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.