The importance of baseline viral load when assessing relative efficacy in treatment-naïve HBeAg-positive chronic hepatitis B: a systematic review and network meta-analysis

Mealing, Stuart; Ghement, Isabella; Hawkins, Neil; Scott, David A; Lescrauwaet, Benedicte; Watt, Maureen; Thursz, Mark; Lampertico, Pietro; Mantovani, Lorenzo; Morais, Edith; Bregman, Bruno; Cucherat, Michel

doi:10.1186/2046-4053-3-21

Systematic Reviews

Table 1 Study characteristics and 1-year outcomes of studies included in the network meta-analysis (HBeAg-positive patients only)

From: The importance of baseline viral load when assessing relative efficacy in treatment-naïve HBeAg-positive chronic hepatitis B: a systematic review and network meta-analysis

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
018 Study Group [13]	52 weeks	Randomised, controlled, open label	44	ADV 10 mg	30	91	52 weeks	Amplicor PCR Assay (Roche)	300 copies/ml	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
ADV 437 Study Group [14]	48 weeks	Randomised, single blind	171	ADV 10 mg	34	76	48 weeks	Amplicor PCR Assay (Roche)	400 copies/ml	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
AHLSG [15]	52 weeks	Randomised, double blind	143	LAM 100 mg	31	74	52 weeks	Solution hybridising assay (Abbott)	1.6 pg/ml	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
AI463023 [12]	96 weeks	Phase 3 randomised, double blind	221	LAM 100 mg	-	-	52 weeks	PCR assay (company unspecified)	300 copies/ml	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
BeHoLD_I [17]	60 weeks	Phase 3 randomised, double blind	355	LAM 100 mg	35	74	48 weeks	Amplicor PCR Assay (Roche)	300 copies/ml	9.69	36.3
Globe study group [19–21]	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
Globe study group [19–21]	NR	Phase 3 randomised, double blind	458	TBV 600 mg	32	73	52 weeks	Amplicor PCR Assay (Roche)	300 copies/ml	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
Hou [22]	104 weeks	Phase 3 randomised, double blind	143	LAM 100 mg	29	75	52 weeks	Amplicor PCR Assay (Roche)	300 copies/ml	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
ILSG [23]	52 weeks	Randomised, partially double blind	69	IFNA	32	81	52 weeks	Solution hybridising assay (Abbott)	1.6 pg/ml	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
Lau [47]	72 weeks	Phase 3 randomised, double blind	272	LAM 100 mg	31.6	79	48 weeks	Amplicor PCR Assay (Roche)	400 copies/ml	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
Leung [25]	Minimum 52 weeks	Phase 3 randomised, open label	32	ADV 10 mg	32	66	48 weeks	Amplicor PCR Assay (Roche)	300 copies/ml	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
Marcellin [26]	48 weeks	Phase 3 randomised, double blind	90	ADV 10 mg	34	71	48 weeks	Cobas Taq-Man PCR Assay (Roche)	169 copies/ml	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
Ren [27]	48 weeks	Randomised	21	ETV 0.5 mg	31	57	48 weeks	PCR assay (company unspecified		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
TBVIG [29]	52 weeks	Phase 2 randomised, double blind	22	TBV 600 mg	40	82	52 weeks	Amplicor PCR Assay (Roche)		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

The systematic review identified 21 studies reporting hepatitis B e antigen (HBeAg)-positive patients; this table only shows the 14 studies included in the network meta-analysis. The remaining 7 studies did not report outcomes at 1 year and so were not included in the network meta-analysis. *Patient numbers for overall population provided, baseline viral load and hepatitis B virus (HBV) DNA reported as HBeAg-positive/HBeAg-negative, outcomes for HBeAg-positive patients only. ADV, adeforvir; ETV, entecavir; IFNA, interferon-alfa; LAM, lamivudine; LLOQ, lower level of quantification; NR, not reported; PegIFNA, pegylated interferon-alfa 2a; TBV, telbivudine; TDF, tenofovir.

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ISSN: 2046-4053

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