Table 2. Main demographic and clinical characteristics of the groups studied.
All patients (n = 123) | Efficacy study (n = 99) | Safety study(n = 113) | ||
Male gender (%) | 74.8 | 74.7 | 74.3 | |
Age (years)* | 41 (38–43) | 40 (38–43) | 40 (38–43) | |
Baseline weight (Kg)** | 69.3±12 | 69.5±12 | 69.3±12 | |
Baseline height (cm)** | 170.7±8.2 | 170.9±8.4 | 170.7±8.3 | |
HCV/HIV acquiring risk factor (%) | IDU | 74 | 72.7 | 72.6 |
Heterosexual | 17.1 | 18.2 | 17.7 | |
Male homosexual | 5.7 | 6.1 | 6.2 | |
Haemophiliac | 0.8 | 1 | 0.9 | |
Other | 2.4 | 2 | 2.7 | |
AIDS (%) | 42.2 | 40.4 | 42.5 | |
HCV genotype (%) | 1 | 43.9 | 45.4 | 44.2 |
2 | 3.3 | 3 | 3.5 | |
3 | 34.1 | 32.3 | 32.7 | |
4 | 18.7 | 19.2 | 19.4 | |
Baseline HCV-RNA>400000 IU/mL (%) | 78.3 | 77.1 | 77.3 | |
Baseline HCV-RNA>600000 IU/mL (%) | 60 | 58.3 | 60 | |
Baseline HCV-RNA>800000 IU/mL (%) | 57.5 | 55.2 | 57.3 | |
Fibrosis score, (%) | 0–1 | 34.9 | 35.7 | 35.1 |
2–4 | 65.1 | 64.3 | 64.9 | |
Steatosis (%) | 34 | 28.6 | 34.1 | |
Baseline CD4 cell count (cells/mL)* | 551 (430–733) | 562 (434–760) | 562 (415–787) | |
Baseline CD4 cell count ≤350 cells/mL (%) | 14.8 | 15.3 | 16.2 | |
Baseline HIV viral load≤200 copies/mL (%) | 78.7 | 75.5 | 77.7 | |
HAART (%) | 84.5 | 82.8 | 84.1 | |
RVR (%) | 38.4 | 35.4 | 36.3 | |
EVR (%) | 75.4 | 73.9 | 74.7 | |
SVR (%) | 49.6 | 51.5 | 50 | |
Discontinuation for toxicity (%) | 11.4 | 0 | 12.8 | |
Toxicity (%) | 92.7 | 90.9 | 92 | |
Anemia (%) | 28.5 | 28.3 | 26.5 | |
Neutropenia (%) | 39.8 | 40.4 | 40.7 | |
Thrombocytopenia (%) | 39 | 38.4 | 39.8 | |
Flu-like syndrome (%) | 69.1 | 69.7 | 68.1 | |
Headache (%) | 15.4 | 16.2 | 15.9 | |
Depression (%) | 32.5 | 32.3 | 33.6 | |
Gastrointestinal symptoms (%) | 24.4 | 26.3 | 24.8 | |
Lactic acidosis (%) | 4.1 | 2 | 3.5 |
Median (25–75% interquartile range).
Mean±standard deviation.
HAART: Highly active antiretroviral therapy. EVR: Early virological response. RVR: Rapid virological response. SVR: Sustained virological response.