title: Randomized phase 3 trial of ombitasvir/paritaprevir/ritonavir for hepatitis C virus genotype 1b-infected Japanese patients with or without cirrhosis.
abstract: GIFT-I is a phase 3 trial evaluating the efficacy and safety of a 12-week regimen of coformulated ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) for treatment of Japanese hepatitis C virus genotype 1b-infected patients. It consists of a double-blind, placebo-controlled substudy of patients without cirrhosis and an open-label substudy of patients with compensated cirrhosis. Patients without cirrhosis were randomized 2:1 to once-daily OBV/PTV/r (25 mg/150 mg/100 mg; group A) or placebo (group B). Patients with cirrhosis received open-label OBV/PTV/r (group C). The primary efficacy endpoint was the rate of sustained virological response 12 weeks posttreatment in interferon-eligible, treatment-naive patients without cirrhosis and hepatitis C virus RNA ≥100,000 IU/mL in group A. A total of 321 patients without cirrhosis were randomized and dosed with double-blind study drug (106 received double-blind placebo and later received open-label OBV/PTV/r), and 42 patients with cirrhosis were enrolled and dosed with open-label OBV/PTV/r. In the primary efficacy population, the rate of sustained virological response 12 weeks posttreatment was 94.6% (106/112, 95% confidence interval 90.5-98.8). Sustained virological response 12 weeks posttreatment rates were 94.9% (204/215) in group A, 98.1% (104/106) in group B (open-label), and 90.5% (38/42) in group C. Overall, virological failure occurred in 3.0% (11/363) of patients who received OBV/PTV/r. The rate of discontinuation due to adverse events was 0%-2.4% in the three patient groups receiving OBV/PTV/r. The most frequent adverse event in patients in any group was nasopharyngitis.
  
  
  CONCLUSIONS
  In this broad hepatitis C virus genotype 1b-infected Japanese patient population with or without cirrhosis, treatment with OBV/PTV/r for 12 weeks was highly effective and demonstrated a favorable safety profile.
authors.affiliation: Department of Hepatology, Toranomon Hospital, Tokyo, Japan.
authors.forename: Hiromitsu
authors.initials: H
authors.lastname: Kumada
authors.affiliation: Department of Gastroenterology and Metabolism, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Chayama
authors.affiliation: AbbVie Inc., North Chicago, IL.
authors.forename: Lino
authors.initials: L
authors.lastname: Rodrigues
authors.affiliation: Department of Hepatology, Toranomon Hospital, Tokyo, Japan.
authors.forename: Fumitaka
authors.initials: F
authors.lastname: Suzuki
authors.affiliation: Department of Hepatology, Toranomon Hospital, Tokyo, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Ikeda
authors.affiliation: Department of Gastroenterology, Ogaki Municipal Hospital, Gifu, Japan.
authors.forename: Hidenori
authors.initials: H
authors.lastname: Toyoda
authors.affiliation: Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Maebashi, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Sato
authors.affiliation: Department of Gastroenterology, Sapporo Kosei General Hospital, Sapporo, Hokkaido, Japan.
authors.forename: Yoshiyasu
authors.initials: Y
authors.lastname: Karino
authors.affiliation: Department of Gastroenterology, Tokyo Medical University, Ibaraki Medical Center, Ibaraki, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Matsuzaki
authors.affiliation: Department of Hepatology Osaka City General Hospital, Osaka, Japan.
authors.forename: Kiyohide
authors.initials: K
authors.lastname: Kioka
authors.affiliation: AbbVie Inc., North Chicago, IL.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Setze
authors.affiliation: AbbVie Inc., North Chicago, IL.
authors.forename: Tami
authors.initials: T
authors.lastname: Pilot-Matias
authors.affiliation: AbbVie Inc., North Chicago, IL.
authors.forename: Meenal
authors.initials: M
authors.lastname: Patwardhan
authors.affiliation: AbbVie Inc., North Chicago, IL.
authors.forename: Regis A
authors.initials: RA
authors.lastname: Vilchez
authors.affiliation: AbbVie Inc., North Chicago, IL.
authors.forename: Margaret
authors.initials: M
authors.lastname: Burroughs
authors.affiliation: AbbVie Inc., North Chicago, IL.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Redman
mesh_terms: D000368:Aged; D000813:Anilides / Q000008:administration & dosage*; D000998:Antiviral Agents / Q000008:administration & dosage*; D044466:Asian People; D002219:Carbamates / Q000008:administration & dosage*; D003521:Cyclopropanes; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000145:classification / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D047029:Lactams, Macrocyclic; D008103:Liver Cirrhosis / Q000150:complications; D047028:Macrocyclic Compounds / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011392:Proline / Q000031:analogs & derivatives; D019438:Ritonavir / Q000008:administration & dosage*; D013449:Sulfonamides; D014633:Valine
chemical_list: D000813:Anilides; D000998:Antiviral Agents; D002219:Carbamates; D003521:Cyclopropanes; D004338:Drug Combinations; D047029:Lactams, Macrocyclic; D047028:Macrocyclic Compounds; D013449:Sulfonamides; C586094:ombitasvir; D011392:Proline; D014633:Valine; D019438:Ritonavir; C585405:paritaprevir