NATAP: IFN-Free Future

[Guest guest]

Interferon-Free Future from Jules: The 1st orally administered HCV antiviral were approved one year ago for the hard to treat genotype 1 patients, 2 HCV protease inhibitors boceprevir & telaprevir were approved to be used in combination with pegIFN+RBV. SVR (cure) rates went up to about 70-75% in phase 3 studies from about 20-45% with pegIFN=RBV, and of note SVR rates in African-Americans wit the new triple therapies doubled & tripled. Now 4 new oral HCV drugs are currently in phase 3- 2 once-daily protease inhibitors, TMC435, BI335, and the 1st drugs in 2 new classes of HCV drugs: nucleotide GS7977 and NS5A inhibitor BMS052. This sets up a situation where in 1 years 3 oral drugs could be used in a combination therapy and they could also be used in combination with pegIFN & RBV for null responders. We have small studies presented at EASL in April, see below, where BMS052+GS7977 in 40 genotype 1 treatment-naive patients who did not have advanced disease achieved 100% SVR rates. 2 studies by Abbott using their HCV protease ABT-450 + their HCV NNRTI + Rbv provided 93-95% SVR rates. In study now with results expected soon is the combination of TMC435+GS7977 in null responders, the hardest to treat patients. A little further back in research are numerous additional new oral HCV antivirals in all the new HCV classes: additional potent potentially 2nd generation NS5A inhibitors, additional potent nucleotides, and numerous HCV NNRTIs. Clearly the future is almost here for interferon-free therapy. If the hardest to treat null responder patients need interferon added along with RBV, lambda interferon is in late stage development now and appears to have little of the side effects associated with the current peginterferons. Its estimated 80% of people infected with HCV are undiagnosed. Screening & identifying these individuals in the USA, Europe & globally will be challenging. Governments and world health organizations are needed to provide screening, access to care and to treatment. In NYC the 1st comprehensive large scale HCV screening project was just launched. It is intended to be a model for screening globally in any city with key components necessary to support screening targeting marginalized patient populations incorporated into this model including cutting edge awareness, screening, formal linkage to care, clinic care & services, and of note webcast online weekly clinician training & case studies. Its a $2 million project conducting 5000 new/recently approved rapid HCV tests which is a key to successful care.EASL 47th Annual Meeting

Barcelona, Spain

April 18th - 22nd 2012Interferon-Free Regimens at EASL - (04/24/12)Recent Successes and Noteworthy Future Prospects in the Treatment of Chronic Hepatitis C: TOWARD AN INTERFERON-FREE FUTURE? - (06/20/12) Gilead Begins Single Pill Hepatitis C Study for 2014 Approval - (07/27/12)HCV Research: new HCV drugs coming; interferon-free therapy - (07/13/12) Global Burden of Hepatitis C: Considerations for Healthcare Providers in the United States - (06/20/12) The Impact of Chronic Hepatitis C Virus Infection on Mortality - Editorial - (07/19/12)

Chronic Hepatitis C Virus Infection Increases Mortality From Hepatic and Extrahepatic Diseases: A Community-Based Long-Term Prospective Study - (R.E.V.E.A.L.)-HCV study - (07/19/12)Mortality Due to HCV-Related Disease in HIV+ - (06/03/12) Medivir announces an interferon-free phase II combination trial with TMC435 and daclatasvir to commence shortly - (07/10/12) Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3, and GT1 - (07/13/12) Overcoming Barriers to Care for Hepatitis C - Perspective - (07/10/12) Open-Label Study of GS-7977 + Ribavirin Pre-Transplant - (06/22/12) Gilead HCV SVR Registries - (06/03/12)