Study [Reference No] | Country | RCT design | Total samples | Age in year (SD or range) | Males | Comparators | Time point in week | Diagnosis of HBV | Main mode of transmission | Remarks |
---|---|---|---|---|---|---|---|---|---|---|
Dore, 1999 [14] | Canada, Australia, Europe, & South Africa (CAESAR) | 2 arms; ITT | 122 | 37a(range: 22–70) | 96% | LMV (150 mg twice/D) vs placebo | 4, 8, 12, 20, 28, 36, 44, 52. | Amplicor PCR (Roche, NJ) |  | 68% ART received |
Dore, 2004 [25] | Western EU, North America, Australia | 2 arms; as treated | Gr 1: 12 Gr2:11 | Gr 1: 40a Gr2:42a | 100%a | Gr1: TDF (300 mg/D) vs placebo. Gr 2:TDF (300 mg/D) vs TDF + LMV (150 mg twice/D). | 12,24,48 | HBV DNA (Roche Amplicor), |  | A sub-study of 908 ART exp. (Gr1) & 903 naive (Gr2); ART naïve group & ART experienced group |
Peters, 2006 [26] | USA | 2 arms; ITT | 52 | 47a | 24% | ADV vs TDF | 12,24,36,48 | Roche Amplicor CobasPCR | IVDU:13.5% | stop early after interim results |
Mathews, 2008 [27] | 3 countries; Netherlands, Australia & Thailand (NAT) | 3 arms; ITT | 36 | 35.5 (SD:±8.4) | 64% | LMV (150 mg twice/D); TDF(300 mg/D) | 12,24,48 | Versant HBV DNA 3.0 bDNA assay (Bayer HealthCare, NY); COBAS TaqMan HBV Test (Roche Diagnostics NJ). | Hetero (78%) | ART naiïve; EFV (600 mg/D) to all 3 groups; 7 (19%) with AIDS |
Avihingsanon,2010 [15] | Thailand | 2 arms; ITT | 16 | 34a(range: 30–39) | 12% | TDF + FTC (600 mg + 300 mg/D) vs FTC (300 mg/D) | 12,24,48 | Versant HBV DNA 3.0 bDNA assay (Bayer HealthCare, NY); COBAS TaqMan HBV Test (Roche Diagnostics NJ). | Hetero (75%) | EFV (600 mg single dose/D) |
Gu, 2014 [28] | China | 2 arms; ITT | 50 | 36 (SD:±9.5) | 88% | TDF+ LMV vs LMP | 12,48,96 | COBAS Ampliprep/COBAS TaqMan | 86% hetro + homo: 51.2% MSM | ART received |
Wang, 2016 [29] | China | 2 arms;ITT | 80 | 29a(range: 24–36) | 0% | TDF + LMV vs LMV | 36 | m2000 RT System (Abbott RT HBV Assay, California), | _ | pregnant women |