adefovir dipivoxil

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adefovir dipivoxil


Pharmacologic class: Nucleotide reverse transcriptase inhibitor

Therapeutic class: Antiviral

Pregnancy risk category C

FDA Box Warning

• Severe acute hepatitis exacerbations have occurred after drug withdrawal. Monitor hepatic function closely for at least several months in patients who discontinue drug or other anti-hepatitis B therapy; if appropriate, resume such therapy.

• Long-term therapy may cause nephrotoxicity in patients with or at risk for underlying renal dysfunction. Monitor renal function closely and adjust dosage as needed.

• Human immunodeficiency virus (HIV) resistance may occur during therapy in patients with chronic hepatitis B infection who have unrecognized or untreated HIV infection.

• Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) may occur with use of drug alone or combined with other antiretrovirals.


Inhibits hepatitis B virus (HBV) DNA polymerase and suppresses HBV replication


Tablets: 10 mg

Indications and dosages

Chronic HBV with active viral replication plus persistent elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or histologically active disease

Adults: 10 mg P.O. daily

Dosage adjustment

• Renal impairment


• Hypersensitivity to drug


Use cautiously in:

• lactic acidosis, renal or hepatic impairment

• elderly patients

• pregnant or breastfeeding patients

• children.


• Offer HIV testing before starting therapy. (Drug may increase resistance to antiretrovirals in HIV patients.)

• Give with or without food.

Adverse reactions

CNS: headache

GI: nausea, vomiting, diarrhea, abdominal pain, flatulence, dyspepsia, anorexia, pancreatitis

GU: renal dysfunction

Hepatic: severe hepatomegaly with steatosis, hepatitis exacerbation (if therapy is withdrawn)

Metabolic: lactic acidosis

Respiratory: pneumonia

Other: fever, infection, pain, antiretroviral resistance in patients with unrecognized HIV


Drug-drug. Acetaminophen, aspirin, indomethacin: granulocytopenia

Acyclovir, adriamycin, amphotericin B, benzodiazepines, cimetidine, dapsone, doxorubicin, experimental nucleotide analogue, fluconazole, flucytosine, ganciclovir, indomethacin, interferon, morphine, phenytoin, probenecid, sulfonamide, trimethoprim, vinblastine, vincristine: increased risk of nephrotoxicity

Drug-diagnostic tests. Amylase, blood glucose, blood urea nitrogen, creatine kinase, hepatic enzymes, lipase: elevated levels

Patient monitoring

• Monitor fluid intake and output.

• Watch for hematuria.

• Assess for signs and symptoms of lactic acidosis, especially in women and overweight patients.

• Check for liver enlargement.

• Monitor liver and kidney function test results.

• After therapy ends, monitor patient for evidence of serious hepatitis exacerbation.

Patient teaching

• Advise patient to take drug with or without food.

• Instruct patient to drink plenty of fluids to ensure adequate urine output.

• Advise patient to monitor urine output and color and to report significant changes.

• Tell patient that drug may cause weakness. Discuss appropriate lifestyle adjustments.

• Caution patient not to take over-the-counter analgesics without prescriber's approval.

• Inform patient that he'll undergo regular blood testing during therapy.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved

Adefovir Dipivoxil

A nucleoside analogue antiviral which is effective against viral polymerases (hepadnaviruses, retroviruses—e.g., HIV—herpesviruses—e.g., CMV), and used to treat hepatitis B in adults who have evidence of active viral replication, increased LFTs, histologically active liver disease, and evidence of HBV resistant to other antivirals—e.g., lamivudine.
Benefits 48 weeks of adefovir dipivoxil results in histologic liver improvement, reduces serum HBV DNA and alanine aminotransferase (LFTs), and slows progression of chronic hepatitis B.
Adverse effects Renal toxicity requiring monitoring, asthenia, diarrhoea, dyspepsia, nausea, severe acute exacerbation of hepatitis B after discontinuing.
Mechanism of action Slows progression of chronic hepatitis B by interfering with viral replication and causing DNA chain termination after its incorporation into viral DNA.
Segen's Medical Dictionary. © 2012 Farlex, Inc. All rights reserved.

adefovir dipivoxil

Virology A nucleotide analogue effective against the polymerases of hepadnaviruses, retroviruses, herpesviruses, used to treat hepatitis Be antigen in adults with evidence of active viral replication, ↑ LFTs, or histologically active liver disease Adverse effects Renal damage requiring monitoring, diarrhea, nausea; in Pts with HBeAg-positive chronic hepatitis B, 48 wks of adefovir dipivoxil resulted in histologic liver improvement, reduced serum HBV DNA and alanine aminotransferase levels, and ↑ rates of HBeAg seroconversion. See AIDS, Hepatitis B.
McGraw-Hill Concise Dictionary of Modern Medicine. © 2002 by The McGraw-Hill Companies, Inc.

adefovir dipivoxil

An antiviral drug used to treat chronic HEPATITIS B. A brand name is Hepsera.
Collins Dictionary of Medicine © Robert M. Youngson 2004, 2005
References in periodicals archive ?
Activity of adefovir dipivoxil against all patterns of lamivudine-resistant hepatitis B viruses in patients.
Currently, Sigmapharm's product line consists of Adefovir Dipivoxil Tablets, for hepatitis B, which is the first and only generic product equivalent to Hepsera tablets; Sodium Phenylbutyrate Powder, for urea cycle disorders, which is equivalent to Buphenyl powder; Acitretin Capsules, equivalent to Soriatane capsules with a primary indication for the treatment of severe psoriasis; Dofetilide Capsules, equivalent to Tikosyn capsules for the treatment of arrhythmia; and Liothyronine Sodium Tablets, equivalent to Cytomel tablets for the treatment of hypothyroidism, which is now only available in 90-count (typical unit of use) bottles and is the most stable Liothyronine product on the market, with a recently Food and Drug Administration-approved shelf life of five years.
Among the available antiviral agents, lamivudine was most commonly used to treat HBV reactivation in this study, although entecavir and adefovir dipivoxil were also used as prophylactic antiviral therapy [Table 3] and [Table 4].{Table 5}
All patients were treated with nucleos(t)ide analogues, such as entecavir (ETV), telbivudine (LDT), lamivudine (LAM), adefovir dipivoxil (ADV), or a combination of LAM and ADV.
Dirsch et al., "Efficacy of combined lamivudine and adefovir dipivoxil treatment for severe HBV graft reinfection after living donor liver transplantation," Clinical Transplantation, vol.
A randomized study of adefovir dipivoxil in place of HBIG in combination with lamivudine as post-liver transplantation hepatitis B prophylaxis.
All patients with hepatitis B have been treated with antiviral therapy (lamivudine, telbivudine, adefovir dipivoxil, and entecavir) except for one patient who was anti-HBs antibody positive.
Lim et al., "Adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B," The New England Journal ofMedicine, vol.
Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B.
NNRTIs include tenofovir and adefovir dipivoxil (Hepsera[R]).
Data are also limited about adefovir dipivoxil but lately many cases of osteomalacia due to adefovir treatment have been reported.
There are six approved drug therapies including small molecule nucleoside analogues lamivudine, entecavir, and telbivudine, acyclic nucleotide analog adefovir dipivoxil, and injection proteins interferon alfa-2b and pegylated interferon alfa-2a for the treatment of chronic hepatitis B virus infection [1].