TABLE 3.
Summary of antiviral activity of FTC
| Cohort (FTC q.d. dose [mg]) | No. (%) of patients with:
|
Median change in log10 HBV DNA level between baseline and day 56 (minimum to maximum) | Median % measurable change at day 56a | |
|---|---|---|---|---|
| Serum HBV DNA level less than or equal to LOD | ≥2 log10 decrease in serum HBV DNA level | |||
| 25 (n = 7) | 0 (0) | 3 (42.9) | −1.68 (−4.11 to −0.48) | 44.8 |
| 50 (n = 8) | 3 (37.5) | 7 (87.5) | −3.15 (−4.24 to −1.57) | 83.7 |
| 100 (n = 11) | 3 (27.3) | 8 (72.7) | −2.65 (−3.97 to −1.47) | 71.1 |
| 200 (n = 9) | 3 (33.3) | 8 (88.9) | −3.04 (−4.47 to −1.09) | 83.1 |
| 300 (n = 10) | 3 (30.0) | 9 (90) | −3.33 (−4.61 to −1.58) | 89.8 |
| All patients (n = 45) | 12 (26.7) | 35 (77.8) | −3.0 (−4.61 to −0.48) | 71.8 |
a
Calculated as the change from the baseline divided by the difference between the LOD (4,700 copies/ml) and the baseline value. Specifically, for each patient the ratio of the observed decrease versus the maximum theoretically measurable decrease was calculated as a percentage, and the median percentage is presented for each dose group.