Beacon NewsFlashes – December 5, 2009
FDA Grants Traditional Approval For Intelence – The FDA has granted traditional approval to Intelence (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI) that is currently marketed in the U.S. by Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P. Intelence is an NNRTI for treatment-experienced individuals who have experienced virologic failure with HIV strains that are resistant to other NNRTIs and antiretroviral agents. The traditional approval was based on data from two Phase 3 studies. For more information, please see the press release from Tibotec.
New Specially Padded Shorts Provide Support For Cancer And HIV Patients – Lipowear LLC has introduced a new type of shorts, called SitRelief Shorts, that are specially padded to help provide support for cancer and HIV patients who experience lipoatrophy, a condition in which the body fat and muscle wears away. Designed by Terry Delonas, a long time HIV/AIDS survivor, these shorts are padded to provide extra support in the sitting area. This allows the wearer to sit comfortably for longer periods of time. The current product is designed for men; however, a similar female product is under development. For more information, please see the article in The Orange County Register or the Lipowear Web site.
Study Finds An Increased Risk Of Genital Ulcer Disease In Women During The First Month Of Antiretroviral Therapy – A recent study in the Journal of Acquired Immune Deficiency Syndromes (JAIDS) finds that women have an increased risk of Genital Ulcer Disease (GUD) in the first month after beginning antiretroviral therapy (ART), especially if they have low CD4 counts or a history of GUD. To determine the risk, the study monitored 134 women at the beginning of ART and one month after. For more information, please see the study in JAIDS (abstract).