For
a second he thought it was a hero’s welcome.
Twenty-one-year-old Tony Sylvester touched
down in San Francisco in 1969 after serving a year in Vietnam. “I saw some girl
come running toward me, and I thought she was going to kiss me,” he
says. “Instead she spit on me.”
Back home in New Jersey, Sylvester felt vilified. Like many
of his war buddies, he drank to numb the feelings and explored
drugs,
eventually injecting heroin. His drug phase ended in the
early 1970s, but the damage was already done.
Twenty-three years later he would learn
that sharing needles exposed him to hepatitis C and that
two decades of drinking
had damaged his liver. But he had no real way of knowing
that when
he was using drugs. Back then, the disease didn’t even
have a name.
His doctor, Eugene Schiff, M.D., has seen
hundreds of similar cases. “Most of the people who have the disease have no
idea they have hepatitis,” says Schiff, chief of the
Division of Hepatology and director of the Center for Liver
Diseases at
the Miller School of Medicine. He is considered one of the
leading authorities on the disease that now affects more
than 180 million
people worldwide.
“They had no idea they have hepatitis,” he says. “They
grew up, went to college, then maybe donated blood in their
50s and found out, wham, they have this disease.”
Like many of his peers, Sylvester, 59, has gone through hepatitis
C treatments but has not cleared the virus. That could change
for many patients in the near future, Schiff says.
New treatments being tested at the Miller
School are proving dramatically successful. Combining existing
therapies with
newly developed protease inhibitors has resulted in decreasing
a patient’s
viral load from 1 million markers, considered highly active hepatitis
C, to only 100 markers after just two days of therapy. In one
case, after four weeks of treatment, 12 out of 12 patients were
negative—showing no sign of the virus.
“That just snowed everybody over,” Schiff
says.
Some of those trials are close to moving to phase 3, which
is the last phase before FDA approval. At that point, the
number of patients receiving treatment will increase from
hundreds
to
several thousand. Eventually, full approval would make these
new treatments available for millions.
New treatments can dramatically improve the quality of life
for patients like Sylvester. An estimated 4 to 5 million
Americans now have the disease, nearly 2 percent of the country,
making
it three times more prevalent than HIV. But only one-fifth
of
U.S. patients even know they are infected. Veterans seem
especially prone to the disease: 10 percent of the patients
at veterans
hospitals have hepatitis C.
For years doctors have been fighting the disease using standard
combination therapy: a weekly shot of interferon plus an
oral agent, ribavirin, in a dose of usually four to five
pills per
day. For many patients, this can lead to a cure. The percentage
of those who clear the virus has been steadily improving,
in some cases eclipsing 50 percent.
This is a dramatic improvement from the
7 to 10 percent clearance rate back in the 1980s, when the
only real treatment was
a shot of interferon three times a week. Yet such progress
extracts
a cost—in this case the side effects, which can be daunting,
almost overwhelming. Many patients can’t endure it.
Within hours of injecting the weekly shot,
for example, they develop flu-like aches and fevers, sometimes
chills and sweats.
These fevers usually diminish within a day, but they can
still be scary to patients if they don’t know what
to expect, says Arie Regev, M.D., associate professor of
medicine and hepatology.
“I know one patient who stopped after two injections
because he was running fevers and thought he was allergic to
the medication,” Regev
says. “That’s not allergy. That’s just
bad communication.”
Treatments can last from six months to one year. Other side
effects of the treatments can include depression of blood
platelets and
white blood cell count, extreme fatigue, loss of libido,
severe depression, loss of appetite, and subsequent weight
loss.
“I dropped from 220 to 190 pounds,” says Tim Sardina, 52,
a strapping 6-4 union shop steward and police boxing instructor. “People
would walk up to me and ask, ‘What’s the matter,
man?’ ”
The worst part was the loss of energy. “There were some
times when I’d be completely drained,” Sardina says. “It’s
like chronic fatigue, you’re just dragging, especially
in the morning. That’s when you have to push yourself.”
These side effects are becoming well known,
Schiff says. “Patients
will come now and say, ‘I was recently diagnosed with C,
do I have to undergo treatment? I have a friend who’s miserable,
and I don’t want to go through what he did.’ ”
Hepatitis C comes in six genotypes. While type 2 is often
curable, especially for women, the most common and hardest
to treat
in this country is genotype 1, which represents about 80
percent of all cases. As the disease progresses and the viral
load
continues
to increase, it becomes much harder for patients to respond
successfully to treatments.
Researchers have been seeking a vaccine and effective cure
for hepatitis C since they first identified it in 1989. Schiff
says
very little ground has been made in developing a vaccine.
The focus has instead been on treating those infected. Currently
some 40 clinical trials in liver disease treatments are taking
place at the Miller School and the Miami Veterans Affairs
Medical
Center. Some of these new agents appear to promise better
results in less time with far fewer side affects.
Hepatologists hope the new combination
therapy will allow all patients to contain the progression
of hepatitis C—comparable
to today’s successful cocktail treatment for HIV—with
one very notable difference: Unlike HIV, they can actually
cure about 50 percent of the hepatitis C patients. And that
cure rate
may grow as high as 80 percent with the new treatments.
Still, Christopher B. O’Brien, M.D.,
professor of clinical medicine, advises most patients to
consider starting treatment
now rather than waiting for new medications. There is no
guarantee these will actually be available in five years
or more.
Most people became infected years ago,
and once the disease does become active it can worsen rapidly. “Rather than waiting
for one of those other medications to become available, I think
many people would be better to recognize what they have and treat
it. I advise them to take action now,” O’Brien
says.
But first doctors must identify the patients.
It’s critical
to be aware of—and ask about—previous risk factors.
Anyone who shared needles, whether for IV drug use or other
injections, should be tested. One large sub-group is Cuban
immigrants who
received vitamin shots as children, often from family members
who re-used needles.
Treatments continue to be especially difficult
for African-American men, whose cure rate is 26 to 27 percent,
barely half the
national average for other patients, says Lennox Jeffers,
M.D., chief
of hepatology for the Miami VA Health Care System. Most of
those patients have type 1, the hardest to treat, and doctors
believe
the virus reacts differently to their immune system. “It’s
going to come out that something in their immune system has gone
awry,” says Jeffers. “Something we have not yet
discovered.”
Some patients who cannot clear the virus
develop failing livers. Many of those will require and ultimately
receive
liver transplants;
more than 80 were performed last year at Jackson Memorial
Hospital for hepatitis C patients. But that still is not
a solution:
the real problem is reinfection. Schiff says 100 percent
of all transplanted
recipients get reinfected, and 30 percent of them develop
cirrhosis in five years. Doctors also face a shortage of
available livers
to transplant—only one for every three people who need
one.
And despite all the recent progress, some
patients still don’t
make it. “The hardest part is watching people try multiple
therapies and see nothing work, and you see them progress to
need a transplant or worse,” O’Brien says. He pauses
and sighs, looking away. “They’ve tried everything,
you’ve done everything with them, but nothing worked.”
For patients like Tim Sardina and Tony Sylvester, both in
their 50s, finding a cure is not part of their expectation.
Treatments
have not worked for them so far, so finding something that
keeps the disease in check would be a vast improvement.
For most patients though, O’Brien says, new treatments
will mean a cure, effectively changing the landscape. “I’ll
be astounded if the new treatments don’t just blow things
away,” he says. |