Potent viral suppression and improvements in alpha-fetoprotein and measures of fibrosis in Japanese patients receiving a daclatasvir/asunaprevir/beclabuvir fixed-dose combination for the treatment of HCV genotype-1 infection

Background In the UNITY-3 study, 96% sustained virologic response (SVR12) rate was observed in Japanese patients with hepatitis C virus (HCV) genotype (GT)-1 infection treated for 12 weeks with fixed-dose daclatasvir, asunaprevir, and beclabuvir (DCV-TRIO). As HCV clearance may improve liver outcome...

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Bibliographic Details
Published in:Journal of gastroenterology 2018-09, Vol.53 (9), p.1089-1097
Main Authors: Akuta, Norio, Toyota, Joji, Karino, Yoshiyasu, Ikeda, Fusao, Ido, Akio, Tanaka, Katsuaki, Takaguchi, Koichi, Naganuma, Atsushi, Tomita, Eiichi, Chayama, Kazuaki, Fujiyama, Shigetoshi, Inada, Yukiko, Yoshiji, Hitoshi, Watanabe, Hideaki, Ishikawa, Hiroki, McPhee, Fiona, Noviello, Stephanie, Kumada, Hiromitsu
Format: Article
Language:English
Subjects:
Abdominal Surgery
Antiviral drugs
Aspartate
Biliary Tract
Biological products industry
Biological response modifiers
Care and treatment
Cirrhosis
Colorectal Surgery
Drug therapy, Combination
Fibrosis
Gastroenterology
Genetic aspects
Genotypes
Glycoproteins
Health aspects
Hepatitis C
Hepatitis C virus
Hepatocellular carcinoma
Hepatology
Infection
Infections
Interferon
Liver
Liver cancer
Liver cirrhosis
Liver diseases
Medicine
Medicine & Public Health
Original Article—Liver
Pancreas
Patients
Ribonucleic acid
RNA
Statistical analysis
Surgical Oncology
α-Fetoprotein
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Summary:Background In the UNITY-3 study, 96% sustained virologic response (SVR12) rate was observed in Japanese patients with hepatitis C virus (HCV) genotype (GT)-1 infection treated for 12 weeks with fixed-dose daclatasvir, asunaprevir, and beclabuvir (DCV-TRIO). As HCV clearance may improve liver outcomes, we assessed hepatic fibrosis and alpha-fetoprotein (AFP), a hepatocellular carcinoma risk marker, pre- and post-treatment in UNITY-3. Methods Treatment-naive or interferon-experienced UNITY-3 patients with HCV GT-1 who received twice-daily DCV-TRIO were assessed for fibrosis [FibroTest; FibroScan; fibrosis-4 index (FIB-4), aspartate-aminotransferase-to-platelet-ratio index] and AFP at baseline and Weeks 4 (FIB-4 only), 12 or 24 post-treatment. Results Of 217 patients, 99% had GT-1b infection, 46% were aged > 65 years, 21% had compensated cirrhosis, and 26% baseline HCV-RNA > 10 7  IU/mL. All GT-1b patients treated ≥ 4 weeks achieved SVR12 with ( n  = 54) or without ( n  = 144) baseline NS5A polymorphisms associated with DCV resistance (positions 28/30/31/93). Statistically significant post-treatment reductions from baseline were observed for all fibrosis measures and AFP, with numerically greater reductions in cirrhotic patients. FibroTest category improved in 44%, remained stable in 50%, and worsened in 6% of patients; 98% with baseline AFP
ISSN:0944-1174
1435-5922
DOI:10.1007/s00535-018-1445-3