Dr. Robert Cosby
c/o USPSTF
540 Gaither Road
Rockville, MD 20850
December xx, 2012
RE: Screening for Hepatitis C Virus Infection in Adults: Comments on the USPSTF
Recommendation Statement Draft
Dear Dr. Cosby,
I am a [provider] who currently serves patients with hepatitis C virus (HCV) infection. I want to thank
the US Preventive Services Task Force for addressing the issue of the large number of undiagnosed
people living with HCV in the US with the recently released “Screening for Hepatitis C Virus Infection in
Adults” draft recommendations. I think that the recommendation to screen for HCV infection in adults
at high risk will help identify these people who currently engage in high risk behaviors, and I strongly
support the grade B recommendation. However, I also strongly urge you to change your recommended
“C” grade for hepatitis C testing of those born from 1945 through 1965 (“baby boomers”) to a “B”
grade.
For example, [insert example of any individuals you have worked with who are within the baby-boomer
cohort, and/or who were either diagnosed in time for treatment or too late]
Over 106,000 people with HCV infection have been reported in Massachusetts, with 8,000-10,000 newly
diagnosed cases reported each year. There are essentially two different HCV epidemics in
Massachusetts. One epidemic is among people with ongoing risk behaviors, primarily injection drug use,
that leave them vulnerable to not only HCV infection, but also HIV, hepatitis B virus infection, and death
from drug overdose. We have a well-documented outbreak of HCV infection in young, injection drug
users with 1,190 confirmed and probable cases of HCV in people age 15-25 reported to the
Massachusetts Department of Public Health in 2011.
The other HCV epidemic is among the population that was likely infected with HCV 20 to 40 years ago,
that does not have ongoing risk behaviors, and will not be identified through outreach in drug
rehabilitation programs, incarceration settings, STI clinics, and other public health venues. I am very
concerned that the grade “C” given by the USPSTF to birth-cohort screening will result in these
individuals continuing to remain undiagnosed because they will not be identified through risk-based
screening.
Although there is overlap with the group that has ongoing high risk behaviors, a common characteristic
of this other HCV epidemic is that approximately 75% of people with HCV infection in Massachusetts
were born between 1945 through 1965. About half of these individuals likely had prior exposure to
injected drugs. However, as discussed in the Institute of Medicine Report on Viral Hepatitis in 2010,
there is reluctance on the part of many providers to ask about certain stigmatizing behaviors and for
patients to reveal such past behaviors. Our specific challenge is that these are also the individuals who
are most likely to have advanced disease because they have been living with HCV for 20 – 40 years. An
estimated 15% to 25% already have cirrhosis and need urgent identification and linkage into care.
The benefits to screening for HCV in this birth cohort are equally compelling to those described in the
Task Force recommendations for high risk groups. We have a narrow window of time in which to
identify this fixed cohort of older patients and link them to care. We estimate that about 15,000 to
25,000 people with HCV infection in Massachusetts already have cirrhosis and need specialized care for
this medical condition. Our Department of Public Health reported that 1,280 patients with HCV died in
Massachusetts in 2009. From 1992-2009, the median age at death was 53, compared to 75 years in
people who did not have HCV (a number very similar to the national average age at death for people
with HCV).1,2 Among those with a reported HCV diagnosis who died, between 3% and 8% died within
two years, and between 8% and 13% died within 5 years of their diagnosis. Starting with cases reported
in 2002, the number of HCV-related deaths (n=616) within three years of a HCV diagnosis surpassed that
of HIV (n=75). At least some of these late diagnoses were likely driven by presentation of end stage liver
complications. Consistent with these data, our transplant centers are seeing increasing numbers of
patients being diagnosed with HCV at the time they present with hepatocellular carcinoma or a liver
decompensation event. Addressing HCV at this late time point allows for very limited and expensive
treatment options and only marginal survival benefits.
The consequences of a ”C“ grade for birth cohort screening include both continued late diagnosis or
failure to diagnose HCV infection, thus missing the period in the natural history of HCV infection when
risk modification is effective and treatment options are potentially curative. The grade of C will not only
discourage screening in a primary care provider’s office, but carries the negative impact on
reimbursement by payers for services that could result in a life-saving intervention. Further, we think
that the prevalence of anti-HCV antibodies in the 1945-1965 birth cohort (3.3%) is not materially
different from that found in other high risk groups, such as people who received blood transfusion prior
to 1992 (5.8%), and is clearly higher than that of the general population. Thus, we do not agree with the
grade C recommendation for screening in this group. We feel strongly that the 1945-1965 birth cohort
be added to the other high prevalence groups and be given a grade B recommendation as well.
In order to be able to intervene prior to the development of advanced liver complications, we need a
mechanism to readily identify people who have been exposed to HCV (through an anti-HCV antibody
test), diagnose active HCV infection (through an HCV RNA test), and use both liver biopsy and noninvasive tests to help determine patients who are most likely to have advanced liver disease. The first
step is improved identification while a patient is asymptomatic. Utilizing liver function screening is
inadequate as 40% or more of those with HCV and concurrent cirrhosis will have normal transaminases
with periodic sampling. Risk-based screening is not easily amendable to electronic medical prompts, and
1
Lijewski V, Church D, Onofrey S, Cocoros N, Caten E, DeMaria A. Mortality Trends Among People Diagnosed with
Hepatitis C Virus Infection: Massachusetts, 1992-2009. Council of State and Territorial Epidemiologists; Omaha,
Nebraska, June 3 -7, 2012.
2
Wise M, Bailek S, Finelli L, Bell BP, Sorvillo F. Changing Trends in Hepatitis C-Related Mortality in the United
States, 1995-2004. Hepatology 2008; 47:1128-1135
there has been a long experience with failure of routine HIV testing based on risk behaviors in spite of
broad and expensive education. This means that we need an alternative in order to reach this
population effectively and in time to intervene. I believe that implementation of a one-time anti-HCV
antibody screening campaign in Massachusetts, directed at the approximately 1.8 million people who
were born from 1945 through 1965, can help us find the 75% of people with HCV in this state who are in
this birth cohort, while inexpensively identifying the ~1.73 million people who do not have HCV. A nonstigmatizing campaign based on medical reminders triggered by year of birth, accompanied by clear
education about how to refer people who are identified as having HCV infection, will help save lives in
this state.
Respectfully,
[your name, title, and affiliation with city and state]