C Treatment Appears to Be Declining; People with Hard-to
Treat Genotypes Are Half as Likely to Receive Therapy
The percentage of people who receive interferon-based
antiviral therapy for chronic
hepatitis C virus (HCV) infection appears
to be declining in the U.S., and lack of
treatment is most often due to not being
diagnosed in a timely manner, according
to a study published in the December issue
of Hepatology. A related study by
researchers at Mount Sinai Medical Center
found that individuals with HCV
genotypes 1 and 4 -- the most difficult
types to treat -- are about half as likely
to start treatment as those with genotypes
2 or 3.
the first study, Michael Volk, Anna Lok, and colleagues
from the University of Michigan at Ann Arbor conducted
a study to determine the number of patients being
treated with antiviral therapy in the U.S., to estimate
the public health impact of these treatment patterns,
and to identify barriers to treatment.
investigators collected data on the number of new
prescriptions for pegylated
interferon (Pegasys or PegIntron) issued each
year from 2002 through 2007. Information was obtained
from Wolters Kluwer, Inc., which maintains an electronic
audit of pharmacies nationwide. Pegylated interferon
plus ribavirin is standard therapy for chronic hepatitis
researchers then constructed a Markov model of the
population with chronic hepatitis C in the U.S. from
2002 through 2030, which they used to estimate the
number of liver-related deaths due to hepatitis C
that would be prevented under current treatment patterns.
they used the National Health and Nutrition Evaluation
Survey (NHANES) Hepatitis C Follow-Up Questionnaire
to investigate reasons for lack of treatment and to
identify strategies for improving access to care.
investigators found that 663,000 patients -- out of
an estimated 3.9 million Americans with HCV infection
-- were prescribed antiviral therapy between 2002
and 2007. During this period, treatment rates appeared
to decline, as fewer prescriptions were written in
later years, falling from 126,000 in 2002 to 83,000
this trend continues," the study authors wrote,
"only 14.5% of liver-related deaths caused by
hepatitis C from 2002-2030 will be prevented by antiviral
therapy." They also projected that fewer than
1.4 million patients in total would be treated by
2030 if this pattern remains stable.
time, HCV can lead to liver cirrhosis and hepatocellular
carcinoma (liver cancer), and it is a leading indication
for liver transplantation. The Centers for Disease
Control and Prevention (CDC) estimates that 8000-12,000
people die each year in the U.S. due to HCV-related
from the NHANES questionnaire suggested that the primary
barrier to treatment is lack of diagnosis, as only
about half (49%) of the 133 respondents were previously
aware they had HCV prior to the survey.
24% of people with HCV, physicians did not recommended
treatment. Reasons commonly cited for not advising
anti-HCV therapy include patient history of depression
or other mental illness (due to side effects of interferon)
and current or past drug or alcohol abuse, although
current treatment guidelines do not require a period
additional 9% of survey participants did not follow
up with their doctors regarding hepatitis C management
and 8% refused treatment. This left only 12% who actually
to treatment included lack of health insurance, limited
access to medical care, and the low rate of HCV screening
by primary care doctors, the study authors suggested.
to improve rates of diagnosis and treatment will be
required if the future public health burden of hepatitis
C is to be ameliorated," they concluded.
is concerning that half of all people with hepatitis
C in the U.S. are unaware of their diagnosis,"
said Dr. Volk in a press release issued by journal
publisher Wiley-Blackwell. "Even with the development
of new and better medications on the horizon, such
medications will have less than optimal impact unless
more patients are diagnosed and referred for treatment."
He added that the current pattern of care is unfortunate,
"since young patients who don't go to the doctor
often may be the best candidates for antiviral therapy"
-- before they develop advanced liver disease.
of HCV Genotype
a related study published in the November 2009 issue
of the Journal of Health Care for the Poor and
Underserved, David Alfandre and colleagues from
Mount Sinai Medical Center aimed to identify clinical
and socio-demographic characteristics associated with
failure to start hepatitis C treatment.
retrospective study looked at a multi-ethnic cohort
of previously untreated HIV negative patients seen
at a primary care hepatitis C clinic in New York City
between January 2003 and May 2007.
researchers identified a total of 168 treatment-eligible
patients, of whom 41 (24%) began treatment. A multivariate
analysis revealed that individuals with HCV genotypes
1 and 4 were half as likely as those with genotypes
2 or 3 to initiate therapy (21% vs 42%, respectively).
often recommend that people with genotypes 2 or 3
start treatment without liver biopsy, because the
course of therapy is short (24 weeks) and the cure
rate is high (70%-80%). For genotypes 1 and 4, in
contrast, the standard treatment duration is 48 weeks
and only about half achieve sustained virological
response. Such patients usually undergo biopsies to
determine whether they have progressive liver damage
-- and therefore should start treatment soon -- or
have stable disease, in which case they might wait
for new directly-targeted anti-HCV therapies currently
researchers also found that unmarried people were
considerably less likely than married individuals
to start treatment (19% vs 49%, respectively). People
with more medical co-morbidities (co-existing conditions)
were also less likely to begin therapy. Patients who
start treatment had an average of 2.9 co-morbidities,
compared with a mean 5.2 co-morbidities among those
who remained untreated. However, age, sex, race/ethnicity,
and language did not significantly influence likelihood
study confirms that genotype is a major barrier to
treatment," said senior author Thomas McGinn
in a press release issued by Mount Sinai. "We
hope these findings will lead to changes in how physicians
approach patient care in a way that increases the
rate of treatment initiation."
people with genotypes 1 and 4 may avoid treatment
because they are concerned about receiving a liver
biopsy. As a result of this study, Mount Sinai has
started a program called "Biopsy Buddies,"
which will pair patients who need a biopsy with those
who have already had one in order to offer information
Volk, R Tocco, S Saini, and AS Lok Public health impact
of antiviral therapy for hepatitis C in the United
States. Hepatology 50(6): 1750-1755.
December 2009. (Abstract).
Alfandre, D Gardenier, A Federman, and T McGinn. Hepatitis
C in an Urban Cohort: Who's Not Being Treated? Journal
of Health Care for the Poor and Underserved 20(4):
1068-1078. November 2009. (Abstract).
Alarming Trend -- Antiviral Therapy to Treat Hepatitis
C is Declining in the U.S. Press release. November
Sinai Medical Center. Mount Sinai Study Finds That
Patients With More Difficult to Treat Forms of Hepatitis
C Are Half as Likely to Treat the Disease. Press
release. November 9, 2009.