![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Data Presented Comparing Viread, Abacavir to Replace Thymidine Analogue
Data Presented Comparing Viread, Abacavir to Replace Thymidine Analogue
Gilead Sciences has announced the presentation of preliminary 48-week data from the RAVE (Randomized Abacavir Viread Evaluation) study.
The RAVE Study, conducted by Chelsea and Westminster Hospital in London, is a randomized, open-label, 48-week comparative trial of abacavir or Viread (tenofovir disoproxil fumarate) as replacement for a thymidine analog as part of highly active antiretroviral therapy in HIV-infected patients with lipoatrophy and controlled HIV RNA.
The RAVE study is designed to evaluate changes in limb fat in HIV patients with moderate-to-severe lipoatrophy and controlled HIV RNA (viral load less than 50 copies/mL) following a switch from a thymidine analog to a nonthymidine analog antiretroviral taken as part of combination therapy. Lipoatrophy is defined as a loss of fat in the limbs and facial area.
The primary endpoint of the study was change in limb fat at Week 48, using an intent-to-treat analysis. Secondary endpoints included HIV RNA, adverse events, visceral fat mass (by CT scan) and fasting metabolic parameters.
Results suggest that at 48 weeks there was a significant increase in limb fat in both groups from baseline values, but not a significant difference between study arms. Median changes in visceral and subcutaneous abdominal fat by CT scan were also similar in the abacavir versus Viread group.
KEYWORDS Drug Pipeline Alert
Upcoming Events
-
11Jul
-
18Jul
-
21Oct