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ADEFOVIR
Adefovir is an antiviral medication used to treat chronic hepatitis B in adults and adolescents, with common side effects including fatigue, headache, and stomach pain.
Adefovir is an antiviral drug indicated for chronic hepatitis B in patients 12 years and older with active viral replication. It is associated with severe acute exacerbations after discontinuation and nephrotoxicity. Common side effects include asthenia, headache, abdominal pain, and nausea.
At a glance
| Generic name | ADEFOVIR |
|---|---|
| Target | DNA polymerase subunit gamma-1, Capsid protein, Protein P |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | discontinued |
Mechanism of action
Adefovir works by blocking a key step in the hepatitis B virus life cycle, preventing the virus from multiplying inside liver cells. It is taken as a tablet and is specifically for people who have chronic hepatitis B with signs of active infection. The drug helps reduce liver inflammation and damage by lowering the amount of virus in the body. It is important to take it regularly and not stop suddenly, as this can cause a sudden worsening of liver disease.
Approved indications
- Chronic type B viral hepatitis
Boxed warnings
- WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS, NEPHROTOXICITY, HIV RESISTANCE, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-Hepatitis B therapy including adefovir dipivoxil tablets. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least sever
Common side effects
- incidence greater than
Drug interactions
- Since adefovir is eliminated by the kidney
Key clinical trials
- Drug Use Investigation for HEPSERA (Adefovir) Tablet (N/A)
- Open-label Treatment Extension Study for Patients Who Complete Study RNA200103-201 (Phase 2)
- Randomized Trial of Switch to Tenofovir Versus Continue Lamivudine/Adefovir Treatment in Lamivudine-resistance Chronic Hepatitis B Patients Who Have Undergone Lamivudine/Adefovir Add-on Treatment (Phase 4)
- A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function (Phase 4)
- Prospective Exploratory Study to Describe in CHB naïve and Non-naïve Patients, Hepatitis B Virus (HBV) Kinetics During the First 24 Weeks of Treatment With Telbivudine (Phase 3)
- A Prospective Randomized Clinical Trial of Combination Sequential Treatment With Y Peginterferon Alfa-2b and ETV (Entecavir) in CHB (Chronic Hepatitis B) Patients NAs (Nucleotides or Nucleosides) Expe (Phase 3)
- A Prospective, Randomized, Open-label Study of the Investigation of Peginterferon Alfa-2a on Optimal in Chronic Hepatitis B Patients Who Have a High Risk of HCC (Phase 4)
- A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents (Age 2 to Less Than 18) With Chronic Hepatitis B (Phase 3)
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 |
|---|---|
| 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:
- ADEFOVIR CI brief — competitive landscape report
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