Hepsera

Chronic Hepatitis B Infection

Treatment

1 FDA approval

8 Active Studies for Hepsera

What is Hepsera

Adefovir dipivoxil

The Generic name of this drug

Treatment Summary

Adefovir dipivoxil, also known as Preveon or Hepsera, is an oral medication used to treat hepatitis B. It is not effective against HIV-1. Adefovir dipivoxil is the prodrug form of the active drug adefovir, meaning it is converted into the active drug in the body.

Hepsera

is the brand name

image of different drug pills on a surface

Hepsera Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Hepsera

Adefovir dipivoxil

2002

4

Approved as Treatment by the FDA

Adefovir dipivoxil, otherwise known as Hepsera, is approved by the FDA for 1 uses which include Chronic Hepatitis B Infection .

Chronic Hepatitis B Infection

Helps manage Hepatitis B Chronic Infection

Effectiveness

How Hepsera Affects Patients

Adefovir dipivoxil is a drug derived from adefovir. Adefovir is an antiviral used to treat human hepatitis B virus (HBV). It works by blocking the production of a protein used by HBV to replicate. In laboratory tests, adefovir was found to be effective at concentrations between 0.2 and 2.5 μM in cells infected with HBV. Combining adefovir with lamivudine has been shown to increase its effectiveness.

How Hepsera works in the body

Adefovir dipivoxil is a drug that treats hepatitis B. It works by converting to its active form, adefovir diphosphate, and binding to the virus' DNA polymerase. This competition with the natural substrate of the virus stops the virus' ability to replicate and therefore helps to slow its spread. Adefovir diphosphate also weakly binds to human DNA polymerases, but not enough to be considered harmful.

When to interrupt dosage

The advocated portion of Hepsera is contingent upon the diagnosed condition. The dosage amount is contingent upon the delivery technique (e.g. Tablet - Oral or Tablet) outlined in the following table.

Condition

Dosage

Administration

Chronic Hepatitis B Infection

10.0 mg,

Tablet - Oral, Oral, , Tablet

Warnings

There are 20 known major drug interactions with Hepsera.

Common Hepsera Drug Interactions

Drug Name

Risk Level

Description

Neomycin

Major

The risk or severity of nephrotoxicity can be increased when Adefovir dipivoxil is combined with Neomycin.

Tenofovir

Major

The serum concentration of Tenofovir can be increased when it is combined with Adefovir dipivoxil.

Tenofovir alafenamide

Major

The serum concentration of Tenofovir alafenamide can be increased when it is combined with Adefovir dipivoxil.

Tenofovir disoproxil

Major

The serum concentration of Tenofovir disoproxil can be increased when it is combined with Adefovir dipivoxil.

Abacavir

Minor

Adefovir dipivoxil may decrease the excretion rate of Abacavir which could result in a higher serum level.

Hepsera Toxicity & Overdose Risk

High doses of adefovir dipivoxil may lead to kidney damage, which can be observed through changes in blood and urine tests. This type of toxicity has been seen in animals with blood levels 3 to 10 times higher than those seen in humans taking the recommended dose of 10 mg per day.

Hepsera Novel Uses: Which Conditions Have a Clinical Trial Featuring Hepsera?

Currently, 3 active trials are underway to assess the potential of Hepsera in managing Chronic Hepatitis B.

Condition

Clinical Trials

Trial Phases

Chronic Hepatitis B Infection

9 Actively Recruiting

Phase 3, Phase 2, Phase 1

Hepsera Reviews: What are patients saying about Hepsera?

5

Patient Review

1/16/2009

Hepsera for Chronic Hepatitis B

I've been on Hepsera for over 10 years now and it's kept me in good shape. My virus count is low and my specialist says everything looks great. I'm still taking the medication and hoping for a cure, but so far this has been the best treatment available.

5

Patient Review

3/13/2008

Hepsera for Chronic Hepatitis B

I started taking this medication 2004 and saw amazing results over the next few years. My bilirubi count went from 35 to 1.8 in 2008.

5

Patient Review

9/2/2008

Hepsera for Chronic Hepatitis B

I've been using Hepsera for about two years now and it's worked great. My viral count is down to an undetectable level. I'm very happy with the results so far, although I was told there may be some resistance developing. If anyone else has experienced problems with burping or belching, please let me know.

5

Patient Review

11/28/2007

Hepsera for Chronic Hepatitis B

I've been on Hepsera for close to two years now, and it's been great in helping my hepatitis B stay in remission.

5

Patient Review

1/26/2009

Hepsera for Chronic Hepatitis B

I've been on this medication for seven years now and it's really helped me. I get blood work done every six months to keep an eye on things, but so far everything looks great.

5

Patient Review

6/22/2009

Hepsera for Chronic Hepatitis B

This treatment has been working well for me so far. My hep levels have stayed down and I'm not as scared anymore.

4.7

Patient Review

10/29/2007

Hepsera for Chronic Hepatitis B

I started this treatment over a year ago and saw great results. My numbers have been steadily improving and I'm very pleased with the progress.

4.3

Patient Review

4/24/2014

Hepsera for Chronic Hepatitis B

I took Hepsera for more than 10 years. I am now taking a different medicine. I didn't have many side effects and it worked well for me.

4

Patient Review

3/18/2016

Hepsera for Chronic Hepatitis B

While it's not a cure, this medication has been great for managing my hepatitis B. I've been taking it for 13 years and my viral count has been undetectable the entire time. However, my doctors won't recommend that I stop taking the medication because it is so expensive. I hope and pray that someday there will be a cure for this disease.

4

Patient Review

10/18/2007

Hepsera for Chronic Hepatitis B

4

Patient Review

10/11/2010

Hepsera for Chronic Hepatitis B

While this drug did contain the virus, it unfortunately also damaged my kidney. My doctor advised me to continue taking it and hope that the kidney damage would not progress.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about hepsera

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How do you take Hepsera?

"The ordinary portion size is one 10 milligram tablet every day. You can take the tablet either with or without food. Attempt to take your doses at a similar time each day, as this will assist you with recalling to take adefovir all the time."

Answered by AI

What is the generic of Hepsera?

"Hepsera is a brand-name drug that costs about $1,876.67 to fill a prescription. However, you can reduce your Hepsera cost by purchasing the generic version of Hepsera, adefovir, or by using a SingleCare Hepsera coupon to reduce your price to $250.60 per 30, 10MG Tablet."

Answered by AI

What is Hepsera used for?

"HEPSERA is not a cure for hepatitis b. Use of other antiviral medicines with HEPSERA may increase the chance of serious side effects.

The medicine HEPSERA is used to treat people aged 12 and over who have chronic (long-lasting) infections with active hepatitis B virus. It is not for use in children under the age of 12. HEPSERA may lower the amount of hepatitis B virus (HBV) in your body, and it may improve the condition of your liver. However, it is not a cure for hepatitis B. If you use other antiviral medicines with HEPSERA, the chance of serious side effects increases."

Answered by AI

How long do you take Hepsera?

"Adefovir dipivoxil doses of 500 mg given daily for 2 weeks, followed by 250 mg given daily for 12 weeks, have been associated with gastrointestinal side effects."

Answered by AI

Clinical Trials for Hepsera

Image of National Institutes of Health Clinical Center in Bethesda, United States.

VIR-2218 + Peginterferon Alfa-2a for Chronic Hepatitis B

18 - 65
All Sexes
Bethesda, MD

Background: Chronic hepatitis B virus (HBV) infection affects 292 million people worldwide; 887,000 die each year from cirrhosis, liver cancer, and related issues. Treatment options are limited. Objective: To test 2 drugs (VIR-2218 and peginterferon) in people with mild or inactive HBV infection. Eligibility: People aged 18 to 65 years with mild or inactive HBV infection. Design: Participants will be screened. They will have blood tests and an eye exam. They will have imaging scans of the liver to check the health of the liver. Participants will be in the study for over 2 years. VIR-2218 is an injection given under the skin of the stomach, upper arm, or thigh. Participants will come to the clinic to receive this injection once a month for 6 months. Peginterferon is also injected under the skin. Participants will have this shot once a week for 6 months. They may either inject themselves at home or come to the clinic to get the injections. Participants will get just the VIR-2218 for 3 months, then both shots for 3 months, then just the peginterferon for 3 months. Participants will have two 3-day stays in the hospital. Tests will include: Liver biopsy. A sample of tissue will be taken from their liver. After the procedure, participants will lie on their right side for 2 hours and then on their back for 4 hours. Fine needle aspiration. A small needle will be used to collect cells from the liver. After the last injection of peginterferon, follow-up visits will continue in the outpatient clinic every 4 to 12 weeks.

Phase 2
Recruiting

National Institutes of Health Clinical Center

Marc G Ghany, M.D.

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Image of Institute of Human Virology, University of Maryland School of Medicine in Baltimore, United States.

HEPLISAV-B Vaccine for Chronic Hepatitis B

18+
All Sexes
Baltimore, MD

The goal of this clinical trial is to learn if HEPLISAV-B, a vaccine that is approved to prevent hepatitis B infection in people that are not already infected, is safe in people already chronically infected with hepatitis B. The main quiestions it aims to answer are: 1. Is HEPLISAV-B safe in people with chronic hepatitis B? 2. What side effects, if any, could HEPLISAV-B cause in people with chronic hepatitis B? 3. How does HEPLISAV-B affect the cells that fight chronic hepatitis B? Participants will: * Receive HEPLISAV-B as an injection in the muscle, one injection every 4 weeks, for a total of 2 injections. * Visit the clinic a total of 5 times, and have 3 phone follow ups over 14 months. * Be asked if they are having any side effects from HEPLISAV-B. * Have blood samples collected.

Phase 1
Recruiting

Institute of Human Virology, University of Maryland School of Medicine (+1 Sites)

Lydia Tang, MBChB