Send to

Choose Destination
N Engl J Med. 2018 Jan 25;378(4):354-369. doi: 10.1056/NEJMoa1702417.

Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.

Author information

From Goethe University Hospital, Frankfurt (S.Z.), and Medizinische Hochschule Hannover, Hannover (H.W.) - both in Germany; Queen Mary University of London, Barts Health, London (G.R.F.); AbbVie, North Chicago (S.W., A.A., J.K., B.F., R.L., T.I.N., T.P.-M., C.-W.L., R.T., F.J.M.), and Northwestern Feinberg School of Medicine, Chicago (S.F.) - both in Illinois; Liver Unit, Auckland City Hospital, Auckland (E.G.), and Christchurch Hospital and University of Otago, Christchurch (C.A.S.) - both in New Zealand; Toronto Centre for Liver Disease, University of Toronto, Toronto (J.J.F.), University of Manitoba, Winnipeg (K.K.), and LAIR Centre, Vancouver, BC (E.T.) - all in Canada; Centre de Recherche sur l'Inflammation, INSERM UMR 1149, Université Paris Diderot, Service d'hépatologie, Assistance Publique-Hôpitaux de Paris Hôpital Beaujon, Clichy (T.A.), Hôpital Saint Joseph, Marseille (M.B.), and Groupe Hospitalier Cochin-Saint Vincent de Paul, Paris (S.P.) - all in France; Ruane Medical and Liver Health Institute, Los Angeles (P.J.R.), Stanford University Division of Gastroenterology and Hepatology, Palo Alto (P.K.), and private practice, Bakersfield (F. Felizarta) - all in California; Klinika Chorób Zakaźnych i Hepatologii UM w Białymstoku, Bialystok, Poland (R.F.); the Texas Liver Institute-University of Texas Health, San Antonio (F.P.), and Baylor College of Medicine, Houston (J.V.); Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan (W.-L.C.); Kirby Institute, University of New South Wales Sydney and St. Vincent's Hospital, Sydney (G.J.D.), and Alfred Hospital, Melbourne, VIC (S.K.R.) - both in Australia; Instituto de Investigación Científica del Sur, Ponce (G.S.-A.), and University of Puerto Rico, San Juan (R.S.-M.) - both in Puerto Rico; Azienda Ospedaliera Ospedale Niguarda Ca' Granda, Milan (M.P.); Mayo Clinic, Phoenix, AZ (H.E.V.); Tel Aviv Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel (R.B.); Centro de Investigaciones Clinicas Viña del Mar, Viña del Mar, Chile (F. Fuster); and Samsung Medical Center, Seoul, South Korea (S.-W.P.).



Glecaprevir and pibrentasvir are direct-acting antiviral agents with pangenotypic activity and a high barrier to resistance. We evaluated the efficacy and safety of 8-week and 12-week courses of treatment with 300 mg of glecaprevir plus 120 mg of pibrentasvir in patients without cirrhosis who had hepatitis C virus (HCV) genotype 1 or 3 infection.


We conducted two phase 3, randomized, open-label, multicenter trials. Patients with genotype 1 infection were randomly assigned in a 1:1 ratio to receive once-daily glecaprevir-pibrentasvir for either 8 or 12 weeks. Patients with genotype 3 infection were randomly assigned in a 2:1 ratio to receive 12 weeks of treatment with either glecaprevir-pibrentasvir or sofosbuvir-daclatasvir. Additional patients with genotype 3 infection were subsequently enrolled and nonrandomly assigned to receive 8 weeks of treatment with glecaprevir-pibrentasvir. The primary end point was the rate of sustained virologic response 12 weeks after the end of treatment.


In total, 1208 patients were treated. The rate of sustained virologic response at 12 weeks among genotype 1-infected patients was 99.1% (95% confidence interval [CI], 98 to 100) in the 8-week group and 99.7% (95% CI, 99 to 100) in the 12-week group. Genotype 3-infected patients who were treated for 12 weeks had a rate of sustained virologic response at 12 weeks of 95% (95% CI, 93 to 98; 222 of 233 patients) with glecaprevir-pibrentasvir and 97% (95% CI, 93 to 99.9; 111 of 115) with sofosbuvir-daclatasvir; 8 weeks of treatment with glecaprevir-pibrentasvir yielded a rate of 95% (95% CI, 91 to 98; 149 of 157 patients). Adverse events led to discontinuation of treatment in no more than 1% of patients in any treatment group.


Once-daily treatment with glecaprevir-pibrentasvir for either 8 weeks or 12 weeks achieved high rates of sustained virologic response among patients with HCV genotype 1 or 3 infection who did not have cirrhosis. (Funded by AbbVie; ENDURANCE-1 and ENDURANCE-3 numbers, NCT02604017 and NCT02640157 .).

[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Atypon
Loading ...
Support Center