Sofosbuvir–velpatasvir plus ribavirin in Japanese patients with genotype 1 or 2 hepatitis C who failed direct-acting antivirals

Autor: Diana M. Brainard, Brian McNabb, Yasuhito Tanaka, Hidenori Toyoda, John G. McHutchison, Kazuaki Chayama, Tatsuya Ide, Gregory Camus, Yoshiyuki Ueno, Satoru Kakizaki, Koichi Takaguchi, Masashi Mizokami, Deyuan Jiang, Satoshi Mochida, Fusao Ikeda, Masayuki Kurosaki, Hirayuki Enomoto, Hiroshi Yatsuhashi, Tetsuo Takehara, Namiki Izumi, Yoshiiku Kawakami, Shampa De-Oertel, Luisa M. Stamm
Rok vydání: 2018
Předmět:
Male
Sustained Virologic Response
DAA-experienced
Administration
Oral
Hepacivirus
Gastroenterology
chemistry.chemical_compound
0302 clinical medicine
Japan
Genotype
Medicine
Treatment Failure
Aged
80 and over
NS5A inhibitor
education.field_of_study
virus diseases
Antiviral resistance
Hepatitis C
Middle Aged
030220 oncology & carcinogenesis
Original Article
Drug Therapy
Combination
Female
030211 gastroenterology & hepatology
Adult
medicine.medical_specialty
Population
Salvage therapy
Antiviral Agents
Heterocyclic Compounds
4 or More Rings
Sofosbuvir/velpatasvir
Drug Administration Schedule
NS5B polymerase inhibitor
Young Adult
03 medical and health sciences
Internal medicine
Ribavirin
Humans
Adverse effect
education
Aged
Hepatology
business.industry
Hepatitis C
Chronic
medicine.disease
Regimen
chemistry
Carbamates
Sofosbuvir
business
Zdroj: Hepatology International
ISSN: 1936-0541
1936-0533
DOI: 10.1007/s12072-018-9878-6
Popis: Background/purpose In Japan, there is a growing population of patients with chronic hepatitis C virus (HCV) infection who failed a direct-acting antiviral (DAA)-based regimen. In this Phase 3 study, we evaluated sofosbuvir–velpatasvir plus ribavirin in Japanese patients with genotype 1 or 2 HCV infection who previously received DAAs. Methods Patients were randomized 1:1 to receive sofosbuvir–velpatasvir plus ribavirin for 12 or 24 weeks. Randomization was stratified by HCV genotype and presence of cirrhosis. The primary endpoint was sustained virologic response 12-week post-treatment (SVR12). Results Of 117 participants, 81% had HCV genotype 1 infection, 33% had cirrhosis, and 95% had NS5A resistance-associated substitutions (RAS) at baseline. Overall, SVR12 rates were 97% (58/60; 95% CI 88–100%) with 24 weeks of treatment and 82% (47/57; 95% CI 70–91%) with 12 weeks. For HCV genotype 1 and 2 infected patients, the SVR12 rates with 24 weeks of treatment were 98% and 92%, respectively. In both treatment groups, SVR12 rates in HCV genotype 1 patients were statistically superior to a historical control rate of 50% (p
Databáze: OpenAIRE
Externí odkaz: