The China and Taiwan Food and Drug Administrations have accepted clinical trial applications filed by Ascletis Innovation for its interferon-free regimen to treat chronic hepatitis C virus infection, according to a press release
Ascletis is the first Chinese company to file clinical trial applications in China for an IFN-free regimen, according to the release, and will initiate a phase 2 trial in Taiwan. The trial will include a combination regimen of Danoprevir (ASC08), a direct-acting antiviral agent and NS3/4A inhibitor, and Ravidasvir (ASC16), an NS5A inhibitor.
“All oral IFN-free regimens are breakthrough treatments of [chronic hepatitis C] marketed outside China at the end of 2014. To date, there are no DAAs approved in China,” Zhuang Hui, MD, academician of the Chinese Engineering Academy and the honorary Chairman of the Chinese society of Hepatology at Peking University Health Science Center, said in the release. “We're very pleased that Ascletis is developing the first IFN-free regimen by a domestic company for [chronic hepatitis C] in China. It shows that the domestic pharmaceutical companies are now catching up with the global development for [chronic hepatitis C].”
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Monday, August 31, 2015
Eliminating Hepatitis C Means Treating Prisoners
Barry Michaelson is one of several people with hepatitis C who have sued this year to get access to new and very expensive treatments for the virus. But Michaelson’s lawsuit, unlike most of the others, isn’t against his insurance company. He’s suing the Minnesota Department of Corrections.
In May, Michaelson and another inmate filed a class-action lawsuit on behalf of Minnesota prisoners to gain access to new, highly effective drugs for hepatitis C, a virus that’s now essentially curable but can cause cirrhosis, liver failure and cancer if left untreated. In the weeks since, similar lawsuits have been filed by inmates in Pennsylvania and Massachusetts.
It wasn’t until 1992 that we could even test for the hepatitis C virus (HCV). Now we effectively have a cure, but at about $84,000 a person, it’s one of the most expensive drugs to ever hit the market. Insurers, including Medicaid and Medicare, are paying for treatment only for people with advanced liver disease in most cases, causing experts to push the White House to expand treatment. But prisoners, though they are the only group in the U.S. with a constitutional right to health care, are even more limited in access to treatment.
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In May, Michaelson and another inmate filed a class-action lawsuit on behalf of Minnesota prisoners to gain access to new, highly effective drugs for hepatitis C, a virus that’s now essentially curable but can cause cirrhosis, liver failure and cancer if left untreated. In the weeks since, similar lawsuits have been filed by inmates in Pennsylvania and Massachusetts.
It wasn’t until 1992 that we could even test for the hepatitis C virus (HCV). Now we effectively have a cure, but at about $84,000 a person, it’s one of the most expensive drugs to ever hit the market. Insurers, including Medicaid and Medicare, are paying for treatment only for people with advanced liver disease in most cases, causing experts to push the White House to expand treatment. But prisoners, though they are the only group in the U.S. with a constitutional right to health care, are even more limited in access to treatment.
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14 million EU citizens living with Hepatitis C; low figures for Malta
There are currently around 13.3 million Europeans living with hepatitis B and 14 million living with hepatitis C, MEP Miriam Dalli pointed out in a question posed to the European Parliament.
“Approximately 120,000 people in Europe every year die because of these diseases.”
In Malta, the number of cases did not seem high in 2013, with 3.3 people per 100,000 being reported as having been infected that year. The number in other states is considerably higher such as in the UK, where the number stood at 21.5 per 100,000 people (nearly 14,000 in total that year).
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Sunday, August 30, 2015
Guest commentary: Perplexed by governor's veto of hepatitis C bill
The governor recently vetoed Senate Bill 661, which is a cost-saving measure intended to save lives by requiring doctors to offer adults born between 1945 and 1965 a one-time screening test for hepatitis C. As the chairman of the Senate Committee on Public Health, I am perplexed by the reasons given for governor's veto and his unwillingness to reach a compromise or an alternative, other than an outright veto.
One of the primary concerns the governor had was that this measure would change a doctor's standard of care with respect to these patients, but I disagree. The Medical Society, the Centers for Disease Control and every doctor who testified before the Senate Public Health Committee all agreed that doctors should be offering the one-time screening test; however, some doctors are not following their own guidelines. This bill would codify the medical community's current guidelines and recommendations.
I also disagree with the governor's assertion that this bill will cost the state more money. The offer to screen a patient does not cost a dime. Additionally, if a patient accepted a doctor's offer to be screened, the current cost of screening is covered by all forms of insurance, including Medicaid. The cost of the screening test is around $10-$20 per test.
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One of the primary concerns the governor had was that this measure would change a doctor's standard of care with respect to these patients, but I disagree. The Medical Society, the Centers for Disease Control and every doctor who testified before the Senate Public Health Committee all agreed that doctors should be offering the one-time screening test; however, some doctors are not following their own guidelines. This bill would codify the medical community's current guidelines and recommendations.
I also disagree with the governor's assertion that this bill will cost the state more money. The offer to screen a patient does not cost a dime. Additionally, if a patient accepted a doctor's offer to be screened, the current cost of screening is covered by all forms of insurance, including Medicaid. The cost of the screening test is around $10-$20 per test.
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Saturday, August 29, 2015
When US, UK doctors refuse to prescribe Indian drugs, it reeks of racism
Greg Jefferys, a 61-year-old historian and author from Australia, hit international headlines when he flew to Chennai to use generic sofosbuvir to successfully cure himself of Hepatitis C. He spent 1/100th — just about $1000 — the amount it would have cost him if he were to use the patented version. Jefferys has since helped hundreds of patients access the medicine cheaply from here. Talking to Rema Nagarajan, Jefferys strongly criticises big pharma and the patent regime that is putting life-saving medicines beyond the reach of patients and allowing companies to make 'obscene profits'
Did you have concerns regarding the safety and quality of the Indian Sofosbuvir?
I have no concerns about Indian generics generally. In all areas of the world, there are issues of quality control and there are good companies and not-so-good companies. India has some of the largest and best pharmaceutical manufacturers in the world. I actually get really angry when doctors in the UK or the US refuse to prescribe life-saving drugs because they are made in India. It reeks of racism or post-colonial arrogance! Did you know that I have had dozens of emails from people in the UK with hep C who have tried to get a prescription for Indian Sofosbuvir and not one doctor in all of the UK would write it for these people. But I have had two prescriptions for Indian Sofosbuvir from the UK. One was from a doctor who had hep C himself and the other was from a doctor whose best friend had hep C. None other than that! It astounds me. Tens of thousands of people in the UK are suffering and dying simply because their GPs refuse to write them a prescription for Indian generic medicines!
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Did you have concerns regarding the safety and quality of the Indian Sofosbuvir?
I have no concerns about Indian generics generally. In all areas of the world, there are issues of quality control and there are good companies and not-so-good companies. India has some of the largest and best pharmaceutical manufacturers in the world. I actually get really angry when doctors in the UK or the US refuse to prescribe life-saving drugs because they are made in India. It reeks of racism or post-colonial arrogance! Did you know that I have had dozens of emails from people in the UK with hep C who have tried to get a prescription for Indian Sofosbuvir and not one doctor in all of the UK would write it for these people. But I have had two prescriptions for Indian Sofosbuvir from the UK. One was from a doctor who had hep C himself and the other was from a doctor whose best friend had hep C. None other than that! It astounds me. Tens of thousands of people in the UK are suffering and dying simply because their GPs refuse to write them a prescription for Indian generic medicines!
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One in four patients with HCV denied initial request for treatment
A new study published in PLoS ONE showed that one in four patients with hepatitis C virus infection who apply for treatment of the infection is initially denied.
“Delay in access may further challenge our ability to cure hepatitis C in this country,” Joseph K. Lim, MD, associate professor of medicine and director of the Yale Viral Hepatitis Program at Yale University, said in a press release. “Some patients are told they must wait until they have advanced liver disease before they can undergo potentially curative treatment. We hope these data may help inform national policy discussions on promoting more rational, patient-centered approaches to HCV treatment access.”
“This is the first study to our knowledge assessing real-world access to interferon-free [direct-acting antiviral] regimens in established cohorts of patients with chronic HCV seeking antiviral therapy,” the researchers wrote. “These results contribute to the limited data available addressing proportion of patients successfully obtaining drug authorization through public and private insurance carriers, time to approval, and predictors for approval. … Further studies are warranted to investigate the impact of evolving drug authorization policies by Medicare/Medicaid and private payers on access to curative HCV therapies such as [sofosbuvir and ledipasvir].” – by Melinda Stevens.
Do A, et al. PLoS One. 2015;doi:10.1371/journal.pone.0135645.
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“Delay in access may further challenge our ability to cure hepatitis C in this country,” Joseph K. Lim, MD, associate professor of medicine and director of the Yale Viral Hepatitis Program at Yale University, said in a press release. “Some patients are told they must wait until they have advanced liver disease before they can undergo potentially curative treatment. We hope these data may help inform national policy discussions on promoting more rational, patient-centered approaches to HCV treatment access.”
“This is the first study to our knowledge assessing real-world access to interferon-free [direct-acting antiviral] regimens in established cohorts of patients with chronic HCV seeking antiviral therapy,” the researchers wrote. “These results contribute to the limited data available addressing proportion of patients successfully obtaining drug authorization through public and private insurance carriers, time to approval, and predictors for approval. … Further studies are warranted to investigate the impact of evolving drug authorization policies by Medicare/Medicaid and private payers on access to curative HCV therapies such as [sofosbuvir and ledipasvir].” – by Melinda Stevens.
Do A, et al. PLoS One. 2015;doi:10.1371/journal.pone.0135645.
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Friday, August 28, 2015
Children as young as 10 are getting tattoos illegally, without realising they risk catching HIV and hepatitis
Children as young as 10 are getting tattoos, shocking new figures have revealed.
A worrying number of youngsters are visiting illegal tattoo parlours, unaware it is against the law for them to be inked before they are 18.
And half admitted to being unaware of the risk of infection from HIV and hepatitis.
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A worrying number of youngsters are visiting illegal tattoo parlours, unaware it is against the law for them to be inked before they are 18.
And half admitted to being unaware of the risk of infection from HIV and hepatitis.
Read more....
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