Blog Posts - New Hcv Drugs



Merck Announces Presentation of Phase 2 Clinical Trial Results of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir at the International Liver Congress™ 2015

Results of C-SALVAGE Study Showed High Sustained Virologic Response Rates in Patients Who Failed Prior Combination Therapy with Certain Direct Acting Antiviral (DAA) Agents Results of C-SWIFT Study Provide Proof-of-Concept for Shorter Than Twelve We...
by Hepatitis C Research and News on Apr 25, 2015

Merck’s Pivotal Phase 3 C-EDGE Program Evaluating Grazoprevir/Elbasvir Shows High Sustained Virologic Responses Across Broad Range of Patients with Chronic Hepatitis C Virus Infection

Data Sets Include Treatment-Naïve, Treatment-Experienced and HIV Co-Infected Patients with Chronic Hepatitis C Virus Genotypes 1, 4 or 6 Infection Merck Remains on Track to Submit New Drug Application (NDA) to U.S. Food and Drug Administration (FDA...
by Hepatitis C Research and News on Apr 24, 2015

U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C

- The New Drug Application (NDA) was accepted by the U.S. Food and Drug Administration (FDA) and is based on results from the PEARL-I study, which demonstrated up to 100 percent sustained virologic response rates at 12 weeks post-treatment with no di...
by Hepatitis C Research and News on Apr 24, 2015

Enanta Announces U.S. FDA Grants Priority Review for AbbVie’s Investigational, All-Oral, Interferon-Free Treatment Regimen for Genotype 4 Chronic Hepatitis C Infection

April 23, 2015 08:16 AM Eastern Daylight Time WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and...
by Hepatitis C Research and News on Apr 23, 2015

Positive preclinical antiviral and safety profile of MIV-802 supports continued development

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announce that the preclinical antiviral and safety profile of MIV-802, Medivir’s wholly-owned nucleotide polymerase inhibitor under development for the treatment of hepatitis C virus (...
by Hepatitis C Research and News on Apr 23, 2015

All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study

Hepatology Volume 61, Issue 4 April 2015 Pages 1127–1135 David R. Nelson, James N. Cooper, Jacob P. Lalezari, Eric Lawitz, Paul J. Pockros, Norman Gitlin, Bradley F. Freilich, Ziad H. Younes, William Harlan, Reem Ghalib, Godson Oguchi, P...
by Hepatitis C Research and News on Apr 23, 2015

Merck Announces Results from Phase 2/3 Study of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir in Patients with Advanced Chronic Kidney Disease

C-SURFER Trial is First to Investigate an All-Oral Ribavirin-Free Hepatitis C Treatment Regimen in Treatment-Naïve and Treatment-Experienced Patients with Advanced Chronic Kidney Disease Infected with Hepatitis C Virus Genotype 1 Thursday, April 2...
by Hepatitis C Research and News on Apr 23, 2015

Gilead Announces Data for Investigational, All-Oral, Pan-Genotypic Three-Drug Regimen of Sofosbuvir, GS-5816 and GS-9857 for Chronic Hepatitis C

-- Data Support Ongoing Trials Evaluating Shortened Course of Therapy -- VIENNA, Austria--(BUSINESS WIRE)--Apr. 23, 2015-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced pre-clinical data and results from Phase 1 and Phase 2 studies supporting...
by Hepatitis C Research and News on Apr 23, 2015

A pre-EASL look at the current landscape of ongoing HCV research

Provided by citeline April 16, 2015 | Doro Shin On 26 April 2015, the International Liver Conference, also referred to as EASL, will be convening for its 50th year in Vienna. This year, the organizers offered a new abstract category named “Clinic...
by Hepatitis C Research and News on Apr 16, 2015

AbbVie's Investigational Chronic Hepatitis C Treatment Granted Priority Review in Japan

- AbbVie's investigational, interferon and ribavirin-free treatment in Japan consists of a 12-week, two direct-acting antiviral, fixed-dosed combination of paritaprevir/ritonavir with ombitasvir, dosed once daily - New Drug Application, based on...
by Hepatitis C Research and News on Apr 15, 2015

Interferon-free Regimen Effective for Genotype-4 Chronic Hepatitis C

By Will Boggs MD April 13, 2015 NEW YORK (Reuters Health) - An all-oral, interferon-free regimen consisting of ombitasvir, paritaprevir and ritonavir is effective at treating patients with genotype-4 chronic hepatitis C virus (HCV), according to a...
by Hepatitis C Research and News on Apr 14, 2015

Virological response after 6 week triple-drug regimens for hepatitis C: a proof-of-concept phase 2A cohort study

Lancet. 2015 Mar 21;385(9973):1107-13. doi: 10.1016/S0140-6736(14)61228-9. Epub 2015 Jan 13 Kohli A1, Osinusi A2, Sims Z3, Nelson A4, Meissner EG4, Barrett LL5, Bon D6, Marti MM4, Silk R7, Kotb C7, Gross C7, Jolley TA4, Sidharthan S3, Petersen T3, T...
by Hepatitis C Research and News on Apr 14, 2015

HCV cure for everyone or which challenges remain?

Journal of Virus Eradication 2015; 1: 55–58 Jürgen Kurt Rockstroh Department of Medicine I, University Hospital Bonn, Germany; German Centre for Infection Research (DZIF), partner site Bonn-Cologne, Bonn, Germany Abstract Following the approva...
by Hepatitis C Research and News on Apr 11, 2015

Revolutionizing Treatment Outcomes in Hepatitis C: Managed Care Implications and Considerations—The New and Evolving Standards of Care

Published Online: March 24, 2015 Gary M. Owens, MD Although the prevalence of hepatitis C virus (HCV) infection is declining, overall costs associated with HCV infection and the burden of advanced liver disease are projected to increase. The recent...
by Hepatitis C Research and News on Apr 11, 2015

Patient-reported Outcomes in Chronic Hepatitis C

Alimentary Pharmacology & Therapeutics Systematic Review The Impact of Liver Disease and New Treatment Regimens Z. Younossi, L. Henry Aliment Pharmacol Ther. 2015;41(6):497-520. Abstract and Introduction Abstract Background Treatment for...
by Hepatitis C Research and News on Apr 11, 2015

All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study

Hepatology. 2015 Apr;61(4):1127-35. doi: 10.1002/hep.27726. Epub 2015 Mar 10 Nelson DR1, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, Freilich BF, Younes ZH, Harlan W, Ghalib R, Oguchi G, Thuluvath PJ, Ortiz-Lasanta G, Rabinovitz M, Berns...
by Hepatitis C Research and News on Apr 10, 2015

Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous null response with or without cirrhosis (C-WORTHY): a randomised, open-label phase 2 trial

Lancet. 2015 Mar 21;385(9973):1075-86. doi: 10.1016/S0140-6736(14)61795-5. Epub 2014 Nov 11. Lawitz E1, Gane E2, Pearlman B3, Tam E4, Ghesquiere W5, Guyader D6, Alric L7, Bronowicki JP8, Lester L9, Sievert W10, Ghalib R11, Balart L12, Sund F13, Lagg...
by Hepatitis C Research and News on Apr 10, 2015

AbbVie to Present New Data from Hepatitis C Clinical Development Program at The International Liver Congress™ 2015

- 29 abstracts, including sub-analyses of AbbVie's approved treatment of VIEKIRAX® + EXVIERA®, as well as new data from Phase 3b development program and AbbVie's HCV pipeline compounds Apr 8, 2015 NORTH CHICAGO, Ill., April 8, 2015 /PRNewswire/ -...

Janssen Highlights Hepatitis C Virus Development Programme at The International Liver Congress™ 2015 of the European Association for the Study of the Liver (EASL)

Presentations include late-breaking final results from the Phase 3 OPTIMIST trials and interim results from the Phase 2 IMPACT trial of simeprevir FOR IMMEDIATE RELEASE FOR MEDICAL AND TRADE MEDIA ONLY April 09, 2015 04:00 AM Eastern Daylight Time...

Grazoprevir/Elbasvir, Merck’s Investigational Chronic Hepatitis C Therapy, Granted FDA Breakthrough Therapy Designations; New Phase 2 and 3 Data in Multiple HCV Patient Types to be Presented at The International Liver Congress™ 2015

Congress Highlights Include Results from Trials in a Wide Range of HCV Patients -- Patients with Chronic Kidney Disease, HIV Co-infection, Cirrhosis, and Prior Treatment Failures Company Remains on Track for NDA Filing with the U.S. FDA During Firs...


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