Telbivudine vs tenofovir in hepatitis B e antigen-negative chronic hepatitis B patients: OPTIMA roadmap study

Table 3 Summary of safety results, safety population n (%)

Safety parameters	Telbivudine			Tenofovir
	Monotherapy (n = 98)	Intensification with tenofovir (n = 22)	Overall (n = 120)	Monotherapy (n = 109)	Intensification with telbivudine (n = 11)	Overall (n = 120)
Any AE	69 (70.4)	17 (77.3)	86 (71.7)	75 (68.8)	8 (72.7)	83 (69.2)
AE related to drug	36 (36.7)	11 (50.0)	47 (39.2)	21 (19.3)	6 (54.5)	27 (22.5)
AE leading to drug discontinuation	2 (2.0)	0 (0.0)	2 (1.7)	5 (4.6)	0 (0.0)	5 (4.2)
Any SAE	6 (6.1)	5 (22.7)	11 (9.2)	11 (10.1)	2 (18.2)	13 (10.8)
SAE related to drug	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (9.1)	1 (0.8)
Death	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
AEs related to drug occurring in ≥ 2% of patients in any treatment arm
Blood CPK increased	23 (23.5)	8 (36.4)	31 (25.8)	13 (11.9)	3 (27.3)	16 (13.3)
Nausea	6 (6.1)	2 (9.1)	8 (6.7)	0 (0.0)	2 (18.2)	2 (1.7)
Myalgia	7 (7.1)	1 (4.5)	8 (6.7)	0 (0.0)	0 (0.0)	0 (0.0)
Alanine aminotransferase increased	2 (2.0)	0 (0.0)	2 (1.7)	3 (2.8)	1 (9.1)	4 (3.3)
Proteinuria	2 (2.0)	0 (0.0)	2 (1.7)	4 (3.7)	0 (0.0)	4 (3.3)
Aspartate aminotransferase increased	3 (3.1)	0 (0.0)	3 (2.5)	2 (1.8)	0 (0.0)	2 (1.7)
Any AE of special interest	35 (35.7)	11 (50.0)	46 (38.3)	23 (21.1)	4 (36.4)	27 (22.5)
AEs of special interest occurring in ≥ 2% of patients in any treatment arm
Blood CPK increased	24 (24.5)	10 (45.5)	34 (28.3)	17 (15.6)	3 (27.3)	20 (16.7)
Myalgia	10 (10.2)	2 (9.1)	12 (10.0)	2 (1.8)	1 (9.1)	3 (2.5)
Alanine aminotransferase increased	5 (5.1)	0 (0.0)	5 (4.2)	5 (4.6)	1 (9.1)	6 (5.0)
Proteinuria	3 (3.1)	0 (0.0)	3 (2.5)	4 (3.7)	0 (0.0)	4 (3.3)
Any patient with muscle event	12 (12.2)	2 (9.1)	14 (11.7)	2 (1.8)	1 (9.1)	3 (2.5)
Experiencing new-onset Grade 3/4 abnormal CPK within the study	4 (4.1)	1 (4.5)	5 (4.2)	0 (0.0)	0 (0.0)	0 (0.0)
Experiencing new-onset Grade 1/2 abnormal CPK within the study	6 (6.1)	1 (4.5)	7 (5.8)	1 (0.9)	1 (9.1)	2 (1.7)
Any patient with new-onset Grade 3/4 CPK episode within the study	17 (17.3)	2 (9.1)	19 (15.8)	3 (2.8)	2 (18.2)	5 (4.2)
Episode not resolved	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)

AE: Adverse event; CPK: Creatine phosphokinase; SAE: Serious adverse event.