Table 1 Summary of study design of the six trials
Study | Marcellin Study 102 [14] | Marcellin Study 103 [14] | Lacombe [16] | Hann [17] | Peters [18] | van Bommel [19] |
|---|---|---|---|---|---|---|
Study location | Worldwide | Worldwide | French multi-centre | Asian-Americans | Worldwide | N/A |
Study design | randomized,double-blind | randomized,double-blind | non-randomized, open label | quasi-randomized, open-label | prospective randomized, double-blind | Nonrandmoized,open-label |
Grade | 5 | 5 | 2 | 3 | 5 | 2 |
Treatment options | Tenofovir 300 mg/d vs Adefovir 10 mg/d | Tenofovir 300 mg/d vs Adefovir 10 mg/d | Tenofovir 300 mg/d vs Adefovir 10 mg/d | Tenofovir 300 mg/d vs Adefovir 10 mg/d | Tenofovir 300 mg/d vs Adefovir 10 mg/d | Tenofovir 300 mg/d vs Adefovir 10 mg/d |
Male | 193(77%) vs. 97(78%) | 119(68%) vs. 64(71%) | 54(96.4%) vs. 28(26.6%) | 37(85%) vs. 49(76%) | 24 (89%) vs. 24 (96%) | 32(91.4%) vs. 14(77.8%) |
Mean age, years | 44 ± 10.6 vs. 43 ± 10 | 34 ± 11 vs. 34 ± 12 | 42.3 vs. 41.5 | 49 vs. 45 | 40 vs. 47 | 47 ± 2 vs. 45 ± 3.7 |
HBeAg-positive (%) | 0:0 | 1:1 | 50(89.3%) vs. 25(86.2%) | 33(75%) vs. 55(84%) | 23 (85%) vs. 20 (80%) | 31(89%) vs16( 89%) |
Treatment (weeks) | 48 weeks | 48 weeks | 48 weeks | 48 weeks | 48 weeks | 72 to 130 weeks vs. 60 to 80 weeks |
Follow-up (weeks) | N/A | N/A | N/A | 48 weeks | 91 weeks vs. 81 weeks | N/A |
Status | N/A | N/A | Coinfect HIV | lamivudine-resistant | Coinfect HIV | lamivudine-resistant |