javascript:void(0)
javascript:void(0)
javascript:void(0)


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.