University of Washington

AIDS Clinical Trials Group

Drug Information Sheet

Adefovir dipivoxil

Other Names: ADV, bis-POM PMEA, Preveon^®

Manufacturer: Gilead Sciences

What is it?

Adefovir is an experimental antiviral medication that is able to inhibit enzymes necessary for Hepatitis B Virus (HBV) and HIV to reproduce. Viruses like HIV and HBV use the genetic material in the body’s cells to produce more virus which can infect other cells. Because adefovir may also decrease the amount of HBV found in the bloodstream, it is currently being studied as a treatment to prevent liver damage that is caused by HBV.

How does it work?

Adefovir interferes with the life cycle of HBV to stop it from producing more virus. Specifically, adefovir ties up the DNA polymerase enzyme so HBV cannot build the genetic material needed to make more virus and infect more cells.

How do I take it?

· Adefovir is available as 10 mg tablets.

· The dose being studied for HBV is one tablet (10 mg) once daily.

· Adefovir may be taken with or without food.

It is extremely important that you take adefovir and any other antiviral medications exactly as directed. You should set up a system that will help you remember to take your medicines so that you do not miss any doses. If you miss a dose, take it as soon as possible; however, if you skip a dose, do not take two doses at once. Do not stop taking the medication for any reason at any time unless you are directed to do so by your study clinician. If you are unable to continue taking your medication due to side effects, you should contact your study clinician immediately.

Special Considerations

· Adefovir should be stored at controlled room temperature in a dry place, out of the reach of children.

· Please bring your medication bottles (empty and partially used) to each study visit.

Interactions

Some drugs taken together may have interactions that cause illness or impair the effectiveness of the drugs. Since adefovir is new, studies are being done to determine what interactions there might be with other medications. It is a good idea to always check with your study clinician before taking any other medications, prescription or otherwise, to be sure it will not interact with adefovir.

Side Effects

Not everyone experiences side effects. When they do occur, they may be mild, moderate or severe. Some side effects cannot be felt by the patient but can be found through laboratory tests, so it is important to see your study clinician regularly for checkups so that side effects can be detected early and treated.

The most common side effects of adefovir are nausea, vomiting, and diarrhea. Taking your dose with a meal may reduce these side effects. Other side effects that may occur include loss of appetite, belching, flatulence (gas), and headache.

Adefovir has also been noted to cause decreased levels of L-carnitine in your body. Carnitine is needed for muscles to work properly and for the breakdown of fat. Phosphorous, an electrolyte found in the bloodstream, may also be lowered.

Adefovir can cause changes in liver function and kidney function. Laboratory tests will be done regularly to monitor for these side effects.

Because adefovir is still experimental, it is very important that you report any side effects to the clinic staff, regardless of the suspected cause.

The Food and Drug Administration (FDA) allows the use of this drug as a treatment for Hepatitis B in research studies only.

Last Updated: 6/6/02