Efficacy and safety of dual therapy with daclatasvir and asunaprevir in elderly patients

Table 1 Background of elderly (≥ 75 years old) and non-elderly (< 75 years old) patients

Parameter	Elderly patients, n = 56	Non-elderly patients, n = 141	P
Cirrhosis/chronic hepatitis	30/26	44/97	0.003
Age in years	77.8 (75-83)	65.3 (34-74)
Male/female	23/33 (41.1%/58.9%)	54/87 (38.3%/61.7%)
HCV genotype 1b, %	100	100
HCV RNA, mean log10 IU/mL	5.85 ± 0.77	6.12 ± 0.70
Pegylated-interferon/ribavirin non-responder, %	17.9	25.5	0.251

HCV: Hepatitis C virus.

Table 2 Virologic outcomes

Parameter	Elderly patients, n = 56	Non-elderly patients, n = 141	P
SVR24	51 (91.1)	127 (90.1)
Viral breakthrough	1 (1.8)	5 (3.5)	0.519
Post-treatment relapse	2 (3.6)	7 (5.0)	0.675
Ratio of patients who achieved SVR24 in the discontinued cases due to side effects	5/7 (71.4)	7/9 (77.8)

Data are presented as n (%). SVR₂₄: Sustained virological response at 24-wk.

Table 3 Adverse events and laboratory abnormalities

Event	Elderly patients, n = 56	Non-elderly patients, n = 141
Nasopharyngitis	5 (8.9)	6 (4.3)
Headache	4 (7.1)	9 (6.4)
Diarrhea	3 (5.4)	5 (3.5)
Pyrexia	2 (3.6)	12 (8.5)
Malaise	7 (12.5)	8 (5.7)
Anorexia	6 (10.7)	8 (5.7)
AST elevation	15 (26.8)	55 (39.0)
ALT elevation	14 (25.0)	54 (38.3)
Hb decrease	8 (14.3)	11 (7.8)
Total bilirubin increase	2 (3.6)	11 (7.8)
Creatinine increase	8 (14.3)	13 (9.2)

Data are presented as n (%). ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; Hb: Hemoglobin.

Table 4 Total number of adverse events in the elderly and non-elderly patients

	Elderly patients	Non-elderly patients
No. of total patients enrolled	56	141
No. of patients who experienced adverse events	31	79
Percentage of patients who experienced adverse events	55.4	56.0

Table 5 Causes of discontinuation and numbers of patients in whom the study drugs were discontinued due to adverse events in the elderly and non-elderly groups

Elderly patients	Non-elderly patients
16 w Malaise, Anorexia1	18 w Elevation of ALT1
6 w Malaise, Anorexia1	6 w Elevation of ALT1
6 w Elevation of ALT1	2 w Pyrexia1
8 w Elevation of ALT1	3 w Pyrexia
3 w Pyrexia	13 w Sepsis due to hemolytic
4 w Cough	streptococcus1
18 w Development of HCC1	18 w Abdominal fullness1
	2 w Elongation of PT
	3 w Elevation of total bilirubin1
	18 w Development of HCC1
Total 7/56 (12.5%)	9/141 (6.4%)

¹Patients achieved sustained virological response at 24-wk. Level of elevation of ALT and total bilirubin at which the drug was discontinued: 200 INU (5-folds of normal) for ALT and 3.0 mg/dL for total bilirubin. HCC: Hepatocellular carcinoma; ALT: Alanine aminotransferase.