Latt NL, Yanny BT, Gharibian D, Gevorkyan R, Sahota AK. 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. World J Gastroenterol 2017; 23(26): 4759-4766 [PMID: 28765697 DOI: 10.3748/wjg.v23.i26.4759]
Corresponding Author of This Article
Nyan L Latt, MD, Transplant Hepatology Fellow, Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Mayo Clinic, 4500 San Pablo Road, Jacksonville, FL 32224, United States. latt.nyan@mayo.edu
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Retrospective Study
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
World J Gastroenterol. Jul 14, 2017; 23(26): 4759-4766 Published online Jul 14, 2017. doi: 10.3748/wjg.v23.i26.4759
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)
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
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
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
Citation: Latt NL, Yanny BT, Gharibian D, Gevorkyan R, Sahota AK. 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. World J Gastroenterol 2017; 23(26): 4759-4766