Thursday, August 8, 2013

Healio: Phase 3 trial assessing therapy for post-liver transplant HCV initiated



Phase 3 trial assessing therapy for post-liver transplant HCV initiated
August 8, 2013

Biotest AG has initiated treatment in a phase 3 clinical trial in North America of a therapy for patients who require liver transplantation because of hepatitis C infection, according to a press release.

The phase 3 trial will assess the efficacy, safety and pharmacokinetics of 10% hepatitis C hyperimmune globulin Civacir (Biotest AG) among patients with HCV undergoing liver transplantation, and will include 90 patients across the United States and Canada. The first patient began treatment after liver transplantation and several weeks of therapy with virostatics.

Treatment is intended to prevent HCV recurrence following liver transplant, as antiviral therapies can lead to tolerability and safety concerns in this patient population. It would be the first treatment approved for this indication, according to the release. The medication has received Orphan Drug designation in the United States and European Union, allowing for market exclusivity for 7 and 10 years, respectively, upon approval.

Exercise may reduce metabolic syndrome among liver transplant recipients
August 8, 2013
Liver transplant recipients were less likely to develop metabolic syndrome when reporting regular and more intense exercise in a recent study.

In a cross-sectional analysis, researchers evaluated 204 liver transplant recipients who had undergone transplantation more than 3 months before study enrollment (median 53.5 months). Height, weight, waist circumference and blood pressure were assessed, and patients reported the duration, frequency per week and metabolic equivalents (METS) of their physical activity.
Full Story »

Afinitor fails to meet survival endpoint for liver cancer indication
August 7, 2013

A global phase 3 study of everolimus as a treatment for patients with advanced liver cancer did not improve survival among users compared with placebo recipients, according to a press release.
Full Story »
 
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2013: August Hepatitis Newsletters


August is here and the end of summer is upon us, where does the time go?

The collection of hepatitis newsletters provided here today are brought to you by devoted advocates and organizations working hard to improve the lives of people affected by hepatitis.

Please read and review this months newsletters and consider signing up to receive an email alert for future publications, or connect on Twitter and Facebook with our valued advocates.


August Newsletters
 
 
 
 The Hepatitis Foundation International is dedicated to liver health and the prevention of liver related diseases. We inform and educate by making available reliable and up-to-date facts. We want you to make well-informed decisions for yourself and your loved ones' health and well-being. We are proud to present this website as your personal Internet gateway to hepatitis information and liver care.

The July-August 2013 Edition of  Health-e Bytes™ newsletter is now available.


Inside:
Hepatitis Foundation International Observes World Hepatitis Day

HFI in the Know...
— HFI Launches Powerful Live-R-Die© DVD
— Upcoming Viral Hepatitis Summits
— National Health Observances

Lifestyle...
— Hepatitis A, Berries and You
— "Do Not Take If..."
— Where Do Celebrities Get Their Tattoos?
— Binge Drinking = Cluster Bomb
— Heroin, Cocaine Use On the Decline?
— Obesity Threatens U.S. National Security

Grand Rounds...
— Victory for HBV Infected Medical Students
— Overactive Gene Linked to Aggressive Liver Cancer
— Psychological, lifestyle and social predictors of
hepatitis C treatment response
— Research Targets HCV’s Ability to Reproduce

In the Pipeline...
— Phase III Trials Address Advanced Liver Cancer
Helping Hands... Next year is HFI's 20th Anniversary!    
Advocacy Alert: Landmark CURE Legislation    
T.I.PS. — Free Healthcare Resources and Information
 
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The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education

August Newsletter

This Issue:
Alan Franciscus, Editor-in-Chief
 
Lucinda K. Porter, RN
 
Jacques Chambers, CLU

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HepCBC’s MONTHLY NEWSLETTER
 
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.


Articles In This Issue Include:

HCV Activists Occupy World Health Organization!
World Hepatitis Day 2013 becomes WHD Week in BC
HepCBC and the Medical Hierarchy - An Analysis by a Medical Student
World Hepatitis Days in Nanaimo and Vancouver (great photos)
"Action Hepatitis Canada" July Meeting Update.
"Should I be Treated?" update with new research and medications
Travel Assistance Program in BC
SVR Honour Roll - people who have been 100% cured
HepCBC's "Liver Warrior" Marathon Team (October 13) and our upcoming AGM (September 10)
Conferences, Medication Assistance, Compensation
HCV Support Groups in Canada
AND MORE!!

Stay Connected

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Hepatitis B August Newsletters

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Learn more about hepatitis B in the news by choosing from the links below:

Connect On Twitter

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CONNECTIONS A Bimonthly e-Newsletter - July - August 2013

On June 12, HHS Assistant Secretary for Health, Dr. Howard Koh, along with CDC, launched Know Hepatitis B—a national, multilingual communication campaign to increase testing for hepatitis B among Asian Americans and Pacific Islanders (AAPIs). The campaign delivers culturally relevant messages in English, Chinese, Korean, and Vietnamese through a variety of multimedia channels. The Know Hepatitis B campaign was created and launched in partnership with Hep B United—a coalition of Asian community groups from around the country. Hep B United partners conduct community-level outreach and will incorporate campaign materials into their education about Hepatitis B. An estimated 1 in 12 AAPIs is living with hepatitis B, yet as many as 2 out of 3 people do not know they are infected.

Follow On Twitter

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2013 - Summer Newsletters
Liver, Viral Hepatitis and Transplants
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New York Presbyterian Hospital 

 Liver Connection Patient Newsletter
 
This quarterly newsletter contains articles addressing all aspects of life before and after liver transplantation. Click here to sign up to receive an email when a new edition of Liver Connection is posted on our website. If you prefer to receive the newsletter by mail, you can add your name to our mailing list—or change your address, if you already receive the newsletter.

Summer 2013

Transplant News
Volunteer of the Year
Silvia's Corner — Silvia Hafliger, MD
Transplant Readiness Part I: Are you prepared for the lifelong journey?
Patient Voices: A Reflection
Caregiving: The Nuts and Bolts of Caregiving
The Pharmacy Corner — Use of Herbal Products After Transplantation
Pediatric News
Staying in Touch
Educational Workshops
Transplant Support Groups
Transplant Resources
Area Support Groups

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In the Summer 2013 issue, Congressman Hank Johnson talks about being cured of his hep C.

Current Issue - Click here to read a digital version of this issue.

by Oriol R. Gutierrez Jr.
More than 3 million people are living with hepatitis C in the United States—and most of them aren't aware of their status. The only way to know if you have hep C is to get tested

by Benjamin Ryan
Cured of his hepatitis C, he now fights for Americans with viral hepatitis.

by Benjamin Ryan
Hepatitis C is a virus that can result in serious liver damage, including cirrhosis (scarring of the liver), liver cancer and possibly death. There is no vaccine for the hep C virus (HCV), but there are treatments that can cure the virus in some people.

by Benjamin Ryan
Those who receive optimal pre-treatment care are much more likely to undergo and complete antiviral treatment for hep C.

by Benjamin Ryan
A report from the Economist Intelligence Unit outlines the inadequate governmental response to the viral hepatitis epidemic around the globe and urges major action to address the escalating medical and economic impact of the virus.

by Benjamin Ryan
Hepatitis C treatment appears to cut in half the rates of liver cancer among those with fibrosis or cirrhosis (scarring of the liver), according to a Danish study.

by Benjamin Ryan
Using syringes designed to have less “dead space”—meaning, they retain a smaller amount of fluid after the plunger has been depressed—may help prevent HIV and hepatitis C transmission among injection drug users.

by Benjamin Ryan
As the baby boomers age, the United States will see a peak and then significant tapering of hep C cases, liver disease and associated health care costs in the next two decades.

Even Moderate Drinking Raises Risk of Death

by Benjamin Ryan
Having even one drink a day can significantly raise your risk of death if you’re living with hepatitis C. 

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Gastroenterology & Endoscopy News

From EASL and DDW  2013

Experts'  Picks: Top Liver Abstracts 
Three expert hepatologists share their opinions of the top liver abstracts:

A Few Abstracts Include:

Sofosbuvir + Peginterferon + Ribavirin for 12 Weeks Achieves 90% SVR12 in Genotype 1, 4, 5, or 6

All Oral Therapy With Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced GT2/3

All-Oral Sofosbuvir-Based 12-Wk Regimens: The ELECTRON Study

Safety and Efficacy of Interferon-Free Regimens of ABT-450/R, ABT-267, ABT-333 ± Ribavirin

View All Top Picks .....

Stay connected

 

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GI & Hepatology News

GI & Hepatology News is the official newspaper of the AGA Institute and provides the gastroenterologist with timely and relevant news and commentary about clinical developments and about the impact of health-care policy. The newspaper is led by an internationally renowned board of editors.

View Current Issue (VOL. 7 NO. 8 AUGUST 2013):
PDF | Interactive Version

 DDW 2013
GI & Hepatology News
DDW 2013 The AGA Report
Download PDF | Digital Edition

Gain insights from the perspectives of Dr. Colin W. Howden, GI & Hepatology News Editor-in-Chief, and invited experts on the top studies reported at Digestive Disease Week® 2013.

Topics In Liver Disease Include

Simeprevir does well in QUEST-2 and PROMISE phase III studies  

Nosocomial infection in cirrhotic patients boosts acute kidney injury risk 

Telaprevir-based triple-drug therapy benefits CHC patients with ESRD
 
After HCV treatment failure, some success with boceprevir-IFN-ribavirin

Connect With AGA

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From NYC Department of Health

NYC Viral Hepatitis Monthly E-Newsletter

06/10/2013 - Summer 2013 NYC Hep ABC Newsletter

Join Us

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July Newsletters
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Hep Chat is Hepatitis Victoria's electronic newsletter that is published 8 times a year
 

Are you about to undertake Hepatitis C treatment?

The Bond University in Queensland is looking for individuals over 18 to complete their survey as part of a The Hepatitis C Treatment Outcome Study.

Participants are being sought from within Australia or from other countries.
 
The study is designed to determine some of the physical, psychological, and social factors associated with Hepatitis C treatment outcomes. 

The primary objective of this research is to increase understanding of individual profiles that are associated with better Hepatitis C treatment outcomes.
 
The first survey must be completed prior to the commencement of treatment and the second at a designated milestone during treatment. The first survey should take 35-40 minutes to complete, whilst the second survey can be completed in 5-10 minutes.
 
Information provided is completely confidential and you have the right to withdraw from the study at any time.
For more information on the study or to participate visit http://hepcstudy.hsstechnology.bond.edu.au

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Our newsletter is sent out for free electronically on the 1st of every month.

To subscribe, please send your email address to slh@hepc-connection.org.

July 2013

 *Check Back With Hep C Connections For Their August Publication

Find Hep C Connections On Facebook

 
 
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Research
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Monthly Pubmed Review of the most relevant research on HCV

August Literature Review

 
Hepatitis C Choices

5th edition Free Online Book




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Links: Hepatitis C Websites
_______________________________________________________________
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These links will take you to the premier Hepatitis C sites and keep you informed with breaking news, clinical studies, new drugs, podcasts, newsletters, support, personal experiences, chat rooms, forums and more.


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Gilead Sciences Carving Out a Wider Moat

Investment Commentary

Gilead Sciences Carving Out a Wider Moat

Stock Investor editor Matt Coffina and senior biotech analyst Karen Andersen discuss Gilead's growing competitive advantages.

By Matthew Coffina, CFA | 08-08-13 | 06:00 AM

I recently sat down with senior biotechnology analyst Karen Andersen to discuss  Gilead Sciences (GILD). A few weeks ago, we raised our fair value estimate for Gilead to $71 per share, based on positive clinical trial results and a lower cost of equity assumption. While Gilead has only a narrow moat, the moat trend is positive. If all goes well with its drug pipeline, Gilead could cross the threshold into wide-moat territory soon

Matt Coffina, editor of Morningstar StockInvestor: Gilead’s historical strength has been in HIV drugs. How has the company's portfolio of HIV drugs evolved, and where are we now in terms of growth potential and patent protection?

Karen Andersen, senior biotechnology analyst: Gilead started out with Viread, which has become the foundation of all of its marketed combination therapies. First, Gilead introduced a combination therapy, Truvada, that can be paired with treatments from other companies. Then Gilead partnered with other firms--  Bristol-Myers Squibb (BMY) and  Johnson & Johnson (JNJ)--to create single-tablet regimens Atripla and Complera. Each new drug has improved upon its predecessors. Atripla is a combination of Truvada and Bristol's Sustiva, but Sustiva causes psychiatric symptoms (depression, nervousness), rash, and elevated cholesterol, and can't be taken by pregnant women. Complera improves upon some of the neurological side effects.

Most recently, Gilead brought Stribild to market, which contains all-Gilead ingredients. Stribild combines Truvada with Gilead's integrase inhibitor, so it's like a more convenient version of Truvada plus  Merck's  (MRK) Isentress. Stribild, in my opinion, looks like a stronger regimen than Complera--it has fewer side effects than Atripla, but it might also be slightly more effective than Atripla, particularly among healthier patients. The better Stribild does, the better for Gilead, since the company doesn't have to share as much of its profit with partners and the Stribild patents go out to 2029.

Overall, Gilead now sees almost $8 billion in annual HIV drug sales. I think Gilead should continue to see high-single-digit sales growth from its HIV portfolio through 2017. These sales should flatten with the expiration of Viread patents in 2018 and begin a slow decline in 2022 as Atripla patents expire.

Matt: Everyone is excited about a variety of hepatitis C drugs in late-stage development. What is hepatitis C and how do you size the potential opportunity?

Karen: Hepatitis C is a viral infection of the liver. Patients left untreated over a period of decades usually develop chronic liver disease, such as cirrhosis, or in the most serious cases liver failure or liver cancer. Most patients in the U.S. today are baby boomers. New infection rates are quite low due to effective blood screening, so we think the market will plateau and then begin to decline as baby boomers age. However, in the meantime, the potential is enormous--there are more than 12 million patients with chronic hepatitis C in major developed markets and more than 3 million in the U.S. alone. Even if diagnosis and treatment rates only improve incrementally over the next few years, we think the global annual market will hit $20 billion by the end of our 10-year forecast.

Matt: Recent clinical trial data for Gilead’s hepatitis C drugs has been very promising. Can you summarize the efficacy and side-effect profile?

Karen: Gilead's strategy is to bring the foundation of its hepatitis C portfolio, sofosbuvir, to market in 2014, and a combination with another drug candidate, ledipasvir, to market in 2015. This oral combination therapy is particularly promising, and efficacy in a recent Phase II trial indicated that cure rates could be as high as 100% after 12 weeks of therapy, with few side effects. For perspective, the current standard of care (with drugs like  Vertex Pharmaceuticals'  (VRTX) Incivek) results in cure rates of around 70% for most previously untreated patients, treatment typically lasts for six months, and side effects--including flulike symptoms, depression, and anemia--prevent many patients from finishing or even initiating therapy. In addition, current treatment involves a complex regimen of once-weekly injections and around a dozen pills a day, while Gilead's regimen will be a once-daily pill.

Matt: How do Gilead’s drugs compare to those in development at competitors like  AbbVie (ABBV), Bristol, Johnson & Johnson, and Vertex?

Karen: Given the market potential I outlined, it is no surprise that several other firms are vying to enter this market. AbbVie is likely to bring its own all-oral combination regimen to market in 2015, but we expect this regimen to require ribavirin, which is part of the current standard of care but which causes anemia. It will also require several pills per day in order to achieve efficacy on par with Gilead's combination regimen. Bristol may be able to bring a ribavirin-free regimen to market with similar efficacy to Gilead's, but Bristol is just entering Phase III trials and also requires several pills per day. I'm most concerned about competition from Vertex, which has a drug that could be similar to Gilead's sofosbuvir. However, Vertex's key trials are only at the Phase II level, which will make the product late to market. Unless Gilead's regimen sees surprisingly weak efficacy in Phase III trials or Vertex is able to significantly shorten treatment times (Gilead is already testing its regimen as an eight-week treatment), we doubt it will be able to offer any improvements relative to Gilead's product.

Matt: Gilead built out its hepatitis C portfolio through the $11 billion acquisition of Pharmasset. Do you think the price it paid was low, high, or about right, given what we know now?

Karen: Given the data we have seen for sofosbuvir and competing products over the past year, we have gone from estimating Pharmasset was purchased at a fair price to estimating it was actually a bargain. For example, last year we conducted a net present value analysis of the acquisition, which implied that Gilead had paid a fair price for Pharmasset assuming a discount rate of 10.2% and $4.5 billion in annual sofosbuvir sales by 2020, followed by flat sales through patent expiration. Today, we assume less than an 8% cost of capital and sales of sofosbuvir flattening around $8 billion by 2020, and the acquisition now looks like it was worth at least twice what Gilead paid.

Matt: Gilead seems to have special expertise in infectious diseases and single-pill formulations that carry across drug classes. Would you agree, and what might this mean for future innovations?

Karen: I think we're starting to see that play out, as the firm's ability to recognize valuable molecules in HIV and strategically create the best combination regimens is clearly carrying over to the field of hepatitis C. I think this is one of the reasons why Gilead will be able to hang on to the high market share it will undoubtedly gain after the launch of sofosbuvir, despite emerging competition. Gilead has a large pipeline of hepatitis C drug candidates that could allow it to serve a broader group of patients with an even shorter duration of therapy. Gilead is also beginning to advance in the field of oncology, which might sound like a stretch. However, Gilead is focusing initially on hematological oncology, where progress looks like it will be heavily focused on combination regimens in niche markets, which is Gilead's specialty.

Matt: We assign Gilead only a narrow economic moat, but the moat trend is positive. What would it take for the company to cross the threshold into wide-moat territory, in your view?

Karen: Assuming clinical data continue to support our thesis that Gilead's hepatitis C pipeline is clearly superior to those of its key competitors, we expect to assign the firm a wide economic moat once sofosbuvir reaches the market (by early 2014). We think patent protection on newer HIV regimens as well as Gilead's lead in producing an all-oral hepatitis C cure will be enough to ensure strong returns for the next couple of decades, and we think visibility on profits is clearer at Gilead than at many of its large-cap biotech peers.

Final thought from Matt: Biotechnology can be a risky place to invest, full of high hopes and dashed dreams, where luck is often as important as skill in the hit-or-miss game of drug development. However, a small handful of biotechs have managed to carve out wide economic moats, based on patents, scale, and the ability to leverage unique expertise across a diversified portfolio of drugs. Gilead appears to be headed in this direction.

http://news.morningstar.com/articlenet/article.aspx?id=606493
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Wednesday, August 7, 2013

Scoring tool predicts outcome of liver cancer treated with arterial embolization

Scoring tool predicts outcome of liver cancer treated with arterial embolization

Last Updated: 2013-08-06 13:49:06 -0400 (Reuters Health)

NEW YORK (Reuters Health) - A score based on four factors -- low albumin, high bilirubin and alfa-fetoprotein, and large tumor size -- is closely associated with mortality risk in patients with hepatocellular cancer (HCC) undergoing transarterial chemoembolization (TACE) or bland arterial embolization (TAE).

The scoring system "may help guide treatment selection, allow stratification in clinical trials and facilitate meaningful comparisons across reported series," according to the authors of the report in the Annals of Oncology online July 14.

As they explain, the prognosis is variable for patients with unresectable HCC for whom arterial embolization may be recommended, and a simple, reliable prognostic index would be valuable.

To develop such a scoring system, Dr. Tim Meyer at University College London and colleagues elsewhere in the UK first identified predictors of survival using data from a set of 114 patients treated with TACE/TAE. They then validated the findings in an independent dataset of 167 patients.

Cox regression analysis showed adjusted hazard ratios for mortality of 3.03 for albumin <36 g/dL; 2.21 for bilirubin >17 mcmol/L; 2.50 for alfa-fetoprotein >400 ng/mL; and 2.51 for a largest lesion >70 mm, according to the report.

The researchers assigned 1 point for each of those risk factors, and the sum of the points formed the individual prognostic score (termed the HAP score).

Median survival for a HAP score of 0, 1, 2 or >2 was 27.6, 18.5, 9.0, and 3.6 months, respectively.

The HAP score was equally predictive in the validation sample. In both cohorts, a HAP score of 2 or greater "defined poor prognosis groups which are unlikely to have benefited from TACE and might now be better served with systemic therapy or supportive care," Dr. Meyer and colleagues suggest.

Furthermore, the HAP score proved more accurate than five other scoring systems in identifying high- and low-risk groups, the team found.

Overall, they conclude, "We have defined a simple and clinically relevant prognostic index requiring the measurement of two tumour variables and two liver variables, specifically for patients undergoing TACE."

Still, they add, "It is appropriate to prospectively validate it on a larger cohort to confirm our findings."

SOURCE: http://bit.ly/16u95o8

Ann Oncol 2013.
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Tuesday, August 6, 2013

Listen To: Why it’s important that baby boomers be tested for Hepatitis C


Dr. Marc Bilodeau


In this interview conducted by Aaron Rand from CJAD 800 Radio, Dr. Marc Bilodeau discusses why baby boomers should be tested for hepatitis C.

The silent epidemic often has no early symptoms, as the disease progresses overtime the liver is slowly damaged and may lead to cirrhosis, liver cancer or liver failure.......



Listen to the interview by clicking the sound file below





Letter: It’s important baby boomers be tested for Hepatitis C (with audio)

The Gazette August 6, 2013 10:12 AM  
 
If you have just recently retired or are nearing retirement age, this is the time in your life when staying healthy means getting to spend more time with family and friends. And staying healthy requires that you make sure you get essential preventive screening. But it is important to know which tests to ask for.

For most people, tests that come to mind may include a colonoscopy or a cholesterol test. Liver cancer might not be on your radar, but it is, in fact, one of the few cancers in Canada that is on the rise. And the most common condition leading to liver cancer is a long-standing infection with a virus known as Hepatitis C.

Continue reading @ The Gazette..

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Hepatitis C Clinical Trials Now Recruiting - Sofosbuvir Trial Updates For July 2013

What Is A Clinical Study?
Take The Time To Learn About Clinical Studies

Clinical Trials.gov - Hepatitis
ClinicalTrials.gov provides regularly updated information about federally and privately supported clinical research in human volunteers. Site gives information about a trial's purpose, who may participate, locations, and phone numbers for more details.
View all Trial Updates @ ClinicalTrials.gov: last 30 days

CenterWatch - U.S. and International
U.S. Hepatitis Clinical Trials Listed By City And State
View all Trial Updates @ CenterWatch

Articles Of Interest
COMMENTARY ON: Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. 

Both Simeprevir and Sofosbuvir Likely Approved by 2014-Clinical/Ethical/Pharmacoeconomic Dilemmas Loom 

Sofosbuvir -FDA Grants Priority Review, Approval Set For December

Hepatitis C Therapy Update 2013-What About Interferon-free Regimens?

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Sofosbuvir Trial Updates For July 2013
____________________________________________________

Phase 3 Study of Sofosbuvir and Ribavirin

This study is currently recruiting participants

Purpose
Sofosbuvir and ribavirin in Japanese subjects with chronic Hepatitis C.

Study Type:Interventional
Study Design:Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 2 HCV Infection

Responsible Party:Gilead Sciences
ClinicalTrials.gov Identifier:NCT01910636     History of Changes
Other Study ID Numbers:GS-US-334-0118
Study First Received:July 23, 2013
Last Updated:July 25, 2013
Health Authority:Japan: Pharmaceuticals and Medical Devices Agency

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Phase 2 Study of SOF+GS-5816 in Treatment Experienced Subjects With Chronic Genotype 3 HCV

This study is currently recruiting participants

Purpose
This study will evaluate sofosbuvir (SOF)+GS-5816 for the treatment of chronic genotype 3 Hepatitis C Virus (HCV) infection in treatment experienced subjects.

Study Type:Interventional
Study Design:Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Experienced Subjects With Chronic HCV Infection
Responsible Party:Gilead Sciences
ClinicalTrials.gov Identifier:NCT01909804     History of Changes
Other Study ID Numbers:GS-US-342-0109
Study First Received:July 17, 2013
Last Updated:July 26, 2013
Health Authority:United States: Food and Drug Administration

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Open-Label Study of GS-7977+ Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

This study is currently recruiting participants

Purpose
Open label study of GS-7977 in combination with ribavirin (RBV) with or without Peginterferon Alfa-2a (PEG) in adults with chronic HCV who participated in a prior Gilead HCV study and have not achieved SVR.

Study Type:Interventional
Study Design:Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:An Open-Label Study of GS-7977 + Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies
Responsible Party:Gilead Sciences
ClinicalTrials.gov Identifier:NCT01625338     History of Changes
Other Study ID Numbers:GS-US-334-0109
Study First Received:June 7, 2012
Last Updated:June 19, 2013
Health Authority:United States: Food and Drug Administration
____________________________________________________

Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naïve and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection.

This study is currently recruiting participants

Purpose
This is a research study to evaluate the safety, tolerability, and anti-viral activity of sofosbuvir with ribavirin in Egyptian adults with genotype 4 hepatitis C infection

Study Type:
Interventional
Study Design:Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naïve and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection.
Responsible Party:Gilead Sciences
ClinicalTrials.gov Identifier:NCT01838590     History of Changes
Other Study ID Numbers:GS-US-334-0138
Study First Received:April 15, 2013
Last Updated:May 22, 2013
Health Authority:United States: Food and Drug Administration
____________________________________________________

A Phase 2a Study of GS-6624 in HIV and/or Hepatitis C- Infected Subjects With Liver Fibrosis

This study is currently recruiting participants.

Purpose
This is an open label, exploratory study of GS-6624 in adult subjects infected with HIV, HCV, or co-HIV/HCV with histological evidence of liver fibrosis. Subjects will receive 700 mg IV GS-6624 every 2 weeks for a total of 24 weeks (12 infusions) while continuing on standard therapy for HIV (HIV-infected subjects only).

Study Type:Interventional
Study Design:Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:A Phase 2a Study of an Anti-LOXL2 Monoclonal Antibody (GS-6624) in HIV and/or Hepatitis C- Infected Subjects With Liver Fibrosis
Responsible Party:Gilead Sciences
ClinicalTrials.gov Identifier:NCT01707472     History of Changes
Other Study ID Numbers:GS-US-321-0107
Study First Received:September 11, 2012
Last Updated:June 4, 2013
Health Authority:United States: Food and Drug Administration
____________________________________________________

A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment

This study is currently recruiting participants.

Purpose
This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.

Study Type:Interventional
Study Design:Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
 
Responsible Party:Gilead Sciences
ClinicalTrials.gov Identifier:NCT01817985     History of Changes
Other Study ID Numbers:GS-US-281-0112
Study First Received:March 20, 2013
Last Updated:July 17, 2013
Health Authority:United States: Food and Drug Administration
 
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A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects

This study is currently recruiting participants.

Purpose
This is an Open-label Phase 3 study in subjects with chronic Genotype 1, 2, 3, and 4 HCV-infection who are co-infected with HIV-1. A total of 220 HCV subjects who are co-infected with HIV-1 will be enrolled into a single arm and treated with oral SOF 400 mg QD plus weight based RBV (1000 or 1200 mg/day) BID for 12 weeks or 24 weeks. The study population will include HCV genotype 1, 2, 3, and 4 HCV treatment naive subjects (including IFN ineligible) and HCV genotype 2 and 3 HCV treatment experienced subjects who have failed prior therapy with PEG/RBV. Approximately 20% of the subjects enrolled will have evidence of compensated cirrhosis at Screening.

Study Type:Interventional
Study Design:Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects

Responsible Party:Gilead Sciences
ClinicalTrials.gov Identifier:NCT01783678     History of Changes
Other Study ID Numbers:GS-US-334-0124
Study First Received:January 31, 2013
Last Updated:April 9, 2013
Health Authority:United States: Food and Drug Administration
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Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection.

This study is currently recruiting participants.

Purpose
The purpose of this study is to determine the effectiveness and safety of sofosbuvir plus ribavirin administered for 16 weeks and 24 weeks in patients with chronic genotype 1 or 3 HCV infection

Study Type:Interventional
Study Design:Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:A Phase 3b, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection.
 
Responsible Party:Gilead Sciences
ClinicalTrials.gov Identifier:NCT01896193     History of Changes
Other Study ID Numbers:GS-US-334-0119
Study First Received:July 2, 2013
Last Updated:July 8, 2013
Health Authority:Russia: Ministry of Health of the Russian Federation
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Phase 2 Study of SOF+GS-5816 in Treatment Naive Subjects With Chronic HCV

This study is ongoing, but not recruiting participants.

Purpose
This study will evaluate sofosbuvir (SOF)+GS-5816 for the treatment of Hepatitis C Virus (HCV) infection.
Study Type:Interventional
Study Design:Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:A Phase 2, Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of Sofosbuvir+ GS-5816 for 12 Weeks in Treatment-naive Subjects With Chronic HCV Infection
Responsible Party:Gilead Sciences
ClinicalTrials.gov Identifier:NCT01858766     History of Changes
Other Study ID Numbers:GS-US-342-0102
Study First Received:May 10, 2013
Last Updated:July 22, 2013
Health Authority:United States: Food and Drug Administration
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Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)

This study is ongoing, but not recruiting participants.

Purpose
The purpose of this study is to evaluate the safety, tolerability and antiviral efficacy of Sofosbuvir/Ledipasvir (FDC) with or without RBV administered for 8 weeks and Sofosbuvir/Ledipasvir (FDC) administered for 12 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.

Study Type:Interventional
Study Design:Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination (FDC) +/- Ribavirin for 8 Weeks and Sofosbuvir/Ledipasvir Fixed-Dose Combination (FDC) for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection

Responsible Party:Gilead Sciences
ClinicalTrials.gov Identifier:NCT01851330     History of Changes
Other Study ID Numbers:GS-US-337-0108
Study First Received:May 3, 2013
Last Updated:July 19, 2013
Health Authority:United States: Food and Drug Administration
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Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Subjects With Chronic Genotype 1, 2, or 3 HCV Infection

This study is currently recruiting participants.

Purpose
The purpose of this study is to evaluate the safety, tolerability and antiviral efficacy of combination therapy with sofosbuvir (SOF)-containing regimens for the treatment of chronic hepatitis C virus (HCV) infection.

Study Type:Interventional
Study Design:Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection


Responsible Party:Gilead Sciences
ClinicalTrials.gov Identifier:NCT01826981     History of Changes
Other Study ID Numbers:GS-US-337-0122
Study First Received:April 1, 2013
Last Updated:April 4, 2013
Health Authority:New Zealand: Medsafe

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Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C

Expanded access is currently available for this treatment.

Purpose
This is a single arm, open-label study which will be opened at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options. Subjects will be treated for 24 weeks with sofosbuvir (400mg QD) with RBV; pegylated interferon may be added at the discretion of the investigator.

Study Type:Expanded Access     What is Expanded Access?
Official Title:An Expanded Access Phase 2 Study of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon for 24 Weeks in Subjects Who Have Undergone Liver Transplantation and Who Have Aggressive, Recurrent Hepatitis C Infection
 
Responsible Party:Gilead Sciences
ClinicalTrials.gov Identifier:NCT01779518     History of Changes
Other Study ID Numbers:GS-US-334-0139
Study First Received:January 23, 2013
Last Updated:June 14, 2013
Health Authority:United States: Food and Drug Administration
United States: Institutional Review Board
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