Eight-week ledipasvir/sofosbuvir in non-cirrhotic, treatment-naïve hepatitis C genotype-1 patients with hepatitis C virus-RNA < 6 million: Single center, real world effectiveness and safety

Table 1 Demographic and clinical characteristics of patients prior to hepatitis c treatment n (%)

Characteristics	n = 736
Age, mean ± SD (yr)	58 ± 10
Range	(23-85)
Male sex	403 (55)
Ethnicity
Caucasian	374 (51)
African American	178 (24)
Hispanic	158 (21)
Asian/Pacific islanders	26 (4)
HCV genotype-subtype
1a	475 (64)
1b	242 (33)
1 without confirmed subtype	19 (3)
Liver biopsy	317 (43)
Vibration-controlled transient elastography	25 (3)
FIBROSpect II	3 (0.4)
Overall fibrosis score
Stage 0	45 (13)
Stage 1	164 (48)
Stage 2	104 (30)
Stage 3	29 (8)
Stage 3-4 or 4	2 (1)
Non-cirrhotic state determined by clinical judgement	391 (53)
HCV RNA - log10 IU/mL, mean ± SD	6.2 ± 0.2
HCV RNA ≥ 2.2 million IU/mL	219 (30)
Pre-treatment laboratory values
GFR, mean ± SD (Range)	79 ± 11 (40-89)
Platelet count (103/mm3), mean ± SD (Range)	218 ± 55 (45-495)
INR, mean ± SD (Range)	0.99 ± 0.7 (0.8-1.3)
Albumin, mean ± SD (Range)	3.9 ± 0.4 (2.1-5.1)
Missing	101 (14.0)
Co-morbid conditions
Psychiatric diagnoses	145 (20.0)
Chronic kidney disease	35 (5.0)
Psoriasis	16 (2.0)
HIV co-infection	5 (0.7)
Cryoglobulinemia	4 (0.5)
HCV-related glomerulonephritis	2 (0.3)
HBV co-infection	2 (0.3)
Hepatocellular carcinoma	1 (0.1)

HCV: Hepatitis C virus; HBV: Hepatitis B virus; GFR: Glomerular filtration rate; INR: International normalized ration; HIV: Human immunodeficiency virus.

Table 2 Sustained viral response 12 rate by various patient characteristics for non-cirrhotic patients with genotype 1 hepatitis C virus infection treated with 8-week ledipasvir/sofosbuvir therapy

Characteristics	SVR12 (%) (n = 736)	P value
Overall	96 (708/736)
Non-cirrhotic state determined by clinical judgement	96 (376/391)	0.962
Non-cirrhotic state determined by biopsy, VCTE, FIBROSPECT II	96 (332/345)
HCV RNA ≥ 2.2 million IU/mL	92 (201/219)	< 0.001
HCV RNA < 2.2 million IU/mL	98 (507/270)
HIV co-infection	100 (6/6)
HBV co-infection	100 (2/2)
Gender		0.071
Male	95 (383/403)
Female	98 (325/333)
HCV genotype-subtype		0.414
1a	96 (454/475)
1b	98 (236/324)
Undetermined	95 (18/19)
Ethnicity
Caucasian	96 (357/374)
African American	96 (171/178)
Hispanic	98 (155/158)	0.544
Asian/Pacific Islander	96 (25/26)
Age groups		0.311
< 55 yr	97 (216/223)
55-65 yr	97 (369/382)
> 65 yr	94 (123/131)
Fibrosis Tests		0.489
Liver biopsy	97 (306/317)
Vibration-controlled transient elastography	92 (23/25)
FIBROSPECT II	100 (3/3)
Overall fibrosis stage (cumulative: biopsy/VCTE/FIBROSPECT II)
Stage 0	98 (44/45)
Stage 1	95 (155/164)	0.611
Stage 2	98 (102/104)
Stage 3	97 (28/29)
Stage 4	100 (2/2)

HCV: Hepatitis C virus; VCTE: Vibration-controlled transient elastography; SVR: Sustained viral response.

Table 3 Odds ratios for sustained viral response at 12 week in multivariate logistic regression for non-cirrhotic, hepatitis c genotype 1 patients treated with 8-week ledipasvir/sofosbuvir therapy

Characteristics	OR (95%CI) for SVR12 (n = 736)	P value
Age 55-65 yr (ref. < 55)	0.92 (0.36-2.34)	0.861
Age > 65 yr (ref. < 55)	0.5 (0.18-1.41)	0.188
Male (ref. female)	0.47 (0.21-1.08)	0.077
African-American (ref. Caucasian)	0.84 (0.11-6.57)	0.868
Hispanic (ref. Caucasian)	2.07 (0.21-20.66)	0.537
Asian/Pacific Islander (ref. Caucasian)	0.98 (0.16-8.28)	0.983
Non-cirrhotic state determined by clinical judgement (ref. Fibrosis Test: biopsy/VCTE/FIBROSPECT)	1.02 (0.48-2.17)	0.962
HCV RNA ≥ 2200000 IU/mL (ref. < 2200000 IU/mL)	0.22 (0.1-0.49)	< 0.001
HCV genotype - subtype 1b (ref. 1a)	2.19 (0.25-19.15)	0.480

HCV: Hepatitis C virus; VCTE: Vibration-controlled transient elastography; SVR: Sustained viral response.

Table 4 Adverse events, hospital admissions and discontinuation rates of patients with genotype 1 hepatitis C virus infection who received 8-wk ledipasvir/sofosbuvir therapy

Adverse events	n (%)
No. adverse event, mean ± SD (Range)	0.5 ± 0.7 (0-6)
Serious adverse events	4 (0.5)
Hospital admissions
Non-cardiac chest pain	2
Drug-induced liver injury	1
Pneumonia	1
Minor adverse events
Fatigue	104 (14)
Headache	98 (13)
Insomnia	35 (5)
Arthralgia/myalgia	29 (4)
Nausea	29 (4)
Cough	15 (2)
Rash	19 (3)
Dizziness	12 (2)
Diarrhea	14 (2)
Pruritus	11 (1)
Irritability/anxiety	10 (1)
Edema	2 (< 0.5)
Discontinuation	4 (0.5)
Drug-induced liver injury	1
Severe rheumatoid arthritis exacerbation	1
Intractable nausea	1
Decreased renal function during treatment (GFR < 30)	1
Death	0

GFR: Glomerular filtration rate.