Canadian Journal of Gastroenterology and Hepatology

Research Article

Virological Changes of Chronic Hepatitis B Patients with Minimally Elevated Levels of Alanine Aminotransferase: A Meta-Analysis and Systematic Review

Table 1

Characteristics of included studies and subjects.


First authors	Year	Geographic locale	Study design	Interventions	Sample size	N included in analysis	Sex (male %)	Age (years)	HBeAg positive (%)	Baseline ALT	Baseline HBV DNA	Samples	ALT analysis method	Study timepoints, weeks	NOS score

Perrillo	2002	Multinational	RCT	LAM	55	55	78	Median: 34 (15–73)	100	≤1 × ULN	Median: 98 (pg/mL, LLOD-2,264)	Serum	NR	52	7
				IFN	2	2	81	Median: 32 (16–70)			Median: 111 (pg/mL, LLOD-1,322)
				LAM + IFN	4	4	71	Median: 34 (15–76)			Median: 94 (pg/mL, LLOD-786)
				Placebo	25	25	80	Median: 35 (15–67)			Median: 79 (pg/mL, LLOD-1,150)
Tseng	2014	Taiwan	RCT	ETV	22	22	59	Mean: 45 ± 10	31.8	Mean: 0.6 ± 0.2 ULN	Mean: 5.95 ± 1.3 log₁₀ copies/ml	Serum	NR	52	9
				Placebo	20	20	55	Mean: 42 ± 12	42.9	Mean: 0.6 ± 0.2 ULN	Mean: 6.31 ± 1.42 log₁₀ copies/ml
Chan	2014	Multinational	RCT	TDF + placebo	64	64	48.4	Mean: 33 (9.5)	98.4	Mean: 26.9 (14.05) U/L	Mean: 8.42 (0.402) log₁₀IU/mL	Serum	NR	192	9
				TDF + FTC	62	62	50	Mean: 33 (11.2)	100	Mean: 26.2 (9.88) U/L	Mean: 8.40 (0.395) log₁₀IU/mL

Lu	2014	China	NRSI	LdT + CPIA	30	30	0	Mean: 28.6	100	≤1 × ULN	>5 × 10⁶ IU/ml	Serum	NR	96	7
				LdT + placebo	38	38	0

De Niet	2017	Netherlands	RCT	PEG-IFN + ADV	46	46	61	Mean: 44 (12)	0	Median: 27 (21–42) U/L	Mean: 2.65 (1.23) log₁₀IU/mL	Serum	NR	72	7
				PEG-IFN + TDF	45	45	47	Mean: 43 (12)		Median: 25 (19–30) U/L	Mean: 2.79 (1.03) log₁₀IU/mL
				No treatment	43	43	60	Mean: 41 (10)		Median: 30 (21–47) U/L	Mean: 2.79 (1.04) log₁₀IU/mL

Cao	2017	China	NRSI	PEG-IFN/+ ADV	94	94	66	38.8 ± 10.0	0	28.3 ± 9.0 IU/L	<2000 IU/mL	Serum	NR	96	7
				No treatment	40	40	65	39.8 ± 10.6		25.4 ± 8.4 IU/L
Zhu	2018	China	RCT	IFN/+ LAM	46	46	65	Median: 7 (8)	100	Median: 45 (28) U/L	Median: 9.95 × 10⁷ IU/mL	Serum	NR	96	7
				No treatment	23	23	57	Median: 8 (8)	100	Median: 48 (31) U/L	Median: 1.72 × 10⁸ IU/mL

Lim	2019	Singapore	RCT	PEG-IFN	60	60	NR	21–75	0	≤1 × ULN	≤20000 IU/ml	Serum	NR	48	6
				No treatment	30	30

Hsu	2021	Taiwan	RCT	TDF	79	74	78	Mean: 45 (39–54)	16	Mean: 53 (45–63) U/L	Mean: 5.26 (4.30–6.23) log₁₀IU/mL	Serum	NR	144	9
				Placebo	81	75	80	Mean: 43 (37–51)	26	Mean: 52 (46–66) U/L	Mean: 5.32 (4.41–6.41) log₁₀IU/mL

RCT, randomized controlled trial; NRSI, nonrandomized studies of interventions; LAM, lamivudine; ETV, entecavir; TDF, tenofovir disoproxil fumarate; FTC, emtricitabine; LdT, telbivudine; ADV, adefovir dipivoxil; IFN, interferon; PEG-IFN, pegylated interferon; CPIA, combination of peg IFN and adefovir; ULN, upper limit of normal; NR, not recorded.