FDA approved Baraclude (entecavir) for Chronic Hepatitis B InfectionFDA approved new pill Baraclude to treat chronic hepatitis B in adults and children.

FDA From the archive Source published March 29, 2005 Summary added August 21, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Baraclude for chronic hepatitis B with active replication, but monitor renal function and note unknown long-term outcomes.

The FDA has approved Baraclude (entecavir), a nucleoside analogue reverse transcriptase inhibitor, for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients aged 2 years and older. The indication requires evidence of active viral replication and either persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. This approval provides a new oral treatment option for a patient population that includes both treatment-naïve and lamivudine-refractory cases, with dosing adjustments for renal impairment and specific guidance for pediatric patients. Clinically, entecavir offers potent viral suppression, but the optimal duration of therapy and its impact on long-term outcomes such as cirrhosis and hepatocellular carcinoma are not yet established, underscoring the need for careful patient selection and monitoring.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Entecavir is a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor. It inhibits HBV replication by interfering with the viral reverse transcriptase enzyme, leading to a decrease in HBV DNA levels.

Indication & Patient Population

Baraclude is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Dosing & Administration

- Administer on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal). - Adults and adolescents ≥16 years with compensated liver disease, nucleoside-inhibitor-treatment-naïve: 0.5 mg once daily. - Adults and adolescents ≥16 years with lamivudine-refractory or known lamivudine or telbivudine resistance substitutions: 1 mg once daily. - Adults with decompensated liver disease: 1 mg once daily. - Pediatric patients (2 years and older, weighing ≥10 kg): weight-based dosing; use oral solution for body weight up to 30 kg. - Renal impairment: dosage adjustment recommended for creatinine clearance <50 mL/min, including hemodialysis or CAPD patients (see Table 2 in label). - Hepatic impairment: no dosage adjustment necessary. - Duration of therapy: optimal duration unknown.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Baraclude is an oral antiviral for chronic hepatitis B, offering an option for both treatment-naïve and lamivudine-refractory patients. Its place in therapy is defined by its efficacy in suppressing HBV DNA and improving liver histology, but clinicians should consider the unknown long-term outcomes and the need for renal dosing adjustments.

The U.S. Food and Drug Administration has approved a new medicine called Baraclude (entacavir) for the treatment of chronic hepatitis B. Hepatitis B is a viral infection that attacks the liver and can lead to serious problems like cirrhosis or liver cancer if not managed. Baraclude is a pill taken by mouth that works by reducing the amount of virus in the body. It is approved for adults and for children aged 2 years and older who have signs of active infection and liver inflammation.

This approval is for patients who have not been treated before, as well as for those who have become resistant to an older drug called lamivudine. The dose may need to be adjusted for people with kidney problems, and there are specific instructions for children. The medicine offers a new option for controlling the virus, which can help protect the liver from further damage.

However, it is important to know that the optimal length of treatment is not yet clear. Also, while Baraclude effectively lowers the virus, it is not yet proven whether it reduces the long-term risk of cirrhosis or liver cancer. Doctors will need to monitor patients closely and decide on the best treatment plan for each person.

If you or a loved one has chronic hepatitis B, talk to your doctor about whether Baraclude might be right for you. This approval provides another tool, but it is not a cure, and ongoing care is essential.

What this means for you:

Baraclude is a new pill for chronic hepatitis B, but talk to your doctor about if it's right for you.

Study Details

Study typeFda approval

PublishedMar 2005

View Original Abstract ↓

1 INDICATIONS AND USAGE BARACLUDE ® (entecavir) is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. BARACLUDE is a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. (1)

FDA approved Baraclude (entecavir) for Chronic Hepatitis B InfectionFDA approved new pill Baraclude to treat chronic hepatitis B in adults and children.

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FDA approved Baraclude (entecavir) for Chronic Hepatitis B InfectionFDA approved new pill Baraclude to treat chronic hepatitis B in adults and children.

Study Details

Intrawound tobramycin plus vancomycin did not reduce deep infection risk compared with vancomycin alone in high-risk tibial fractures

Adding Antibiotics to Bone Surgery Didn't Lower Infection Risk

Clinical research that matters. Delivered to your inbox.

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