Australia's Avexa has announced positive results from a Phase III study of apricitabine (ATC), a new therapy to treat patients with HIV.
The Phase III trial compared ATC to 3TC in drug-resistant HIV patients, showing ATC improved the overall clinical effectiveness of HIV therapy compared to the best-available standard of care.
ATC improved the overall clinical effectiveness of HIV therapy in four key aspects, including: the durability of supressing viral load to below detectable levels, the ability of ATC to improve immunological function by increasing the numbers of CD4+ cells; the positive effect of ATC on HIV disease progression; and a very good safety and tolerance record.
Avexa chief scientific officer Dr Jonathan Coates said that these results highlight the ability of ATC to maintain suppression of patients' viral loads while increasing CD4+ cell numbers, resulting in a clear clinical benefit.
"This data indicates that ATC could be a significant clinical addition to the drugs already available, including the new classes of HIV integrase and CCR5 inhibitors plus the new generation of NNRTis and protease inhibitors," Coates said.
In the study, 53% of patients in the 800mg ATC arm had their viral loads reduced to undetectable levels. The number of patients who lost control of their viral suppression (6.3%) was half that of those who received the best-available standard of care (12.2%).
Avexa expects to present a more detailed analysis of the Phase III results by the end of the first quarter of 2010.