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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

1
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.).

Abstract

BACKGROUND:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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 ClinicalTrials.gov numbers, NCT02604017 and NCT02640157 .).

PMID:
29365309
DOI:
10.1056/NEJMoa1702417
[Indexed for MEDLINE]
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