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The U.S. Food and Drug Administration has approved two new drugs - boceprevir and telaprevir - to treat hepatitis C, a virus that can cause liver damage and cancer. The new drugs are expected to improve cure rates for some of the more than 170 million people worldwide affected by this potentially fatal disease. Hepatitis C is a blood-borne virus. If blood is not screened for diseases, the virus can be transmitted through transfusions or organ transplants. In the United States, the most common cause of infection is sharing drug-injection needles.
It can take years, or even decades, for the virus to cause enough liver damage to produce symptoms and about three-quarters of Americans with hepatitis C dont know they have it. People got their hepatitis C in the 60s and 70s, and early 80s, and now are having all these problems from it, 20 or 30 years later, says liver disease specialist Dr. Bruce Bacon of Saint Louis University, adding that about 20 percent of people exposed to hepatitis C recover from the virus on their own, without treatment. The flip side of that is about 80 percent of people - 80, 85 percent of people - do get chronic hepatitis. And of those patients, 20 to 30 percent of people develop cirrhosis, and of those, two to three percent of patients develop liver cancer.
There are six different strains, or genotypes, of hepatitis C. Saint Louis University researcher Dr. Adrian Di Bisceglie says that, in the U.S., about 70 percent of patients have genotype 1, a form of the virus that is also the most common in Latin America, Europe, and parts of Asia. And it turns out that genotype 1 is the most hard to treat, he says. For the past decade, treatment for hepatitis C has meant a year-long regimen of two drugs: an immune-system booster called pegylated interferon and an antiviral medication known as ribavirin.
But often, Di Besceglie says, that two-drug treatment hasnt worked for patients with the genotype 1 virus. In that genotype, only about 40 percent of patients get cured when theyre treated with interferon and ribavirin. In a clinical trial funded by the drug maker Vertex, Di Besceglie helped test how hard-to-treat genotype 1 patients responded when a new Vertex drug, telaprevir, was added to the current two-drug treatment. The cure rates or the rates of sustained virologic response go from the 40 percent number that I mentioned in patients with genotype 1, to 75 percent. A clinical trial for a similar medication, boceprevir, was funded by Merck, the drugs developer.
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Medical experts are calling for global action to tackle the viruses that cause the liver disease hepatitis. The first worldwide estimates in drug users show 10 million have hepatitis C while 1.3 million have hepatitis B. Writing in the Lancet, experts say only a fraction of those who could benefit are receiving antiviral drugs. Only one in five infants around the world are vaccinated against hepatitis B at birth, they say.
The figures, published in the Lancet, show about 67% of injecting drug users in the world have been exposed to hepatitis C, while around 10% have come into contact with hepatitis B. In the UK, around half of injecting drug users have been infected with the hepatitis C virus, while the rate for exposure to hepatitis B is 9% - the highest in western Europe.
The research was led by Prof Louisa Degenhardt of the Centre for Population Health, Burnet Institute, Melbourne, Australia, and Paul Nelson from the National Drug and Alcohol Research Centre at the University of New South Wales. They say: "The public-health response to blood-borne virus transmission in injecting drug users has mainly centred on HIV. "Maintenance and strengthening of the response to HIV in injecting drug users remains crucial, but the significance of viral hepatitis needs to receive greater attention than it does at present."
Commenting on the study in the Lancet, Dr Joseph Amon, of Human Rights Watch, New York City, US, said: "This study provides us with a first step and powerful data to draw attention to the problem of viral hepatitis in people who use drugs. "The next step is to challenge governments to act, and hold them accountable for implementation of rights-respecting and evidence-based programmes."
Health risks
Those born between 1945-1965 are most likely to be infected but it is thought only a quarter of this generation has been tested for the virus. The US Centers for Disease Control (CDC) believes its campaign could save more than 120,000 lives. The CDC estimates some 17,000 hepatitis C infections currently occur each year. Health officials believe hundreds of thousands of infections occurred each year in the 1970s and '80s, when baby boomers would have been young adults.
The disease, which was first identified in 1989, can take decades to cause liver damage. Many of those infected may not even be aware of their condition. One reason for the CDC advice is that from 1999-2007 the number of Americans dying from hepatitis C-related diseases nearly doubled. Two million of the 3.2 million Americans known to be infected with the blood-borne virus are baby boomers.
CDC officials believe new testing could lead to 800,000 more baby boomers seeking treatment. Many infections of hepatitis C come from sharing needles to inject drugs. Before widespread screening began in 1992, it was also transmitted through blood transfusions. "The CDC views hepatitis C as an unrecognised health crisis for the country, and we believe the time is now for a bold response," said Dr John Ward, the CDC's hepatitis chief.
BBC News - US baby boomers urged to take hepatitis C blood test
Scientists have long been experimenting with the 3D printing of cells and blood vessels, building up tissue structure layer by layer with artificial cells. But the synthetically engineered cells often die before the tissue is formed. The technology, in which a 3D printer uses sugar as its building material, could one day be used for transplants. The study appears in the journal Nature Materials.
Dr Jordan Miller from the lab of the lead scientist, Dr Christopher Chen, at the University of Pennsylvania, told BBC News: "The big challenge in understanding how to grow large artificial tissue is how to keep all the cells alive in these engineered tissues, because when you put a lot of cells together, they end up taking nutrients and oxygen from neighbouring cells and end up suffocating and dying," he said. The body's cardiovascular system - blood vessels - solves this issue with natural cells and tissues.
So a group of scientists from the University of Pennsylvania and the Massachusetts Institute of Technology (MIT) decided to build a synthetic vascular system that would serve the same purpose - by creating a place where the future artificial blood vessels would be located. Dr Miller's colleague Prof Sangeeta Bhatia, from MIT, said that the technique was similar to creating the shape of a vase in wax, surrounding it with molten metal and then melting the wax away.
Sugar use
But instead of wax, the team used sugar. "So far, it's been difficult to make organs big enough so that they could provide useful function - and if you implant any tissue thicker than about a millimetre, we can't provide it enough without also engineering blood vessels into the tissue," said Prof Bhatia. "We created a network of places that we wish vessels to grow into, so they would become piping into the tissue, and we printed those in 3D out of sugar.
More BBC News - 3D-printed sugar network to help grow artificial liver
A study in injecting drug users in Greece indicated that each infected person spread the disease to 20 others - 10 of these in the first two years. The researchers said their results would help tackle the disease's spread. Globally up to 180 million people live with the virus, most are unaware that they have it. Those infected do not develop symptoms for up to 20 years and spread it to others without realising. Study leader Dr Gkikas Magiorkinis, from Oxford University, said when people were infected with something such as flu it was very easy to work out where it had come from, because people knew they were infected within days. But with hepatitis C, no-one has been able to pin down how the virus spreads, because cases occur months or years apart.
Genetic signature
To overcome this problem, the researchers looked at four hepatitis C epidemics in Greece, using data from 943 patients collected between 1995 and 2000. But to provide more detail on how it spreads, they also included genetic information on the virus taken from 100 samples. Plugging the details into a computer model, they calculated that injecting drug users were "super-spreaders", each transmitting the virus to 20 other people. Most importantly they discovered that most of the transmissions occurred in the first couple of years, they report in PLoS Computational Biology. The researchers said that people were more infectious at in the early days of catching hepatitis C because they had higher levels of virus. The evidence they have produced suggests programmes targeting the diagnosis and treatment of hepatitis C in high-risk groups as early as possible would prevent many new infections and associated health care costs many years down the line.
About 20% of those infected will develop cancer or liver scarring after 20 years of infection, at which point the only treatment is liver transplantation, which costs about £100,000 ($160,000). Dr Magiorkinis, who did the work in collaboration with the University of Athens and Imperial College London, said the model had helped build a "solid argument" to improve early diagnosis and antiviral treatment in drug users. "Working out how many people are likely to be infected by each super-spreader of Hepatitis C, as well as how soon they will be infected, has been a puzzle for over 20 years," he said. "Our research has resolved this issue and paves the way for a modelling study to show what kind of public health interventions could really make a difference." He added the approach could be useful in other infections such as HIV.
Charles Gore, chief executive of The Hepatitis C Trust and president of the World Hepatitis Alliance, said: "This study is potentially very important. "If we are better able to identify where the majority of transmission is happening in many Western countries, we will be able to improve and more cost effectively target interventions. "It needs to be said, however, that globally hepatitis C is not 'a drug users' disease. "Of the 150 million people living with the virus, only about 10 million are people who inject drugs, according to The Lancet. The vast majority of infections are the result of unsafe healthcare and we equally need to target prevention there."
BBC News - Spread of hepatitis C pinpointed
Furthermore, the department said Dr. Raymond Schinazi, a former VA researcher officials previously claimed invented the drug alternately known as Sofosbuvir or Sovaldi, did not do so. "Our review of Dr. Schinazi's work indicates that VA has no financial right to this drug. Dr. Schinazi was not the inventor nor does he hold the patent on the drug. Therefore, VA has no ownership rights," VA spokeswoman Ndidi Mojay told Military.com on Thursday. The drug has been used to cure tens of thousands of veterans of the disease. The treatment regimen last about 12 weeks and costs the VA an average of $40,000 per veteran, officials have told Congress.
House lawmakers' anger over treatment costs when the VA claimed to have a role in developing the drug led the department to review what, if any, ownership rights it might have. Under a technology transfer program, the VA can declare an interest on inventions it helps develop, with a percentage of commercial sales going into VA coffers for continued research. In January, Rep. Jeff Miller, R-Florida, denounced Gilead Sciences of California, the company that has reaped billions in sales of the drug, noting it charges only about $900 for the same course of treatment for which the VA pays $40,000. "Gilead's tone-deaf pricing strategy also fails to take into account the fact that without the Department of Veterans Affairs, the drug at the center of this debate would not even exist," Miller said in an op-ed posted on CNN, adding that the drug "was invented by a team led by a VA doctor, who sold the company" to Gilead.
Raymond Schinazi
The VA in the past has played up Schinazi's role as a VA researcher, and in 2015 presented him the Middleton Award, the top honor given by VA Biomedical Laboratory Research and Development, for his development of drugs to treat hepatitis infections as well as HIV. The VA statement on Thursday that it had no part in the drug's development is consistent with what Schinazi told Military.com in early February. He said the work all was done at Pharmasset, his own research laboratory, which he operated while he also worked for the VA in Atlanta and Emory University. In 2011 he sold Pharmasset -- and with it the drug -- to Gilead in a deal that netted him more than $400 million. As for the drug itself, Schinazi told Military.com on Thursday that he never claimed to be its inventor.
Ownership will eventually be decided by a court, he said, because it has been the subject of a lawsuit for several years. Miller invited several VA officials to testify to his committee on the drug in early February, but Schinazi was a no-show. He put in for retirement the same day that Miller's committee invited him, Under Secretary for Health Dr. David Shulkin and others to testify, and it took effect on Feb. 1, two days before the hearing. Schinazi told Military.com he was never made aware of the hearing. "I never received the letter or was asked by the VA to attend this meeting," he wrote last month in an email. "I decided to retire from the VA well before all this. My labs are now based at Emory University and I am now 65 years old."
VA Concedes It Had No Role in Developing Hepatitis 'Miracle Drug' | Military.com
Navy Adm. Kurt Tidd, head of U.S. Southern Command, said both were men and that it was "a fairly straightforward procedure" to recover from the virus. He said the service members remained in the region -- one was in Brazil and the other was in Colombia. Tidd also said that one woman service member who is pregnant was transferred out of the region as a precaution. The Zika virus is spread by mosquitoes, much like other tropical viruses, including dengue. The World Health Organization has declared that the spread of Zika in the Americas a global emergency. The virus is linked to a spike in the number of babies born with abnormally small heads and the rise in a rare neurological syndrome that can cause paralysis and death.
A screengrab from a U.S. Navy instructional video on preventing the Zika virus.
In other comments Thursday, Tidd said that rough estimates suggest that there are 100-150 Islamic State militants across his region, although officials in some countries say it could be higher than that. "We need to recognize that radicalization within our region is occurring," said Tidd, who took over the Southern Command about two months ago. "There is general, broad agreement that this is a problem that we all have to pay attention to, and that we are all going to have to share information much more effectively than we might have been willing to in the past."
He said that in many cases fighters in the region are traveling overseas to join the Islamic State battle in countries like Iraq or Syria. But there also are concerns about lone wolf extremists who may stay in the region and conduct attacks there. So far, he said, officials have tracked a number of potential threats, but none have borne out. Asked about the upcoming summer Olympic Games in Brazil, Tidd said that there have been not yet been any specific threats, but officials are planning to work together and share information as needed.
2 US Military Members Get Zika Virus; Both Recovered | Military.com
The Food and Drug Administration approved the combination pill from Gilead Sciences for patients with and without liver damage. The agency has approved a number of hepatitis C drugs in the last three years but all were targeted to specific strains of the virus or patients with various stages of liver disease.
Epclusa, the new pill from Gilead Sciences, combines the company's first hepatitis drug, Sovaldi, with a new drug that attacks the virus using a different mechanism.
Gilead's hepatitis pills have raked in billions of dollars by replacing an older approach that involved a grueling pill-and-injection cocktail.
News from The Associated Press
It is said by all articles that Hepatitis C comes from food and water. Eating 'bad' food and/or drinking 'bad' water can lead to Hepatitis C. My kitchen sink's faucet water smells like 'fish and tastes like fish'. I guess it's bad tap water. If I continued drinking the tap water from my kitchen, it could have resulted in me getting Hepatitis C. The same applies to food. My solution? I began having home delivered 'bottled water' jugs to be delivered to my address. A large water dispenser and 5 gallon water jugs, to throw the 5 gallon distilled water jug onto does much better for me that smelling fish in my tap drinking water, if I did not get this. The 5 gallon distilled water is 8 dollars.. Check this out. 5 gallons equate to 640 fl. ounces. A cup is 8 fl.oz. If you have a measuring cup at home, you will know how much water is 1 cup. Doctors recommend drinking 8-8 fl. oz. of water daily so basically they are saying that drinking 64 fl. oz. of water daily is good. So if you take a regular 12 fl oz Pepsi soda bottle as a quick refreshment, 64 fl.oz would equal 5.3 of those Pepsi bottles. So basically, they are saying to drink 5.3 'pepsi bottles' of water daily.New meds for Hep C...
New Drugs Promise Higher Cure Rates for Hepatitis C
June 10, 2011 - Medications recently approved for use in the US
The U.S. Food and Drug Administration has approved two new drugs - boceprevir and telaprevir - to treat hepatitis C, a virus that can cause liver damage and cancer. The new drugs are expected to improve cure rates for some of the more than 170 million people worldwide affected by this potentially fatal disease. Hepatitis C is a blood-borne virus. If blood is not screened for diseases, the virus can be transmitted through transfusions or organ transplants. In the United States, the most common cause of infection is sharing drug-injection needles.
It can take years, or even decades, for the virus to cause enough liver damage to produce symptoms and about three-quarters of Americans with hepatitis C dont know they have it. People got their hepatitis C in the 60s and 70s, and early 80s, and now are having all these problems from it, 20 or 30 years later, says liver disease specialist Dr. Bruce Bacon of Saint Louis University, adding that about 20 percent of people exposed to hepatitis C recover from the virus on their own, without treatment. The flip side of that is about 80 percent of people - 80, 85 percent of people - do get chronic hepatitis. And of those patients, 20 to 30 percent of people develop cirrhosis, and of those, two to three percent of patients develop liver cancer.
There are six different strains, or genotypes, of hepatitis C. Saint Louis University researcher Dr. Adrian Di Bisceglie says that, in the U.S., about 70 percent of patients have genotype 1, a form of the virus that is also the most common in Latin America, Europe, and parts of Asia. And it turns out that genotype 1 is the most hard to treat, he says. For the past decade, treatment for hepatitis C has meant a year-long regimen of two drugs: an immune-system booster called pegylated interferon and an antiviral medication known as ribavirin.
But often, Di Besceglie says, that two-drug treatment hasnt worked for patients with the genotype 1 virus. In that genotype, only about 40 percent of patients get cured when theyre treated with interferon and ribavirin. In a clinical trial funded by the drug maker Vertex, Di Besceglie helped test how hard-to-treat genotype 1 patients responded when a new Vertex drug, telaprevir, was added to the current two-drug treatment. The cure rates or the rates of sustained virologic response go from the 40 percent number that I mentioned in patients with genotype 1, to 75 percent. A clinical trial for a similar medication, boceprevir, was funded by Merck, the drugs developer.
MORE
Incorrect.It is said by all articles that Hepatitis C comes from food and water.
Globally, an estimated 400 million people are infected with Hepatitis B and C. That is more than 10 times the number of people infected with HIV. Despite that, the WHO says about 1.45 million people die each year from the disease. The WHO calls Hepatitis a silent killer because of a lack of awareness. As a consequence, people do not get tested or treated for the preventable disease, which is largely prevalent in sub-Saharan Africa and Asia. Hepatitis B and C infections are transmitted through contaminated blood, as well as through dirty needles among people who inject drugs. Over time, the infection damages the liver and people die from cirrhosis or cancer.
A patient with hepatitis is treated at a hospital in El Sereif village, North Darfur, Sudan
The head of the WHO’s global hepatitis program, Stefan Wiktor, says good tools are available to prevent and treat the needless deaths. He tells VOA a great vaccine exists for Hepatitis B, which can be transmitted from an infected mother to her newborn child. “It is part of the childhood immunization schedule," said Wiktor. "More than 82 percent of children in the world get it. So, they are protected from Hepatitis B. So, we have seen tremendous results in many countries, especially in Asia.” Although a dose of the vaccine only costs 17 cents, Wiktor says it is logistically more difficult for people in low-income countries in Africa to access the vaccine, so fewer children become inoculated. He says governments must make a greater effort to make the vaccines available.
A new class of medicines developed in 2013 has revolutionized the treatment for people with Hepatitis C, 90 percent of whom can be cured. The price of the drug is $84,000 in rich countries; but, prices have dropped dramatically, to about $200 a treatment, in countries that have access to generic drugs. Most generics are being produced in India. Governments at this year’s World Health Assembly adopted the first ever Global Health Strategy to reduce new viral hepatitis infections by 90 percent and the number of deaths by 65 percent by 2030. Wiktor says 7 million deaths could be prevented by 2030.
Generic drugs for Hepatitis C have dropped the price of life-saving medicine from $84,000 to $200
Knowingly transmitting a dangerous virus may sound drastic but two leading transplant centers are betting the strategy will save lives — if new medications that promise to cure hepatitis C allow use of organs that today go to waste. Pilot studies are under way at the University of Pennsylvania and Johns Hopkins University to test transplanting kidneys from deceased donors with hepatitis C into recipients who don't already have that virus. If the research eventually pans out, hundreds more kidneys — and maybe some hearts and lungs, too — could be transplanted every year. "We always dreaded hepatitis C," said Dr. Peter Reese, a Penn kidney specialist who is helping lead the research. "But now hepatitis C is just a different disease," enough to consider what he calls the tradeoff of getting a new kidney years faster but one that comes with a hopefully treatable infection.
It's a tradeoff prompted by the nation's organ shortage. More than 99,000 people are on the national kidney waiting list but only about 17,000 people a year get a transplant and 4 percent a year die waiting, according to the United Network for Organ Sharing (UNOS). "If we had enough organs, we wouldn't do this," said Dr. Niraj Desai, who is leading the Hopkins study. But, "most patients are pretty open to the idea once they hear what the alternatives are." Doctors had told Irma Hendricks, 66, to expect at least a five-year wait for a kidney transplant. Dialysis three times a week was keeping the East Stroudsburg, Pennsylvania, woman alive but left her with no energy for even routine activities. "I call it the zombie syndrome," she said.
HealthBeat Kidney Transplants Hepatitis C: Irma Hendricks has blood drawn at the Hospital of the University of Pennsylvania in Philadelphia, on Oct. 6, 2016. Hendricks received a kidney transplant from a donor with hepatitis C, and took medications after surgery that cleared away the virus and left her feeling healthy again. Hendricks is part of a pilot study testing if new drugs that promise to cure most hepatitis C could allow use of organs that today go to waste, and speed transplants to people who might otherwise die waiting.
So she jumped at the chance to enroll in Penn's study, even though doctors made clear they hoped for but couldn't guarantee a hepatitis cure. "My son said, 'Mom, this is a no-brainer. Just do it,'" Hendricks said, She swallowed an anti-hepatitis pill daily for three months, in addition to the usual post-transplant medications. Testing showed the drugs rapidly cleared hepatitis C out of her bloodstream. And with her new kidney functioning well, she now has enough energy to play with her toddler grandson. "This is giving people in my situation new hope," Hendricks said.
Kidney transplant specialists are closely watching the research. "It makes sense to me," said Dr. Matthew Cooper, a transplant surgeon at MedStar Georgetown University Hospital, who is not involved in the research. He cautioned that the studies should use only kidneys that are young and otherwise high-quality, and that patients must understand the risks. "They need to know you place their safety as the highest priority," Cooper said. "But at the same time, recognize that we have these obstacles. We don't want people to die on dialysis and there are not enough organs available for everybody."
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