Sofosbuvir plus ribavirin is tolerable and effective even in elderly patients 75-years-old and over

doi:10.4254/wjh.v12.i9.672

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World Journal of Hepatology

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Prospective Study

World J Hepatol. Sep 27, 2020; 12(9): 672-684
Published online Sep 27, 2020. doi: 10.4254/wjh.v12.i9.672

Table 1 Patient characteristics

	n = 265
Age in yr	68 (17-86)
≥ 75 yr	83 (31%)
Sex as male/female	150/115 (57%/43%)
Cirrhosis	91 (34%)
Moderate chronic kidney disease, eGFR < 60 mL/min/1.73 m²	53 (20%)
History of HCC treatment	33 (12%)
History of pegylated IFN + ribavirin therapy	39 (15%)
Height in cm	160.2 (134.0-182.0)
Weight in kg	58.0 (32.3-99.3)
BMI in kg/m²	22.6 (15.5-35.0)
Baseline HCV-RNA in logIU/mL	6.0 (1.4-7.4)
WBC as /mm³	5000 (1810-13260)
Hb in g/dL	13.6 (10.2-20.1)
Platelets as × 10⁴/mm³	16.2 (4.6-38.9)
AST in IU/L	43 (12-257)
ALT in IU/L	39 (6-394)
γ-GT in IU/L	32 (5-898)
eGFR	73 (31-156)
AFP in ng/mL	4.3 (1.0-88.3)

Values are expressed as median (range) or numbers (percentage). γ-GT: γ-glutamyl transferase; AFP: Alpha-fetoprotein; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; BMI: Body mass index; eGFR: Estimated glomerular filtration rate; Hb: Hemoglobin; HCC: Hepatocellular carcinoma; HCV: Hepatitis C virus; HCV-RNA: Hepatitis C virus-ribonucleic acid; IFN: Interferon; WBC: White blood cells.

Table 2 Comparison of pre-treatment factors between patients ≥ 75-years-old and < 75-years-old

Factors	Patients ≥ 75-yr-old, n = 83	Patients < 75-yr-old, n = 182	P value
Age in yr	79 (75-86)	64 (17-74)	< 0.001
Sex as male/female	42/41 (51%/49%)	108/74 (59%/41%)	0.183
Height in cm	156.7 (134.0-170.0)	162.0 (140.0-182.0)	< 0.001
Weight in kg	53.5 (32.3-81.4)	60.0 (37.6-99.3)	< 0.001
BMI in kg/m²	22.2 (15.5-29.5)	23.1 (16.5-35.0)	0.009
Cirrhosis	41 (49%)	50 (28%)	< 0.001
CKD, eGFR < 60 mL/min/1.73 m²	28 (34%)	25 (14%)	< 0.001
History of HCC treatment	18 (22%)	15 (8%)	0.002
History of IFN-based therapy	21 (25%)	42 (23%)	0.693
HCV-RNA as logIU/mL	6.1 (2.3-7.3)	5.9 (1.4-7.4)	0.894
WBC in mm³	4540 (1810-13260)	5200 (2200-11400)	0.004
Hb in g/dL	12.9 (10.2-20.1)	14.1 (10.6-17.6)	< 0.001
Platelets as × 10⁴/mm³	14.2 (4.9-32.8)	17.4 (4.6-38.9)	< 0.001
AST in IU/L	40 (14-183)	42 (12-252)	0.589
ALT in IU/L	30 (6-139)	44 (6-394)	< 0.001
γ-GT in IU/L	25 (7-361)	37 (5-888)	0.001
AFP in ng/mL	3.9 (1-32.9)	4.8 (1.1-88.3)	0.014
eGFR	66.0 (33.0-106.9)	77.6 (30.9-156.0)	< 0.001

Values are expressed as median (range) or number (percentage). γ-GT: γ-glutamyl transferase; AFP: Alpha-fetoprotein; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; BMI: Body mass index; CKD: Chronic kidney disease; eGFR: Estimated glomerular filtration rate; Hb: Hemoglobin; HCC: Hepatocellular carcinoma; HCV: Hepatitis C virus; HCV-RNA: Hepatitis C virus-ribonucleic acid; IFN: Interferon; WBC: White blood cells.

Table 3 Uni- and multivariate analyses of pre-treatment factors contributing to sustained virological response

	Univariate			Multivariate
Factors	P value	OR	95%CI	P value	OR	95%CI
Age, per 1-yr increase	0.782	0.991	0.931-1.055
≥ 75 yr	0.874	1.144	0.217-6.022
Sex, female	0.977	1.023	0.224-4.663
Height, per 1-cm increase	0.316	0.957	0.879-1.043
Weight, per 1-kg increase	0.568	0.982	0.924-1.044
BMI, per 1-kg/m² increase	0.929	0.990	0.792-1.238
Cirrhosis	0.214	0.382	0.084-1.743
CKD, eGFR > 60 mL/min/1.73 m²	0.569	0.616	0.116-3.266
History of HCC treatment	0.027	0.175	0.037-0.822	0.072	0.225	0.044-1.145
History of IFN-based therapy	0.763	0.774	0.146-4.091
HCV-RNA, per 1-logIU/mL increase	0.644	0.831	0.380-1.821
WBC in mm³	0.703	1.009	0.963-1.057
Hb, per 1-g/dL increase	0.196	1.411	0.837-2.380
Platelets, per 1 × 10⁴/mm³ increase	0.790	0.984	0.873-1.109
AST, per 1-IU/L increase	0.552	1.007	0.983-1.033
ALT, per 1-IU/L increase	0.608	1.005	0.987-1.023
γ-GT, per 1-IU/L increase	0.490	1.007	0.987-1.027
AFP, per 1-ng/mL increase	0.004	0.955	0.926-0.985	0.015	0.959	0.926-0.992
eGFR, per 1-mL/min/1.73 m² increase	0.124	1.036	0.990-1.083

γ-GT: γ-glutamyl transferase; AFP: Alpha-fetoprotein; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; BMI: Body mass index; CI: Confidence interval; CKD: Chronic kidney disease; eGFR: Estimated glomerular filtration rate; Hb: Hemoglobin; HCC: Hepatocellular carcinoma; HCV: Hepatitis C virus; HCV-RNA: Hepatitis C virus-ribonucleic acid; IFN: Interferon; OR: Odds ratio; WBC: White blood cells.

Table 4 Comparison of factors between patients with and without sustained virological response

Factors	SVR, n = 258	Non-SVR, n = 7	P value
Age in yr, n (range)	68 (17-86)	74 (39-79)	0.682
Sex as male/female	146/112	4/3	1.000
Height in cm	160.1 (134.0-182.0)	161.5 (155.0-177.0)	0.350
Body weight in kg	58.0 (32.3-99.3)	63.2 (54.0-66.2)	0.267
BMI in kg/m²	22.6 (15.5-38.0)	22.6 (20.2-25.9)	0.778
Cirrhosis	87	4	0.237
CKD	51	2	0.630
History of HCC treatment	30	3	0.044
History of IFN-based therapy	61	2	0.672
HCV-RNA as logIU/mL	6.1 (2.7-7.6)	6.3 (3.3-7.0)	0.713
White blood cells as /mm³	5005 (1810-13260)	4100 (2260-8700)	0.581
Hemoglobin in g/dL	13.6 (10.2-20.1)	12.5 (11.6-14.7)	0.793
Platelets as × 10⁴/mm³	16.2 (4.6-38.9)	14.9 (9.9-30.3)	0.930
AST in IU/L	42 (12-252)	37 (19-90)	0.789
ALT in IU/L	39 (6-394)	57 (19-79)	0.843
γ-GTP in IU/L	32 (5-888)	36 (13-461)	0.942
AFP in ng/mL	5.2 (1.0-445.0)	10.6 (1.3-29.7)	0.521
eGFR in mL/min/1.73 m²	73.1 (30-240.2)	72.2 (50.5-105.8)	0.166
Ribavirin adherence in %	100 (28-100)	100 (100-100)	0.323

Values are expressed as median (range) or number of patients. γ-GTP: γ-glutamyl transferase; AFP: Alpha-fetoprotein; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; BMI: Body mass index; CKD: Chronic renal disease; eGFR: Estimated glomerular filtration rate; HCC: hepatocellular carcinoma; HCV: Hepatitis C virus; HCV-RNA: Hepatitis C virus-ribonucleic acid; IFN: Interferon; SVR: Sustained virological response.

Table 5 Adverse events during treatment

	Total,n = 265	Patients ≥ 75-yr-old, n = 83	Patients < 75-yr-old, n = 182	P value
Treatment discontinuation due to adverse events¹	1 (0.4%)	1 (1.2%)	0	0.313
Dose reduction or interruption of ribavirin due to anemia²	32 (13.2%)	18 (21.7%)	14 (7.7%)	0.002
Dermatitis	9 (3.4%)	1 (1.2%)	8 (4.4%)	0.281
Depression	3 (1.1%)	1 (1.2%)	2 (0.5%)	1.000
Headache	4 (1.5%)	0	4 (2.2%)	0.313
Infection	4 (1.5%)	1 (1.2%)	3 (1.6%)	1.000
Other adverse events	11 (4.2%)	5 (6.0%)	6 (3.3%)	0.328
Elevated bilirubin level	2 (0.8%)	1 (1.2%)	1 (0.5%)	0.529
Elevated transaminase level	4 (1.5%)	2 (2.4%)	2 (1.1%)	0.592
Elevated serum ammonia level	5 (1.9%)	2 (2.4%)	3 (1.6%)	0.650
Elevated uric acid level	26 (9.8%)	10 (12.0%)	16 (8.8%)	0.504

¹Drug-induced pneumonitis with positivity to sofosbuvir on drug-induced lymphocyte stimulation test.

²Significant difference between patients ≥ 75-years-old and < 75-years-old (P < 0.01).

Citation: Tamai H, Shingaki N, Ida Y, Shimizu R, Maeshima S, Okamura J, Kawashima A, Nakao T, Hara T, Matsutani H, Nishikawa I, Higashi K. Sofosbuvir plus ribavirin is tolerable and effective even in elderly patients 75-years-old and over. World J Hepatol 2020; 12(9): 672-684
URL: https://www.wjgnet.com/1948-5182/full/v12/i9/672.htm
DOI: https://dx.doi.org/10.4254/wjh.v12.i9.672