Document Detail

Exploratory study of oral combination antiviral therapy for hepatitis C.
MedLine Citation:
PMID:  23281975     Owner:  NLM     Status:  MEDLINE    
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.
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).
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.
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; number, NCT01306617.).
Fred Poordad; Eric Lawitz; Kris V Kowdley; Daniel E Cohen; Thomas Podsadecki; Sara Siggelkow; Michele Heckaman; Lois Larsen; Rajeev Menon; Gennadiy Koev; Rakesh Tripathi; Tami Pilot-Matias; Barry Bernstein
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study    
Journal Detail:
Title:  The New England journal of medicine     Volume:  368     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-01-03     Completed Date:  2013-01-17     Revised Date:  2013-10-30    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  45-53     Citation Subset:  AIM; IM    
University of Texas Health Science Center at San Antonio, Division of Gastroenterology and Nutrition (MC7878), 7703 Floyd Curl Dr., San Antonio, TX 78229, USA.
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MeSH Terms
Antiviral Agents / adverse effects,  therapeutic use*
Drug Therapy, Combination
Hepacivirus / genetics,  isolation & purification
Hepatitis C, Chronic / drug therapy*
Middle Aged
Protease Inhibitors / adverse effects,  therapeutic use*
RNA, Viral / metabolism
Ribavirin / adverse effects,  therapeutic use*
Ritonavir / adverse effects,  therapeutic use
Viral Load
Viral Nonstructural Proteins / antagonists & inhibitors
Reg. No./Substance:
0/Antiviral Agents; 0/NS-5 protein, hepatitis C virus; 0/NS3 protein, hepatitis C virus; 0/Protease Inhibitors; 0/RNA, Viral; 0/Ritonavir; 0/Viral Nonstructural Proteins; 36791-04-5/Ribavirin
Comment In:
J Hepatol. 2013 Oct;59(4):885-8   [PMID:  23707374 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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