Film puts Hep C in the spotlight

Nursing in Practice

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
8 April, 2015 03:01 PM

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.

Danny Morris, clinical lead for the RCGP certificate in the detection, diagnosis and management of Hepatitis B and C in primary care, said: “GPs will increasingly be involved in delivering care and support to these patients, so it is vital that we raise awareness of the virus, improve education around disease prevention, improve rates of diagnosis and increase access to hepatitis C treatment throughout primary care.”

The open-access ‘Detecting and Managing Hepatitis C in Primary Care’ is available to view for free on the HCV Action website.

Abstracts Have Been Posted: International Liver Congress™ 2015 of the European Association for the Study of the Liver (EASL)

Abstracts for The International Liver Congress™ 2015 for the 50th annual meeting of the European Association for the Study of the Liver (EASL) are now available.

The meeting will take place in Vienna, Austria from April 22 – 26, 2015.

Navigating Tips For First Time Visitors
Oral and Poster Abstracts Available Online:
Download PDF - JOURNAL OF JOURNAL OF HEPATOLOGY 

HEPATOLOGY VOLUME 62, SUPPLEMENT 2, PAGES S187–S932

EASL Website

To View Or Search For Poster Abstracts

1- Click here  

2- Once you have landed on the page, click on "Show All Details" or "List"

Click "Show All Details"
3 - After the page loads, scroll past "Late Breakers"

*A link to each abstract over the course of the meeting will be listed. 

If you are primarily interested in therapy for hepatitis C scroll down near the bottom of the page.

Click "List"
An index will appear, click on:Late Breakers or Viral hepatitis: Hepatitis C

Links
Click here for updates

Click here to view the oral abstracts

For poster abstracts, click here 

EASL Website
Programme Highlights

Blog/Media - Updates

Janssen Highlights Hepatitis C Virus Development Program at The International Liver Congress™ 2015

Janssen Highlights Hepatitis C Virus Development Program 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, April 8, 2015 /PRNewswire/ -- 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.

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," saidGaston Picchio, hepatitis disease area leader, Janssen. "Janssen has an extensive and ongoing clinical trial program 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-naive and -experienced patients with chronic HCV genotype 1 infection without cirrhosis: The OPTIMIST-1 study
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-naive or -experienced patients with chronic HCV genotype 1 infection and cirrhosis: The OPTIMIST-2 study
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-naive and -experienced patients with chronic hepatitis C virus genotype 1 or 4 infection and decompensated liver disease: Interim results from the Phase 2 IMPACT study
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 Study
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 study
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 study
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 study
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)
Abstract P1346
Lead Author: M. El Raziky, Departments of Pediatrics, CairoUniversity, Cairo, Egypt
Baseline factors associated with increased SVR rates in 123 treatment-naive chronic HCV genotype 1 patients treated with a shortened 12-week simeprevir plus pegylated interferon and ribavirin regimen: A multivariate analysis
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 perspective
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 database
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 SVR12
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 analogs
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 C
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.

About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease, is a major global public health concern. Approximately 170 million people are infected with hepatitis C worldwide and 350,000 people per year die from the disease globally. When left untreated, hepatitis C can cause significant damage to the liver, including cirrhosis. Additionally, hepatitis C may increase the risk of developing complications from cirrhosis, which may include liver failure.

About Janssen's HCV Development Program
The goal of the Janssen HCV clinical development program is to provide physicians with multiple treatment options in order to offer patients the best possible chance at successful therapy.

Ongoing studies focus on the investigation of the NS3/4A protease inhibitor simeprevir in a number of different treatment combinations and HCV patient populations, including those who are difficult to cure.

Janssen's HCV pipeline also includes JNJ-56914845, an investigational NS5A replication complex inhibitor currently in Phase 2 studies, and following the acquisition of Alios BioPharma by Johnson & Johnson in November 2014, AL-335, a uridine based nucleotide analog in Phase 1 development, and AL-516, a guanosine based nucleotide analog NS5B polymerase inhibitor in pre-clinical development.

These compounds are being developed with the express intent of targeting critical steps of the hepatitis C virus replication cycle.

About Simeprevir (OLYSIO®)
Simeprevir is an NS3/4A protease inhibitor which has been developed by Janssen Sciences Ireland UC in collaboration with Medivir AB.

In November 2013, simeprevir was approved by the U.S. Food & Drug Administration and, in May 2014, it was granted marketing authorisation by the European Commission. Subsequent marketing authorisations have followed in several other countries around the world. Indications vary by market.

Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB retains marketing rights for simeprevir in these countries under the marketing authorisation held by Janssen-Cilag International NV.

Merck's Grazoprevir/Elbasvir Gets FDA Breakthrough Designation - New Data to be Presented at The International Liver Congress™ 2015

Related:
WSJ - Merck Gets Breakthrough Designation for Hepatitis C DrugsGrazoprevir, elbasvir have high cure-rate in mid-stage clinical trials

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

Wednesday, April 8, 2015 7:00 am EDT

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-SURFERstudy, 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 50thannual 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.

Merck’s Commitment to HCV

For nearly 30 years, Merck has been at the forefront of the response to the HCV epidemic. Merck employees are dedicated to applying their scientific expertise, resources and global reach to deliver innovative healthcare solutions that support people living with HCV worldwide.

About Merck

Today’s Merck is a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, Merck’s ability to complete the offering and Merck’s expectations for the use of proceeds from the offering. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions; and timing of the offering.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise except as required by applicable law. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2014 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contact:
Merck
Media:
Doris Li, 908-246-5701
Sarra Herzog, 908-740-1871
or
Investors:
Joe Romanelli, 908-740-1879
Justin Holko, 908-740-1986

AbbVie (ABBV) To Present New Data From Hepatitis C Clinical Development Program At The International Liver Congress 2015

AbbVie (ABBV) To Present New Data From Hepatitis C Clinical Development Program At The International Liver Congress 2015

NORTH CHICAGO, Ill., April 8, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) 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 4:15pm4:30pm 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 4:00pm4:15pm 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 8:30am8:45am 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/.

About VIEKIRAX® + EXVIERA®

VIEKIRAX + EXVIERA is approved in the European Union for the treatment of genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection.

VIEKIRAX consists of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily, and EXVIERA consists of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily taken with or without ribavirin, dosed twice daily. VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV, except in GT1a and GT4 patients with compensated cirrhosis, who should take it for 24 weeks.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.

Additional information about AbbVie's hepatitis C development program can be found on www.clinicaltrials.gov.

EU Indication

VIEKIRAX is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. EXVIERA is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.

Important EU Safety Information
Contraindications:

VIEKIRAX + EXVIERA are contraindicated in patients with severe hepatic impairment (Child-Pugh C). Patients taking ethinyl estradiol-containing medicinal products must discontinue them and switch to an alternative method of contraception prior to initiating VIEKIRAX + EXVIERA. Do not give VIEKIRAX with certain drugs that are sensitive CYP3A substrates or strong inhibitors of CYP3A. Do not give VIEKIRAX and EXVIERA with strong or moderate enzyme inducers. Do not give EXVIERA with certain drugs that are strong inhibitors of CYP2C8.

Special warnings and precautions for use:

VIEKIRAX and EXVIERA are not recommended as monotherapy and should be used in combination with other medicinal products for the treatment of hepatitis C infection.

Pregnancy and concomitant use with ribavirin
When VIEKIRAX + EXVIERA are used in combination with ribavirin, women of childbearing potential or their male partners must use an effective form of contraception during the treatment and 6 months after the treatment. Refer to the Summary of Product Characteristics for ribavirin for additional information.

ALT elevations
Transient elevations of ALT to >5x ULN without concomitant elevations of bilirubin occurred in clinical trials with VIEKIRAX + EXVIERA and were more frequent in a subgroup who were using ethinyl estradiol-containing contraceptives.

Use with concomitant medicinal products
Use caution when administering VIEKIRAX with fluticasone or other glucocorticoids that are metabolized by CYP3A4. A reduction in colchicine dosage or interruption in colchicine is recommended in patients with normal renal or hepatic function. VIEKIRAX with or without EXVIERA is expected to increase exposure of statins so certain statins need to be discontinued or dosages reduced. Low dose ritonavir, which is part of VIEKIRAX, may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy. HIV co-infected patients without suppressive antiretroviral therapy should not be treated with VIEKIRAX.

Adverse Reactions
Most common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with RBV were fatigue and nausea.

Full summary of product characteristics is available at www.ema.europa.eu.

Globally, prescribing information varies; refer to the individual country product label for completeinformation.

About AbbVie

AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs more than 26,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/abbvie-to-present-new-data-from-hepatitis-c-clinical-development-program-at-the-international-liver-congress-2015-300062654.html

SOURCE AbbVie

Pricing of Drugs and Formulary Placement: Making Sense of Hepatitis C Treatment

Pricing of Drugs and Formulary Placement: Making Sense of Hepatitis C Treatment
The webinar took place on Tuesday, March 31, 2015.
View the complete program, here.

Overview
Assessment of Needs
The IAS–USA offers this state-of-the-art activity as part of a nationwide CME effort for physicians on the evolving challenges of managing hepatitis C virus. This webinar will explore how insurance companies determine access to hepatitis C regimens, and what clinicians can do to help ensure that the best decisions are being made for people living with hepatitis C.

View Webinar 

Gilead Submits New Drug Application to FDA for Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide for HIV Treatment

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide for HIV Treatment

FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 7, 2015-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) for the treatment of HIV-1 infection in adults and pediatric patients age 12 years and older, in combination with other HIV antiretroviral agents.

TAF is a novel nucleotide reverse transcriptase inhibitor (NRTI) that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead's Viread® (tenofovir disoproxil fumarate, TDF), as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials.

"Gilead has a long history of innovating HIV treatments, and with F/TAF we have the potential to further optimize therapies for HIV patients who face a lifetime of antiretroviral treatment," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "With its high antiviral efficacy and favorable safety profile, F/TAF may offer an improved backbone for a new generation of HIV regimens."

Today's filing is Gilead's second F/TAF-based NDA submitted to the FDA for review. In November 2014, Gilead filed an NDA for an investigational once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF 10 mg (E/C/F/TAF). Under the Prescription Drug User Fee Act, the FDA has set a target action date of November 5, 2015. Additionally, a Marketing Authorization Application in the European Union for E/C/F/TAF was fully validated on December 23, 2014.

The F/TAF NDA is supported by data from Phase 3 clinical studies evaluating the safety and efficacy of E/C/F/TAF for the treatment of HIV-1 infection among treatment-naïve adults, in which the F/TAF-based regimen (administered as E/C/F/TAF) resulted in non-inferior efficacy and improved renal and bone laboratory parameters as compared to F/TDF-based therapy (administered as E/C/F/TDF or Stribild®). The NDA is also supported by data from additional Phase 3 studies evaluating the F/TAF-based regimen (administered as E/C/F/TAF) among treatment-naïve adolescents, virologically suppressed adults who switched regimens and adults with mild-to-moderate renal impairment. Lastly, bioequivalence studies demonstrated that the formulation of the fixed-dose combinations of F/TAF achieved the same drug levels in the blood as in E/C/F/TAF.

The recommended dose of F/TAF is 200/25 mg; if it is used in combination with a protease inhibitor that is administered with either ritonavir or cobicistat, the recommended dose is 200/10 mg.

Additional F/TAF-based regimens for HIV treatment are currently in development. In December 2014, Gilead announced the expansion of its existing agreements with Janssen Sciences Ireland UC for the development and commercialization of two new investigational once-daily single tablet regimens containing F/TAF. One combines F/TAF with Janssen's rilpivirine. The other regimen contains F/TAF, cobicistat and Janssen's darunavir.

Gilead plans to submit a regulatory application for F/TAF in the European Union in the second quarter of 2015.

F/TAF-based regimens are investigational products and have not been determined to be safe or efficacious.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility that the FDA and other regulatory authorities may not approve F/TAF, E/C/F/TAF and other F/TAF-based regimens in the currently anticipated timelines or at all, and marketing approvals, if granted, may have significant limitations on their use. As a result, F/TAF, E/C/F/TAF and other F/TAF-based regimens may never be successfully commercialized. In addition, Gilead may be unable to file for regulatory approval for F/TAF with other regulatory authorities in the currently anticipated timelines. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

U.S. full prescribing information for Viread and Stribild, including BOXED WARNINGS, is available at www.gilead.com.

Viread and Stribild are registered trademarks of Gilead Sciences, Inc., or its related companies.

For more information on Gilead Sciences, please visit the company's website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Source: Gilead Sciences, Inc.

Gilead Sciences, Inc.
Sung Lee, 650-524-7792 (Investors)
Ryan McKeel, 650-377-3548 (Media)

Hepatitis C virus recurrence after liver transplantation: A 10-year evaluation

World J Gastroenterol 2015 April 7; 21(13): 3912-3920

Copyright ©The Author(s) 2015.
Published by Baishideng Publishing Group Inc. All rights reserved.

Hepatitis C virus recurrence after liver transplantation: A 10-year evaluation
Stefano Gitto, Luca Saverio Belli, Ranka Vukotic, Stefania Lorenzini, Aldo Airoldi, Arrigo Francesco Giuseppe Cicero, Marcello Vangeli, Lucia Brodosi, Arianna Martello Panno, Roberto Di Donato, Matteo Cescon, Gian Luca Grazi, Luciano De Carlis, Antonio Daniele Pinna, Mauro Bernardi and Pietro Andreone.

Received August 7, 2014; Revised October 10, 2014; Accepted November 18, 2014;

Abstract

AIM: To evaluate the predictors of 10-year survival of patients with hepatitis C recurrence.

METHODS: Data from 358 patients transplanted between 1989 and 2010 in two Italian transplant centers and with evidence of hepatitis C recurrence were analyzed. A χ², Fisher’s exact test and Kruskal Wallis’ test were used for categorical and continuous variables, respectively. Survival analysis was performed at 10 years after transplant using the Kaplan-Meier method, and a log-rank test was used to compare groups. A P level less than 0.05 was considered significant for all tests. Multivariate analysis of the predictive role of different variables on 10-year survival was performed by a stepwise Cox logistic regression.

RESULTS: The ten-year survival of the entire population was 61.2%. Five groups of patients were identified according to the virological response or lack of a response to antiviral treatment and, among those who were not treated, according to the clinical status (mild hepatitis C recurrence, “too sick to be treated” and patients with comorbidities contraindicating the treatment). While the 10-year survival of treated and untreated patients was not different (59.1% vs 64.7%, P = 0.192), patients with a sustained virological response had a higher 10-year survival rate than both the “non-responders” (84.7% vs 39.8%, P < 0.0001) and too sick to be treated (84.7% vs 0%, P < 0.0001). Sustained virological responders had a survival rate comparable to patients untreated with mild recurrence (84.7% vs 89.3%). A sustained virological response and young donor age were independent predictors of 10-year survival.

CONCLUSION: Sustained virological response significantly increased long-term survival. Awaiting the interferon-free regimen global availability, antiviral treatment might be questionable in selected subjects with mild hepatitis C recurrence.

Keywords: Hepatitis C, Liver transplantation, Hepatitis C virus recurrence, Antiviral treatment, Ten-year survival

Core tip: 

The recurrence of hepatitis C virus (HCV) infection after liver transplantation is still a great clinical challenge. Currently, the treatment opportunities are growing with the development of new antivirals; however, in several countries, their availability will not be immediate. The decision to start treatment for HCV recurrence might be difficult in some cases, and the data on the long-term impact are extremely useful in this setting. This study reports the results of 10-year survival analysis on an Italian cohort of liver transplant cases focusing on the differences in outcomes, not only between the treated and not-treated subjects but also in specific subgroups of patients with mild recurrence and those considered too sick to be treated. 

DISCUSSION Only

View Full Text: Introduction, Tables, Results and References, here. 

Because LT is agreed to be a life-saving therapy for end-stage liver disease, HCV has become one of its leading indications. Re-infection of the graft is virtually universal and HCV recurrence after LT is a “new disease” whose clinical, virological and immunological characteristics are determined by complex, and almost unknown, interactions between patient, graft and the virus. However, it is well known that fibrosis progression is accelerated in HCV recurrence compared with the pre-LT period and a small proportion of patients (approximately 5%) show a fast and aggressive disease after LT[22]. In this context, it can be very complex to decide whether and when it is appropriate to treat the HCV recurrence.

Berenguer et al[7] compared 89 treated patients with 75 matched untreated controls and, among the treated cases, patients who achieved a SVR with subjects who did not. The authors first demonstrated that all the main measures of outcome (mortality, development of cirrhosis and decompensation) were worse for untreated patients compared to patients who were treated and for NR compared to SVR. Our study confirms the findings of Berenguer et al[7] regarding the positive role of SVR. Moreover, it offers an additional analysis focused on the long-term outcome of the broad and heterogeneous population of untreated patients, which has never been thoroughly investigated.

Our data indicate that the treatment itself was not associated with a better long-term outcome. In fact, we showed that treated and untreated patients had a comparable 10-year survival rate. However, the untreated group comprised a very inhomogeneous population. In particular, the reason for the choice not to start antiviral therapy could also be related to conditions different from a mild disease all having a distinct impact on survival, such as a too severe hepatic condition, a comorbidity (of varying severity) or the lack of compliance.

It should be acknowledged that the design of the study from Berenguer et al[7] was more appropriate as the results emerged from the comparison with a population of matched controls. Indeed, we analyzed a heterogeneous group of untreated patients, which comprised three different subgroups: (1) patients with mild HCV recurrence; (2) patients too sick to be treated; and (3) patients with comorbidities. Interestingly, untreated patients with mild HCV recurrence showed a 10-year survival rate that was comparable to treated patients achieving a SVR (89.3% vs 84.7%, respectively). Notably, patients included in the mild recurrence subgroup had no clinically relevant comorbidities nor graft malfunction and/or complications after LT. In fact, these conditions a priori can affect long-term survival.

Our data confirm that a SVR is an independent predictor of 10-year survival as only two SVR patients of 63 died of an HCV-related cause in the follow-up period. Together with achieving a SVR, our study once again confirms the impact of donor age on the severity of HCV-recurrence, the response to antiviral therapy and survival. In fact, it has been largely reported that older donor age negatively affects the progression of fibrosis in transplanted patients[23-27].

Regarding the treatment of HCV recurrence, it is important to consider the oncoming availability of DAAs. Currently, several reports on first wave PI treatment in the post-LT period are available. Recent studies reporting data on the efficacy and safety of BOC/TVR and PegIFN/RBV[28,29] showed encouraging efficacy results but also a complex side effects profile including infections, hematological and dermatological toxicity, renal failure, diabetes, drug-drug interactions with immunosuppressants and severe forms of plasma-cell hepatitis with occasional fatal outcomes[28-32]. The data on triple BOC/TVR based regimens are of great importance considering that the second/third wave DAA cost issue will continue to produce controversy for a certain amount of time in the future. Sofosbuvir, a pan-genotypic inhibitor of polymerase activity, is reported to have a good virological outcome and favorable safety profile when associated with Daclatasvir[33] or PegIFN ± RBV[18,19,34], and also in the treatment of severe HCV recurrence.

The main limitation of our study is the retrospective design. Nonetheless, this approach is a feasible one to analyze the long-term outcomes of transplanted patients. The most important issue emerging from our data is that the antiviral treatment should be undertaken in patients with moderate-severe disease because of the high risk of progression to recurrent cirrhosis, decompensation and death in the time of a few years[2,3]. Evidence has emerged from our study and many others that clearly indicate that achievement of a SVR may avoid this unfortunate course. On the other hand, our data suggest that patients with mild HCV recurrence have a very favorable long-term outcome even if untreated. Interestingly, a prospective randomized trial conducted in Italy confirms, at least partially, the observations emerging from our retrospective cohort[35]. Notably, it appears mandatory to have, in the first three years after LT, a correct histological classification for patients with HCV recurrence.

Our results can be useful in the complex decision-making process regarding whether and when to start antiviral treatment in LT recipients with HCV recurrence. This is even more important today with the availability of new DAAs, whose inappropriate use can dramatically increase costs, adverse event rates, drug-drug interactions and the risk of a virological resistance outbreak. 

Finally, the results from our cohort reveal that a certain rate of mortality in post-LT HCV recurrence concerns patients with comorbidities that are often considered as contraindications to antiviral treatment. Along with the availability of antiviral agents with a low-toxicity profile, the limitations related to the patients’ eligibility for the treatment are expected to be reassessed. Furthermore, according to recent compassionate program derived results, the antiviral treatment will become increasingly applicable in the so called too sick to be treated population[18]. However, in those cases in whom a severe HCV recurrence is diagnosed, due to the latter’s rapidly progressive nature, the treatment should be started as soon as possible.

Thus, more information from predictive analyses are necessary at this moment because data focused on the long-term effectiveness of antiviral therapy would help with a more feasible guidelines conception, correct clinical approach and rational cost-effectiveness treatment management in the LT population.

In conclusion, awaiting the consolidation of new interferon-free regimens, we suggest that, in carefully selected patients with predictors of long-term favorable outcomes, antiviral treatment might be delayed. Most likely, the development of interferon-free regimens will completely change the approach to HCV in both pre- and post-LT settings. Nevertheless, studies focusing on the mechanisms and factors leading to a mild HCV recurrence will still be extremely useful.

View Full Text: Introduction, Tables, Results and References, here.