Ledipasvir/sofosbuvir for treatment-naive and treatment-experienced Chinese patients with genotype 1 HCV: an open-label, phase 3b study
| Autor: | Jun Cheng, Hong Tang, Lai Wei, Qin Ning, Shanming Wu, Jin Lin Hou, Gregory Camus, Diana M. Brainard, Qing Xie, Brian McNabb, Jidong Jia, Yuemin Nan, Peng Hu, Guozhong Gong, Guiqiang Wang, Jianning Jiang, Fangqiu Zhang, Zhuangbo Mou, Jun Li, Zhongping Duan, Anu Osinusi, Yanhang Gao, Lunli Zhang, Hongmei Mo |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Ledipasvir
Adult Male medicine.medical_specialty China Sofosbuvir Hepatitis C virus medicine.disease_cause Single-tablet regimen Antiviral Agents Drug Administration Schedule 03 medical and health sciences chemistry.chemical_compound Young Adult 0302 clinical medicine Internal medicine Drug Resistance Viral medicine Humans 030212 general & internal medicine Adverse effect Aged Fluorenes Hepatology business.industry Hepatitis C Chronic Middle Aged medicine.disease Genotype 1 Discontinuation Regimen Upper respiratory tract infection Treatment Outcome chemistry RNA Viral 030211 gastroenterology & hepatology Original Article Benzimidazoles Female Patient Safety business Uridine Monophosphate medicine.drug Tablets |
| Zdroj: | Hepatology International |
| ISSN: | 1936-0541 1936-0533 |
| Popis: | Background Chronic hepatitis C virus (HCV) infection is a significant medical burden in China, affecting more than 10 million persons. In clinical trials and real-world settings, treatment with ledipasvir/sofosbuvir in patients with genotype 1 HCV infection resulted in high sustained virologic response rates. Ledipasvir/sofosbuvir may provide a highly effective, short-duration, single-tablet regimen for Chinese patients with HCV infection. Methods Chinese patients with genotype 1 HCV infection who were HCV treatment naive or treatment experienced, without cirrhosis or with compensated cirrhosis, were treated with open-label ledipasvir/sofosbuvir for 12 weeks. The primary efficacy endpoint was sustained virologic response 12 weeks after completing treatment (SVR12). For treatment-naive patients, SVR12 was compared to a historical rate of 57%. The primary safety endpoint was adverse events leading to permanent discontinuation of study drug; serious adverse events were also evaluated. The presence of resistance-associated substitutions (RASs) was evaluated by viral sequencing. Results All 206 enrolled patients achieved SVR12 (100%; 95% CI 98–100%), including 106 treatment-naive patients (100%; 95% CI 97–100%), which was superior to a historical SVR rate of 57% (p |
| Databáze: | OpenAIRE |
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