Grazoprevir and Elbasvir in Patients with Genotype 1 Hepatitis C Virus Infection: A Comprehensive Efficacy and Safety Analysis
Background. It is urgent for patients with hepatitis C virus (HCV) infection to find a safe, effective, and interferon-free regimen to optimize therapy. A comprehensive analysis was performed to evaluate the efficacy and safety of the grazoprevir combined with elbasvir, with or without ribavirin (RB...
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| Format: | Article |
| Language: | English |
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Wiley
2017-01-01
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| Series: | Canadian Journal of Gastroenterology and Hepatology |
| Online Access: | http://dx.doi.org/10.1155/2017/8186275 |
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| author | Yinan Yao Ming Yue Jie Wang Hongbo Chen Mei Liu Feng Zang Jun Li Yun Zhang Peng Huang Rongbin Yu |
| author_facet | Yinan Yao Ming Yue Jie Wang Hongbo Chen Mei Liu Feng Zang Jun Li Yun Zhang Peng Huang Rongbin Yu |
| author_sort | Yinan Yao |
| collection | DOAJ |
| description | Background. It is urgent for patients with hepatitis C virus (HCV) infection to find a safe, effective, and interferon-free regimen to optimize therapy. A comprehensive analysis was performed to evaluate the efficacy and safety of the grazoprevir combined with elbasvir, with or without ribavirin (RBV), in 777 treatment-naive and treatment-experienced patients with HCV genotype 1 infection from 3 randomized controlled trials (RCTs). Method. We collected data from the following trials: C-WORTHY (NCT01717326), C-SALVAGE (NCT02105454), and C-EDGE (NCT02105467). All patients received grazoprevir plus elbasvir with or without RBV for 12 or 18 weeks. The sustained virological response (SVR) 12 weeks after end of treatment was calculated for overall and subgroups. Results. 568 (73%) patients were treatment-naive. Overall, 95% (95% CI: 93–96) patients achieved SVR12, 95% (95% CI: 92–96) for treatment-naive and 96% (95% CI: 92–98) for previously treated patients, respectively. Treatment duration and treatment regimen did not have great difference in SVR12 rates. The most common AEs were fatigue (18%–29%), headache (20%), nausea (8%–14%), and asthenia (4%–12%). One patient (<1%) receiving grazoprevir plus elbasvir alone and one (<1%) receiving grazoprevir plus elbasvir plus RBV had treatment-related serious AEs. Conclusions. The result shows that 12-week grazoprevir plus elbasvir therapy is safe and effective for treatment-naive patients with HCV genotype 1. |
| format | Article |
| id | doaj-art-54639c4b490d401bb2412e7cb43a9399 |
| institution | Kabale University |
| issn | 2291-2789 2291-2797 |
| language | English |
| publishDate | 2017-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Canadian Journal of Gastroenterology and Hepatology |
| spelling | doaj-art-54639c4b490d401bb2412e7cb43a93992025-02-03T01:09:45ZengWileyCanadian Journal of Gastroenterology and Hepatology2291-27892291-27972017-01-01201710.1155/2017/81862758186275Grazoprevir and Elbasvir in Patients with Genotype 1 Hepatitis C Virus Infection: A Comprehensive Efficacy and Safety AnalysisYinan Yao0Ming Yue1Jie Wang2Hongbo Chen3Mei Liu4Feng Zang5Jun Li6Yun Zhang7Peng Huang8Rongbin Yu9Department of Epidemiology and Biostatistics, School of Public Health, Nanjing Medical University, Nanjing 211166, ChinaDepartment of Infectious Diseases, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, ChinaDepartment of Basic and Community Nursing, School of Nursing, Nanjing Medical University, Nanjing 211166, ChinaDepartment of Infectious Diseases, The Jurong People’s Hospital, Jurong 212400, ChinaDepartment of Epidemiology and Biostatistics, School of Public Health, Nanjing Medical University, Nanjing 211166, ChinaDepartment of Epidemiology and Biostatistics, School of Public Health, Nanjing Medical University, Nanjing 211166, ChinaDepartment of Infectious Diseases, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, ChinaDepartment of Epidemiology, Medical Institute of Nanjing Army, Nanjing 210002, ChinaDepartment of Epidemiology and Biostatistics, School of Public Health, Nanjing Medical University, Nanjing 211166, ChinaDepartment of Epidemiology and Biostatistics, School of Public Health, Nanjing Medical University, Nanjing 211166, ChinaBackground. It is urgent for patients with hepatitis C virus (HCV) infection to find a safe, effective, and interferon-free regimen to optimize therapy. A comprehensive analysis was performed to evaluate the efficacy and safety of the grazoprevir combined with elbasvir, with or without ribavirin (RBV), in 777 treatment-naive and treatment-experienced patients with HCV genotype 1 infection from 3 randomized controlled trials (RCTs). Method. We collected data from the following trials: C-WORTHY (NCT01717326), C-SALVAGE (NCT02105454), and C-EDGE (NCT02105467). All patients received grazoprevir plus elbasvir with or without RBV for 12 or 18 weeks. The sustained virological response (SVR) 12 weeks after end of treatment was calculated for overall and subgroups. Results. 568 (73%) patients were treatment-naive. Overall, 95% (95% CI: 93–96) patients achieved SVR12, 95% (95% CI: 92–96) for treatment-naive and 96% (95% CI: 92–98) for previously treated patients, respectively. Treatment duration and treatment regimen did not have great difference in SVR12 rates. The most common AEs were fatigue (18%–29%), headache (20%), nausea (8%–14%), and asthenia (4%–12%). One patient (<1%) receiving grazoprevir plus elbasvir alone and one (<1%) receiving grazoprevir plus elbasvir plus RBV had treatment-related serious AEs. Conclusions. The result shows that 12-week grazoprevir plus elbasvir therapy is safe and effective for treatment-naive patients with HCV genotype 1.http://dx.doi.org/10.1155/2017/8186275 |
| spellingShingle | Yinan Yao Ming Yue Jie Wang Hongbo Chen Mei Liu Feng Zang Jun Li Yun Zhang Peng Huang Rongbin Yu Grazoprevir and Elbasvir in Patients with Genotype 1 Hepatitis C Virus Infection: A Comprehensive Efficacy and Safety Analysis Canadian Journal of Gastroenterology and Hepatology |
| title | Grazoprevir and Elbasvir in Patients with Genotype 1 Hepatitis C Virus Infection: A Comprehensive Efficacy and Safety Analysis |
| title_full | Grazoprevir and Elbasvir in Patients with Genotype 1 Hepatitis C Virus Infection: A Comprehensive Efficacy and Safety Analysis |
| title_fullStr | Grazoprevir and Elbasvir in Patients with Genotype 1 Hepatitis C Virus Infection: A Comprehensive Efficacy and Safety Analysis |
| title_full_unstemmed | Grazoprevir and Elbasvir in Patients with Genotype 1 Hepatitis C Virus Infection: A Comprehensive Efficacy and Safety Analysis |
| title_short | Grazoprevir and Elbasvir in Patients with Genotype 1 Hepatitis C Virus Infection: A Comprehensive Efficacy and Safety Analysis |
| title_sort | grazoprevir and elbasvir in patients with genotype 1 hepatitis c virus infection a comprehensive efficacy and safety analysis |
| url | http://dx.doi.org/10.1155/2017/8186275 |
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