Skip to main content

Advertisement

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
  1. Patients were classified as “LOE,” “non-LOE,” or “completed” depending on the first set of persistence and laboratory conditions met. If the patients died before the end of their treatment period or met no complete set of conditions due to a lack of laboratory observations, they were excluded from further analysis.
  2. Key: G – genotype; HCV-RNA – laboratory test for hepatitis C virus levels; LOE – lack-of efficacy.
  3. aExcluded patients were not analyzed in this study and do not contribute to the final cohort. Unknown patients were analyzed in this study and do contribute to the final cohort.