and Ribavirin Combination Appears Promising for Those
with HIV and HCV
Since the introduction of highly
active combination drug therapy for HIV, liver failure
attributable to infection with the hepatitis C virus (HCV)
has become a leading cause of death among those infected
with the virus that causes AIDS. Now a multi-center
study has found that the newest treatment for patients
infected with HCV alone also helps those infected with
both pathogens by significantly improving the clearance
of HCV from the bloodstream. The report appears in the
July 29 New England Journal of Medicine.
"Hepatitis C has become the
new opportunistic infection among HIV-infected
patients," says Raymond Chung, MD, director of the
Center for Liver Disorders in the Gastrointestinal Unit
at Massachusetts General Hospital (MGH), who led the
study. "About 25 percent of those with HIV are
coinfected with HCV, largely because these viruses share
modes of transmission. The problem is immense and
growing. (Note: Dr. Raymond Chung was the recipient
of HFI’s Career Development Research Award in 2000)
Chung notes that what had been the
standard treatment for those infected with HCV only –
interferon and ribavirin – was not effective for
patients also infected with HIV. In those with both
viruses, control of HCV levels in the blood was
diminished and side effects were more pronounced,
leading many patients to stop therapy. Recently, the FDA
has approved a treatment for HCV-only infection using a
chemically modified form of interferon, which keeps the
drug active in the body for a longer period of time. The
current study was designed to investigate whether this
new approach could safely improve treatment success in
those infected with both viruses.
Researchers at 21 centers around
the U.S. enrolled patients infected with both HCV and
HIV who had not previously received interferon
treatment. The 133 enrolled patients were randomized to
receive either the newer drug peginterferon and
ribavirin or the previous standard treatment of
interferon and ribavirin. Halfway through the 48-week
study period, blood tests were taken to see whether HCV
blood levels had dropped in response to therapy.
Participants who did not show a viral response had liver
biopsies to determine whether the treatment had reduced
liver damage. Those who exhibited either viral clearance
or improved liver biopsy findings continued with the
experimental treatment, while those with no response
At the end of the study period,
about 40 percent of those receiving peginterferon had
cleared HCV from their bloodstream, compared with only
12 percent of the interferon group. Follow-up blood
tests were taken 24 weeks after the study period, and
again those in the peginterferon group fared
significantly better, with 27 percent showing sustained
clearance of HCV compared to 12 percent in the
interferon group. The number of participants who
discontinued treatment because of side effects was low,
at a level similar to that seen in patients with HCV
only, and no participants showed progression of HIV
symptoms or adverse drug interactions with their
"This is really a foot in the
door, a promise that we will be able to help many of
these patients without adversely affecting control of
their HIV disease," says Chung, an assistant
professor of Medicine at Harvard Medical School.
"Even among those who failed to clear HCV from
their blood, over one third of those receiving treatment
were found to have improved liver biopsies, which
suggests that maintenance therapy with peginterferon at
doses that do not clear virus could still help prevent
the progression of liver disease."
The study, supported by grants from
the National Institute of Allergy and Infectious
Diseases, was conducted through the AIDS Clinical Trial
Group. Chung's co-authors are Gregory Robbins, MD, and
Atul Bhan, MD, of the MGH; Janet Andersen, ScD, and Tun
Liu, Harvard School of Public Health; Paul Volberding,
MD, and Marion Peters, MD, University of California at
San Francisco; Kenneth Sherman, MD, PhD, University of
Cincinnati; Margaret Koziel, Beth Israel Deaconess
Medical Center; Beverly Alston, MD, National Institute
of Allergy and Infectious Diseases; Dodi Colquhoun,
Frontier Science Technology and Research Foundation; Tom
Nevin, Social and Scientific Systems; George Harb, MD,
Roche Laboratories; and Charles van der Horst, MD,
University of North Carolina at Chapel Hill.
Young Scientists Receive HFIs Research Awards —
Hepatitis B and C
The Board of Directors approved
research applications from two young research scientists to expand
the understanding of the epidemiology of hepatitis B and C.
Scott Fung, MD, FRCP, who is a Research Fellow in Internal Medicine
at the University of Michigan Medical Center, will be conducting his
research under the supervision of Dr. Anna Lok, world renowned
The focus of Dr. Fung’s research
is to differentiate patients with E-chronic hepatitis B from
inactive HBsAg carriers. This study will help identify active
carriers of hepatitis B previously misclassified as inactive
carriers who may benefit from antiviral therapy reducing the risk of
cirrhosis and end-stage liver disease.
Doctoral student at Harvard School
of Public Health, Robert Suruki, also the recipient of HFIs Career
Development Research Award will examine the correlation between
baseline levels of markers for immunity and the progression of
hepatitis C to more severe disease. The potential benefit for early
identification of subjects that may have an increased chance for
more severe disease has great public health importance.
The purpose of HFI’s Career
Development Awards is to provide funds to support research projects
in hepatitis epidemiology, health promotion and outcomes research
and to encourage young investigators to continue research in the
field of viral hepatitis.
Killer Cells Linked to Genes
In a study to be published in Science online Aug. 6,
researchers at Johns Hopkins have found that genes
involved in suppressing the body's defensive
"killer" immune cells are a potential key
factor in spontaneous recovery from hepatitis C.
News and Medical Updates on Hepatitis from the AASLD 2003
Meetings. Visit HCV Advocate now!
January 8, 2004, Nutley, N.J. --
Roche announces the FDA approval of the availability of Pegasys
in a pre-filled syringe.
November 26, 2003 --
The results of a study on the environmental stability of hcv
infected blood outside the body begin to shed light on a very
important questions asked by patients and providers.
November 14, 2003, Pasadena, CA --
An abstract was presented by Myron Tong, M.D., et al on the
results of a Continuous Pump Infusion of Consensus Interferon in
Non-responders to HCV Therapy.
November 2, 2003, Germany --
A new and
promising drug called BILN 2061 that targets an enzyme to block
the replication of the hepatitis C virus is under close study.
October 24, 2003, San Francisco, CA --
University of California San Francisco announces approval of an
NIH sponsored to examine the effects of alcohol on the
progression of chronic hepatitis C infection. Dr. Norah
Terrault, MD and Marion Peters, MD are the
Investigators on this project. For more information, call
September 23, 2003, Kenilworth, N.J. - Schering
Plough to initiate first head-to-head study study with
Peg-Intron and Pegasys.
August 20, 2003, San Francisco, CA -- The
Hepatitis C Support Project announces the launch of their
redesigned web site at www.hcvadvocate.org.
The web site features information on hepatitis C, including a
monthly newsletter and its recent publication on depression and
the hcv patient.
June 2, 2003, Santa Barbara, CA - The Santa Barbara Task Force on Hepatitis C announced the completion of the Strategic Plan. The process, led by Back to Life Santa Barbara is
download. Santa Barbara is the second county in California (following Orange County) to set to task and develop such a document.
May 21, 2003 Digestive Disease Week, Orlando, Florida -
Researchers are Building New Livers in Lab...
May 19, 2003 Digestive Disease Week, Orlando, Florida -
After Liver Transplant Generally Mild, New Study
April 7, 2003, New York - A certain type of
cancer may be linked to
April 3, 2003, Tarrytown, NY - Bayer Group
announces approval for
Versant HCV RNA, a test that measures the
hepatitis C virus...
March 31, 2003, San Diego, CA -
Intermune presents a review of the
antiviral activity of both
Interferon-gamma 1b and Infergen...
March 18, 2003 - Announcing a
new online course on Hepatitis C designed for
counselors and outreach professionals, sponsored by CEATTC...
January 23, 2003 -
Intermune, Inc, Brisbane, CA announces Phase 1 clinical trials
with PEG-Alfacon, a pegylated version of Infergen...
January 23, 2003 - Nabi
Biopharmaceuticals announces FDA acceptance for priority review
of a Hepatitis B Inmmune Globulin for the prevention of
hepatitis B virus infection of transplanted livers in
HbsAg-positive liver transplant patients...
January 16, 2003 -
Advocacy Day in California is drawing near. You can
participate. For more information, visit the new web
January 13, 2003 -
Roche dramatically reduces the cost of combination therapy for
millions of Americans Chronically Infected with Hepatitis C...
January 2, 2003,
announces it will take the lead on development and
commercialization of an oral protease inhibitor called VX-950
for hepatitis C...
31, 2002, Washington (AP) -
The American Red
Cross received reports that 134 people, including one who died,
got hepatitis B after blood transfusions, but the organization
did not investigate them...
December 20, 2002, New York -
A panel of
experts has approved new
rules aimed at improving safety for living donors of partial
transplantation performed in New York state
December 9, 2002, Nutley, N.J.
Roche launches new web site at www.pegasys.com for
product information for both patients and medical providers.
Find complete Product Information on Pegasys and Copegus.
December 3, 2002, Nutley, N.J.
- FDA approves
Pegasys and Copegus for the treatment of hepatitis C.
November 20, 2002, HealthScoutNews -
Injection drug users who consistently use bleach may
reduce transmission of the hepatitis C virus.
November 20, 2002, HealthScout News -
Can ticks spread the hepatitis C virus to humans?
November 20, 2002,
drug users who consistently use bleach may reduce transmission
of the hepatitis C virus.
November 20, 2002, HealthScout
News - Can ticks
spread the hepatitis C virus to humans?
November 19, 2002, Associated Press, Nebraska -
At least 81 people treated at a Nebraska clinic have tested
positive for hepatitis C in an outbreak that may have been
caused by a contaminated vial of medicine.
November 14, 2002, Bethesda, MD
FDA Advisory Committee met in a public hearing in and
voted 11-0 to recommend to the FDA approval for the
combination therapy of Pegasys plus Copegus (the Roche
brand of ribavirin) for treating chronic hepatitis C for
previously untreated patients.
November 13, 2002, Washington, D.C.
Approximately 1/5th of all liver transplant recipients under the
new policies have hepatocellular carcinoma.
November 13, 2002 - USA - ATTENTION
On-Line provided by Medscape - Pegylated Interferons and
Advances in Therapy for Chronic Hepatitis C.
November 13, 2002, Washington, D.C.
Approximately 1/5th of all liver transplant recipients
under the new policies have hepatocellular carcinoma.
November 13, 2002, Atlanta, Georgia
Centers for Disease Control and Prevention (CDC) reports
reflect a decrease in the numbers of new hepatitis A,
hepatitis B, and hepatitis C infections in 2001.
November 8, 2002, Tarrytown, NY -
Bayer Announces FDA Approval for VERSANT(R) HCV RNA Qualitative
November 5, 2002, Brisbane, CA -
InterMune announces Phase IV clinical trial data on Infergen in
combination and its effectiveness compared to Rebetron at the
meeting of the American Association for the Study of Liver
Diseases (AASLD) in Boston today.
November 4, 2002, San Mateo, CA -
Results of a study presented at the American Association
for the Study of Liver Diseases (AASLD) meeting suggest
that Zadaxin in combination with pegylated alpha
interferon may have a benefit for hepatitis C
November 4, 2002, Boston -
Achillion Pharmaceuticals presents positive clinical and
pharmaceutical data on a potential treatment for
hepatitis B at the American Association for the Study of
Liver Diseases (AASLD) meeting.
November 1, 2002, AIDS, (November
Trends in Hepatitis C and HIV Infection Among Inmates
Entering Prisons in California, 1994 versus 1999.
October 31, 2002, San Diego, CA -
Prometheus Laboratories, Inc. announces that it is
introducing a non-invasive approach to help detect liver
fibrosis in patients with chronic hepatitis C.
October 31, 2002, Costa Mesa, CA -
Ribapharm, Inc. announces submittal of an application to
the FDA to initiate Phase I clinical study for Hepavir B
in patients with chronic hepatitis B.
October 21, 2002, Bethesda, MD -
National Center for Complementary and Alternative
(NCCAM) and 16 Federal co-sponsors announce the launch
of an Institute of Medicine (IOM) study of the
scientific and policy implications of the use of
complementary and alternative medicine (CAM) by the
October 16, 2002, Nutley, NJ -
The Food and Drug Administration has approved a new
pegylated interferon called Pegasys for the treatment of
More about the program>
October 8, 2002, Brisbane and San
Carlos, Calif. -
Intermune and Inhale Therapeutic Systems, Inc. announce
an agreement for use of Inhale's technology to develop a
PEGylated version of Infergen for the treatment of
chronic hepatitis C infections.
More about this treatment>
October 7, 2002, San Francisco -
Organizations establish a scholars program to provide
scholarships to Hispanic and African-American students
who have hepatitis C or who are dependents of a person
with the disease.
Read NIH Announces Institute of Medicine Study of
Complementary and Alternative Medicine
SEPTEMBER 28, 2002, ORANGE COUNTY –
Back to Life, A Tides Center Project and the Advisory
Council announce the publication of a Hepatitis C
Strategic Plan for Orange County.
SEPTEMBER 20, 2002 WASHINGTON (AP)
FDA OKs Chronic Hepatitis B Drug. Patients suffering
from the liver-destroying hepatitis B virus will be able
to use a new drug therapy.