Showing posts with label 2016-DDW. Show all posts
Showing posts with label 2016-DDW. Show all posts

Saturday, June 25, 2016

Now that we have the hepatitis C virus on the run, can a universal cure be attained?


Hepatitis C: Let's Get 'Real'
Digestive Disease Week (DDW) 2016
Clinical trials have shown that current treatment approaches for hepatitis C are highly successful. Can this degree of success be attained in real-world populations?

William F. Balistreri, MD
June 24, 2016

Hepatitis C virus (HCV) infection remains a significant problem worldwide, with risk for progression to cirrhosis, liver failure, and hepatocellular carcinoma. The good news is that with the development and validation of a spate of new direct-acting antiviral (DAA) drugs and novel treatment strategies, a significant proportion of patients can be cured of HCV infection.

Current highly successful strategic treatment approaches have achieved high sustained virologic response (SVR) rates in clinical trials. However, the question remains: Can this degree of success be replicated in a real-world application of these strategies? And will this level of success apply to all patients? Research presented at this year's Digestive Disease Week (DDW) discussed real-world outcomes and the prospects for ensuring the best outcome for all patients with chronic hepatitis C, including certain patient populations—those with cirrhosis or decompensated liver disease and those who failed to respond to treatment—who may require enhanced strategies such as a longer duration of therapy, the addition of ribavirin, or the use of new ribavirin-free combinations. There are also new possibilities, therapeutic agents that will soon be available to add to the expanding armamentarium of DAAs and combination regimens. For example, the next-generation investigational pangenotypic once-daily combination tablet containing 400 mg of sofosbuvir (SOF) and 100 mg of velpatasvir (VEL) was granted priority review designation from the US Food and Drug Administration (FDA) and is scheduled for approval this quarter. A key area of concern is the possibility of treatment failure due to the existence and emergence of resistant variants of the virus. Investigators discussed the potential impact and use of regimens that offer non-overlapping resistance profiles.

Curative treatment has clear advantages compared with the management of end-stage disease, yet treatment costs and access to treatment for HCV infection are ongoing issues, even though increased competition among pharmaceutical manufacturers may ultimately reduce the price of DAA regimens.

Some of the relevant presentations from DDW 2016 in which investigators shed light on these important issues are highlighted herein.

Continue reading commentary.....

* Free registration required
In The Journals
Access to Treatment Regimens in Chronic HCV Patients
Journal of Viral Hepatitis, June 24, 2016

The Direct-acting Antiviral Era in HCV Cirrhosis
Alimentary Pharmacology & Therapeutics, June 24, 2016

HCV Transmission Associated With a CAM Injection Therapy
Morbidity & Mortality Weekly Report, June 23, 2016

Direct Acting Antiviral Therapy After Liver Transplantation
Current Opinion in Gastroenterology, June 22, 2016

Surveillance for Liver Cancer in Hepatitis C Patients
Liver International, June 21, 2016

Thursday, May 26, 2016

Watch Lisa Backus: Examining Efficacy of Hepatitis Medications

Examining Efficacy of Hepatitis Medications

Watch Video

As medications for hepatitis C become more widely used, studies are being done to see how effective these treatments are when used in combination. Speaking at the annual Digestive Disease Week (DDW) 2016 meeting in San Diego, California, Lisa Backus, MD, PhD , from the US Department of Veterans Affairs discussed the results of a recent study looking at some of the more popular medications available on the market. Backus said the study was important because they wanted to see whether the treatments were as effective in real-world practice as they were during clinical trials in the approval process.

Also on MD Magazine >>>

More news from Digestive Disease Week 2016 -:

Wednesday, May 25, 2016

Investigative Combo ABT-493 plus ABT-530 - Succeeds Against Multiple HCV Genotypes

Novel Drug Combo Succeeds Against Multiple HCV Genotypes
by Ed Susman
Contributing Writer, MedPage Today

No cases of virologic failure observed with ABT-493 plus ABT-530

SAN DIEGO -- An investigative combination of two drugs helped patients infected with hepatitis C virus (HCV) across genotypes 1, 2, 3.4, 5 and 6 achieve sustained virologic responses, researchers reported here.

No cases of virologic failure were observed in the 8-week courses of ABT-493 plus ABT-530 in non-cirrhotic patients infected with genotypes 1, 2 and 3, and no virologic failures were observed among patients with genotypes 4, 5 and 6 who were treated in a 12-week course, according to Tarek Hassanein, MD, of the Southern California GI and Liver Centers/UC San Diego Health System, David Wyles, MD, of the University of California San Diego, and colleagues.

In multiple presentations at the annual Digestive Disease Week (DDW), they described preliminary studies using the pangenotypic agents against the 6 different genotypes of HCV.

The only patients across the studies who failed to achieve a sustained virologic response at 12 weeks (SVR12) -- the standard defined as a function cure of the disease -- were three individuals who failed to complete their regimens. All of them, however, had no quantitative level of circulating virus at the time they left the study, the researchers reported.

During a DDW press conference, Kimberly Brown, MD, of Henry Ford Hospital in Detroit, noted that ABT-493 plus ABT-450 were "able to achieve very similar outcomes with the 8-week regimen as compared with 12 weeks of therapy. And in a third study, they were able to treat more difficult genotypes 4, 5 and 6 with their 12-week therapy with excellent outcomes."

The studies "highlight the advances in safety and tolerability as well as the cure rates for these therapies," she said.

ABT-493 is a pangenotypic NS3/4A protease inhibitor which was paired with ABT-530, a pangenotypic NS5a inhibitor. The regimens did not contain either ribavirin or interferon, which up to 5 years ago were considered mainstays of HCV treatment, but have taken a bit of a backseat to more effective, better tolerated treatments.

For genotypes 1 and 2, the researchers enrolled non-cirrhotic treatment-naïve patients or pegylated interferon/ribavirin treatment-experienced non-responders who received once-daily ABT-493 at a dose of 300 mg plus ABT-530 at a dose of 120 mg for 8 weeks.

For genotype 3, the researchers enrolled treatment-naïve patients without cirrhosis and treated them with a once-daily ABT-493 dose of 300 mg plus ABT-530 at a dose of 120 mg for 8 weeks.

For genotypes 4, 5 and 6, the researchers enrolled treatment-naïve or pegylated interferon/ribavirin treatment-experienced patients who were treated with once-daily ABT-493 at a dose of 300 mg plus ABT-530 at a dose of 120 mg for 12 weeks.

Hassanein reported that in 34 patients diagnosed with genotype 1, 33 patients achieved an SVR12 after 8 weeks of treated with the investigative agents. In the modified intention-to-treat protocol, 33 of 33 patients achieved SVR12.

Also, in 54 patients diagnosed with genotype 2, 53 patients achieved an SVR12 after 8 weeks of treatment with the once-daily regimen, and in the modified intention-to-treat protocol, all achieved SVR12.

Wyles reported that in 29 patients diagnosed with genotype 3, 28 patients achieved an SVR12 after 8 weeks of treatment, and in the modified intention-to-treat protocol, all patients achieved SVR12.

In 11 patients diagnosed with genotype 4, all patients achieved an SVR12 after a 12-week treatment regimen, Hassanein stated.

One patient diagnosed with genotype 5 achieved an SVR12 after the 12-week regimen, and in 22 patients diagnosed with genotype 6, all achieved an SVR12 after the 12-week regimen, he said.

"Based on these findings, and those in patients with hepatitis C virus genotype 1, 2 and 3 infection, phase III studies are evaluating ABT-493 and ABT-530 in patient with and without cirrhosis across all 6 major hepatitis C virus genotypes, including 8-week duration treatments," Hassanein said.

Wyles and Hassanein reported few adverse events in the patients, with none discontinuing the trials due to adverse drug reactions. One patient left the study because he found blood draws intolerable. One patient was removed from the study due to advanced adenocarcinoma, not related to the drugs, Hassanein said. One person was lost to follow-up after 6 weeks of treatment.

"Over the past 10 years, we have made huge strides in the area of hepatitis C, a disease which really impacts...3.5 million people in this country," Brown stated. "With this research, there is greater understanding of the genome and several proteins in the virus and that has led to several developments, which now means we have the opportunity to cure more than 95% of these patients."

"In particular, researchers have been looking at direct-acting agents, which target specific proteins within the virus, disrupting viral replication," she added. "With these advances, investigators are now looking to see if we can shorten therapies. We have gone from treatment periods that have lasted nearly a year for patients with fairly significant side effects to...the majority of treatment paradigms [lasting] 12 weeks with very minimal side effects."

The studies were supported and funded by AbbVie. The company participated in the interpretation of data, review, and approval of the content.

Hassanein disclosed relevant relationships with AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb (BMS), Eisai, Gilead Sciences, Ikaria, Janssen, La Jolla Pharmaceuticals, Merck, Mochida, NGM BioPharmaceuticals, Obalon, Roche, Ocera, Sundise, Salix, Taigen, Takeda, Tobria, Vertex, Vital Therapies, and Baxter.

Wyles disclosed relevant relationships with AbbVie, BMS, Gilead, Merck, Tacere Therapeutics, and Janssen.
Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco

Primary Source
Digestive Disease WeekSource Reference: Poordad F, et al "High SVR rates with the combination of ABT-493 + ABT-530 for 8 weeks in non-cirrhotic patients with HCV genotype 1 or 2 infection" DDW 2016; Abstract 752.

Secondary Source
Digestive Disease WeekSource Reference: Gane E, et al "SURVEYOR-1: 100% Svr12 and favorable safety of Abt-493 + Abt-530 administered for 12 weeks in non-cirrhotic patients with genotypes 4, 5, or 6 infection (Surveyor-I)" DDW 2016; Abstract 755.

Additional Source
Digestive Disease WeekSource Reference: Muir A, et al "High SVR Rates with ABT-493 + ABT-530 co-administered for 8 weeks in non-cirrhotic patients with HCV genotype 3 infection" DDW 2016; Abstract 753.

Monday, May 23, 2016

The Future of Hep C Treatment

The Future of Hep C Treatment
Posted By: DDW Communications
on: May 23, 2016
In: AASLD, By Society, Explore Sessions, Watch Videos

DDW TV covered this exciting and informative State-of-the-Art Lecture which presented the very latest information on hepatitis C. We talked to the session’s speaker, Norah Terrault, MD, MPH, about a range of new therapies coming out that will help difficult to treat populations. Dr. Terrault also talks about the future – and what the discussions around hepatitis C are likely to be in 2017.

DDW 2016 abstracts are available via the Online Planner
1 - Click on Abstracts
2 - Under Abstract Category​ click on hepatitis C

Of Interest
May 24
Digestive Disease Week 2016
ASTRAL studies: New combination yields encouraging patient-reported outcomes
SAN DIEGO —   Treatment with velpatasvir/sofosbuvir was associated with improvements in a number of patient self-reported quality of life measures, according to findings presented at Digestive Disease Week 2016.

May 13
THE FIVE The International Liver Congress
Alan Franciscus, Editor-in-Chief

Gilead Sciences (GILD) Presents at 2016 UBS Global Healthcare Brokers Conference - Transcript
May 23
We have a few other programs in clinical development, the first one is a combination of sofosbuvir and velpatasvir, this is a once-daily Pan-Genotypic single-tablet regimen, the NDA was filed late last year and we've a PDUFA date coming up next month, June 28th. And in the United in the -- this was by the way joined the priority of review and in the Europe we have the similar timelines....
*Free registration required

Sofosbuvir/Velpatasvir (SOF/VEL) and SOF/VEL Plus GS-9857
Gilead's Press Release
Gilead's Sofosbuvir/Velpatasvir and SOF/VEL Plus GS-9857 at The International Liver CongressTM
– Studies Highlight Progress with Approved Therapies and Investigational Pangenotypic Regimens, Including Sofosbuvir/Velpatasvir (SOF/VEL) and SOF/VEL Plus GS-9857 –

April 14
Sofosbuvir/Velpatasvir (SOF/VEL) and SOF/VEL Plus GS-9857 
The International Liver Congress 2016 Press Release
Sofosbuvir/velpatasvir and experimental compound GS-9857 shows promise in Hepatitis C infected patients whose previous treatment has failed
High sustained virologic response achieved with sofosbuvir/velpatasvir and GS-9857, even in patients unsuccessfuly treated with direct-acting antivirals

Nam aidsmap
Sofosbuvir/Velpatasvir (SOF/VEL) and SOF/VEL Plus GS-9857
Reported by Liz Highleyman
Sofosbuvir/velpatasvir + GS-9857 works well for treatment-experienced hepatitis C patients
A triple combination of Gilead Sciences' sofosbuvir, velpatasvir and GS-9857 demonstrated a high sustained response rate for treatment-experienced people with all hepatitis C virus (HCV) genotypes who previously were not cured with prior direct-acting antivirals (DAAs), according to two presentations yesterday at the 2016 International Liver Congress in Barcelona.Interferon-free DAA therapy has revolutionised treatment for chronic hepatitis C, but there is still room to optimise therapy for difficult-to-treat patients. Ideally such regimens will be pangenotypic, meaning they could be routinely prescribed without the need for HCV genotype testing.
Eric Lawitz of the Texas Liver Institute presented findings from studies of a three-drug regimen consisting of the HCV NS5B polymerase inhibitor sofosbuvir (Sovaldi), the pangenotypic second-generation NS5A inhibitor velpatasvir (formerly GS-5816), and the investigational pangenotypic HCV NS3/4A protease inhibitor GS-9857. Combining drugs that attack multiple steps of the HCV lifecycle improves efficacy and may enable shorter treatment.

Sofosbuvir/Velpatasvir (SOF/VEL) and SOF/VEL Plus GS-9857 -

Racial disparities found in liver cancer survival rates

Public Release: 23-May-2016

Racial disparities found in liver cancer survival rates

Blacks have greater risk of mortality and are transplanted less often

Digestive Disease Week

San Diego, CA (May 23, 2016) -- Black patients diagnosed with hepatocellular carcinoma (HCC), the most common liver cancer, had a 33 percent increased risk of death compared to non-Hispanic whites. They also were far less likely to receive life-saving liver transplants, according to a new study being presented at Digestive Disease Week® (DDW) 2016, the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

"When we looked at a diverse sample of patients being diagnosed with HCC, race was the strongest predictor of survival," said Patricia D. Jones, MD, MSCR, the study's lead author, assistant professor of medicine and member at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, FL. "Black patients were more likely to present with tumors that were larger -- indicating that they were at a later stage of HCC when diagnosed, potentially delaying their eligibility for a liver transplant, a curative option for HCC."

When researchers analyzed patient records by race, they found the median survival after diagnosis was 301 days for black patients, compared to 534.5 days for non-Hispanic white patients and 437 days for Hispanics. After adjusting for factors, such as alcohol use, tobacco use, insurance and age at diagnosis, non-Hispanic whites had a 25 percent reduced risk of death and Hispanics had a 21 percent reduced risk of death, compared to black patients. Researchers also found that black patients were more likely to have hepatitis B virus (HBV), which is an underlying cause of HCC.

Dr. Jones and her team conducted a retrospective analysis of 999 patients diagnosed with HCC at the University of Miami Sylvester Comprehensive Cancer Center/Jackson Memorial Hospitals between 2005 and 2014. These centers serve a diverse patient population, where 14.7 percent of patients are black, 34.9 percent are Hispanic, and approximately 50 percent are born outside North America.

The team also found that, overall, liver transplants were associated with a 66 percent reduction in deaths, but only 11.9 percent of black patients received a transplant, compared to 33.3 percent of non-Hispanic whites.

"We are conducting additional research to determine which factors contribute to the lower survival rate in black patients, such as access to care, birthplace, socio-economic status or increased prevalence of viral hepatitis," added Dr. Jones. "Hepatitis B can be prevented by vaccination and management of this infection depends on access to care, which may be an underlying issue for this community."

According to the National Cancer Institute, HCC is the sixth most prevalent cancer and the third leading cause of cancer-related deaths worldwide. Its incidence in the U.S. is rising, specifically in relation to the spread of hepatitis C virus (HCV) infection. HBV and HCV infections appear to be the most significant causes of HCC globally.

Researchers plan to conduct additional community-based research to explore the perceptions of HBV and HCV in at-risk populations and determine where the opportunities for further education and screening exist in order to ensure earlier cancer detection.

Dr. Patricia D. Jones will present data from the study, "Racial Disparities in Survival after Hepatocellular Carcinoma Diagnosis in a Diverse American Population," abstract Mo1491, on Monday, May 23, at 9:30 a.m. PT, in Hall C of the San Diego Convention Center. For more information about featured studies, as well as a schedule of availability for featured researchers, please visit Dr. Jones did have any disclosures for DDW research. Faculty disclosures can be found online at


Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 21-24, 2016, at the San Diego Convention Center, San Diego, CA. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at

Follow us on Twitter @DDWMeeting; hashtag #DDW16. Become a fan of DDW on Facebook

Treatment options evolve as HCC becomes more common

Treatment options evolve as HCC becomes more common
Posted By: DDW Daily News on: May 23, 2016
In: AASLD, By Society, DDW Daily News, Monday, May 23

A panel of experts will discuss the latest surveillance options, liver transplantation rules and immunotherapy guidelines for the treatment of hepatocellular carcinoma (HCC) during an AASLD Clinical Symposium Tuesday morning titled Hepatocellular Cancer.

Lewis R. Roberts, MB, ChB, PhD

Lewis R. Roberts, MB, ChB, PhD, professor of medicine and director of the hepatobiliary neoplasia clinic at Mayo Clinic, Rochester, MN, will co-moderate the session with Laura Kulik, MD, associate professor of hepatology at Northwestern University’s Feinberg School of Medicine, Chicago, IL.

“HCC is increasing in the U.S. and worldwide,” Dr. Roberts said. “It may not be inherently more pernicious than other cancers, but it is too often diagnosed at a late stage when effective treatment is difficult.”

As the prevalence of HCC increases, a growing body of evidence is helping to refine surveillance and increase earlier detection when treatment is more likely to be effective. At the same time, the profile of HCC is changing. Many clinicians matured in an era when viral hepatitis was the primary risk factor for HCC. Newer, more effective therapies can cure hepatitis C (HCV) in most patients, but simply curing a patient of HCV does not completely eliminate the need for HCC surveillance. And mounting evidence linking fatty liver disease to HCC adds to the importance of identifying patients at increased risk of progressing to cirrhosis and possibly HCC.

And even as the HCC burden shifts from patients with viral hepatitis to patients with advanced fatty liver disease, organ allocation rules for liver transplants are changing.

“The new rules are basically making HCC patients wait longer to get a liver,” Dr. Kulik said. “There is a kind of time-out period — six months — before the priority points that HCC patients get begin to work in their benefit. That six-month waiting period makes it particularly important for physicians to refer patients for transplant as early as possible.”

The new rules are intended to weed out patients with aggressive HCC who are less likely to benefit from a liver transplant. One consequence of the waiting period is a renewed push for liver-directed therapy.

“What we are seeing is a need to be more aggressive in treatment for these patients,” Dr. Roberts said. “For some patients, we treat in the hope of downstaging them so they become eligible for transplantation. For others with advanced cancer who have no likelihood of becoming eligible for transplantation, the focus is on developing more effective treatments.”

Novel checkpoint inhibitors that block tumor cells’ ability to evade the immune system have shown significant effects in treating lung cancers and melanomas. Some of those same agents show promise against liver cancer in early-stage clinical trials, Dr. Roberts noted.

“Researchers have identified some of the mechanisms by which cancer cells cloak themselves from attack by the immune system,” he explained. “New agents such as the PD1 inhibitor nivolumab unmask tumor cells so the immune system finds and destroys them. The early results were quite exciting because we could see significant response rates even in advanced HCC.”

The new checkpoint inhibitors can cause both gastrointestinal and hepatic side effects, therefore it is important for GIs to become familiar with the agents, Dr. Kulik noted.

“We know that clinicians are only going to be seeing more HCC in daily practice,” she said. “This symposium will provide the most up-to-date information so they can better handle these patients.”

Please refer to the DDW Mobile App or the schedule-at-a-glance in Tuesday’s issue for the time and location of this and other DDW® events.

Sunday, May 22, 2016

The AASLD Meeting at DDW 2016 - Program Overview

Digestive Disease Week® 2016 San Diego Convention Center San Diego, CA Digestive Disease Week (DDW)

Published on May 21, 2016
2016 DDW TV
AASLD Secretary - Kimberly A. Brown, MD, FAASLD – gives an overview of the most important things happening as part of AASLD’s program – and talks about what a huge difference a year makes in the treatment and – more importantly – the cure — of certain liver diseases.

Digestive Disease Week® 2016 San Diego Convention Center San Diego, CA Digestive Disease Week (DDW)

2016 DDW TV
Follow DDW TV for highlights from the 2016 meeting. We'll have studio interviews with leading experts in the field, session highlights, attendee perspectives and a look at what institutions around the world are doing to advance the field.

Next-generation HCV treatments should benefit challenging patient groups

Next-generation HCV treatments should benefit challenging patient groups
Posted By: DDW Daily News on: May 22, 2016In: AASLD, By Society, DDW Daily News, Sunday, May 22

Michael Fried, MD

Despite treatment success rates of 95 percent and better, hepatitis C (HCV) therapy can still improve. Finding a universal cure is the goal, according to Michael Fried, MD, professor of medicine and director of the UNC Liver Center at the University of North Carolina, Chapel Hill.

“We are really at the point of curing all patients of hepatitis C, of leaving no SVR [sustained viral response] behind,” Dr. Fried said. “Even though the regimens we have today are incredibly effective, there are certain populations that may benefit from longer duration of therapy, addition of ribavirin under certain circumstances or other tweaks so that we are approaching universal cure.”

Dr. Fried will moderate the AASLD Clinical Symposium, Prospects for New HCV Treatments, Monday afternoon. The session’s expert presenters will review the latest thinking on special populations that may need more intensive treatment, the prospects for curing patients with decompensated liver disease, dealing with patients who fail to respond to treatment and the prospects for new therapeutic agents in the near term.

“These are topics no one would have believed 10 years ago, even five years ago,” Dr. Fried said. “The world has changed in dramatic ways when we start talking about ways to improve on 95 percent treatment success. Patients with hepatitis C should be incredibly hopeful, as they already are.”

In the early days of HCV treatment, success rates fell between 7 and 20 percent. Today, overall response rates routinely top 95 percent. And while there are no longer problem populations, there are populations that are more challenging than most. For these patients, the goal is to optimize treatment from a growing armamentarium of direct-acting antiviral agents and combination regimens.

Patients with decompensated liver disease can be treated for HCV and even cured, Dr. Fried noted. However, these patients are excluded from certain treatment regimens because of potential toxicity. Additionally, the question remains whether curing these patients will bring significant long-term advantages, such as avoiding liver transplantation.

Patients who fail treatment are another challenging group. Fortunately only a relatively small number of patients do not respond to treatment even when they are 100 percent adherent.

“We think treatment failure for these patients may have to do with resistant variants of the virus that need to be managed,” Dr. Fried said. “When you truly fail therapy, you usually fail with a selection of resistant variants. Knowing what to do for these patients with some of the newer generations of medications will be very important for that minority who fail despite their best efforts.”

Several new agents and new combinations within existing treatment categories will likely be approved over the next 18 months, Dr. Fried added.

“I want to stress that the current regimens are incredibly effective,” he said. “But when people do fail therapy, we will have regimens that have non-overlapping resistance profiles with which to treat them. We are looking at the very real possibility of new dual- and triple-agent regimens that will treat more patients more effectively.”
Access to treatment is also improving, he said, noting that increased competition is bringing prices down and payors are beginning to recognize the advantage of curative treatment.

“We have an outstanding panel of speakers for this symposium who will present new and key information in a very concise way,” Dr. Fried said. “This symposium will immediately change clinical practice for those who currently manage or plan to manage patients with hepatitis C.”

Please refer to the DDW Mobile App or the schedule-at-a-glance in Monday’s issue for the time and location of this and other DDW® events.