ó Barbara Walter has experienced the full medical odyssey of
chronic hepatitis C infection, having faced its every major
challenge while benefiting from all of the modern breakthrough
one of the lucky few. She is cured, with no detectable virus
in her blood since July.
is a medical roller-coaster ride for the 4 million Americans
and 180 million people worldwide with hepatitis C.
latest issue involves two new antiviral medications that can
cure a patient in 12 weeks and one expected soon to be
available once the U.S. Food and Drug Administration finalizes
approval. But those breakthroughs are tempered by the drugsí
price of $1,000 a pill, limiting their use to only those with
the severest complications or biggest bank accounts.
12-week treatment regimen with one of two drugs costs $60,000
and $80,000 respectively, with a full regimen of both drugs
costing $144,000, which is a prohibitive cost for public and
private health plans for most people with the disease.
major step forward in treating the infection must be weighed
against the drugsí costs that pose a "potential threat
to the viability of the U.S. health-care system," states
proposed guidelines for use of the drugs outlined last week in
the Journal of the American Medical Association. The
controversy involves the drugs sofosbuvir (sold as Sovaldi)
and simeprevir (sold as Olysio), often prescribed along with
other drugs. A single-drug regimen awaiting FDA approval could
cure the disease in as little as eight weeks.
Sciences Inc., the manufacturer of sofosbuvir, raised the bar
of controversy recently with its announcement that it would
license generic versions of sofosbuvir to be manufactured by
various drug companies to be sold for a fraction of the
American price in India and 90 other nations whose citizens
cannot afford full-market price. A full round of treatment in
India could cost less than $1,800, about a penny on the dollar
when compared with the American price.
100 Americans has hepatitis C, with 80 percent of the cases
infecting baby boomers. Many contracted the disease decades
ago when blood transfusions were not screened for the virus.
The infection also can be transmitted through intravenous drug
use and sexual transmission.
National Medical Association says of every 100 people with the
infection, 75 percent to 85 percent develop chronic hepatitis,
with 60 percent to 70 percent of those developing chronic
liver disease. As many as 20 will develop cirrhosis of the
liver (liver scarring), and as many as five will die from
cirrhosis or liver failure..
67, of Fairview, Pa., received a blood transfusion in 1976
during a medical procedure. This eventually led to her
diagnosis of hepatitis C in 2000 after a routine blood test.
Most people with the virus often donít know they have it
until they begin experiencing the symptoms of cirrhosis or
I felt good," she said. "A lot of patients get
discoloration, but I wasnít yellow. I did not lose weight. I
really looked healthy."
after diagnosis, she was placed on the traditional course of
peginterferon and ribavirin, which requires about a year of
treatment to produce a cure about 50 percent of the time but
with adverse side effects. The drugs did not work for Walter,
and the side effects required medication.
pain in December 2011 led to discovery of a cancerous liver
tumor, which University of Pittsburgh Medical Center
physicians removed. That led to her being listed for a liver
transplant due to advancing cirrhosis. She underwent a
successful transplant in April 2013 at UPMC Montefiore. Then,
last April, the liver began showing signs of rejection once
hepatitis had infected the new liver.
received insurance approval for the expensive dual-drug
combination of sofosbuvir and simeprevir, which she took May
through July, with a $10,000 copay and a total medication cost
of $144,000, she said. And it worked. Since her blood test in
July, she has had no signs of infection.
you already went through a transplant, you donít want
anything to happen to the new liver," Walter said.
"Life depends on it. So my husband said, ĎWhatever the
cost, itís worth it.í"
liver is the bodyís largest organ, with more than 500
functions, said Vinod K. Rustgi, the UPMC medical director of
Centers for Disease Control now recommends people born between
1945 and 1965 be screened with a blood test for the hepatitis
C infection. Symptoms donít typically appear until liver
function declines to less than 30 percent, with typical
symptoms of jaundice, a swollen abdomen, confusion and
bleeding, Dr. Rustgi said. People who reach this stage of
infection face a 50 percent death rate within five years,
which points to the need for drug treatments and liver
the death rate from hepatitis C began exceeding that of human
immunodeficiency virus infections in the United States.
"HIV has received a lot of publicity, and it is incumbent
upon us to make people aware that hepatitis C is more common
than HIV and it is curable."
allows for earlier recognition of symptoms and allows for
lifestyle changes, including dietary changes and abstinence
from alcohol, Dr. Rustgi said.
you look at an area like Pittsburgh, where there are 2.4
million people (in the metropolitan area), we may have 50,000
people with hepatitis C, with only 10,000 identified as having
it," he said. "That is why screening is so
is important that the average person not be afraid or ashamed
to be screened because there is better recognition of the
problem, and we can address it before we get to a point where
the situation is irretrievable," Dr. Rustgi said.
Gellad, co-director of the Center for Pharmaceutical Policy
and Prescribing at the University of Pittsburgh, said the
hepatitis debate "may be a harbinger of whatís to
come" with expensive drugs to treat various illnesses.
lot of drugs are really expensive, but they are not used for
conditions as common as hepatitis C," he said.
"These decisions about what drugs to cover and what to
screen for are extremely difficult decisions."
many of those decisions are made by Medicare and private
health insurance providers. Treating people early to prevent
huge costs in 20 years might seem like a no-brainer in terms
of cost and conscience.
not everyone who has hepatitis C will end up with a transplant
or cirrhosis, and we donít know how to exactly predict who
those people will be," Dr. Gellad said. "I donít
want to minimize it. This is an important cause of death and
liver transplants, and a very important disease, but not
everyone who gets the infection ends up with these advanced
issue being debated is the cost to research, develop, test and
manufacture the drugs. That question arose in recent weeks
when the pharmaceutical company Gilead announced agreements to
sell generic sofosbuvir overseas at the dramatically reduced
is seeking FDA approval for yet another revolutionary
hepatitis C medication ó a fixed-dose pill that combines
sofosbuvir with the experimental drug ledipasvir that has been
shown to cure hepatitis C in just eight weeks in most cases.
"Everyone will be waiting with bated breath to see how it
will be priced," Dr. Gellad said.
pharmaceutical company said a regimen of Solvadi (sofosbuvir)
"is the most cost-effective treatment option for
patients" infected with the primary type of hepatitis C
because of fewer treatment failures and adverse events, along
with averted liver-disease costs. Earlier use of Solvadi, it
says, "yields better health and economic outcomes
compared with later initiation," by reducing such
complications as cancer and the "downstream costs
associated with advancing (liver) disease."
JAMA report, the American Association for the Study of Liver
Diseases and the Infectious Diseases Society of America said
such drug prices "drive up health insurance premiums and
put a strain on state Medicaid budgets."
the prices of the new drugs decrease, public and private
insurers face an untenable spike in short-term costs and will
be forced to develop stringent patient eligibility criteria as
the only way to manage the tension between access and
affordability," said Daniel A. Ollendorf of the Institute
for Clinical and Economic Review in Boston, who studied the
cost-effectiveness of using the new drugs.