Australia-based biotechnology company Avexa has announced positive data from the ongoing Phase IIb clinical trial of apricitabine. After 96 weeks of treatment, no signature resistance to ATC has been identified.
After 96 weeks of treatment, over 85% of patients continue to have HIV levels below detectable and all patients continue to receive apricitabine (ATC) treatment. In addition, patients’ CD4 cells continued to increase in number over the 96 weeks, the company said.
The Phase IIb extension study is an open label trial for patients who completed the Phase IIb study. All patients continued to take 800mg ATC twice daily, with other HIV medications as required. Patients who entered the Phase IIb trial had already failed their HIV treatment, including 3TC, and some had failed multiple previous HIV treatments.
In AVX-201, patients originally received either 600mg ATC, 800mg ATC, or 150mg 3TC, all twice daily. From week 24, all patients received 800mg ATC twice daily, and have continued to 96 weeks of treatment in the Phase IIb extension study. The final endpoint of the Phase IIb extension study is at week 144.
At week 96, the number of patients whose plasma levels of HIV were below the limit of detection (<400 copies/ml) is approximately 87%. All patients continue to receive ATC. Levels of CD4 cells continued to increase, although more slowly which is expected as levels return to normal. At week 96, the average number of CD4 cells was around 500 to 600 cells/ìL, very close to the levels of an uninfected, healthy individual. No evidence of resistance to ATC was observed up to 96 weeks of treatment, the company added.