Table 3.
Summary of study characteristics.
| First-author reference | Study type | Sample size (n) | Substance/alcohol use (Y/N) | HCV genotypes, 1–6 (%) | DAA regimens (%) | Number of tablets—dosing frequency/day | Treatment duration in weeks (%) | Adherence monitoring tools | Mean cumulative DAA adherence (%) | SVR12 (%) |
|---|---|---|---|---|---|---|---|---|---|---|
| Dore et al. 23 | Randomized (immediate deferred) HCV treatment |
201 100 |
Y | 1a (75.7) 1b (15) 4 (6) 6 (3) Mixed (0.3) |
EBR/GZR | 1 QD | 12 | Electronic medication diary | 96.5 95.8 |
91.5 89.5 |
| Petersen et al. 25 | Three-arm phase-2a clinical trial | 60 (20/arm) | Y | 1 | LDV/SOF LDV/SOF/GS-9451 LDV/SOF/GS-9669 |
1 QD 2 QD 3 BID |
12 6 6 |
Medication events monitoring system (Electronic MEMS Caps) | 97.6 97.3 95 |
96.6 |
| Litwin et al. 31 | Single-arm prospective trial | 61 | Y | 1 (97.7) 4 (3.3) |
LDV/SOF (75) SIM/SOF (25) |
1 QD 1QD |
8 (8) 12 (82) 24 (10) |
Electronic blister packs (Med-ic ECM®) |
73.4 (daily) 90.2 (weekly) |
98.4 94 |
| Cunningham et al. 5 /Grebely et al. 13 | Single-arm open-label | 103 | Y | 1 (35) 2 (5) 3 (58) 4 (2) |
SOF/VEL | 1 QD | 12 (100) | Electronic blister packs (Med-ic ECM®) |
94 (daily) 98 (weekly) |
94 |
| Akiyama et al. 33 (Prevail study) | Randomized to DOT GT SIT (control) |
150 51 (DOT) 48 (GT) 51 (SIT) |
Y | 1a (85) 1b (15) |
LDV/SOF (69) SIM/SOF (7) SOF/RBV(11) SOF/IFN/RBV (10) TVR/IFN/RBV (2) |
1 QD 1 QD 1 QD 1 QD 1 QD |
8–12 | Electronic blister packs (Med-ic ECM®) | 78 (overall) 86 (DOT) 80 (GT) 75 (SIT) |
95 (overall) 100 95 90 |
| Coffin et al. 39 | Randomized to mDOT or Wisepill |
31 | Y | 1 (100) | LDV/SOF | 1 QD | 8 (100) | Electronic pill boxes (Wisepill®) | 39.2 (weekly dosing), 49.9 (36.6) (weekend dosing) | 89.7 (as treated), 90.3 (ITT) |
| Brooks et al. 42 | Randomized to Wisepill (WOT) or vDOT | 31 29 |
Y | 1a (65) 1b (22) 1 (8) 4/4a (5) |
LDV/SOF (100) | 1 QD | 12 | Electronic pill boxes WOT: Wisepill, or video-based directly observed therapy (vDOT—emocha®) |
89 (WOT)98 (vDOT) |
96 (overall), 83.9 (pill box), 89.7 (vDOT) |
| Litwin et al. 45 | Prospective single-arm, non-randomized | 17 | Y | 1 (100) | LDV/SOF (100) | 1 QD | 8–12 | Artificial intelligence platforms (AIP, AiCure) | 91.3 | 88.2 |
| Leo et al.46 | Invited to use AIP versus usual care | 35 (AIP) 58 (usual care) |
N/A | LDV/SOF SOF/VEL GLE/PIB |
1 QD 1 QD 3 QD |
Artificial intelligence platforms (AIP, AiCure) | 96.2 | N/A | ||
| Sulkowski et al. 49 | Prospective, single-arm, open-label | 288 | Y | 1a (65) 1b (13) 2 (6) 3 (12) 4 (1) |
VEL/SOF (19) LDV/SOF (26) GLE/PIB (55) |
1 QD 1 QD 3 QD |
Ingestible sensors systems (Proteus Digital Health) | 95 | 99.1 | |
| Bonacini et al. 55 | Prospective, observational, open-label, single-arm | 28 | Y | 1a(100) | LDV/SOF (100) | 1 QD | Ingestible sensors systems (Proteus Digital Health) | 97 | 92.9 |
AIP: artificial intelligence platform; BID: twice daily; DOT, directly observed therapy; EBR/GZR: elbasvir/grazoprevir; GLE/PIB: glecaprevir/pibrentasvir; GT: group treatment; HCV: hepatic C virus; IFN: interferon; ITT: intention-to-treat; LDV/SOF: ledipasvir/sofosbuvir; mDOT: modified directly observed therapy; N/A: not available; RBV: ribavarin; SIM/SOF: simeprevir/sofosbuvir; SOF/VEL: sofosbuvir/velpatasvir; SIT: self-administered individual treatment; TVR: telaprevir; vDOT: video directly observed therapy; wDOT: wireless direct observed therapy; QD: once daily.