Efficacy and safety of telaprevir- and simeprevir-based triple therapies for older patients with chronic hepatitis C

doi:10.4254/wjh.v9.i5.252

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World Journal of Hepatology

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Retrospective Study

World J Hepatol. Feb 18, 2017; 9(5): 252-262
Published online Feb 18, 2017. doi: 10.4254/wjh.v9.i5.252

Table 1 Patient characteristics by age (telaprevir)

Factors (median, range)	Patients aged < 66	Patients aged ≥ 66	P value
n	78	34
Gender, n (male/female)	41/37	20/14	0.68
Age (yr)	56 (28-65)	69 (66-81)	< 0.001
Body weight (kg)	61.1 (35.0-97.4)	57.8 (41.0-74.8)	0.105
Body mass index (kg/m²)	22.7 (15.8-32.2)	22.9 (17.9-28.9)	0.892
Baseline HCV-RNA (log IU/mL)	6.7 (3.9-7.7)	6.7 (3.1-7.8)	0.766
White blood cell (/mm³)	5000 (1900-8720)	4500 (2700-7700)	0.245
Hemoglobin (g/dL)	14.0 (9.1-18.6)	13.5 (9.5-16.3)	0.121
Platelets (× 10⁴/mm³)	15.8 (6.5-28.7)	13.4 (8.3-29.0)	0.068
Albumin (mg/dL)	4.1 (2.7-5.9)	3.9 (2.4-4.4)	0.007
AST (IU/L)	40 (17-249)	45 (20-163)	0.909
ALT (IU/L)	48 (15-278)	38 (15-189)	0.486
γ-GTP (IU/L)	39 (11-717)	25 (11-144)	0.034
Serum creatinine (mg/dL)	0.7 (0.4-1.2)	0.8 (0.4-1.0)	0.036
Estimated GFR (mL/min)	79.0 (44.0-134.0)	71.5 (39.0-101.9)	0.006
Prior treatment response, n (naïve/relapse/non-responder)	45/26/7	15/15/4	0.403
Liver histology (F0-2/3-4/ND)	21/6/51	4/3/27	0.348
IL28B SNP (rs8099917), n (TT/non-TT/ND)	51/22/5	28/5/1	0.235
HCV ISDR, n (0/1-3 /4-/NT)	32/26/6/14	15/10/2/7	0.955
HCV Core 70, n (Wild/Mutant/ND)	46/18/14	18/10/6	0.751
HCV Core 91, n (Wild/Mutant/ND)	42/22/14	19/9/6	1
Serum CXCL10 (pg/mL)	510 (95-1794)	543 (118-1218)	0.445

GFR: Glomerular filtration rate; IL28B SNP: Interleukin-28B single nucleotide polymorphism; ND: Not determined; ISDR: Interferon sensitivity-determining region; HCV Core 70 or 91: At position 70 or 91 of the HCV core protein; CXCL10: Chemokine (C-X-C motif) ligand 10; HCV: Hepatitis C virus; AST: Aspartate transaminase; ALT: Alanine aminotransferase; γ-GTP: γ-glutamyl-transpeptidase.

Table 2 Patient characteristics by age (simeprevir)

Factors (median, range)	Patients aged < 66	Patients aged ≥ 66	P value
n	37	39	-
Gender, n (%) (male/female)	19/18 (48.6)	14/25 (64.1)	0.123
Age (yr)	59 (36-65)	71 (66-86)	< 0.001
Body weight (kg)	62.0 (39.8-94.0)	56.0 (37.5-76.6)	0.011
Body mass index (kg/m²)	22.8 (17.2-30.3)	22.7 (17.8-32.1)	0.287
Baseline HCV-RNA (log IU/mL)	6.7 (5.4-7.8)	6.6 (4.7-7.6)	0.631
White blood cells (/mm³)	4620 (2600-7800)	4300 (2400-8100)	0.010
Hemoglobin (g/dL)	13.8 (11.0-16.7)	13.1 (9.8-16.8)	< 0.001
Platelets (× 10⁴/mm³)	16.4 (8.7-28.8)	16.3 (7.3-31.7)	0.291
Albumin (mg/dL)	4.2 (2.8-4.8)	4.0 (3.1-4.6)	0.002
AST (IU/L)	45 (21-159)	34 (19-128)	0.056
ALT (IU/L)	42 (16-316)	29 (12-112)	0.006
γ-GTP (IU/L)	29 (13-260)	27 (9-171)	0.388
Serum creatinine (mg/dL)	0.70 (0.44-1.01)	0.70 (0.42-1.36)	0.689
Estimated GFR (mL/min)	78.7 (50.0-112.6)	77.4 (41.3-109.0)	0.221
Prior treatment response, n (naïve/relapse/non-responder)	20/10/7	13/16/10	0.197
Liver histology (F0-2/3-4/ND)	12/6/19	19/5/15	0.483
IL28B SNP (rs8099917), n (TT/non-TT/ND)	17/19/1	18/17/4	1
HCV ISDR, n (0/1-3/4-/ND)	9/13/5/10	11/12/2/14	0.044
HCV Core 70, n (Wild/Mutant/ND)	17/13/7	15/8/16	1
HCV Core 91, n (Wild/Mutant/ND)	18/12/7	18/5/16	0.385

GFR: Glomerular filtration rate; IL28B SNP: Interleukin-28B single nucleotide polymorphism; ND: Not determined; ISDR: Interferon sensitivity-determining region; HCV core 70 or 91: At position 70 or 91 of the HCV core protein; HCV: Hepatitis C virus; AST: Aspartate transaminase; ALT: Alanine aminotransferase; γ-GTP: γ-glutamyl-transpeptidase.

Table 3 Treatment tolerability (telaprevir)

	Patients aged < 66	Patients aged ≥ 66	P value
Initial doses (median, range)
PEG-IFN/BW (μg/kg per week)	1.48 (0.98-2.00)	1.49 (1.15-1.87)	0.859
TVR/BW (mg/kg per day)	33.0 (19.2-64.3)	29.2 (7.5-54.2)	0.044
TVR (2250 mg/1500 mg/others), n	55/23/0	11/21/2	< 0.001
RBV/BW (mg/kg per day)	11.4 (6.8-20.0)	11.4 (5.7-28.0)	0.103
Dose reduction, n (%)
PEG-IFN	7 (8.9)	6 (17.6)	0.209
TVR	19 (24.3)	12 (35.3)	0.256
RBV	40 (51.2)	27 (79.4)	0.006
Discontinuation, n (%)
PEG-IFN	13 (16.7)	4 (11.8)	0.580
TVR	12 (15.4)	9 (26.5)	0.192
RBV	12 (15.4)	7 (20.6)	0.585
Adherence, mean ± SD (%)
PEG-IFN	88.2 ± 25.7	90.1 ± 19.8	0.606
TVR	88.8 ± 22.8	83.5 ± 25.5	0.103
RBV	79.3 ± 26.2	62.7 ± 25.3	< 0.001

PEG-IFN: Pegylated interferon; BW: Bodyweight; TVR: Telaprevir; RBV: Ribavirin.

Table 4 Treatment tolerability (simeprevir)

	Patients aged < 66	Patients aged ≥ 66	P value
Initial doses (median, range)
PEG-IFNα2a (180/90) (μg/wk)	19/0	10/1	0.366
PEG-IFNα2b (120/100/80/others) (μg/wk)	2/16/5/1	0/25/5/1	0.422
SMV/BW (mg/kg per day)	1.6 (1.1-2.5)	1.8 (1.3-2.7)	0.011
RBV/BW (mg/kg per day)	11.6 (6.8-17.1)	12.3 (6.0-20.6)	0.166
Dose reduction, n (%)
PEG-IFN	5 (13.5)	6 (15.3)	1
SMV	0	0	1
RBV	3 (8.1)	6 (15.3)	0.481
Discontinuation, n (%)
PEG-IFN	5 (13.5)	5 (12.8)	1
SMV	2 (5.4)	2 (5.1)	1
RBV	11 (29.7)	23 (58.9)	0.012
Adherence, mean ± SD (%)
PEG-IFN	93.6 ± 16.8	92.3 ± 19.5	0.592
SMV	98.1 ± 7.2	93.9 ± 18.1	0.079
RBV	91.0 ± 16.1	86.8 ± 20.2	0.126

PEG-IFN: Pegylated interferon; SMV: Simeprevir; BW: Bodyweight; RBV: Ribavirin.

Table 5 Univariate and multivariate analysis of factors contributing to SVR24 (telaprevir)

Factors	Univariate analysis		Multivariate analysis
Factors	Odds ratio (95%CI)	P value	Odds ratio (95%CI)	P value
Age	1.012 (0.955-1.072)	0.689
Gender (female)	0.784 (0.262-2.342)	0.663
Body mass index (kg/m²)	1.074 (0.875-1.318)	0.495
Prior treatment response (non-NR)	3.850 (0.830-17.861)	0.085
Baseline HCV-RNA (log IU/mL)	1.264 (0.457-3.495)	0.652
Baseline ALT (IU/mL)	1.008 (0.998-1.017)	0.105
Baseline platelets (× 10⁴/mm³)	1.017 (0.906-1.142)	0.775
Baseline hemoglobin (g/dL)	1.038 (0.736-1.464)	0.830
IL28B SNP (TT)	6.700 (1.826-24.584)	0.004	8.160 (1.593-41.804)	0.012
Initial dose of TVR (2250 mg/d)	2.069 (0.670-6.553)	0.204
TVR/BW (mg/kg per day)	0.938 (0.870-1.011)	0.093
RBV/BW (mg/kg per day)	0.811 (0.617-1.066)	0.133
PEG-IFN dose reduction (none)	2.134 (0.253-17.988)	0.486
TVR dose reduction (none)	1.020 (0.281-3.703)	0.976
RBV dose reduction (none)	1.548 (0.433-5.525)	0.501
Adherence of RBV (> 60%)	6.873 (1.784-26.474)	0.005	11.052 (1.160-105.273)	0.037
RVR (none)	0.88 (0.123-1.216)	0.104

HCV: Hepatitis C virus; ALT: Alanine aminotransferase; NR: Non-responder; IL28B SNP: Interleukin-28B single nucleotide polymorphism; TVR: Telaprevir; RVR: Rapid virological response; PEG-IFN: Pegylated interferon; BW: Bodyweight; RBV: Ribavirin.

Table 6 Univariate and multivariate analysis of factors contributing to SVR24 (simeprevir)

Factors	Univariate analysis		Multivariate analysis
Factors	Odds ratio (95%CI)	P value	Odds ratio (95%CI)	P value
Age	0.998 (0.942-1.058)	0.953
Gender (female)	0.330 (0.083-1.314)	0.116
Body mass index (kg/m²)	1.164 (0.934-1.450)	0.175
Prior treatment response (non-NR)	2.955 (0.811-10.764)	0.101
Baseline HCV-RNA (log IU/mL)	0.767 (0.328-1.791)	0.540
Baseline ALT (IU/mL)	0.998 (0.985-1.012)	0.785
Baseline platelets (× 10⁴/mm³)	1.082 (0.953-1.228)	0.224
Baseline hemoglobin (g/dL)	1.257 (0.827-1.910)	0.285
IL28B SNP (TT)	12.593 (1.516-104.576)	0.019	9.677 (1.114-84.087)	0.040
SMV/BW (mg/kg per day)	0.306 (0.054-1.742)	0.182
RBV/BW (mg/kg per day)	1.085 (1.138-3.913)	0.501
PEG-IFN dose reduction (none)	7.250 (1.712-30.700)	0.007	6.557 (1.328-32.377)	0.021
RBV dose reduction (none)	1.556 (0.470-5.160)	0.470
RVR (none)	0.351 (0.075-1.637)	0.183

HCV: Hepatitis C virus; ALT: Alanine aminotransferase; NR: Non-responder; IL28B SNP: Interleukin-28B single nucleotide polymorphism; SMV: Simeprevir; BW: Bodyweight; PEG-IFN: Pegylated interferon; RBV: Ribavirin; RVR: Rapid virological response.

Citation: Yamagiwa S, Ishikawa T, Waguri N, Sugitani S, Wakabayashi H, Ohkoshi S, Tsukishiro T, Takahashi T, Watanabe T, Terai S. Efficacy and safety of telaprevir- and simeprevir-based triple therapies for older patients with chronic hepatitis C. World J Hepatol 2017; 9(5): 252-262
URL: https://www.wjgnet.com/1948-5182/full/v9/i5/252.htm
DOI: https://dx.doi.org/10.4254/wjh.v9.i5.252