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 HEPSERA. 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, resumption of anti-Hepatitis B therapy may be warranted [see Warnings and Precautions].
In patients at risk of or having underlying renal dysfunction, chronic administration of HEPSERA may result in nephrotoxicity. These patients should be monitored closely for renal function and may require dose adjustment [see Warnings and Precautions and Dosage and Administration].
HIV resistance may emerge in chronic hepatitis B patients with unrecognized or untreated Human Immunodeficiency Virus (HIV) infection treated with anti-hepatitis B therapies, such as therapy with HEPSERA, that may have activity against HIV [see Warnings and Precautions].
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals [see Warnings and Precautions].
HEPSERA is the tradename for adefovir dipivoxil, a diester prodrug of adefovir. Adefovir is an acyclic nucleotide analog with activity against human hepatitis B virus (HBV).
HEPSERA is indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
This indication is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and HBeAg- chronic hepatitis B with compensated liver function, and in adult patients with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function.
Published Studies Related to Hepsera (Adefovir Dipivoxil)
Hepatitis B virus wild-type and rtN236T populations show similar early HBV DNA
decline in adefovir refractory patients on a tenofovir-based regimen. 
Hepatitis B virus (HBV) pol/RT mutations that confer clinical resistance to
tenofovir disoproxil fumarate (TDF) have not been detected to date. In vitro, the
rtN236T adefovir dipivoxil (ADV)-associated resistance mutation confers low-level
cross-resistance to tenofovir: 3- to 13-fold changes in EC(50) from wild type...
[One-year combination therapy de novo of adefovir dipivoxil and lamivudine for decompensated cirrhosis related to HBV]. [2011.04]
OBJECTIVE: To evaluate the efficacy and potential renal impairment of one-year combination therapy de novo of adefovir dipivoxil (ADV) and lamivudine (LMV) for decompensated cirrhosis related to HBV... CONCLUSION: Present study reveals that in populations with decompensated cirrhosis related to HBV, one-year combination therapy de novo of ADV and LMV is superior to monotherapy of LMV, and the renal safety is favorable within one year.
Peginterferon plus adefovir versus either drug alone for hepatitis delta. [2011.01.27]
BACKGROUND: Chronic infection with hepatitis B virus and hepatitis delta virus (HDV) results in the most severe form of viral hepatitis. There is no currently approved treatment. We investigated the safety and efficacy of 48 weeks of treatment with peginterferon alfa-2a plus adefovir dipivoxil, peginterferon alfa-2a alone, and adefovir dipivoxil alone... CONCLUSIONS: Treatment with peginterferon alfa-2a for 48 weeks, with or without adefovir, resulted in sustained HDV RNA clearance in about one quarter of patients with HDV infection. (Current Controlled Trials number, ISRCTN83587695.).
Adefovir plus lamivudine are more effective than adefovir alone in lamivudine-resistant HBeAg- chronic hepatitis B patients: a 4-year study. [2010.01]
BACKGROUND AND AIM: Adefovir dipivoxil (ADV) is effective in lamivudine (LAM)-resistant hepatitis B e antigen-negative (HBeAg(-)) chronic hepatitis B (CHB). However, it is unclear whether LAM treatment should be continued in these patients. We aimed to compare the long-term efficacy of adding ADV to ongoing LAM treatment versus switching to ADV monotherapy in LAM-resistant HBeAg(-) CHB... CONCLUSIONS: Adding ADV to LAM is more effective than switching to ADV monotherapy in LAM-resistant patients with HBeAg(-) CHB.
[Efficacy and durability of generic adefovir dipivoxil in patients with HBeAg positive chronic hepatitis] [2009.12]
OBJECTIVE: To study the efficacy and durability of generic adefovir dipivoxil (ADV) in patients with HBeAg positive chronic hepatitis... CONCLUSIONS: Treatment of chronic hepatitis B with generic ADV was effective and well tolerated, but relapse may develop when treatment was discontinued.
Clinical Trials Related to Hepsera (Adefovir Dipivoxil)
Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT [Completed]
This project is a randomized, open-label trial of adefovir dipivoxil (Hepsera) and lamivudine
combination therapy versus adefovir dipivoxil (Hepsera) monotherapy. Both adefovir dipivoxil
and lamivudine are nucleoside analogues approved by the U. S. FDA for the treatment of chronic
The primary hypothesis is that subjects treated with combination therapy will see their viral
DNA count decrease in an amount greater than subjects treated with monotherapy. The
secondary hypothesis is that subjects treated with combination therapy will have a higher
HBeAg conversion rate compared to historical controls of subjects treated with lamivudine or
adefovir dipivoxil monotherapy.
A Phase II Study to Determine the Safety and Efficacy of Interferon-Gamma in Patients With Chronic Hepatitis B [Not yet recruiting]
Open-label, prospective, two part study evaluating IFN-γ 1b at a dose of 200μg by
subcutaneous injection every day either alone or in combination with Adefovir dipivoxil or
Adefovir dipivoxil alone at a dose of 10mg QD in patients with chronic Hepatitis B.
Switch From Adefovir to Tenofovir in Chronic Hepatitis B for Suboptimal Response to Adefovir-based Combination Therapy [Recruiting]
In Korea, the number of suboptimal responders to rescue combination therapy is also
increasing. As a matter of fact, according to the investigations in Korea, HBV DNA
undetectability at 48 weeks of adefovir and lamivudine combination rescue therapy for
patients with lamivudine resistance was reported to be only 32. 4%, which suggested that the
appropriate another rescue therapy might be urgently required. However, there is no
promising oral antiviral agents to control these patients in Asia-Pacific region, where
tenofovir is not widely available. Tenofovir has a higher potent antiviral efficacy and a
negligible drug resistance rate. The switch from adefovir to tenofovir in patients who have
insufficient hepatitis B virus (HBV) suppression (HBV DNA â¥ 60 IU/mL by PCR) may lead to
increased viral suppression or more HBeAg loss/seroconversion.
Here, the investigators aimed to conduct a randomized study on evaluating the antiviral
efficacy, safety, and tolerability of switching from adefovir to tenofovir in chronic
hepatitis B patients who have suboptimal response to adefovir-based combination rescue
therapy due to nucleoside analogues Resistance (SATIS study).
Switch to Tenofovir Versus Continue Lamivudine/Adefovir Treatment in Lamivudine-resistance Chronic Hepatitis B Patients [Recruiting]
1. Adefovir add-on therapy is superior to switching to adefovir monotherapy or entecavir
1mg monotherapy for chronic hepatitis B (CHB) patients with lamivudine resistance
2. Long-term adefovir add-on therapy was effective for viral suppression. However, the
economic burden for such dual antiviral therapy is heavy because of infinite treatment.
3. Tenofovir disoproxil fumarate (TDF) is a potent antiviral agent. TDF demonstrated
potent antiviral efficacy in a subset of lamivudine experienced HBeAg-positive
patients. TDF is also superior to ADV in HBeAg-negative and HBeAg-positive
4. Theoretically, TDF can replace LAM/ADV when viral suppression has been achieved by
LAM/ADV combination treatment in LAM-R CHB patients.
A Study to Compare Tenofovir Versus Hepsera (Adefovir) for the Treatment of HBeAg Negative Chronic Hepatitis B [Active, not recruiting]
This study is designed to evaluate the safety and antiviral activity of tenofovir disoproxil
fumarate (DF) compared to Hepsera for the treatment of HBeAg negative chronic hepatitis B.
Patients will either receive tenofovir or the approved hepatitis B therapy, Hepsera.
Reports of Suspected Hepsera (Adefovir Dipivoxil) Side Effects
Blood Creatinine Increased (34),
Renal Impairment (33),
Fanconi Syndrome (30),
Blood Alkaline Phosphatase Increased (26),
Multiple Fractures (25),
Blood Phosphorus Decreased (22),
Fanconi Syndrome Acquired (18),
Arthralgia (18), more >>
Page last updated: 2014-11-30