Table 1 Discontinuation reason classification rule
From: High rates of early treatment discontinuation in hepatitis C-infected US veterans
Persistence condition | Laboratory condition | Classification |
|---|---|---|
Patient died before the end of their target treatment duration (20 weeks for G2/3 or 44 weeks for G1/4) | Any | Excluded a |
Patient discontinued before week 10 (before the lower limit of the 12-week stopping rule) | Any | Non-LOE |
Patient discontinued between week 10 (lower limit of the 12-week stopping rule) and week 20 for G2/3 (lower limit of “completion”) or week 22 for G1/4 (lower limit of the 24-week stopping rule) | Most recent quantitative or qualitative HCV-RNA since week 10 was “undetectable” or 2-log lower than baseline | Non-LOE |
Most recent post-baseline quantitative HCV-RNA since week 10 was NOT 2-log lower than baseline | LOE | |
Insufficient lab data (i.e., in structured data or in clinic notes) for one of the above classifications | Unknown | |
G1/4 only: Patient discontinued between week 22 (lower limit of the 24-week stopping rule) and week 44 (lower limit of “completion”) | Most recent post-baseline quantitative or qualitative since week 22 HCV-RNA is “undetectable” | Non-LOE |
Most recent post-baseline quantitative or qualitative HCV-RNA since week 22 is still detectable | LOE | |
Not enough lab data (i.e., in structured data or in clinic notes) for one of the above classifications | Unknown | |
Patient completed 20 (G2/3) or 44 (G1/4) weeks (“completion”) | Any | Completed |