TIP SHEET
For Immediate ReleaseMay 16, 2001 Media Contacts:Kirk Monroe202-331-0175[email protected]
Sam Franklin202-331-0175[email protected]
The Nation's Leading Liver Researchers to Reveal Findings in Hepatitis C, Liver Transplantation, Toxicity in AIDS Patients
ATLANTA, GA--This tip sheet highlights only a few of the hundreds of abstracts being presented by members of the American Association of the Study of Liver Diseases (AASLD) at Digestive Disease Week (DDW), the largest international meeting of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.
Findings will include the following:
Hepatotoxicity in the U.S. adult AIDS Clinical Trials Group
A retrospective study encompassing 21 clinical trials and 9,003 adult AIDS patients has found that 10 percent of patients experienced serious liver toxicity as a side effect of AIDS treatment. The study is the largest of its kind in a representative cohort of American adult AIDS patients.
"It is fairly clear that the promise of highly active antiretroviral therapy is not deliverable to all patients with HIV," said Raymond T. Chung, M.D., from Massachusetts General Hospital, Boston, and senior author of the study. "Liver toxicity is a serious problem irrespective of the class of antiretroviral therapy being given."
Patients were treated with one of several drug regimens including one or more non-nucleoside reverse transcriptase inhibitors (NNRTIs), nucleoside reverse transcriptase inhibitors, and protease inhibitors. Of the patients experiencing toxicity, 23 percent had to discontinue anti-HIV therapy. Of all deaths during the study period, 2.5 percent were liver related.
The next step, said Chung, is to "define the baseline factors that correlate with hepatotoxicity. For example, did people experiencing toxicity also have hepatitis C, hepatitis B, pre-existing chronic liver disease, or metabolic abnormalities that predisposed them to liver injury?" This work is now under way.
In November, the Food and Drug Administration issued an alert for the NNRTI nevirapine based on reports of liver toxicity. This study found that 33 percent of patients who experienced toxicity while taking nevirapine had to discontinue their drug regimens.
Nonalcoholic fatty liver disease affects nearly 1 in 4 in the United States
Current scientific evidence suggests that nonalcoholic fatty liver disease (NAFLD) can progress to liver fibrosis and eventually to cirrhosis. In Europe and Asia, estimates of the prevalence of the disease range from 14 to 21 percent, but no estimates exist for the United States.
Using data from 13,500 adults who participated in the Third National Health and Nutrition Examination Survey, researchers from the Johns Hopkins University School of Medicine, Baltimore, found that 23.5 percent of adults have some form of NAFLD. The disease was more common in men (33 percent) than women (17 percent), and more common in African Americans (33 percent) than whites (23 percent).
"It's been said this is a disease of middle-aged white women, but when we applied the rules to the population we found it was a disease of everybody but middle-aged white women," said Anna Mae Diehl, M.D., senior author on the study. "That probably reflects who goes to the doctor . . . the unique thing about this study is that it wasn't biased by referral to gastroentereologists."
NAFLD was more likely in older people and those with higher body mass index (a measure of obesity), higher levels of triglycerides, or diabetes. Even after controlling for these four variables, men had 2.5 times the risk of NAFLD compared with women, and African Americans had twice the risk of whites.
Pegylated interferon alfa-2a (PEGASYS) in combination with ribavirin: Efficacy and safety results from a phase III, randomized, actively controlled multicenter study
A total of 1,149 adults with hepatitis C were randomized in this study to receive one of three treatments:-- pegylated interferon alfa-2a (PEGASYS) plus ribavirin;-- PEGASYS plus placebo;-- standard interferon alfa-2b plus ribavirin.
The results of the trial -- the first of its kind -- will be presented at DDW and could change treatment for hepatitis C.
"Everyone will be looking at the results of this trial because pegylated interferons are the next generation of treatment," said Michael Fried, M.D., University of North Carolina, Chapel Hill, who will present the results.
Pegylated interferons -- interferons with polyethylene glycol added -- stay in the body longer and produce steady detectable interferon levels throughout the course of a week. Standard interferon therapy requires three injections a week and there are times when interferon levels are undetectable, meaning that the hepatitis C virus is not being suppressed.
Pegylated interferon has already been shown to be more effective than standard interferon; now, said Fried, "we've taken the next logical step -- adding ribavirin."
MELD scoring system not predictive of mortality in patients waiting for liver transplantation
The Model for End-stage Liver Disease (MELD) has been shown to predict mortality in patients undergoing transjugular intrahepatic portosystemic shunt surgery and in those with cirrhosis who do not require a liver transplant. To see if the model predicts mortality in patients awaiting liver transplants, researchers at the University of Nebraska Medical Center, Omaha, followed 70 patients and used MELD to calculate risk scores.
MELD successfully separated patients into low- and high-risk groups; over 12 months, 8 of 61 patients died in the low-risk group and 8 of 9 died in the high-risk group. However, the model underestimated mortality in the high-risk group and overestimated it in the low-risk group.
"The model was set up to calculate mortality for three months, but a lot of patients wait [for a transplant] for two years," said Timothy McCashland, M.D., who will present the results at DDW. "There's still a big spread on what the model predicts and what actually happened with our patients . . . At the very top and bottom I think [the model] does a good job, but in the middle I think there's still a shade of gray."
Last year, the United Network for Organ Sharing recommended MELD for use in patients awaiting liver transplants.
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AASLD is the leading medical organization for advancing the science and practice of hepatology. Founded by physicians in 1950, AASLD's vision is to prevent and cure liver diseases. Today, AASLD provides representation and education for nearly 2,400 liver researchers, physicians, and surgeons worldwide. Visit AASLD's website at http://www.aasld.org.
Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. DDW showcases close to 5000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. The meeting also provides an opportunity for professionals in the field to discuss the medical, technological, ethical, regulatory and legal issues facing the profession today.
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