Efficacy of the protease inhibitor BI 201335, polymerase inhibitor BI 207127, and ribavirin in patients with chronic HCV infection
| Autor: | Tarik Asselah, Stanislas Pol, Jean-Pierre Bronowicki, Dominique Larrey, Beat Müllhaupt, Markus H. Heim, Stefan Zeuzem, George Kukolj, Jerry O. Stern, Stuart K. Roberts, Gerhard Nehmiz, Peter W Angus, Keikawus Arastéh, Edward Gane, Marcus Schuchmann, Jean-Pierre Zarski, Carla Haefner, Ansgar W. Lohse, Wulf Otto Boecher, Fabien Zoulim |
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| Rok vydání: | 2011 |
| Předmět: |
Male
Aminoisobutyric Acids Genotype Proline Hepatitis C virus Hepacivirus Pharmacology Viral Nonstructural Proteins medicine.disease_cause Antiviral Agents chemistry.chemical_compound Leucine Ribavirin medicine Humans Protease inhibitor (pharmacology) Protease Inhibitors Adverse effect Hepatology business.industry Gastroenterology virus diseases Hepatitis C Hepatitis C Chronic Middle Aged Viral Load medicine.disease RNA-Dependent RNA Polymerase Rash digestive system diseases Thiazoles Treatment Outcome chemistry Acrylates Faldaprevir Quinolines RNA Viral Benzimidazoles Drug Therapy Combination Female medicine.symptom business Viral load Oligopeptides |
| Zdroj: | Gastroenterology. 141(6) |
| ISSN: | 1528-0012 |
| Popis: | Therapeutic regimens are being developed for patients with hepatitis C virus (HCV) infection that do not include the combination of peginterferon alfa and ribavirin. We investigated the antiviral effect and safety of BI 201335 (an inhibitor of the NS3/4A protease) and BI 207127 (an inhibitor of the NS5B non-nucleoside polymerase) with ribavirin.Thirty-two treatment-naïve patients with chronic HCV genotype 1 infection were randomly assigned to groups that were given 400 mg or 600 mg BI 207127 3 times daily plus 120 mg BI 201335 once daily and 1000 to 1200 mg/day ribavirin for 4 weeks. The primary efficacy end point was virologic response (HCV RNA level25 IU/mL at week 4). Thirty-two patients received treatment; 31 completed all 4 weeks of assigned combination therapy.In the group given BI 207127 400 mg 3 times daily, the rates of virologic response were 47%, 67%, and 73% at days 15, 22, and 29; a higher rate of response was observed in patients with genotype-1b compared with genotype-1a infections. In the group given BI 207127 600 mg 3 times daily, the rates of virologic response were 82%, 100%, and 100%, respectively, and did not differ among genotypes. One patient in the group given 400 mg 3 times daily had virologic breakthrough (≥1 log(10) rebound in HCV RNA) at day 22. The most frequent adverse events were mild gastrointestinal disorders, rash, and photosensitivity. There were no severe or serious adverse events; no patients discontinued therapy prematurely.The combination of the protease inhibitor BI 201335, the polymerase inhibitor BI 207127, and ribavirin has rapid and strong activity against HCV genotype-1 and did not cause serious or severe adverse events. |
| Databáze: | OpenAIRE |
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