mental health AIDS

Fall 2004 Newsletter / Volume 6, Issue 1

HIV Treatment News

On August 2, 2004, the U.S. Food and Drug Administration (FDA) announced the approval of two fixed-dose combination (FDC) antiretroviral drug products (i.e., two medications - in these cases, two nucleoside reverse transcriptase inhibitors [NRTIs] - in one pill) designed to simplify dosing regimens when treating adults with HIV infection:

• EpzicomT, composed of abacavir (ABC or Ziagen®) and lamivudine (3TC or Epivir®); and

• TruvadaT, composed of tenofovir (TDF or Viread®) and emtricitabine (FTC or EmtrivaT).

Each of these FDCs need only be taken once daily in conjunction with other antiretrovirals from different classes (i.e., non-nucleoside reverse transcriptase inhibitors [NNRTIs] or protease inhibitors [PIs]) (FDA, 2004a).

On August 3, 2004, the FDA approved Sculptra, a biodegradable, biocompatible, injectable synthetic filler to correct facial lipoatrophy (wasting), a condition that occurs in the context of HIV disease and its treatment."Analysis indicated that the product significantly improved facial appearance, and was safe for restoration and/or correction of shape and contour deficiencies resulting from facial fat loss in patients with HIV/AIDS. ... After an initial treatment series, repeat treatments may be needed to maintain the correction. ... The studies also demonstrated significant improvement in quality of life, and measures of anxiety and depression, conditions which can be associated with lipoatrophy" (FDA, 2004b).

Though use of questionnaires, investigators in France (Spire et al., 2004) identified 327 people living with HIV who had experience with efavirenz (EFV or Sustiva®): 175 who took EFV for at least six months and 152 (46% ) who discontinued its use between two and 10 months after initiation (median = 4 months). Discontinuation was independently associated with the following factors: being female, being unemployed, having a steady sexual partner, and having a history of multiple depressive episodes. Spire and colleagues urge clinicians to be mindful of"the neuropsychiatric risks of EFV during the first year, especially among patients with a history of multiple depressive episodes" (p. 558).

Indicates this file is in Adobe PDF format and requires the Adobe Acrobat Reader program.

Disclaimer Privacy Policy Accessibility Department of Health and Human Services