Tenofovir vs lamivudine plus adefovir in chronic hepatitis B: TENOSIMP-B study

Table 1 Sociodemographic characteristics of the study population n (%)

Characteristic	TDF	LAM+ADV	Total	P value
	(n = 22)	(n = 24)	(n = 46)
Age - average (range)	53.14 ± 11.95	56.35 ± 11.86	54.82 ± 11.88	0.377
Gender
Male	17 (77.3)	22 (91.7)	39 (84.4)
Female	5 (22.7)	2 (8.3)	7 (15.2)
Weight - average (range)	75.37 (46 - 105)	78.72 (62 - 107)	77.08 (46 - 107)	0.663
Height - average (range)	1.68 (1.48 - 1.93)	1.70 (1.56 - 1.80)	1.69 (1.48 - 1.93)	0.30
BMI - average (range)	26.59 (17.10 - 32.96)	27.17 (21.45-34.54)	26.89 (17.1-34.54)	0.883
< 18.50 - Underweight	2 (9.10)	1 (4.20)	3 (6.50)
18.50 - 24.99 - Normal	7 (31.80)	8 (33.30)	15 (32.60)
25.0 - 29.9 - Overweight	9 (40.90)	10 (41.70)	19 (41.30)
≥ 30.0 - Obese	4 (18.20)	5 (20.8)	9 (19.60)
LAM resistance establishment				0.725
Clinical records	18 (81.8)	18 (75.0)	36 (78.3)
Resistance test	4 (18.2)	6 (25.0)	10 (21.7)
Cirrhosis, F4 state	3 (13.6)	1 (4.2)	4 (8.7)	0.336
Diabetes mellitus and/ or hypertension	2 (9.1)	6 (25.0)	8 (17.4)	0.247

ADV: Adefovir dipivoxil; BMI: Body mass index; F: Fibrosis; LAM: Lamivudine; TDF: Tenofovir dipivoxil fumarate.

Table 2 Biochemical parameters: Baseline visit vs final visit

	Baseline visit			Visit at 48 wk
	TDF	LAM+ADV	P value	TDF	LAM+ADV	P value
	average (range)	average (range)		average (range)	average (range)
AST (UI/mL)	26.66 (9.00-74.00)	26.69 (15.00-69.00)	0.904	26.41 (14.00-71.00)	26.05 (18.00-52.00)	0.916
ALT (UI/mL)	25.41 (12.00-62.00)	23.62 (13.60-40.00)	0.646	26.32 (12.00-55.00)	27.29 (17.00-51.00)	0.965
Phosphorus (mmol/dL)	3.00 (1.80-4.00)	2.84 (1.90-3.80)	0.263	3.08 (1.70-4.40)	2.95 (2.00-3.70)	0.832
Urea (mg/dL)	36.14 (20.00-53.00)	36.96 (18.00-61.90)	0.698	38.29 (25.00-57.00)	38.69 (22.00-53.00)	0.479
Serum creatinine (mg/dL)	0.88 (0.70-1.16)	0.89 (0.60-1.35)	0.912	0.88 (0.69-1.16)	0.92 (0.60-1.27)	0.396
Glomerular filtration rate (mL/min/1.73 m2)	94.13 (66.95-121.03)	97.48 (60.47-157.83)	0.922	93.11 (66.75-123.55)	93.14 (59.14-151.26)	0.468
Creatinine clearance (mL/min)	103.52 (65.57-185.25)	105.43 (64.79-166.22)	0.831	100.85 (60.84-149.66)	102.32 (60.26-157.5)	0.308

ADV: Adefovir dipivoxil; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; LAM: Lamivudine; TDF: Tenofovir dipivoxil fumarate.

Table 3 Adverse clinical events at week 48 n (%)

Event	Intensity	TDF ( n = 26)	LAM+ADV ( n = 27)	Total (n = 53)	P value
Adverse reactions		2 (7.70)	0	2 (3.57)	0.236
Digestive intolerance	moderate	1 (3.85)	0	1 (1.89)	1.000
Muscle pains	moderate	1 (3.85)	0	1 (1.89)	1.000
Adverse events		14 (53.85)	9 (37.5)	23 (43.40)	0.17
Common cold	mild	3 (11.54)	2 (7.41)	5 (9.43)	0.699
Headache	mild	1 (3.85)	1 (3.70)	2 (3.77)	1.000
Retrosternal oppression with heartburn	moderate	0	1 (3.70)	1 (1.89)	1.000
Otitis	mild	1 (3.85)	0	1 (1.89)	0.491
Molar extraction	mild	1 (3.85)	0	1 (1.89)	0.491
Right- and left-flank pain	mild	1 (3.85)	0	1 (1.89)	0.491
Vomiting	mild	1 (3.85)	0	1 (1.89)	0.491
Osteoarticular pain in hands	mild	0	1 (3.70)	1 (1.89)	1.000
Hypophosphatemia and hypomagnesemia	moderate	0	1 (3.70)	1 (1.89)	1.000
Renal colic	mild	1 (3.85)	0	1 (1.89)	0.491
Epigastric pain	mild	1 (3.85)	0	1 (1.89)	0.491
Back pain	mild	1 (3.85)	0	1 (1.89)	0.491
Chronic prostatitis	mild	0	1 (3.70)	1 (1.89)	1.000
Epidermoid carcinoma	moderate	1 (3.85)	0	1 (1.89)	0.491
Vertiginous syndrome	mild	0	1 (3.70)	1 (1.89)	1.000
Itching (eyes, nose and mouth)	mild	1 (3.85)	0	1 (1.89)	0.491
Vertigo	mild	0	1 (3.70)	1 (1.89)	1.000
Choluria	mild	1 (3.85)	0	1 (1.89)	0.491

ADV: Adefovir dipivoxil; LAM: Lamivudine; TDF: Tenofovir dipivoxil fumarate.

Table 4 Average costs per patient (€, 2014)

Costs - average, € (SD)	TDF	LAM+ADV	Difference TDF vs LAM+ADV	P value
	(n = 22)	(n = 24)
Studied medication	2966 (69)	4218 (558)	-1252	< 0.0011
Concomitant medication	218 (599)	82 (213)	136	0.484
Medical visits	505 (158)	500 (137)	5	0.942
Tests	1388 (182)	1363 (242)	25	0.834
Admissions and surgeries	0 (0)	0 (0)	0 (0)	NA
Total	4943 (1059)	5811 (1538)	-868	< 0.0011

¹Statistically significant difference. ADV: Adefovir dipivoxil; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; LAM: Lamivudine; TDF: Tenofovir dipivoxil fumarate.