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Baraclude (ENTECAVIR)
Entecavir works by inhibiting the replication of the hepatitis B virus.
Baraclude (Entecavir) is a small molecule antiviral medication developed by Bristol Myers Squibb, currently owned by the same company. It is used to treat chronic type B viral hepatitis and lamivudine-refractory chronic hepatitis B. Entecavir was FDA-approved in 2005 and has since become off-patent with 17 generic manufacturers available. The medication has a high bioavailability of 99% and a long half-life of 128-149 hours. It is a commercially available treatment option for patients with these indications.
At a glance
| Generic name | ENTECAVIR |
|---|---|
| Sponsor | Bristol-Myers Squibb |
| Drug class | entecavir |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2005 |
Mechanism of action
Entecavir is an antiviral drug against the hepatitis virus. [see Microbiology (12.4)].
Approved indications
- Chronic type B viral hepatitis
- Lamivudine-Refractory Chronic Hepatitis B
Boxed warnings
- WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, AND LACTIC ACIDOSIS AND HEPATOMEGALY Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ] . Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if entecavir is used to treat chronic hepatitis B virus (HBV) infection in patients with HIV infection that is not being treated. Therapy with entecavir is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART) [see Warnings and Precautions (5.2) ] . Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue inhibitors alone or in combination with antiretrovirals [see Warnings and Precautions (5.3) ] . WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY See full prescribing information for complete boxed warning. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely for at least several months after discontinuation. Initiation of anti-hepatitis B therapy may be warranted. (5.1) Entecavir is not recommended for patients co-infected with human immunodeficiency virus (HIV) and hepatitis B virus (HBV) who are not also receiving highly active antiretroviral therapy (HAART), because of the potential for the development of resistance to HIV nucleoside reverse transcriptase inhibitors. (5.2) Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue inhibitors. (5.3)
Common side effects
- ALT 10 ULN and 2 baseline
- ALT 5 ULN
- Total bilirubin >2.5 ULN
- Lipase >= 2.1 ULN
- Creatinine 3 ULN
- Hyperglycemia, fasting 250 mg/dL
- Glycosuria
- Hematuria
- Platelets 50,000 /mm3
- Any Grade 3-4 laboratory abnormality
- Fatigue
- Dizziness
Key clinical trials
- Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP (PHASE3)
- Entecavir Resistance-Associated Mutations in Chronic HBV Patients in Turkey (STREAM Study)
- Stopping Antiviral Treatment in Chronic Hepatitis B
- A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection (PHASE1)
- Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Tolerant Chronic Hepatitis B (PHASE4)
- Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Active Chronic Hepatitis B (PHASE4)
- A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection (PHASE2)
- Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Baraclude CI brief — competitive landscape report
- Baraclude updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI