Table 2.
Virological outcomes for patients who reached the pre-defined time points
Parameter | EOT | EOT+12 weeks | EOT+24 weeks | EOT+12 or EOT+24 weeks combined |
---|---|---|---|---|
Number of patients evaluated at the time point, N | 127 | 83 | 77 | 105 |
In follow-up at the time point, n | 0 | 22 | 50 | 22 |
Lost to follow-up, n | 1* | 1* | 2*# | 1* |
Missed visit, n | 1 | 22§ | 0 | 0 |
Patients with available HCV RNA data, n | 125 | 82 | 75 | 104 |
HCV RNA target detected, quantifiable, n | 0 | 1 | 1 | 1 |
HCV RNA target detected, below LLD, n | 1 | 0 | 0 | 0 |
HCV RNA target not detected, n/N (%) | 124 | 81 | 74 | 103 |
Virological response rate, ITT, n/N (%) | 125/127 (98.4) | 81/83 (97.6) | 74/77 (96.1) | 103/105 (98.1) |
Virological response rate, mITT, n/N (%) | 125/125 (100.0) | 81/82 (98.8) | 74/75 (98.7) | 103/104 (99.0) |
One patient died due to myocardial infarction while on therapy; not included in modified ITT analysis.
One patient who reached SVR12 died due to recurrent hepatocellular carcinoma and deterioration of liver disease before EOT+24 weeks time point; not included in modified ITT SVR24 analysis.
HCV RNA testing at EOT+12 weeks time point is not mandatory in Hungary.
N – total number of patients, n – number of patients, EOT – end of treatment, HCV – hepatitis C virus, RNA – ribonucleic acid, LLD – lower limit of detection, ITT – intent to treat, mITT – modified intent to treat, SVR – sustained virological response