Randomized phase 3 trial of ombitasvir/paritaprevir/ritonavir for hepatitis C virus genotype 1b-infected Japanese patients with or without cirrhosis.

Abstract

UNLABELLED:

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.

CONCLUSION:

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: Hiromitsu Kumada, Kazuaki Chayama, Lino Rodrigues Jr, Fumitaka Suzuki, Kenji Ikeda, Hidenori Toyoda, Ken Sato, Yoshiyasu Karino, Yasushi Matsuzaki, Kiyohide Kioka, Carolyn Setze, Tami Pilot-Matias, Meenal Patwardhan, Regis A Vilchez, Margaret Burroughs, Rebecca Redman
• Journal: Hepatology (Baltimore, Md.) (Hepatology) Vol. 62 Issue 4 Pg. 1037-46 (Oct 2015) ISSN: 1527-3350 [Electronic] United States
• PMID: 26147154 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 The Authors. Hepatology published by Wiley Periodicals, Inc., on behalf of the American Association for the Study of Liver Diseases.

Chemical References

• Anilides
• Antiviral Agents
• Carbamates
• Cyclopropanes
• Drug Combinations
• Lactams, Macrocyclic
• Macrocyclic Compounds
• Sulfonamides
• ombitasvir
• Proline
• Valine
• Ritonavir
• paritaprevir

Topics

• Aged
• Anilides (administration & dosage)
• Antiviral Agents (administration & dosage)
• Asian People
• Carbamates (administration & dosage)
• Cyclopropanes
• Double-Blind Method
• Drug Combinations
• Female
• Genotype
• Hepacivirus (classification, genetics)
• Hepatitis C, Chronic (complications, drug therapy)
• Humans
• Lactams, Macrocyclic
• Liver Cirrhosis (complications)
• Macrocyclic Compounds (administration & dosage)
• Male
• Middle Aged
• Proline (analogs & derivatives)
• Ritonavir (administration & dosage)
• Sulfonamides
• Valine