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Physician Update - More Cure, Less Misery for Hepatitis C
Physician Update Spring 2013
More Cure, Less Misery for Hepatitis C
Date: April 1, 2013
“You have a chronic disease that could kill you and, oh, by the way, says the doctor, I have a treatment with a 75 percent chance of curing you. Who wouldn’t want to take it?” asks Mark Sulkowski. “A lot of people,” he says, “and that’s been a dilemma in HCV therapy, until now, we think.”
Last August’s announcement by the CDC that all baby boomers should have a one-time screening for hepatitis C came, in part, after the government realized that its focus on screening drug users or other risky populations wasn’t catching everybody. Also, with timely therapy, boomers still stand a chance at keeping hepatitis C’s insidious damage from advancing to end-stage cirrhosis or liver cancer.
But the real drive behind the move, says Mark Sulkowski, “is that we’re on the cusp of a huge change in therapy for the hepatitis C virus [HCV], one that can make a dramatic difference for patients. And the CDC sees that coming.”
Sulkowski knows whereof he speaks. For some time, the infectious disease expert has directed Johns Hopkins’ clinical trials of HCV drug protocols. He’s kept abreast of its seminal work to map the body’s response to the hepatitis virus. And earlier studies by Sulkowski and his group contributed to the existing pharmaceutical arsenal against HCV. Now the researchers are part of what borders on a breakthrough.
“It’s not as though we haven’t had any effective treatment for HCV,” Sulkowski says. The early double-drug therapy of immune-boosting interferon plus ribavirin, a general antiviral, eradicates the virus in about half the patients who are able to take it. Even better, he says, are therapies that arrived in 2011. Protease inhibitors, the first drug class aimed directly at HCV’s replicating machinery, added to the interferon combo to bring a hepatitis cure in roughly 75 percent of patients.
Unfortunately, the newer triple treatment is still no “whammy.”
“Adding protease inhibitors increases the likelihood of a cure,” Sulkowski explains, but the treatment protocol is complicated, with multiple doses of various drugs taken three times a day, often for a year. And the major baggage is the drugs’ significant side effects. Interferon, for example, typically makes patients fatigued and depressed. Ribavirin, especially, causes anemia, though the others add to it.
“It’s not easy convincing a patient with no obvious symptoms to sign up,” Sulkowski says, “and, even harder, to stick to the regimen.” And because of the therapy’s rigor, prescribing the mix for patients who come to the clinic farther along the road to liver failure brings a much-heightened need for specialized care.
So, like his colleagues, Sulkowski was all ears this past November during late-breaking presentations at the annual American Association for the Study of Liver Diseases meeting. “People were stunned,” he says, “to hear that a new generation of oral, direct-acting antiviral agents can actually cure more than 95 percent of patients.” And also good: “It’s possible that treatment may be a single pill, once a day, for three months.”
Sulkowski, a presenter, reported on a Hopkins study—now going into phase III—of a new protocol that upsets viral replication and doesn’t involve interferon or even ribavirin. “We saw minimal side effects and very high success rates even in hard-to-treat patients,” he says. “And unlike therapies for HIV, we can actually clear the virus. We can say cure.
“More Americans now die of hepatitis C than AIDS,” Sulkowski says, “largely because of this country’s aggressive program to identify people with HIV and treat them. We need to do that for hepatitis C.”
Then, together with the new therapies marked for approval by early 2014, he says, “we’ll have the disease on the run.”
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