Table 2.
Treatment and Safety Outcomes Among Patients With Chronic HCV Infection Receiving Sofosbuvir-Based Therapies in the ION, ASTRAL, and POLARIS Phase 3 Clinical Trials, by Receipt of Opioid Substitution Therapy
| Characteristic | OST at Enrollment | No OST at Enrollment | P |
|---|---|---|---|
| Overall, n/N (%) | |||
| Treatment completion | 189/194 (97.4) | 4501/4549 (98.9) | .064 |
| ≥90% adherence | 175/194 (90.2) | 4291/4549 (94.3) | .027 |
| SVR12 | 183/194 (94.3) | 4405/4549 (96.8) | .062 |
| Adverse events | 152/194 (78.4) | 3517/4549 (77.3) | .79 |
| Severe adverse events | 7/194 (3.6) | 108/4549 (2.4) | .24 |
| Ledipasvir/sofosbuvir ± ribavirin | |||
| Treatment completion | 51/53 (96.2) | 1863/1899 (98.1) | .28 |
| ≥90% adherence | 47/53 (88.7) | 1791/1899 (94.3) | .12 |
| SVR12 | 49/53 (92.5) | 1839/1899 (96.8) | .093 |
| Adverse events | 47/53 (88.7) | 1513/1899 (79.7) | .12 |
| Severe adverse events | 2/53 (3.8) | 50/1899 (2.6) | .65 |
| Sofosbuvir/velpatasvir | |||
| Treatment completion | 89/92 (96.7) | 1634/1643 (99.5) | .022 |
| ≥90% adherence | 82/92 (89.1) | 1559/1643 (94.9) | .029 |
| SVR12 | 87/92 (94.6) | 1601/1643 (97.4) | .099 |
| Adverse events | 68/92 (73.9) | 1251/1643 (76.1) | .62 |
| Severe adverse events | 4/92 (4.3) | 33/1643 (2.0) | .13 |
| Sofosbuvir/velpatasvir/voxilaprevir | |||
| Treatment completion, n (%) | 49/49 (100.0) | 1004/1007 (99.7) | 1.00 |
| ≥90% adherence | 46/49 (93.9) | 941/1007 (93.4) | 1.00 |
| SVR12 | 47/49 (95.9) | 965/1007 (95.8) | 1.00 |
| Adverse events | 37/49 (75.5) | 753/1007 (74.8) | 1.00 |
| Severe adverse events | 1/49 (2.0) | 25/1007 (2.5) | 1.00 |
Abbreviations: HCV, hepatitis C virus; OST, opioid substitution therapy.