Tuesday, March 31, 2015

Update-Recruiting Hepatitis C Clinical Trial Daclatasvir/Sofosbuvir/Ribavirin

Update-Recruiting HCV Clinical Trial Daclatasvir/Sofosbuvir/Ribavirin/Genotype 3

March 24, 2015 Trial Update

Bristol-Myers Trial Data 
Daclatasvir Plus Sofosbuvir - Genotype 3
If you haven't seen it yet, study results from the phase III study (ALLY-3;ClinicalTrials.gov: NCT02032901) has been published in the April issue of Hepatology, here is the link;
All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study.

In short, trial results using daclatasvir with sofosbuvir in HCV genotype 3 without cirrhosis and without ribavirin - SVR12 was achieved in 96% of patients. In people with cirrhosis, both treatment-experienced or treatment-naive - SVR12 was lower, at 63%.
In summary, a 12-week regimen of DCV plus SOF achieved SVR12 in 96% of treatment-naïve and treatment-experienced patients with genotype 3 infection without cirrhosis and was well tolerated. This regimen, without the addition of RBV and with a shorter treatment duration relative to currently approved all-oral regimens, demonstrated high SVR12 rates across patient subgroups, except in patients with cirrhosis and regardless of past treatment response. These findings support the 12-week regimen of DCV plus SOF as an efficacious, well-tolerated treatment option. Additional evaluation to optimize efficacy in genotype 3–infected patients with cirrhosis is underway.

In The News
This month Bristol-Myers announced that the Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) of daclatasvir in combination with sofosbuvir for the treatment of chronic hepatitis C (HCV) genotype 3. Bristol-Myers withdrew its FDA application for daclatasvir and asunaprevir to treat genotype 1b last October.

Bristol-Myers trial information is provided below, as well as Gilead's trial for HCV genotypes 2, 3, 4, 5, or 6, using GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination, and one study for genotype 1 patients. 

Gilead Sciences is currently evaluating a single-tablet of sofosbuvir and GS-5816 in four Phase III studies, unfortunately those trials are no longer recruiting. Gilead hopes that the above mentioned clinical trial using GS-9857 a pan-genotypic protease inhibitor in combination with sofosbuvir and GS-5816 may potentially further reduce treatment duration from eight to 12 weeks to four to six weeks, read more here.

Genotype 3 & 1 Gilead


With and without cirrhosis, Genotype 1 and 3 
*and with and without using ribavirin







GT1 
with cirrhosis		GT3 
without cirrhosis		GT3
with cirrhosis
SOF+GS-5816 100 mg100% (n=20/20)100% (n=7/7)100% (n=27/27)88% (n=23/26)
SOF+GS-5816 100 mg +RBV100% (n=18/18)90% (n=9/10)100% (n=26/26)
96% (n=25/26)

In genotype 3, 100% of patients without cirrhosis, and without using ribavirin achieved SVR12.
In genotype 3 patients with cirrhosis SVR12 is at 88%. 

However, 96% of genotype 3 treatment-experienced patients with cirrhosis achieved SVR12 using ribavirin.

In February Gilead told investors Phase III results are expected in the third quarter of 2015. You can read the full transcript @ Seeking Alpha, registration is required. 

Gilead Sciences
This study is currently recruiting participants
ClinicalTrials.gov Identifier:
NCT02378961

HCV genotypes 2, 3, 4, 5, or 6
Treatment experienced, treatment-naive, with and without cirrhosis

Purpose
This study will evaluate the safety, tolerability, and efficacy of GS-9857 plus sofosbuvir (SOF)/GS-5816 fixed dose combination (FDC) in adults with chronic non genotype 1 hepatitis C virus (HCV) infection.

Contact: Gilead Study Team 367-11681169alerts@gilead.com

Locations
United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States
Stanford University Recruiting
Palo Alto, California, United States
Huntington Memorial Hospital Liver Center Recruiting
Pasadena, California, United States
Medical Associates Research Group, Inc. Recruiting
San Diego, California, United States
United States, Florida
Borland-Groover Clinic Recruiting
Jacksonville, Florida, United States
University of Miami Recruiting
Miami, Florida, United States
Orlando Immunology center Recruiting
Orlando, Florida, United States
South Florida Center of Gastroenterology, P.A. Recruiting
Wellington, Florida, United States
United States, Georgia
Center for Hep C/Atlanta Medical Center Recruiting
Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia, PC Recruiting
Marietta, Georgia, United States
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States
United States, Indiana
Indianapolis Gastroenterology & Hepatology, Inc. Recruiting
Indianapolis, Indiana, United States
United States, Massachusetts
Beth Isreal Deconess Medical Center Recruiting
Boston, Massachusetts, United States
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States
United States, Michigan
Henry Ford Hospital and Health System Recruiting
Detroit, Michigan, United States
United States, New Jersey
ID Care Recruiting
Hillsborough, New Jersey, United States
United States, New Mexico
Southwest Care Center Recruiting
Santa Fe, New Mexico, United States
United States, New York
North Shore/Long Island Jewish PRIME Recruiting
Lake Success, New York, United States
United States, North Carolina
Cumberland Research Associates, LLC Recruiting
Fayetteville, North Carolina, United States
Digestive Health Specialists, PA Recruiting
Winston-Salem, North Carolina, United States
United States, Pennsylvania
University of Pennsylvania Health Systems Recruiting
Philadelphia, Pennsylvania, United States
UPMC Center for Liver Diseases Recruiting
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States
United States, Tennessee
Gastro One Recruiting
Germantown, Tennessee, United States
Nashville Gastrointestinal Specialists, Inc. Recruiting
Nashville, Tennessee, United States
United States, Texas
Texas Liver Institute Recruiting
San Antonio, Texas, United States
United States, Virginia
Liver Institute of Virginia Recruiting
Richmond, Virginia, United States
New Zealand
Auckland Clinical Studies Recruiting
Auckland, New Zealand
Christchurch Clinical Studies Trust Recruiting
Christchurch, New Zealand
Puerto Rico
Fundacion de Investigacion de Diego Recruiting
San Juan, Puerto Rico

Sponsors and Collaborators
Gilead Sciences

Genotype 1
This study is currently recruiting participants
Phase 2
ClinicalTrials.gov Identifier:
NCT02378935

Purpose
This study will evaluate the safety, tolerability, and efficacy of GS-9857 plus sofosbuvir (SOF)/GS-5816 fixed dose combination (FDC) in adults with chronic genotype 1 hepatitis C virus (HCV) 
infection.

Contacts
Contact: Gilead Study Team 367-11681169alerts@gilead.com

Locations
United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States
Stanford University Recruiting
Palo Alto, California, United States
Huntington Memorial Hospital Liver Center Recruiting
Pasadena, California, United States
Medical Associates Research Group, Inc. Recruiting
San Diego, California, United States
United States, Florida
Borland-Groover Clinic Recruiting
Jacksonville, Florida, United States
University of Miami Recruiting
Miami, Florida, United States
Orlando Immunology center Recruiting
Orlando, Florida, United States
South Florida Center of Gastroenterology, P.A. Recruiting
Wellington, Florida, United States
United States, Georgia
Center for Hep C/Atlanta Medical Center Recruiting
Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia, PC Recruiting
Marietta, Georgia, United States
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States
United States, Indiana
Indianapolis Gastroenterology & Hepatology, Inc. Recruiting
Indianapolis, Indiana, United States
United States, Massachusetts
Beth Isreal Deconess Medical Center Recruiting
Boston, Massachusetts, United States
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States
United States, Michigan
Henry Ford Hospital and Health System Recruiting
Detroit, Michigan, United States
United States, New Jersey
ID Care Recruiting
Hillsborough, New Jersey, United States
United States, New Mexico
Southwest Care Center Recruiting
Santa Fe, New Mexico, United States
United States, New York
North Shore/Long Island Jewish PRIME Recruiting
Lake Success, New York, United States
United States, North Carolina
Cumberland Research Associates, LLC Recruiting
Fayetteville, North Carolina, United States
Digestive Health Specialists, PA Recruiting
Winston-Salem, North Carolina, United States
United States, Pennsylvania
University of Pennsylvania Health Systems Recruiting
Philadelphia, Pennsylvania, United States
UPMC Center for Liver Diseases Recruiting
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States
United States, Tennessee
Gastro One Recruiting
Germantown, Tennessee, United States
Nashville Gastrointestinal Specialists, Inc. Recruiting
Nashville, Tennessee, United States
United States, Texas
Texas Liver Institute Recruiting
San Antonio, Texas, United States
United States, Virginia
Liver Institute of Virginia Recruiting
Richmond, Virginia, United States
New Zealand
Auckland Clinical Studies Recruiting
Auckland, New Zealand
Christchurch Clinical Studies Trust Recruiting
Christchurch, New Zealand
Puerto Rico
Fundacion de Investigacion de Diego Recruiting
San Juan, Puerto Rico

Sponsors and Collaborators
Gilead Sciences

Additional Gilead trials, here.
The HCV clinical trials in this post are not a complete list; to learn more about Hepatitis C virus clinical trials or to find out if a study is enrolling patients in your area, please click here.

Bristol-Myers
Daclatasvir Plus Sofosbuvir - Clinical Trials 

Completed 
ClinicalTrials.gov Identifier:
NCT02319031
Last updated: March 24, 2015
Last verified: February 2015

Purpose
The purpose of this study is to determine if the use of Daclatasvir, Sofosbuvir, and Ribavirin in combination is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with compensated cirrhosis. Patients in this study may have already been treated prior for HCV or may have never received treatment for their HCV.

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #. 

Locations
Australia, New South Wales
Local Institution Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Site 0002
Australia, Queensland
Local Institution Recruiting
Greenslopes, Queensland, Australia, 4120
Contact: Site 0006
Australia, South Australia
Local Institution Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Site 0005
Australia, Victoria
Local Institution Recruiting
Clayton, Victoria, Australia, 3168
Contact: Site 0001
Local Institution Recruiting
Fitzroy, Victoria, Australia, 3065
Contact: Site 0003
Local Institution Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Site 0004
France
Local Institution Recruiting
Creteil Cedex, France, 94010
Contact: Site 0007
Local Institution Recruiting
Grenoble Cedex 09, France, 38043
Contact: Site 0010
Local Institution Recruiting
Paris Cedex 14, France, 75679
Contact: Site 0009
Local Institution Recruiting
Vandoeuvre Les Nancy, France, 54511
Contact: Site 0008

Sponsors and Collaborators
Bristol-Myers Squibb

Recruiting 
ClinicalTrials.gov Identifier:
NCT02304159
Verified January 2015 by Southern California Research Center

Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02304159

Purpose
This is a randomized, open label, single center safety and efficacy study. At least 40 cirrhotic subjects with HCV genotype 3 will receive standard of care treatment of sofosbuvir and ribavirin (SOF/RBV) as well as 60 mg daily of Daclatasvir (investigational product). Subjects will be randomized in a 1:1 to receive either:
Group A: 16 weeks of DCV/SOF/RBV
Group B: 24 weeks of DCV/SOF/RBV

Subjects will return to the study center at various time points throughout the 16 or 24 weeks of treatment in addition to 12 weeks post taking last dose of study drug to monitor safety and efficacy. These visits will be according to standard of care.

Contacts
Contact: Tarek Hassanein, M.D. 619-522-0330 thassanein@livercenters.com
Contact: Fatma Barakat, MAS 858-717-0241 fbarakat@livercenters.com

Locations
United States, California
Southern California Research Center Recruiting
Coronado, California, United States, 92118
Contact: Karel Biando 619-522-0330
Principal Investigator: Tarek Hassanein, MD

WHAT IS EXPANDED ACCESS?
A process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide investigational new drugs to patients with serious diseases or conditions who cannot participate in a clinical trial.

For more information on expanded access programs, visit the FDA Understanding Expanded Access/Compassionate Use Web site.

Available
Expanded access is currently available for this treatment
ClinicalTrials.gov Identifier:
NCT02097966

Purpose
The primary objective of this program is to provide Daclatasvir in combination with Sofosbuvir with or without Ribavirin to subjects with chronic Hepatitis C who are at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02097966

This program is conducted in the EU (Germany, Austria, Norway, The Netherlands, Sweden and United Kingdom only)

Contacts
Contact: For Site information please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time

Study Locations
Austria
Local Institution
Amstetten, Austria
Contact: Site 0090
Local Institution
Braunua/Inn, Austria
Contact: Site 0074
Local Institution
Graz, Austria
Contact: Site 0022
Local Institution
Innsbruck, Austria
Contact: Site 0098
Local Institution
Innsbruck, Austria
Contact: Site 0059
Local Institution
Linz, Austria
Contact: Site 0026
Local Institution
Linz, Austria
Contact: Site 0024
Local Institution
Oberndorf, Austria
Contact: Site 0048
Local Institution
Oberndorf, Austria
Contact: Site 0047
Local Institution
Oberpullendorf, Austria
Contact: Site 0094
Local Institution
Salzburg, Austria
Contact: Site 0060
Local Institution
Vienna, Austria
Contact: Site 0075
Local Institution
Wien, Austria
Contact: Site 0054
Local Institution
Wien, Austria
Contact: Site 0044
Local Institution
Wien, Austria
Contact: Site 0097
Local Institution
Wien, Austria
Contact: Site 0023
Germany
Local Institution
Aachen, Germany
Contact: Site 0064
Local Institution
Augsburg, Germany
Contact: Site 0002
Local Institution
Berlin, Germany
Contact: Site 0001
Local Institution
Berlin, Germany
Contact: Site 0005
Local Institution
Berlin, Germany
Contact: Site 0041
Local Institution
Berlin, Germany
Contact: Site 0040
Local Institution
Berlin, Germany
Contact: Site 0037
Local Institution
Berlin, Germany
Contact: Site 0038
Local Institution
Berlin, Germany
Contact: Site 0107
Local Institution
Bonn, Germany
Contact: Site 0046
Local Institution
Bonn, Germany
Contact: Site 0015
Local Institution
Cologne, Germany
Contact: Site 0050
Local Institution
Essen, Germany
Contact: Site 0035
Local Institution
Essen, Germany
Contact: Site 0006
Local Institution
Frankfurt, Germany
Contact: Site 0108
Local Institution
Frankfurt, Germany
Contact: Site 0007
Local Institution
Frankfurt Am Main, Germany
Contact: Site 0061
Local Institution
Hamburg, Germany
Contact: Site 0036
Local Institution
Hamburg, Germany
Contact: Site 0021
Local Institution
Hamburg, Germany
Contact: Site 0031
Local Institution
Hamburg, Germany
Contact: Site 0014
Local Institution
Hannover, Germany
Contact: Site 0068
Local Institution
Hannover, Germany
Contact: Site 0019
Local Institution
Heidelberg, Germany
Contact: Site 0011
Local Institution
Herne, Germany
Contact: Site 0028
Local Institution
Jena, Germany
Contact: Site 0042
Local Institution
Kiel, Germany
Contact: Site 0030
Local Institution
Leipzig, Germany
Contact: Site 0009
Local Institution
Muenchen, Germany
Contact: Site 0034
Local Institution
Muenster, Germany
Contact: Site 0008
Local Institution
Munchen, Germany
Contact: Site 0033
Local Institution
Munchen, Germany
Contact: Site 0039
Local Institution
Stuttgart, Germany
Contact: Site 0032
Local Institution
Tuebingen, Germany
Contact: Site 0004
Local Institution
Ulm, Germany
Contact: Site 0003
Local Institution
Wuerzburg, Germany
Contact: Site 0029
Local Institution
Wuerzburg, Germany
Contact: Site 0027
Netherlands
Local Institution
Amsterdam, Netherlands
Contact: Site 0066
Local Institution
Amsterdam, Netherlands
Contact: Site 0017
Local Institution
Rotterdam, Netherlands
Contact: Site 0016
Local Institution
Urecht, Netherlands
Contact: Site 0018
Sweden
Local Institution
Falun, Sweden
Contact: Site 0073
Local Institution
Gothenburg, Sweden
Contact: Site 0058
Local Institution
Helsingborg, Sweden
Contact: Site 0051
Local Institution
Kalmar, Sweden, SE-391 85
Contact: Site 0053
Local Institution
Lulea, Sweden
Contact: Site 0106
Local Institution
Lund, Sweden
Contact: Site 0065
Local Institution
Stockholm, Sweden
Contact: Site 0063
Local Institution
Sundsvall, Sweden
Contact: Site 0052
United Kingdom
Local Institution
Plymouth, Devon, United Kingdom
Contact: Site 0085
Local Institution
London, Greater London, United Kingdom
Contact: Site 0078
Local Institution
London, Greater London, United Kingdom
Contact: Site 0081
Local Institution
Manchester, Greater Manchester, United Kingdom
Contact: Site 0087
Local Institution
Manchester, Greater Manchester, United Kingdom
Contact: Site 0076
Local Instituition
Liverpool, Merseyside, United Kingdom, L7 8XP
Contact: Site 0080
Local Institution
Nottingham, Nottinghamshire, United Kingdom
Contact: Site 0077
Local Institution
Oxford, Oxfordshire, United Kingdom
Contact: Site 0089
Local Institution
Newcastle Upon Tyne, Tyne And Wear, United Kingdom
Contact: Site 0084
Local Institution
Birmingham, West Midlands, United Kingdom
Contact: Site 0086
Local Institution
Leeds, Yorkshire, United Kingdom
Contact: Site 0079
Local Institution
Brighton, United Kingdom
Contact: Site 0082
Local Institution
Cardiff, United Kingdom
Contact: Site 0104
Local Institution
Frimley, United Kingdom
Contact: Site 0088
Local Institution
Guildford, United Kingdom
Contact: Site 0092
Local Institution
London, United Kingdom
Contact: Site 0069
Local Institution
London, United Kingdom
Contact: Site 0083
Local Institution
London, United Kingdom
Contact: Site 0055
Local Institution
London, United Kingdom
Contact: Site 0057
Local Institution
Wrexham, United Kingdom
Contact: Site 0105

Sponsors and Collaborators
Bristol-Myers Squibb

Available 
ClinicalTrials.gov Identifier:
NCT02161939

Expanded access is currently available for this treatment.

Purpose
The primary objective of this program is to provide DCV for 24 weeks to be given in combination with SOF to subjects with chronic hepatitis C with decompensated cirrhosis or post-liver transplant subjects with chronic hepatitis C recurrence with either advanced fibrosis or fibrosing cholestatic hepatitis and who have a serious or immediately life-threatening condition or experienced an event that has decreased their life expectancy to <12 months, therefore, no research hypothesis will be tested and no specific endpoints are defined. However, safety data will be collected throughout the study as well as efficacy data

Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02161939

Contacts
Contact: HCV-TARGET/University of Florida -- Angie Bauer bauera@medicine.ufl.edu
Contact: Lauren Morelli lauren.morelli@medicine.ufl.edu

Locations
United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
Contact: Hugo Vargas, Site 0002 480-342-1010
United States, California
USC - Keck Medical Center
Los Angeles, California, United States, 90033
Contact: Saro Khemichian, Site 0019 323-442-6171
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Contact: Conseuelo Soldevila-Pico, Site 0004 352-273-9465
United States, Georgia
Piedmont Transplant
Atlanta, Georgia, United States, 30309
Contact: Devina Bhasin, Site 0021 404-548-0937
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Contact: Paul Kwo, Site 0010 317-274-3090
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Contact: Shobha Joshi, Site 0013 504-842-4015
United States, Massachusetts
Mass General
Boston, Massachusetts, United States, 02114
Contact: Ray Chung, Site 0008 617-643-0446
United States, Michigan
Henry Ford
Detroit, Michigan, United States, 48202
Contact: Stuart Gordon, Site 0011 313-916-9465
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Contact: Paul Gaglio, Site 0017 718-920-4644
Columbia University Medical Center
New York, New York, United States, 10032
Contact: Robert Brown, Site 0007 212-305-0662
United States, North Carolina
UNC
Chapel Hill, North Carolina, United States, 27599
Contact: Jama Darling, Site 0014 919-933-8938
Carolinas Healthcare Institute
Charlotte, North Carolina, United States, 28204
Contact: Philipe Zamor, Site 0022 704-355-6649
United States, Pennsylvania
University of Pennsylvania
Philadephia, Pennsylvania, United States, 19104
Contact: Rajender Reddy, Site 0005 215-662-4311
United States, Texas
Research Specialist of Texas
Houston, Texas, United States, 77030
Contact: Joseph Galati, Site 0003 713-634-5110
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Contact: Richard Sterling, Site 0016 804-828-9034

Sponsors and Collaborators
Bristol-Myers Squibb

Additional Bristol-Myers Squibb (BMS) trials, here.

The HCV clinical trials in this post are not a complete list; to learn more about Hepatitis C virus clinical trials or to find out if a study is enrolling patients in your area, please click here.


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New HCV Drugs Cost-effective for Some With Genotypes 2 and 3

Medscape Medical News 

New HCV Drugs Cost-effective for Some With Genotypes 2 and 3
Marcia Frellick

March 31, 2015
Researchers assessing the cost-effectiveness of expensive new interferon-free hepatitis C drugs looked beyond the most common group, genotype 1, and found the drugs are cost-effective for some patients with genotypes 2 and 3, budgets permitting.

The sofosbuvir-based drugs have cure rates above 90% and have previously been shown to be cost-effective for at least genotype 1, as reported in Medscape Medical News.

However, the drugs cost nearly $1000 a pill, or $28,000 for 4 weeks of therapy, which may be too expensive for patients in publicly funded insurance programs, which do not guarantee access to them. So society is left with the question of who should get the medications.

In an article published online March 30 in the Annals of Internal Medicine, Benjamin Linas, MD, MPH, from Boston Medical Center, HIV Epidemiology and Outcomes Research Unit, Massachusetts, and colleagues, using evidence-based simulation modeling, report that at its current cost, sofosbuvir-based hepatitis C virus (HCV) therapy improves outcomes and provides good economic value if patients have cirrhosis, if they have genotype 2 or 3 infection, and if they were previously treated with interferon.

However, in patients without cirrhosis who have never been treated and for whom the less expensive pegylated interferon-ribavirin remains an option, sofosbuvir-based therapy is not cost-effective. In those cases, the sofosbuvir-based therapy for genotype 2 or 3 infection is well over the US willingness-to-pay threshold of $100,000 per quality-adjusted life-year that insurers use.
There are two reasons for that, the authors write. First, the potential benefits of interferon-free treatments are lower if the interferon-based treatment is an option and works with 80% efficacy in treatment-naive patients.

Second, patients are at low risk for death from HCV until they develop cirrhosis, and not all of them will. As a result, the sustained virologic response benefits of interferon-free therapy do not translate directly into large boosts in life expectancy or quality-adjusted life expectancy in noncirrhotic patients.

"This finding was consistent even when we increased mortality in cirrhotic patients, assumed lower [quality of life] with early-stage HCV infection, and assumed higher costs attributable to HCV infection," the authors write.

Should Anyone Get Interferon?
The research raises questions of when, if ever, providers should administer interferon to save costs. Recent HCV guidelines identified pegylated interferon-ribavirin as a regimen "to avoid."
Patients who have insurance are unlikely to want the older therapies that have longer treatment and higher toxicity. So, from a societal perspective, is it acceptable to limit the total number of people treated to avoid interferon therapies at all costs?

The authors write that the best option is for insurers to negotiate discounts for the new drug prices, but if that does not happen, the authors support offering the interferon treatments to treatment-naive noncirrhotic patients and saving sofosbuvir for patients with cirrhosis and those who cannot tolerate or have previously not benefited from interferon therapy.
Such a strategy would treat the sickest first while offering a less costly alternative to those with early disease.

Cost Stands in Way of Eradication
In an accompanying editorial, Ohad Etzion, MD, and Marc Ghany, MD, MHSc, from the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health in Bethesda, Maryland, agree that the simplest solution would be lowering the dug prices, but they acknowledge that if that happened, it would be too late for many patients, and still the prices would be too high in some settings.

They find, as authors of other studies have found, that cost may be the only thing standing in the way of eradicating HCV.

"Medicine does not often have the potential to eradicate a disease with significant public health burden," they write. "Results from the studies discussed here offer a price that would make these treatments cost-effective, but is society willing to pay even the reduced price?"

This study was funded by the National Institute on Drug Abuse and the National Institute of Allergy and Infectious Disease. Dr Linas and a coauthor received grants from the National Institute on Drug Abuse. Another coauthor reports receiving grants and personal fees from Gilead Sciences, Bristol-Myers Squibb, and Abbvie Pharmaceuticals outside the work. The other authors have disclosed no relevant financial relationships. Dr Ghany reports receiving nonfinancial support from Bristol Meyers Squibb outside the work. Dr Etzion has disclosed no relevant financial relationships.
Ann Intern Med.

Published online March 30, 2015. Article abstract/a>, Editorial extract

Source - Medscape
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Relationship between gallbladder polyps and fatty liver?

Hepatic fat is associated with gallbladder polyps

News imageThe latest issue of the Journal of Gastroenterology & Hepatology reports that hepatic fat, not visceral fat, is associated with gallbladder polyps.

Gallbladder polyps appear to be strongly associated with obesity and metabolic disease.

To date, the relationship between gallbladder polyps and fatty liver has not been adequately evaluated.

Dr Donghee Kim and colleagues from South Korea investigated whether gallbladder polyps are associated with fatty liver, which is an ectopic regional fat deposit, independent of visceral adipose tissue.

The team conducted a cross-sectional study using 2643 health checkup subjects.
The subjects underwent various laboratory tests, abdominal fat computed tomography (CT), and hepatic ultrasonography.

The degree of fatty liver showed a dose-dependent relationship with large gallbladder polyps
Journal of Gastroenterology & Hepatology
The mean age of the subjects was 51 years, and 74% were male.
The research team found that gallbladder polyps were significantly associated with fatty liver.

The team noted that gallbladder polyps were significantly associated with the presence of fatty liver, and adjusting for the homeostatic metabolic assessment index had little effect on this association.

Additionally, gallbladder polyps remained significantly associated with the presence of fatty liver after adjustments for CT-measured visceral adipose tissue and subcutaneous adipose tissue.

The researchers observed that the degree of fatty liver showed an independent, and dose-dependent relationship with large gallbladder polyps.

Dr Kim's team concludes, "Fatty liver, an ectopic regional fat deposit, was found to be closely associated with gallbladder polyps independent of known metabolic risk factors, insulin resistance, and CT-measured visceral adipose tissue, confirming a relevant clinical relationship between the two diseases."

Abstract Summary - http://www.gastrohep.com/news/news.asp?id=111026  
Abstract - J Gastroenterol Hepatol 2015: 30(4): 767–774
31 March 2015

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Monday, March 30, 2015

U.S. cancer incidence, mortality largely stable or decreasing

U.S. cancer incidence, mortality largely stable or decreasing
BY ANDREW M. SEAMAN

There are areas of concern, Sherman told Reuters Health in a phone interview.

For example, liver cancers are increasing, likely due to an increase in hepatitis C infections that goes back decades.

“A couple decades ago, the rate of hepatitis C infections increased and that in turn is being reflected in liver cancer rates,” Sherman said. Fortunately, two of the biggest risk factors for liver cancer are hepatitis C infection and alcohol abuse, which are preventable and treatable, she said.

(Reuters Health) – - The rate of people being diagnosed or killed by cancer in the U.S. is stable or decreasing for men and women, according to a new report.

“For the main cancers, it’s really pretty much good news, incidence and mortality is decreasing,” said Recinda Sherman, an author of the new report from the North American Association of Central Cancer Registries (NAACCR) in Springfield, Illinois.

A highlight of the report is that for the first time it breaks breast cancer into specific groups based on how it responds to hormones, said Ahmedin Jemal, vice president of surveillance and health service research at the American Cancer Society (ACS).

Continue reading....

SOURCE: bit.ly/UckC33 Journal of the National Cancer Institute, online March 30, 2015.
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The Cost of a Cure: Medicare Spent $4.5 Billion on New Hepatitis C Drugs Last Year

The Cost of a Cure: Medicare Spent $4.5 Billion on New Hepatitis C Drugs Last Year

By Charles Ornstein | ProPublica March 29 at 10:00 PM
This story was co-published with the Washington Post.

Medicare spent $4.5 billion last year on new, pricey medications that cure the liver disease hepatitis C — more than 15 times what it spent the year before on older treatments for the disease, previously undisclosed federal data shows.

The extraordinary outlays for these breakthrough drugs, which can cost $1,000 a day or more, will be borne largely by federal taxpayers, who pay for most of Medicare’s prescription drug program. But the expenditures will also mean higher deductibles and maximum out-of-pocket costs for many of the program’s 39 million seniors and disabled enrollees, who pay a smaller share of its cost, experts and federal officials said.

The spending dwarfs the approximately $286 million that the program, known as Part D, spent on earlier-generation hepatitis C drugs in 2013, said Sean Cavanaugh, director of Medicare and deputy administrator at the Centers for Medicare and Medicaid Services (CMS).

The most-discussed of the new drugs, Sovaldi, which costs $84,000 for a 12-week course of treatment, accounted for more than $3 billion of the spending. Spending on another drug, Harvoni, hit $670 million even though it came on the market only in October. Bills for a third drug, Olysio, often taken in conjunction with Sovaldi, reached $821 million.

Medicare also spent $157 million on older hepatitis C drugs in 2014, bringing the total spending for the category to more than $4.7 billion.

The spending surge is unlike anything Part D has seen. The nine-year-old program has benefited in recent years from a slowdown in prescription drug costs as several blockbusters, including the cholesterol-lowering drug Lipitor and the blood thinner Plavix, lost patent protection and have faced competition from generics.

The new hepatitis C drugs, along with other expensive specialty medications in the pipeline, threaten to drastically increase the program’s costs. The federal government spent $65 billion on Part D in 2013, according to the Medicare Payment Advisory Commission. That figure doesn’t include monthly premiums paid by patients...

Continue reading...

 ProPublica is an independent, nonprofit newsroom that produces investigative journalism in the public interest. A version of this article is available at www.propublica.org. ProPublica data reporter Ryann Grochowski Jones contributed to this report.

Related
Reducing the cost of new hepatitis C drugs
Daclatasvir, Harvoni (ledipasvir/sofosbuvir)/Sovaldi/Viekira Pak.
An index of articles pointing the reader to the current controversy over the high price of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.

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Saturday, March 28, 2015

Weekend Reading: Current options for treating HCV genotypes 1-4

Weekend Reading: State-of-the-Art Decision Making in HCV Genotypes 1-4 

Good afternoon folks, when a new learning activity is launched with basic information about HCV this blog offers a quick summary and links to the presentation. 

A new Web-based CME presented by IAS–USA; An Intensive Workshop on Evolving Strategies in Viral Hepatitis Management, aired this month in Atlanta, GA. 

Although this learning activity is clinical in nature and directed at physicians, anyone living with HCV and considering treatment has an opportunity to learn more about disease management, testing, methods used to assess fibrosis, current options for treating HCV genotypes 1-4, and more. 

Participants can listen to an audio, or view a slide-set along with the webcast. I highly recommend watching the webcast, it offers an index for navigating through the program. 

Links
1- Begin by clicking, here. 
2- Under "An Intensive Workshop on Evolving Strategies in Viral Hepatitis Management" 
Click on a subject.
3- Decide to either listen or watch the webcast, when clicking on the latter a new page will launch, click on “I have read these instructions and understand them,” at the bottom of the page to begin the activity.



Index 
Learning Objectives
________________________________________________

Enjoyable, easy listening. 
________________________________________________

________________________________________________

Kenneth E. Sherman, MD, PhD

________________________________________________

Kenneth E. Sherman, MD, PhD

________________________________________________



     
________________________________________________

Michael S. Saag, MD

________________________________________________

Source - IAS–USA; An Intensive Workshop on Evolving Strategies in Viral Hepatitis Management


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CDC Hepatitis Updates - HCV Testing Makes Public Health Sense



CDC Hepatitis Updates - HCV Testing Makes Public Health Sense
Centers for Disease Control and Prevention (CDC) sent this bulletin at 03/27/2015 11:18 AM EDT

Viral Hepatitis Updates from CDC

HCV Testing Makes Public Health Sense
In response to Is widespread screening for hepatitis C justified?, Drs. Jonathan Mermin and John W. Ward of CDC wanted to set the record straight on a number of key points including “the CDC and USPSTF recommendations for one-time testing of persons born during 1945-1965 are based on sound evidence that HCV testing linked to care is beneficial for patients, cost effective, and with the potential of averting over 120,000 deaths from HCV.”
http://www.bmj.com/content/350/bmj.g7809/rr-11

WHO issues its first hepatitis B treatment guidelines
WHO issued its first-ever guidance for the treatment of chronic hepatitis B. Worldwide, some 240 million people have chronic hepatitis B virus with the highest rates of infection in Africa and Asia. People with chronic hepatitis B infection are at increased risk of dying from cirrhosis and liver cancer. Key recommendations include: the use of a few simple non-invasive tests to assess the stage of liver disease to help identify who needs treatment; prioritizing treatment for those with cirrhosis - the most advanced stage of liver disease; the use of two safe and highly effective medicines for the treatment of chronic hepatitis B; and regular monitoring using simple tests for early detection of liver cancer, to assess whether treatment is working, and if treatment can be stopped.
http://apps.who.int/iris/bitstream/10665/154590/1/9789241549059_eng.pdf?ua=1&ua=1

New Hepatitis C & Injection Drug Use Fact Sheet
CDC has developed a fact sheet on Hepatitis C and injection drug use. The fact sheet includes an overview of hepatitis C including symptoms, testing, transmission, prevention, treatment, and reinfection.
http://www.cdc.gov/hepatitis/HCV/PDFs/FactSheet-PWID.pdf

FDA Safety Alert
Hepatitis C Treatments Containing Sofosbuvir in Combination With Another Direct Acting Antiviral Drug: Drug Safety Communication - Serious Slowing of Heart Rate When Used With Antiarrhythmic Drug Amiodarone
http://www.fda.gov/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/ucm439662.htm
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Friday, March 27, 2015

Depression rather than liver impairment reduces quality of life in patients with hepatitis C

Revista Brasileira de Psiquiatria
Print version ISSN 1516-4446
Rev. Bras. Psiquiatr. vol.37 no.1 São Paulo Jan./Mar. 2015
http://dx.doi.org/10.1590/1516-4446-2014-1446

ORIGINAL ARTICLES

Depression rather than liver impairment reduces quality of life in patients with hepatitis C

Luciana D. Silva12, Cláudia C. da Cunha1, Luciana R. da Cunha1, Renato F. Araújo1, Vanessa M. Barcelos1, Penélope L. Menta1, Fernando S. Neves3, Rosangela Teixeira12, Gifone A. Rocha4, Eliane D. Gontijo5
1Viral Hepatitis Outpatient Clinic, Instituto Alfa de Gastroenterologia, School of Medicine, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte - MG - Brazil
2Department of Internal Medicine, School of Medicine, UFMG, Belo Horizonte - MG - Brazil
3Department of Mental Health, School of Medicine, UFMG, Belo Horizonte - MG - Brazil
4Laboratory of Research in Bacteriology, School of Medicine, UFMG, Belo Horizonte - MG - Brazil
5Department of Preventive and Social Medicine, School of Medicine, UFMG, Belo Horizonte - MG - Brazil

Abstract, introduction, and discussion only provided below, for full text article please click here. 

ABSTRACT
Objective:
Patients with chronic hepatitis C (CHC) have a poorer quality of life than those with other chronic liver diseases. However, some of the factors that determine health-related quality of life (HRQOL) in these patients, such as the degree of liver fibrosis, are still controversial. Therefore, the aim of the present study was to investigate the impact of CHC on HRQOL by conducting clinical, psychiatric, and sociodemographic evaluations.

Methods:
One hundred and twenty-four consecutive patients attending a referral center for hepatitis were evaluated using the Mini-International Neuropsychiatry Interview, the Hamilton Depression Rating Scale, the Hospital Anxiety and Depression Scale, and the Medical Outcomes Study 36-Item Short-Form Health Survey. Multiple linear regression analyses were used to quantify independent associations between HRQOL and the clinical, psychiatric, and sociodemographic variables of interest.

Results:
Reduced HRQOL was independently associated with major depressive disorder (MDD) and with elevated levels of alanine aminotransferase, but was not associated with hepatic cirrhosis.

Conclusions:
MDD rather than the grade of liver fibrosis was strongly associated with HRQOL impairment in patients with CHC. These findings highlight that, in patients with CHC, the psychological effects of the disease deserve more attention and the implementation of integrated medical, psychiatric, and psychological care may be helpful.

Key words: Chronic hepatitis C; cirrhosis; health-related quality of life; major depressive disorder

Introduction
Approximately 170 million individuals are infected with the hepatitis C virus (HCV) worldwide.1 HCV is a major cause of chronic liver disease, cirrhosis, and hepatocellular carcinoma (HCC), and is responsible for more than 475,000 deaths around the world each year.1 The natural course of chronic hepatitis C infection (CHC) is slow and insidious; 50-80% of acutely infected individuals will progress to HCV chronic carrier status. Of these, 20% develop cirrhosis and its complications after 20 to 30 years of infection.2 In addition, HCV infection is associated with a series of extrahepatic manifestations, including depressive and anxiety symptoms, fatigue, and musculoskeletal/joint pain, which have been linked to reduced health-related quality of life (HRQOL).3

Issues linked to HRQOL have become remarkably important in the healthcare field.4 HRQOL is one dimension of broader quality of life that is more directly related to health, and it focuses on the patient's subjective evaluation of well-being, individual experiences, and values regarding the process of being sick.5 Evaluation of this parameter is essential, because it is known that the distress caused by a disease transcends target organ damage. Consequently, patients with a similar pattern of liver injury might have different degrees of suffering.

Although HRQOL is variably impaired in cirrhotic patients, the results of studies evaluating the impact of the degree of liver fibrosis on HRQOL are still controversial.6,7 Particularly in patients with CHC, scores indicative of poorer HRQOL have been identified even in the absence of clinically significant hepatic disease when compared with the scores of healthy individuals.8

Furthermore, the influence of viral load on HRQOL is unclear. Although it has been suggested that host factors are the major determinants of HRQOL in patients with CHC, some studies have shown that a sustained viral response improves HRQOL in patients receiving specific treatment for HCV.9
Despite the fact that CHC has a negative influence on all dimensions of HRQOL, including its physical, psychological, and social aspects,10 relevant issues should be raised, such as the translation of the results measured with generic or specific HRQOL instruments into clinical practice and, consequently, how these findings may influence clinical decision-making. Furthermore, regardless of the stage of liver disease, other potential predictors contribute to impaired HRQOL in patients with CHC, particularly psychiatric illness, which is common among these subjects.11 The interrelationship between liver function and psychiatric profile may be more multifaceted than suspected.11,12 Few prospective studies have assessed HRQOL in CHC patients using detailed clinical and psychiatric approaches in combination with semi-structured interviews for psychiatric diagnosis.13,14
Depressive symptoms have been extensively identified in adults with chronic health conditions,15 and correlate negatively with HRQOL. Patients with CHC have a high prevalence of depressive disorders,11,16 up to 70%, which is seven-fold higher than that found in the general population, independently of the degree of hepatic injury.8 As described above, CHC interferes not only with physical symptoms but also with psychological and social functioning.8

This study focuses on the integration of the patients' medical history, especially the evaluation of aspects beyond liver disease, while simultaneously measuring quality of life in the context of CHC. To this end, a multiprofessional and interdisciplinary approach was used to integrate the diverse health-related, psychological, and social aspects that are strongly linked to HRQOL. Expanding the assessment of these patients enables us to not only enhance knowledge about hepatitis C and other liver diseases, but also to recognize other medical issues, such as comorbid psychiatric difficulties, which, as a whole, may significantly influence the HRQOL of patients with chronic diseases,17 such as CHC.

Therefore, the aim of this study was to investigate whether variables related to sociodemographic characteristics, degree of liver impairment, clinical comorbidities, and psychiatric illnesses - especially depressive disorders - are independently associated with HRQOL in patients with CHC. We hypothesized that depressive symptoms might be significantly associated with reduced HRQOL in HCV-infected patients, regardless of the presence of clinically significant hepatic disease.

Discussion Only - Full text article, click here. 
In the present study, depressive disorder had a deeper impact on the HRQOL of patients with CHC than did the severity of liver disease. These results confirm that depressive symptoms have a negative influence on quality of life in individuals with chronic infection, as observed elsewhere.8,28,29 Additionally, our results demonstrated that not only the presence of MDD but also the severity of depressive disorder was associated with lower scores in all SF-36 domains, as well as in the physical component summary. It should be emphasized that the SF-36 domain scores and summary component scores were analyzed in combination. Several studies have demonstrated that the SF-36 summary component scores are not independent, i.e., the PCS and MCS may be partially measuring the same constructs.26 Therefore, the PCS/MCS scoring method imprecisely summarizes the scores of the SF-36 domains, and must be carefully analyzed and interpreted in combination with the domain scores.26

In health care, an alternative manner of assessing the HRQOL of patients would be to use instruments that are targeted at specific aspects of a particular disease. These disease-specific questionnaires are designed to identify disease-specific domains with high specificity and sensitivity.30 In addition to hepatic disease severity, other factors that influence CHC patients' HRQOL should be recognized. The administration of an instrument able to detect small changes in quality of life may increase identification of HRQOL-related issues. Among them, the diagnosis of psychological factors, such as depressive symptoms and anxiety, should be emphasized. Moreover, this process also permits physicians to make changes in patient management. In the present study, when a specific instrument was used to evaluate HRQOL in patients with CHC, MDD was strongly associated with poorer HRQOL, independently of the stage of liver disease.31 Altogether, these findings highlight the significance of psychiatric issues in HRQOL impairment in CHC patients.

The high prevalence of MDD (30.6%) observed in the present study is consistent with the results of previous investigations using structured psychiatric interviews in CHC patients.14 However, the pathogenesis of HCV-related psychiatric symptoms has not been completely clarified. Several lines of evidence have demonstrated that the virus is able to cross the blood-brain barrier. Recently, studies focusing on the analysis of quasispecies have allowed the identification of HCV-RNA in brain tissue.32 Otherwise, the role played by the host's immune response (especially cytokine-related effects) on psychiatric disorders in CHC should not be disregarded.33

In addition to depression, CHC has been shown to be associated with other psychiatric comorbidities that may themselves contribute to a poorer HRQOL.4,16,34 Despite the results of multivariate analyses in this study, the influence of anxiety disorder influence on the HRQOL of patients with CHC should not be ignored. The prevalence of anxiety disorders in patients with CHC has been shown to be as high as that of clinical depression.13,16 Some authors have explained that these elevated levels of psychiatric morbidity are related to coping with stigma and prejudice during the disease process.35 Overall, these life experiences and feelings may be responsible for increased rates of anxiety and contribute to the negative impact of chronic diseases, such as CHC, on HRQOL.36 Additionally, in this study, alcohol abuse was another psychiatric comorbidity associated with a reduction in the scores of two domains of the SF-36. This negative impact of alcohol use on HRQOL is consistent with previous studies.37

To the best of our knowledge, this is the first study to demonstrate an association between lower scores on the Functional Capacity domain of the SF-36 and HTN in patients with CHC. The high (35.5%) prevalence of HTN may be explained by the older age of the study population. Ethnicity and dietary and cultural habits should also be considered.

In agreement with previous studies, none of the SF-36 scores correlated with presence of cirrhosis, presence of necroinflammatory activity, or viral load.8,10,38 However, in contrast to previous investigations,10,38 higher ALT concentrations in this study were associated with decreased SF-36 scores in five domains and in two summary components. As CHC has been associated with several extrahepatic manifestations,3 one may speculate that elevated ALT concentrations might be associated with the activation of a systemic host immune response. This event might interfere with target organs beyond the liver, including the central nervous system.

Among the sociodemographic variables evaluated in the current study, family income and educational attainment were positively associated with three SF-36 domain scores. Helbling et al. showed that low income was the major factor associated with a reduced HRQOL among patients with CHC.10 In addition, previous investigations have demonstrated the positive influence of education on the HRQOL of patients with this disease.3,4

Of note, regarding host-related variables, it should be emphasized that the majority of studies assessing the HRQOL of patients affected by CHC have taken place in the context of routine medical care and did not use structured psychiatric interviews to confirm anxiety or mood disorders. Our subjects were patients of a university hospital; consequently, a close working relationship between clinicians, hepatologists, psychiatrists, and psychologists evaluating and treating these subjects was enhanced. An interdisciplinary and multiprofessional approach was developed for a better comprehension of CHC patients' clinical/psychiatric manifestations, with a particular focus on evaluating the deleterious effects of HCV that extend beyond liver disease.

The present study has some limitations. First, the subjects included were recruited from a referral center and, consequently, may not be representative of all patients with CHC. Second, although the SF-36 is considered to be the most appropriate generic instrument for HRQOL assessment in patients with chronic liver disease,22 some issues need to be evaluated. Independent of clinical/psychiatric illnesses, HCV infection alone has been shown to negatively impact HRQOL.8 Upon receiving a diagnosis of HCV, which is a contagious liver disease, these patients are faced with various challenges, such as adjusting to chronic comorbidity and coping with the stigma and the stress of social and familial relationships.35 In addition, individuals with CHC live with illness uncertainty, which may become a great psychological stressor for these subjects.39 Based on these aspects, use of the SF-36 instrument only may be insufficient for an appropriate evaluation of the HRQOL of patients with CHC, which is influenced by multiple complex factors. Furthermore, some studies point to the possibility of an overlap between HRQOL domains and psychiatric abnormalities, especially depressive symptoms. In the present study, the “depressive view” of depressed patients may have introduced bias in the interpretation of the SF-36 domain scores and summary component scores.40

In conclusion, we have clearly demonstrated that psychiatric disorders (particularly MDD) and active medical comorbidities, rather than the severity of liver disease, are the determinants of HRQOL impairment in patients with CHC. These findings highlight that the psychological effects of the disease on patients living with CHC deserve more attention, and that implementation of integrated medical, psychiatric, and psychological care may be helpful for patients with CHC.

Full text article, click here. 

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Thursday, March 26, 2015

Gilead’s Sovaldi® for HCV Genotype 2 Approved By Japan’s Ministry of Health, Labour and Welfare

Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Sovaldi® (sofosbuvir) for the Treatment of Genotype 2 Chronic Hepatitis C
Source News
Company Gilead Sciences, Positron
Date March 26, 2015

-- Sovaldi Part of First All-Oral Treatment Regimen for Genotype 2 Patients in Japan --

-- 96 Percent Cure Rates and Shortened, 12-Week Course of Therapy --

FOSTER CITY, Calif., Mar. 26, 2015 -- (BUSINESS WIRE) -- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Sovaldi® (sofosbuvir), a once-daily nucleotide analog polymerase inhibitor, for the suppression of viremia in patients with genotype 2 chronic hepatitis C virus (HCV) infection with or without compensated cirrhosis. Sovaldi is indicated for use in combination with ribavirin (RBV) for 12 weeks. Sovaldi (in combination with RBV) is the first all-oral, interferon-free treatment regimen for genotype 2 HCV infection. Sovaldi is also the first product to be marketed by Gilead in Japan.

“Today’s approval represents an important step forward in the management of hepatitis C in Japan, enabling genotype 2 infected patients the opportunity of a cure in 12 weeks with an all-oral regimen that eliminates the need for interferon,” said Masao Omata, MD, Yamanashi Prefectural Hospital Organization.

Primarily due to HCV, Japan has one of the highest rates of liver cancer of any industrialized country. Of the more than one million people chronically infected with HCV, 20-30 percent have the genotype 2 strain of the virus. Currently approved therapies in Japan for genotype 2 HCV infection involve 24-48 weeks of injections with pegylated interferon, which may not be suitable for many patients.

Sovaldi’s approval is supported by data from a Phase 3 clinical trial conducted in Japan (Study GS-US-334-0118) among treatment-naïve and treatment-experienced genotype 2 patients. Approval was based on 96 percent (n=135/140) of genotype 2 HCV-infected patients who received 12 weeks of an all-oral regimen of Sovaldi plus RBV 600–1,000 mg/day achieving a sustained virologic response 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV infection. The approval is also supported by SVR12 results from four international Phase 3 studies (FISSION, FUSION, POSITRON and VALENCE), which included genotype 2 HCV patients.

“There is a need in Japan for new HCV treatment options that are more effective and better tolerated and we have been pleased to partner with the medical community here in Japan to demonstrate the efficacy and safety of Sovaldi,” said Norbert Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “We look forward to making Sovaldi available in Japan as quickly as possible, while simultaneously continuing to work with the agency on its review of our second application for an all-oral sofosbuvir-based regimen for the treatment of genotype 1 HCV infection.”

Gilead filed a New Drug Application (NDA) in Japan for a single-tablet regimen of sofosbuvir and the NS5A inhibitor ledipasvir for the treatment of genotype 1 HCV infected patients on September 24, 2014. The ledipasvir/sofosbuvir single tablet regimen is an investigational product in Japan and its safety and efficacy have not yet been established.

IMPORTANT SAFETY INFORMATION

Use with potent P gp inducers: Drugs that are potent P-gp inducers in the intestine are expected to decrease sofosbuvir plasma concentration. Sovaldi is contraindicated in patients receiving the following substances: carbamazepine, phenytoin, rifampicin or St. John’s wort. Also, Sovaldi should be administered with care when coadministered with the following drugs: rifabutin, and phenobarbital.

Contraindications: Sovaldi is contraindicated in patients with severe renal function impairment (eGFR<30 mL/min/1.73m2) or patients with renal insufficiency requiring dialysis.

Anemia occurred in patients receiving Sovaldi in combination with ribavirin. Patients should be carefully observed and hemoglobin should be periodically monitored and appropriate measures should be taken including ribavirin dose adjusted according to the ribavirin package insert. If ribavirin is permanently discontinued, Sovaldi should also be discontinued.

Adverse reactions: In the Japanese Phase 3 clinical study, 61 of 140 (43.6 percent) patients experienced adverse reactions, including abnormal laboratory test values. The major adverse reactions were 21 anemia/hemoglobin decreased (15.0 percent), 7 headache (5.0 percent), 6 malaise (4.3 percent), 6 nausea (4.3 percent), and 6 pruritus (4.3 percent).

About Gilead

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 physicians and patients may not see advantages of Sovaldi over other therapies and may therefore be reluctant to prescribe the product, and the risk that payers may be reluctant to approve or provide reimbursement for the product. Further, the ledipasvir/sofosbuvir single tablet regimen may not be approved in Japan in the currently anticipated timelines or at all, and approval, if granted, may have significant limitations on its 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, 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 Sovaldi and Harvoni is available at www.gilead.com .
Sovaldi and Harvoni 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.

Gilead Sciences, Inc.
Investors:
Patrick O’Brien, +1 650-522-1936
Media:
Cara Miller, +1 650-522-1616
Seiko Noma, +81-3-6837-0790 (Japan)


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