May 14, 2014

Eradication of hepatitis C on the horizon

Originally published in the The Washington Times

By Lenny Bernstein May 12 at 7:00 am

gilead

Darryl Kato, research scientist for Gilead Sciences Inc., works on the synthesis of a potential hepatitis C virus drug candidate at the company’s lab in Foster City, California in 2012. (David Paul Morris/Bloomberg)

It’s an easy and reliable applause line for budget cutters to find some basic medical research and complain that it’s a complete waste of money, especially if those dollars are put up by taxpayers, as they often are. And let’s face it, those who feel otherwise don’t always do the best job of arguing the opposite position.

One exception I recently read is an article by two physicians, Raymond T. Chung and Thomas F. Baumert, with the lofty title: “Curing Chronic Hepatitis C — The Arc of a Medical Triumph.” Their analysis in an April issue of the New England Journal of Medicine shows exactly how valuable such research and a cooperative government can be.

For those who are not aware, the piece points out that 130 million to 170 million people — three percent of the world’s population —  are infected with the virus that causes hepatitis C. In the United States, Chung and Baumert note, chronic hepatitis C is the leading cause of death from liver disease and the top reason for liver transplants. It also recently passed HIV infection as a cause of death. According to the Centers for Disease Control and Prevention, for every 100 people in the United States infected by the hepatitis C virus, one to five will die from cirrhosis of the liver or liver cancer.

Unfortunately,  70 percent to 80 percent of people with the virus have no symptoms and many have no idea they are infected. Most at risk are injection drug users, dialysis patients, people who get tattoos or body piercings with non-sterile instruments, some health-care workers, people with HIV and children born to mothers with hepatitis C, according to the CDC.

But the good news is that today the development of anti-viral drugs “has revolutionized [hepatitis C] treatment by offering genuine prospects for the first comprehensive cure of a chronic viral infection in humans,” according to the the authors, who are affiliated with Harvard Medical School and Massachusetts General Hospital. “This success can be traced to important scientific, clinical, and regulatory developments.”

At the risk of oversimplifying the piece, the authors note that the virus was discovered 25 years ago using new scientific approaches, and further research led to the discovery that the virus “requires continuous replication for its existence — an observation that would be leveraged for the design of strategies to permanently clear” it. Then, guided by the experience of developing the drugs used against HIV, researchers developed therapies that use more than one anti-viral agent.

The Food and Drug Administration then agreed to an unusual design of clinical trials that fast-tracked the testing of the drugs, which proved successful more than 90 percent of the time.

The result, Chung and Baumert say, is that “it may now be possible to imagine the global eradication of [hepatitis C]” if issues of cost, early detection and re-infection can be overcome — a potential landmark in public health progress, brought about by the system created to accomplish just that.

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