Tenofovir disoproxil fumarate is superior to lamivudine plus adefovir in lamivudine-resistant chronic hepatitis B patients

Table 1 Baseline clinical characteristics of the study patients

Variable	Total (n = 59)	TDF (n = 28)	LAM + ADV (n = 31)	P value
Age1 (yr)	36.36 ± 10.14 (18-58)	35.81 ± 9.85 (18-56)	32.06 ± 8.36 (21-58)	0.656
Male gender, n (%)	54 (91.52)	26 (92.9)	28 (90.32)	0.698
Initial ALT1 (U/L)	101.54 ± 26.14	98.25 ± 28.16	104.94 ± 24.33	0.542
Serum creatinine1 (μmol/L)	94.61 ± 18.92	89.85 ± 18.83	98.82 ± 16.65	0.340
Serum phosphorus1 (mmol/L)	1.14 ± 0.23	1.14 ± 0.22	1.16 ± 0.25	0.740
HBeAg positivity, n (%)	52 (88.14)	25 (89.29)	27 (87.10)	1.000
Cirrhosis, n (%)	5 (8.49)	2 (7.14)	3 (9.68)	0.932
Serum HBV DNA1 (log10 copyies/mL)	5.08 ± 1.11	5.13 ± 1.08	5.04 ± 31.16	0.639
Prior LAM + ADV therapy (mo)
Median	11	11	12
Range (mix-max)	6-24	6-22	8-24
LAM resistance mutation, n (%)	47 (79.66)	23 (82.14)	24 (77.42)	0.653
rtM204I/V	15 (25.42)	6	9
rtL180M	4 (6.78)	2	2
rtM204I/V + rtL180M	28 (47.46)	15	13
ADV resistance mutation, n (%)	3 (5.08)	1 (3.57)	2 (6.45)	1.000
rtN236T		0	1
rtA181T		1	0
rtA181V		0	1
Unknown2		4	5

¹mean ± SD;

²Patients with virological breakthrough during continued LAM treatment without detection of any known genotypic resistance mutation to LAM (rtM204V/I or rtL180M) or ADV (rtN236T, rtA181T, or rtA181V). TDF: Tenofovir disoproxil fumarate; LAM: Lamivudine; ADV: Adefovir; ALT: Alanine aminotransferase; HBV: Hepatitis B virus; HBeAg: Hepatitis B e antigen.

Table 2 Biochemical, virological, and serological responses n (%)

	Value for patient group
	TDF(n = 28)	LAM + ADV(n = 31)	P value
Normalization of ALT1
Week 12	21 (75.00)	5 (17.86)	< 0.001
Week 24	22 (78.57)	17 (54.84)	0.097
Week 48	25 (89.26)	21 (67.74)	0.062
HBV DNA undetectability (< 103 copies/mL)
Week 4	5 (17.86)	2 (6.45)	0.240
Week 12	21 (75.00)	5 (16.13)	< 0.001
Week 24	23 (82.14)	7 (22.58)	< 0.001
Week 36	25 (89.29)	8 (25.81)	< 0.001
Week 48	27 (96.43)	9 (29.03)	< 0.001
HBeAg loss at week 48	1 (4)	0	0.481

¹The alanine aminotransferase (ALT) reference range was < 50 U/L. TDF: Tenofovir disoproxil fumarate; LAM: Lamivudine; ADV: Adefovir; HBV: Hepatitis B virus; HBeAg: Hepatitis B e antigen.