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Monthly Archives: March 2013

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Patients with HCV may deliberately skip early treatment doses when feeling well

Hepatitis C Blog Posted on March 27, 2013 by Alan FranciscusMarch 27, 2013

Medication nonadherence during the first 24 weeks of treatment for
chronic hepatitis C was often deliberate and attributed to feeling well,
as opposed to forgetfulness or other factors, in a recent study.

Researchers evaluated adherence to treatment in a cohort of 401 patients with chronic HCV
genotype 1. All participants had been enrolled in the Virahep-C study
and received therapy with pegylated interferon (PEG) and ribavirin (RBV)
for 24 weeks, with responders receiving an additional 24 weeks (n=242).
Adherence was measured using the Medication Event Monitoring System,
which recorded when the medication container was opened via a computer
chip in the cap.

Read more…..

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Tagged adherence, Treatment Response

Gilead Announces Update on Phase 3 Study of Oral Fixed-Dose Combination of Sofosbuvir and Ledipasvir for Genotype 1 Hepatitis C Patients

Hepatitis C Blog Posted on March 26, 2013 by Alan FranciscusMarch 26, 2013
— Enrollment in ION-1 Study Continues Following Planned DSMB
Review —
 

FOSTER CITY, Calif.–(BUSINESS WIRE)–Mar. 26, 2013–
Gilead Sciences, Inc. (Nasdaq: GILD) today provided an update on ION-1,
a Phase 3 clinical trial evaluating a once-daily fixed-dose combination
of the nucleotide sofosbuvir and the NS5A inhibitor ledipasvir with and
without ribavirin (RBV) for 12 or 24 weeks among treatment-naïve
genotype 1 patients with hepatitis C virus (HCV) infection (n=800). A
planned review by the study’s Data and Safety Monitoring Board (DSMB) of
safety data from 200 patients in all four arms and of SVR4 rates
(sustained virologic response four weeks after completion of therapy)
from 100 patients in the two 12-week duration arms concluded that the
trial should continue without modification. This recommendation is based
upon the observed SVR4 rates exceeding the predefined threshold of 60
percent and the absence of significant safety issues. Enrollment of the
remaining 600 patients in ION-1 is now underway.

Sofosbuvir/ledipasvir is also being evaluated in a second Phase 3 study,
ION-2, initiated in January 2013, which is now fully enrolled. ION-2 is
evaluating sofosbuvir/ledipasvir with RBV for 12 weeks, and with and
without RBV for 24 weeks, among 400 treatment-experienced genotype 1 HCV
patients. Participants in this study failed to respond to past therapy
containing pegylated interferon (peg-IFN) or peg-IFN plus a protease
inhibitor.

Sofosbuvir, ledipasvir and the sofosbuvir/ledipasvir fixed-dose
combination are investigational products and their safety and efficacy
have not yet been established.

Read complete press release here

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Tagged Clinical Trials, Genotype 1, Interferon Free Treatment, ledipasvir, Sofosbuvir

Hepatic Encephalopathy Explored in New Film, Clinical Studies

Hepatitis C Blog Posted on March 26, 2013 by Alan FranciscusMarch 26, 2013

A new documentary and
several new studies are bringing attention to an often overlooked and
undertreated form of liver disease: hepatic encephalopathy (HE).

The documentary, a 30-minute film called “Wrestling the Monster,”
follows four patients and their caregivers as they struggle with the
effects of HE, a deterioration of brain function that occurs when the
liver is no longer able to remove toxic substances from the blood. The
film, which is accessible online at www.hesback.com,
is co-sponsored by the American Liver Foundation and Salix
Pharmaceuticals; Salix markets Xifaxan (rifaximin) for reduction in risk
for overt HE recurrence in patients aged 18 years or older. The film
does not advertise a specific treatment; instead, it focuses on
portraying the tremendous psychological and physical effects of HE.

Read more….

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Tagged Awareness, brain fog, Disease Progression, encephalopathy, Side Effects

Hyperpigmentation common adverse event of interferon-based chronic HCV therapy

Hepatitis C Blog Posted on March 26, 2013 by Alan FranciscusMarch 26, 2013

More than 20% of patients with chronic hepatitis C treated with
interferon developed hyperpigmentation as a side effect of therapy in a
recent study.

Researchers evaluated 77 patients with chronic hepatitis C
treated with pegylated interferon alfa-2b and ribavirin at the
University Hospital of Nice in France. All had received therapy for 3
months or longer. Dermoscopic and clinical examinations were performed
on the skin, nails and mucous membranes of each participant, along with
skin biopsies if necessary.

Read more….

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Tagged dermatological disorders, hyperpigmentation, interferon, skin disorders, treatment side effects

A new hepatitis threat—Hepatitis E

Hepatitis C Blog Posted on March 26, 2013 by Alan FranciscusMarch 26, 2013

A new hepatitis virus—once thought to occur only in Asia and Africa—is increasingly showing up among North Americans and Europeans. And this new liver infection poses a serious threat to people already infected with chronic hepatitis B or C.

Recently, researchers are using more refined tools and looking more closely at the prevalence of hepatitis E virus (HEV) infection. A Medscape overview on HEV reports that 21% of U.S. adults screened had signs of resolved HEV infections and a report in this month’s journal of Emerging Infectious Diseases revealed that 17% of blood samples submitted to the U.S. Centers for Disease Control and Prevention between 2005 and 2012 were infected with hepatitis E.

Risk of HEV infection increases with age. Fewer than 10% of children and teens had been infected, compared to 40% of those 60 and older.

Hepatitis E shares some similarities to hepatitis A. It is spread through the fecal-oral route. An infected person or animal sheds the virus through their stool, and it spreads through contaminated drinking water. Doctors used to think that the rare hepatitis E infection that was diagnosed in the United States resulted from international travel to areas with contaminated drinking water—but not any more.

More and more HEV cases are showing up in people who have never traveled and researchers are finding HEV in pork meat and livers, rabbit and other home-grown species, which may be the source for the growing number of infections in North America and Europe.

Recently, a European study found that 15% of Dutch pigs and 7% of Belgium pigs in two slaughterhouses were HEV-infected, and a study published this month reports that 16.5% of farm-raised rabbits in Virginia had HEV in their blood stream. Eating under-cooked pork or rabbit, or contact with water or shellfish contaminated by animal waste clearly poses a risk.

Like hepatitis A, HEV usually causes a short-lived infection with few symptoms. But when pregnant women are infected with HEV, they experience high rates of miscarriages and death especially when in late pregnancy.

In people with chronic hepatitis B or C, another liver infection can be deadly. One study from Brazil found people coinfected with HEV and hepatitis C suffered a high rate of severe liver damage and death.

“HEV infection is an under-diagnosed disease because of the use of low-sensitivity (lab tests),” researchers reported in this month’s journal, Current Opinion in Gastroenterology. They noted researchers are discovering new HEV strains or genotypes that can even cause chronic infections in people with suppressed immune systems.

Currently, pegylated interferon and ribavirin have been found to effectively treat HEV infection. China reportedly has developed a vaccine that prevents HEV infection, but it has not been distributed worldwide.

Christine M. Kukka
Project Manager
HBV Advocate

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Tagged HBV, HEV, Warnings

Millions on Verge of Diabetes Don’t Know It: CDC

Hepatitis C Blog Posted on March 22, 2013 by Alan FranciscusMarch 22, 2013

Only 11 percent of the 79 million Americans with prediabetes aware they have the condition

This is article is not directly related to HCV although it has been
well-documented that the hepatitis C virus causes insulin resistance (a
precursor to diabetes).  Because of the link to HCV and the number of people
with HCV who also have diabetes it is important that everyone with HCV
should be evaluated by their medical provider for diabetes –Alan

THURSDAY, March 21 (HealthDay News) — Only 11 percent of the
estimated 79 million Americans who are at risk for diabetes know they
are at risk, federal health officials reported Thursday.

The condition, known as prediabetes, describes
higher-than-normal blood sugar levels that put people in danger of
developing diabetes, according to the U.S. Centers for Disease Control
and Prevention.

Read more…

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Tagged diabetes, high-risk groups, insulin resistance, metabolic syndrome, Quality of Life, risk factors, Testing

Affordable Care Act extended free preventive care to 71 million Americans with private health insurance

Hepatitis C Blog Posted on March 22, 2013 by Alan FranciscusMarch 22, 2013

News Release

FOR IMMEDIATE RELEASE
March 18, 2013
  Contact: HHS Press Office
(202) 690-6343

Health Care Law’s third anniversary sees health costs slowing down, more value for consumers

Health
and Human Services (HHS) Secretary Kathleen Sebelius announced today
that about 71 million Americans in private health insurance plans
received coverage for at least one free preventive health care service,
such as a mammogram or flu shot, in 2011 and 2012 because of the
Affordable Care Act. The new data was released in a report from HHS
today.

Additionally, an estimated 34 million Americans in
traditional Medicare and Medicare Advantage plans have received at least
one preventive service, such as an annual wellness visit at no out of
pocket cost because of the health care law.

Taken together, this
means about 105 million Americans with private health plans and Medicare
beneficiaries have been helped by the Affordable Care Act’s prevention
coverage improvements.
Preventive services, consumer protections,
and other reforms under the Affordable Care Act are giving millions of
Americans of all ages more value for their health care dollars and
contributing to the slowest growth in health care costs in 50 years.

“Preventing
illnesses before they become serious and more costly to treat helps
Americans of all ages stay healthier,” Secretary Sebelius said.  “No
longer do Americans have to choose between paying for preventive care
and groceries.”

Secretary Sebelius released the preventive
services report as HHS celebrates the Affordable Care Act’s third
anniversary this week.  The law is keeping down costs and providing more
value for consumers and taxpayers through new consumer protections,
holding insurance companies accountable, building a smarter health care
system, and providing seniors with vital savings on their prescription
drugs.
The Affordable Care Act is giving Americans better value for their health insurance plans by:

  • Eliminating
    lifetime dollar caps on essential health benefits, and phasing out
    annual caps. About 105 million Americans no longer have to fear their
    benefits will disappear when they need them most because their insurer
    put a lifetime cap on the amount it would pay.
  • Prohibiting
    health insurance companies from denying coverage to children based on a
    pre-existing condition, such as asthma or cancer.
  • And in 2014,
    it will be illegal for health insurance companies to deny coverage to
    any American or to charge more because of a pre-existing condition.  No
    longer will 129 million Americans with health conditions have to fear
    seeing their premiums increased or getting locked out of the insurance
    market.
  • The law will also make it illegal for a health insurer
    to charge women more simply because they are women. “That means,”
    Secretary Sebelius said, “being a woman will no longer be a pre-existing
    condition.”

The full report on expanded preventive care for Americans with private health insurance is available at http://aspe.hhs.gov/health/reports/2013/PreventiveServices/ib_prevention.cfm.
Learn more about the key features of the Affordable Care Act at http://www.healthcare.gov/law/timeline/full.html.


###

Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.
Follow HHS on Twitter @HHSgov exit disclaimer icon and sign up for HHS Email Updates.
Follow HHS Secretary Kathleen Sebelius on Twitter @Sebelius exit disclaimer icon.

Last revised: March 18, 2013
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Tagged Access, Affordable Care Act (ACA), Disability and Insurance, health care, Poverty

Better Long-Term Outcomes With Low Hep C Viral Load

Hepatitis C Blog Posted on March 22, 2013 by Alan FranciscusMarch 22, 2013

In patients with hepatitis C virus (HCV)-related hepatocellular
carcinoma, low viral load predicts better long-term surgical outcomes,
regardless of the serologic eradication of HCV, according to research
published in the Feb. 20 issue of the Journal of Clinical Oncology.

FRIDAY, March 22 (HealthDay News) — In patients with
hepatitis C virus (HCV)-related hepatocellular carcinoma (HCC), low HCV
viral load predicts better long-term surgical outcomes, regardless of
the serologic eradication of HCV, according to research published in the
Feb. 20 issue of the Journal of Clinical Oncology.

Read more…..

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Tagged Disease Management, Disease Progression, Liver cancer HCC, Treatment Response

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