Friday, April 25, 2014

Local patients in clinical trials cured of Hepatitis C

Local patients in clinical trials cured of Hepatitis C
April 25

More than 150 local patients with hepatitis C have participated in clinical trials that not only cured most of them of a liver-destroying disease but also led to a breakthrough treatment showing record-high cure rates.

Getting rid of hep C used to involve a year of injections with a raft of side effects, a treatment that didn't always keep the virus from coming back.

But local patients had a hand in testing drugs that started arriving on the market several months ago drugs with success rates well above 90 percent, clearing the virus in as little as eight weeks. The oral medications are also much easier on the body.

This new generation of hep C drugs is being described as a game changer in the battle against a disease that has become the leading cause of liver transplants and that kills more people annually in this country than HIV/AIDS.

But here's the rub: The antiviral drugs come at a high price, in some cases $1,000 for a single pill taken daily for three months.

Insurance companies are balking at the $60,000-to-$100,000 drug regimen, as they scramble to balance cost and cure.

Douglas Gray, executive director of the Virginia Association of Health Plans, said drugs such as the hep C treatment are going to be a challenge for both private and government insurers. At a time when the Affordable Care Act is emphasizing control of health care costs, there's an array of effective, but very expensive, drugs that could break the budget.

The hep C drugs have been grabbing headlines lately, with one health insurer, UnitedHealth Group Inc., reporting it spent $100 million on a version from Gilead Sciences Sovaldi, approved by the Food and Drug Administration in December in its first three months on the market.

The debate is likely to intensify because not everyone with hep C which is spread primarily through contact with the blood of an infected person will have serious health consequences. The disease ranges in severity from a mild illness to scarring of the liver that can lead to cirrhosis or liver cancer.

So, who are the best candidates for the drug? And do you provide it only to people with hep C symptoms? Or also to people without symptoms to prevent liver damage from occurring? Those in early stages of the disease have shown higher cure rates.

There's also concern about populations that don't have ready access to health care, such as the homeless, prisoners, the uninsured and poor people in developing countries.

Dr. Michael Ryan, of Digestive & Liver Disease Specialists in Norfolk, has enrolled about 100 local hep C patients during the past five years in clinical trials of companies that are in a race to produce these drugs.

Ryan, a professor of clinical internal medicine at Eastern Virginia Medical School, has been participating in drug trials for years, but the cocktail of drugs including sofosbuvir, which suppresses replication of the virus, has shown particular effectiveness.

He said cost is the biggest issue, and about half of the patients for whom he's prescribed the new medication regimen since it was approved by the FDA have been turned down.

Dr. Mitchell Shiffman, medical director of the Bon Secours Liver Institute of Virginia, also has enrolled local hep C patients in various trials that have led to a cure, at both the institute's offices in Newport News and in Richmond.

Shiffman said it's been an exciting time, moving from early years of research where interferon injection treatment had terrible side effects and a cure rate of less than 50 percent. He said some of his patients in the most recent trials had been through several rounds of unsuccessful treatment before receiving the most recent drugs that cured them.

"Grown men break down in tears."

He said insurance companies have had varying responses to coverage since FDA approval, and some of his patients have been turned down, leading them to file multiple appeals. Some insurance companies are covering it only for people whose livers are already scarred.

"How would you feel if you had a virus and someone said we won't treat you until you have more scarring on your liver?"

The Centers for Disease Control and Prevention estimates 3.2 million Americans have the chronic form of hep C. Because it's a slow-moving disease, many people live with it for years before being diagnosed.

The CDC recommends all baby boomers be tested for it, because more than three-quarters of the cases are in that demographic.

Dennis Wyand, 62, of Virginia Beach fell in that cohort. He never experienced symptoms of hep C, but bloodwork done for his diabetes in 2010 led to a liver biopsy and diagnosis.

He was referred to Ryan, who suggested he enter a clinical trial that included the antiviral drug sofosbuvir and interferon shots. He was a little nervous to be part of a clinical trial, and he ran the idea past several of his doctors before deciding to enroll in it in 2012.

Within three months, his body was clear of the hep C virus. "I was elated," he said.

The treatment combination he took has since been approved by the FDA.

Less fortunate are those people who weren't part of the trials of the most recent breakthrough drugs and whose insurance won't cover the treatment. A 61-year-old Virginia Beach woman with hep C is discovering it's all about timing when it comes to volunteering for clinical trials.

The woman, who didn't want to be identified because she wanted to keep her health condition private, was part of a clinical trial that Ryan was involved in with interferon shots in 2001. She described the shots, which produce flu-like symptoms, as "hell on wheels."

While the interferon shots have worked for some patients, they didn't for her. Three months after she finished the treatment, the hep C virus returned.

She's now on a waiting list for another trial, hoping she'll qualify for the newer generation of drugs rather than trying to get her insurance to pay for them. "They say it's $90,000 for three months, and that doesn't include doctors that's just the drugs."

Ryan and Shiffman said the number of clinical trials has gone down as the successful drugs have hit the market. But there are still ongoing trials of competing companies, and trials with various combinations of oral meds with different types of the disease. Tests to determine the smallest amount of time you can take the medications and still be cured also are under way.

Results of those trials are expected to bring new brands of drugs on the market that will likely reduce cost.


Elizabeth Simpson, 757-222-5003,

Posted to: Health News

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