Table 2.
Predictive model of SVR analyzed for all patients treated with PI-triple therapy (TVR + BOC; n = 131), and analyzed for subgroups of patients treated with TVR (n = 102) or BOC (n = 29)
| SVR 24 | p value | SVR 24 | p value | SVR 24 | p value | |
|---|---|---|---|---|---|---|
| (TVR + BOC) | (TVR + BOC) | (TVR) | (BOC) | (BOC) | ||
| (n/N;% # ) | (n/N;% # ) | (TVR) | (n/N;% # ) | |||
| Viral kinetics ## | ||||||
| eRVR | 71/80; 89% | <0.0001 | 58/64; 91% | <0.0001 | 13/16; 81% | 0.0969 |
| Non-eRVR | 23/45; 51% | 18/34; 53% | 5/11; 45% | |||
| PI-TW 4 < LLOD | 72/83; 87% | <0.0001 | 59/67; 88% | 0.0005 | 13/16; 81% | 0.0969 |
| PI-TW 4 > LLOD | 22/42; 52% | 17/31; 55% | 5/11; 45% | |||
| PI-TW 4 < LLOD | 72/83; 87% | 0.0193 | 59/67; 88% | 0.0619 | 13/16; 81% | 0.5528 |
| PI-TW 4 minimal viral load (> LLOD, < LLOQ) | 20/29; 69% | 17/24; 71% | 3/5; 60% | |||
| PI-TW 4 viral load < LLOQ | 92/112; 82% | <0.0001 | 76/91; 84% | <0.0001 | 16/21; 76% | 0.1358 |
| PI-TW 4 viral load > LLOQ | 2/13; 15% | 0/7; 0% | 2/6; 33% | |||
| Baseline demographic parameters | ||||||
| Fibrosis | ||||||
| Liver Cirrhosis (Ishak 5 + 6) | 26/41; 63% | 0.0931 | 24/34; 71% | 0.3331 | 2/7; 29% | 0.0712 |
| No Liver Cirrhosis (Ishak 1–4) | 70/90; 78% | 54/68; 79% | 16/22; 73% | |||
| Sex | ||||||
| Male | 49/73; 67% | 0.1675 | 39/53; 74% | 0.6541 | 10/20; 50% | 0.0959 |
| Female | 46/58; 79% | 38/49; 78% | 8/9; 89% | |||
| Age | ||||||
| Patients ≥ 60 years | 23/31; 74% | 1.0000 | 19/26; 73% | 0.6053 | 4/5; 80% | 0.6221 |
| Patients < 60 years | 73/100; 73% | 59/76; 78% | 14/24; 58% | |||
| Baseline viral load ### | ||||||
| High viral load (>800.000 IU/ml) | 60/84; 71% | 0.6804 | 49/66; 74% | 0.8126 | 11/18; 56% | 0.6942 |
| Low viral load (<800.000 IU/ml) | 35/46; 76% | 27/35; 77% | 8/11; 73% | |||
| Genotype | ||||||
| 1a | 23/35; 66% | 0.3763 | 19/28; 68% | 0.3068 | 4/7; 57% | 1 |
| 1b | 72/96; 75% | 58/74; 78% | 14/22; 64% | |||
| Baseline platelet count | ||||||
| Platelets > 100/nl | 91/116; 78% | 0.0001 | 73/90; 81% | 0.0012 | 18/26; 69% | 0.0452 |
| Platelets < 100/nl | 4/11; 36% | 4/12; 33% | 0/3; 0% | |||
| Previous non-response vs. other* | ||||||
| Non-response | 20/36; 55% | 0.0075 | 19/28; 68% | 0.2948 | 1/8; 13% | 0.0014 |
| Other | 76/95; 80% | 59/74; 80% | 17/21; 81% |
Fisher’s exact test was used. Significant calculations (p < 0.05) are printed bold. #number of patients who achieved SVR 24 in category/total number in category. ##6 patients (4 TVR-, 2 BOC-patients) had no measurement of viral load at TW 4 due to premature treatment discontinuation or because they did not show up for scheduled visit; therefore they were excluded from analysis. ###1 baseline viral load missing. *Other (includes treatment naïve, relapsers, unknown response, pretreatment with other interferon than pegylated interferon). Abbreviations: BOC Boceprevir, eRVR Extended rapid virological response, LLOD Lower limit of detection, LLOQ Lower limit of quantification, PI Protease inhibitor, SVR Sustained virological response, TVR Telaprevir, TW Treatment week.