Blog Posts - Genotype 1



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

AbbVie Presents Late-Breaking, Preliminary Phase 3b Data with VIEKIRAX® + EXVIERA® in Chronic Hepatitis C Patients with Renal Impairment at The International Liver Congress™ 2015

- RUBY-I evaluates treatment-naïve, non-cirrhotic, genotype 1 chronic hepatitis C patients with severe renal impairment - In preliminary data from RUBY-I, patients receiving VIEKIRAX + EXVIERA with or without ribavirin who reached post-treatment w...
by Hepatitis C Research and News on Apr 25, 2015

Janssen Announces SVR12 Rates with Twelve Weeks of Treatment with All-Oral, Once-Daily Regimen of Simeprevir Plus Sofosbuvir in Genotype 1 HCV Patients With and Without Cirrhosis

- Data from OPTIMIST-1 and OPTIMIST-2 Trials Showing SVR12 Rates of 97 Percent and 84 Percent to be Presented at The International Liver Congress™ 2015 of the European Association for the Study of the Liver - CORK, Ireland, April 23, 2015 /PRNewsw...
by Hepatitis C Research and News on Apr 23, 2015

Gilead’s Harvoni and Sovaldi Demonstrate Efficacy and Safety among Chronic Hepatitis C Patients with Advanced Liver Disease

-- High Cure Rates in More Than 600 Genotype 1 and 4 Patients With Limited or No Approved Treatment Options -- VIENNA, Austria--(BUSINESS WIRE)--Apr. 23, 2015-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from several Phase 2 clinic...
by Hepatitis C Research and News on Apr 23, 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

Ledipasvir-sofosbuvir plus ribavirin for patients with genotype 1 HCV previously treated in clinical trials of sofosbuvir regimens

Hepatology Accepted Article (Accepted, unedited articles published online and citable. The final edited and typeset version of record will appear in future.) Viral Hepatitis David Wyles1,*, Paul Pockros2, Giuseppe Morelli3, Ziad Younes4, Evguenia...
by Hepatitis C Research and News on Apr 11, 2015

Ombitasvir/Paritaprevir/r and Dasabuvir Plus Ribavirin in HCV Genotype 1-Infected Patients on Methadone or Buprenorphine

Journal of Hepatology Articles in Press Jacob Lalezari, J. Greg Sullivan, Peter Varunok, Edward Galen, Kris V. Kowdley, Vinod Rustgi, Humberto Aguilar, Franco Felizarta, Barbara McGovern, Martin King, Akshanth R. Polepally, Daniel E. Cohen DOI:...
by Hepatitis C Research and News on Apr 11, 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

An Interferon-free Antiviral Regimen for HCV after Liver Transplantation

New England Journal of Medicine Paul Y. Kwo, M.D., Parvez S. Mantry, M.D., Eoin Coakley, M.D., Helen S. Te, M.D., Hugo E. Vargas, M.D., Robert Brown, M.D., M.P.H., Fredric Gordon, M.D., Josh Levitsky, M.D., Norah A. Terrault, M.D., M.P.H., James R.
by Hepatitis C Research and News on Nov 11, 2014

Achillion Reports 100% SVR12 in a Phase 2 Combination Study With ACH-3102 at the Liver Meeting 2014 (AASLD)

- Achillion Achieves 100% SVR12 in Eight-Week Phase 2 Trial Evaluating a Ribavirin-Free Regimen of ACH-3102 and Sofosbuvir for Genotype 1 HCV ("Proxy Study") Including Nine of 12 Patients With Viral Loads Higher Than 6 Million IU/ml at Base...

OLYSIO® (simeprevir) Gains Additional FDA Approval as Once-Daily, All-Oral Interferon- and Ribavirin-Free Treatment Option in Combination with Sofosbuvir for Adults with Genotype 1 Chronic Hepatitis C Infection

--Expanded indication includes both treatment-naive and treatment-experienced adult patients with or without cirrhosis-- TITUSVILLE, N.J., Nov. 5, 2014 /PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced the U.

Re-treatment of Chronic Hepatitis C Virus Genotype 1 Infection After Relapse: An Open-Label Pilot Study Re-treatment of Chronic HCV Genotype 1 Infection After Relapse

Original Research | 4 November 2014 Anu Osinusi, MD; Anita Kohli, MD; Miriam M. Marti, BS; Amy Nelson, RN; Xiaozhen Zhang, MS; Eric G. Meissner, MD, PhD; Rachel Silk, RN; Kerry Townsend, BA; Phillip S. Pang, MD, PhD; G. Mani Subramanian, MD, PhD; Jo...

European Medicines Agency Validates Marketing Authorization Applications for AbbVie's Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 1 Chronic Hepatitis C

Jun 17, 2014 NORTH CHICAGO, Ill., June 17, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that the Marketing Authorization Applications (MAAs) for its investigational, all-oral, interferon-free regimen for the treatment of adult patients w...
by Hepatitis C Research and News on Jun 17, 2014

Should we await IFN-free regimens to treat HCV genotype 1 treatment-naive patients? A cost-effectiveness analysis (ANRS 95141)

Journal of Hepatology Volume 61, Issue 1, Pages 7–14, July 2014 Sylvie Deuffic-Burban, Michaël Schwarzinger, Dorothée Obach, Vincent Mallet, Stanislas Pol, Georges-Philippe Pageaux, Valérie Canva, Pierre Deltenre, Françoise Roudot-Thoraval,...
by Hepatitis C Research and News on Jun 16, 2014

OLYSIO™ available soon in all Nordic countries for the treatment of adults with hepatitis C genotype 1 and 4 infection

10-Jun-14 06:30 Treatment of hepatitis C patients with Olysio (simeprevir) has begun in Sweden, Finland and Denmark Stockholm, Sweden — Medivir AB (OMX: MVIR) today announces that Olysio will be available in all of the Nordic countries withi...
by Hepatitis C Research and News on Jun 15, 2014

My Treatment Approach to Chronic Hepatitis C Virus (Genotypes 1–6)

Article in Press Mitchell L. Shiffman, MD, April G. Long, NP, Amy James, FNP, Phillip Alexander, NP Published Online: May 24, 2014 DOI: http://dx.doi.org/10.1016/j.mayocp.2014.04.013 Publication stage: In Press Corrected Proof...
by Hepatitis C Research and News on Jun 14, 2014

Simeprevir approved in the European Union for the treatment of adults with hepatitis C genotype 1 and 4 infection

OLYSIO™ (Simeprevir) provides a new triple therapy treatment option, as well as the first ever 12-week interferon-free and ribavirin independent treatment regimen, in combination with sofosbuvir, for appropriate patients in Europe Stockholm, Swed...
by Hepatitis C Research and News on May 16, 2014

Janssen Submits Supplemental New Drug Application to U.S. FDA for OLYSIO™ (Simeprevir) for Once-Daily Use in Combination with Sofosbuvir for 12 Weeks for the Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C

Filing Includes Data from Treatment-Naïve Patients with Advanced Fibrosis and Null Responders with All Stages of Liver Fibrosis RARITAN, New Jersey – May 7, 2014 – Janssen Research & Development, LLC (Janssen) today announced it has submitt...

A supplemental New Drug Application has been submitted to the U.S. FDA for Simeprevir in combination with Sofosbuvir

The Supplemental New Drug Application for OLYSIO™ (simeprevir) for once-daily use in combination with sofosbuvir is for 12 Weeks treatment of adult patients with genotype 1 chronic hepatitis C. The filing includes data from treatment naïve pati...

AbbVie Submits for EU Marketing Authorization its Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Chronic Hepatitis C

May 8, 2014 -- Submission based on the largest Phase III program in genotype 1 (GT1) hepatitis C patients conducted to date[1] -- European Medicines Agency has granted AbbVie's request for accelerated assessment NORTH CHICAGO, Illinois, May 8, 201...


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