Research News

New data from Boehringer Ingelheim’s interferon-free SOUND-C3 study were presented during the APASL Liver Week in Singapore. The Phase IIb study investigated the efficacy and safety of faldaprevir+ and deleobuvir+ (BI 207127) plus ribavirin in treatment-naïve patients with genotype-1b (GT-1b) hepatitis C virus (HCV),1 one of the most common types of HCV globally.

Results showed that 95% of genotype-1b (GT-1b) infected patients (19/20) who received BI’s interferon-free combination therapy achieved viral cure after 16 weeks of treatment.1 20% (4/20) of GT-1b patients in the study had liver cirrhosis (an advanced form of liver disease), all of whom achieved viral cure.

In patients with chronic Hepatitis C virus (HCV) infection, a sustained viral response to treatment regimens 12 weeks after therapy (SVR12) is a good indicator that the response will be maintained until week 24 (SVR 24), based on an analysis of pooled clinical trial data published in the June issue of Gastroenterology. Therefore SVR12 can be used instead of SVR24 as a primary end point for registration trials.

A SVR24 (undetectable levels of HCV RNA in serum 24 weeks after completion of therapy) is considered to indicate successful treatment—most patients who achieve SVR24 maintain their serum-negative status and have reduced complications from liver disease and increased survival times.

Gilead submitted their New Drug Application (NDA) to the FDA this past Spring for several uses, indications of Sofosbuvir (GS7977) including for gt1 with SOF+Peg/Rbv for 12 weeks duration of therapy and also for Gt2/3 with SOF+Rbv for 12 weeks.

As well Janssen submitted their NDA for Simeprevir (protease)+Peg/Rbv this past Spring. Boehringer Ingelheim will soon follow in step with their NDA submission for Faldaprevir (protease)+Peg/Rbv.

Hepatitis C virus (HCV) infects more than 170 million people worldwide. Approximately 80 percent of infections lead to chronic illness including fibrosis, cirrhosis, cancer and also hepatic iron overload. A new study completed by researchers at Loyola University Chicago Stritch School of Medicine reveals that HCV not only alters expression of the iron-uptake receptor known as transferrin receptor 1 (TfR1) but that TfR1 also mediates HCV entry.

Treatments against hepatitis C virus have only been partially successful. A major problem is that antivirals generate drug resistance. Now Seong-Wook Lee of Dankook University, Yongin, Republic of Korea and his collaborators have developed agents that bind to the business end of a critical protein, disabling it so successfully that no resistance has arisen. The research is published in the June 2013 issue of the Journal of Virology.

Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced the nomination of the preclinical compound, ACH-3422, a novel small molecule nucleotide prodrug of a uridine analog designed to inhibit HCV NS5B polymerase. This compound will be advanced as a development candidate for the treatment of chronic hepatitis C (HCV) viral infection. Achillion plans to complete regulatory submissions during the first quarter of 2014, with first-in-human studies anticipated in the first half of 2014, followed by combination development in the second half of 2014.

Phase II HELIX-1 trial is first hepatitis C clinical study to commence through collaboration agreement between Janssen Pharmaceuticals Inc. and Idenix Pharmaceuticals Inc.

Medivir AB (OMX: MVIR) today announced that Idenix Pharmaceuticals Inc. has initiated a phase II clinical trial, called HELIX-1, evaluating an all-oral, direct-acting antiviral (DAA) HCV combination regimen of simeprevir, a once-daily protease inhibitor jointly developed by Medivir and Janssen R&D Ireland and samatasvir (IDX719), Idenix’s once-daily pan-genotypic NS5A inhibitor.

SeraCare Life Sciences, a provider of high quality biological materials that help optimize diagnostic performance, reliability and repeatability across the IVD lifecycle, announced it has launched three new ACCUVERT™ seroconversion panels and one new ACCUSET™ performance panel. These product additions expand the company’s offerings that assist in vitro diagnostics manufacturers in challenging new and existing assays.