GI & Hepatology News - December 2012 - 1

GI & HEPATOLOGY NEWS
VOL. 6
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NO. 12

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DECEMBER 2012

T H E O FF I C I A L N EWSPAPER OF THE AGA INSTITU TE

©J.L. M ARTRA /P HOTO R ESEARCHERS, I NC

Fatty Liver Cited for Hepatocellular Carcinoma Increase
Analysis rules out cirrhosis as a factor.
B Y J E F F E VA N S

I N S I D E
News

Hepatitis B
Investigational vaccine is effective, but FDA advisory panel says adjuvant needs more safety data. • 4

News

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BOSTON – Nonalcoholic fat-

Post–Liver Transplant Outcomes, Treatments
studies take aim at improving hepatitis C virus inNewtacrolimus-associatedoutcomes; reducingdetermining fection post-transplant post-transplant, renal dysfunction; the value of young donor age; and finding factors associated with acetaminophen-associated acute liver failure. See pages 2 and 19-23.

Pay Rule Contains Good and Bad News
B Y A L I C I A A U LT

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physician Medicare’s pay2013based fee schedule for contains both a 26.5% cut on the Sustainable Growth Rate formula and pay increases for care coordination and for primary care provided under Medicaid. Under current law, the Sustainable Growth Rate (SGR) formula will kick in Jan. 1 and lop one-fourth off doctors’ pay under Medicare, unless Congress steps in to halt the cut. In issuing the fee schedule final regulation on Nov. 1, the Obama administration noted that Congress has reversed the mandated cut every year since 2003. The administration “is committed to fixing the SGR update

methodology and ensuring these payment cuts do not take effect,” according to a statement. “The AGA supports eliminating the flawed SGR formula and developing a new mechanism for payment that will ensure access to high-quality care for all Medicare beneficiaries, said Dr. Loren Laine, AGAF, president of the AGA Institute and professor of medicine and director of clinical research at the Yale University School of Medicine, New Haven, Conn. The American Medical Association also decried the SGR cut. “Eliminating this failed formula will allow us to enter a period when physicians can begin transitioning to new payment See Pay Rule • page 34

ty liver disease without cirrhosis appears to be a significant contributor to the rise in the incidence of hepatocellular carcinoma in the past two decades, according to a study linking populationbased data from the National Cancer Institute with Medicare enrollment and claim files during 1993-2007. “Our data suggest a unique underlying pathophysiology for development of HCC [hepatocellular carcinoma] in noncirrhotic NAFLD [nonalcoholic fatty liver disease],” Dr. Rubayat Rahman said at the annual meeting of the American Association for the Study of Liver Diseases. The finding may help to explain the rise in the incidence of the malignancy, which has had no clear explanation, added Dr. Rahman of the di-

vision of gastroenterology and hepatology at the University of Missouri, Columbia. Of 17,895 HCC cases in the linked Surveillance, Epidemiology and End Results (SEER)Medicare database, 2,863 (16%) had only NAFLD without any other risk factors or etiologies for HCC. The linked database covers 30% of the U.S. Medicare population. SEER itself contains data from 18 cancer registries covering 28% of the U.S. population, and 93% of the individuals in the database who are at least 65 years are matched to a Medicare enrollment file. At 16%, NAFLD was third most common risk factor for HCC after infection (44%) and alcoholic diseases (19%) – 21% were other causes – but it was the second most common risk factor after infection in Asians and Pacific Islanders, said Dr. Rahman. See Fatty Liver • page 2

Health Care-Associated Infections
CDC survey finds that GI infections are third most common, and Clostridium difficile is the most common pathogen. • 5

Liver Disease

Hepatitis C Regimens
‘Dizzying’ combinations of investigational direct-acting antiviral agents show promise in trials. • 16

GI Oncology

Advanced Liver Cancer
Investigational drug brivanib does not meet noninferiority end points in phase III trial against sorafenib. • 26

Dabigatran, Warfarin Bleed Risk Equal
BY ELIZABETH M E C H C AT I E

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Drug AdminThe Food and satisfied isthat istration is dabigatran’s bleeding risk no greater than that of warfarin and will not change the drug’s label. The rates of gastrointestinal and intracranial bleeding among

patients who have been prescribed the anticoagulant dabigatran “do not appear to be higher” than the rates among patients who have been prescribed warfarin, according to an analysis of insurance claims and administrative data conducted by the agency. The results of this analysis, conducted in response to postmarketing reports of bleeding

among people treated with dabigatran, are “consistent with observations” in the RELY trial, the study of 18,000 patients that was the basis of the approval of the anticoagulant for reducing the risk of stroke and blood clots in patients with nonvalvular atrial fibrillation (AF), the FDA said in the MedSee Dabigatran • page 11

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