Hopes for Hepatitis C

From: "Bruce K. Melson" <doc32751@cookeville.com>

X-RCPT-TO: <Will@willpete.com>

> VA Researchers Pegging Hopes for Hepatitis C Treatment on Hybrid Drug
> http://www.nejm.org/content/2000/0343/0023/TOC.asp
> Jan 15, 2001
> Randolph Fillmore
> Stars and Stripes Medical Correspondent
>  Part I of a three-Part Series
> The results of two studies published in the Dec. 7 New England Journal of
> Medicine have bolstered VA researchers' hopes of successfully treating
> hepatitis C, a blood-borne disease that afflicts almost 3 million
> and is responsible for thousands of deaths each year.
> The VA researchers joined others around the world in studying
> a hybrid drug created by using a process called "pegylating" to attach an
> extra molecule to interferon alpha-2, a drug currently being used to treat
> hepatitis C.
> In patients with chronic hepatitis C, a regimen of peginterferon alpha-2
> given once weekly is more effective than a regimen of interferon alpha-2
> given three times weekly,
> - Theresa L. Wright, M.D
> "In patients with chronic hepatitis C, a regimen of peginterferon alpha-2
> given once weekly is more effective than a regimen of interferon alpha-2
> given three times weekly," said study co-author Theresa L. Wright, M.D.,
> the San Francisco VA Medical Center. "In patients with chronic hepatitis C
> and cirrhosis or bridging fibrosis (pre-cirrhosis), peginterferon is
> significantly more effective than standard interferon-a."
> 100,000 Veterans
> These findings are good news in the VA's drive to defeat hepatitis C,
> possibly affects some 100,000 veterans. It is estimated that 35,000
> Americans are newly infected each year and that deaths from hepatitis C
> could reach an annual 38,000 by 2010.
> The hepatitis C virus (HCV) is transmitted through contact with infected
> blood. Most cases are the result of transfusion of infected blood,
> blood now is routinely screened for HCV. Contact with infected blood also
> can come from sharing razors, needles and piercings, tattooing or even
> toothbrushes. Transmission is also possible through sexual contact.
> HCV symptoms may not appear for decades. Early flu-like symptoms can
> diagnosis. Hepatitis C ultimately can cause severe liver damage, cirrhosis
> and liver cancer. Left untreated, it is often fatal.
> Unlike hepatitis A and B, there is no hepatitis C vaccine--and no immunity
> after becoming infected once. The disease is life-long; treatment is
> directed at lowering the viral activity.
> Funding Increase
> Last October, the VA announced stepped-up efforts to fight the disease by
> increasing funds provided to the Veterans Integrated Service Networks
> (VISNs) for each hepatitis C patient from $3,249 to $42,153. The VA also
> transferred hepatitis C care responsibilities from its Acute Care Service
> Chronic Care Services, under the direction of Lawrence R. (Bopper) Deyton,
> M.D., who supervises the VA's HIV/AIDS programs.
> Like HIV, hepatitis C is a chronic disease, and perhaps 30 percent of the
> VA's hepatitis C patients are co-infected with HIV.
> - Theresa L. Wright, M.D
> "The change makes good sense," said Wright. Like HIV, hepatitis C is a
> chronic disease, and perhaps 30 percent of the VA's hepatitis C patients
> co-infected with HIV, she said.
> The VA has estimated that almost 7 percent of veterans are infected with
> HCV, a rate three times that of the civilian population. Some veterans
> returned from Vietnam unaware that they had become infected. The virus was
> not identified until 1989.
> According to Gary Roselle, M.D., of the Cincinnati VAMC, 54,682
> veterans tested positive for hepatitis C between 1998-99. Their average
> was 49.4 years.
> "These data have implications for planning of patient care initiatives,
> educational programs and budgetary projections," said Roselle, who
> the findings at the September 2000 meeting of the Infectious Disease
> of America.
> Less is More
> The good news about peginterferon is that less is more. Less frequent
> were found to be more effective, and effective for longer periods, than
> interferon-a. The brand name of the peginterferon manufactured by
> Roche is called Pegasys; the Scheming product is called Peg Intron.
> Scientists note subtle but important differences between the two.
> In pegylation, the process by which the two drugs are created, one or more
> chains of polyethylene glycol (PEG) are attached to the interferon-alpha
> molecule. Researchers believe that the PEG structure prevents the
> interferon-a molecule from being degraded in the body as quickly as a
> non-PEG molecule would be. The PEG helps the interferon suppress the
> hepatitis C virus longer. A single weekly dose is as effective as a
> three-times-weekly dose of unpegylated interferon-a because pegylated
> interferon-a stays in the blood for a longer time, according to the
> researchers.
> The combination molecule's behavior depends on the size of the PEG and the
> nature of its link to the interferon-a molecule, said Wright. The size of
> the PEG is determined by the number of repeating carbon atoms attached to
> hydrogen and oxygen. PEG can have branching or linear attachments.
> PEG has longer sustained absorption and is cleared more quickly by the
> liver. Linear PEG has a shorter absorption period but is cleared by the
> kidneys.
> Researchers testing hepatitis C patients with and without accompanying
> cirrhosis of the liver found peginterferon to be effective in suppressing
> the virus when administered once weekly.
> Side Effects
> Patients with advanced HCV-caused liver disease frequently cannot tolerate
> the side effects of current therapies, and researchers hope that pegylated
> interferon will be easier on them. When the drug becomes available for
> clinical use, it will be coupled with ribavirin, a drug now being used to
> treat hepatitis C. Researchers hope that the combination of pegylated
> interferon-a and ribavirin will be even more effective.
> Wright said that pegylated versions of interferon-a have not yet been
> approved by the Food and Drug Administration. She is uncertain which
> of pegylated interferon-a the VA will use once approval is granted. "There
> are trade-offs between the two," she said.
> Treatment of patients co-infected with HCV and HIV can be tricky. Some
> physicians have expressed concern that the pegylated drugs might increase
> anemia in these patients.
> Wright said that both kinds of interferon-a might be included in the VA's
> formulary, the list of drugs approved for use in the VA health care
> The VA is battling hepatitis C on two fronts--one in Miami and one in San
> Francisco. Wright said that data from clinical trials and other sources
> be evaluated at the San Francisco VAMC.
> "Keep on, Keepin' on",    Support Veterans
>  & Thanks.......Colonel Dan
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