Tarik Asselah1,2, Stanislas Pol3, Christophe Hezode4, Veronique Loustaud-Ratti5, Vincent Leroy6, Si Nafa Si Ahmed7, Violaine Ozenne8, Jean-Pierre Bronowicki9, Dominique Larrey10, Albert Tran11,12,13, Laurent Alric14, Eric Nguyen-Khac15, Michael N Robertson16, George J Hanna16, Deborah Brown16, Ernest Asante-Appiah16, Feng-Hsiu Su16, Peggy Hwang16, Jessie Durrand Hall16, Amir Guidoum16, Karin Hagen16, Barbara A Haber16, Rohit Talwani16, Lawrence Serfaty17. 1. Department of Hepatology and Gastroenterology, University Paris Diderot, Sorbonne Paris Cité, CRI, UMR 1149 INSERM, Paris, France. 2. Department of Hepatology, AP-HP Hôpital Beaujon, Clichy, France. 3. Department of Hepatology, APHP Hôpital Cochin/Université Paris Descartes/INSERM U1223, Institut Pasteur, Paris, France. 4. Department of Hepatology, Henri Mondor Hospital, APHP, University of Paris-Est, INSERM U955, Créteil, France. 5. Department of Hepatology and Gastroenterology, CHU de Limoges, U850 INSERM, Université Limoges, Limoges, France. 6. CHU de Grenoble Alpes, Grenoble, France. 7. Department of Hepatology and Gastroenterology, Pȏle de Recherche Clinique, Hôpital Saint Joseph, Marseille, France. 8. Department of Hepatology and Gastroenterology, Hôpital Saint Antoine, Paris, France. 9. Department of Hepatology and Gastroenterology, CHU de Nancy, Nancy, France. 10. Department of Hepatology, Hôpital Saint Eloi, Ecole de Médecine de Montpellier, Montpellier, France. 11. Department of Gastroenterology, Université Côte d'Azur, Nice, France. 12. Centre Digestif, CHU de Nice, Nice, France. 13. INSERM, U1065, C3M, Team 8, Nice, France. 14. Department of Internal Medicine/Gastroenterology, CHU de Toulouse, Toulouse, France. 15. Department of Hepatology and Gastroenterology, CHU de Amiens, Amiens, France. 16. Department of Infectious Diseases, Merck & Co., Inc., Kenilworth, NJ, USA. 17. Department of Hepatology, Hôpital de Hautepierre, Universitaires de Strasbourg, Strasbourg, France.
Abstract
BACKGROUND & AIMS: Hepatitis C virus (HCV) genotype (GT) 4 infection is prevalent in sub-Saharan Africa and the Middle East, particularly in Egypt. This study evaluated the safety and efficacy of elbasvir/grazoprevir administered for 8 and 12 weeks in participants with HCV GT4 infection. METHODS: In this partially randomized, open-label multicentre study conducted in France (NCT03111108; Protocol MK5172-096), treatment-naive participants with GT4 infection and F0-F2 fibrosis were randomized 2:1 to elbasvir (50 mg)/grazoprevir (100 mg) for 8 or 12 weeks. Treatment-naive participants with F3-F4 fibrosis and all treatment-experienced participants (F0-F4) were assigned to elbasvir/grazoprevir for 12 weeks. The primary endpoint was sustained virologic response (SVR) 12 weeks after the end of therapy. RESULTS: One hundred and seventeen participants were enrolled. Among treatment-naive participants with F0-F2 fibrosis, SVR was achieved by 94% (50/53) and 96% (26/27) of those receiving elbasvir/grazoprevir for 8 or 12 weeks, respectively, and four participants relapsed. In the 12-week arm, 95% (35/37) achieved SVR and two participants relapsed. NS5A resistance-associated substitutions were present at baseline and virologic failure in five of the participants with relapse. Drug-related adverse events occurred in 42% (n = 22) and 50% (n = 32) of participants receiving 8 and 12 weeks of treatment, respectively. No participant discontinued treatment owing to an adverse event. CONCLUSION: These data confirm the efficacy of elbasvir/grazoprevir administered for 12 weeks in treatment-experienced individuals with HCV GT4 infection and those with advanced fibrosis. Treatment-naive individuals with mild fibrosis can be treated effectively with an 8-week regimen.
BACKGROUND & AIMS: Hepatitis C virus (HCV) genotype (GT) 4 infection is prevalent in sub-Saharan Africa and the Middle East, particularly in Egypt. This study evaluated the safety and efficacy of elbasvir/grazoprevir administered for 8 and 12 weeks in participants with HCV GT4 infection. METHODS: In this partially randomized, open-label multicentre study conducted in France (NCT03111108; Protocol MK5172-096), treatment-naive participants with GT4 infection and F0-F2 fibrosis were randomized 2:1 to elbasvir (50 mg)/grazoprevir (100 mg) for 8 or 12 weeks. Treatment-naive participants with F3-F4 fibrosis and all treatment-experienced participants (F0-F4) were assigned to elbasvir/grazoprevir for 12 weeks. The primary endpoint was sustained virologic response (SVR) 12 weeks after the end of therapy. RESULTS: One hundred and seventeen participants were enrolled. Among treatment-naive participants with F0-F2 fibrosis, SVR was achieved by 94% (50/53) and 96% (26/27) of those receiving elbasvir/grazoprevir for 8 or 12 weeks, respectively, and four participants relapsed. In the 12-week arm, 95% (35/37) achieved SVR and two participants relapsed. NS5A resistance-associated substitutions were present at baseline and virologic failure in five of the participants with relapse. Drug-related adverse events occurred in 42% (n = 22) and 50% (n = 32) of participants receiving 8 and 12 weeks of treatment, respectively. No participant discontinued treatment owing to an adverse event. CONCLUSION: These data confirm the efficacy of elbasvir/grazoprevir administered for 12 weeks in treatment-experienced individuals with HCV GT4 infection and those with advanced fibrosis. Treatment-naive individuals with mild fibrosis can be treated effectively with an 8-week regimen.
Authors: Ahmad AlEid; Areej Al Balkhi; Adel Qutub; Shahem Abbarh; Abed AlLehibi; Abdullah Almtawa; Nawwaf Al Otaibi; Ahmed AlGhamdi; Adel AlGhamdi; Abdulrahman Alamr; Shameem Ahmad; Khalid Al Sayari; Bashaar Al Ibrahim; Abdullah AlKhathlan Journal: Saudi J Gastroenterol Date: 2022 May-Jun Impact factor: 3.214