Reported by Jules Levin
62% of African Americans/Blacks achieved SVR with telaprevir compared to 25% of African Americans/Blacks who were treated with pegylated-interferon and ribavirin alone. Additionally, 62% of people with advanced liver fibrosis or cirrhosis (scarring of the liver) achieved SVR with telaprevir compared to 33% who were treated with pegylated-interferon and ribavirin alone. Old studies of peg/rbv in African-Americans yielded SVR rates of 5-26%.
African-Americans treatment-naïve: 61% had undetectable viral load at week 4 (RVR) and 46% at weeks 4 and 12 (eRVR)- 72% with RVR achieved SVR & 85% with eRVR achieved SVR. Similar for Latinos...
Hepatitis Awareness Month --- May 2011 Weekly
May 6, 2011 / 60(17);537
This month marks the 16th anniversary of Hepatitis Awareness Month in the United States. Viral hepatitis, particularly infection with hepatitis B virus (HBV) or hepatitis C virus (HCV), is a major cause of morbidity and mortality. This issue of MMWR includes a report that focuses on a recent trend in HCV infection.
The report shows an increase in cases of HCV infection during 2002--2009 among adolescents and young adults aged 15--24 years in Massachusetts and highlights the fundamental role of surveillance in identifying emerging patterns of transmission and developing appropriate public health response. The Massachusetts cases were reported from all areas of the state, primarily among non-Hispanic whites. Injection drug use (IDU) was the most common risk factor for HCV transmission, and the increase in case reports suggests an epidemic of HCV infection related to IDU in this age group in Massachusetts.
In 2010, the Institute of Medicine (IOM) of the National Academies of Sciences issued a report on viral hepatitis outlining recommendations for the prevention and control of HBV and HCV infection, including improvement in public health surveillance for viral hepatitis and viral hepatitis screening linked with prevention and care (1). In response to the IOM report, the U.S. Department of Health and Human Services is developing a comprehensive viral hepatitis action plan that will set forth strategies to improve viral hepatitis prevention, care, and treatment in the United States. Additional information regarding viral hepatitis is available from CDC at http://www.cdc.gov/hepatitis
| Most patients with NASH who develop hepatocellular carcinoma are men | ||
A study in the most recent issue of Clinical Gastroenterology & Hepatology investigates characteristics of patients with NASH who develop hepatocellular carcinoma. | ||
Nonalcoholic steatohepatitis (NASH) can progress to hepatocellular carcinoma. Dr Kohichiroh Yasui and colleagues characterized the clinical features of NASH patients with hepatocellular carcinoma. In a cross-sectional multicenter study in Japan, the team examined 87 patients with histologically proven NASH who developed hepatocellular carcinoma. The clinical data were collected at the time hepatocellular carcinoma was diagnosed. Obesity, diabetes, dyslipidemia, and hypertension were present in 62%, 59%, 28%, and 55% of patients, respectively. In nontumor liver tissues, the degree of fibrosis was stage 1 in 11% of patients, stage 2 in 17%, stage 3 in 21%, and stage 4 in 51%. The research team observed that the prevalence of cirrhosis was significantly lower among male patients compared with female patients. Dr Yasui's team concluded, "Most patients with NASH who develop hepatocellular carcinoma are men." "The patients have high rates of obesity, diabetes, and hypertension." "Male patients appear to develop hepatocellular carcinoma at a less advanced stage of liver fibrosis than female patients." Clin Gastroenterol Hepatol 2011: 9(5): 428-33 06 May 2011
In approximately 70% of patients with hepatocellular carcinoma treated by resection or ablation, disease recurs within 5 years. Although gene expression signatures have been associated with outcome, there is no method to predict recurrence based on combined clinical, pathology, and genomic data. Dr Augusto Villanueva and colleagues from Spain evaluated gene expression signatures associated with outcome in a large cohort of patients with early stage, single-nodule hepatocellular carcinoma and heterogeneity of signatures within tumor tissues. The research team assessed 287 hepatocellular carcinoma patients undergoing resection and tested genome-wide expression platforms using tumor and adjacent nontumor, cirrhotic tissue. The team evaluated gene expression signatures with reported prognostic ability generated from tumor or cirrhotic tissue in 18 and 4 reports, respectively. In 15 additional patients, the team profiled samples from the center and periphery of the tumor, to determine stability of signatures. The researchers found that gene expression signatures that were associated with aggressive hepatocellular carcinoma were clustered, as well as those associated with tumors of progenitor cell origin and those from nontumor, adjacent, cirrhotic tissues. The team observed that the tumor-associated signature G3-proliferation, and an adjacent poor-survival signature were independent predictors of hepatocellular carcinoma recurrence, along with satellites. Samples from different sites in the same tumor nodule were reproducibly classified. Dr Villanueva's team concluded, "We developed a composite prognostic model for hepatocellular carcinoma recurrence, based on gene expression patterns in tumor and adjacent tissues." "These signatures predict early and overall recurrence in patients with hepatocellular carcinoma, and complement findings from clinical and pathology analyses." Gastroenterol 2011: 140(5): 1501-1512 05 May 2011 |
Show and Shines to support liver society
Two years and nine months: that's how long Karen Stacey has been on the waiting list for a liver transplant.
Despite the obvious stress experienced as well as impact on her day-to-day health, Stacey, 50, has not only stayed patient, she's stayed positive, dedicating herself to helping others facing a similar diagnosis with a liver disease. From family members to her community, Stacey has always been active in helping others. In 2008, she took her community activism to the next level by founding the Happy Liver Society, a non-profit providing advocacy and support services to liver disease patients. "I've always been that person that looks after people . . . It just is a comfortable role for me," she says.
Two new clinical trials registries established
1. The Cuban Public Registry of Clinical Trials / Registro Público Cubano de Ensayos Clínicos (RPCEC). This is the first Primary Registry to include trials in both Spanish and English. Spanish speakers might be interested in watching a video of the event held to make the announcement by the Ministry of Health in Havana, Cuba on 5th April 2011. Go to http://youtu.be/STeI9F-lnM0
2. The Brazilian Clinical Trials Registry / Registro Brasileiro de Ensaios Clinicos (REBEC) will focus on trials recruiting in Brazil. Announced on 12th April by the Brazilian Ministry of Health, it is the first Primary Registry in the Latin American region to include trials registered in Portuguese, and also allows registration in Spanish and English. Other Portuguese-speaking countries including Angola, Cabo Verde, Guiné-Bissau, Moçambique, Portugal, São Tomé e Príncipe and Timor-Leste are also encouraged to use the registry. Prospective registration of clinical trials is a legal requirement in Brazil (http://www.anvisa.gov.br/eng/index.htm).
REBEC is the first registry to use the open-source clinical trial registration software developed by Bireme (http://reddes.bvsalud.org/projects/clinical-trials/wiki) in partnership with the Department of Science and Technology/MoH and FIOCRUZ/MoH, called "Open Trials".
Imaging For Full-Body MRIs Significantly Improved By New Algorithm
05 May 2011
A new study reveals an improved algorithm that can dramatically improve how radiologists capture and interpret full-body MRIs, particularly in the abdominal region. Motion artifacts in MRIs, such as patient movement, often...,
Dramatic Shift In Understanding Of Personalized Medicine Suggested By New Research
Researchers at Mount Sinai School of Medicine, in collaboration with researchers at Loyola University Chicago Stritch School of Medicine, have made a critical discovery that may lead scientists to abandon the use of broad conventional ethnic labels - African-American, Hispanic, and Caucasian - to estimate a patient's genetic risk for disease. This first-of-its kind study conducted with diverse patients receiving care at a single urban academic medical center, marks an important step in the clinical application of personalized medicine.
The data are published online in the peer-reviewed journal PLoS ONE.
The Mount Sinai Biobank, a program of the Charles R. Bronfman Institute for Personalized Medicine, enrolls consented patients representing the diverse communities surrounding The Mount Sinai Medical Center, who confidentially provide DNA and plasma samples to aid in genomic and personalized medicine research. Researchers used state-of-the-art genomic technology to determine the genetic make-up, or genotype, of nearly 1,000 local Biobank participants who self-identified as European American, African-American, or Hispanic. They found that there was a continuum in ancestral genetic heritage at the individual level of African-American and Hispanic patients receiving care at Mount Sinai - meaning considerable fractions of their genome came from mixed European or African ancestry, respectively - and with it genetic variants that indicate risk for developing disease.
"Our data indicate that historical population labels may not be helpful in predicting disease risk or guiding how a patient will respond to certain medications," said Erwin Bottinger, MD, Director of the Bronfman Institute, and the Irene and Dr. Arthur M. Fishberg Professor of Medicine. "Rather, a spectrum of mixed ancestry is emerging in the largest U.S. minority groups. These findings further validate the importance of considering the unique genotype of the individual patient rather than grouping patients by self-reported ethnicity."
To date, genomic studies have overwhelmingly focused on populations with European ancestry, causing concerns about the applicability of their findings to determine disease risk and responsiveness to therapies for non-European, and in particular, mixed genetic backgrounds receiving care at urban medical centers.
"Our data indicate how important it is to evaluate patient populations at a local level," said Dr. Bottinger. "Now that we can determine the genotypic breakdown of our patients, we can begin to develop tests and tailor therapies for the diverse community we serve, allowing us to provide highly effective, personalized care."
On the basis of their findings, researchers at the Bronfman Institute are evaluating the clinical use potential of hundreds of genetic markers for major diseases, such as heart disease, kidney disease, liver disease, and diabetes, and various drug responses, in all Biobank samples. The goal is to identify those genetic markers that may be useful to predict disease risk in local people with mixed genetic backgrounds. The project will be completed with all 20,000 Biobank samples by the end of 2011.
"We anticipate the results, for the first time, will lead us to select the right genetic markers, and allow us to bring personalized genomic medicine to patients in the diverse Mount Sinai community who are being treated for diabetes and heart, kidney, and liver diseases, among other conditions," says Dr. Bottinger.
Also, Dr. Bottinger and his team at the Charles R. Bronfman Institute for Personalized Medicine are able to help guide other medical centers around the country in replicating their study. Additionally, they are continuing to broaden the number of consented donors in the Mount Sinai Biobank in an effort to uncover more genetic markers of disease and connections between self-identified population groups.
This study was supported by The Andrea and Charles Bronfman Philanthropies, Inc.
Source:
Mount Sinai Press Office
The Mount Sinai Hospital / Mount Sinai School of Medicine
Type 2 Diabetes Patients on Medication Report High Rates of Hypoglycemia
SAN DIEGO – Regardless of whether they take oral diabetes medications, roughly 40%-43% of type 2 diabetes patients who took insulin reported having hypoglycemia in the past month, according to survey findings from 2,801 adults.
"Hypoglycemia is a leading limiting factor in the glycemic management of adults with type 2 diabetes mellitus who are treated with insulin or a sulfonylurea agent," Dr. Andrew Green said at the annual meeting of the American Association of Clinical Endocrinologists. The findings suggest a need to consider the risk of hypoglycemia as part of a risk-versus-benefit analysis when designing a treatment regimen for type 2 diabetes patients, he added.
Of the survey respondents who received oral medications, 52% reported receiving sulfonylureas. And among those patients using sulfonylureas for the past 12 months, significantly more of them reported having hypoglycemia during the past month than did those who did not receive sulfonylureas (28% vs. 19%).
The 5-year population-based survey, known as the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD) was initiated in 2005.
Overall, 1,793 patients (64%) received oral medication only, 221 (8%) received insulin only, 361 (13%) received both types of therapy, and 426 (15%) were not receiving any diabetes treatment at the time of the survey. The average ages of the patients in group ranged from 61 to 65 years; more than 70% of the patients in each group were white, and more than half (58%-64%) were women, said Dr. Green, an endocrinologist in Overland Park, Kansas.
Patients who received both insulin and oral medications were significantly more likely to be younger and obese compared with those who received either type of treatment alone.
The study was limited by the use of self-reports and the lack of data on the severity and causes of hypoglycemia.
The study was supported by AstraZeneca.
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