title: High Efficacy of ABT-493 and ABT-530 Treatment in Patients With HCV Genotype 1 or 3 Infection and Compensated Cirrhosis.
abstract: The combination of ABT-493 (NS3/4A protease inhibitor) plus ABT-530 (NS5A inhibitor) has shown high rates of sustained virologic response at post-treatment week 12 (SVR12) in noncirrhotic patients infected with hepatitis C virus (HCV) genotypes (GTs) 1-6. We describe 2 open-label phase 2 studies investigating the efficacy and safety of ABT-493 plus ABT-530 with or without ribavirin (RBV) in GT1- or GT3-infected patients with compensated cirrhosis.
  
  
  
  Patients with GT1 infection received 200 mg ABT-493 plus 120 mg ABT-530 for 12 weeks. Patients with GT3 infection were randomized 1:1 to receive 300 mg ABT-493 plus 120 mg ABT-530 with or without once-daily 800 mg RBV for 12 weeks; treatment-experienced patients who were not treated with RBV received 16 weeks of therapy. Efficacy was measured by SVR12, defined as an HCV-RNA level less than 25 IU/mL. Adverse events and laboratory parameters were evaluated throughout the study.
  
  
  
  Twenty-seven patients with GT1 infection and 55 patients with GT3 infection were enrolled. The majority were treatment-naive (84%) and male (65%). In patients with GT1 infection, SVR12 was achieved by 96% (26 of 27; 95% confidence interval [CI], 82-99) of patients, with 1 relapse. Among GT3-infected patients, SVR12 was achieved in 96% (27 of 28; 95% CI, 82-99) of patients in the RBV-free arm (1 relapse), and in 100% (27 of 27; 95% CI, 88-100) in the RBV-containing arm. The most common adverse events were headache, fatigue, and nausea. Laboratory abnormalities were rare; no patient discontinued treatment.
  
  
  
  In cirrhotic HCV GT1- or GT3-infected patients, ABT-493 plus ABT-530 with or without RBV achieved SVR12 rates of 96%-100% and was well tolerated. ClinicalTrials.gov identifiers NCT02243280 and NCT02243293.
authors.affiliation: University of Auckland, Auckland, New Zealand. Electronic address: edgane@adhb.govt.nz.
authors.forename: Edward
authors.initials: E
authors.lastname: Gane
authors.affiliation: Texas Liver Institute, University of Texas Health Science Center, San Antonio, Texas.
authors.forename: Fred
authors.initials: F
authors.lastname: Poordad
authors.affiliation: AbbVie, Inc, North Chicago, Illinois.
authors.forename: Stanley
authors.initials: S
authors.lastname: Wang
authors.affiliation: AbbVie, Inc, North Chicago, Illinois.
authors.forename: Armen
authors.initials: A
authors.lastname: Asatryan
authors.affiliation: Indiana University School of Medicine, Indianapolis, Indiana.
authors.forename: Paul Y
authors.initials: PY
authors.lastname: Kwo
authors.affiliation: Quest Clinical Research, San Francisco, California.
authors.forename: Jacob
authors.initials: J
authors.lastname: Lalezari
authors.affiliation: University of California San Diego, La Jolla, California.
authors.forename: David L
authors.initials: DL
authors.lastname: Wyles
authors.affiliation: Southern California GI and Liver Centers and Southern California Research Center, Coronado, California.
authors.forename: Tarek
authors.initials: T
authors.lastname: Hassanein
authors.affiliation: Louisiana Research Center, Shreveport, Louisiana.
authors.forename: Humberto
authors.initials: H
authors.lastname: Aguilar
authors.affiliation: University of Rochester Medical Center, Rochester, New York.
authors.forename: Benedict
authors.initials: B
authors.lastname: Maliakkal
authors.affiliation: AbbVie, Inc, North Chicago, Illinois.
authors.forename: Ran
authors.initials: R
authors.lastname: Liu
authors.affiliation: AbbVie, Inc, North Chicago, Illinois.
authors.forename: Chih-Wei
authors.initials: CW
authors.lastname: Lin
authors.affiliation: AbbVie, Inc, North Chicago, Illinois.
authors.forename: Teresa I
authors.initials: TI
authors.lastname: Ng
authors.affiliation: AbbVie, Inc, North Chicago, Illinois.
authors.forename: Jens
authors.initials: J
authors.lastname: Kort
authors.affiliation: AbbVie, Inc, North Chicago, Illinois.
authors.forename: Federico J
authors.initials: FJ
authors.lastname: Mensa
mesh_terms: D000621:Aminoisobutyric Acids; D000998:Antiviral Agents / Q000008:administration & dosage*; D001562:Benzimidazoles / Q000008:administration & dosage*; D003521:Cyclopropanes; D004359:Drug Therapy, Combination; D005260:Female; D005355:Fibrosis / Q000188:drug therapy* / Q000821:virology; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects* / Q000235:genetics; D006526:Hepatitis C / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D047029:Lactams, Macrocyclic; D007930:Leucine / Q000031:analogs & derivatives; D008297:Male; D008875:Middle Aged; D011392:Proline / Q000031:analogs & derivatives; D011759:Pyrrolidines / Q000008:administration & dosage*; D011810:Quinoxalines / Q000008:administration & dosage*; D012254:Ribavirin / Q000008:administration & dosage; D013449:Sulfonamides / Q000008:administration & dosage*; D000072230:Sustained Virologic Response
chemical_list: D000621:Aminoisobutyric Acids; D000998:Antiviral Agents; D001562:Benzimidazoles; D003521:Cyclopropanes; D047029:Lactams, Macrocyclic; D011759:Pyrrolidines; D011810:Quinoxalines; D013449:Sulfonamides; C000622691:pibrentasvir; D012254:Ribavirin; D011392:Proline; D007930:Leucine; C000612853:glecaprevir
keywords: Glecaprevir; Hepatitis C; Pibrentasvir; SURVEYOR