ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% sustained virologic response with or without ribavirin in treatment-experienced patients with HCV genotype 1b infection.
Abstract | BACKGROUND & AIMS: METHODS: We performed a multicenter, open-label, phase 3 trial of 179 patients with HCV genotype 1b infection, without cirrhosis, previously treated with peginterferon and ribavirin. Patients were assigned randomly (1:1) to groups given ABT-450, ritonavir, ombitasvir, and dasabuvir, with ribavirin (group 1) or without (group 2) for 12 weeks. The primary end point was SVR 12 weeks after treatment (SVR12). We assessed the noninferiority of this regimen to the rate of response reported (64%) for a similar population treated with telaprevir, peginterferon, and ribavirin. RESULTS: Groups 1 and 2 each had high rates of SVR12, which were noninferior to the reported rate of response to the combination of telaprevir, peginterferon, and ribavirin (group 1: 96.6%; 95% confidence interval, 92.8%-100%; and group 2: 100%; 95% confidence interval, 95.9%-100%). The rate of response in group 2 was noninferior to that of group 1. No virologic failure occurred during the study. Two patients (1.1%) discontinued the study owing to adverse events, both in group 1. The most common adverse events in groups 1 and 2 were fatigue (31.9% vs 15.8%) and headache (24.2% vs 23.2%), respectively. Decreases in hemoglobin level to less than the lower limit of normal were more frequent in group 1 (42.0% vs 5.5% in group 2; P < .001), although only 2 patients had hemoglobin levels less than 10 g/dL. CONCLUSIONS: The interferon-free regimen of ABT-450, ritonavir, ombitasvir, and dasabuvir, with or without ribavirin, produces a high rate of SVR12 in treatment-experienced patients with HCV genotype 1b infection. Both regimens are well tolerated, as shown by the low rate of discontinuations and generally mild adverse events. ClinicalTrials.gov number: NCT01674725.
|
Authors | Pietro Andreone, Massimo G Colombo, Jeffrey V Enejosa, Iftihar Koksal, Peter Ferenci, Andreas Maieron, Beat Müllhaupt, Yves Horsmans, Ola Weiland, Henk W Reesink, Lino Rodrigues Jr, Yiran B Hu, Thomas Podsadecki, Barry Bernstein |
Journal | Gastroenterology
(Gastroenterology)
Vol. 147
Issue 2
Pg. 359-365.e1
(Aug 2014)
ISSN: 1528-0012 [Electronic] United States |
PMID | 24818763
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Video-Audio Media)
|
Copyright | Copyright © 2014 AGA Institute. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Anilides
- Antiviral Agents
- Biomarkers
- Carbamates
- Cyclopropanes
- Lactams, Macrocyclic
- Macrocyclic Compounds
- RNA, Viral
- Sulfonamides
- ombitasvir
- Ribavirin
- Uracil
- Proline
- 2-Naphthylamine
- dasabuvir
- Valine
- Ritonavir
- paritaprevir
|
Topics |
- 2-Naphthylamine
- Adult
- Aged
- Anilides
(adverse effects, therapeutic use)
- Antiviral Agents
(adverse effects, therapeutic use)
- Biomarkers
(blood)
- Carbamates
(adverse effects, therapeutic use)
- Cyclopropanes
- Drug Therapy, Combination
- Europe
- Female
- Genotype
- Hepacivirus
(drug effects, genetics, growth & development)
- Hepatitis C
(diagnosis, drug therapy)
- Humans
- Lactams, Macrocyclic
- Macrocyclic Compounds
(adverse effects, therapeutic use)
- Male
- Middle Aged
- Proline
(analogs & derivatives)
- Puerto Rico
- RNA, Viral
(blood)
- Ribavirin
(adverse effects, therapeutic use)
- Ritonavir
(adverse effects, therapeutic use)
- Sulfonamides
(adverse effects, therapeutic use)
- Time Factors
- Treatment Outcome
- United States
- Uracil
(adverse effects, analogs & derivatives, therapeutic use)
- Valine
- Viral Load
|
|
Join CureHunter, for free Research Interface BASIC access!
Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease.
Find out why thousands of doctors, pharma researchers and patient activists
around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!
|