Source | Treatment duration | Study design | Number of patients | Treatment | Age (years) | Male (%) | Endpoint timepoint | Method used to measure HBV DNA | LLOQ | Baseline viral load (log10copies/ml) | Undetectable HBV DNA at 1 year (%) |
---|---|---|---|---|---|---|---|---|---|---|---|
018 Study Group [13] | 52 weeks | Randomised, controlled, open label | 45 | TBV 600 mg | 34 | 78 | 52 weeks | Amplicor PCR Assay (Roche) | 300 copies/ml | 9.57 | 60 |
44 | ADV 10 mg | 30 | 91 | 9.98 | 40.9 | ||||||
ADV 437 Study Group [14] | 48 weeks | Randomised, single blind | 167 | Placebo | 37 | 71 | 48 weeks | Amplicor PCR Assay (Roche) | 400 copies/ml | 8.12 | 0 |
171 | ADV 10 mg | 34 | 76 | 8.25 | 21.1 | ||||||
AHLSG [15] | 52 weeks | Randomised, double blind | 72 | Placebo | 29 | 72 | 52 weeks | Solution hybridising assay (Abbott) | 1.6 pg/ml | 1.85 | NR |
143 | LAM 100 mg | 31 | 74 | 1.8 | NR | ||||||
AI463023 [12] | 96 weeks | Phase 3 randomised, double blind | 225 | ETV 0.5 mg | - | - | 52 weeks | PCR assay (company unspecified) | 300 copies/ml | 8.80 | 73.8 |
221 | LAM 100 mg | - | - | 8.70 | 37.6 | ||||||
BeHoLD_I [17] | 60 weeks | Phase 3 randomised, double blind | 354 | ETV 0.5 mg | 35 | 77 | 48 weeks | Amplicor PCR Assay (Roche) | 300 copies/ml | 9.62 | 66.7 |
355 | LAM 100 mg | 35 | 74 | 9.69 | 36.3 | ||||||
NR | Phase 3 randomised, double blind | 463 | LAM 100 mg | 33 | 76 | 52 weeks | Amplicor PCR Assay (Roche) | 300 copies/ml | 9.50 | 40.4 | |
458 | TBV 600 mg | 32 | 73 | 9.50 | 60 | ||||||
Hou [22] | 104 weeks | Phase 3 randomised, double blind | 147 | TBV 600 mg | 28 | 80 | 52 weeks | Amplicor PCR Assay (Roche) | 300 copies/ml | 9.30 | 66.7 |
143 | LAM 100 mg | 29 | 75 | 9.70 | 37.8 | ||||||
ILSG [23] | 52 weeks | Randomised, partially double blind | 82 | LAM 100 mg | 30 | 71 | 52 weeks | Solution hybridising assay (Abbott) | 1.6 pg/ml | 2.04 | 60 |
69 | IFNA | 32 | 81 | 1.78 | 29.1 | ||||||
Lau [47] | 72 weeks | Phase 3 randomised, double blind | 271 | PegIFNA | 32.5 | 79 | 48 weeks | Amplicor PCR Assay (Roche) | 400 copies/ml | 9.90 | 25.1 |
272 | LAM 100 mg | 31.6 | 79 | 10.10 | 39.7 | ||||||
Leung [25] | Minimum 52 weeks | Phase 3 randomised, open label | 33 | ETV 0.5 mg | 37 | 61 | 48 weeks | Amplicor PCR Assay (Roche) | 300 copies/ml | 10.30 | 57.6 |
32 | ADV 10 mg | 32 | 66 | 9.88 | 18.8 | ||||||
Marcellin [26] | 48 weeks | Phase 3 randomised, double blind | 176 | TDF 300 mg | 34 | 68 | 48 weeks | Cobas Taq-Man PCR Assay (Roche) | 169 copies/ml | 8.64 | 76.1 |
90 | ADV 10 mg | 34 | 71 | 8.88 | 13.3 | ||||||
Ren [27] | 48 weeks | Randomised | 21 | LAM 100 mg | 34 | 52 | 48 weeks | PCR assay (company unspecified | Unspecified | 8.49 | 38 |
21 | ETV 0.5 mg | 31 | 57 | 8.52 | 71.4 | ||||||
TBVIG [29] | 52 weeks | Phase 2 randomised, double blind | 19 | LMV 100 mg | 34 | 74 | 52 weeks | Amplicor PCR Assay (Roche) | 200 copies/ml | N/R | 31.6 |
22 | TBV 600 mg | 40 | 82 | N/R | 61.4 | ||||||
USLIG [30] | 68 weeks | Prospective, randomised, double blind | 71 | Placebo | 38 | 80 | 52 weeks | Unspecified | Unspecified | 5.70 | 15.9 |
66 | LAM 100 mg | 40 | 86 | 10.20 | 44.4 |