Table 3.
Response | Ledipasvir/Sofosbuvir for 8 Weeks (N = 27) |
---|---|
HCV RNA load <LLOQ TND | |
On therapy, n (%) | |
Week 1 | 5 (19) |
Week 2 | 12 (44) |
Week 4 | 22 (82) |
End of therapy (week 8), n (%) | 25 (92)a |
After end of therapy, n (%) | |
Week 2 (SVR2) | 27 (100) |
Week 4 (SVR4) | 26 (96)b |
Week 8 (SVR8) | 26 (96)b |
Week 12 (SVR12) | 27 (100) |
Week 24 (SVR24) | 26 (96)c |
Virologic breakthrough during treatment | 0 |
Relapse in patients with HCV RNA load <LLOQ TND at end of therapy | 0 |
Each instance of SVR and a number indicates the SVR that number of weeks after the date of the last dose of study treatment.
Abbreviations: <LLOQ TND, less than lower limit of quantification target not detected; HCV, hepatitis C virus; SVR, sustained virologic response.
aThere were 2 subjects that missed the week 8 visit and did not meet imputation criteria.
bThere were 2 subjects that each had a detectable HCV RNA load (1 at week 4 after therapy and 1 at week 8 after therapy; 74 and 161 IU/mL, respectively). Both achieved undetectable HCV RNA loads at week 4 on therapy and both achieved SVR12.
cThere was 1 subject that was lost to follow-up after achieving SVR12.