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Issue No. 12 | March 26, 2010

News and Features

FDA Advisory Committee Meeting Planned for May 27, 2010, to Review Egrifta

“The Food and Drug Administration (FDA) will hold a public meeting of its Endocrinologic and Metabolic Drugs Advisory Committee to discuss the safety and efficacy of new drug application (NDA) 22–505, EGRIFTA (tesamorelin acetate), sterile lyophilized powder for injection, by Theratechnologies, Inc. EGRIFTA is an analogue (a chemical compound that resembles another compound in structure) of growth hormone releasing hormone (GHRH). The proposed indication (use) for EGRIFTA in this application is to induce and maintain a reduction of excess visceral abdominal fat in human immunodeficiency virus (HIV)-infected patients with lipodystrophy (a condition in which abnormal deposits of fat are seen partly as a result of using certain drugs to treat HIV disease).

“The meeting will take place on May 27, 2010, from 8 a.m. to 5 p.m[.], at The Inn and Conference Center, University of Maryland University College (UMUC), 3501 University Blvd. East, Adelphi, MD. You can contact the hotel directly at 301–985– 7300 for directions or to arrange accommodations.

“The meeting will be open to the public, and no registration is required.

“FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material can be found at …

“Please call the FDA Advisory Committee Information Line for up-to-date information about this meeting, at 1–800–741–8138 (301–443–0572 in the Washington, DC area), and use code 3014512536.”

More information is available:

Viread (tenofovir disproxil fumarate) Label Expanded for Adolescent Dosing

"On March 24, 2010, the FDA approved revised labeling for Viread (tenofovir disproxil fumarate) to expand the indication to include the treatment of... HIV infection in combination with other antiretroviral agents in patients 12 to less than 18 years of age based on 48-week clinical data from Study GS-US-104-0321.

"For the treatment of HIV-1 in adolescents with body weight >35 kg ( >77 lb): The dose is one 300 mg VIREAD tablet once daily taken orally, without regard to food."

The complete revised label will be available on the FDA web site.

More information is available:

Study Suggests Minocycline May Have Future Role in HIV Treatment

“The immunomodulatory antibiotic minocycline could be an effective, low-cost adjunctive treatment to HAART. Minocycline mediated a dose-dependent decrease in single-cycle CXCR4-tropic HIV infection and decreased viral RNA after infection of CD4+ T cells with HIV NL4-3. Reactivation from latency was also decreased in a primary CD4+ T cell-derived model and in resting CD4+ T cells from HIV-infected patients. Minocycline treatment resulted in significant changes in activation marker expression and inhibited proliferation and cytokine secretion of CD4+ T cells in response to activation. This study demonstrates that minocycline reduces HIV replication and reactivation and decreases CD4+ T cell activation. The anti-HIV effects of minocycline are mediated by altering the cellular environment rather than directly targeting virus, placing minocycline in the class of anticellular anti-HIV drugs.”

More information is available: