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.
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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)
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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
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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
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