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Bevirimat (PA-457)
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AIDS virusBevirimat is in a new category of HIV medicines known as maturation inhibitors. For a description of the life-cycle of the AIDS virus, and the targets of each class of drugs, click here.

Bevirimat is being developed by Panacos Pharmaceuticals. They have a web site that includes descriptions of their treatments for HIV currently in development: click here.

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Pronunciation(s):

What is the most important information I should know about bevirimat?
  • Bevirimat is an experimental anti-HIV drug being developed by Panacos Pharmaceuticals. It is currently in Phase II clinical trials.

What is Bevirimat?
  • Bevirimat is an anti-HIV medication. It is in a new category of HIV medicines known as maturation inhibitors.
     
  • Bevirimat is a derivative of a Chinese herb called Syzigium claviflorum.
     
  • Virus maturation is the process that occurs during the last stages of HIV reproduction, after the virus has been released from the infected cell. It involves the processing of viral proteins and is required for the virus to become infectious. By blocking, or inhibiting, the virus maturation process, new virus cannot go on to infect other cells in the body.
     
  • Because bevirimat works differently than currently available anti-HIV drugs, it will likely be effective for HIV-positive people who are new to anti-HIV treatment or have failed other anti-HIV treatments in the past.
     
  • Bevirimat will likely be used in combination with other anti-HIV drugs.

What is already known about bevirimat?
  • Bevirimat will likely need to be taken once a day, by mouth. The correct dose of bevirimat, in adults and children, has not yet been determined. Bevirimat is currently being tested in a liquid formulation; attempts to develop a tablet formulation of the drug have not yet been successful.
     
  • Like other drugs, bevirimat might interact with other medications, including those used to treat HIV. It is important that your personal physician and/or the research nurse or study investigator be aware of all drugs you are taking, including those you buy without a prescription.

What do we know about bevirimat from clinical trials?
  • In one small phase IIa study, HIV-positive patients were selected to receive either 25mg, 50mg, 100mg, or 200mg bevirimat liquid, or a placebo, once daily for ten days, without any other anti-HIV drugs. At the 200mg dose, the average viral load reduction after ten days of treatment was 1.03 log (a 90% reduction). The average viral load reductions using the three lower doses were less than 0.5 log.
     
  • In a phase IIb study, patients on a failing HIV drug regimen took either placebo or a 400mg tablet version of bevirimat that was thought to be equivalent to the 200mg liquid version used in the phase IIa study. After 14 days, however, the blood concentrations of the drug—along with its effects on viral load—were poorer than anticipated. This suggested to the researchers that the tablet formulation used in the study did not deliver the drug as expected.
     
  • Results from a second phase IIb study, using the original liquid formulation of the drug, are being reported gradually by the developer. In this study, treatment-experienced patients on a drug regimen that is no longer working effectively for them are adding either placebo or different doses of bevirimat for 14 days. Three doses of bevirimat have been studied thus far: 250mg, 300mg and 350mg. Among the eight patients receiving 250mg bevirimat, viral loads decreased by an average of 0.68 log after 14 days, compared with a 0.18 log reduction among two patients receiving placebo. Among the eight patients in the 300mg group, six had at least a 0.5 log drop in virus and five had a greater than 1.0 log drop after 14 days, compared to almost no change among two patients receiving placebo. In nine patients in the 350mg group, three had at least a 0.5 log drop in virus, and the same three actually had a greater than 1.0 log drop after 14 days. Panacos will continue its phase IIb study, enrolling patients into a 400mg study group for 14 days.

What is known about side effects?
  • Not much is known about the side effects of bevirimat. In the phase IIa study discussed above, the main side effects included nausea and headache. One volunteer with a history of high blood pressure suffered a stroke, but investigators thought it was unrelated to the study treatment.
     
  • More information about the side effect profile of bevirimat will be made available once larger phase II clinical trials are completed.

Who should not take bevirimat?
  • It is not known whether bevirimat will harm an unborn baby. It is very important to treat HIV/AIDS during pregnancy to reduce the risk of infecting your baby. Talk to your doctor about your treatment options.
     
  • It is not known whether bevirimat passes into breast milk and what effect it may have on a nursing baby. To prevent transmission of the virus to uninfected babies, it is recommended that HIV-positive mothers not breast-feed.

Where can I learn more about clinical trials of bevirimat?
  • If you would like to find out if you are eligible for any clinical trials that include bevirimat, there is an interactive web site run by ACRIA, the AIDS Community Research Initiative of America.
     
  • Another useful service for finding clinical trials is AIDSinfo.nih.gov, a site run by the U.S. National Institutes of Health. They have "health information specialists" you can talk to at their toll-free number at 1-800-HIV-0440 (1-800-448-0440).

Last Revised: January 03, 2008

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