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Issue No. 44 | October 24, 2008

News and Features

FDA Announces Changes to Darunavir Approval

From the FDA:

"On October 21, 2008, FDA granted traditional approval to Prezista (darunavir) 600 mg, co-administered with 100 mg ritonavir and with other antiretroviral agents, for the treatment of HIV-1 infection in treatment-experienced adult patients. ...

In addition to the traditional approval, a new dosing regimen for treatment-naïve patients was approved. The recommended dose for treatment-naïve adult patients is Prezista 800 mg (two 400 mg tablets) taken with ritonavir 100 mg once daily, with food. The type of food does not affect exposure to darunavir. ...

Additionally, the pregnancy category was changed from B to C."

The updated label will be available from the FDA soon. More information is available:

  • AIDSinfo: Darunavir Drug Fact Sheet
  • AIDSinfo: Adult Treatment Guidelines

NIH: Potent HIV-Inhibiting Antibody Identified

"A small antibody fragment that is highly effective in neutralizing the human immunodeficiency virus (HIV) by preventing the virus from entering cells has been identified by researchers at the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). This finding may provide insight into the development of new treatments against HIV and other viruses, hopefully in the not too distant future."

Read the full NIH press release.

Study: HIV Can Re-Emerge from a Single Infected Cell

"In the new study, Gunthard and colleagues examined the AIDS virus from 20 patients who had gone off their medications for two weeks at a time as part of a study. By examining how the virus evolved over time, the researchers found that the disease can emerge from a small number of cells, or even a single one, when medication is stopped."

Read the full story.

Study: Resistance Training in HIV-Infected Elderly Patients

"This study describes a case series of HIV-positive elderly patients who participated in a progressive resistance training program and evaluates their body composition, muscular strength, physical fitness and the evolution of CD4+ and CD8+ cell counts."

Read the full study abstract.