Additional Relevant Details
The Phase 2a trial will enroll 60 treatment-naïve patients with chronic HBV infection. This study will consist of a sequential dose escalation, with 10 patients per cohort receiving four weeks of a once-daily dose of either 5, 10, 25, 50 or 100 mg of CMX157, plus two patients per cohort receiving 300 mg of TDF, the standard dose of Viread. As in the Phase 1b study, initiation of each higher dose cohort will follow review of the data from the previous cohort, and there will be another DSMB review between the 25 mg and 50 mg CMX157 cohorts. Final results from this study are expected in the fourth quarter of 2016.