Doctors are monitoring five patients who may have been exposed to
Hepatitis B while they received treatment at Boston Medical Center, the
hospital said Saturday.
“Recently, we became aware that a small number of patients were
potentially exposed to (the) Hepatitis B virus and five patients are
potentially at risk from the exposure,” said BMC spokeswoman Jennifer
Watson. “We have communicated with these patients and are monitoring
them closely. Additional measures have been put in place to avoid the
possibility of a similar exposure in the future.”
The Oklahoma state health department is contacting some 7,000
patients of Tulsa-area dentist Dr. W. Scott Harrington to warn them they
may have been exposed to “blood-borne viruses.” An investigation of his
office found rusty instruments in use and many unsanitary practices.
in Harrington’s office also allegedly carried out tasks that only a
licensed dentist may perform, including giving IV sedation. More
worrisome, as The Associated Press reports, the dentist and his staff
told investigators that they treated numerous patients who were ill with infectious diseases.
But it’s far from clear that anyone was ever sickened because they were
treated by Harrington. Oklahoma state health department epidemiologist
Kristy Bradley told the AP there’s still an active investigation. “I
want to stress that this is not an outbreak,” she said.
Susan Rogers, executive director of Oklahoma’s Board of Dentistry told CNN that when investigators first learned how the dentist’s office was run, “we were just physically kind of sick. I mean, that’s how bad (it was) and I’ve seen a lot of bad stuff over the years.”
— Filing Based on Phase 3 Data in Treatment-Naïve and Treatment-Experienced Patients with Compensated Liver Disease —
RARITAN, N.J., March 28, 2013
/PRNewswire/ — Janssen Research & Development, LLC (Janssen) today
announced it has submitted a New Drug Application (NDA) to the U.S.
Food and Drug Administration (FDA) seeking approval for simeprevir
(TMC435), an investigational NS3/4A protease inhibitor, administered as a
150 mg capsule once daily with pegylated interferon and ribavirin for
the treatment of genotype 1 chronic hepatitis C in adult patients.
C is a complicated disease and genotype 1 hepatitis C can be
particularly difficult to cure. Given the complexity and diversity of
the patient population, physicians need multiple options to provide
their patients a chance at treatment success,” said Wim Parys ,
Global Head of Development, Infectious Diseases and Vaccines, Janssen.
“The U.S. filing represents an important step forward in bringing
simeprevir to market and in helping to battle this challenging disease.”
Hepatitis C virus (HCV) is a blood-borne infectious disease of the liver that affects approximately 3.2 million people in the United States. When left untreated over time, HCV can cause significant damage to the liver, including cirrhosis.
regulatory submission for simeprevir is supported in part by data from
three pivotal Phase 3 studies: QUEST-1 and QUEST-2 in treatment-naïve
patients and PROMISE in patients who have relapsed after prior
interferon-based treatment. In each study, participants were treated
with one 150 mg simeprevir capsule once daily for 12 weeks plus
pegylated interferon and ribavirin for 24 or 48 weeks. Primary efficacy
data from the Phase 3 studies will be presented at an upcoming medical
(TMC435) is an investigational NS3/4A protease inhibitor jointly
developed by Janssen and Medivir AB for the treatment of genotype 1
chronic hepatitis C in adult patients with compensated liver disease.
Simeprevir is believed to work by blocking the protease enzyme that
enables the hepatitis C virus to survive and replicate in host cells.
Data from a phase 2 trial suggest that adding 12 weeks of sofosbuvir
to peginterferon alfa-2a and ribavirin may be beneficial in
non-cirrhotic, treatment-naive patients with genotypes 1, 2 and 3
hepatitis C virus infection.
In the two-cohort trial, patients with HCV genotype 1, 2 or 3 from 22
centers in the United States were recruited from Aug. 16 to Dec. 13,
2010. The 122 patients with HCV genotype 1 were allocated to cohort A.
These patients were randomly assigned to 200 mg sofosbuvir
(Gilead Sciences), 400 mg sofosbuvir or placebo for 12 weeks, with
peginterferon and ribavirin. Depending on viral response, the patients
continued peginterferon and ribavirin for an additional 12 weeks or 36
weeks. The 25 patients with genotypes 2 or 3 comprised cohort B. These
patients all received 400 mg sofosbuvir plus peginterferon and ribavirin
for 12 weeks.
In findings that may represent a breakthrough in the treatment of hepatitis C infection, researchers have reported that weekly injections of an experimental medication that denies the virus
a foothold in the liver substantially drove down subjects’ viral loads
after five weeks of treatment. Fourteen weeks after the injections
ended, researchers found that five of 18 infected subjects getting the
medication’s higher doses showed no detectable trace of infection.
The new study
describes a treatment approach that could outsmart the hepatitis C
virus’s penchant for developing resistance to existing drugs and
“provide curative therapy to a large proportion” of the 170 million
people in the world who are infected with the virus, wrote Harvard University physician Dr. Judy Lieberman and Dr. Peter Sarnow of Stanford University.
Four of the nine patients who got the highest dose of miravirsen
temporarily cleared the virus after five injections. “That compares very
well to current treatments,” Janssen says.
One of the drugs in the pipeline, called miravirsen, may be able to
stop the virus with little side effects, doctors from University Health
Network in Toronto, Canada, reported Wednesday.
Their findings, published in The New England Journal of Medicine, are
preliminary — the doctors gave the drug to just 27 patients for about a
month. (Another 9 patients in the study were given a placebo.) But the
study is still drawing attention because it offers proof-of-concept for a
whole new class of drugs, called RNA interference drugs.
DATE & TIME: Wednesday, March 27th 2013, 12:00 PM – 1:30 PM EDT
COURSE ID: 1042853
HOW TO REGISTER: Go to www.train.org, sign in or create a valid account, and search for the course ID
COURSE DURATION: 1 hour and 30 minutes
COURSE DESCRIPTION: This is the second webinar in a series produced
by the CT-RI Public Health Training Center in conjunction with the NE
ATTC, the CDC and the DHHS. This webinar will review tools available for
clinical education, training and communications surrounding Hepatitis B
Understand how May Hepatitis Awareness Month & National Hepatitis Testing day support the Viral Hepatitis Action Plan
Understand at least 3 available strategies to promote awareness
during the May Hepatitis Awareness Month & National Hepatitis
Learn what is effective from others who have implemented May activities
Cynthia Jorgensen, DrPH, is the Lead for Education,
Training and Communication in CDC’s Division of Viral Hepatitis. Dr.
Jorgensen has worked at the CDC for over 24 years, working on
educational campaigns in HIV/AIDS, before going on to lead several
national cancer prevention campaigns. She joined the Division of Viral
Hepatitis and leads the Know More Hepatitis national hepatitis C
campaign and is planning a new national campaign on hepatitis B. She is
a Past President of national SOPHE (Society for Public Health
Education) and is an adjunct faculty member at Emory University’s School
of Public Health, where she teaches classes on health communication and
health behavior change.
Corinna Dan, RN MPH, is with the Office of HIV/AIDS
and Infectious Disease Policy (OHAIDP) at the US Department of Health
and Human Services and is the Viral Hepatitis Policy Advisor working to
implement the National Viral Hepatitis Action Plan and support
coordination of viral hepatitis activities across federal agencies and
the community. Prior to joining the OHAIDP, Corinna served as Hepatitis B
Policy Fellow at the Association of Asian Pacific Community Health
Organizations (AAPCHO). In this role, Corinna worked with community
leaders and policy makers to promote improved prevention, diagnosis,
treatment and care of viral hepatitis in Asian American communities
across the United States. Before joining AAPCHO, Corinna held positions
in the Hepatitis Foundation International (Chief Operating Officer) and
the Chicago Department of Public Health (Hepatitis C Virus Program
Coordinator). Corinna received a Bachelor of Arts degree in Asian
Studies from Connecticut College, a Bachelor of Science in Nursing from
Rush University in Chicago and Masters in Public Health from the
University of Illinois at Chicago.
Chari Cohen serves as the Director of Public Health
for the Hepatitis B Foundation (HBF), in Doylestown, PA. For over 10
years, she has worked with the HBF public health team to plan, implement
and evaluate community programs and research projects focusing on
hepatitis B and liver cancer. Currently, her research focuses on
reducing HBV and liver cancer health disparities, and developing models
for improved health care access and management for chronic HBV
infection, including the early detection and prevention of liver cancer.
Ms. Cohen directs Hep B United Philadelphia, a campaign to increase
testing and vaccination to fight hepatitis B and liver cancer. She
served as Vice-Chair of the National Task Force on Hepatitis B: Focus on
Asians and Pacific Islander Americans from 2005-2012, and is currently
Caucus Councilor for the Asian Pacific Islander Caucus of APHA. Ms.
Cohen is actively involved in national advocacy efforts, working with
organizations around the U.S. to help them become HBV advocates and
learn how to implement HBV-related projects using best practices. She
received her MPH in Community Health Education from Temple University in
2001 and is currently a doctoral candidate at Drexel University School
of Public Health.
Philip E. Reichert, MPH, has been the manager of the
Florida Department of Health’s hepatitis program since 2005. He has
worked in the public health field in STD and HIV/AIDS prevention and
control for over thirty-three years. He earned his bachelor’s degree in
communications from Florida State University and his master’s degree in
public health from the University of South Florida.