Response-guided Telaprevir Combination Treatment in Genotype 1 Chronic Hepatitis C Patients who had Prior Relapse to Peginterferon Alfa-2a/Ribavirin
Reported by Jules Levin
Presented at the American College of Gastroenterology Annual Scientific Meeting, Washington, DC, USA, October 28 - November 2, 2011
Telaprevir in Combination with Peginterferon Alfa-2a and Ribavirin Increased Sustained Virologic Response in Genotype 1 Chronic HCV
Reported by Jules Levin
Presented at the American College of Gastroenterology Annual Scientific Meeting, Washington, DC, USA, October 28 - November 2, 2011
Liver cancer risk among solid organ transplant recipients
This week's issue of the Journal of the American Medical Association investigates the spectrum of cancer risk among solid organ transplant recipients in the USA.
Dr Eric Engels and colleagues from Maryland, USA describe the overall pattern of cancer following solid organ transplantion.
The research performed a cohort study using linked data on solid organ transplant recipients from the US Scientific Registry of Transplant Recipients (1987-2008), and 13 state and regional cancer registries.
The team's main outcome measures included standardized incidence ratios, and excess absolute risks assessing relative and absolute cancer risk in transplant recipients compared with the general population.
The registry linkages yielded data on 175,732 solid organ transplants.
the team observed that the overall cancer risk was elevated with 10,656 cases, and an incidence of 1375 per 100,000 person-years.
Risk was increased for 32 different malignancies, some related to known infections, and others unrelated.
The research team found that the most common malignancies with elevated risk were non-Hodgkin lymphoma, and cancers of the lung, liver, and kidney.
Lung cancer risk was most elevated in lung recipients but also increased among other recipients.
The team noted that liver cancer risk was elevated only among liver recipients, who manifested exceptional risk in the first 6 months, and a 2-fold excess risk for 10 to 15 years thereafter.
Among kidney recipients, kidney cancer risk was elevated, and bimodal in onset time.
The researchers observed that kidney cancer risk also was increased in liver recipients, and heart recipients.
Dr Engels's team concludes, "Compared with the general population, recipients of a kidney, liver, heart, or lung transplant have an increased risk for diverse infection-related and unrelated
There’s a silent killer loose in America. It is viral hepatitis, and it contributes to the death of 15,000 Americans every year. Most people don’t even know they have it until years later when it’s too late for any treatment to work.
That is why we’re fighting back with new legislation being introducing today: the Viral Hepatitis Testing Act of 2011, the start of what we expect to be a historic national effort to fight – and ultimately eradicate – Hepatitis B (HBV) and C (HCV) in America. The current approach is not working. Typically, despite the pervasive nature of Hepatitis B and C, health providers do not screen Americans at high-risk for hepatitis. Moreover, most people don’t recognize symptoms until later stages when they have developed cancer or liver disease.
It is not surprising, then, that viral hepatitis is more common than HIV/AIDs but remains unrecognized as a serious threat to public health. In addition, viral hepatitis disproportionately impacts racial and ethnic populations. For example, HCV is twice as prevalent among African Americans as among Caucasians. Asian Americans comprise more than half of the known hepatitis B population in the United States and consequently maintain the highest rate of liver cancer among all ethnic groups
There is no federal funding for core public health services for viral hepatitis. Nor is there any federal funding to educate the public about the risks of chronic hepatitis B and C or get people proper treatment once they’re infected.
Consequently, Assistant Secretary of Health Dr. Howard Koh and a team of experts sprang into action last May, developing a comprehensive plan to unmask this silent killer. The legislation we are introducing today builds on that plan.
Our bill will fill the gaping hole in our public health system when it comes to viral hepatitis. It will help to avoid needless tragedies by setting up prevention and testing programs and educating Americans on the pervasive nature of hepatitis B and hepatitis C.
The Viral Hepatitis Testing Act of 2011 will establish four measurable goals that will help us keep track of progress in our war on this silent killer.
First, it requires testing programs around the nation to increase the number of individuals who are aware of their infection. Around 75 percent of people carrying viral hepatitis today don’t even know they are infected, so improved testing can flip that disturbing statistic on its head in just five years, with an estimated 75 percent of infected people aware of their status by 2016. This will allow people and their doctors to treat this disease before it develops into something worse. This program will also focus these efforts on minority communities that are at higher risk of infection.
Second, our legislation will require the development and distribution of public information about viral hepatitis detection and control of infections. Education is an important step in making hepatitis a detectable and manageable disease.
Third, it will call for better coordination of medical treatment and counseling so that infected people have access to the best services.
Lastly, the bill will improve the education, training, and skills of health professionals in the detection and control of viral hepatitis infections, giving providers the skills they need to tackle this public health threat.
Passing the Viral Hepatitis Testing Act of 2011 will save lives and improve health care. It will also save family’s and taxpayer’s money. The costs of education, research, and treatment pale in comparison to the health costs that will be incurred if we do nothing.
Without effective prevention and vaccination methods, chronic hepatitis B and C are expected to drain our country of billions of dollars in the coming years. The aging baby-boomer population is estimated to account for two out of every three cases of chronic hepatitis C. In the next decade, the costs of hepatitis C to commercial insurance and Medicare will more than double. Within 20 years, Medicare costs will increase fivefold and medical costs for patients with hepatitis C infection will skyrocket from $30 billion to more than $85 billion.
Without action, thousands more Americans will die each year from this disease, a tragedy that is preventable. We know what we need to do and we have the tools to get it done. We can lower costs, improve care, save lives and retire this silent killer once and for all.
Congressman Michael Honda is Silicon Valley’s Representative. He has represented the 15th Congressional District of California in the U.S. House of Representatives for a decade. In Congress, Rep. Honda is a member of the House Appropriations and Budget Committees and Chair Emeritus of the Congressional Asian Pacific American Caucus.
Senator John Kerry of Massachusetts is the tenth most senior Senator and the second longest serving Senator in his seat. He also holds senior positions on the Finance, Commerce, and Small Business Committees.
Lawsuit launched in Ottawa clinic health scare;
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Farazli's clinic is open for business, and while she is allowed to conduct business as any normal doctor would, she is not allowed to do endoscopies and colonoscopies.
CTVNews.ca Staff
Date: Thursday Nov. 3, 2011 1:43 PM ET
A class action lawsuit has been launched against an Ottawa doctor whose endoscopic clinic is at the centre of an infection scare.
The lawsuit was announced Thursday, the day after CTV Ottawa's Joanne Schnurr discovered that the doctor named in the suit, Dr. Christiane Farazli, 61, is once again seeing patients.
The Merchant Law Group LLP filed the lawsuit on Thursday. It claims that Farazli failed to consistently follow standard practices and procedures to sterilize the clinic's endoscopes. It also alleges that patients have suffered "worry, anxiety, and possible bodily injuries."
None of the allegations have been proven in court.
Two of Farazli's former patients are the lead plaintiffs in the class action. They are seeking $20 million for the 6,800 or so patients affected.
Last month, public health officials announced that close to 7,000 of Farazli's patients over a 10-year period may have been put at risk of contracting HIV or hepatitis B or C. That came after and investigation by Ontario's College of Physicians and Surgeons found that Farazli had not always followed proper instrument sterilization protocols.
Health officials have said there is a very low risk that any of Farazli's patients over the last 10 years were ever exposed to viruses during procedures at the clinic.
But at least one of Farazli's patients did have hepatitis C before she visited the clinic.
Liette Vachon told Schnurr that she is worried she may have inadvertently infected others after she underwent a colonoscopy at the clinic.
Vachon contracted hepatitis C years ago, when she was a teenage runaway. She says it's a lifelong infection she wouldn't wish on anyone.
Vachon says when she had the colonoscopy at Dr. Farazli's office nine years ago, she made sure the doctor knew she had hepatitis C. She remembers that in the room where she had the procedure, there was a container with dirty brown water in it.
"If she didn't clean it between the last patient and me, what are the chances that she did between me and the next?" Vachon wonders.
With a report from CTV Ottawa's Joanne Schnurr
Pharmaceutical
Incivek's $1 bil. in sales this year would set record for fastest launch, analyst says
Vertex's drug for treating hepatitis C virus, Incivek (telaprevir), is on course to smash the previous record for the biggest revenue-generating drug launch ever, says an analyst firm.
The direct-acting antiviral generated $494.1 million in sales from its US launch in May through the end of September, Vertex disclosed recently in an earnings report. The EU approved the med, branded as Incivo, during the third quarter, as did Canada and Japan. With launches in all those markets under way through the fourth quarter, Incivek should reach a billion dollars in sales by year's end, Wolters Kluwer inThought analyst Julie Hoggatt wrote in a research note yesterday.
Assuming Incivek goes blockbuster in under nine months, that would be half the time it took for Genentech cancer med Avastin to reach the same sales level after approval in 2004, Hoggatt pointed out. Abbott's RA injection Humira and Merck diabetes pill Januvia took about two years to earn blockbuster status, after those drugs reached market in 2002 and 2006, respectively.
Rival hep. C antiviral Victrelis, which was approved a week before Incivek, is moving along a slower adoption curve. Merck reported sales through September of only $53 million for Victrelis. On a prescription basis, Incivek is consistently averaging 1,000 new scripts (NRx) per week, compared to 300/week for Victrelis—a 3:1 average NRx ratio, not including refills.
Based on the most recent quarterly numbers, Wolters Kluwer raised its Incivek revenue forecast to $1.0 billion in 2011 and $1.4 billion in 2012, and lowered its Victrelis estimate to $100 million in 2011 and $256 million for 2012.
Incivek is clearly winning the market share battle. The question now becomes, how will it sustain sales?
That will depend on the size of the remaining pool of untreated hep. C patients, Hoggatt wrote. Weekly new prescription counts for the two drugs are “consistent but not growing” over the last several weeks, suggesting that sales will plateau in 2012 for both drugs, she predicted. (IMS Health data suggesting Incivek TRx were flat in late September were due to a data supply issue, IMS said.) All-oral hep. C regimens, expected to arrive in 2014 at the earliest, will be another cap on Incivek/Victrelis sales.
But near term, there's still some room for sales growth. Both new protease inhibitors are used in combination with ribavirin and with pegylated interferons, either Merck's own PegIntron or Roche's Pegasys, which is the market leader. The number of unique doctors prescribing Incivek in September was half the number of unique writers of Pegasys, Wolters Kluwer data show. That bodes well for the Vertex brand, assuming Pegasys represents a ceiling, of sorts, for the number of prescribers and scripts written per doctor.
Moreover, both the number of Incivek-writing physicians (2,061 as of September) and the average number of Incivek scripts per doctor (3.7, vs. 2.7 per prescriber of Victrelis) suggest that Vertex's drug is being written by half of the clinicians who are likely to prescribe it, and that those docs are already using it for nearly as many of their patients as they are prescribing Pegasys. As new prescribers (55-60% of scripts for all these agents are written by gastroenterologists) come on board, older ones probably won't go to the Rx pad as often.
Incidentally, Wolters Kluwer predicts that the first of the all-oral HCV regimens—which are being designed to avoid injected intereferon—won't reach market until 2015. Companies testing these regimens include Abbott, Roche, Pharmasset, Boehringer Ingelheim, Bristol-Myers Squibb and Gilead. Vertex recently experienced a setback with is own all-oral attempt but it and Merck may still pursue the approach.
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