Dec. 07--On Friday, the Food and Drug Administration announced its approval of
the new drug Sovaldi, sofosbuvir, for hepatitis C.
In clinical trials, the polymerase inhibitor, the first used in hepatitis C
treatment, has shown a more than 90 percent success rate in curing the deadly
virus that causes liver failure and cancer of the liver.
"It has gone from there being no treatment to almost complete eradication in 23
years," said Mitchell Shiffman, the medical director of the Liver Institute of
Virginia, which has offices at Bon Secours Mary Immaculate Hospital in Newport
News and Bon Secours St. Mary's Hospital in Richmond.
Shiffman has been researching hepatitis C since 1990. At that time, in the first
interferon trials, the cure rate was 5 percent, he said. Over the past two
years, Shiffman has treated more than 80 hepatitis C patients -- more than half
on the Peninsula -- with sofosbuvir.
"Nearly all of them are cured," he said in a phone interview from Nashville,
Tenn., where he was presenting a paper on the topic. "It's very, very potent."
The oral antiviral, manufactured by Gilead, also has a low resistance profile,
meaning the virus doesn't return in most people. It is also the first drug found
to be effective against some strains of hepatitis C without the need for
co-administration with interferon. Interferon is widely known for its harsh side
More than 3.2 million Americans are infected with hepatitis C.
"The challenge now is to identify the patients," said Shiffman, as fully 75
percent of those affected are unaware and may therefore seek treatment too late.
Last year the Centers for Disease Control recommended that everyone born between
1945 and 1965, who account for the vast majority of cases, be automatically
screened for the disease. Early diagnosis and treatment can now prevent fatal
"It's a challenge for primary care physicians. Every week an individual comes to
the Liver Institute with advanced cirrhosis or incurable liver disease. They're
not identified until they have a catastrophic illness. At that point treatment
doesn't help," he said.
Hepatitis C is spread mostly through tainted blood. Often it is caught by the
American Red Cross when screening blood donors. That's how Chesapeake resident
Ken Mitchell, 55, learned that he was infected with type 1 -- both the most
common, accounting for 70 percent of infections, and the most difficult to treat
-- in 2000. He had no symptoms and initially chose to modify his lifestyle --
avoiding alcohol, Tylenol, and anything that might stress his liver -- rather
than submitting to the harsh treatment regimen.
More than a decade later, in 2011, Mitchell joined a clinical trial with
Shiffman to test an experimental drug. It didn't work. Then he tried a "rescue"
regimen, 48 weeks of the same drug combination he'd been offered originally. The
virus came back. Six months ago, he tried sofosbuvir, taking the oral antiviral
pill daily in combination with ribavirin and once-weekly shots of interferon for
12 weeks. In the three months since, he continues to test clear of the disease
that he contracted as a high school senior.
"This is an incredible breakthrough. It's going to rock the world," said
Mitchell, noting the relatively short duration of treatment compared to the
typical year-long regimen.
The success rates shown by sofosbuvir, a once-daily pill taken in combination
with other drugs, was such that the FDA dubbed it a "breakthrough therapy" --
just the third drug to receive the designation -- and fast-tracked its review,
according to Carol Billingsley, a public relations agent with Free Agents
Two weeks ago, the FDA approved Olysio, simeprevir, a protease inhibitor for use
in hepatitis C treatment; it joined others in the class, telaprevir and
boceprevir. Those are only effective with genotype 1, require up to a year of
treatment, and have a cure rate between 75 and 80 percent, according to
Shiffman. In contrast, sofosbuvir works with all strains in just three months.
Its cure rate with types 2 and 3, when used just with ribavirin, is 95 percent.
Shiffman anticipates that in the next two years there will also be an oral
interferon-free treatment for type 1 as well.
"The future of hepatitis C treatment is incredibly bright and promising. The key
is identifying it," he said. "We're on the verge of curing it 95 percent of the
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