TABLE 1.
LVD-refractory patients analyzed for resistance
| Patient populationa | No. (%) of patients
|
|||
|---|---|---|---|---|
| Study 015/901 | Study 014/901 | Study 026/901 | Total | |
| LVD refractory at baseline | 9 | 181 | 276 | 466 |
| Evidence of LVDr and ETVr | 1 | 8 | 18 | 27 (6) |
| Treatment with 1.0 mg ETV | ||||
| Yr 1 monitored | 9 | 40 | 138 | 187 |
| Yr 1 rebounds | 0 | 0 | 5 | 5 |
| Rebounds with preexisting LVDr and ETVr | 0 | 0 | 0 | 0 |
| Rebounds with emerging LVDr and ETVr | 0 | 0 | 2 | 2 (1)b |
| Total rebounds with LVDr and ETVr | 0 | 0 | 2 | 2 (1) |
| Emerging LVDr and ETVr without rebound | 1 | 0 | 8 | 9 (5) |
| Biochemical failuresc | 0 | 0 | 0 | 0 |
| Yr 2 monitored | 9 | 25 | 117 | 151 |
| Yr 2 rebounds | 2 | 2 | 17 | 21 |
| Rebounds with preexisting LVDr and ETVr | 2 | 0 | 6 | 8 (5) |
| Rebounds with emerging LVDr and ETVr | 0 | 1 | 5 | 6 (4) |
| Total rebounds with LVDr and ETVr | 2 | 1 | 11 | 14 (9) |
| Emerging LVDr and ETVr without rebound | 1 | 0 | 5 | 6 (4) |
| Biochemical failuresc | 0 | 0 | 0 | 0 |
The baseline includes all LVD-refractory patients, irrespective of treatment, including LVD and ETV at 0.1, 0.5, and 1.0 mg for study 014 (4); ETV and LVD for study 026; and ETV for study 015. The patients monitored during treatment included those with an HBV DNA measurement beyond week 24 for year 1 and within the second year for year 2. Data were collected in the windowed time point indicated or for the sample obtained at the end of dosing. Year 2 data from rollover study 901 were included if treatment gaps did not exceed 5 weeks.
Patients with isolates with a substitution at T184, S202, or M250. The frequency is the number of patients infected with isolates with sequence changes divided by the number of patients monitored.
Biochemical failure, alanine aminotransferase levels 10 times the upper limit of normal or 2 times the reference level (at the baseline or the end of treatment).