Six Late-breaking Abstracts Selected for Oral Presentation at The Liver Meeting®

BOSTON, Nov. 2, 2012 /PRNewswire/ -- 

Late-breaking Oral Session
Monday, November 12, 2012 – 3:00-4:30 pm
Auditorium, Hynes Convention Center

The six abstracts that will be presented at our late-breaking oral session relate to new therapies for patients with chronic liver diseases.

Four of the six studies (see numbers 1 - 4 below) report on the results of oral therapy for the treatment of hepatitis C, a disease that affects more than 3 million Americans and that is currently treated with weekly injections of a medication called interferon, in addition to pills. These studies show that almost all patients who receive these new pills (without interferon) eliminate the hepatitis C virus, even those who had not responded to interferon-based therapies. Given that these drugs are well-tolerated, these findings, if confirmed in longer follow up periods, can potentially lead to important changes in practice. 

Viral hepatitis and other chronic liver diseases can lead to liver failure and/or liver cancer, requiring liver transplantation. After liver transplantation, one of the main complications is renal failure due to tacrolimus-based therapy to prevent rejection. The final results of a randomized study (see number 5 below) in patients with liver transplant shows that the addition of everolimus, another anti-rejection medication, allows us to minimize the dose of tacrolimus with comparable efficacy and better renal function. 

Advanced unresectable liver cancer is currently treated with sorafenib, an oral anti-tumor medicine. A very large multinational, multicenter study (see number 6 below) enrolling over 1000 patients showed that brivanib was inferior to sorafenib in overall survival and was less well tolerated, and therefore sorafenib will continue to be the standard of care for these patients.

"We are living in very exciting times," says AASLD President Guadalupe Garcia-Tsao, MD. "While years ago there were no specific therapies for liver diseases, we now have many different therapies for patients with different types of liver disease and at different stages of disease. One of the most exciting areas is the therapy of hepatitis C, one of the main causes of liver disease in the world. At our late-breaking session, data will be presented on different therapeutic strategies that seem capable of eliminating the hepatitis C virus in practically all patients."

The following six studies will be presented at the late-breaking oral session:

1. A 12-Week Interferon-free Treatment Regimen with ABT-450/r, ABT-267, ABT-333 and Ribavirin Achieves SVR12 Rates (Observed Data) of 99% in Treatment-Naive Patients and 93% in Prior Null Responders with HCV Genotype1 Infection
   A regimen of 3 direct acting antiviral medicines plus ribavirin was well tolerated and achieved high 12-week post-treatment viral elimination rates in both new patients and prior null responders with hepatitis C virus genotype 1 infection.
2. High Rate of Sustained Virologic Response with the All-Oral Combination of Daclatasvir (NS5A Inhibitor) Plus Sofosbuvir (Nucleotide NS5B Inhibitor), With or Without Ribavirin, in Treatment-Naive Patients Chronically Infected With HCV Genotype 1, 2, or 3
   A 24-week regimen of an all oral combination of once-daily daclatasvir (DCV) plus sofosbuvir (SOF) achieved high 12-week viral elimination rates in previously untreated patients infected with hepatitis C virus genotype 1, 2, or 3.
3. An Interferon-free, Ribavirin-free 12-Week Regimen of Daclatasvir (DCV), Asunaprevir (ASV), and BMS-791325 Yielded SVR4 of 94% in Treatment-Naive Patients with Genotype (GT) 1 Chronic Hepatitis C Virus (HCV) Infection
   A 12-week interferon and ribavirin free regimen of three direct-acting antivirals, daclatasvir, asunaprevir, and BMS-791325 was well tolerated and achieved high 4-week post-treatment viral elimination rates in treatment-naive patients infected with hepatitis C virus genotype 1.
4. High Efficacy Of GS-7977 In Combination With Low or Full dose Ribavirin for 24 weeks In Difficult To Treat HCV Infected Genotype 1 Patients : Interim Analysis From The SPARE Trial
   A 24-week regimen of nucleotide NS5B inhibitor GS-7977 combined with low dose ribavirin was highly effective in suppressing hepatitis C virus replication in difficult to treat patients.
5. Everolimus-Facilitated Reduction Of Tacrolimus Provides Comparable Efficacy And Superior Renal Function Versus Standard Tacrolimus In De Novo Liver Transplant Recipients: 24-Month Results Of A Randomized Trial
   24-month results show that the minimization of tacrolimus (TAC) by introduction of everolimus (EVR) one month post liver transplant results in comparable overall efficacy and superior l renal function compared to standard TAC immunosuppression.
6. Brivanib (BRI) versus Sorafenib (SOR) as First-line Therapy in Patients with Unresectable, Advanced Hepatocellular Carcinoma (HCC): Results from the Phase 3 BRISK-FL Study
   The anti-tumor and anti-angiogenic drugbrivanib (BRI was less effective than sorafenib (SOR) when comparing overall survival rates in patients with advanced hepatocellular carcinoma, despite having a similar antitumor activity.  BRI was also similar to SOR in terms of time to progression, objective response rate, and disease control rate but was less well-tolerated than SOR

Late-breaking abstracts contain research of new and sufficient scientific importance that merited special consideration after the standard abstract submission deadline. Late-breaking abstracts describe either large clinical studies or high-impact translational research that could not be completed prior to the original abstract submission deadline. The closure date of the study must have been March 21 or later with clinical trials (phase 2 or 3) being considered for oral presentation.

Founded in 1950, AASLD is the leading organization of scientists and health care professionals committed to preventing and curing liver disease. AASLD has grown into an international society responsible for all aspects of hepatology, and the annual meeting attracts 8,500 physicians, surgeons, researchers, and allied health professionals from around the world.

The Liver Meeting® is the premier meeting in the science and practice of hepatology, including the latest findings on new drugs, novel treatments, and the results from pilot and multicenter studies.

When: November 9-13, 2012

Where:
Hynes Convention Center
Boston, Massachusetts

Contact: Please click here to obtain a press pass for this event.

Press releases and all abstracts are available online at www.aasld.org.

Media Contact: Ann Haran
703/299-9766
[email protected]
Press Room: November 10 – November 13, 2012
Hynes Convention Center, Room 208

"This release was issued through The Xpress Press News Service, merging e-mail and satellite distribution technologies to reach business analysts and media outlets worldwide. For more information, visit http://www.XpressPress.com."

SOURCE American Association for the Study of Liver Diseases (AASLD)

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