A boomer balancing act: Treat hepatitis C now, or wait?

EDITOR'S NOTE: Due to a coding error, this story temporarily contained an "updated" date in 2017. It was published on June 28, 2012.

Roughly two million to three million baby boomers are chronically infected with hepatitis C, putting them at risk of serious liver damage if left untreated. Dramatic improvements in what is now a very unpleasant drug regimen are expected over the next several years.

Should they wait?

Before deciding that this story doesn't apply to you, note that chronic hepatitis C can lie dormant for decades with no symptoms. Most people who have it are unaware of the infection. So the first step is to get a blood test, which the Centers for Disease Control and Prevention last month proposed recommending for everyone born from 1945 to 1965.

If it's positive, the short answer about what to do next is - sorry - ask your doctor. People with significant liver disease need to be treated now while others may have reason to hold off. But physicians say that complexities of the condition, other medical issues, classes of drugs and their side effects mean that patients should not attempt to choose on their own.

"This is a rapidly evolving field," said Rajender Reddy, director of hepatology for the University of Pennsylvania Health System, where about a dozen different drug combinations are in clinical trials.

Baby boomers account for more than 75 percent of Americans infected with the blood-borne virus. That's partly because transfusions and blood products weren't screened until 1992 but mostly due to drug use with shared needles, even just once or twice, as teenagers or young adults. After years of chronic infection, more and more people are arriving at hepatologists' offices with advanced liver disease, which also makes the underlying virus harder to suppress.

But there have been plenty of reasons to avoid treatment.

The longtime standard regimen - weekly injections of immune-boosting pegylated interferon plus twice-daily ribavirin pills - takes 48 weeks, causes nasty side effects, and works less than 50 percent of the time.

In May 2011, the Food and Drug Administration approved the first changes in a decade: adding to the standard either Merck's Victrelis (also called boceprevir) or Vertex Pharmaceuticals' Incivek (telaprevir). The direct-acting antivirals nearly doubled the percentage of patients whose virus was reduced to undetectable levels, essentially a cure. In the case of telaprevir, the duration of treatment for some patients was cut to 24 weeks or less.

"They work well but many people either can't take them because of contraindications like depression or won't take them because of the side effects," said Mark Sulkowski, medical director of the Viral Hepatitis center at Johns Hopkins in Baltimore, whose data on the next generation of drugs energized a conference in Barcelona, Spain, two months ago.

Side effects, mostly from the interferon, include fatigue, flu-like symptoms, personality changes, sleep disturbances, and on and on. People with severe depression or anemia, autoimmune diseases, and decompensated cirrhosis are ineligible. So are the 25 percent of infected people in this country whose virus is not genotype 1.

Hep C was not a big surprise for Samuel Morales, 55. He'd used heroin for much of his life and also has hepatitis A, hepatitis B, and HIV, all of which are more easily treated than hep C (there are vaccines against A and B). They often run together in high-risk groups like prisoners. Morales said he got clean in prison in 1993. The hepatitis infections were discovered when he got a liver biopsy around 2000.

Because the treatments then were not very effective, he said, his doctor suggested he wait for something better. His genotype 2 infection, which is more common among intravenous drug users, ruled out the drugs approved last year. A biopsy several months ago that showed worsening cirrhosis - he has never felt symptoms - led his doctor to urge treatment with the old drugs now.

"The side effects are real bad. You get depressed, you don't eat, you get diarrhea, you get cold, you get hot, like a woman going through PMS, it is really bad. Your joints, they hurt, you know," said Morales. His infectious-disease doctor at Penn Presbyterian Medical Center required weekly sessions with a therapist and monthly with a psychiatrist, who prescribed Celexa to manage depression.

"But when you get the results back from the blood work and you see your body viral load is down to 'undetected,' it is worth all that struggle," said Morales, who is three months into what is likely to be nearly a yearlong course of treatment. He has been volunteering with organizations near his North Philadelphia home, encouraging people to get tested for hepatitis C.

Many of those who are positive will have more options than he did.

Dozens of drugs are in development, and researchers expect several to reach the market within two to five years. The first, like the two drugs approved last year, will probably be protease inhibitors for genotype 1; they will still require shots of interferon to help the immune system fight the virus.

After that, however, are several drugs that in small trials have been powerful enough to work without the immune system booster, and with far fewer side effects. Like the drug "cocktails" used to treat HIV, these are given in combination, disrupting the virus' life cycle at different points, so that it cannot mutate and replicate.

The most promising results presented at a recent liver conference in Barcelona were from a combination of GS-7977, a polymerase inhibitor owned by Gilead Sciences Inc., and daclatasivir, a Bristol-Myers Squibb drug that is part of a class known as NS5A inhibitors. One pill a day of each drove the virus to undetectable levels in all 29 patients with genotype 1, the most common in the U.S., and 28 out of 30 patients with genotypes 2 and 3.

That finding, while dramatic, was just four weeks after a 24-week course of treatment (a 12-week course is being tested as well). Because of relapses, doctors don't normally consider a patient cured until 12 to 24 weeks after completion.

But they are a sign of the future.

Reddy, who is medical director of Penn's liver transplant program, said that deciding whether to get treated with the older drugs now or wait for a future generation is a balancing act.

When a biopsy shows significant liver disease, "we say 'hey, you've got to get treated.' But if a patient has relatively mild disease," he said, the ordeal of current treatments may tip the scale. "The side effects are not easy to handle if you don't have a support system."

Reddy was involved with trials of both drugs approved last year and is currently testing the most promising new drugs and others in various combinations in people infected with different genotypes who have failed previous treatments and in others who have never tried them.

The complexity of the treatments, along with rising numbers of people who need them, have led the Penn, Temple and Jefferson health systems to create viral hepatitis centers, with others likely soon. Because these centers also run clinical trials, some patients who are weighing approved drugs now vs. later may have a third choice.

"It's a good time to come out of the woodwork, get your diagnosis and get treated," said Jonathan Fenkel, director of the Hepatitis C Center at Thomas Jefferson University Hospital.