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CDC urges hepatitis tests for baby boomers. Advertisement ... THE PROBLEM WITH HEPATITIS CIS THERE'S NO VACCINATION

Posted by Celine Gounder   The New Yorker

Two years ago, the pharmaceutical company Gilead Sciences paid eleven billion dollars for Pharmasset, a small biotechnology firm based in New Jersey. Pharmasset did not have a single major drug on the market, but the company had developed a drug called sofosbuvir, which promised to do for hepatitis C what protease inhibitors did for H.I.V. in the mid-nineties: transform a hard-to-treat illness into an easily managed disease. The Food and Drug Administration officially approved sofosbuvir, also known by the brand name Sovaldi, last week, six years after it was first synthesized. It is now all but guaranteed to become a blockbuster drug and generate billions of dollars in sales for Gilead.

Hepatitis C, the target of sofosbuvir, is behind what the magazine’s Jerome Groopman described as a “shadow epidemic” of liver disease and cancer: rates of liver cancer are increasing faster than rates for any other type of cancer in the United States. Hepatitis C, which inflames and scars the liver, is thought to account for half of this rise. Worse, up to three quarters of the three million Americans who are infected with hepatitis C are not aware of it. By the time they become symptomatic, they may have been infected for decades. All the while, the hepatitis-C virus has been silently doing its terrible work. About a third of the six thousand Americans who get liver transplants each year now do so as a result of hepatitis C, as the late Lou Reed did.

Hepatitis C is one of a number of viruses that infect the liver. It, along with hepatitis B and D, are transmitted through sex and blood exposure. There is no vaccine for it. In 1998, the Centers for Disease Control and Prevention began recommending screenings for hepatitis C based on risk and exposure. But, because patients don’t always own up to or remember their potential exposures, and because many physicians are embarrassed to ask patients about drug use and sex, the C.D.C. now recommends that all Americans born between 1945 and 1965—the baby boomers, who make up three-quarters of those infected—also be screened. Even so, many clinicians remain reluctant to test patients, because the treatment is so difficult to endure.

The existing treatment regimen involves weekly injections of a substance called interferon combined with other drugs. Interferon is naturally produced by the body to combat viral infections; it’s what makes you feel tired, feverish, and generally miserable when you have the flu. In the treatment of hepatitis C, it boosts the immune system. But the injections have brutal side effects: reduced appetite and hair loss, and, over long periods of time, anemia, fatigue, and depression. If the side effects of interferon don’t sound bad enough, the other drugs often cause more anemia, fatigue, chills, nausea, vomiting, diarrhea, hair loss, and rash.

The months of misery do not guarantee that the patient will emerge cured, either, since some strains of hepatitis C—there are six genotypes—are more responsive to current treatment than others. Because hepatitis C and H.I.V. are transmitted similarly, patients are often infected with both, which further complicates treatment because of toxicities, drug interactions, and difficulties getting the doses right.

Sofosbuvir, on the other hand, is the first hepatitis-C treatment that does not require interferon injections, can be taken simply as a pill with other drugs—like the antiviral ribavirin—and typically works in a fraction of the time of existing treatment cycles. According to Alan Franciscus, the executive director of the Hepatitis C Support Project, a patient-advocacy group that educates patients and clinicians about hepatitis C, “Sofosbuvir has the potential to change the treatment of hepatitis C because of the ease of use—one-pill-a-day therapy, very high cure rates, shorter treatment duration, and fewer side effects.” After enduring his own year and a half of interferon treatment before finally being cured of hepatitis C, “I am a bit envious,” Franciscus admitted.

Sofosbuvir was invented by, and named after, Michael Sofia, the kind of person who daydreams about enzymes metabolizing drugs. Sofia was raised in a rowhouse on the northeastern side of Baltimore. His parents, a barber and a payroll clerk, were both children of Italian immigrants, and born within a block of each other in Baltimore’s Little Italy. Although they instilled an immigrant’s appreciation for education in their three children, who would all go on to work in science, Sofia’s reading skills were so poor as a child that in the fourth grade he was put in a remedial reading class. Sofia credits the nun who taught him with transforming into a “completely different student.”

Sofia eventually enrolled at Cornell and went on to earn his Ph.D. from the University of Illinois, before leaving academia to focus on drug development. Early in his career, at Squibb, he worked on cholesterol-lowering drugs. But he preferred working at small biotech companies, which function more like Internet startups, to Big Pharma. “You have an idea, you discuss it, you make a decision, you move forward,” Sofia explained to me. So, in 2005, Sofia took a risk and joined Pharmasset, then a minor biotech firm.

When Sofia arrived at Pharmasset, the company had already started moving away from the H.I.V.-drug development that it was initially known for, since the market had become saturated with “nucleoside” drugs that worked reliably with manageable side effects. Nucleosides are the building blocks of D.N.A. and R.N.A.; they can be chemically altered to terminate chains of genetic code early, producing something like a defective Lego that can’t be build onto, stopping the growth of the virus. Though this chemistry had been used successfully to treat H.I.V., only a few labs were trying this approach with hepatitis C. Sofia noted that one of the company’s test drugs, PSI-6130, showed activity against hepatitis C.

Sofia realized that any effective hepatitis-C drug not only needed to get into the liver, where the virus was replicating, but stay there, to avoid unintended side effects elsewhere in the body. It is relatively easy to transport a drug to the liver: when you eat or drink something, it is absorbed into the bloodstream by the stomach and intestines, and in turn flows directly to the liver, the body’s metabolic engine. The problem is that, in their active form, nucleoside drugs don’t enter liver cells. Sofia hypothesized that if he could shroud a nucleoside with an “invisibility cloak” to get it into liver cells he could then count on the liver’s enzymes to break down the cloak and activate the drug. Once the cloak has been shed, the nucleoside would be trapped inside, protecting the rest of the body from exposure. “A lot of people were telling me when I had this idea that this is never going to work,” he told me. “People have been trying to do this for a long time, this is a hopeless cause.”

Sofia explicitly engineered sofosbuvir with this and a number of other goals in mind—that the drug would be taken orally, ten times more potent than PSI-6130, and effective against all six genotypes of hepatitis C. Beginning with a modified version PSI-6130, after three years of development, Sofia and his colleagues arrived at sofosbuvir in 2007. What’s remarkable, according to Sofia, is that it was not in fact a happy accident, but a product of explicit engineering. “It does exactly what we designed it to do, which is one of those things that hardly ever happens,” he said.

Sofia’s clinical colleagues at Pharmasset began testing sofosbuvir in human patients between 2010 and 2011. When Pharmasset’s medical advisory group reviewed the data, they realized for the first time that sofosbuvir could potentially treat hepatitis patients without interferon—considered a heresy at the time. Since then, others have conducted larger trials of sofosbuvir—studies named POSITRON, FUSION, FISSION, NEUTRINO, and VALENCE, playing on the idea that sofosbuvir is a nucleotide—which showed that the drug is effective against all six genotypes of hepatitis C, with minimal side effects. Last month, at The Liver Meeting in Washington, D.C., scientists presented studies showing that sofosbuvir could also help cure hepatitis C in harder-to-treat patients, like those who also have H.I.V. or more advanced liver disease. There will be more studies of sofosbuvir to come, including post-marketing trials that will look for previously undetected side effects—as well as research on how sofosbuvir can best be used in combination with other new drugs in the pipeline.

Sofosbuvir does have limits, however. The first genotype of hepatitis C has always been the most difficult to treat, and remains so, even with the advent of sufosbuvir. Most patients infected with that genotype still need a combination of interferon injections and ribavirin, at least until other, new drugs hit the market, which is anticipated to happen in the next year or two. More problematically for the hundred and fifty million people worldwide who suffer from hepatitis C, Franciscus and other advocates are worried that sofosbuvir and other new drugs in the pipeline may be too expensive. Gilead announced that the wholesale cost of sofosbuvir will be a thousand dollars a pill, with the total cost of treatment easily exceeding a hundred thousand dollars per patient. Insurance companies, meanwhile, may only cover treatment for hepatitis-C patients who already have liver damage.

Following the acquisition in 2011, Sofia worked with Gilead for about a year to manage the transition process, a time he doesn’t recount fondly. “When you develop something and you take very personal ownership of it, and see it move on to where you’re no longer involved in a direct way to what’s happening to that drug,” Sofia said, “well, it’s very difficult to go through that.”

Afterward, Sofia and some of his old Pharmasset colleagues started a new company, OnCore BioPharma, to develop cures for hepatitis B. Hepatitis B is another leading cause of liver cancer, and is far more transmissible from mother to child, during pregnancy and birth, than hepatitis C; many who succumb to hepatitis B were infected as infants. Currently, we only have drugs that suppress hepatitis B, but you may have to take them for the rest of your life to keep the virus in check.

I asked Sofia what he’d be calling his next drug. “I consider myself very lucky to have one drug, he replied. “When I was doing undergraduate research at Cornell, I was told that I had to be comfortable with failure because eighty per cent of what you’re going to do is going to fail.”

Celine Gounder is a physician, public-health specialist, and medical journalist.

Photograph: David Paul Morris/Bloomberg via Getty

James Cavallini/Science Source

The Food and Drug Administration is expected any day now to approve the first in a new class of drugs that can cure the leading cause of liver failure and liver cancer.

The disease is hepatitis C, a slow-moving but deadly virus that infects more than 3 million Americans. The new treatment is a once-a-day pill that can cure at least 85 percent of victims without the need for injections of interferon, an immune stimulant that causes severe side effects.

The advent of interferon-free treatments for hepatitis C is an advance that's "about as hot as I've ever seen," says Dr. David Thomas, a liver specialist at Johns Hopkins University.

He says the new drugs are almost like curing lung cancer with only three months of once-a-day pills.

"That's kind of an exaggeration because lung cancer treatment is worse than what we used to do (to treat hepatitis C)," Thomas says. "But it's that kind of thing — where we did something that didn't work that much and hurt people a lot. And then we go from that to something that's ... really an amazing transformation."

The first of the new hepatitis C drugs is Gilead Science's sofosbuvir. It interferes with the virus' replication without much affecting cell metabolism. The drug won a unanimous recommendation for approval from of an FDA advisory committee last October for interferon-free treatment of two strains of the virus, in combination with the oral drug ribavirin. Agency approval is expected by Dec. 8.

The advisory panel also recommended approval of sofosbuvir for treatment of the most common and difficult-to-treat strain of hepatitis C, called genotype-1. But in that case, it needs to be used with interferon.

But other new hep-C drugs are in the pipeline, with approvals expected in late 2014 or early 2015. Some regimens may enable treatment of genotype-1 without interferon too.

"This is really a landmark shift in the treatment of hepatitis C," says Dr. Eric Lawitz of the Texas Liver Institute. "It's going to lead to a new generation of all-oral pills for all patients without the use of interferon, which is very tough for patients to take."

One of Lawitz's patients illustrates the potential. Over the past eight years, Henry Alameda, a 54-year-old carpenter who lives in San Antonio, endured two grueling six-month treatment regimens that failed to clear the virus from his blood. He thinks he was infected 20 years ago from the contaminated needle of an amateur tattoo artist.

The interferon side effects were hard to take. It's "like waking up with a bad cold," he says. "You would have to get under the blanket and you would start shaking. You would get real bad chills." Interferon, which is intended to get patients' immune systems to attack the virus, also commonly causes fatigue, nausea, diarrhea, anemia and depression.

Two years ago Alameda got into a study of sofosbuvir in combination with ribavirin. "It was like a miracle pill," he says. "It was just like taking an aspirin. I had no side effects at all." Some study patients have had headaches, fatigue, nausea, itching and weakness, but few have had to stop taking the pills because of side effects.

The new regimen worked for Alameda. Fifteen months after he finished taking the pills, there's no trace of the virus in his blood. Doctors have pronounced him cured.

The safety, effectiveness and low rate of side effects from the new regimens are expected to increase the number of hepatitis C patients who get treatment, although many doctors may hold off until other drugs are approved and combinations are tested in different types of patients.

The potential impact is huge. Hepatitis C infects up to five times as many people as HIV – another insidious virus that takes years to cause life-threatening disease. The U.S. Preventive Services Task Force says all Americans born between 1945 and 1965 should get tested for the infection – a population that includes 79 million baby boomers.

Thomas says the new treatments are coming at just the right time. Many baby boomers got infected decades ago – by experimenting with drug use, from blood transfusions or medical treatments that exposed them to contaminated blood, from things like tattoos and piercings. The virus can be transmitted sexually as well, although the evidence is controversial.

Now an increasing number of infected people are beginning to show signs of liver damage. Untreated, the virus causes progressive liver scarring and eventually cirrhosis that can require liver transplants. It's also the reason that liver cancer rates are increasing. Alcohol use greatly accelerates the damage.

But the new drugs won't come cheap. The price of sofosbuvir hasn't been set, but it's expected to cost around $90,000 for a course of treatment.

That's going to spark a lot of debate about who should be treated at what stage of infection.

But Johns Hopkins' Thomas says society should consider the cost of forgoing treatment. "If we fail to provide treatment to an expanding population of persons at risk of cirrhosis and liver cancer, then we'll have even greater costs," he says. "And they won't all be economic."

World News | November 27, 2013

Lynne Taylor



The upcoming US market launches of two new hepatitis C virus (HCV) treatments will result in current triple- and dual-therapy regimens losing considerable market share, according to new research from BioTrends Research Group.  



Related LinksUS docs hold back patients until new HCV drugs arrive Following the launches of Gilead’s sofosbuvir and Janssen/Medivir’s simeprevir, the currently-marketed triple-therapy regimens based on Vertex’s Incivek (telaprevir) and Merck & Co’s Victrelis (boceprevir), and dual-therapy HCV regimens, will lose market share to these new arrivals, says the study.

 

When asked about treatment practices in the next six months, physicians surveyed for the study reported that they plan to treat 17% of their genotype 1 and 21% of their actively-treated genotype 2/3 HCV patients with a sofosbuvir- and/or simeprevir-containing regimen.

 

The study also finds that the majority of surveyed US physicians report, unaided, that they are currently “warehousing” HCV patients in anticipation of new therapies, with nearly 30% of this warehousing specifically attributed to waiting for access to sofosbuvir/polymerase inhibitors. 

 

While most surveyed physicians said that they are warehousing treatment-naive and treatment-experienced patients as they wait for the approval of simeprevir, sofosbuvir and/or other interferon-free therapy options, only 12% of surveyed physicians indicated that they are satisfied with currently-approved therapies, it adds.

 

“In anticipation of availability of new directly-acting antivirals, the shift in the HCV treatment paradigm is already apparent,” said BioTrends Research Group analyst Sandra Renz.

 

“With the imminent approval of simeprevir and sofosbuvir – agents offering potentially shorter treatment duration, possible interferon-free regimens, improved safety and tolerability profiles and higher cure rates – physicians are eagerly awaiting these new regimens and holding off on prescribing treatment until they are part of the arsenal,” she added.

 

The study also finds that at least one-third of surveyed physicians have received a patient request for one of the currently-available HCV brands in the past month. Further, a subset of surveyed doctors has already received patient requests for sofosbuvir and simeprevir, suggesting that awareness of these products exists among patients even ahead of their anticipated US launch later this year, it adds.