Table 3.
Patient Disposition by First-Year vRNA Response
| CS Group (N=199) n (%) |
LLV Group (N=111) n (%) |
NS Group (N=63) n (%) |
|
|---|---|---|---|
| Completed 240 weeks of treatment | 133 (66.8) | 69 (62.2) | 19 (30.2) |
| Discontinued due to virologic failure† | 7 (3.5) | 10 (9.0) | 15 (23.8) |
| Discontinued due to lack of efficacy‡ | 4 (2.0) | 3 (2.7) | 13 (20.6) |
| Discontinued for other reasons | 55 (27.6) | 29 (26.1) | 16 (25.4) |
| Clinical adverse event | 10 (5.0) | 6 (5.4) | 3 (4.8) |
| Consent withdrawn | 12 (6.0) | 8 (7.2) | 7 (11.1) |
| Lost to follow-up | 6 (3.0) | 2 (1.8) | 2 (3.2) |
| Other reasons†† | 27 (13.6) | 13 (11.7) | 4 (6.3) |
†
Virologic failure was considered to have occurred if vRNA did not decrease to <400 copies/mL or by >1 log10 copies/mL from baseline; if vRNA increased by >1 log10 copies/mL from the nadir level on two consecutive measurements; or if vRNA was ≥400 copies/mL on two consecutive measurements after having been <400 copies/mL.
‡
Lack of efficacy was determined by the site investigator.
††
Includes the following: protocol deviation, did not enter extension phase, moved or relocated, or clinical trial was terminated at the site.