No beneficial effect of all-trans retinoic acid in previous non-responder patients with chronic hepatitis C : The ATRACTION study, a phase II randomised trial
| Autor: | Marcus Schuchmann, Thomas Berg, Daniel Wachtlin, Peter R. Galle, Stefan Zeuzem, Tim Zimmermann, Roger Gösseringer, Wulf O. Böcher, Konrad Neumann, Jens M. Kittner, Christoph Eisenbach, Dietmar M. Klass, Rainer Günther, Jörg F. Schlaak, Christian Trautwein, Martin F. Sprinzl, Anne Ehrlich |
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| Jazyk: | angličtina |
| Rok vydání: | 2013 |
| Předmět: |
Adult
Male medicine.medical_specialty Retinoic acid Medizin Tretinoin Hepacivirus Pharmacology Antiviral Agents Gastroenterology Polyethylene Glycols chemistry.chemical_compound Chronic hepatitis Internal medicine Ribavirin medicine Clinical endpoint Humans Adverse effect Hepatology business.industry Interferon-alpha Hepatitis C Chronic Middle Aged Viral Load Recombinant Proteins Clinical trial chemistry Tolerability Drug Therapy Combination Female business medicine.drug |
| Popis: | Background Preclinical data suggested all-trans retinoic acid (tretinoin) as a potential antiviral agent against chronic hepatitis C infection. Aims To assess efficacy, safety, and tolerability of tretinoin in combination with peg-interferon and ribavirin in genotype-1 infected patients with prior non-response. Method We performed an open-label multicentre clinical trial. Patients were randomised to either receive additional tretinoin (45 mg/m 2 /day) for 12 weeks (arm A), or peg-interferon and ribavirin alone (arm B). Primary endpoint was the slope of the third phase of viral decline (M δ ) as determined in an established kinetic model known to correlate with treatment outcome. Secondary endpoints were additional kinetic parameters, viral response rates, safety, and tolerability. Results 27 patients in arm A and 30 patients in arm B were treated per protocol until week 12. Viral kinetic parameters did not differ. Rates of early virological response (>2 log 10 drop at week 12) were similar (10/27 versus 11/30 patients). In arm A, patients experienced a higher rate and intensity of adverse events, most commonly skin and mucosal dryness, and headache. Conclusion Addition of tretinoin was safe and acceptably well tolerated. However, it did not influence viral kinetics and thus cannot be further considered as a treatment option. |
| Databáze: | OpenAIRE |
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