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Exploratory study of oral combination antiviral therapy for hepatitis C.
- Source :
-
The New England journal of medicine [N Engl J Med] 2013 Jan 03; Vol. 368 (1), pp. 45-53. - Publication Year :
- 2013
-
Abstract
- Background: There is a need for interferon-free treatment regimens for hepatitis C virus (HCV) infection. The goal of this study was to evaluate ABT-450, a potent HCV NS3 protease inhibitor, combined with low-dose ritonavir (ABT-450/r), in addition to ABT-333, a nonnucleoside NS5B polymerase inhibitor, and ribavirin, for the treatment of HCV infection.<br />Methods: We conducted a 12-week, phase 2a, open-label study involving patients who had HCV genotype 1 infection without cirrhosis. All patients received ABT-333 (400 mg twice daily) and ribavirin (1000 to 1200 mg per day) and one of two daily doses of ABT-450/r. Groups 1 and 2 included previously untreated patients; group 1 received 250 mg of ABT-450 and 100 mg of ritonavir, and group 2 received 150 mg and 100 mg, respectively. Group 3, which included patients who had had a null or partial response to previous therapy with peginterferon and ribavirin, received daily doses of 150 mg of ABT-450 and 100 mg of ritonavir. The primary end point was an undetectable level of HCV RNA from week 4 through week 12 (extended rapid virologic response).<br />Results: A total of 17 of the 19 patients in group 1 (89%) and 11 of the 14 in group 2 (79%) had an extended rapid virologic response; a sustained virologic response 12 weeks after the end of treatment was achieved in 95% and 93% of the patients, respectively. In group 3, 10 of 17 patients (59%) had an extended rapid virologic response, and 8 (47%) had a sustained virologic response 12 weeks after therapy; 6 patients had virologic breakthrough, and 3 had a relapse. Adverse events included abnormalities in liver-function tests, fatigue, nausea, headache, dizziness, insomnia, pruritus, rash, and vomiting.<br />Conclusions: This preliminary study suggests that 12 weeks of therapy with a combination of a protease inhibitor, a nonnucleoside polymerase inhibitor, and ribavirin may be effective for treatment of HCV genotype 1 infection. (Funded by Abbott; ClinicalTrials.gov number, NCT01306617.).
- Subjects :
- Adult
Antiviral Agents adverse effects
Drug Therapy, Combination
Female
Genotype
Hepacivirus genetics
Hepacivirus isolation & purification
Humans
Male
Middle Aged
Protease Inhibitors adverse effects
RNA, Viral metabolism
Ribavirin adverse effects
Ritonavir adverse effects
Ritonavir therapeutic use
Viral Load
Viral Nonstructural Proteins antagonists & inhibitors
Antiviral Agents therapeutic use
Hepatitis C, Chronic drug therapy
Protease Inhibitors therapeutic use
Ribavirin therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1533-4406
- Volume :
- 368
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- The New England journal of medicine
- Publication Type :
- Academic Journal
- Accession number :
- 23281975
- Full Text :
- https://doi.org/10.1056/NEJMoa1208809