Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial.
Identifieur interne : 000298 ( PubMed/Corpus ); précédent : 000297; suivant : 000299Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial.
Auteurs : Michael Manns ; Henk Reesink ; Thomas Berg ; Geoffrey Dusheiko ; Robert Flisiak ; Patrick Marcellin ; Christophe Moreno ; Oliver Lenz ; Paul Meyvisch ; Monika Peeters ; Vanitha Sekar ; Kenneth Simmen ; Rene VerloesSource :
- Antiviral therapy ; 2011.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Antiviral Agents (administration & dosage), Antiviral Agents (adverse effects), Antiviral Agents (therapeutic use), Bilirubin (analysis), Double-Blind Method, Drug Therapy, Combination, Female, Genotype, Hepacivirus (drug effects), Hepatitis C (drug therapy), Hepatitis C (virology), Heterocyclic Compounds, 3-Ring (administration & dosage), Heterocyclic Compounds, 3-Ring (adverse effects), Heterocyclic Compounds, 3-Ring (therapeutic use), Humans, Interferon-alpha (administration & dosage), Interferon-alpha (therapeutic use), Male, Middle Aged, Polyethylene Glycols (administration & dosage), Polyethylene Glycols (therapeutic use), Protease Inhibitors (administration & dosage), Protease Inhibitors (adverse effects), Protease Inhibitors (therapeutic use), RNA, Viral (blood), Recombinant Proteins (administration & dosage), Recombinant Proteins (therapeutic use), Ribavirin (administration & dosage), Ribavirin (pharmacology), Ribavirin (therapeutic use), Simeprevir, Sulfonamides (administration & dosage), Sulfonamides (adverse effects), Sulfonamides (therapeutic use), Viral Load.
- MESH :
- chemical , administration & dosage : Antiviral Agents, Heterocyclic Compounds, 3-Ring, Interferon-alpha, Polyethylene Glycols, Protease Inhibitors, Recombinant Proteins, Ribavirin, Sulfonamides.
- chemical , adverse effects : Antiviral Agents, Heterocyclic Compounds, 3-Ring, Protease Inhibitors, Sulfonamides.
- chemical , analysis : Bilirubin.
- chemical , blood : RNA, Viral.
- chemical , pharmacology : Ribavirin.
- chemical , therapeutic use : Antiviral Agents, Heterocyclic Compounds, 3-Ring, Interferon-alpha, Polyethylene Glycols, Protease Inhibitors, Recombinant Proteins, Ribavirin, Sulfonamides.
- drug effects : Hepacivirus.
- drug therapy : Hepatitis C.
- virology : Hepatitis C.
- Adolescent, Adult, Aged, Double-Blind Method, Drug Therapy, Combination, Female, Genotype, Humans, Male, Middle Aged, Simeprevir, Viral Load.
Abstract
Antiviral activity of TMC435, an oral, once-daily, HCV NS3/4A protease inhibitor, was evaluated with pegylated interferon-α2a/ribavirin (P/R) in HCV genotype-1 patients.
DOI: 10.3851/IMP1894
PubMed: 22024518
Links to Exploration step
pubmed:22024518Le document en format XML
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<front><div type="abstract" xml:lang="en">Antiviral activity of TMC435, an oral, once-daily, HCV NS3/4A protease inhibitor, was evaluated with pegylated interferon-α2a/ribavirin (P/R) in HCV genotype-1 patients.</div>
</front>
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<DateCreated><Year>2011</Year>
<Month>10</Month>
<Day>25</Day>
</DateCreated>
<DateCompleted><Year>2012</Year>
<Month>04</Month>
<Day>20</Day>
</DateCompleted>
<DateRevised><Year>2015</Year>
<Month>11</Month>
<Day>19</Day>
</DateRevised>
<Article PubModel="Print"><Journal><ISSN IssnType="Electronic">2040-2058</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>16</Volume>
<Issue>7</Issue>
<PubDate><Year>2011</Year>
</PubDate>
</JournalIssue>
<Title>Antiviral therapy</Title>
<ISOAbbreviation>Antivir. Ther. (Lond.)</ISOAbbreviation>
</Journal>
<ArticleTitle>Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial.</ArticleTitle>
<Pagination><MedlinePgn>1021-33</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.3851/IMP1894</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Antiviral activity of TMC435, an oral, once-daily, HCV NS3/4A protease inhibitor, was evaluated with pegylated interferon-α2a/ribavirin (P/R) in HCV genotype-1 patients.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Optimal Protease inhibitor Enhancement of Response to TherApy (OPERA-1; TMC435-C201; NCT00561353) is a Phase IIa, randomized, placebo-controlled study. Treatment-naive patients (n=74) received 25, 75 or 200 mg TMC435 once daily, or placebo for 7 days followed by 21 days of triple therapy with P/R, or triple therapy for 28 days. Treatment-experienced patients (n=37; 56.8% with cirrhosis) received 75, 150 or 200 mg TMC435 once daily, or placebo with P/R for 28 days. Patients continued P/R up to week 48.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Treatment-naive patients who received initial monotherapy had a rapid decline in HCV RNA by day 3. At day 7, HCV RNA reductions were greatest for the 75 and 200 mg doses (0.02, -2.63, -3.43 and -4.13 log(10) IU/ml for placebo, and TMC435 25, 75 and 200 mg, respectively). At day 28, all patients who received triple therapy with TMC435 75 or 200 mg had HCV RNA<25 IU/ml versus 4/9 for placebo. In total, 18/28 treatment-experienced patients (9/9 prior relapsers, 9/19 non-responders) who received TMC435 had HCV RNA<25 IU/ml at day 28 versus 0/9 for placebo; similar results were observed for the 150 and 200 mg doses. Most adverse events were grade 1/2. No relevant changes in laboratory parameters occurred, except mild and reversible bilirubin elevations, mostly at the 200 mg dose.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Once-daily TMC435 with P/R showed potent, dose-dependent antiviral activity over 28 days, and had a favourable tolerability profile.</AbstractText>
</Abstract>
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<ForeName>Michael</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany. manns.michael@mh-hannover.de</Affiliation>
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<ForeName>Thomas</ForeName>
<Initials>T</Initials>
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<Author ValidYN="Y"><LastName>Dusheiko</LastName>
<ForeName>Geoffrey</ForeName>
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<ForeName>Robert</ForeName>
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<ForeName>Kenneth</ForeName>
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<ForeName>Rene</ForeName>
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