Detail Response-guided telaprevir combination treatment for hepatitis C virus infection (from The New England Journal of Medicine, 2011, 365 (11), 1014-1024) Bibliografi Author: 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 Topik: Hepatitis C virus infection - Treatment; Telaprevir; Hepatitis - Drug Bahasa: (EN )     Penerbit: Massachusetts Medical Society     Tahun Terbit: 2011     Jenis: Article - diterbitkan di jurnal ilmiah internasional Fulltext: nejmoa1014463.pdf (683.34KB; 0 download) Abstract 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 µg 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<0.001). Conclusions: In this study, among patients with chronic HCV infection who had not received treatment previously, a regimen of peginterferon–ribavirin for 24 weeks, with telaprevir for the first 12 weeks, was noninferior to the same regimen for 48 weeks in patients with undetectable HCV RNA at weeks 4 and 12, with an extended rapid virologic response achieved in nearly two thirds of patients. [hepatitis - drug] Opini Anda Klik untuk menuliskan opini Anda tentang koleksi ini! Lihat Sejarah Pengadaan  Konversi Metadata   Kembali

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