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Senator Kirk Joins American Legion to Raise Hepatitis C Awareness for Veterans

Hepatitis C Blog Posted on May 30, 2015 by Alan FranciscusDecember 13, 2015
Kirk’s Veterans Bill Passed by Appropriations Committee Funds $900 Million Worth of Groundbreaking New Hepatitis C Treatments; Veterans Suffer From Hepatitis C at a Rate Three Times That of the Civilian Population

Summit, Ill. –(ENEWSPF)–May 29, 2015.  In an effort to raise hepatitis C virus (HCV) awareness for veterans, U.S. Senator Mark Kirk (R-Ill.) joined Marty Conatser, Adjutant of the American Legion Department of Illinois, Paul Gardner, Senior Vice Commander of the American Legion Department of Illinois, and Argo Summit Post Commander Reggie Rice at a free Hepatitis C testing event in Summit, IL. Service Officers from the American Legion and representatives from the Department of Veterans Affairs were also present to counsel veterans on VA benefit claims and recommend next steps for HCV medical care to any veterans that tested positive for the virus.

“In the Department of Veterans Affairs we have cured more people of Hepatitis C in the last 16 months than in the last 16 years,” Senator Kirk said. “We will continue work to make sure that those who wore the uniform can have a better life.”

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Tagged Senator Kirk, VA Funding

Senator Kirk Joins American Legion to Raise Hepatitis C Awareness for Veterans

Hepatitis C Blog Posted on May 30, 2015 by Alan FranciscusDecember 1, 2015
Kirk’s Veterans Bill Passed by Appropriations Committee Funds $900 Million Worth of Groundbreaking New Hepatitis C Treatments; Veterans Suffer From Hepatitis C at a Rate Three Times That of the Civilian Population

Summit, Ill. –(ENEWSPF)–May 29, 2015.  In an effort to raise
hepatitis C virus (HCV) awareness for veterans, U.S. Senator Mark Kirk
(R-Ill.) joined Marty Conatser, Adjutant of the American Legion
Department of Illinois, Paul Gardner, Senior Vice Commander of the
American Legion Department of Illinois, and Argo Summit Post Commander
Reggie Rice at a free Hepatitis C testing event in Summit, IL. Service
Officers from the American Legion and representatives from the
Department of Veterans Affairs were also present to counsel veterans on
VA benefit claims and recommend next steps for HCV medical care to any
veterans that tested positive for the virus.

“In the Department of Veterans Affairs we have cured more people of
Hepatitis C in the last 16 months than in the last 16 years,” Senator
Kirk said. “We will continue work to make sure that those who wore the
uniform can have a better life.”

Read more…

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Tagged Senator Kirk, VA Funding

Lee County Health Department offers Hep C rapid test

Hepatitis C Blog Posted on May 30, 2015 by Alan FranciscusDecember 13, 2015
Also looks into creating a needle exchange in response to heroin increase in county 

 DIXON – It’s not just law enforcement agencies that are taking a proactive approach to Lee County’s increased heroin usage — the health department is making strides, too.

This week, the Lee County Health Department started offering rapid screening for Hepatitis C. It’s an action that Administrator Cathy Ferguson hopes will stave off any future heroin-related public health crises, like the one that southeastern Indiana has seen.
According to the latest figures, there are now 162 people in Indiana who have been diagnosed with HIV as part of an outbreak that, officials say, stemmed from the sharing of heroin needles.
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Tagged heroin epidemic, IL, Lee County, needle exchange

Lee County Health Department offers Hep C rapid test

Hepatitis C Blog Posted on May 30, 2015 by Alan FranciscusDecember 1, 2015
Also looks into creating a needle exchange in response to heroin increase in county 

 DIXON – It’s not just law enforcement agencies that are taking a
proactive approach to Lee County’s increased heroin usage — the health
department is making strides, too.

This week, the Lee County Health Department started offering
rapid screening for Hepatitis C. It’s an action that Administrator
Cathy Ferguson hopes will stave off any future heroin-related public
health crises, like the one that southeastern Indiana has seen.
According
to the latest figures, there are now 162 people in Indiana who have
been diagnosed with HIV as part of an outbreak that, officials say,
stemmed from the sharing of heroin needles.
Read more…
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Tagged heroin epidemic, IL, Lee County, needle exchange

Meeting Report Now Available: Hepatitis C among African Americans

Hepatitis C Blog Posted on May 30, 2015 by Alan FranciscusDecember 13, 2015

African Americans are among the populations prioritized by the Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis (Action Plan) which outlines steps to educate communities about the benefits of viral hepatitis prevention, care, and treatment as well as actions to enhance healthcare provider knowledge about populations disproportionately impacted. A two-day forum convened by HHS in March 2015 focused on strengthening the response to hepatitis C in African American communities and included participation from over 30 organizations from across the country. The Action Plan is a national plan that requires the participation and engagement of many partners in order to achieve its goals and the newly released forum report includes themes and strategic considerations that all stakeholders can use to address the important health disparity of hepatitis C among African Americans in the United States.

Read the full report from the HHS Forum on Hepatitis C in African American Communities (PDF 8.4MB)

– See more at: https://blog.aids.gov/2015/05/meeting-report-now-available-hepatitis-c-among-african-americans.html#sthash.8N3zjGUp.dpuf

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Tagged African-Americans, Viral Hepatitis Action Plan

Meeting Report Now Available: Hepatitis C among African Americans

Hepatitis C Blog Posted on May 30, 2015 by Alan FranciscusDecember 1, 2015

African
Americans are among the populations prioritized by the Action Plan for
the Prevention, Care, and Treatment of Viral Hepatitis (Action Plan)
which outlines steps to educate communities about the benefits of viral
hepatitis prevention, care, and treatment as well as actions to enhance
healthcare provider knowledge about populations disproportionately
impacted. A two-day forum convened by HHS in March 2015 focused on
strengthening the response to hepatitis C in African American
communities and included participation from over 30 organizations from
across the country. The Action Plan is a national plan that requires the
participation and engagement of many partners in order to achieve its
goals and the newly released forum report includes themes and strategic
considerations that all stakeholders can use to address the important
health disparity of hepatitis C among African Americans in the United
States.

Read the full report from the HHS Forum on Hepatitis C in African American Communities (PDF 8.4MB)

– See more at: https://blog.aids.gov/2015/05/meeting-report-now-available-hepatitis-c-among-african-americans.html#sthash.8N3zjGUp.dpuf

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Tagged African-Americans, Viral Hepatitis Action Plan

Phase I/II Opdivo (nivolumab) Trial Shows Bristol-Myers Squibb’s PD-1 Immune Checkpoint Inhibitor is First to Demonstrate Anti-Tumor Activity In Patients With Hepatocellular Carcinoma

Hepatitis C Blog Posted on May 29, 2015 by Alan FranciscusDecember 13, 2015
  • Interim results show favorable safety profile of Opdivo, and durable responses in previously-treated patients
  • Overall survival rate of 62% at 12 months observed at this interim analysis
  • Hepatocellular carcinoma is the second most frequent cause of cancer-related death worldwide and remains an area of significant unmet medical need
  • Patients with hepatocellular carcinoma who have relapsed or have disease progression, following standard of care, have a median survival with best supportive care of ~7 to 8 months

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced results from an interim analysis of CA209-040, a Phase I/II dose-ranging trial evaluating the safety and anti-tumor activity of Opdivo (nivolumab) in previously-treated patients with hepatocellular carcinoma (HCC) or advanced liver cancer. Initial findings demonstrated that the estimated survival rate in evaluable patients (n=47) was 62% at 12 months. Results also show the safety profile of Opdivo is generally consistent with that previously-reported for Opdivo in other tumor types. These data will be featured today, May 29, during the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) press briefing at 1:00 – 2:00 p.m. CDT and presented on Saturday, May 30 from 8:27 a.m. – 8:39 a.m. CDT (Late Breaking Abstract #101).

“Hepatocellular carcinoma is an aggressive and fatal cancer, comprising 90 percent of all liver cancer in adults worldwide with limited therapeutic options for patients with advanced stage disease; no treatment advances have been made for patients who fail to respond or progress on the current standard of care,” said Anthony B. El-Khoueiry, MD, lead study author and associate professor of clinical medicine and phase I program director at the University of Southern California Norris Comprehensive Cancer Center. “These preliminary data are encouraging and support the ongoing evaluation of nivolumab in this patient population, as they show promising preliminary survival data, and durable partial or complete response in one out of five nivolumab-treated patients, with many others experiencing stable disease.”

More than 700,000 people around the world are diagnosed with HCC each year with a majority of all HCC cases caused by infection with the hepatitis B virus (HBV) or hepatitis C virus (HCV), making HBV/HCV the most common risk factor for liver cancer worldwide. Patients with advanced HCC receiving the current standard of care have a median overall survival of less than 1 year. For patients who have relapsed or have disease progression, median survival with best supportive care is approximately 7 to 8 months.

“Bristol-Myers Squibb’s experience in hepatitis and Immuno-Oncology make us poised as leaders to advance Opdivo into additional studies of hepatocellular carcinoma,” said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. “Opdivo has demonstrated improvements in survival in a number of different tumor types. We are excited that this trial has shown the potential that this may extend to advanced liver cancer and hope to confirm these findings in future trials.”

About the CA209-040
CA209-040 is a Phase I/II dose-ranging trial that evaluated the safety and anti-tumor activity of Opdivo in patients with HCC, the majority of whom had received prior treatment. The trial included 47 HCC patients who were enrolled into one of three treatment arms depending on whether or not they were infected with HCV or HBV. Patients enrolled in the trial received Opdivo doses ranging from 0.1 – 10 mg/kg intravenously every 2 weeks for up to 2 years. The primary objective was safety, tolerability, dose limiting toxicities, and maximum tolerated dose. Anti-tumor activity was a secondary objective (using RECIST 1.1 criteria), and overall survival was an exploratory objective.

As of this interim analysis, 62% of patients in the study were still alive after 12 months. Eight (19%) patients (of 42 evaluable patients) achieved a complete or partial response, meaning that the size of their tumors measured at baseline decreased by 30–100% with Opdivo treatment. In patients with response, duration of response ranged from more than 1.4 – 12.5 months. Seventeen patients remained on study treatment and 30 discontinued treatment due to progressive disease (n=26), complete response (n=2), or adverse events (n=2).

CA209-040 is the first trial to characterize the safety profile of Opdivo monotherapy in patients with HCC, including those with HCV and HBV infections. In the trial, safety and tolerability were well-characterized, with the frequency and intensity of treatment-related adverse events (AEs) being consistent across Opdivo dose levels. The majority of side effects were mild to moderate in nature with abnormal liver enzymes (19% AST and 15% ALT), rash (17%) and elevation of amylase (15%) and lipase (17%) being the most common; the abnormal liver enzymes and elevated amylase and lipase were not accompanied by any significant clinical symptoms. Grade 3–4 treatment-related AEs were infrequent (19%). There were no treatment-related deaths reported.

About Opdivo
Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials – as monotherapy or in combination with other therapies – in which more than 8,000 patients have been enrolled worldwide.

Opdivo became the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world on July 4, 2014 when Ono Pharmaceutical Co. announced that it received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma. In the U.S., the U.S. Food and Drug Administration (FDA) granted its first approval for Opdivo for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. On March 4, 2015, Opdivo received its second FDA approval for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

Read complete press release here

 
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Tagged BMS, HCC, Opdivo

Phase I/II Opdivo (nivolumab) Trial Shows Bristol-Myers Squibb’s PD-1 Immune Checkpoint Inhibitor is First to Demonstrate Anti-Tumor Activity In Patients With Hepatocellular Carcinoma

Hepatitis C Blog Posted on May 29, 2015 by Alan FranciscusDecember 1, 2015
  • Interim results show favorable safety profile of Opdivo, and durable responses in previously-treated patients
  • Overall survival rate of 62% at 12 months observed at this interim analysis
  • Hepatocellular
    carcinoma is the second most frequent cause of cancer-related
    death worldwide and remains an area of significant unmet medical
    need
  • Patients with
    hepatocellular carcinoma who have relapsed or have disease
    progression, following standard of care, have a median survival
    with best supportive care of ~7 to 8 months

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers
Squibb Company
(NYSE:BMY) today announced results from
an interim analysis of CA209-040, a Phase I/II dose-ranging trial
evaluating the safety and anti-tumor activity of Opdivo (nivolumab)
in previously-treated patients with hepatocellular carcinoma (HCC) or
advanced liver cancer. Initial findings demonstrated that the estimated
survival rate in evaluable patients (n=47) was 62% at 12 months. Results
also show the safety profile of Opdivo is generally consistent
with that previously-reported for Opdivo in other tumor types.
These data will be featured today, May 29, during the 51st Annual
Meeting of the American Society of Clinical Oncology (ASCO) press
briefing at 1:00 – 2:00 p.m. CDT and presented on Saturday, May 30 from
8:27 a.m. – 8:39 a.m. CDT (Late Breaking Abstract #101).

“Hepatocellular carcinoma is an aggressive and fatal cancer, comprising
90 percent of all liver cancer in adults worldwide with limited
therapeutic options for patients with advanced stage disease; no
treatment advances have been made for patients who fail to respond or
progress on the current standard of care,” said Anthony B. El-Khoueiry,
MD, lead study author and associate professor of clinical medicine and
phase I program director at the University of Southern California Norris
Comprehensive Cancer Center. “These preliminary data are encouraging and
support the ongoing evaluation of nivolumab in this patient population,
as they show promising preliminary survival data, and durable partial or
complete response in one out of five nivolumab-treated patients, with
many others experiencing stable disease.”

More than 700,000 people around the world are diagnosed with HCC each
year with a majority of all HCC cases caused by infection with the
hepatitis B virus (HBV) or hepatitis C virus (HCV), making HBV/HCV the
most common risk factor for liver cancer worldwide. Patients with
advanced HCC receiving the current standard of care have a median
overall survival of less than 1 year. For patients who have relapsed or
have disease progression, median survival with best supportive care is
approximately 7 to 8 months.

“Bristol-Myers Squibb’s experience in hepatitis and Immuno-Oncology make
us poised as leaders to advance Opdivo into additional studies of
hepatocellular carcinoma,” said Michael Giordano, senior vice president,
Head of Development, Oncology, Bristol-Myers Squibb. “Opdivo has
demonstrated improvements in survival in a number of different tumor
types. We are excited that this trial has shown the potential that this
may extend to advanced liver cancer and hope to confirm these findings
in future trials.”

About the CA209-040

CA209-040 is a Phase I/II dose-ranging trial that evaluated the safety
and anti-tumor activity of Opdivo in patients with HCC, the
majority of whom had received prior treatment. The trial included 47 HCC
patients who were enrolled into one of three treatment arms depending on
whether or not they were infected with HCV or HBV. Patients enrolled in
the trial received Opdivo doses ranging from 0.1 – 10 mg/kg
intravenously every 2 weeks for up to 2 years. The primary objective was
safety, tolerability, dose limiting toxicities, and maximum tolerated
dose. Anti-tumor activity was a secondary objective (using RECIST 1.1
criteria), and overall survival was an exploratory objective.

As of this interim analysis, 62% of patients in the study were still
alive after 12 months. Eight (19%) patients (of 42 evaluable patients)
achieved a complete or partial response, meaning that the size of their
tumors measured at baseline decreased by 30–100% with Opdivo
treatment. In patients with response, duration of response ranged from
more than 1.4 – 12.5 months. Seventeen patients remained on study
treatment and 30 discontinued treatment due to progressive disease
(n=26), complete response (n=2), or adverse events (n=2).

CA209-040 is the first trial to characterize the safety profile of Opdivo
monotherapy in patients with HCC, including those with HCV and HBV
infections. In the trial, safety and tolerability were
well-characterized, with the frequency and intensity of
treatment-related adverse events (AEs) being consistent across Opdivo
dose levels. The majority of side effects were mild to moderate in
nature with abnormal liver enzymes (19% AST and 15% ALT), rash (17%) and
elevation of amylase (15%) and lipase (17%) being the most common; the
abnormal liver enzymes and elevated amylase and lipase were not
accompanied by any significant clinical symptoms. Grade 3–4
treatment-related AEs were infrequent (19%). There were no
treatment-related deaths reported.

About Opdivo

Bristol-Myers Squibb has a broad, global development program to study Opdivo
in multiple tumor types consisting of more than 50 trials – as
monotherapy or in combination with other therapies – in which more than
8,000 patients have been enrolled worldwide.

Opdivo became the first PD-1 immune checkpoint inhibitor to
receive regulatory approval anywhere in the world on July 4, 2014 when
Ono Pharmaceutical Co. announced that it received manufacturing and
marketing approval in Japan for the treatment of patients with
unresectable melanoma. In the U.S., the U.S. Food and Drug
Administration (FDA) granted its first approval for Opdivo for
the treatment of patients with unresectable or metastatic melanoma and
disease progression following Yervoy (ipilimumab) and, if BRAF
V600 mutation positive, a BRAF inhibitor. On March 4, 2015, Opdivo
received its second FDA approval for the treatment of patients with
metastatic squamous non-small cell lung cancer (NSCLC) with progression
on or after platinum-based chemotherapy.

Read complete press release here

 
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Tagged BMS, HCC, Opdivo

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