{"id":"adefovir","rwe":[{"n":null,"pmid":"19408969","year":"2008","title":"Management of chronic hepatitis B.","finding":"Adults with CHB have an increased risk of death, hepatic decompensation, and HCC. Mono or combined drug therapy improves selected virological, biochemical, and histological markers with no consistent effects on all examined outcomes. Patient and disease characteristics may modify treatment-induced i","journal":"Evidence report/technology assessment","studyType":"Observational"},{"n":null,"pmid":"35983302","year":"2022","title":"Safety and Efficacy of Antiviral Drugs for the Treatment of COVID-19: A Systematic Review.","finding":"","journal":"Infection and drug resistance","studyType":"Meta-analysis"},{"n":null,"pmid":"40687725","year":"2025","title":"An in-depth investigation of NAs-induced osteoporosis adverse events: a real-world, network toxicology and molecular docking analysis.","finding":"","journal":"Frontiers in medicine","studyType":"Observational"},{"n":null,"pmid":"25309089","year":"2014","title":"Clinical characteristics and current management of hepatitis B and C in China.","finding":"","journal":"World journal of gastroenterology","studyType":"Observational"},{"n":null,"pmid":"27977591","year":"2016","title":"Relationship between nephrotoxicity and long-term adefovir dipivoxil therapy for chronic hepatitis B: A meta-analysis.","finding":"","journal":"Medicine","studyType":"Meta-analysis"}],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":["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"],"safetySignals":[],"drugInteractions":[{"drug":"Since adefovir is eliminated by the kidney","severity":"Avoid","mechanism":"","management":"","clinicalEffect":", coadministration of adefovir dipivoxil with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either adefovir and/or these coadministered drugs [See Clinical Pharmacology ( 12.3) ]. Patien"}],"commonSideEffects":[{"notes":"","effect":"incidence greater than","severity":"mild","placeboRate":null,"incidenceRate":"5%"}],"contraindications":["Breastfeeding (mother)","Drug Resistance to Anti-retroviral Therapy","Kidney disease","Lactic acidosis","Obesity","Steatosis of liver","Toxic nephropathy"],"specialPopulations":{"Pregnancy":"Pregnancy exposure registry available; prospective data insufficient to assess risk","Paediatric use":"Safety, efficacy, and pharmacokinetics evaluated in pediatric patients 12 to less than 18 years"},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT01863589","NCT00230490","NCT01491295","NCT00641082","NCT00640588","NCT02327416","NCT03084250","NCT00095121","NCT01086085","NCT03736265","NCT00002128","NCT01597934","NCT01829685","NCT00096785","NCT01264354","NCT01639066","NCT03491553","NCT03236584","NCT00441974","NCT04102176","NCT00986778","NCT01023217","NCT02743260","NCT01581242","NCT01799486","NCT00645294","NCT00496002","NCT01341743","NCT00023309","NCT05021406","NCT00324961","NCT00013702","NCT02598063","NCT01928511","NCT03253250","NCT00000912","NCT00002419","NCT01264133","NCT01706575","NCT01436539","NCT01529255","NCT00496158","NCT01146808","NCT03366571","NCT02644538","NCT00798460","NCT00002326","NCT01139203","NCT00895596","NCT00002184"],"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"2007","type":"neutral","milestone":"Phase 3 Initiated","description":"A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeA — Chronic Hepatitis B"},{"date":"2008","type":"neutral","milestone":"Phase 4 Initiated","description":"Effect of Age on the Renal Clearance of Adefovir — Other Conditions That May Be A Focus of Clinical Attention"},{"date":"2009","type":"neutral","milestone":"Phase 2 Initiated","description":"A Phase II Study to Determine the Safety and Efficacy of Interferon-gamma in Patients With Chronic H — Hepatitis B"}],"aiSummary":"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.","brandName":"ADEFOVIR","companyId":"unknown","ecosystem":[],"mechanism":{"target":"DNA polymerase subunit gamma-1, Capsid protein, Protein P","novelty":"","modality":"Small molecule","drugClass":"","explanation":"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.","oneSentence":"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.","technicalDetail":"Adefovir is an antiviral drug that targets hepatitis B virus replication. It is a nucleotide analog that inhibits viral DNA polymerase, thereby blocking viral DNA synthesis. The drug is indicated for chronic hepatitis B in patients with evidence of active viral replication and either elevated liver enzymes or active liver disease. Its mechanism involves direct inhibition of the viral polymerase enzyme, leading to suppression of viral replication."},"commercial":null,"references":[],"biosimilars":[],"companyName":"","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"},{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"ADEFOVIR","indications":{"approved":[{"name":"Chronic type B viral hepatitis","diseaseId":"chronic-type-b-viral-hepatitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT01863589","phase":"N/A","title":"Drug Use Investigation for HEPSERA (Adefovir) 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