Table 2.
Overview of Primary and Secondary Outcomes Summarized by Total and Intervention Condition
| Total (n = 200) |
Intervention (n = 98) | Control (n = 102) |
Risk Difference | Risk Ratio (95% CI) | |
|---|---|---|---|---|---|
| Primary outcome | |||||
| Treatment completion within 6 months | |||||
| N | 103 | 67 | 36 | ||
| % (95% CI) | 51.5 (44.3–58.6) | 68.4 (58.2–77.4) | 35.3 (26.1–45.4) | 33.1 (20.0–46.1) | 1.9 (1.4–2.6) |
| Failure to accomplish completion, n (%) | |||||
| Delayed treatment initiation | 39 (19.5) | 7 (7.1) | 32 (31.4) | NA | NA |
| Treatment discontinuation | 13 (6.5) | 10 (10.2) | 3 (2.9) | ||
| Short life expectancy or death | 15 (7.5) | 6 (6.1) | 9 (8.8) | ||
| Declined treatment | 2 (1.0) | 1 (1.0) | 1 (1.0) | ||
| Prolonged treatment | 1 (0.5) | 1 (1.0) | 0 (0) | ||
| Loss to follow-up | 27 (13.5) | 6 (6.1) | 21 (20.6) | ||
| Secondary outcomes | |||||
| Treatment initiation within 6 months | |||||
| n | 131 | 84 | 47 | ||
| % (95% CI) | 65.5 (58.5–72.1) | 85.7 (77.2–92.0) | 46.1 (36.2–56.2) | 39.6 (27.7–51.5) | 1.9 (1.5–2.3) |
| Treatment initiation within data lock | |||||
| n | 159 | 87 | 72 | ||
| % (95% CI) | 79.5 (73.2–84.9) | 88.8 (80.8–94.3) | 70.6 (60.7–79.2) | 18.2 (7.4–29.0) | 1.3 (1.1–1.5) |
| SVR ≥4 | |||||
| n | 126 | 60 | 66 | ||
| % (95% CI) | 63.0 (55.9–69.7) | 61.2 (50.8–70.9) | 64.7 (54.6–73.9) | −3.5 (−16.9–9.9) | 0.95 (.76–1.2) |
| SVR ≥12 | |||||
| n | 104 | 51 | 53 | ||
| % (95% CI) | 52.0 (44.8–59.1) | 52.0 (41.7–62.2) | 52.0 (41.8–62.0) | 0.0 (−0.14–0.14) | 1.00 (.77–1.3) |
| Failure to accomplish SVR ≥4, n (%) | |||||
| Virologic failure | 8 (4.0) | 6 (6.1) | 2 (2.0) | NA | NA |
| Loss to follow-up (missing SVR data) | 25 (12.5) | 21 (21.4) | 4 (3.9) | ||
| No treatment | 41 (20.5) | 11 (11.2) | 30 (29.4) |
Abbreviations: CI, confidence interval; NA, not applicable; SVR, sustained virologic response.