The pharmaceutical industry at its best: Hepatitis C cures around the corner

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Screen Shot 2013-10-28 at 2.22.00 PMUntil the past few years, few people had even heard of hepatitis C. Yet, it is estimated that 200 million people worldwide are infected with the hepatitis C virus (HCV) approximately four times that of HIV.

The main reason that the infection isn t isn t in the headlines like HIV is the same reason for its pseudonym The Silent Killer. Unlike HIV, HCV is spread almost exclusively by blood. And its pathology is very different. Following infection, the virus finds a home in the liver where it replicates at an astounding rate. But unlike HIV, symptoms do not arise for 2-3 decades, so most of those infected are unaware of it. By the time symptoms set in, the liver is profoundly damaged. Indeed, HCV is the number one cause of liver transplants in the U.S.

Prior to 2011, the only treatment for the infection was the immune stimulator interferon and another drug called ribavirin. This combination was only modestly effective (about a 40% cure rate, depending on the virus strain), and the treatment was brutal. The side effects from interferon are severe and many people simply stopped therapy because they could not live with them.

The virus wasn t discovered until 1989, but within a couple of years virtually every pharmaceutical company was working on it. And this was a tough nut to crack. The number of candidates that failed in clinical trials was astronomical dozens of potential drugs met their demise because of lack of efficacy or toxicity.

It took 14 years from the first reports of AIDS until the first effective drugs (AIDS cocktails) became available. By comparison, for HCV, it took 22 years. In 2011 the first two specific HCV drugs (from Merck and Vertex) were introduced within weeks of each other. But both had problems, and were added to the existing regimen, rather than replacing it.

From the onset, the ultimate goal was to find a combination of effective drugs that would wipe out the virus and do so without the toxicity of the interferon therapy. This goal is now right around the corner.

The FDA advisory committee unanimously recommended both Gilead Science s sofosbuvir,and Jansen s simeprevir. FDA approval of both is all but guaranteed. And clinical trials involving these and other late-stage candidates are showing 100 percent cure rates in certain patient populations.

ACSH s Dr. Josh Bloom, formerly a researcher in this field comments, The HCV and HIV campaigns were about as good as it gets. The pharmaceutical industry poured many billions of dollars into research and development, and the results speak for themselves: HIV can now be controlled, and HCV can be cured. Those who consider the industry to be evil ought to think about this.

He adds, This should really serve to silence know-nothing critics of the industry Marcia Angell of the Harvard Medical School being a prime example who claim that all drugs that follow the original discovery are simply me-too drugs, which exist simply to pad the pockets of drug companies, while providing little benefit to patients. She could hardly be more wrong.