19:53 , Sep 1, 2017 |  BC Week In Review  |  Clinical News

CoCrystal reports Phase I data for HCV candidate CC-31244

CoCrystal Pharma Inc. (OTCQB:COCP) reported data from a Phase Ia/Ib trial in 42 healthy volunteers and 15 patients with HCV genotype 1 infection showing that CC-31244 led to no dose-limiting toxicities (DLTs), discontinuations due to...
20:31 , Feb 16, 2017 |  BC Week In Review  |  Clinical News

Aptima HCV Quant Dx assay regulatory update

FDA approved a PMA for Hologic’s Aptima HCV Quant Dx assay to diagnose HCV infection and monitor viral load. The in vitro nucleic acid amplification test detects and quantifies HCV RNA levels in plasma and...
01:42 , Dec 30, 2016 |  BC Week In Review  |  Clinical News

JNJ-4178: Ph IIb OMEGA-1 started

Achillion said Johnson & Johnson began the open-label, international Phase IIb OMEGA-1 trial to evaluate oral JNJ-4178 once daily for 6 or 8 weeks in about 300 patients without cirrhosis. JNJ-4178 comprises 800 mg AL-335...
07:00 , Oct 31, 2016 |  BC Week In Review  |  Clinical News

Sofosbuvir/velpatasvir/voxilaprevir: Phase III data

Top-line data from the open-label, international Phase III POLARIS-3 trial in 219 patients with chronic HCV genotype 3 infection and compensated cirrhosis who were not previously treated with a direct-acting antiviral (DAA) showed that once-daily...
07:00 , Oct 31, 2016 |  BC Week In Review  |  Clinical News

Sofosbuvir/velpatasvir/voxilaprevir: Phase III data

Top-line data from the open-label, international Phase III POLARIS-2 trial in 941 patients with chronic HCV genotypes 1-6 infection who were not previously treated with a direct-acting antiviral (DAA) showed that once-daily oral sofosbuvir/velpatasvir/voxilaprevir for...
07:00 , Oct 31, 2016 |  BC Week In Review  |  Clinical News

Cobas MPX regulatory update

FDA approved Roche’s cobas MPX test to detect HCV, HBV and HIV in donated blood and serum. The real-time PCR in vitro test detects HIV-1 Group M and O RNA, HIV-2 RNA, HCV RNA and...
07:00 , Oct 31, 2016 |  BC Week In Review  |  Clinical News

Sofosbuvir/velpatasvir/voxilaprevir: Phase III data

Top-line data from the double-blind, international Phase III POLARIS-1 trial in 415 patients with chronic HCV genotypes 1-6 infection who failed prior treatment with an HCV NS5A protein inhibitor showed that once-daily oral sofosbuvir/velpatasvir/voxilaprevir for...
07:00 , Oct 31, 2016 |  BC Week In Review  |  Clinical News

Sofosbuvir/velpatasvir/voxilaprevir: Phase III data

Top-line data from the open-label, international Phase III POLARIS-4 trial in 333 patients with chronic HCV genotypes 1-4 infection who failed prior treatment with a direct-acting antiviral (DAA) that did not include an HCV NS5A...
07:00 , May 9, 2016 |  BC Week In Review  |  Clinical News

Sofosbuvir/velpatasvir/GS-9857: Phase II data

Top-line data from the open-label, U.S. Phase II TRILOGY-3 trial in 49 DAA-experienced patients with chronic HCV genotype 1 infection with or without cirrhosis showed that once-daily 400/100/100 mg oral sofosbuvir/velpatasvir/GS-9857 with or without ribavirin...
07:00 , May 9, 2016 |  BC Week In Review  |  Clinical News

Sofosbuvir/velpatasvir: Phase III data

Top-line data from the open-label, U.S. Phase III ASTRAL-5 trial in 104 patients with chronic HCV genotype 1-6 and HIV co-infection showed that once-daily 400/100 mg oral sofosbuvir/velpatasvir for 12 weeks led to an SVR...