Table 3. SVR12 According to HIV coinfection status (ITT analysis).
HCV (83.97%) |
HIV/HCV (16.03%) |
Total (100%) |
Adjusted Total*** SVR12 |
Noni-Inferiority 90%IC |
|
---|---|---|---|---|---|
ITT | 1,961/2,022 (97.0%) [96.1–97.7%] |
366/386 (94.8%) [92.1–96.8%] |
2,327/2,408 (96.6%) [95.8–97.3%] |
96.6% [95.9–97.3%] |
-2.2% [-4.5% to 0.2%] |
mITT1* | 1,961/2,009 (97.6%) [96.8–98.2%] |
366/385 (95.1%) [92.4–97.0%] |
2,327/2,394 (97.2%) [96.5–97.8%] |
97.2% [96.5–97.8%] |
-2.6% [-4.9% to -0.3%] |
mITT2** | 1,961/1,994 (98.3%) [97.7–98.9%] |
366/379 (96.6%) [94.2–98.2%] |
2,327/2,373 (98.1%) [97.4–98.6%] |
98.0% [97.5–98.6%] |
-1.8% [-3.7% to 0.1%] |
Abbreviations: HCV, hepatitis C virus; HIV, human immunodeficiency virus; mITT modified intention-to-treat; SVR12, sustained virologic response at 12 weeks.
* ITT modified criteria (mITT1) excludes patients with no response due to loss of follow-up.
** ITT modified criteria (mITT2) excludes patients with no response due to loss of follow-up and patients with other non-virologic reasons for missing data 70 days post-treatment.
*** The SVR12 analysis was adjusted according to the estimated proportion of HIV/HCV (82% and 18% of HCV and HIV/HCV patients, respectively).