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Week Ending: December 29th, 2007
Alan Franciscus
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December 22nd, 2007
Michigan voters likely will decide whether to legalize medical marijuana in November
http://www.battlecreekenquirer.com
The LansingState Journal
Lynn Allen is in a great deal of pain. And he thinks marijuana would ease it.
The 51-year-old Williamston man was born with hemophilia and was infected with HIV and hepatitis C more than 20 years ago.
His greatest pain comes from arthritis related to his hemophilia. He must use a wheelchair to get around. He takes narcotics that help with pain, but they have side effects, including constipation and memory problems. Unless it’s legal, he won’t use marijuana.
“I had children in the home, and I didn’t want to set a bad example for them,” Allen said. “They’ve since gone off to college, but I just don’t think it’s a good idea to break the law.”
Michigan voters will probably decide next November whether to allow seriously ill patients to use marijuana based on the recommendation of a physician.
Supporters have turned in nearly half a million petition signatures to the Secretary of State’s Office — they need 304,000 valid signatures to get the issue on the ballot.
But opponents question the medicinal value of marijuana and the sincerity of the effort. Ingham County Sheriff Gene Wriggelsworth is among them.
“There’s plenty of pain medication out there,” Wriggelsworth said. “I don’t think anybody’s concern is about ill people. It’s just a way for people who have a predisposition to use drugs to try to get them legalized.”
Twelve states allow the use of marijuana for medicinal purposes. In Michigan, five cities — Ann Arbor, Detroit, Ferndale, Flint and Traverse City — have ordinances to do so, although use and possession are illegal under both state and federal law.
Under the Michigan proposal, seriously ill patients could legally use marijuana with a doctor’s recommendation. The measure specifically lists treatment for such diseases as HIV, cancer and Alzheimer’s as well as for less specific “severe and chronic pain.”
Patients would register with the state and have an ID card to help police know they have the right to use marijuana.
Those who are registered would have the right to grow up to 12 marijuana plants. They could not be prosecuted for buying marijuana, although it would still be a crime for someone to sell it.
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December 25th, 2007
State to hold itself liable in hep C bill
http://www.japantimes.co.jp
Kyodo News
A bill to aid people who contracted hepatitis C through tainted blood products will mention that the government bears certain responsibility for the infections, Prime Minister Yasuo Fukuda indicated Monday.
Fukuda also said he intends to meet with the victims, who are seeking damages from the government and drugmakers.
"The government provides approvals in pharmaceutical affairs, so it bears moral and other responsibilities," Fukuda said in reference to the bill to be sponsored by lawmakers. "The ruling bloc will promote further discussions."
He also said he is "not reluctant to meet" with people who filed lawsuits against the government and drug makers.
Fukuda made the remarks a day after announcing that the Liberal Democratic Party-New Komeito ruling bloc would craft legislation to aid all of the victims uniformly.
But Chief Cabinet Secretary Nobutaka Machimura appeared reluctant to clarify the government's liability in the envisaged bill.
The legislation will refer to the "minimum necessary" responsibility of the government, he told reporters separately.
As for Fukuda's recognition of moral responsibility, Machimura said, "It is difficult to decide how (such responsibility) should be written" in the bill.
The government should not delay implementation of relief measures by "wasting time" discussing details of its responsibility, Machimura added.
Later in the day, plaintiffs in hepatitis C lawsuits filed nationwide gathered in Tokyo and adopted a paper urging the government to clarify its responsibility in the envisaged legislation.
Toshihiro Suzuki, chief lawyer for the plaintiffs, told a news conference the legislation should explicitly state that the government "reflects on causing more than 10,000 people to contract the hepatitis C virus" and therefore "assumes responsibility for providing uniform compensation to all victims."
The plaintiffs' group will lobby lawmakers to pressure the government to include those phrases as it crafts the legislation, Suzuki said.
The plaintiffs also proposed at the gathering that the government set up an impartial, third-party organ to investigate hepatitis C infection through tainted blood products.
The reversal of the government's earlier stance came after the plaintiffs expressed their intention to break off negotiations because the government rejected their proposal to pay uniform compensation to all patients.
In its original plan, the government had offered to pay a total of ¥14 billion to eligible people based on an Osaka High Court settlement proposal and another ¥3 billion to patients who are not eligible under the court's plan.
The Osaka court earlier this month urged the defendants to pay ¥12 million to ¥40 million in compensation to each of the patients who were given tainted blood products for a certain period of time and developed certain diseases, based on a Tokyo District Court decision in March limiting the scope of the defendants' responsibility.
The defendants in the lawsuits are the government, Mitsubishi Tanabe Pharma Corp., its subsidiary Benesis Corp. and Nihon Pharmaceutical Co.
The plaintiffs refused to accept the court settlement plan and proposed Dec. 19 that the government and drugmakers pay an average of ¥15 million to all patients regardless of when they were administered the blood products, which products they received, or whether they had joined lawsuits.
Hepatitis C is a viral disease affecting the liver and is often transmitted through contact with infected blood.
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5 infected with hepatitis C after undergoing heart test at hospital
http://www.pacifichealthonline.com/
asahi.com
CHIGASAKI, Kanagawa Prefecture–A municipal hospital’s practice of reusing a disposable device for monitoring blood pressure during cardiac catheter tests resulted in five people developing hepatitis C as a result of the checkup.In a news conference at city hall here Tuesday, officials of Chigasaki Municipal Hospital disclosed details of this scandalous situation and apologized. They were joined by Chigasaki Mayor Nobuaki Hattori who also apologized.
The male patients in their 60s and 70s underwent the test at the hospital’s cardiovascular internal medicine department between December 2006 and April.
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December 26th, 2007
For Chinese, a push against hepatitis stigma
http://www.iht.com
By Shannon Pettypiece
Bloomberg News
SHANGHAI: Cheng Lei had fame, fortune and good looks going for him. Then, seven years ago, when the television performer's career was at its peak, a disease that had lain dormant in him for 17 years put all that in jeopardy.
Hepatitis B, a virus that can destroy a person's liver, dropped Cheng's weight to about 130 pounds, or 59 kilograms, leaving the 6-foot, or 1.8-meter, entertainer exhausted, bed-ridden and one of 130 million Chinese with the disease. Since then, he has worked to lessen the discrimination linked to hepatitis B.
In America, about eight people die every day from the illness. In China, hepatitis B kills an average of 808 people daily, making it one of the most neglected public health threats in the world.
Many Chinese have not gotten medicine because of the stigma and expense. Now, Cheng's activities and a growing middle class of 300 million people may open doors for Western pharmaceutical companies like Bristol-Myers Squibb and GlaxoSmithKline, which sell drugs to treat the virus.
"There's tremendous growth in China and a large population that is becoming wealthier and more able to afford more expensive health care," said Aaron Woolsey, a health-care analyst with Decision Resources, in Waltham, Massachusetts.
"But so many people - millions really - remain priced out of the market," Woolsey said.
Western drugs to treat hepatitis B, like Baraclude from Bristol-Myers Squibb, cost between $2 and $5 a day in China. The average worker there earned less than $6 daily in 2006, according to the World Bank. Baraclude, which costs five times more in the United States, can be taken for several years or for life.
Schering-Plough sells Peg-Intron, costing between $3,000 and $5,000 for a full course of treatment.
Even among the middle class in China, many are afraid to get tested or seek treatment because the disease, like AIDS, carries a social stigma, Cheng said.
Hepatitis B, like HIV, is transmitted through the exchange of body fluids like blood, saliva or semen. It attacks the liver and can lead to scarring, cancer or organ failure. The virus can lie dormant for years, then suddenly erupt with symptoms like yellowing of the skin and eyes, vomiting, fatigue and joint pain.
"When it first flared up, I felt like I would rather die than live with this disease," said Cheng, 37, in Shanghai, where he lives.
Hepatitis spreads through unsanitary medical practices and unprotected sex. About 40 percent of those carrying the virus were infected by their mothers at birth, said Samuel So, the director of the Asian Liver Center at Stanford University.
"This is one of the most neglected public health problems," So said. "It is a great challenge that the Chinese government really has not seriously taken up."
Chinese officials did little to contain the epidemic until 2005, when they started a program of free vaccines for infants, So said. Even now, the government does not cover the cost of medicine for those who cannot afford treatment, according to So. Moreover, authorities have not educated people about the disease, unlike their response to AIDS. About 650,000 people in China had HIV in 2005, according to the World Health Organization.
The Chinese Ministry of Health in Beijing did not respond to repeated requests for comment, including questions earlier this month.
"The discrimination of hepatitis B patients has been widely publicized in China," Cheng said. "I think much of the rejection comes not from indifference or callousness, but from little knowledge of the disease itself."
Fifty-two percent of Chinese hepatitis B patients have lost a job or education opportunity because of their infection, according to a 2005 survey by Synovate Healthcare, a research firm.
In one case, a college student, Zhou Yichao, fatally stabbed a government official in 2003 who refused to hire him because he had hepatitis B.
The government later revised its policy to allow the hiring of people who carry the virus and do not show symptoms. Last year, officials announced that fighting the disease was a national priority, according to People's Daily Online, a government-run media outlet.
"Now many celebrities and famous and talented people have said they are carriers of hepatitis B," Cheng said. "They still manage to be successful, so I think that changed people's misconceptions."
Still, doctors interviewed in China say most people are more aware of AIDS than hepatitis B.
Consumer advertising of prescription drugs is banned in China, so the companies rely on sales representatives to persuade doctors to prescribe their drugs. About half of hepatitis B patients who take medicine for the illness choose a Western drug, according to Decision Resources.
"The market is important to us because we have an effective therapy that can actually help change patients lives for the better," said Trevor Juniper, Schering-Plough's general manager in China.
Sales of hepatitis B drugs in China are expected to double to $630 million in three years, said Woolsey, the Decision Resources analyst. Medicines for the disease generated $793.5 million in U.S. revenue in 2006, and vaccines had sales of $10.5 million, according to Wolters Kluwer Health, a market research firm based in Conshohocken, Pennsylvania.
Drug makers are also working with the government and nonprofit groups to increase public awareness of the epidemic. Western pharmaceutical companies said they cannot cut prices for their treatments because they have to recoup development costs, which can exceed $1 billion for a single drug.
Some public health advocates say the Chinese government should step in and help people who cannot afford the drugs.
"China really needs to invest in its people now," said Henk Bedekam, formerly the World Health Organization's representative in China. "The country needs to start spending on the services and people as a way to maintain the economic growth they've created to this point. The response is too late; this is overdue."
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December 27th, 2007
Stokes sentenced to 10.5 years in prison
http://www.wzzm13.com
John Bumgardner/Matt Campbell
GRAND RAPIDS - A federal judge Thursday sentenced Dr. Robert Stokes to 10.5 years in prison for medical insurance fraud. The sentence is below the recommendation of the U.S. Attorney's Office which called for 12.5-15 years in prison.
The government's case against Stokes began five years ago. That's when federal agents began investigating Stokes' charges to insurance companies. He was indicted on health care fraud charges in June 2006.
Prosecutors say Stokes billed insurance companies for more expensive procedures than his patients actually received. A jury convicted him last April.
Stokes Thursday was also ordered to pay a $175,000 fine. Judge Gordon Quist will order Stokes to pay restitution at a later date. Prosecutors have said Stokes' fraud totaled nearly two million dollars.
Several former patients of the East Grand Rapids dermatologist testified during the day long sentencing. One of them, Robert May, told the judge that Stokes "put us in harm's way for greed...the charges you face can't compare to the fear we face."
A representative of insurer Blue Cross Blue Shield, Gregory Anderson, said "the real victims are the citizens of Michigan and the employers that provide health insurance...the cost of fraud gets passed on to all of us."
Stokes did not admit any guilt or offer any apology when he had a chance to address Judge Quist. He said: "I never intended to harm any patients, and I don't think that I did. I regret if some feel I did...I hope the sentence you impose gives me the chance to rebuild my life."
One of Stokes' lawyers called the case "a run of the mill fraud case", a comment that produced laughter from some of his former patients seated in the fourth floor courtroom.
Assistant U.S. Attorney Ray Beckering said Stokes "plowed forward with fraud despite warnings, and then he lied at his trial."
During his trial for insurance fraud, Stokes' alleged improper sterilization of medical instruments came to light. County health departments say thousands of the dermatologist's patients were at risk of infection. Thursday, six of Stokes' patients tested positive for Hepatitis C, though state health experts say they can't be certain those patients were infected through Stokes' care.
Stokes will be ordered to turn himself in to federal authorities to start serving his sentence at a later date. As he left the courthouse with one of his sons, he offered no comment to reporters.
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In Largest U.S. Hepatitis C Trial, Researchers Determine Weight-Based Dosing Is Key to Optimal Treatment
http://www.newswise.com
Newswise — As reported recently in the journal Hepatology, WIN-R, a multicenter study of over 5,000 patients with hepatitis C virus (HCV) showed treatment with weight-based REBETOL® (ribavirin, USP) (RBV) in combination with pegylated interferon (PEG-IFN) alfa-2b achieved significantly higher rates of sustained virologic response (SVR) and lower relapse rates compared to combination therapy using a flat dose of RBV 800 mg/day. Superior response was found particularly in patients with the most difficult-to-treat form of the disease, genotype 1 HCV. Efficacy was consistent across all weight groups.
For patients infected with genotype 2 or 3, a 24 week course of treatment with flat dose RBV + PEG-IFN was as effective as the standard 48-week course, with better tolerability, and in the overall study population flat dosing of ribavirin was as effective as weight-based ribavirin. However, within the flat-dose cohort of patients with genotypes 2 and 3, sustained response rates showed a slight decline in the higher weight patients given flat-dosed ribavirin.
"These findings help define optimal therapy for U.S. hepatitis C patients," says the study's principal investigator, Dr. Ira M. Jacobson, the Vincent Astor Professor of Clinical Medicine at Weill Cornell Medical College and chief of the Division of Gastroenterology and Hepatology at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. "Our findings underscore that weight-based-dosed combination therapy is significantly more effective than the flat-dosed RBV regimen, especially in more difficult-to-treat patient groups, such as patients with genotype 1 and African-American patients. Patients being treated for hepatitis C should talk to their doctors to be sure they are receiving the most effective therapy."
Reported in the same journal is a subanalysis of the WIN-R data that evaluates the efficacy of weight-based dosing among African-American participants with genotype 1 infection. Twice as many of these patients cleared the virus when treated with the weight-based RBV regimen vs. the flat dose (21% vs. 10%); a lower rate was shown in the general study population with genotype 1 HCV, 34% vs. 28.9%. (However, the fact that over 300 patients with an end of treatment response missed their 24-week, post-treatment follow-up appointment accounts for some treatment failures under a strict intent-to-treat analysis.)
"These results are particularly significant for African-Americans, a group with known lower rates of response to HCV therapy than reported in other ethnic groups. Weight-based dosing vs. flat dosing clearly showed the greatest therapeutic impact in this group," says Dr. Jacobson.
"The study data strongly suggest adopting a 1400 mg/dose for patients who weigh more than 105 kg. In my opinion, the larger dose provides an opportunity for very heavy patients to have the same chance of cure as lighter patients without compromising safety," says Dr. Jacobson.
Overall safety with weight-based dosing was similar to that of the flat 800 mg dose. There was no difference in the occurrence of serious adverse events in the entire group, as well as in the African-American group.
Researchers at NewYork-Presbyterian/Weill Cornell are at the forefront of developing more effective prescription therapy for patients with HCV genotype 1 and are testing many drugs in various stages of development.
Collaborating with the study's principal investigator Dr. Jacobson was Dr. Robert S. Brown Jr., co-principal investigator of the study and associate professor of clinical medicine at Columbia University College of Physicians and Surgeons; and chief of clinical hepatology and medical director of the Center of Liver Disease and Transplantation at NewYork-Presbyterian Hospital/Columbia University Medical Center.
Dr. Jacobson is also medical director of the Center for the Study of Hepatitis C in New York City, a unique interdisciplinary Center established jointly by The Rockefeller University, New York-Presbyterian Hospital, and Weill Cornell Medical College. He serves as a consultant, investigator and speaker for Schering-Plough.
WIN-R Study
WIN-R (Weight-Based Dosing of PEG-INTRON and REBETOL) is a community-based access trial involving more than 5,000 patients at 225 centers across the U.S.
The uniquely large database of the WIN-R study allowed investigators to address other questions of interest, which have been presented at international meetings, including analyses of the response to HCV therapy based on age, baseline viral load, degree of liver fibrosis (scarring), and the study site at which the medication was delivered.
WIN-R is an investigator-initiated clinical study supported by Schering-Plough Corporation and monitored by Schering-Plough Research Institute as part of a post-marketing commitment to the U.S. Food and Drug Administration (FDA). PEG-INTRON and REBETOL are registered trademarks of Schering-Plough.
Hepatitis C
Hepatitis C is the most common blood-borne infection in America. It affects approximately 4 million people, or about one in every 50 adults, including a disproportionately high percentage of African-Americans. Chronic hepatitis C can cause cirrhosis, liver failure and liver cancer. It has been estimated that at least 20 percent of patients with chronic hepatitis C develop cirrhosis, and a smaller percentage of patients with chronic disease develop liver cancer. Patients with chronic hepatitis C and related cirrhosis are 100 times more likely to develop liver cancer than uninfected persons. About half of all cases of primary liver cancer in the developed world are caused by hepatitis C, and hepatitis C–related liver disease is now the leading cause for liver transplants.
NewYork-Presbyterian Hospital/Weill Cornell Medical Center
NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and Weill Cornell Medical College, the medical school of Cornell University. NewYork-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine, and is committed to excellence in patient care, education, research and community service. Weill Cornell physician-scientists have been responsible for many medical advances -- from the development of the Pap test for cervical cancer to the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial for gene therapy for Parkinson's disease, the first indication of bone marrow's critical role in tumor growth, and, most recently, the world's first successful use of deep brain stimulation to treat a minimally-conscious brain-injured patient. NewYork-Presbyterian, which is ranked sixth on the U.S.News & World Report's list of top hospitals, also comprises NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children's Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Westchester Division and NewYork-Presbyterian Hospital/The Allen Pavilion. Weill Cornell Medical College is the first U.S. medical college to offer a medical degree overseas and maintains a strong global presence in Austria, Brazil, Haiti, Tanzania, Turkey and Qatar. For more information, visit http://www.nyp.org and http://www.med.cornell.edu.
Source: NewYork-Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell Medical College
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Researchers Show that Fibrosis can be Stopped, Cured and Reversed
http://health.ucsd.edu/news/2007/12-27-fibrosis
Modified Protein Developed by UC San Diego Researchers May Lead to First Cure for Cirrhosis of the Liver
University of California, San Diego researchers have proven in animal studies that fibrosis in the liver can be not only stopped, but reversed. Their discovery, to be published in PLoS Online on December 26, opens the door to treating and curing conditions that lead to excessive tissue scarring such as viral hepatitis, fatty liver disease, cirrhosis, pulmonary fibrosis, scleroderma and burns.
Six years ago, the UC San Diego School of Medicine research team discovered the cause of the excess fibrous tissue growth that leads to liver fibrosis and cirrhosis, and developed a way to block excess scar tissue in mice. At that time, the best hope seemed to be future development of a therapy that would prevent or stop damage in patients suffering from the excessive scarring related to liver or lung disease or severe burns.
In their current study, Martina Buck, Ph.D., assistant professor of medicine at UCSD and the Veterans Affairs San Diego Healthcare System, and Mario Chojkier, M.D., UCSD professor of medicine and liver specialist at the VA, show that by blocking a protein linked to overproduction of scar tissue, they can not only stop the progression of fibrosis in mice, but reverse some of the cell damage that already occurred.
In response to liver injury - for example, cirrhosis caused by alcohol - hepatic stellate cell (HSC) activated by oxidative stress results in large amounts of collagen. Collagen is necessary to heal wounds, but excessive collagen causes scars in tissues. In this paper, the researchers showed that activation of a protein called RSK results in HSC activation and is critical for the progression of liver fibrosis. They theorized that the RSK pathway would be a potential therapeutic target, and developed an RSK inhibitory peptide to block activation of RSK.
The scientists used mice with severe liver fibrosis - similar to the condition in humans with cirrhosis of the liver - that was induced by chronic treatment with a liver toxin known to cause liver damage. The animals, which continued on the liver toxin, were given the RSK-inhibitory peptide. The peptide inhibited RSK activation, which stopped the HSC from proliferating. The peptide also directly activated the caspase or "executioner" protein, which killed the cells producing liver cirrhosis but not the normal cells.
"All control mice had severe liver fibrosis, while all mice that received the RSK-inhibitory peptide had minimal or no liver fibrosis," said Buck.
Buck explained that the excessive collagen response is blocked by the RSK-inhibitory peptide, but isn't harmful to the liver. "The cells continue to do their normal, healing work but their excess proliferation is controlled," Buck said. "Remarkably, the death of HSC may also allow recovery from liver injury and reversal of liver fibrosis."
The researchers found a similar activation of RSK in activated HSC in humans with severe liver fibrosis but not in control livers, suggesting that this pathway is also relevant in human liver fibrosis. Liver biopsies from patients with liver fibrosis also showed activated RSK.
The study expands on work reported in 2001 in the journal Molecular Cell announcing that a team led by Buck had found that a small piece of an important regulatory protein called C/EBP beta was responsible for fibrous tissue growth, or excessive scar tissue following injury or illness. When normal scarring goes awry, excessive build-up of fibrous tissue can produce disfiguring scars or clog vital internal organs and lead to serious complications. Buck and colleagues developed a mutated protein that stopped this excessive fibrous tissue growth.
"Six years ago, we showed a way to prevent or stop the excessive scarring in animal models," said Buck. "Our latest finding proves that we can actually reverse the damage."
Worldwide, almost 800,000 people die from liver cirrhosis each year, and there is currently no treatment for it. Excessive tissue repair in chronic liver disease induced by viral, toxic, immunologic and metabolic disorders all result in excessive scar tissue, and could benefit from therapy developed from the UCSD researchers' findings.
The research was supported by grants from the National Institutes of Health, the Department of Veterans Affairs and UCSD's Medical Research Foundation. Buck is the recipient of a Howard Temin Award from the National Cancer Institute.
Media Contact: Debra Kain, 619-543-6163, ddkain@ucsd.edu
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December 28th, 2007
Hepatitis viruses detected in four more Green Cross blood products
http://www.japantimes.co.jp
Kyodo News
A forensic doctor has detected hepatitis viruses in four kinds of blood products that are not covered in a series of damages suits filed by people who contracted hepatitis C from tainted blood-clotting agents, the doctor and other medical sources said Friday.
The four are immunoglobulin, haptoglobin, plasmin and cholinesterase blood products made in the 1970s and 1980s by now-defunct drug maker Green Cross Corp., which is now part of Mitsubishi Tanabe Pharma Corp.
Immunoglobulin is a drug to combat measles, while haptoglobin is an antihemolytic anemia agent. Plasmin is a blood solvent and cholinesterase is effective for repairing nerve connection damage.
Tatsuo Nagai, a professor emeritus at Kitasato University in Kanagawa Prefecture, detected the viruses after analyzing protein materials and gene information contained in the blood products, which he had obtained from Green Cross.
Nagai detected the hepatitis C virus from immunoglobulin made in 1977, and the hepatitis B virus from haptoglobin made in 1976 and 1987, plasmin made in 1976 and cholinesterase made in 1977, the sources said.
Both hepatitis B and C viruses were found in haptoglobin made in 1976.
Nagai said he worries about a possible outbreak of hepatitis caused by those products on top of the outbreak due to the fibrinogen and christmassin covered in the lawsuits.
The Health, Labor and Welfare Ministry has already instructed drugmakers to check whether there are patients who contracted hepatitis through blood products other than fibrinogen and christmassin.
Health minister Yoichi Masuzoe told a news conference Friday that his ministry has filed an inquiry with Nagai about his research but has yet to receive a reply.
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Eltrombopag Effective for Hepatitis C Patients With Low Blood-Platelet Counts
http://www.newswise.com
Newswise — For patients with hepatitis C, having a low blood platelet count is a frequent complication associated with advanced disease. This problem is compounded by the fact that standard antiviral treatment for the disease can further reduce platelet numbers to dangerously low levels, effectively denying these patients the treatment they urgently need. Now, research published in the New England Journal of Medicine finds that a new drug, eltrombopag, appears to significantly boost platelet counts, opening the door to effective treatment.
"In this study, eltrombopag increased platelet counts in a dose-dependent manner, allowing more patients to complete the first 12 weeks of antiviral therapy -- an important treatment goal," says Dr. Samuel Sigal, who led the study at NewYork-Presbyterian Hospital/Weill Cornell Medical Center in New York City -- one of 22 study sites.
Dr. Sigal is assistant professor of medicine in the Division of Gastroenterology and Hepatology at Weill Cornell Medical College and assistant attending hepatologist in the Center for Liver Diseases and Transplantation at NewYork-Presbyterian/Weill Cornell.
The Phase 2 placebo-controlled study followed 74 patients with low platelet counts and cirrhosis of the liver due to hepatitis C virus (HCV) infection. Seventy-four percent of those randomized to take the lowest dose (30 milligrams daily) saw their platelet counts go up significantly, while 79 percent and 95 percent of the participants saw increases with the higher doses (50 or 75 milligrams daily, respectively). And, 12 weeks of antiviral therapy were completed by 36, 53 and 65 percent of patients at the three dose levels -- with increased numbers matched to the size of the dose. Underlining the trend, less than a quarter of patients receiving placebo completed their therapy.
The study identified side effects -- including headaches, dry mouth, abdominal pain and nausea. None were serious enough to discontinue the therapy.
It's estimated that 4 million people in the U.S. and 170 million worldwide carry the hepatitis C virus. HCV is transmitted primarily by blood and blood products. The majority of infected individuals have either received blood transfusions prior to 1990 (when screening of the blood supply for HCV was implemented) or have used intravenous drugs. More rarely, it can also be transmitted through sexual intercourse and perinatally (mother to baby).
The virus causes inflammation and scarring in the liver, and while it is curable in about half of those who have it, it can lead to significant liver damage, liver cancer and death in others. HCV infection is a common cause of cirrhosis and the most common reason for a liver transplant.
With other eltrombopag findings, NewYork-Presbyterian/Weill Cornell's Dr. James Bussel led research, also reported in the New England Journal of Medicine, finding the platelet growth factor successfully increased platelet counts and decreased bleeding in patients with Immune Thrombocytopenic Purpura (ITP), an autoimmune disease that dramatically reduces the number of platelets in their blood. (Dr. Bussel is an Advisory Board Member for GlaxoSmithKline; has received research grant support, lecture fees, and consulting fees from GlaxoSmithKline; and reports equity ownership in the company.)
The current study was sponsored by GlaxoSmithKline, which is developing eltrombopag. Eltrombopag (marketed as Promacta in the U.S. and Revolade in Europe) is an investigational oral, non-peptide platelet growth factor that induces the proliferation and differentiation of cells to produce platelets. While other drugs that restore normal platelet functions are infusions or injections, eltrombopag is a once-a-day pill.
The study's principal investigator was Dr. John McHutchison, of the Duke Clinical Research Institute, Durham, N.C. Additional participating institutions included Royal Free Hospital, London; Virginia Commonwealth University Medical Center, Richmond; Fundación de Investigación de Diego, San Juan; Hopital St. Joseph, Marseille; Henry Ford Hospital and Health System, Detroit; GlaxoSmithKline; and Beth Israel Deaconess Medical Center, Boston.
For more information, patients may call (866) NYP-NEWS.
Source: NewYork-Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell Medical College
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