Background
Methods
Search
Study selection
Study Population (P)
Interventions (I)
Comparisons (C)
Study Outcomes (O)
Study design (S)
Data extraction
Methodological quality assessment
Data synthesis
Pairwise comparison
Network meta-analyses
Assessing the quality of evidence
Results
Trials included
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 |
Six-node analysis
Treatment comparison | Number of head-to head trials(n) | Study limitations` | Precision | Consistency | Directness | Publication bias | Direct Estimate; OR (95% CI) | Absolute effect per 100 treated (95% CI) | Overall quality of evidence |
---|---|---|---|---|---|---|---|---|---|
LMV vs TDF plus LMV | 4 (158) | seriousa | very seriousb | very serious (I2: 62%)c | serious | likely to exist | 0.37 (0.06–2.41) | 218 fewer (from 121 more to 602 fewer) | very low ⊕◯◯◯ |
FTC vs TDF | 1 (15) | seriousa | very seriousa | not serious | not serious | likely to exist | 0.07 (0.00–1.14) | 513 fewer (0 to 11 more) | very low ⊕◯◯◯ |
LMV vs TDF | 2 (84) | seriousa | very seriousa | very seriousc(I2: 78%) | serious | likely to exist | 0.12 (0.00–5.71) | 27 fewer (87 fewer to 141 more) | very low ⊕◯◯◯ |
LMV vs placebo | 2 (130) | seriousa | very seriousa | not serious (I2: 0%) | serious | likely to exist | 0.73 (0.2–2.69) | 432 fewer (0 to 109 more) | very low ⊕◯◯◯ |
TDF vs TDF plus LMV | 2 (37) | seriousa | very seriousa | very seriousc(I2: 51%) | serious | likely to exist | 1.21 (0.06–23.06) | 21 more (127 more to 586 fewer) | very low ⊕◯◯◯ |
TDF vs placebo | 1 (12) | seriousa | very seriousb | not serious | not serious | likely to exist | 105.00(1.65–6697.38) | 0 fewer (0 fewer to 0 fewer) | very low ⊕◯◯◯ |
TDF plus LMV vs placebo | 1 (15) | seriousa | very seriousb | not serious | not serious | likely to exist | 7.00 (0.24–206.78) | 239 more (294 more to 341 fewer) | very low ⊕◯◯◯ |
ADV vs TDF | 1 (52) | seriousa | very seriousb | not serious | not serious | likely to exist | 3.23 (0.85–12.35) | 212 more (19 fewer to 534 more) | very low ⊕◯◯◯ |
Treatment comparison | Direct estimate; OR (95% CI) | quality of evidence | Indirect estimate; OR (95% CI) | quality of evidence | Network estimate; OR (95% CI) | quality of evidence |
---|---|---|---|---|---|---|
ADV FTC | Not available | Not available | 0.02 (0.00–3.01) | Very low ⊕◯◯◯ | 0.02 (0.00–3.01) | Very low ⊕◯◯◯ |
ADV vs LMV | Not available | Not available | 0.07 (0.00–3.36) | Very low ⊕◯◯◯ | 0.07 (0.00–3.36) | Very low ⊕◯◯◯ |
ADV vs TD | Not available | Not available | 0.31 (0.02–6.28) | Very low ⊕◯◯◯ | 0.31 (0.02–6.28) | Very low ⊕◯◯◯S |
ADV vs TDF plus LMV | Not available | Not available | 0.18 (0.00–9.2) | Very low ⊕◯◯◯ | 0.18 (0.00–9.2) | Very low ⊕◯◯◯ |
ADV vs placebo | Not available | Not available | 0.05 (0.00–4.71) | Very low⊕◯◯◯ | 0.05 (0.00–4.71) | Very low ⊕◯◯◯ |
FTC vs LMV | Not available | Not available | 3.01 (0.03–287.25) | Very low ⊕◯◯◯ | 3.01 (0.03–287.25) | Very low ⊕◯◯◯ |
FTC vs TDF plus LMV | Not available | Not available | 7.82 (0.08–778.9) | Very low | 7.82 (0.08–778.9) | Very low |
FTC vs placebo | Not available | Not available | 2.23 (0.01–370.4) | Very low ⊕◯◯◯ | 2.23 (0.01–370.4) | Very low ⊕◯◯◯ |