| Tolerability failure was infrequent and statistically similar in all study arms: 6.7% with tenofovir monotherapy, 4.4% with tenofovir/emtricitabine, and 9.1% with entecavir. |
| Overall, 8 patients taking tenofovir, 3 taking tenofovir/emtricitabine, and 3 taking entecavir discontinued their assigned study drug prior to week 48; 10 switched to open-label tenofovir/emtricitabine. |
| Protocol-defined kidney impairment was also uncommon, occurring in 8.9%, 6.7%, and 4.5%, respectively -- not a significant difference. |
| Most participants across all study arms reported adverse events, but adverse event profiles and laboratory abnormalities were consistent with advanced liver disease, with no unexpected safety signals. |
| 6 patients died (no deaths considered related to study drugs) and 6 received liver transplants with no HBV recurrence. |
| At week 48, similar proportions of patients taking tenofovir (70.5%) and entecavir (72.7%) had HBV DNA < 400 copies/mL, rising to 87.8% in the tenofovir/emtricitabine combination arm. |
| These proportions rose to 76.7%, 87.8%, and 85.7%, respectively, when participants who switched to open-label tenofovir/emtricitabine were included. |
| Similarly, 57% taking tenofovir and 55% taking entecavir had normal ALT, rising to 76% in the combination arm. |
| 21% of tenofovir recipients and 27% of tenofovir/emtricitabine recipients experienced HBeAg loss, compared with none of the entecavir recipients. |
| Corresponding rates of HBeAg seroconversion were 21%, 13%, and 0%, respectively. |
| CTP and MELD scores improved in all treatment arms. |
| No participants developed resistance to any study drug. |