Efficacy of Elbasvir and Grazoprevir in Participants with Hepatitis C Virus Genotype 4 Infection: A Pooled Analysis
| Autor: | Janice Wahl, Tarik Asselah, Hendrik W. Reesink, Bach-Yen Nguyen, Ernest Asante-Appiah, Michael N. Robertson, Peggy Hwang, Victor de Ledinghen, Eliav Barr, Lawrence Serfaty, Rohit Talwani, Paul J. Pockros, Jan Gerstoft |
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| Přispěvatelé: | Other departments |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Adult
Cyclopropanes Liver Cirrhosis Male medicine.medical_specialty Elbasvir Internationality Genotype Sustained Virologic Response Population Hepacivirus Antiviral Agents Young Adult 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Quinoxalines Internal medicine Drug Resistance Viral Ribavirin medicine Clinical endpoint Humans 030212 general & internal medicine NS5A education Aged Benzofurans Sulfonamides education.field_of_study Hepatology business.industry Imidazoles virus diseases Hepatitis C Hepatitis C Chronic Middle Aged medicine.disease Amides Pooled analysis Grazoprevir chemistry Drug Therapy Combination Female 030211 gastroenterology & hepatology Carbamates business |
| Zdroj: | Liver international, 38(9), 1583-1591. Wiley-Blackwell |
| ISSN: | 1478-3223 |
| Popis: | Background & aims The aim of this integrated analysis was to assess the efficacy of the once-daily combination of elbasvir 50 mg and grazoprevir 100 mg, with and without ribavirin in HCV genotype 4 (GT4)-infected participants enrolled in the Phase 2/3 clinical programme with elbasvir/grazoprevir. Methods Treatment-naive and treatment-experienced participants 18 years of age or older with chronic HCV GT4 infection and baseline HCV RNA ≥10 000 IU/mL were included in the analysis. The analysis population was the full analysis set (FAS; all participants who received at least 1 dose of study medication) and a total of 155 HCV GT4 participants were evaluated. The primary endpoint was sustained virologic response at week 12 (SVR12; HCV RNA less than the lower limit of quantitation at 12 weeks after the completion of study therapy). Results Overall, among GT4-infected participants treated with 12 or 16 weeks of elbasvir/grazoprevir ± ribavirin, the SVR12 efficacy rates were 96.4% (107/111) in treatment-naive participants and 88.6% (39/44) in treatment-experienced participants. The SVR12 rates were 96.0% (97/101) in treatment-naive participants treated with 12 weeks of elbasvir/grazoprevir and 100% (8/8) in treatment-experienced participants treated with 16 weeks of elbasvir/grazoprevir plus ribavirin. Efficacy was not impacted by GT4 subtype. Conclusions The regimens of 12 weeks of elbasvir/grazoprevir without ribavirin, and 16 weeks of elbasvir/grazoprevir plus ribavirin, were efficacious in HCV GT4-infected treatment-naive and treatment-experienced participants respectively. Baseline NS5A resistance-associated substitutions did not impact the efficacy of elbasvir/grazoprevir in GT4-infected participants. |
| Databáze: | OpenAIRE |
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