Gilead Sciences this week announced sustained virological response rates from the Phase 3 ION trials testing a combination pill containing its newly approved HCV polymerase inhibitor sofosbuvir (Sovaldi) plus the NS5A inhibitor ledipasvir. Across the 3 studies, sofosbuvir/ledipasvir taken for 8 or 12 weeks cured more than 90% of treatment-naive and treatment-experienced genotype 1 patients.
مژده برای مبتلایان دو عفونت ویروسی با اچ آی وی و هپاتیت سی و یا بیماران مبتلا به ویروس هپاتیت سی. با تائید یک داروی ترکیبی جدید با نام Sofosbuvir/Ledipasvir از سوی پزشکان میتوان بیش از 90 درصد و به تائید شرکت دارویی Gilead اینک میتوان قریب به 94 درصد سخت ترین گروه هپاتیت سی ژن یک را نیز در مدت 8 هفته شفا داد.
The U.S. Food and Drug Administration this month approved sofosbuvir for use with ribavirin alone for people with HCV genotype 2 or 3, or as an add-on to pegylated interferon/ribavirin for those with genotype 1. While the agency said a longer course of sofosbuvir/ribavirin could be used for genotype 1 patients who cannot tolerate interferon, many still await more effective and shorter duration interferon-free regimens.
Gilead said it expects to request approval of the sofosbuvir/ledipasvir coformulation in early 2014, putting it on track for approval by the end of next year.
Gilead Announces SVR12 Rates From Three Phase 3 Studies Evaluating a Once-Daily Fixed-Dose Combination of Sofosbuvir and Ledipasvir for Genotype 1 Hepatitis C Patients
- High Cure Rates Observed with Single Tablet Regimen May Eliminate Interferon and Ribavirin from HCV Therapy for Genotype 1 Patients
- U.S. NDA Submission Planned for Q1 2014
Foster City, Calif. — December 18, 2013 — Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from three Phase 3 clinical trials (ION-1, ION-2 and ION-3) evaluating the investigational once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg and the NS5A inhibitor ledipasvir (LDV) 90 mg, with and without ribavirin (RBV), for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection.
Across the three studies, 1,952 patients with genotype 1 HCV infection were randomized to receive SOF/LDV with or without RBV for eight, 12 or 24 weeks of therapy. Of these, 1,512 patients were treatment-naive, 440 were treatment experienced and 224 had compensated cirrhosis.
The intent-to-treat SVR12 rates observed to date in the ION studies are summarized in the table below. Results of the 24-week arms from ION-1 will be available in the first quarter of 2014 and will be presented at a future scientific meeting.