An Egg Harbor Township clinic is on the cutting edge of research in treating hepatitis C, a blood-borne virus that attacks the liver and can result in death if left untreated.
The disease, which is diagnosed in about 7,000 people every year in New Jersey, is insidious. Its symptoms may not show for decades and, when they do, existing therapies often come with serious side effects.
“A lot of people are afraid of the side effects,” said Dr. John J. Santoro, whose Atlantic Gastroenterology Associates is one of about 20 clinics nationwide testing a less-invasive therapy. “When they know they can take a pill instead, maybe more will seek treatment.”
The disease traditionally afflicted at-risk groups such as injection-drug users and those who practice unsafe sex.
That is no longer the case.
According to the Centers for Disease Control and Prevention, baby boomers represent about 75 percent of hepatitis C cases due to the lack of testing for the virus in blood supplies prior to 1992 and to previous risky behavior.
Locally, cases of hepatitis C have steadily increased, leading some health officials to say the disease has reached “epidemic” levels in some populations. In Atlantic County, new cases more than tripled between 2001 and 2011, according to state Department of Health data. Cumberland County saw an even more dramatic increase, up 454 percent to 338 cases in 2011. In Cape May County, the figures jumped 580 percent over the same period, but have fluctuated widely over the last five years.
The most common treatment for the disease includes a once-a-week injection of interferon — typically in combination with other drugs — over the course of 24 or 48 weeks. Santoro said interferon is a naturally occurring protein the body normally secrets as an antiviral.
“When we boost your interferon, we’re boosting your own innate response,” he said.
But Santoro said interferon therapy comes with symptoms similar to what patients feel when they have the flu. Those side effects include fatigue, headache and muscle pain, and can affect patients’ ability to work and engage in other activities during treatment.
Current trials of less-invasive therapy, which are being monitored by the U.S. Food and Drug Administration, involve two types of drugs called polymerase and protease inhibitors that can be taken orally over a 12-week course of treatment.
“They actually go in and home in on the replicative system of the virus,” or RNA, for those who remember middle school biology, Santoro said.
The new drugs have been remarkably effective in reducing side effects.
“In general, patients think they’re on a placebo because they’re not experiencing the side effects,” he said. “There are some potential unknown side effects when you’re doing research, but for the most part, there’s no side effects. It’s unbelievable.”
Santoro said the therapy has also shown a 95 percent “cure rate,” meaning that lab tests show the virus at undetectable levels in 95 percent of patients who complete the therapy. As with all current treatments, however, the virus could potentially return to higher levels over time.
That compares favorably to the 80 percent cure rate of the most recently developed drugs on the market, Telaprevir and Boceprevir, for which the Egg Harbor Township clinic also conducted trials leading up to those drugs’ FDA approval in 2011.
Treatment of the disease has come a long way since Santoro began studying liver disease in the early 1980s. When he first came to the Egg Harbor Township clinic in 1983, Santoro said, there were few effective therapies available.
So far, Santoro’s clinic has treated about 30 patients using the new therapy and is about to launch a another trial with between six and 10 patients.
Patients could not be made available for comment due to federal privacy laws.
Sofosbuvir, one of the drugs being tested, was developed by Princeton-based Pharmasset Inc. In 2011, the company was purchased by Gilead Sciences for $11 billion, largely in order to acquire the drug.
“That shows you how promising this is,” Santoro said.
Dr. Kenneth Rothstein, chief of the division of gastroenterology and hepatology at Drexel University’s College of Medicine, said the 95 percent cure rate may not translate into real-world practice because trials tend to be conducted among a highly selective group of patients. Harder to treat patients, such as those already suffering from cirrhosis, may not have the same results.
However, the drugs do mark a step forward.
“So far, these drugs look to be very safe and very effective,” he said. “There’s one made by Gilead that we’re expecting full FDA approval on by the end of the year that will not only increase the success rate but (shorten) the duration of treatment.”
Rothstein said therapies have come a long way since the early 1990s, when the first interferon treatments cured about 4 percent of patients.
“I think it’s pretty amazing,” he said. “It took a long time, but we’re getting to the point where we’ll be curing the majority of hepatitis C patients.”
Rothstein stressed the importance for people, especially baby boomers, to get screened for the disease and consult of a doctor if they test positive.
Santoro said the current experimental therapies are probably about a one to 11/2 years from approval by the FDA. Santoro spoke recently at a conference in Galloway for medical professionals hosted by the Atlantic Gastroenterology Associates.
“It has to show safety and efficacy and, really, superiority to the current treatments that are out there,” he said. “So far, it looks good.”
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