New Jersey Star Ledger
May 14, 2011
Merck gets to finish line first with new anti-viral drug for Hepatitis C
By Susan Todd
Nearly two years ago, Warren Schumann, a 58-year-old retired UPS truck driver, endured two rounds of harsh drug treatments in hopes of fighting hepatitis C, a virus that was weakening and slowly destroying his liver.
The treatments lasted nearly a year and involved weekly shots of interferon and twice daily doses of Ribavirin, an antiviral pill. The drugs left Schumann anemic and so run down, it felt like he had a bad case of the flu — constantly.
In the end, he did not even get better. The virus survived the onslaught of medicine.
But Schumann, a Dumont resident who is now suffering from cirrhosis of the liver, may soon have another shot at a cure.
On Friday, Merck won approval from federal regulators to begin marketing Victrelis, its new anti-viral drug for hepatitis C, beating out Massachusetts-based Vertex Pharmaceuticals to push out the first new treatment for the virus in a decade. Vertex is expected to get its drug, Incivek, approved later this month.
For most of the major pharmaceutical companies, hepatitis C has become a focus. Bristol-Myers Squibb, Johnson & Johnson and Roche are all clamoring for a piece of a market that is expected to balloon to $6.4 billion by 2014.
The drive to develop new medicines reflects the staggering impact of the virus:
In the United States, an estimated 3.2 million people — nearly two-thirds are aging baby boomers — are living with chronic hepatitis C and nearly 17,000 new cases are reported annually, according to estimates from the Centers for Disease Control and Prevention. In New Jersey, 7,609 new cases were reported last year, according to preliminary estimates compiled by the state Department of Health and Senior Services.
The impact of the virus appears even more grave when you consider that the current treatment — the harsh, year-long regimen of peginterferon alfa and Ribavirin that Schumann endured — will cure only about half of those patients.
In the pharmaceutical industry, it is not uncommon for two or more drug makers working on treatments for the same disease to compete to be the first to market, which is an advantage in capturing profits.
Eliav Barr, Merck’s vice president of infectious disease, said different factors were at work in the race to develop a Hepatitis C drug. "There are patients lined up waiting for new drugs. There are people getting liver transplants and liver cancer,’’ Barr said. "That’s where the pressure was coming from.’’
Hepatitis C is spread through contact with infected blood — it takes only a microscopic amount. Once infected, individuals can go decades without realizing they have the virus. Over time, the virus destroys the patient’s liver.
Melissa Palmer, medical director of hepatology at NYU Hepatology Associates on Long Island, said many baby boomers learn they have the virus when they buy life insurance and lab tests detect the hepatitis C antibody.
"People may have non-specific symptoms like fatigue, so they don’t really know what it is,’’ Palmer said.”The liver is a large sturdy organ so it takes a lot.’’
The spread of hepatitis C is blamed on several things, including blood transfusions and organ transplants that occurred before 1992 when blood supplies started being screened. Intravenous drug use — even one experience — Palmer said, is blamed for many infections.
In Schumann’s case, he believes he became infected at the age of 21 when he received blood when he was hospitalized with a kidney disease. After experiencing extreme bouts of fatigue in his early 50’s, Schumann said, his primary doctor discovered the virus with a blood test. "The scary thing is, most people are walking around and don’t know they have it,’’ Schumann said.
The drugs developed by Merck and Vertex are known as protease inhibitors — enzymes that are capable of interfering with the virus’s ability to replicate. In comparison, Interferon and Ribavirin, work by revving up the patient’s own immune system so it can try to eliminate the virus.
In clinical studies, researchers added the protease inhibitors to the standard treatment of interferon and Ribavirin for six months and saw a spike in the number of patients who appeared to clear the virus. With the standard treatment, the virus was no longer detectable in about 40 percent of the patients. While the two drugs vary in their effectiveness, generally at least 70 percent of the patients had what researchers call a sustained virological response.
"I think we’ve set a really high bar,’’ said Camilla Graham, vice president of global medical affairs at Vertex. "We’re looking for high cure rates for as short a treatment period as possible.’’
"To be able to shorten the treatment period to 24 weeks is a big step forward,’’ she said.
The new drugs aren’t perfect though. Both may still cause a patient to develop anemia and Vertex struggled through problems in early studies when some patients developed a severe rash. "Vertex tackled it head-on and developed a rash management program’’ to limit the severity of the side effect, said Seamus Levine-Wilkinson, an analyst with Decision Resources.
Jihad Slim, an infectious disease physician at St. Michael’s Medical Center in Newark, said the availability of the new medicines is "the first step on a long road.’’
"There are dozens of other medications in investigational studies right now,’’ he said.
Barr, the Merck executive, said the treatment of hepatitis C is likely to evolve in the same way as HIV medicines. "What we’re working toward is getting new drugs that attack the virus in different places and then we’re going to combine those drugs,’’ he said.
Levine-Wilkinson agreed. "The researchers want to copy the playbook of HIV and hit the (hepatitis C) virus at every step of the life cycle,’’ he said. "That’s why the combination therapies are the focus of everyone.’’
For researchers, Barr said, the brass ring will be to create an all-oral therapy that eliminates the need for interferon, which causes such severe side effects. "The field is working hard in that direction,’’ he said.
For Schumann, the prospect of going through a third round of drugs is as daunting as it is hopeful.
"After two times, it’s hard. I’m trying to mentally psyche myself up,’’ he said. "I feel like it’s a chance to clear this virus out of my body.’’
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