AASLD, The Liver Meeting, hepatitis C, Hep C, HCV, sofosbuvir, simprevir, ledipasvir, Olysio, Harvoni, Sovaldi, cost-effectiveness,
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AbbVie (NYSE: ABBV) released phase III results for the investigational three direct-acting-antiviral (3D) regimen plus ribavirin in patients with chronic, genotype 1 (GT1) hepatitis C virus (HCV) infection. In the 394-patient SAPPHIRE-II study, 96 percent of patients who previously failed pegylated interferon and ribavirin treatment, including approximately 49 percent of who were prior null responders, achieved sustained virologic response at 12 weeks (SVR12) with the regimen. The majority of patients were GT1a, considered a difficult-to-treat subtype, and the SVR12 rates of GT1a and GT1b were 96 percent and 97 percent, respectively. Virologic relapse or breakthrough was noted in 2 percent of patients receiving the 3D regimen plus ribavirin. In addition, the discontinuation rate due to adverse events was 1 percent.
Globally, approximately 160 million people are chronically infected with hepatitis C. AbbVie's multinational HCV program is the largest all-oral, interferon-free clinical program in GT1 patients being conducted to date. GT1 (with subtypes 1a and 1b) is the most prevalent genotype worldwide, with a higher prevalence of 1a in the U.S. and 1b in Europe.
RESULTS FURTHER CONFIRM PHASE II STUDIES, WITH CONSISTENT VIROLOGIC RESPONSE AND TOLERABILITY PROFILE--SAPPHIRE-II IS THE SECOND OF SIX PHASE III TRIALS STUDYING THE INVESTIGATIONAL 3D REGIMEN--FUTURE DATA ANTICIPATED FROM ABBVIE'S CLINICAL TRIALS EXAMINES 3D REGIMEN WITH AND WITHOUT RIBAVIRIN, AS WELL AS TREATMENT OF HEPATITIS C IN PATIENTS WITH CIRRHOSIS-
Krishan Maggon 's insight:
Another breakthrough interferon and ribavarin free oral regiment for Hepatitis C patients. FDA and EMA approval expected next year. If priced below Gilead and J&J recently approved drugs Solvadi and Olysio then AbbVie can get better market share than rivals.
Incivek (telaprevir, Vertex, J&J) was approved by the FDA on 23 May, 2011 (PDUFA date). Victrelis (Boceprevir,...
Incivek (telaprevir, Vertex, J&J, Mitsubishi Tanabe)
The FDA approved Incivek (telaprevir, Vertex, J&J) by its PDUFA due date on 23 May, 2011. The drug was approved fot the treatment of chronic hepatitis C infection in treatment naïve, null or partial responders or relapsed patients. The safety and effectiveness of Incivek was evaluated in three phase 3 clinical trials with about 2,250 adult patients who were previously untreated, or who had received prior therapy. In all studies patients also received the drug with standard of care. In previously untreated patients, 79 percent of those receiving Incivek experienced a sustained virologic response (i.e. the infection was no longer detected in the blood 24 weeks after stopping treatment) compared to standard treatment alone.
The sustained virologic response for patients treated with Incivek across all studies, and across all patient groups, was between 20 and 45 percent higher than current standard of care.
The studies indicate that treatment with Incivek can be shortened from 48 weeks to 24 weeks in most patients. Sixty percent of previously untreated patients achieved an early response and received only 24 weeks of treatment (compared to the standard of care of 48 weeks). The sustained virologic response for these patients was 90 percent.
Incivek is a pill taken three times a day with food. Incivek should be taken for the first 12 weeks in combination with peginterferon alfa and ribavirin. Most people with a good early response to the Incivek combination regimen can be treated for 24 weeks rather than the recommended 48 weeks of treatment with the standard of care. Incivek is part of a class of drugs referred to as protease inhibitors, which work by binding to the virus and preventing it from multiplying.
The most commonly reported side effects in patients receiving Incivek in combination with peginterferon alfa and ribavirin include rash, low red blood cell count (anemia), nausea, fatigue, headache, diarrhea, itching (pruritus), and anal or rectal irritation and pain. Rash can be serious and can require stopping Incivek or all three drugs in the treatment regimen.
FDA approves Incivek for hepatitis C
Full U.S. Prescribing Information (PDF)
Financial Assistance and Patient Support Program for INCIVEK
Incivek (telaprevir) For Patients With Hepatitis C Approved By FDA
Medical News Today - 37 minutes ago
Patients with genotype 1 chronic hepatitis C with functioning but damaged livers (compensated liver disease), including cirrhosis may now be prescribed Incivek (telaprevir), which was approved today for such indications by the FDA (Food and Drug ...