About nine months ago, a hepatitis C advocate contacted me and asked if I
would be open to having a discussion on hepatitis C among healthcare
professionals. Specifically, should we disclose or shouldn’t we? He
talked about hepatitis C-positive medical professionals faced with the
dilemma of disclosing their hepatitis C status to their employer. Some
who divulged their status were terminated. There are also cases of those
who were denied a job because pre-employment screening revealed that
they had hepatitis C.
About nine months ago, a hepatitis C advocate contacted me and asked if I would be open to having a discussion on hepatitis C among healthcare professionals. Specifically, should we disclose or shouldn’t we? He talked about hepatitis C-positive medical professionals faced with the dilemma of disclosing their hepatitis C status to their employer. Some who divulged their status were terminated. There are also cases of those who were denied a job because pre-employment screening revealed that they had hepatitis C.
In August 2014, the American Association for the
Study of Liver Diseases (AASLD) and the Infectious Diseases Society of
America (IDSA) prioritized who should be treated for hepatitis C virus
(HCV) infection. In Recommendations for Testing, Managing, and Treating Hepatitis C,
the AASLD and IDSA acknowledged the benefits of HCV treatment,
particularly early treatment. From this, I surmise that they endorse
treating everyone with HCV. However, the AASLD and IDSA recognize the
tragic reality we are facing: the cost of new HCV drugs and a shortage
of medical providers may make it hard to treat everyone initially.
Given these limitations, who should be treated first?
Top priority is given to HCV
patients who are at the highest risk for severe complications, such as
those with stage 3 fibrosis or stage 4 compensated cirrhosis, and organ
transplant patients. The next tier is labeled “high priority,” and it
is separated into two categories: a) those who are at high risk for
complications, and b) those who have a high HCV transmission risk.
Examples of those who are at high risk for complications are HCV
patients with stage 2 fibrosis, or coinfected with HIV or hepatitis B.
The list of persons who have a high HCV transmission risk includes
active injection drug users, the incarcerated, and HIV-positive men who
have sex with men (MSM) with high-risk sexual practices.
If I still had hepatitis C, and
had stage one fibrosis, I’d be at the bottom of the treatment priority
list. I’d be outraged if insurance denied treatment to me because my
liver disease wasn’t advanced, a practice we are seeing played out in
state Medicaid programs. To me it’s akin to saying to a cancer patient,
“Come back when your cancer is worse.” Add to this that if I were an
active injection drug user or incarcerated, I’d be assigned a higher
priority, I might feel abandoned by the health care system. This left
me wondering about the rationale for giving treatment priority to those
at high risk for transmitting HCV over those with stage one fibrosis
and low transmission risk.
In this column I’ll examine the
facts and discuss why it makes sense to treat those who are at high
risk of transmitting HCV. I’ll end with a reality check, but hint: I
need not worry that those with high risk of HCV transmission were given
priority over those with low-fibrosis scores. There are bigger issues
to worry about.
People with High HCV Transmission Risk
Data from the National Health and Nutrition
Examination Survey (NHANES) from 2003 to 2010 estimated that 1.3% of
the U.S. population has chronic hepatitis C. The NHANES surveys only
sampled people living in homes. Data was not collected from certain
high-risk populations, including the incarcerated, homeless,
hospitalized, the military, and immigrants. Some researchers estimate
higher HCV prevalence at 2.0% of the U.S. population. Let’s call it 1%
to 2% and compare this to high risk groups.
People Who Inject Drugs (PWIDs): Research published by Amy Lansky and colleagues (Estimating
the Number of Persons Who Inject Drugs in the United States by
Meta-Analysis to Calculate National Rates of HIV and Hepatitis C Virus
Infections; PlosOne May 2014) estimates that 6,612,488 adults and
adolescent in the U.S. have injected drugs sometime in their life. This
is 2.6% of the population. Researchers estimate a huge range of HCV
prevalence among PWIDs, anywhere from 30% to 90%. Regardless of the
actual prevalence, HCV risk is high among PWIDs.
People Who Are Incarcerated: HCV
prevalence in jails and prisons is also high. The Centers for Disease
Control and Prevention (CDC) estimates that of the 2.2 million people
in U.S. jails and prisons, 30% have hepatitis C. Other estimates are
between 17% and 60%. We don’t know the actual prevalence since HCV
screening is relatively uncommon in state prisons.
HIV-Positive MSM with High-Risk Sexual Practices:
HCV sexual transmission risk, which is normally low in most situations,
is increased among HIV-positive MSM. A study conducted in Amsterdam
reported that among HIV-positive MSM, the HCV prevalence may be as high
as 21%. Although injection drug use may account for some of the HCV
prevalence in HIV-positive MSM, there was a correlation between fisting
and HCV-positivity. (Fisting is the practice of inserting the hand
into the rectum or vagina.) Note: Two recent studies reported that HCV appears to be transmitted sexually in HIV-negative MSM.
Why It Makes Sense to Treat Those at High Risk for HCV Transmission
Prevention is the best medicine; cure is the second
best. There is no HCV vaccine, but the disease is curable. The AASLD
and IDSA Recommendations state, “Persons who have successfully
achieved an SVR (virologic cure) no longer transmit the virus to
others…successful treatment benefits public health.”
It’s easier than ever to cure
HCV, and we are doing so with as little as 12 weeks of treatment.
Virologic cure rates for people with genotype 1 are 90% to 100%; other
genotypes have high response rates too. We are even curing those who are
coinfected with HIV and HCV. Drug development is progressing rapidly,
with shorter treatment durations on the horizon.
Since prevention is the best medicine, then curing hepatitis C early
is second best. In short, stop it before it spreads. The CDC estimated
nearly 22,000 new HCV infections in the U.S. in 2012, which is an
increase of 75% since 2010.1 The vast majority of these
incidents are among PWIDs. This creates a transmission risk for those
who have blood-to-blood contact with PWIDs, including other PWIDs,
family, friends, and health care workers. Cure these early infections
before the virus has a chance to sink its ugly viral teeth into the
livers of our precious friends, family, and community.
You could ask, “Do we really
want to spend our healthcare dollars on people who are at a high risk of
HCV reinfection?” The answer is yes. Stopping HCV in one person,
regardless of how many times he or she is infected is far cheaper than
treating everyone who acquires HCV as a result of the virus spreading
like an out-of-control wildfire.
The Reality Check
If I thought for a single moment that treating
those who are at a high risk for transmitting HCV was going to take
precedence over HCV patients with minimal fibrosis, I was delusional.
The reality is that despite the AASLD and IDSA Recommendations and
the fact that it is the right thing to do, PWIDs, the incarcerated,
and HIV-positive MSM are not exactly attracting public health care
dollars. In fact, viral hepatitis receives less than 3% of the funding
HIV receives from the CDC. According to Emily McCloskey of the
National Alliance of State and Territorial AIDS Directors, “State health
departments receive less than $1 dollar in federal funding for every
person living with viral hepatitis for the Viral Hepatitis Prevention
Coordinator (VHPC) program.” The U.S. Congress can’t get it together to
fund the Viral Hepatitis Testing Act of 2014, which will help screen
baby boomers and other at-risk individuals.
However, just because public
funding isn’t pouring in to treat those at high risk of HCV
transmission, it should. We share this world with those at high risk for
transmitting HCV, and if we want to knock HCV off the planet, we need
to cure everyone. Where best to start? Start where HCV is at its
highest, and reach out to PWIDs, the incarcerated, and HIV-infected
MSM. It’s not just good health policy, it’s the right policy.
However, we don’t stop there.
Everyone should have access to HCV treatment, regardless of fibrosis
stage. The words of Diane Sylvestre, the director of the Oasis clinic
in Oakland, CA ring truer now than ever, “If one of us has hepatitis C,
all of us have it.”
Changing Epidemiology of Hepatitis C Virus Infection in the United
States: National Health and Nutrition Examination Survey 2001 through
2010 – Ivo Ditah, et al. Source:Journal of Hepatology Accepted manuscript November 2013
The National Health and
Nutrition Examination survey (NHANES) collects hepatitis C virus (HCV)
data in the U.S. civilian population. The goal of this study was to
assess the current burden of HCV. More than 52,000 participated; 38,000
were tested for HCV.
The results showed a decline in
HCV-antibody prevalence from 1.9% in 2001 to 1.3% in 2005, remaining
stable through 2010. About 67% of these were positive for HCV RNA,
which was extrapolated to 2.3 million people with chronic HCV
infection; 70% of HCV infections occur in those born between 1945 and
The risk of acquiring HCV
infection in the US is at its lowest since the 1990s. HCV-antibody
prevalence among those under age 30 is approximately 17,000 new
infections annually. This survey confirms other recent studies showing
that risk of HCV transmission among non-HIV infected heterosexual
partners is almost nonexistent, regardless of the number of lifetime
sexual partners. Sexual transmission of HCV is a significant risk among
HIV-infected men who have sex with men.
The Bottom Line:
The biggest risk factors for HCV are being between ages 45 and 65,
born in the USA, having less than high school education, lifetime drug
use, abnormal alanine aminotransferase (ALT) levels, and
having antibodies to herpes simplex virus type 2.
The statement that stands out for me in this paper is, “This
prevalence is almost certainly an underestimate as NHANES does not
include some high risk populations, including the incarcerated,
hemodialysis patients and the homeless.” Since NHANES collects data
from the non-institutionalized, civilian U.S. population, the numbers
have long been called into question. Other experts feel the numbers are
significantly higher, a possibility this paper acknowledges.
Article:Minimal Impact of Sofosbuvir and Ribavirin on Health Related Quality of Life in Chronic Hepatitis C – Zobair Younassi, et al. Source: Journal of Hepatology December 2013
Interferon-based treatment has long been
associated with reduced quality of life in hepatitis C patients. The
goal of this study was to assess health-related quality of life in
patients using interferon-free hepatitis C treatments. Comparisons were
made in the following:
patients taking sofosbuvir and ribavirin versus placebo
patients taking sofosbuvir and ribavirin with and without pegylated interferon
Health-related quality of life
decreased in all treatment arms. Scores were similar between sofosbuvir
and ribavirin versus placebo. However, patients taking pegylated
interferon had significantly reduced quality of life. Longer durations
of treatment with sofosbuvir and ribavirin did not further reduce
quality of life. Patients taking sofosbuvir and ribavirin who had a
sustained virologic response at 12 weeks (SVR-12) had improved
health-related quality of life.
The Bottom Line:
Patients taking sofosbuvir and ribavirin reported mild reductions in
health-related quality of life, but appeared to be improved after
achieving an SVR-12.
Hepatitis C patients have waited a long time for interferon-free
treatment. With the approval of Sovaldi (sofosbuvir), the wait is over
for patients with genotypes 2, 3, and other sub groups. Patients are
wondering if they should start treatment now or wait for ribavirin-free
choices. This study may help them make that choice.
Minimum Costs for Producing Hepatitis C Direct Acting Antivirals, for
Use in Large-Scale Treatment Access Programs in Developing Countries –
Andrew Hill, et al. Source:Clinical Infectious Diseases Advance Access published January 6, 2014
In this study, Andrew Hill and colleagues predict
manufacturing costs for 12-week courses of various hepatitis C drugs.
Here are the findings in U.S. dollars:
$68 – $136 for sofosbuvir (Sovaldi)
$130 – $270 for simeprevir (Olysio)
$21- $63 for ribavirin
$10 – $30 for daclatasvir (not FDA-approved yet)
$100 – $210 for faldaprevir (not FDA-approved yet)
The Bottom Line: These numbers make it possible to treat hepatitis C globally in the next fifteen years.
Editorial Comment: The
cost of research and development drives up the cost of drugs, but so
does profit. This analysis seems so optimistic when compared to the
Wholesale Acquisition Costs of sofosbuvir (Sovaldi) at $84,000 and
simeprevir (Olysio) at $66,360. Although I hope that profit does not
interfere with the very real chance that hepatitis C could be
eradicated, I alternate between being skeptical and cautiously
Article: Health Care Reform and Hepatitis C: A Convergence of Risk and Opportunity – Kathryn Fitch, et al. Source: Milliman Report commissioned by Janssen Therapeutics December 2014
The Affordable Care Act (ACA) is changing
healthcare, and this report explores the impact of hepatitis C virus
(HCV) on public health and policy. The Milliman Report authors use the
term “the great convergence” to describe factors that are coming
CDC recommendations endorsed by the USPSTF to
screen the U.S. Baby Boomers, those born 1946 to 1964. This screening
is a covered service that must be provided at no cost to those who have
The “baby boomer” population is entering into Medicare.
These factors mean that more people will become aware of their HCV status.
Because of ACA, the number of those with health insurance is expanding, thus more people will have access to HCV treatment.
New HCV treatments are in development, opening up more opportunities for patients.
Editorial Comment: My 2009 copy of the Milliman Report, Consequences of Hepatitis C Virus (HCV) is dog-eared from use. This current report is not as compelling, but contains good graphics and information.