Showing posts with label 2016 International Liver Congress. Show all posts
Showing posts with label 2016 International Liver Congress. Show all posts

Friday, April 21, 2017

Real-World Observational Study in the U.S. Veterans Affairs System Evaluating Use of Merck’s ZEPATIER® (Elbasvir and Grazoprevir) Shows High Sustained Virologic Response Rates in Patients with Chronic Hepatitis C

Real-World Observational Study in the U.S. Veterans Affairs System Evaluating Use of Merck’s ZEPATIER® (Elbasvir and Grazoprevir) Shows High Sustained Virologic Response Rates in Patients with Chronic Hepatitis C

Study Evaluated VA Population with High Incidence of Co-Morbidities

April 21, 2017 10:00 AM Eastern Daylight Time
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of findings from a retrospective database analysis of patients with chronic hepatitis C virus (HCV) infection who were administered ZEPATIER® in the U.S. Department of Veterans Affairs (VA) healthcare system. For the evaluable population (n=2,436), 95.6 percent of veterans treated with ZEPATIER achieved the primary outcome of sustained virologic response (SVR), defined as undetectable HCV RNA at least twelve weeks after the end of treatment. For patients with no HCV RNA measurements at or after 12 weeks (19% of the study cohort), the analysis used HCV RNA measurements available at least four and less than 12 weeks after the end of treatment. The response rates in the real-world setting of the VA supplement the overall findings from the controlled clinical studies of ZEPATIER. These findings will be presented today in an oral session (abstract #PS-095) at The International Liver Congress™ 2017 being held in Amsterdam, the Netherlands.

In the United States, ZEPATIER is indicated for the treatment of chronic HCV GT1 or GT4 infection in adults. ZEPATIER is indicated for use with ribavirin (RBV) in certain patient populations. The U.S. Prescribing Information for ZEPATIER includes a Boxed Warning about the risk of hepatitis B virus (HBV) reactivation in patients co-infected with HCV and HBV. In controlled clinical studies of ZEPATIER, SVR was the primary endpoint defined as HCV RNA less than lower limit of quantification (LLOQ) at 12 weeks after the cessation of treatment (SVR12).

“U.S. veterans are three times more likely to have chronic hepatitis C compared to the general U.S. population and a high proportion suffer co-morbid conditions that can make treatment challenging,” said Jennifer Kramer, investigator, Michael E. DeBakey VA Medical Center, Houston, Texas, and assistant professor of medicine, department of medicine, Baylor College of Medicine. “This study shows that chronic hepatitis C antiviral treatment can result in a high rate of sustained virologic response in U.S. veterans.”

This retrospective database analysis included patients with chronic HCV treated with ZEPATIER (elbasvir and grazoprevir) in the VA healthcare system between February 1, 2016 and August 1, 2016. Study outcomes include real-world utilization and SVR rates. Please see additional information about the design, methodology and limitations of this observational study below.

After applying study exclusion criteria, 2,436 patients were included in the evaluable population cohort. The mean age of subjects was 63.5 years. The prevalence of co-morbidities as determined by ICD-9 and CPT codes as recorded in the VA database was as follows: cirrhosis (33.2%), diabetes (53.2%), depression (57.2%) and HIV co-infection (3%). Additionally, more than half of the patients had a history of drug (53.9%) or alcohol (60.5%) abuse. The population included 1,988 previously untreated patients and 448 treatment-experienced patients (322 of whom previously received an interferon-based regimen with or without an NS3/4A HCV protease inhibitor, and 126 of whom previously received an interferon-free direct-acting antiviral regimen).

A total of 95.6 percent (2,328/2,436) of patients in the evaluable population achieved SVR following treatment with ZEPATIER. The SVR rates by genotype (GT) were as follows: all GT1, 95.4 percent (2218/2324); GT1a, 93.4 percent (788/844); GT1b, 96.6 percent (1379/1428); and GT4, 96.9 percent (62/64). The SVR rates by baseline viral load (BVL) were as follows: BVL greater than 800,000 IU/ml, 94.7 percent (1497/1580); and BVL less than or equal to 800,000 IU/ml, 97.3 percent (726/746).

The SVR rates by baseline patient characteristics were as follows: male, 95.5 percent (2,245/2,350); female, 96.5 percent (83/86); African American, 95.9 percent (1,342/1,400); Hispanic, 95.1 percent (77/81); White, 95.0 percent (783/824); previously untreated, 96.1 percent (1,910/1,988); treatment-experienced, 93.3 percent (418/448); cirrhosis, 95.5 percent (772/808); without cirrhosis, 95.6 percent (1556/1628); stage 3 chronic kidney disease (CKD) (eGFR 30 to 59 mL/min/1.73m2), 96.7 percent (380/393); stage 4-5 CKD (eGFR less than 30 mL/min/1.73m2), 96.3 percent (392/407); HIV positive, 98.6 percent (73/74); HIV negative, 95.5 percent (2255/2362); history of alcohol abuse, 95.9 percent (1412/1473); no history of alcohol abuse, 95.1 percent (916/963); history of drug abuse, 95.3 percent (1251/1313); no history of drug abuse, 95.9 percent (1077/1123).

Adverse event data were not collected as part of this real-world data analysis.

“Analysis of data from real-world medical settings can provide useful insights to supplement knowledge gained from randomized clinical trials,” said Susan Shiff, senior vice president, center for observational and real-world evidence, Merck. “These data from a real-world VA setting add to the body of evidence on ZEPATIER (elbasvir and grazoprevir) and help deepen scientific understanding of the treatment of this complex disease affecting diverse, sometimes difficult to treat, patient populations.”

Study Methodology

Patients with chronic HCV treated with ZEPATIER from February 1 to August 1, 2016 were identified from the VA Corporate Data Warehouse, a national repository of VA electronic medical records. Inclusion criteria specified initiation of ZEPATIER therapy, at least 18 years of age, positive HCV RNA, and at least one inpatient or outpatient visit within a one-year period prior to treatment initiation (n=2,985). Patients were excluded if they had RBV added greater than one month after treatment initiation (n=23). Patients without SVR data or on-treatment HCV RNA data (n=494), or those treated with ZEPATIER for greater than seventeen weeks (n=32), were excluded as well. The total number of patients in the evaluable population was 2,436.

SVR was assessed based on undetectable HCV RNA at least twelve weeks after the end of treatment. For patients with no HCV RNA measurements at or after 12 weeks, the analysis used HCV RNA measurements available at least four and less than 12 weeks after the end of treatment. SVR was evaluated based on HCV RNA measurement at least 12 weeks post treatment in 81 percent of the study population.

About Real-World Data Analyses and Associated Limitations

Real-world studies analyze data generated outside of randomized clinical trials, such as through analyses of electronic medical records or claims databases, to provide insight into how medicines perform or are used from a clinical and economic viewpoint in real-world clinical settings. Information from real-world analyses alone does not provide sufficient evidence to validate efficacy or safety of a therapeutic regimen and does not provide a substitute for evidence obtained from randomized controlled clinical trials.

This study is subject to certain limitations. The VA population may not be generalizable to the entire U.S. population, due in part to the potential for a differing demographic make-up and/or risk factors. Bias may exist as diagnoses and co-morbidities were identified through ICD-9 and CPT codes. Treatment completion was identified through prescription records which may not reflect adherence. Database analyses are also prone to errors in coding and missing data, including unavailable SVR data at or after the 12-week post-treatment time point. Additionally, some laboratory data including data on the presence of baseline NS5A resistance associated substitutions was not available at the time of this analysis.

About the VA Corporate Data Warehouse (CDW)

The Department of Veterans Affairs Veterans Healthcare Administration (VHA) is supported by one of the largest integrated healthcare information systems in the United States. The VHA's Corporate Data Warehouse (CDW) was developed in 2006 to accommodate the massive amounts of data being generated from more than 20 years of use and to streamline the process of knowledge discovery to application.

Monday, June 6, 2016

June Hep C Newsletters - Medicaid programs should be taking “a long hard look” at their drug policies under state and federal law

June Hepatitis Newsletters and Updates

It's that time of the month for our index of June Newsletters, with noteworthy updates from around the web. 

Web Updates

Ele Hamburger: Medicaid programs should be taking “a long hard look” at their drug policies under state and federal law

Ele Hamburger, one of the plaintiffs’ attorneys in the recent lawsuit against the Washington Health Care Authority, the state Medicaid agency, over its Hepatitis C drug policy, sat down with State of Reform to talk about the case which is already having national implications.

June 6
We cover news in other states where similar policies of cost-based rationing for Hepatitis-C drugs are in place for Medicaid programs. Do you think it likely that other states will begin to model themselves after Washington following this decision?
Ele Hamburger: I think as a result of this case, Medicaid programs should be a taking a long hard look at whether their rationing criteria are justified under the state and federal law. When you have CMS saying it is not proper, and a federal judge saying it is inconsistent with federal Medicaid law, we hope you’re going to start to see other state programs eliminating those restrictions voluntarily.
That’s what just happened in Florida on the same day, Friday May 27. Advocates there went to Florida’s Medicaid Program and asked “do you really want this fight?” And they ended up resolving it.
In New York State, the AG [Attorney General Eric Schneiderman] started going after private insurers over rationing [of HCV medications] and got voluntary agreements from many of them to eliminate it, and then the state Medicaid program followed suit. In Pennsylvania, it has been eliminated through organizing and advocacy without litigation.

Save The Date - Twitter Chat June 15 @ 2 p.m. EDT
Join Hep B United, the National Viral Hepatitis Roundtable, CDC’s Division of Viral Hepatitis, and the Hepatitis B Foundation for a Twitter #HepChat Wednesday, June 15 at 2 p.m. EDT. The chat will highlight Hepatitis Awareness Month outreach events and allow hepatitis B and C partner organizations to share their successes, challenges, and lessons learned from their efforts.
VIDEO: Sofosbuvir/velpatasvir may offer improved patient reported outcomes
June 6
SAN DIEGO — In this exclusive video from DDW 2016, Zobair Younossi, MD, MPH, chairman of the department of medicine, Inova Fairfax Hospital, and vice president for research of Inova Health System, discusses new data showing the pan-genotypic regimen of a fixed-dose combination of Sovaldi (sofosbuvir, Gilead Sciences) and velpatasvir (Gilead Sciences) was associated with improved patient reported outcomes, or PROs.
Watch the video, here

Clinical Care Options
Date posted: 6/1/2016

In this downloadable slideset, Ira M. Jacobson, MD, reviews the newest regimens and data for genotype 1 HCV infection.
Free registration required

Hepatitis C Spread by Alternative Therapy
Injections given as an alternative medical treatment known as "prolotherapy" or "regenerative injection therapy" spread hepatitis C among at least seven patients of 400 who were potentially exposed. All were treated at a clinic in Santa Barbara, CA, the US Centers for Disease Control and Prevention reported.

Top hepatitis stories for Hepatitis Awareness Month
May 30, 2016
As Hepatitis Awareness Month comes to an end, and HCV Next have compiled a list of the latest, most relevant research on hepatitis B and C virus infections published on in May.

In Case You Missed It

EASL: Summary from EASL 2016 for Hepatitis C Highly efficacious pan-genotypic DAA combinations on their way: the last gaps in difficult-to-treat patient populations are going to be closed soon. - Jurgen K. Rockstroh M.D., Professor of Medicine University of Bonn, Germany

Foretelling toxicity: FDA researchers work to predict risk of liver injury from drugs
In December 2014, the US Food and Drug Administration (FDA) approved a new drug cocktail, from the Chicago-based pharmaceutical company AbbVie, to treat hepatitis C infection. Less than a year later, the agency warned that the cocktail, Viekira Pak, and another, newer AbbVie hepatitis C therapy could cause serious liver injury in individuals with advanced liver disease. The agency noted that it had received reports of at least 26 cases of liver injuries that might have been caused by the drugs...

June Newsletters

HCV Advocate
The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education.

June Newsletter

Dear Advocaters,

Summer is right around the corner and we have you covered for the latest news about hepatitis C with our newsletters, website and our blog.

In the current issue of the HCV Advocate newsletter we feature the following articles:
Snapshots by Alan Franciscus – detailed abstracts about the benefits of curing people with cirrhosis, and the association between head and neck cancers and hepatitis C virus.

“Facing Unique Hurdles in Pursuit of Healthcare” by Matthew Zielske delves into testing, linkage to care and the many barriers that face people with hepatitis C.

HealthWise by Lucinda Porter, RN – “Hepatitis C: Working with a Health Coach”—Lucinda discusses her health coach journey and how to find a health coach that might work for you.

The HCV Advocate Drug Pipeline by Alan Franciscus – I have updated our Drug Pipeline to include more information about the Merck new pan-genotypic drugs being developed to treat hepatitis C.

What’s Up! – We have reviewed and updated the following:
A Guide to Understanding HCV: 2016 – the guide was updated to reflect the newly released epidemiology numbers released by the Centers for Disease Control and Prevention.
Easy C Facts:
HIV and HCV Coinfection Facts
Methadone and HCV
HCV and Hepatitis B Coinfection
HCV and Transgender People

We always welcome any comments or suggestions.


Alan and the staff of the HCV Advocate

Get tested, Get Treated, Get Cured

View all newsletters here....

Connect With HCV Advocate


Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and Hep Magazine are the go-to source for educational and social support for people living with hepatitis.

HEP Summer 2016 - Special Issue

In This Issue
Super Friend: Gloria Guzman Inspires Others Hoping for a Hep C Cure
Gloria Guzman, a peer educator at the Special Treatment and Research (STAR) Health Center in Brooklyn, knows a thing or two about survival. At 67, she’s lived through bad relationships, the loss of a child, addiction, HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV). Thankfully, she’s now cured of hep C.

Screening Among 
Baby Boomers Is Inadequate
Despite guidelines calling for universal testing of hepatitis C virus (HCV) among baby boomers, testing rates remain low, with various demographic factors influencing who is screened, as well as who is treated.

Treating Hepatitis C Earlier Is More Cost Effective
Using Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) to treat hepatitis C virus (HCV) when individuals with genotype 1 of the virus have milder cases of liver fibrosis is more cost effective than waiting until their liver disease progresses. Researchers came to this conclusion by devising a mathematical model to help them estimate how earlier versus delayed treatment, specifically among those never before treated for the virus, affected the proportional cost associated with improving their life span as well as individual health.

View more

Stay updated

NYC Hep C Task Force
The New York City Hepatitis C Task Force is a city-wide network of service providers and advocates concerned with hepatitis C and related issues. The groups come together to learn, share information and resources, network, and identify hepatitis C related needs in the community. Committees form to work on projects in order to meet needs identified by the community.

Check Back For June Newsletter....

May 2016 Hep Free NYC Newsletter

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Join Us



HepCBC Hepatitis C Education and Prevention Society

The hepc.bull, has been “Canada’s hepatitis C journal” since the late 1990′s and has been published nonstop since 2001. The monthly newsletter contains the latest research results, government policy changes, activities and campaigns you can get involved in, articles by patients and caregivers, and a list of support groups plus other useful links.

Just Released May Newsletter

May, 2016 hepc.bull HERE.

Attend Hearings on Blood Scandal Funds at Vancouver Courthouse: June 20-22 (p 6)
Enjoy HepCBC's Roadshow Outreach trip to Northern Rural and Remote BC! (p 4)

Give your Patient or Caregiver Input to get Sunvepra™ covered by PharmaCare (p 7)


· HepCBC Participates in Review of BC Centre for Excellence in HIV/AIDS - HCV-Related Cirrhosis Prevalence Increases over Time - CT Scans: Another HCV Transmission Route - Curing HCV can Reverse Need for Liver Transplant - page 1

· Hepatic Encephalopathy Drug Zaxine™ (rifamaxin) soon to be Covered in All Provinces EXCEPT BC! - page 2

· Upcoming HepCBC EVENTS looking for Visitors and VOLUNTEERS! - page 3

· Photo Essay on HCV Outreach Roadshow to Rural and Remote BC now Online - New Hepatitis C Dietary Supplement Digest by NCCIH - $1500 HCV CURE (Using Generic Drugs) - page 4

· Join "HepCBC Liver Warriors" Team in 2016 Victoria Marathon! - Looking for Potential HepCBC Board Members - Welcome to SVR "Honour Roll" - Upcoming International Conferences - page 5

· ATTEND June 20-22 BLOOD SCANDAL HEARINGS in VANCOUVER (or Montreal or Toronto!) - Patient Input Requested by BC Pharmacare for Sunvepra™ (asunaprevir) - WORLD Hepatitis Day 2016 - Daklinza™ (daclatasvir) Approved by Health Canada for Difficult-to-Treat Patients - page 6

· Medication Co-Pay Subsidy and Care Programs - Compensation Info - page 7

June Newsletter
Please Check Back... 

View All Newsletters, Here

Stay Connected


Blog Updates

Some people actually have the words “I told you I was sick” engraved on their tombstone. That SO would be like me. From the age of 30 on I was telling my doctors that my food didn’t metabolize well, my body ached, there was dizziness, fatigue, and a bunch of other symptoms. I honestly felt like a hypochondriac some of the time...

When the Pain won't go away
Kimberly Morgan Bossley
It is a daily struggle to manage pain while trying to manage a active life

Hepatitis C Treatment and a Tincture of Perseverance
Lucinda K. Porter, RN
A discussion about insurance coverage of hepatitis C treatment

Generic Hepatitis C Treament in the UK... Things are improving
Greg Jefferys
Progress regarding hep C generics is happening, albeit slowly

Main Site
Your Guide To Hepatitis

These special issues of Hep provide information and education for people living with viral hepatitis, including hepatitis C (HCV), hepatitis B (HBV) and hepatitis A (HAV).

Today's Headlines

Original Articles

How To Appeal a Social Security Disability Denial
By Mariah Z. Leach - June 6, 2016
Though the statistics vary somewhat from state to state, nationwide about 65% of all disability claims are denied on the first application. Luckily, receiving a denial does not mean that you will...

Expertise and HCV
By Daryl Luster - June 5, 2016
I have always been a little uncomfortable with the term “expert” but do understand that it describes a person having expertise in a given subject or field. The reason I am writing...

Talking to Loved Ones about Hepatitis C
By Jenelle Marie Davis - June 2, 2016
I just got diagnosed, how do I tell my family/friends? As you sit in your doctor’s office or clinic after a positive hepatitis C diagnosis, your first instinct may be to run...

Dr. Kristine Novak is the science editor for Gastroenterology and Clinical Gastroenterology and Hepatology. She has worked as an editor at biomedical research journals and as a science writer for 15 years, covering advances in gastroenterology, hepatology, cancer, immunology, biotechnology, molecular genetics, and clinical trials. She has a PhD in cell biology and an interest in all areas of medical research.

Can Blood Levels of Ammonia Predict Risk and Frequency of Hepatic Encephalopathy in Patients With Cirrhosis?
Fasting levels of ammonia (NH3) in blood identify patients at risk for complications of overt hepatic encephalopathy (HE), researchers report in the June issue of Clinical Gastroenterology and Hepatology. Patients with HE might benefit from NH3-lowering therapy. Humans have no repository for excess dietary nitrogen, so we convert excess dietary

What is
The mission of is to improve the public dialogue about health care by helping consumers critically analyze claims about health care interventions and by promoting the principles of shared decision-making reinforced by accurate, balanced and complete information about the tradeoffs involved in health care decisions. evaluates health care journalism, advertising, marketing, public relations and other messages that may influence consumers and provides criteria that consumers can use to evaluate these messages themselves. Improving the quality and flow of health care news and information to consumers can be a significant step towards meaningful health care reform.

Readers drowning in flawed “liquid biopsy” stories; other coverage throws a lifeline
The big story out of the American Society of Clinical Oncology meeting over the weekend came from a study about so-called “liquid biopsies.” Major news organizations headlined it as follows:
Washington Post: ‘Liquid biopsy’ study offers hope for a blood test to find cancer
New York Times: ‘Liquid’ Cancer Test Offers Hope for Alternative to Painful Biopsies
TIME magazine: A blood test for cancer gets closer
I think many if not most news consumers are likely to draw the wrong conclusion from these messages.

As these stories later point out with varying levels of urgency, the study involved blood samples from people already known to have cancer. And the researchers compared results from these samples with biopsy tissue samples that were available for about 400 patients. The point was to compare the profile of the tumor as assessed by the blood sample with the existing surgical biopsy sample.
The researchers were not trying to “find cancer” as the Post misleadingly suggests. Nor did the study involve a “blood test for cancer” as TIME states. The cancer had already been found and diagnosed using a surgical biopsy. (Despite the hyped suggestions.....
Read more....


Of Interest

Researchers were able to improve liver damage in mice, but this does not amount to curing an addiction to alcohol.

The study showed it was possible to create "bespoke friendly" viruses to infect cells known as myofibroblasts, which are cells associated with tissue repair. The virus passed on instructions that transformed the myofibroblasts into healthy liver cells in mice who had fibrosis (scarring) of the liver, known as cirrhosis.

Not all the experiments in the mice worked, but in those that did, the transformed liver cells looked and behaved normally, replaced some of the diseased liver cells, and led to less liver scarring

Healthy You

Check out the June issue of NIH News in Health, the monthly newsletter bringing you practical health news and tips based on the latest NIH research. To search for more trusted health information from NIH, bookmark

Can You Lengthen Your Life?
Researchers Explore How To Stay Healthy Longer
The best way to boost your chance of living a long and active life is through healthy behaviors, including regular physical activity.
Read more about living healthy and longer

Seeking Allergy Relief
When Breathing Becomes Bothersome

When sneezing, runny nose, or itchy eyes suddenly appear, allergies may be to blame.

Health Capsules
Experimental Therapy Shows Promise for Type 1 Diabetes

Complementary Approaches for Depression

Featured Website: Prescription Drug Abuse

Wishing you all a wonderful summer.

Friday, April 29, 2016

Watch Advances in Chronic Hepatitis C: Management and Treatment/Independent Review of the 51st Annual EASL

Happy Friday everyone, if you have the time check out this recently released Internet symposium over at ViralEd. The program will feature real-world data on current HCV therapies presented at The International Liver Congress this month.
The Advances in Chronic Hepatitis C: Management and Treatment
Independent Review of the 51st Annual EASL
Internet Symposium: EASL 2016 Review 
The review and discussion will focus on HCV therapeutic options and developments, including: current treatment and management strategies, algorithms and recommendations; therapies in development; epidemiology; and diagnosis and clinical management of specific patient populations, including HCV/HIV co-infected and cirrhotic patients.

Saturday, April 23, 2016

Best of viral hepatitis at ILC2016

Published on Apr 22, 2016
Video Link
In this video, Pr. Jean-Michel Pawlotsky and Pr. Thomas Berg review and discuss the “Best of viral hepatitis at ILC2016”. An extensive summary of the latest advances in the fields of hepatitis B and hepatitis C is covered

For webcasts, posters and slides from the ILC2016 see LiverTree

Thursday, April 21, 2016

CCO - Our Expert Picks in HCV Now Available From Barcelona‏ EASL 2016*

CCO Independent Conference Coverage: Clinical Impact of New Data From EASL 2016*

Capsule Summaries

David R. Nelson, MD
Nancy Reau, MD, FAASLD, AGAF

Examine key data emerging from the most important HCV studies presented in Barcelona, as selected by the experts. Capsule Summaries available to date include:

C-EDGE Head to Head: Grazoprevir/Elbasvir Superior to Sofosbuvir + PegIFN/RBV in the Treatment of HCV Genotype 1 and 4 Infection
Interferon-free therapy demonstrates superior efficacy and safety to interferon-containing regimen in comparative study.
Read More

GS-1168/1169: 12 Weeks of Sofosbuvir/Velpatasvir + GS-9857 Highly Effective Across Genotypes in Treatment-Experienced HCV-Infected Patients
Novel all-oral, multiclass regimen effective regardless of HCV genotype, cirrhosis status, and extent of treatment experience.
Read More

ASTRAL-5: 12 Weeks of Sofosbuvir/Velpatasvir Safe, Highly Effective in Patients With HCV/HIV Coinfection on Stable ART
Treatment was well tolerated without renal perturbations or HIV virologic rebound.
Read More

HEPA-C: Decompensated Cirrhosis Associated With Decreased Response and Increased Risk of Severe Outcomes After DAA Therapy in Real-World Setting
MELD score of ≥ 18 predicted increased risk of severe adverse events or death.
Read More

Real-World Data Suggest Feasibility of Individualized Retreatment After IFN-Free DAA Combination Failure in Genotypes 1 and 3 HCV
Selecting the retreatment regimen based on resistance analysis revealed DAA combination regimens likely to be effective after failure of an initial interferon-free DAA combination regimen.
Read More

HCV-TARGET: Baseline RAVs Are Frequently Detected in Patients With Genotype 1 HCV But Have Limited Effect on Efficacy of LDV/SOF or SMV + SOF ± RBV
Little evidence that specific variants influence response to sofosbuvir-containing regimens, although Y93C/H/N RAV may reduce effectiveness of ledipasvir/sofosbuvir.
Read More

SURVEYOR-II: 100% SVR12 Rate With Once-Daily ABT-493 + ABT-530 ± Ribavirin in Treatment-Naive Patients With Genotype 3 HCV Infection and Compensated Cirrhosis
Presence of baseline NS3 and/or NS5A variants did not impact efficacy.
Read More

HepNet IV: 6-Week Regimen of Ledipasvir/Sofosbuvir Highly Effective in Acute Genotype 1 HCV Monoinfection
A short course of ledipasvir/sofosbuvir achieved an SVR12 rate of 100% against genotype 1 HCV with rapid normalization of ALT and bilirubin in most patients.
Read More

Saturday, April 16, 2016

ABT-493 and ABT-530 gets 1 step closer to offering HCV genotype 3 patients an effective therapeutic option

Related: View Todays Meeting Coverage @ Healio

ABT-493, ABT-530 produce high SVR4 rates in HCV genotype 3
BARCELONA — In this exclusive video interview at International Liver Congress, Paul Y. Kwo, MD, professor of medicine and director of liver transplantation at Indiana University, and HCV Next Editorial Board member, discusses results from the two SURVEYOR studies investigating the safety and efficacy of pangenotypic agents ABT-493 and ABT-530 in patients with hepatitis C virus genotype 3 infection with and without cirrhosis.

AbbVie Press Release
AbbVie ABT-493 and ABT-530 For Genotypes 1-6: New Phase 2 Data Presented At The International Liver Congress
- 97-98 percent SVR12 achieved with eight weeks of ABT-493 and ABT-530 in genotypes 1-3 hepatitis C virus patients without cirrhosis in SURVEYOR-1 and 2 studies(1,2)
- 100 percent SVR12 achieved with 12 weeks of treatment in difficult-to-treat genotype 3 patients with compensated cirrhosis (Child-Pugh A) new to therapy (3)
- 100 percent SVR12 achieved with 12 weeks of treatment in genotypes 4-6 patients without cirrhosis; eight-week duration investigated in this ongoing study (4)

Today At The International Liver Congress™

Phase 2 data show treatment efficacy in 'difficult-to-cure' hepatitis C patients

Investigational oral combination hepatitis C (HCV) treatment gets 1 step closer to offering HCV genotype 3 patients an effective therapeutic option

European Association for the Study of the Liver

April 16, 2016, Barcelona, Spain: A Hepatitis C (HCV) drug currently under investigation, ABT-493 and ABT-530, which is an all-oral once-daily antiviral treatment, helped HCV genotype 3 patients with heavily scarred livers and no previous treatment history to achieve a 100% sustained virologic response after receiving the treatment for 12 weeks (SVR12).

Additional data from this study, also presented at The International Liver CongressTM today in Barcelona, Spain, show that 97% of patients with the same HCV genotype, but without scarred livers, achieved SVR12 after eight weeks on the same treatment without ribavirin (RBV).

As treatments for HCV have evolved, genotype 3 patients have become the most difficult subgroup of patients to cure.1 Although there have been recent advances in direct-acting antiviral therapies for HCV genotype 1, genotype 3 remains a challenge and is a highly prevalent strain of the infection globally, with a particularly high concentration of cases in Asia.1

The current standard of care for HCV genotype 3 is the nucleotide polymerase inhibitor sofosbuvir with weight-based RBV for 24 weeks. This recommendation comes from the Valence study where high SVR rates were seen in those who had no previous HCV treatment history, without or with scarring of the liver, known as cirrhosis (93% and 92%, respectively). However, treatment-experienced genotype 3 cirrhotic patients experienced a lower SVR rate of 60%.2

"We are pleased to see the efficacy of this two direct-acting antiviral investigational, pan-genotypic regimen has been validated for treatment-naïve Hepatitis C genotype 3 patients - with 100% of cirrhotic patients treated for 12 weeks and 97% of non-cirrhotic patients treated for eight weeks achieving sustained virologic response at 12 weeks post treatment," said Dr Paul Kwo from Indiana University School of Medicine, Indianapolis, US and one of the lead study authors. "Clinical trials are ongoing to evaluate the safety and efficacy of the investigational treatment, and we are now focusing on a larger cohort of HCV genotype 3 patients, including treatment-experienced patients."

In the international Phase 2 clinical trial, two study arms enrolled 24 cirrhotic patients each, none who had previously been treated for HCV infection. In the two patient groups taking the investigational combination treatment ABT-493 and ABT-530 with and without once-daily RBV, all achieved SVR12 after 12 weeks on treatment. No patient discontinued the study or experienced virologic failure.

In another trial treatment arm that focused on non-cirrhotic patients, 29 genotype 3-infected patients were enrolled. SVR12 was achieved by 97% (28/29) of patients with no patient experiencing virologic failure. The most common side effects were the same across both studies, including headache, and fatigue.

"These data mark another step forward in continued research efforts to address the unmet medical need among HCV patients," said Professor Frank Tacke, EASL Governing Board member. "We will be watching with close interest to see whether similar efficacy levels can be achieved for treatment-experienced genotype 3 HCV patients - a group known for being hard to cure."


About The International Liver Congress™

This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. The International Liver Congress™ takes place from April 13 - 17, 2016, at the Fira Barcelona Gran Via, Barcelona, Spain.

About EASL

Since EASL's foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European Association with international influence, with an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.


For more information, please contact the ILC Press Office at:

Telephone: +44 (0)7841 009 252

Onsite location reference

Late-breaker session, Hall 6.0
Saturday 16 April, 16:00 - 18:00
Presenter: Paul Kwo, United States
Abstract: LB01, 100% SVR4 with ABT-493 and ABT-530 with or without Ribavirin in Treatment-Naïve HCV Genotype 3-Infected Patients with Cirrhosis

Viral hepatitis C (2), Hall 6.0
Saturday 16 April, 11:30 - 13:30
Presenter: Andrew Muir, United States
Abstract: PS098, High SVR Rates with ABT-493 + ABT-530 Co-Administered for 8 Weeks in Non-Cirrhotic Patients with HCV Genotype 3 Infection

Author disclosures of interest

Paul Kwo - Advisory board: Abbott, Abbvie, BMS, Gilead, Merck, Janssen. Grant support: Abbvie, BMS, Gilead, Janssen, Merck

Andrew Muir - Research grants: AbbVie, Achilion, BMS, Gilead, GSK, Hologic, Intercept, Janssen, Merck, NGM Biopharm, Roche. Educational activities: Salix. Consulting services: AbbVie, Achilion, BMS, Gilead, Inovio Pharmaceuticals, Intercept, Janssen, Lumena, Merck, Portola Pharmaceuticals, Regulus Therapeutics, Salix, Shire Pharmaceuticals, Theravance.


1 US National Library of MedicineNational Institutes of Health. Review article: HCV genotype 3 - the new treatment challenge. Available from: Last accessed: March 2016.
2 The Hepatitis C Trust. Genotype 3: One of the Remaining Challenges for Hepatitis C. Available from: Last accessed: March 2016.

Generic direct-acting antivirals for hepatitis C virus infection Presented at International Liver Congress

Low-cost generic direct-acting antiviral treatment for hep C is equivalent to branded formulations

New data indicate that generics are a feasible alternative to support access to direct-acting antiviral treatment for hepatitis C sufferers

European Association for the Study of the Liver

April 16, 2016, Barcelona, Spain: Data presented today demonstrates that generic direct-acting antivirals (DAAs) are as effective and safe as branded treatments to cure Hepatitis C.

The summary results presented today at The International Liver Congress™ 2016 in Barcelona, Spain, showed high sustained virologic response (SVR) after treatment with generic sofosbuvir, ledipasvir, daclatasvir and ribavirin, confirming clinical efficacy equivalent to outcomes seen in Phase 3 clinical trials of branded combination treatments.

The high costs of branded DAAs prevent access to treatment in many countries.1 Generic DAAs are being mass-produced and are available for less than 1% of the retail price of their branded counterparts. Medication costing $94,000 per person in the US can currently be obtained for less than $1,000 as a generic, and a 12 week course of treatment could be produced for as little as $200 in the future.1

"Our interim data suggests a potential solution for Hepatitis C patients in areas where treatment access has been restricted as a result of the high prices demanded for branded treatment," said Dr James Freeman, of GP2U Telehealth, Hobart, Australia and lead author of the study. "At the price level of generic direct-acting antivirals, treating the entire global Hepatitis C epidemic could be financially feasible. Furthermore, if a patient is cured of Hepatitis C, there is evidence for improved survival, and lower risks of liver cancer and liver cirrhosis and cured patients could return to work, delivering further economic benefits to society."

In this study, people with HCV legally imported low-cost generic treatment to cure their infection. The study included people treated in Australia, USA, UK, Canada, Europe, SE Asia and Africa.

Generic DAAs were first evaluated for quality in Australia, using high precision liquid chromatography, nuclear magnetic resonance and mass spectroscopy. Patients were assessed pre-treatment, during treatment, and then at weeks 4 (SVR4) and 12 (SVR12) following the end of treatment. The objective of the analysis was to assess the efficacy and safety of generic DAAs legally imported for each patient's personal use.

The interim results show that for genotype 1 the overall SVR rate was 95%. Treatment with generic sofosbuvir and ledipsavir led to SVR4 rates of 93% and treatment with generic sofosbuvir and daclatasvir led to SVR4 rates of 97%.

"Across all genotypes, the SVR rate was 94% after treatment with generic DAAs. This indicates that generic DAAs can deliver the same success rates as branded equivalents, but at a price which is 1/100th of the current cost," explained Dr James Freeman.

"There is a clear role for generic treatments such as these for people with Hepatitis C across the world. The implications of increased availability of these drugs could be enormous, presenting more people with the possibility of a 'cure' for what is often a debilitating condition," said Professor Laurent Castera, EASL Secretary General.

Low-cost generic hepatitis C drugs match branded products in viral response
 Keith Alcorn
Generic versions of direct-acting antivirals purchased from China and India by people unable to obtain treatment in their own countries were just as effective and safe as the branded products, a study
Continue reading....

Study shows generics pose safe, economic option for patients with HCV
April 16, 2016
BARCELONA — Generic direct-acting antivirals for hepatitis C virus infection presented a similar biochemical makeup and sustained virological… “In this interim analysis, legally imported generic DAAs led to high SVR rates,” James Freeman, MD, executive director, GP2U Telehealth, Australia, said during a press conference. “A generic cure for hepatitis C is available now for $1,000 and works as expected. … Not in the future, but right now.”

Freeman explained that this endeavor began with one patient asking for assistance in obtaining a generic DAA as, at the time, only Olysio (simeprevir, Janssen) was available in Australia. He chose to assist the patient and test the generics to ensure safety. That patient went on to achieve SVR with the generic medication.

“The news leaked and one became a dozen,” Freeman said
Continue Reading...

View Todays Meeting Coverage @ Healio

ABT-493, ABT-530 produce high SVR4 rates in HCV genotype 3
BARCELONA — In this exclusive video interview at International Liver Congress, Paul Y. Kwo, MD, professor of medicine and director of liver transplantation at Indiana University, and HCV Next Editorial Board member, discusses results from the two SURVEYOR studies investigating the safety and efficacy of pangenotypic agents ABT-493 and ABT-530 in patients with hepatitis C virus genotype 3 infection with and without cirrhosis.

“We are clearly in need of different strategies for these individuals so the genotype 3 population can get the same benefits as the other [genotype patients],” Kwo told HCV Next.

Lean-NAFLD patients with large waist circumference linked to worse metabolic profile
April 16, 2016
BARCELONA — New data presented during the International Liver Congress showed patients with nonalcoholic fatty liver disease and a large waist…
Lower SVR rates, more death with DAA therapy in high MELD setting
April 16, 2016
BARCELONA — Physicians need to counsel patients with hepatitis C virus and MELD score higher than 18 prior to treatment with direct-acting…

Meeting News Coverage
Fibroscan improves multiple scoring systems' risk stratification for PBC
April 16, 2016
BARCELONA — Adding liver stiffness measurement through Fibroscan to Globe and UK-PBC risk scores — two high-performance scoring systems…

Gilead's Sofosbuvir/Velpatasvir and SOF/VEL Plus GS-9857 at The International Liver CongressTM

Gilead Announces Multiple Scientific Presentations Demonstrating Broad Utility of Sofosbuvir-Based Hepatitis C Therapies

– Studies Highlight Progress with Approved Therapies and Investigational Pangenotypic Regimens, Including Sofosbuvir/Velpatasvir (SOF/VEL) and SOF/VEL Plus GS-9857
FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 16, 2016-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced results from several Phase 2 and Phase 3 studies evaluating its two investigational, pangenotypic, fixed-dose combination therapies for the treatment of chronic hepatitis C virus (HCV) infection, as well as new data highlighting the potential use of Harvoni® (ledipasvir/sofosbuvir) in adolescents aged 12 to 17. Data were presented this week at The International Liver CongressTM 2016 in Barcelona, Spain.
“The data presented this week continue to underscore the high cure rates and safety of our sofosbuvir-based HCV therapies, and support their utility across all patient HCV genotypes and disease stages,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “We are pleased to have the opportunity to further characterize the pangenotypic profiles of our two new investigational fixed-dose combinations, sofosbuvir/velpatasvir and sofosbuvir/velpatasvir plus GS-9857, and to highlight results from the first study to evaluate interferon-free HCV therapy in adolescents.”
Sofosbuvir/Velpatasvir (SOF/VEL)
Results from the open-label, Phase 3 ASTRAL-5 study (PS104), led by David L. Wyles, MD, Associate Professor of Medicine, Division of Infectious Diseases, University of California, San Diego, California, evaluating once-daily SOF/VEL for 12 weeks among patients with HCV genotype 1-6 who are co-infected with HIV demonstrated that SOF/VEL was well-tolerated and resulted in high SVR12 rates. The SVR12 rate was 95 percent (n=99/104) overall, and 100 percent (n=19/19) and 97 percent (n=28/29) in patients with cirrhosis and prior treatment-failure, respectively. Two patients relapsed, while three patients were lost to follow up or withdrew consent. Two patients achieved SVR4 but have not yet returned for the post-treatment week 12 visit. The most common adverse events (>10 percent) were fatigue and headache.
SOF/VEL is currently being evaluated by regulatory agencies in the United States, Europe and Canada.
Sofosbuvir/Velpatasvir (SOF/VEL) Plus GS-9857
Data from three Phase 2 trials evaluating SOF/VEL plus GS-9857, a pangenotypic protease inhibitor, (Studies GS-US-367-1168 and GS-US-367-1169 and TRILOGY-3) also were selected for presentation.
Studies 1168 and 1169
Studies 1168 and 1169 evaluated 6 and 8 weeks of SOF/VEL plus GS-9857, with or without ribavirin (RBV), among treatment-naïve patients and 12 weeks of SOF/VEL plus GS-9857 among patients who failed prior treatment including those previously exposed to a direct acting antiviral (DAA) regimen. Study 1168 evaluated 197 genotype 1 patients and Study 1169 evaluated 128 genotype 2-6 patients.
Treatment-naïve patients: Poster SAT-138 highlighted combined safety and efficacy results from Studies 1168 and 1169 evaluating SOF/VEL plus GS-9857, with or without ribavirin, in genotype 1-6, treatment-naïve patients, with and without cirrhosis.  SVR12 rates were:
    SOF/VEL plus GS-9857   SOF/VEL plus GS-9857 with RBV
  6 weeks   8 weeks 8 weeks
SVR12 79% (n=53/67) 96% (n=95/99) 81% (n=25/31)
The most common adverse events (>10 percent) across the three study arms were headache, nausea, fatigue, diarrhea and anemia.
Treatment-experienced patients: Oral presentation PS008 highlighted combined safety and efficacy results from Studies 1168 and 1169 evaluating 12 weeks of SOF/VEL plus GS-9857 in genotype 1-6, treatment-experienced patients.  Twenty-seven percent of patients were NS5A inhibitor-experienced, 52 percent were non-NS5A inhibitor, DAA-experienced and 21 percent failed interferon-based treatment without a DAA.  Overall, the SVR12 rate was 99 percent (n=127/128). One genotype 3 patient with cirrhosis who had failed prior treatment with sofosbuvir plus pegylated interferon/ribavirin relapsed. Frequently reported adverse events (>10 percent) were headache, fatigue, diarrhea and nausea.

Studies 1168 and 1169 were led by Edward J. Gane, MD, Auckland City Hospital, Auckland, New Zealand (SAT-138); and Eric Lawitz, MD, Texas Liver Institute, University of Texas Health Science Center, San Antonio, Texas (PS008), respectively.
A late-breaker oral presentation (PS021) featuring data from a Phase 2 trial, led by Dr. Lawitz, evaluated 12 weeks of a fixed-dose combination of SOF/VEL/GS-9857, with or without RBV, among genotype 1, DAA-experienced, HCV-infected patients, including patients with cirrhosis. One hundred percent (n=24/24) of patients receiving 12 weeks of therapy with SOF/VEL/GS-9857 and 96 percent (n=24/25) of patients receiving SOF/VEL/GS-9857 plus RBV achieved SVR12. Among the 49 patients in this trial, 41 percent had prior exposure to an NS5A inhibitor and 47 percent previously received at least two classes of DAA. The most common adverse events (>10 percent) across both treatment arms were fatigue and anemia.
Based on these data a fixed-dose combination of SOF/VEL/GS-9857 is being evaluated in four Phase 3 studies (POLARIS-1, POLARIS-2, POLARIS-3 and POLARIS-4). SOF/VEL/GS-9857 has been granted a Breakthrough Therapy designation by the U.S. Food and Drug Administration for the treatment of chronic genotype 1 HCV patients who have previously failed an NS5A inhibitor-containing regimen.
Harvoni is the first single tablet HCV regimen approved in the United States for use in a broad range of patient populations, including HCV genotypes 1, 4, 5 and 6, HCV/HIV-1 coinfection, HCV genotype 1 and 4 liver transplant recipients and genotype 1-infected patients with decompensated cirrhosis.
Data from an evaluation of Harvoni in genotype 1 HCV-infected adolescents aged 12 to 17 have been selected for presentation in a late breaker oral session (LB-4597). Presented by Sanjay Bansal, MD, MRCPCH, Kings College Hospital, London, United Kingdom, and led by Kathleen B. Schwarz, MD, Pediatric Liver Center, Johns Hopkins University School of Medicine, Baltimore, Maryland, the Phase 2 study demonstrated that Harvoni is well tolerated and results in high SVR12 in this population. Of the 100 patients enrolled, 97 percent (n=97/100) achieved SVR12. The three patients who did not achieve SVR12 were lost to follow up; no patients experienced virologic failure. The most common adverse events were headache, diarrhea and fatigue. Further evaluation of Harvoni in a pediatric population of children aged 3 to 11 is ongoing.
Further information about the clinical studies described above can be found at
Uses for Harvoni in certain HCV patient populations highlighted above are investigational and have not been determined to be safe or efficacious. SOF/VEL and SOF/VEL/GS-9857 are investigational products and have not been determined to be safe or efficacious.
Important Safety Information for Harvoni
If Harvoni is used in combination with ribavirin (RBV), all contraindications, warnings and precautions, in particular pregnancy avoidance, and adverse reactions to RBV also apply. Refer to RBV prescribing information.
Warnings and Precautions
Risk of Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with Harvoni due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.
Risk of Reduced Therapeutic Effect of Harvoni Due to P-gp Inducers: Rifampin and St. John’s wort are not recommended for use with Harvoni as they may significantly decrease ledipasvir and sofosbuvir plasma concentrations.
Related Products Not Recommended: Harvoni is not recommended for use with other products containing sofosbuvir (Sovaldi).
Adverse Reactions
Most common (≥10%, all grades) adverse reactions were fatigue, headache and asthenia.
Drug Interactions
In addition to rifampin and St. John’s wort, co-administration of Harvoni is also not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such co-administration is expected to decrease the concentration of ledipasvir and sofosbuvir, reducing the therapeutic effect of Harvoni.
Co-administration of Harvoni is not recommended with simeprevir due to increased concentrations of ledipasvir and simeprevir. Co-administration is also not recommended with rosuvastatin or co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate due to increased concentrations of rosuvastatin and tenofovir, respectively.
Consult the full Prescribing Information for Harvoni for more information on potentially significant drug interactions, including clinical comments.
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 risk that Gilead may observe unfavorable results from additional clinical trials involving SOF/VEL, SOF/VEL/GS-9857 and Harvoni in certain patient populations, including adolescents aged 12 to 18. In addition, the regulatory filings for SOF/VEL and SOF/VEL/GS-9857 may not be approved by regulatory agencies, and marketing approvals, if granted, may have significant limitations on their use. 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, 2015, 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 Harvoni is available at
Harvoni is a registered trademark of Gilead Sciences, Inc. or its related companies.
For more information on Gilead Sciences, please visit the company’s website at, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

AbbVie ABT-493 and ABT-530 For Genotypes 1-6: New Phase 2 Data Presented At The International Liver Congress

AbbVie Presents New Phase 2 Data for Investigational, Once-Daily, Ribavirin-Free, Pan-Genotypic Regimen of ABT-493 and ABT-530 for Hepatitis C Genotypes 1-6
Apr 16, 2016
- 97-98 percent SVR12 achieved with eight weeks of ABT-493 and ABT-530 in genotypes 1-3 hepatitis C virus patients without cirrhosis in SURVEYOR-1 and 2 studies(1,2)
- 100 percent SVR12 achieved with 12 weeks of treatment in difficult-to-treat genotype 3 patients with compensated cirrhosis (Child-Pugh A) new to therapy (3)
- 100 percent SVR12 achieved with 12 weeks of treatment in genotypes 4-6 patients without cirrhosis; eight-week duration investigated in this ongoing study (4)
BARCELONA, April 16, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that with eight weeks of treatment, 97-98 percent of genotype 1-3 (GT1-3) chronic hepatitis C virus (HCV) infected patients without cirrhosis treated with AbbVie's investigational, once-daily, ribavirin (RBV)-free, pan-genotypic regimen of ABT-493 and ABT-530 achieved sustained virologic response at 12 weeks post-treatment (SVR12).1,2 Results for GT1 (n=33/34), GT2 (n=53/54) and treatment-naïve GT3 (n=28/29) patients were based on an Intent-to-Treat (ITT) analysis.1,2 Additionally, 100 percent (n=34/34) of genotype 4-6 (GT4-6) chronic HCV infected patients without cirrhosis achieved SVR12 with 12 weeks of treatment.4 These new data from the Phase 2 SURVEYOR-1 and SURVEYOR-2 studies will be presented at The International Liver Congress™ (ILC) 2016 in Barcelona, Spain.

"These results move us closer to our ultimate goal of providing a treatment option for as many hepatitis C patients as possible. We will continue to examine our investigational, pan-genotypic regimen through our dedicated clinical trial program, including an eight-week duration across all genotypes," said Rob Scott, M.D., vice president, development and chief medical officer, AbbVie.
In separate late-breaking data from the SURVEYOR-2 study, 100 percent of GT3 chronic HCV infected patients with compensated cirrhosis (Child-Pugh A) new to therapy achieved SVR12 with 12 weeks of treatment both with and without RBV (n=24/24 in each arm).3 No patients discontinued treatment due to adverse events.3 Data in GT3 chronic HCV infected patients with and without cirrhosis were featured in the official ILC 2016 press program.

"The recent evolution in hepatitis C treatment has resulted in high cure rates for many patients with specific genotypes, but there remain distinct areas of unmet need," said Paul Kwo, M.D., professor of medicine at the Indiana University School of Medicine. "These new data show us the potential of ABT-493 and ABT-530 in genotype 3 patients new to therapy even with the added complication of compensated cirrhosis."

In a pooled analysis of 531 patients across both SURVEYOR studies, of five treatment regimens of ABT-493 and ABT-530 evaluated, the most commonly reported adverse events were fatigue (18 percent), headache (17 percent), nausea (13 percent) and diarrhea (10 percent).5 Three patients across all study arms evaluated to date, two of whom received RBV, discontinued study drugs early due to adverse events.5

Overview of SURVEYOR-1 and SURVEYOR-2 Clinical Data Presented at ILC: 
Patient Profile/Study
Patient number (n)/
Patient Population
Duration of Treatment
Treatment Regimen
SVR12 Rates
pegIFN/RBV treatment experienced=15%
8 weeks
ABT-493 (300mg) + ABT-530 (120mg) once daily
pegIFN/RBV treatment
8 weeks
ABT-493 (300mg) + ABT-530 (120mg) once daily
Treatment-naïve =100%
8 weeks
ABT-493 (300mg) + ABT-530 (120mg) once daily
(Child-Pugh A) 
Treatment-naïve= 100%
12 weeks
ABT-493 (300mg) + ABT-530 (120mg) without RBV
once daily
12 weeks
ABT-493 (300mg) + ABT-530 (120mg) +
 RBV (800mg)
once daily
GT 4,5,6
(GT4=22; GT5=1; GT6=11)
pegIFN/RBV treatment experienced=15%
12 weeks
ABT-493 (300mg) + ABT-530 (120mg) once daily
Intent-to-treat (ITT) population is defined as all patients who received at least one dose of the study drugs

About SURVEYOR-11,4,5
SURVEYOR-1 is an ongoing Phase 2 two-part study designed to evaluate the safety and efficacy of ABT-493 and ABT-530, with and without RBV, for eight to 12 weeks, in cirrhotic and non-cirrhotic adult genotype 1 patients, and non-cirrhotic adult patients with genotypes 4, 5 or 6 chronic HCV infection who were new to therapy or did not respond to previous treatment with pegylated interferon (pegIFN)/RBV (null responder).

About SURVEYOR-21,2,3,5
SURVEYOR-2 is an ongoing Phase 2, four-part study designed to evaluate the safety and efficacy of ABT-493 and ABT-530, with or without RBV, in adult patients with genotypes 2, 3, 4, 5 or 6 chronic HCV infection who were new to therapy or had failed previous treatment with pegylated interferon (pegIFN)/RBV.
The primary endpoint of both studies is the percentage of subjects achieving SVR12.
Safety and efficacy data for Part 1 of the studies were presented at The Liver Meeting® 2015, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco.

About pooled safety analysis of SURVEYOR-1 and SURVEYOR-25
531 patients were included in this safety analysis: 26 percent GT1, 24 percent GT2, 43 percent GT3, and 6 percent with GT4, 5 or 6 infection. Patients across genotypes received ABT-493/ABT-530 at five doses: 300/120mg (n=258), 300/120mg with RBV (n=27), 200/120mg (n=121), 200/120mg with RBV (n=56), and 200/40mg (n=69).

About AbbVie's HCV Clinical Development Program
AbbVie's HCV clinical development program is intended to advance scientific knowledge and the clinical care of people with chronic HCV infection by investigating pan-genotypic (genotypes 1-6), all-oral, ribavirin-free, once-daily treatment for 12 weeks. An eight-week treatment duration with ABT-493 and ABT-530 will be investigated across all genotypes in our comprehensive Phase 2/Phase 3 clinical trial program, which focuses on areas of ongoing need in HCV.
AbbVie's investigational regimen includes 300mg ABT-493, an NS3/4A protease inhibitor, and 120mg ABT-530, an NS5A inhibitor.
ABT-493 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

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. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

1 Poordad, F et al. High SVR Rates with the Combination of ABT-493 + ABT-530 for 8 Weeks in Non-Cirrhotic Patients with HCV Genotype 1 or 2 Infection. Poster presentation #SAT-157; presented at The International Liver Congress™ (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, April 13-17, 2016.
2 Muir, A et al. High SVR Rates with ABT-493 + ABT-530 Co-Administered for 8 Weeks in Non-Cirrhotic Patients with HCV Genotype 3 Infection. Oral presentation #PS098; presented at The International Liver Congress™ (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, April 13-17, 2016.
3 Kwo, P et al. 100% SVR12 with ABT-493 And ABT-530 with or without Ribavirin in Treatment-Naïve HCV Genotype 3-Infected Patients with Cirrhosis; Late Breaker presentation #LB01; presented at The International Liver Congress™ (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, April 13-17, 2016
4 Gane, E et al. 100% SVR4 and Favorable Safety of ABT-493 + ABT-530 Administered for 12 Weeks in Non-Cirrhotic Patients with Genotypes 4,5, or 6 Infection (SURVEYOR-I). Poster presentation #SAT-137; presented at The International Liver Congress™ (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, April 13-17, 2016.
5 Kwo, P et al. Safety of ABT-493 and ABT-530 Co-Administered in Patients with HCV Genotype 1-6 Infection: Results From the SURVEYOR-I and SURVEYOR-II Studies; Poster presentation #SAT-239; presented at The International Liver Congress™ (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, April 13-17, 2016.