Real-world efficacy and safety of ledipasvir and sofosbuvir in patients with hepatitis C virus genotype 1 infection: a nationwide multicenter study by the Japanese Red Cross Liver Study Group

Autor: Yasushi Uchida, Nami Mori, Kouji Joko, Atsunori Kusakabe, Keiji Tsuji, Ryouichi Narita, Masayuki Kurosaki, Ryou Nakata, Yuji Kojima, Namiki Izumi, Haruhiko Kobashi, Hiroyuki Kimura, Takehiro Akahane, Hitoshi Yagisawa, Akeri Mitsuda, Jun Itakura, Jirou Takezawa, Chikara Ogawa, Tamada T, Shintaro Takaki, Chitomi Hasebe, Tetsuro Sohda, Masahiko Kondou
Rok vydání: 2018
Předmět:
Liver Cirrhosis
Male
Cirrhosis
Sofosbuvir
Sustained Virologic Response
Hepacivirus
Viral Nonstructural Proteins
Gastroenterology
chemistry.chemical_compound
0302 clinical medicine
Japan
Prospective Studies
Treatment Failure
Aged
80 and over
Liver Neoplasms
Middle Aged
030220 oncology & carcinogenesis
Hepatocellular carcinoma
030211 gastroenterology & hepatology
Drug Therapy
Combination
Female
alpha-Fetoproteins
medicine.drug
Ledipasvir
Adult
Risk
medicine.medical_specialty
Carcinoma
Hepatocellular
Lower risk
Antiviral Agents
Polymorphism
Single Nucleotide
03 medical and health sciences
Young Adult
Internal medicine
medicine
Humans
Aged
Retrospective Studies
Fluorenes
business.industry
Odds ratio
Hepatology
Hepatitis C
Chronic
medicine.disease
Red Cross
digestive system diseases
chemistry
Benzimidazoles
business
Kidney disease
Zdroj: Journal of gastroenterology. 53(10)
ISSN: 1435-5922
Popis: We aimed to describe the real-world efficacy and safety of combination therapy with ledipasvir and sofosbuvir (LDV/SOF) for chronic hepatitis C virus (HCV) genotype 1 (GT1) infection. This retrospective analysis of a prospective, nationwide, multicenter registry included GT1-infected patients treated with LDV/SOF for 12 weeks. We assessed the rate of sustained virological response at 12 weeks post-treatment (SVR12), incidence of adverse events, and serum markers of hepatocellular carcinoma (HCC). Among the 1461 patients included (mean age, 69 years; 29.5% aged > 75 years; cirrhosis, 23.8%; history of treatment for HCC, 10.9%), the overall SVR12 rate was 98.4% (1438/1461). Factors associated with treatment failure were cirrhosis (odds ratio, 4.19; p = 0.014) and resistance-associated substitutions (RASs) in NS5A at baseline (odds ratio, 7.78; p = 0.0004). The SVR12 rate in patients with cirrhosis and NS5A RASs was 93.0% compared to 100% in patients without cirrhosis or NS5A RASs. In patients with SVR, the levels of alpha-fetoprotein (AFP), AFP-L3, and Mac-2 binding protein glycosylation isomer (M2BPGi) decreased from baseline to end of treatment (from 13.4 ± 37.6 to 6.0 ± 10.6 ng/mL, p
Databáze: OpenAIRE
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