), pancreatitis, severe allergic reaction |
Seek prompt medical attention for unusual muscle pain, difficulty breathing, unexplained fatigue with abdominal discomfort, or signs of an allergic reaction while taking Entecavir.
Contraindications of Entecavir
Entecavir is contraindicated in patients with a known hypersensitivity to Entecavir or to any component of the formulation.
Frequently Asked Questions about Entecavir
What is Entecavir used for?
Entecavir is an antiviral medicine used to treat long-term (chronic) hepatitis B virus infection in adults and children 2 years of age and older who have signs of active viral replication and liver inflammation. It is not used for hepatitis C, hepatitis A, or HIV infection.
Can I stop taking Entecavir once I feel better?
No. You should never stop Entecavir without your physician's guidance. Stopping suddenly can trigger a severe, sometimes life-threatening, flare of hepatitis B, even if you feel well. Your doctor will monitor your liver function closely for several months after any planned discontinuation.
How should I take Entecavir for best results?
Take Entecavir once daily, by mouth, on an empty stomach - at least 2 hours after eating and at least 2 hours before your next meal - for optimal absorption. Take it at the same time each day.
Is Entecavir safe during pregnancy or breastfeeding?
Data on Entecavir in pregnancy are limited, so it should be used in pregnancy only if the potential benefit clearly justifies the potential risk to the baby, and only under a physician's supervision. Do not stop it during pregnancy without medical advice because of the flare risk. Breastfeeding is generally not recommended while taking Entecavir unless your doctor advises otherwise.
Does Entecavir need dose adjustment for kidney problems?
Yes. Because Entecavir is eliminated by the kidneys, patients with reduced kidney function (creatinine clearance below 50 mL/min) need a lower dose and/or a longer interval between doses. Your physician will calculate the correct dose and interval for you.
What is the most serious risk with Entecavir?
Entecavir carries boxed warnings for rare but serious lactic acidosis with liver fat accumulation, severe hepatitis B flare after stopping treatment, and a risk of HIV drug resistance if used in a patient with undiagnosed HIV infection. You should be tested for HIV before starting Entecavir, and never stop the medicine without medical supervision.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.