Table 2.
On-treatment and post-treatment virologic response (full analysis set)
| n/N (%) | SMV 50 mg combined (n = 40) | SMV 100 mg combined (n = 39) | PR48 (control) (n = 13) |
|---|---|---|---|
| Undetectable HCV RNA at week 2 | 11/39 (28) | 17/39 (44) | 0/13 (0) |
| LS mean change in plasma HCV RNA from baseline at week 4 (95 % CI)a | −5.2 (−5.4, −5.0) | −5.2 (−5.4, −5.0) | −2.9 (−3.2, −2.5) |
| LS mean change of difference in plasma HCV RNA from baseline at week 4 (95 % CI)b | −2.4 (−2.7, −2.0) | −2.4 (−2.8, −2.0) | |
| RVR | 33/40 (83) | 35/39 (90) | 1/13 (8) |
| cEVR | 39/40 (98*) | 36/39 (92*) | 7/13 (54) |
| SMV12/PR24 50 mg (n = 27) | SMV24/PR24 50 mg (n = 13) | SMV12/PR24 100 mg (n = 26) | SMV24/PR24 100 mg (n = 13) | PR48 (control) (n = 13) | |
|---|---|---|---|---|---|
| SVR24 | |||||
| All patients | 21/27 (78) | 10/13 (77) | 20/26 (77) | 12/13 (92) | 6/13 (46) |
| Patients who completed treatment at week 24c | 20/24 (83) | 9/10 (90) | 18/20 (90) | 9/10 (90) | |
| Viral relapsed | 4/26 (15) | 2/12 (17) | 4/26 (15) | 1/13 (8) | 4/11 (36) |
aLeast-squares mean change from baseline and their 95 % confidence intervals for each dose group
bDifference in least-squares mean change from baseline from PR48 control and their 95 % confidence intervals for each dose group from ANCOVA model
cPatients who completed treatment at week 24 as per RGT, excluding patients who discontinued treatment before week 24
dThe denominator is the number of patients with undetectable HCV RNA at the end of treatment
cEVR complete early virologic response, undetectable HCV RNA at week 12 in treatment period, HCV hepatitis C virus, PR pegylated interferon alpha-2a and ribavirin, RVR rapid virologic response undetectable HCV RNA at week 4 of treatment, SVR24 sustained virologic response 24 weeks after the end of treatment
* P ≤ 0.05 vs PR48 group; Fisher’s exact test