Science Policy For All

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Science Policy Around the Web – September 25, 2015

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By: Elisavet Serti, Ph.D.

Image courtesy of NIH Image Bank

Drug Policy

The new hepatitis C virus bottleneck: Can delaying therapy be justified?

Chronic Hepatitis C infection affects more than 3.2 million people in the United States, resulting in severe liver disease, cirrhosis, hepatocellular carcinoma and death. The FDA approval of the new anti-Hepatitis C direct acting antivirals marked a revolution in HCV therapeutics; it is now possible to offer patients safe and highly effective (more than 90%) alternatives to pegylated interferon and ribavirin. However, the high cost of these new treatment regimens has proven to be a major obstacle to their delivery. Twelve weeks of anti-Hepatitis C oral treatment costs between $80,000 and $95,000, and it has been estimated that total health care costs related to Hepatitis C therapy could soon reach $27 billion per year. As a consequence, many state-funded and private insurance programs have restricted access to direct acting antiviral-based therapy to patients with advanced fibrosis and extra-hepatic manifestations. In Texas, Medicaid has elected not to cover this type of therapy at all.

In a recent Hepatology editorial, the editors wondered about the potential burdens of this Hepatitis C therapy bottleneck that leads to exclusion of the majority of chronic patients due to high costs. The editors argue that “while persons with advanced fibrosis are clearly at higher risk for short-term complications, it is not clear that persons with lesser degrees of fibrosis are not at risk for harm.” A recent meta-analysis has demonstrated that rates of fibrosis progression may be far more accelerated than previously thought. This means that the option of delaying therapy runs the risk of progression to cirrhosis and development of hepatocellular carcinoma. The editors argue that delaying therapy could introduce the added burden of implementation of hepatocellular carcinoma or portal hypertension screening. Also, chronic Hepatitis C has been associated with a variety of extra-hepatic manifestations like diabetes, cardiovascular disease, psychiatric disorders, depression, renal dysfunction and rheumatologic conditions. This means that we should factor these extra-hepatic complications when calculating the cost effectiveness of the new Hepatitis C therapies. For these and several other reasons, the American Association for the Study of Liver Diseases (AASLD) – Infectious Diseases Society of America (IDSA) HCV guidance recommends that all infected persons should be treated.  (Tracy G. Simon and Raymond T. Chung, Hepatology)

Biomedical Research

Is the Alzheimer’s protein contagious?

A study recently published in Nature concluded that human transmission of amyloid-b pathology and cerebral amyloid angiopathy is possible. In simpler terms, they concluded that Alzheimer’s disease can be transmissible person-to-person, under special iatrogenic (or medical treatment) routes. The researchers examined the brains of eight people that had died of iatrogenic Creutzfeldt-Jakob disease (CJD) as a result of treatment with human cadaveric pituitary-derived growth hormone contaminated with prions. Prions are misfolded proteins with incubation periods that can exceed five decades. Human transmission of prions has occurred via medical and surgical procedures worldwide as well as via cannibalism in Papua New Guinea. Although treatment with cadaveric-derived growth hormone stopped in 1985, iatrogenic CJD continues to be found.

The researchers showed evidences of amyloid-β spread in the brains of these subjects, which is responsible for the development of Alzheimer’s disease, supporting the theory that the contaminated growth hormone injections could have contributed to the development of iatrogenic Alzheimer’s disease as well. It has never been reported in the past that amyloid-β protein can be transmittable through other medical procedures, such as brain surgery or blood transfusion. These results and their interpretation spurred criticism from several neuro-specialists and researchers who noted that the prions causing CJD can also trigger the formation of amyloid deposits in these brains. Still, there is no epidemiological connection between the contaminated growth hormone injections and the development of Alzheimer’s disease (Emily Underwood, Science Latest News).

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Written by sciencepolicyforall

September 25, 2015 at 9:00 am

Posted in Linkposts

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