Thursday, July 14, 2011

HCV In The News; Hepatitis C Relapse

New On The Blog;
HCV genotype 6 respond better to interferon-based therapy vs genotype 1
Virological suppression and hepatocellular carcinoma risk in chronic Hep B patients with cirrhosis
Update Telaprevir-Incivek; Video on retreatment and previously untreated chronic hepatitis C patients
Pain After Gallbladder Surgery; Sphincter of Oddi (SOD) .
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Over Half Million of Bulgarians Have Hepatitis
Bulgarians who have hepatitis B are 450A 000, while those with hepatitis C - 100A 000, according to data from the National Association against Hepatitis - " Hepassist ." The Coordinator of the Association, Vesela Slavova , however, points out there is no official statistics and the data might not be fully accurate since the ailment is often without ...

Factors that Raise the Risk of Hepatitis C Relapse
One of the reasons we desperately need better treatments for Hepatitis C is because many who initially respond to treatment relapse. By recognizing which individuals are more likely to have a Hepatitis C relapse, healthcare practitioners may be able to make useful adjustments to their treatment protocol. For those most susceptible to a relapse, such an adjustment might improve their odds of remaining free of Hepatitis C.

His life deserves to stand for something'
Silence helps nobody and changes nothing,' says Kerry McPhail. 'Talking about it can't hurt Jim now and I no longer care if it hurts me.' For a long time Kerry and her adored husband Jim didn't talk to strangers about the hepatitis C which was to rob him of his life and her of a soul-mate. But since Jim's death on December 4, 2007, Kerry is ...

Aiken woman suing federal government for alleged contraction of disease at VA hospital
Hundreds of area veterans get their care at Augusta's Charlie Norwood VA Medical Center.
"The allegations are, and the U.S. Attorney has admitted, that they improperly, they were using improper procedures to sterilize equipment that was used to view the vocal cords of patients in the clinic for a period of time," said Attorney Clancey Bounds.



Once-Daily AIDS Pill Can Slash HIV Infection Risk
Ben Hirschler
(Reuters, July 13, 2011)
"AIDS drugs designed to treat HIV can also be used to reduce dramatically the risk of infection among heterosexual couples, two studies conducted in Africa showed for the first time…The findings add to growing evidence that the type of medicines prescribed since the mid-1990s to treat people who are already sick may also hold the key to slowing or even halting the spread of the sexually transmitted disease. The research involving couples in Kenya, Uganda and Botswana found that daily AIDS drugs reduced infection rates by an average of at least 62 percent when compared with placebo. Margaret Chan, director-general of the World Health Organization (WHO), said…the United Nations health agency would now work with countries to use the new findings to implement better protection strategies." .
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Healthy You
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City vs. Country:
Who Is Healthier?
"Americans residing in major cities live longer, healthier lives overall than their country cousins -- a reversal from decades past. Many cities that were once notorious for pollution, crime, crowding and infectious diseases have generally cleaned up, calmed down and spread out in recent years, while rural problems have festered. Rural residents are now more likely than other Americans to be obese, sedentary and smoke cigarettes. They also face higher rates of related health problems including diabetes, stroke, heart attacks and high blood pressure, according to County Health Rankings (CHR), a research project that recently issued its second annual report of state-by-state comparisons of health measures in every U.S. county. To be sure, city dwellers live with more air pollution and violent crime. They also have higher rates of sexually transmitted diseases and low-birth-weight babies and are more likely to drink excessively. But overall, urbanites tend to rate their own health more highly and are less likely to die prematurely than rural Americans, according to the county rankings report. In many measures, residents of suburban areas are the best off…These broad generalities don't hold true for every region…Much of the health advantage in cities may be a function of age, income and education levels…Limited access to care might help explain the overall poorer health of rural residents. About 25% of the U.S. population lives in rural areas, but they are served by only 10% of the country's physicians. They are also less likely to have private health insurance, prescription drug coverage or be covered by Medicaid…Determining what areas are 'urban' or 'rural' can be murky…Statistics are generally gathered and compared on a county basis, but many counties contain a mix of urban, suburban and rural areas. A variety of conditions come together to make country living less healthy…Of course, country living has some advantages."Melinda Beck
(The Wall Street Journal, New York, July 12, 2011)
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Australia: Diabetes Rate Soars in Poorer Areas
Erik Jensen
(The Sydney Morning Herald, July 11, 2011)
"New analysis shows the incidence of [Type 2] diabetes in NSW [New South Wales, Australia] has increased by an average of 27 per cent in that period…Overwhelmingly, the research showed diabetes to be a disease of poverty: the unemployment rate in the top 10 electorates for diabetes is more than twice that for the bottom 10; median household income is almost half; the number of Aborigines is close to seven times what it is for the bottom 10. But when the research analysed growth over the past decade, the disease swung dramatically to the coast…Stig Pramming, a former head of the Oxford Health Alliance and adviser to the National Preventative Health Taskforce, said Australia performed reasonably well in diabetes care but the problem was complicated by distance between services."

Superbugs & Viruses
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Fast-Food Playlands Under Scrutiny
Monica Eng and Jared S. Hopkins
(Chicago Tribune, July 12, 2011)
"Joan Rose, a co-director of the Center for Advancing Microbial Risk Assessment at Michigan State University…stresses that places that serve children need disinfection policies…University of Arizona professor Chuck Gerba, who is one of the nation's foremost authorities on germ transmission notes that children are major virus passers. 'And viruses which cause diarrhea can survive up to a month on surfaces' such as playgrounds, he wrote in an email to the Tribune…Public health departments currently inspect restaurants with food safety, not playground safety, in mind. Jose Munoz of the Chicago Department of Public Health said a city restaurant inspector could not cite a restaurant for a dirty playland."
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Pharmaceutical
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FDA must be empowered to oversee supply chain; report

Congress must grant the FDA additional powers to bring oversight of manufacturing inline with shifts in production practices, according to a report.

In a report titled After Heparin , Pew Health Group breaks down current weaknesses in the supply chain and proposes fixes. Empowering the US Food and Drug Administration (FDA) is one of the main themes of the Pew report.
Congress must institute reforms to ensure that the FDA’s oversight of overseas manufacturing is increased, and that industry is held accountable for the security and safety of increasingly globalised and outsourced supply chains”, concludes the report.

Giving the FDA the power to force a drug recall is one of the extra regulatory authorities called for by Pew. The other is the power to subpoena witnesses and documents to quicken investigations into drug product quality.

Pew also calls on the FDA to significantly increase the rate of foreign inspections and, if possible, make unannounced visits. Ideally, the FDA will be given resources to conduct these inspections but, acknowledging this is unlikely in the short-term, Pew proposes some workarounds.
Manufacturer registration fees could be an extra income source to support an uptick in overseas inspections. Using this extra funding the FDA could pay independent third-party inspectors to visit overseas production plants. Collaboration with other regulators could also help.

The FDA could immediately alleviate resources by reducing its inspectional activity in the EU by relying on the results of inspections carried out by European regulators”, one person told Pew. As in-PharmaTechnologist revealed last month , Europe has made this proposal to the FDA.

Industry action
Industry also has a significant role to play. Many experts told Pew “you cannot inspect quality into a product; it must be built in to every process”. Improvements in quality systems, subcontractor agreements, supplier audits, supply chain documentation and testing can help meet this goal.
There was strong agreement that manufacturers must be held accountable for their full supply chain and that they need to have concrete knowledge of suppliers when they are selected”, said Pew.
Greater transparency is also needed. Sharing of information on suppliers, risk signals and other data is one element. A requirement for drug companies to list the country of origin of finished products and active pharmaceutical ingredients (API) on their websites is another proposal.

Report methodology
Pew based its report on conversations with: the FDA, US Pharmacopeia (USP), pharmaceutical manufacturing and distribution trade associations, the retail pharmacy industry, medical and pharmacy professional associations, consumer groups and supply chain experts.
FDA documents, US Government Accountability Office (GAO) reports, Congressional testimony, peer-reviewed journal articles and commercial publications were also sources of information.
Video footage of a two-day roundtable discussion hosted by Pew is available .

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