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

CORK, Ireland--(BUSINESS WIRE)--Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), today announced that clinical data for simeprevir, its NS3/4A protease inhibitor for the treatment of hepatitis C virus (HCV) infection, will be presented at The International Liver Congress™ 2015 of the European Association for the Study of the Liver (EASL) taking place in Vienna from April 22-26. Early-stage data on the investigational nucleotide analog polymerase inhibitors AL-335 and AL-516, which were recently obtained through Janssen’s acquisition of Alios BioPharma, will also be presented.

“Janssen has an extensive and ongoing clinical trial programme for hepatitis C, including confirmatory and new exploratory studies, and we look forward to sharing these results. We remain focused on investigating alternative and more immediate treatment options for patients with a high unmet need.”

Several key presentations will report on the efficacy and tolerability of simeprevir in interferon-free combination regimens in Phase 2, Phase 3 and real-world clinical settings.

“Hepatitis C remains a serious health problem. The breadth of data we are presenting at The International Liver Congress™ reinforces our commitment to reducing the significant burden of this infectious disease around the world,” said Gaston Picchio, hepatitis disease area leader, Janssen. “Janssen has an extensive and ongoing clinical trial programme for hepatitis C, including confirmatory and new exploratory studies, and we look forward to sharing these results. We remain focused on investigating alternative and more immediate treatment options for patients with a high unmet need.”

A total of 14 company-sponsored abstracts supporting Janssen’s marketed and investigational therapies for HCV will be presented, including three abstracts on simeprevir accepted as late-breaking presentations. The scope and rigor of these data underscore Janssen’s commitment to being a positive catalyst in the fight against this serious public health threat.

“These data highlight the strength of our commitment to advancing research in the area of viral hepatitis,” said Lawrence M. Blatt, Ph.D., global head therapeutics, Janssen Infectious Diseases and Vaccines, and president and chief executive officer of Alios BioPharma. “We are delighted to present additional data for simeprevir in combination with other currently available therapeutic options alongside early-stage data for our nucleotide portfolio.”

Studies on Janssen’s HCV portfolio to be presented at The International Liver Congress™ 2015 include:

 
Late-Breaking Poster Presentations
All posters will be displayed electronically from Thursday 23 April, 07:30 to Saturday 25 April, 20:00 in Hall B.

• A Phase 3, randomised, open-label study to evaluate the efficacy and safety of 12 and 8 weeks of simeprevir (SMV) plus sofosbuvir (SOF)▼ in treatment-naïve and -experienced patients with chronic HCV genotype 1 infection without cirrhosis: The OPTIMIST-1 study¹
  • Abstract LP14
  • Lead Author: P. Kwo; Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University, Indianapolis, IN, USA

• A Phase 3, open-label, single-arm study to evaluate the efficacy and safety of 12 weeks of simeprevir (SMV) plus sofosbuvir (SOF) in treatment-naïve or -experienced patients with chronic HCV genotype 1 infection and cirrhosis: The OPTIMIST-2 study²
  • Abstract LP04
  • Lead Author: E. Lawitz; Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX, USA

• Simeprevir (SMV) plus daclatasvir (DCV)▼ and sofosbuvir (SOF) in treatment-naïve and -experienced patients with chronic hepatitis C virus genotype 1 or 4 infection and decompensated liver disease: Interim results from the Phase 2 IMPACT study¹
  • Abstract LP07
  • Lead Author: E. Lawitz; Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX, USA

Oral Presentation

• On-treatment virologic response and tolerability of simeprevir, daclatasvir and ribavirin in patients with recurrent hepatitis C virus genotype 1b infection after orthotopic liver transplantation (OLT): Interim data from the Phase 2 SATURN Study¹
  • Abstract 0004: Thursday 23 April, 16:45 – 17:00, Hall D
  • Lead Author: X. Forns; Liver Unit, Hospital Clinic, Barcelona, Spain

Poster Presentations
All posters will be displayed electronically from Thursday 23 April, 07:30 to Saturday 25 April, 20:00 in Hall B.

• Significant drug-drug interaction between simeprevir and cyclosporine A but not tacrolimus in patients with recurrent chronic HCV infection after orthotopic liver transplantation: The SATURN study¹
  • Abstract P0834
  • Lead Author: S. Ouwerkerk-Mahadevan; Janssen Research & Development, Beerse, Belgium
• Deep sequencing analyses in HCV genotype 1-infected patients treated with simeprevir plus sofosbuvir with/without ribavirin in the COSMOS study⁶
  • Abstract P0780
  • Lead Author: B. Fevery; Janssen Infectious Diseases BVBA, Beerse, Belgium
• Effectiveness of simeprevir (SMV)-containing regimens among patients with chronic hepatitis C virus (HCV) in various U.S. practice settings: Interim analysis of the SONET study⁷
  • Abstract P0826
  • Lead Author: I. Alam; Austin Hepatitis Center, Austin, TX, USA
• Study protocol for a partly randomised, open-label Phase 2a trial of once-daily simeprevir combined with sofosbuvir for the treatment of HCV genotype 4-infected patients with or without cirrhosis (OSIRIS)⁸
  • Abstract P1346
  • Lead Author: M. El Raziky, Departments of Pediatrics, Cairo University, Cairo, Egypt
• Baseline factors associated with increased SVR rates in 123 treatment-naïve chronic HCV genotype 1 patients treated with a shortened 12-week simeprevir plus pegylated interferon and ribavirin regimen: A multivariate analysis⁹
  • Abstract P0792
  • Lead Author: T. Asselah, Beaujon Hospital, University of Paris, France
• Clinical characteristics and outcomes of chronic hepatitis C (CHC) patients treated with newer direct-acting antiviral (DAA)-based regimens from a large U.S. payer perspective¹⁰
  • Abstract P0852
  • Lead Author: N. Tandon; Janssen Scientific Affairs, LLC, Titusville, NJ, USA
• A descriptive analysis of a real-world population with chronic hepatitis C (CHC) treated with simeprevir (SMV)-and/or sofosbuvir (SOF)-based regimens: Findings from a U.S. payer database¹¹
  • Abstract P0827
  • Lead Author: J.B. Forlenza; Janssen Scientific Affairs, LLC, Titusville, NJ, USA
• Real world effectiveness and cost of simeprevir- and/or sofosbuvir-based HCV treatments: $175,000 per SVR12¹²
  • Abstract P0881
  • Lead Author: K. Bichoupan; Division of Liver Diseases, Icahn School of Medicine at the Mount Sinai Medical Center, New York, NY, USA

Alios BioPharma Poster Presentations

• Derisking the potential for mitochondrial toxicity of nucleoside analogs¹³
  • Abstract P0679
  • Lead author: Z. Jin; Alios BioPharma, San Francisco, CA, USA
• Preclinical characterization of AL-335, a potent uridine based nucleoside polymerase inhibitor for the treatment of chronic hepatitis C¹⁴
  • Abstract P0682
  • Lead Author: H. Tan; Alios BioPharma, San Francisco, CA, USA

Full session details and data presentation listings for The International Liver Congress™ 2015 can be found at http://www.ilc-congress.eu.

Press Release Source: 

Study tallies huge cost of hepatitis C drugs for RI prisons

A new study finds that effective new hepatitis C drugs are so expensive the state of Rhode Island would have to spend almost twice its entire prison health budget to treat all its chronically infected inmates. Even providing the medicine only to the very sickest inmates who will remain in custody for at least another year would exceed the state prison system's pharmacy budget more than five times over.

The budget impact analysis, published online in the Journal of Urban Health, provides detailed new evidence of the "sticker shock" that states face in battling an epidemic that affects millions of people nationwide. The prevalence of the liver disease, which is often spread via injection drug use, is especially high in prisons. Meanwhile, the U.S. Supreme Court has obliged prison systems to provide inmates with care comparable to what is available in the community.

"The big problem is, even if you just take the most advanced disease, you can't afford it with the current correctional budget," said Dr. Brian Montague, assistant professor medicine and public health at Brown University and a physician in the Division of Infectious Diseases at The Miriam Hospital, who led the study. "There was an option to defer treatment before because the [prior] treatments were significantly more toxic and the risks often outweighed the benefits. Now, with safe and highly effective treatments, morally and ethically there's no option to not treat, particularly for those with more advanced disease."

Read more.....

Action Alert: Tweet the Surgeon General!

Hello Advocates:

This is National Public Health Week and the new Surgeon General is taking questions from social media until 2:30pm Easter Time today.

There is an effort to tweet the same or similar question by advocates and patients from around the country. It would be incredibly powerful if we could all tweet something like this:

Here's a good Tweet or Facebook message to use:

With #HCV at epidemic levels in the US when will you put #hepatitis at the top of nation's public health agenda #AskTheSurgeonGeneral #NPHW

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  

NORTH CHICAGO, Ill., April 8, 2015 /PRNewswire/ -- AbbVie today announced that 29 abstracts from its ongoing hepatitis C clinical development program have been accepted for presentation during The International Liver CongressTM (ILC) 2015 in Vienna, Austria from April 22-26. Data being presented include sub-analyses of the recently approved VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets), Phase 3b studies, including a head-to-head comparison of AbbVie's three direct-acting antiviral treatment with telaprevir-based therapy and Phase 2/3 studies investigating AbbVie's combination treatment in genotype 1 (GT1) and genotype 4 (GT4). Additionally, data from Phase 1 studies of ABT-493 and ABT-530 will be presented.

"We are pleased to present new investigational data at ILC that reinforces our broad HCV clinical development program beyond the approval of VIEKIRAX + EXVIERA," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "We are studying the diverse populations seen in clinical practice and expanding our research and development, including our new HCV pipeline compounds."

AbbVie's ongoing HCV pipeline development program focuses on investigating a pan-genotypic, ribavirin (RBV)-free, once-daily treatment that may also allow for treatment durations of as little as eight weeks. Preliminary results from a Phase 2b study (n=79) of ABT-493 and ABT-530 in non-cirrhotic GT1 patients receiving the RBV-free recommended regimen for 12 weeks demonstrated a sustained virologic response rate at four weeks post treatment (SVR4) of 99 percent (n=78/79). These results, announced for the first time today, included both GT1a and GT1b, treatment-naïve and pegylated-interferon and RBV prior null responders. Patients across both study arms were randomized to receive ABT-493 (200mg) and either 120mg or 40mg of ABT-530. To date, the most common (>5 percent) adverse reactions were fatigue, headache, nausea, diarrhea and anxiety. Data from these Phase 2b studies of ABT-493 and ABT-530 will not be presented at ILC 2015, and will be released at future medical congresses.

Abstracts for AbbVie's HCV Pipeline Compounds:

• Pharmacokinetics of ABT-493 and ABT-530 is Similar in Healthy Caucasian, Chinese and Japanese Adult Subjects; Wang, T; ePoster # P0855
• Steady-state Pharmacokinetics and Safety of Co-administration of Pan-genotypic, Direct Acting Protease Inhibitor, ABT-493 with Pan-genotypic NS5A Inhibitor, ABT-530, in Healthy Adult Subjects; Lin, C; ePoster # P0715

Abstracts for Approved VIEKIRAX and EXVIERA:

• Long-Term Follow-up of Treatment-emergent Resistance-associated Variants in NS3, NS5A and NS5B with Paritaprevir/r-, Ombitasvir- and Dasabuvir-based Regimens; Krishnan, P; Oral Presentation, Viral Hepatitis C: Clinical Session, Friday, April 24 at 4:15pm–4:30pm CEST; # O057
• Implications of Baseline HCV RNA Level and Intrapatient Viral Load Variability on OBV/PTV/R + DSV 12-Weeks Treatment Outcomes; Brown, R; ePoster # LP39
• High SVR Rates Despite Multiple Negative Predictors in Genotype 1 Patients Receiving Ombitasvir/Paritaprevir/R, Dasabuvir with or without Ribavirin for 12 and 24 Weeks: Integrated Analysis of Six Phase 3 Trials; Bernstein, D; ePoster # P0781
• Pharmacokinetics of Paritaprevir, Ombitasvir, Ritonavir and Ribavirin in Subjects with HCV Genotype 4 Infection; Eckert, D; ePoster # P0823
• Improvement in Liver Function and Non-Invasive Estimates of Liver Fibrosis 48 Weeks After Treatment with Ombitasvir/Paritaprevir/R, Dasabuvir and Ribavirin in HCV Genotype 1 Patients with Cirrhosis; Wedemeyer, H; ePoster # P0808
• Pharmacokinetics of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir and Ribavirin in Subjects with HCV Genotype 1 Infection in Phase 3 Studies; Mensing, S; Khatri, A; ePoster # P0820
• Exposure-Response Analyses for Efficacy (SVR12) for the Direct Acting Antiviral Regimen of ABT-450/R, Ombitasvir with Dasabuvir ± Ribavirin in Subjects with HCV Genotype 1 Infection; Khatri, A; ePoster # P0902
• Adherence to Ombitasvir/Paritaprevir/R, Dasabuvir, and Ribavirin is >98% in the SAPPHIRE-I and SAPPHIRE-II Trials; Hassanein, T; ePoster # P0908

Abstracts for Phase 3b Program:

• Safety of Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir for Treating HCV GT1 Infection in Patients with Severe Renal Impairment or End-stage Renal Disease: The RUBY-I Study; Pockros, P; Oral Presentation, Late Breakers Session, Saturday, April 25 at 4:00pm–4:15pm CEST
• MALACHITE-I: Phase 3b Trial of Ombitasvir/Paritaprevir/R and Dasabuvir+/-Ribavirin or Telaprevir + Peginterferon/Ribavirin in Treatment-Naïve Adults with HCV Genotype 1; Conway, B; ePoster # P0842
• MALACHITE-II: Phase 3b Trial of Ombitasvir/Paritaprevir/R and Dasabuvir + Ribavirin or Telaprevir + Peginterferon/Ribavirin in Peginterferon/Ribavirin Treatment-Experienced Adults with HCV Genotype 1; Dore, G; ePoster # P0847
• Phase 3b Studies to Assess Long-term Clinical Outcomes in HCV GT1-Infected Patients Treated with Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with or without Ribavirin; Dumas, E; ePoster # P1331

Abstracts for AbbVie's HCV Investigational Treatment:

• Ombitasvir/Paritaprevir/Ritonavir for Treatment of HCV Genotype 1b in Japanese Patients with or without Cirrhosis: Results from GIFT-I; Sato, K; Rodrigues-Jr, L; Oral Presentation, General Session 3 & Award Ceremony 2: Saturday, April 25 at 8:30am–8:45am CEST; # G13
• A Randomized, Open-label Study to Evaluate Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir Co-administered with Ribavirin in Adults with Genotype 4 Chronic Hepatitis C Infection and Cirrhosis; Asselah, T; ePoster # P1345
• An Open-label Study to Evaluate the Efficacy and Safety of Co-formulated Ombitasvir/Paritaprevir/Ritonavir with Ribavirin in Adults with Chronic HCV Genotype 4 Infection in Egypt; Doss, W; ePoster # P1351
• No Significant Interaction Among Ombitasvir/Paritaprevir/Ritonavir ± Dasabuvir and Sofosbuvir; King, J; ePoster # P0905

Abstracts for Health Economics and Outcomes Research (HEOR) and Other AbbVie Data:

• The Public Health Value of Sparing Livers for Transplantation Through Systematic Treatment of Hepatitis C; Stevens, W; Juday, T; ePoster # P0025
• Healthcare Costs by Stage of Liver Disease in Chronic Hepatitis C Patients in the United States; Walker, D; ePoster # P0719
• The Value of Survival Benefits from Treating Hepatitis C at Different Fibrosis Stages with All-oral, Interferon-free Therapy Relative to 'Watchful Waiting'; Gonzalez, Y; ePoster # P0806
• Cost-effectiveness of Treating Different Stages of Genotype 1 Hepatitis C Virus (HCV) with AbbVie 3D (ABT-450/Ritonavir/Ombitasvir and Dasabuvir) +/- Ribavirin Compared to No Treatment in the United States; Samp, J; ePoster # P0815
• Reduction in Annual Medical Costs with Early Treatment of HCV Using AbbVie 3D (ABT-450/Ritonavir/Ombitasvir and Dasabuvir) +/- Ribavirin in the United States; Samp, J; ePoster # P0816
• Percent of Subjects Experiencing Liver Morbidity Over A Lifetime Horizon with AbbVie 3D (ABT-450/Ritonavir/Ombitasvir And Dasabuvir) Versus No Treatment; Samp, J; ePoster # P0850
• Public Health Impact of HCV Screening and Treatment in the French Baby-boomer Population; Ethgen, O; ePoster # P1245
• Impact of Pill Count on Medication Adherence During the First 12 Weeks of HIV Antiviral Treatment: Implications for HCV Treatment; Walker, D; ePoster # P0741
• The Impact of Ribavirin on Real World Adherence and Discontinuation Rates in HCV Patients Treated with Sofosbuvir + Simeprevir; Walker, D; Juday, T; ePoster # P0864    
• Ombitasvir/Paritaprevir /Ritonavir and Dasabuvir with Ribavirin (RBV) has Minimal Impact on Health-Related Quality of Life (HRQoL) Compared with Placebo During 12-Week Treatment in Treatment-Naïve Adults with Chronic Hepatitis C (CHC); Liu, Y; ePoster # P0873
• Ombitasvir/Paritaprevir /Ritonavir and Dasabuvir with Ribavirin (RBV) has Mild Impact on Health-Related Quality of Life (HRQoL) Compared with Placebo During 12-Week Treatment in Treatment-Experienced Adults with Chronic Hepatitis C (CHC); Liu, Y; ePoster # P0856

The full ILC 2015 scientific program can be found at www.ilc-congress.eu/.

Read complete press release here: 

Film Puts Hep C in the Spotlight

A film to raise awareness and increase knowledge of hepatitis C among GPs and other primary care practitioners has been launched today by the Royal College of GPs (RCGP),the Hepatitis C Trust and HCV Action.

Hepatitis C affects around 214,000 people in the UK and the virus can lead to liver disease and cancer, making it a significant public health issue.

With 90% of all patient contacts in the NHS conducted by GPs and their teams, it is likely that patients with hepatitis C will at some point be treated in general practice and wider primary care services, yet guidance from both the National Institute for Health and Care Excellence (NICE) and Public Health England suggests that more needs to be done to raise awareness levels among primary care professionals.

Editor's note:  The link to the film in the article is bad.  Please use this one instead: http://hcvaction.org.uk/resource/film-detecting-managing-hepatitis-c-primary-care

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Could An Allergy Drug Treat Hepatitis C?

An over-the-counter drug commonly used to treat allergies may one day also contribute to the treatment of hepatitis C, according to new research in mice published in the journal Science Translational Medicine.

For the last 10 years, researchers at the National Institutes of Health (NIH) and Hiroshima University have been searching for new, better drugs to treat hepatitis C, an infectious disease that attacks the liver. By screening thousands of drug compounds in a U.S. Food and Drug Administration library—many of which are already approved and on the market—the researchers have determined that a class of antihistamines may be repurposed to treat hepatitis C. The drug chlorcyclizine HCI (CCZ)—a drug that’s been approved since the 1940s—was shown to be the most promising inhibitor of the virus, the new research found.

“Current drugs against hepatitis C, although they are effective, are expensive, have side effects, and are associated with drug resistance,” says study author Dr. T. Jake Liang, a senior investigator of liver disease at NIH. “There’s definitely unmet needs in the current regime of treatment.”

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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 First Half of 2015 

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that grazoprevir/elbasvir, an investigational single tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection, has received two new Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA) for the treatment of patients with chronic HCV genotype 4 (GT4) infection, and for the treatment of chronic HCV genotype 1 (GT1) infection in patients with end stage renal disease on hemodialysis. Additionally, the company announced presentations from the broad grazoprevir/elbasvir development program at the upcoming International Liver Congress™. A total of 14 abstracts from studies evaluating grazoprevir/elbasvir are scheduled to be presented, including three from the company’s ongoing Phase 3 pivotal C-EDGE program, one from the pivotal Phase 2b/3 C-SURFER study, and seven from ongoing or completed Phase 2 studies. The range of data to be presented underscores the company’s ongoing commitment to developing an all-oral regimen with wide application across diverse patient populations. The International Liver Congress™ 2015 – the 50^th annual congress of the European Association for the Study of the Liver – is scheduled to take place at the Reed Messe Convention Center, Vienna, Austria, from April 22 – 26, 2015.

“HCV remains a global public health epidemic. At Merck, we are focused on the development of an efficacious, well-tolerated, once-daily therapy that can be used to treat multiple genotypes and a diverse population of chronic HCV patients,” said Dr. Eliav Barr, vice president, infectious diseases, Merck Research Laboratories. “Our clinical program is among the largest and most comprehensive, with studies dedicated to patient populations where significant unmet medical need still exists, such as prior treatment failures, as well as those living with co-morbid conditions, including HIV infection, chronic kidney disease and individuals on opiate substitution therapy.”

In October 2013, the FDA granted Breakthrough Therapy designation for grazoprevir/elbasvir for the treatment of patients with chronic HCV genotype 1 (GT1). In January 2015, the FDA notified Merck of its intention to rescind that Breakthrough Therapy designation. The FDA has now granted two new Breakthrough Therapy designations for grazoprevir/elbasvir; the designations are now for the treatment of patients infected with chronic HCV GT1 with end stage renal disease on hemodialysis, and patients infected with chronic HCV genotype 4 (GT4). Breakthrough Therapy designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

At The International Liver Congress 2015™, key data presentations will include:

• Primary results from the C-EDGE program, Phase 3 clinical trials evaluating grazoprevir/elbasvir (with and without ribavirin) across multiple HCV genotypes (1, 4 and 6) and diverse patient populations, including those difficult to treat, over a 12-week treatment duration
  • C-EDGE TN in treatment-naïve patients; Oral presentation, General Session 2 & Award 1, Abstract #G07, Friday, April 24, 8:30 a.m. – 8:45 a.m. CEST
  • C-EDGE CO-INFXN in patients with HCV/HIV co-infection; E-poster #P0887, Thursday, April 23 at 7:30 a.m. CEST until Saturday, April 25 at 8:00 p.m. CEST
  • C-EDGE TE in treatment-experienced (prior peg-interferon/ribavirin treatment failures); E-poster #P0886, Thursday, April 23 at 7:30 a.m. CEST until Saturday, April 25 at 8:00 p.m. CEST

• First results from C-SURFER, a Phase 2b/3 clinical trial evaluating grazoprevir/elbasvir (without ribavirin) in treatment-naïve and treatment-experienced patients with HCV genotype 1 infection and advanced chronic kidney disease
  • Late-breaking E-poster #LP02, Thursday, April 23 at 7:30 a.m. CEST until Saturday, April 25 at 8:00 p.m. CEST
• Results from C-SALVAGE, a Phase 2 clinical trial evaluating grazoprevir/elbasvir (with and without ribavirin) for chronic HCV in genotype 1 infection after failure of direct-acting antiviral (DAA) therapy, including boceprevir, telaprevir, or simeprevir
  • Oral presentation, Viral Hepatitis C Therapy session, Abstract #O001, Thursday, April 23, 4:00 p.m. – 4:15 p.m. CEST
• Results from C-SWIFT, a Phase 2 clinical trial evaluating shorter treatment durations (4, 6, 8 and 12 weeks) of grazoprevir/elbasvir plus sofosbuvir in treatment-naïve, treatment-experienced/prior treatment failure/null-response, cirrhotic and non-cirrhotic patients with genotype 1 or 3 infection
  • Oral presentation, Viral Hepatitis C Therapy session, Abstract #O006, Thursday, April 23, 5:15 p.m. – 5:30 p.m. CEST
• Phase 2 efficacy and safety results from the C-SALT clinical trial, evaluating grazoprevir/elbasvir in genotype 1 infected patients with Child-Pugh class B cirrhosis
  • Oral presentation, Viral Hepatitis C Therapy session, Abstract #O008, Thursday, April 23, 5:45 p.m. – 6:00 p.m. CEST
• Results from C-WORTHy, a Phase 2 clinical trial evaluating treatment with grazoprevir/elbasvir (with or without ribavirin) in genotype 1 and 3 infection, and in a variety of patient sub-populations including treatment-naïve, treatment-experienced, cirrhotic, non-cirrhotic, and HIV/HCV co-infected
  • C-WORTHy Part C in treatment-naïve, non-cirrhotic patients with genotype 1b infection; E-poster #P0769, Thursday, April 23 at 7:30 a.m. CEST until Saturday, April 25 at 8:00 p.m. CEST
  • C-WORTHy Part D in treatment-naïve patients with genotype 3 infection treated with ribavirin; E-poster #P0776, Thursday, April 23 at 7:30 a.m. CEST until Saturday, April 25 at 8:00 p.m. CEST
  • C-WORTHy resistance analysis of virologic failures in hepatitis C genotype 1 infected patients; E-poster #P0891, Thursday, April 23 at 7:30 a.m. CEST until Saturday, April 25 at 8:00 p.m. CEST
• Results from C-SCAPE, a Phase 2 trial evaluating the efficacy and safety of 12 weeks of grazoprevir/elbasvir (with or without ribavirin) in patients with genotype 2, 4, 5 or 6 infection
  • E-poster #P0771, Thursday, April 23 at 7:30 a.m. CEST until Saturday, April 25 at 8:00 p.m. CEST
• Results from a Phase 1 study to evaluate the interaction of novel nucleotide inhibitor MK-3682 (formerly IDX21437), with grazoprevir and NS5A inhibitor MK-8408 in healthy subjects
  • E-poster #P0824, Thursday, April 23 at 7:30 a.m. CEST until Saturday, April 25 at 8:00 p.m. CEST

About Grazoprevir/Elbasvir
Grazoprevir/elbasvir is an investigational, once-daily single tablet regimen consisting of grazoprevir (NS3/4A protease inhibitor) and elbasvir (NS5A replication complex inhibitor). As part of Merck’s broad clinical trials program, grazoprevir/elbasvir is being studied in multiple HCV genotypes and in patients with difficult-to-treat conditions such as HIV/HCV co-infection, advanced chronic kidney disease, inherited blood disorders, cirrhosis and those on opiate substitution therapy.

Read complete press release here...