Why carry out this study?
|
Aid in establishing the lower limit of detection (LLoD) in order to confirm for HCV cure. |
Determining LLOD at virologic failure aids in increasing testing feasibility through point-of-care assays in resource-limited settings. |
What was learned from the study?
|
At post-treatment week 12, 100% of virologic failures had an HCV RNA > 3.0 log10 IU/ml. |
The data are encouraging that a point-of-care test with a LLOD of 3.0 log10 IU/ml would likely identify all treatment failures accurately. |
Digital Features
Introduction
Methods
Study Population
Statistical Analyses
Results
Overall Patient Population
Characteristic | Overall N = 5033 n (%) |
---|---|
Male | 2774 (55) |
Race | |
White | 3123 (62) |
Black or African American | 291 (6) |
Asian | 1543 (31) |
Age ≥ 65 years | 888 (18) |
BMI (kg/m2) (median, range) | 25.4 (14.2–65.7) |
GT | |
1 | 2388 (47) |
2 | 1054 (21) |
3 | 1140 (23) |
4–6 | 451 (9) |
Treatment-naïve | 3843 (76) |
IFN or SOF-based treatment experience | 1014 (20) |
DAA-based treatment experience | 175 (4) |
Country (≥ 5% of patient population) | |
USA | 1321 (26) |
China | 512 (10) |
Japan | 430 (8.5) |
Korea, Republic of | 253 (5) |
Fibrosis score | |
F0–F1 | 2972 (62) |
F2 | 343 (7) |
F3 | 497 (10) |
F4 | 979 (20) |
Baseline HCV RNA level (IU/ml) (mean, SD) | 4,193,712 ± 5,955,028 |
Baseline HCV RNA level (IU/ml) (median, range) | 1,930,000 (5.6–56,600,000) |
< 1,000,000 | 1809 (36) |
≥ 1,000,000—< 2,000,000 | 751 (15) |
≥ 2,000,000 | 2473 (49) |
Baseline HCV RNA level (log10 IU/ml) (mean, SD) | 6.2 ± 0.8 |
Baseline HCV RNA (log10 IU/ml) (median, range) | 6.3 (0.8–7.8) |
HIV co-infectiona | 188 (5) |
Recent injection drug Useb | 66 (1) |
HCV RNA Levels in the Overall Population at Baseline
Patients Experiencing Virologic Failure
Characteristic | Virologic failure at PTW12 N = 69 n (%) |
---|---|
Male | 51 (74) |
Race | |
White | 45 (65) |
Black or African American | 1 (1) |
Asian | 23 (33) |
Age ≥ 65 years | 8 (12) |
BMI (kg/m2) (median, range) | 25.1 (17.0–42.6) |
GT | |
1 | 17 (25) |
2 | 7 (10) |
3 | 42 (61) |
4–6 | 3 (4) |
Treatment-naïve | 33 (48) |
IFN or SOF-based treatment experience | 23 (33) |
DAA-based treatment experience | 13 (19) |
Country (≥ 5% of patient population) | |
USA | 21 (30) |
China | 13 (19) |
New Zealand | 8 (12) |
Australia | 7 (10) |
Japan | 6 (9) |
Fibrosis score | |
F0–F1 | 33 (49) |
F2 | 9 (13) |
F3 | 11 (16) |
F4 | 14 (21) |
Baseline HCV RNA level (IU/ml) (mean, SD) | 9,585,957 ± 8,247,669 |
Baseline HCV RNA level (IU/ml) (median, range) | 8,140,000 (135,000–36,100,000) |
< 1,000,000 | 5 (7) |
≥ 1,000,000— < 2,000,000 | 7 (10) |
≥ 2,000,000 | 57 (83) |
HCV RNA level (IU/ml) (median, range) | |
On-treatment virologic failurea | 7,425,000 (61,200–28,500,000) |
Relapse by PTW12b | 2,130,000 (7,040–27,900,000) |
Relapse by PTW4c | 1,780,000 (72,400–20,300,000) |
Relapse between PTW4 and PTW12d | 3,990,000 (7040–27,900,000) |
All virologic failure subjects | 3,350,000 (7040–28,500,000) |
Baseline HCV RNA level (log10 IU/ml) (mean, SD) | 6.8 ± 0.5 |
Baseline HCV RNA level (log10 IU/ml) (median, range) | 6.9 (5.1–7.6) |
HCV RNA level (log10 IU/ml) (median, range) | |
On-treatment virologic failurea | 6.9 (4.8–7.5) |
Relapse by PTW12b | 6.3 (3.8–7.4) |
Relapse by PTW4c | 6.3 (4.9–7.3) |
Relapse between PTW4 and PTW12d | 6.6 (3.8–7.4) |
All virologic failure subjects | 6.5 (3.8–7.5) |
HIV co-infectione | 1 (2) |
Recent injection drug usef | 1 (1) |