Response-Guided Telaprevir Combination Treatment for Hepatitis C Virus Infection
| Autor: | Sherman, Kenneth E, Flamm, Steven L, Afdhal, Nezam H, Nelson, David R, Sulkowski, Mark S, Everson, Gregory T, Fried, Michael W, Adler, Michael, Reesink, Hendrik W, Martin, Marie, Sankoh, Abdul J, Adda, Nathalie, Kauffman, Robert S, George, Shelley, Wright, Christopher I, Poordad, Fred, ILLUMINATE Study Team, the, Van Vlierberghe, Hans |
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| Přispěvatelé: | Gastroenterology and Hepatology |
| Rok vydání: | 2011 |
| Předmět: |
Adult
Male medicine.medical_specialty PEGINTERFERON ALPHA-2A Alpha interferon Hepacivirus Interferon alpha-2 Antiviral Agents Gastroenterology Article Polyethylene Glycols Telaprevir GENOTYPE-1 Young Adult chemistry.chemical_compound Internal medicine Boceprevir Ribavirin Medicine and Health Sciences medicine Humans Rapid Virologic Response Aged business.industry Interferon-alpha virus diseases Anemia General Medicine Hepatitis C Exanthema Middle Aged medicine.disease PLUS RIBAVIRIN Recombinant Proteins Regimen chemistry Immunology Faldaprevir Drug Therapy Combination Female business Oligopeptides medicine.drug |
| Zdroj: | NEW ENGLAND JOURNAL OF MEDICINE New England journal of medicine, 365(11), 1014-1024. Massachussetts Medical Society |
| ISSN: | 1533-4406 0028-4793 0075-8043 |
| Popis: | Background : Patients with chronic infection with hepatitis C virus (HCV) genotype 1 often need 48 weeks of peginterferon-ribavirin treatment for a sustained virologic response. We designed a noninferiority trial (noninferiority margin, -10.5%) to compare rates of sustained virologic response among patients receiving two treatment durations. Methods : We enrolled patients with chronic infection with HCV genotype 1 who had not previously received treatment. All patients received telaprevir at a dose of 750 mg every 8 hours, peginterferon alfa-2a at a dose of 180 mu g per week, and ribavirin at a dose of 1000 to 1200 mg per day, for 12 weeks (T12PR12), followed by peginterferon-ribavirin. Patients who had an extended rapid virologic response (undetectable HCV RNA levels at weeks 4 and 12) were randomly assigned after week 20 to receive the dual therapy for 4 more weeks (T12PR24) or 28 more weeks (T12PR48). Patients without an extended rapid virologic response were assigned to T12PR48. Results : Of the 540 patients, a total of 352 (65%) had an extended rapid virologic response. The overall rate of sustained virologic response was 72%. Among the 322 patients with an extended rapid virologic response who were randomly assigned to a study group, 149 (92%) in the T12PR24 group and 140 (88%) in the T12PR48 group had a sustained virologic response (absolute difference, 4 percentage points; 95% confidence interval, -2 to 11), establishing noninferiority. Adverse events included rash (in 37% of patients, severe in 5%) and anemia (in 39%, severe in 6%). Discontinuation of all the study drugs was based on adverse events in 18% of patients overall, as well as in 1% of patients (all of whom were randomly assigned) in the T12PR24 group and 12% of the patients randomly assigned to the T12PR48 group (P |
| Databáze: | OpenAIRE |
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