TABLE 1.
Study design and treatment outcome of the AVIATOR 3D regimen with and without RBV
| Study population and arm | Inclusion of RBV with 3Da regimen | Duration (wk) of treatment | Paritaprevir dose (mg)b | % SVR24c |
No. of patients experiencing VFd |
||||
|---|---|---|---|---|---|---|---|---|---|
| Breakthrough |
Relapse |
||||||||
| GT1a | GT1b | GT1a | GT1b | GT1a | GT1b | ||||
| Treatment naive | |||||||||
| A | + | 8 | 150 | 83.9 (47/56) | 95.8 (23/24) | 9 | 1 | ||
| E | − | 12 | 150 | 82.7 (43/52) | 100 (25/25) | 1 | 4 | ||
| F | + | 12 | 100 | 96.3 (26/27) | 100 (12/12) | ||||
| G | + | 12 | 150 | 92.6 (25/27) | 100 (13/13) | 1 | |||
| H | + | 24 | 100 | 92.6 (25/27) | 92.3 (12/13) | 1 | |||
| I | + | 24 | 150 | 85.2 (23/27) | 100 (12/12) | ||||
| Treatment-experienced null responders | |||||||||
| K | + | 12 | 100 | 86.7 (13/15) | 100 (8/8) | 2 | |||
| L | + | 12 | 150 | 92.3 (12/13) | 100 (9/9) | 1 | |||
| M | + | 24 | 100 | 92.9 (13/14) | 88.9 (8/9) | 1 | |||
| N | + | 24 | 150 | 100 (13/13) | 100 (7/7) | ||||
a
The 3D regimen consisted of paritaprevir/r, ombitasvir, and dasabuvir.
b
The daily dose of paritaprevir (plus 100 mg of ritonavir) in each arm is indicated; ombitasvir was included at 25 mg once daily, dasabuvir was included at 400 mg twice daily, and RBV was included at 1,000 mg if the body was less than 75 kg or 1,200 mg if the body weight was 75 kg or more.
c
Data in parentheses represent the number of patients achieving SVR24/total number of patients in the treatment arm.
d
Patients not achieving SVR24 for nonvirologic reasons, e.g., early discontinuations and missing SVR24 data, were not considered VFs.