The World Health Organization has issued a guidance document on the design of bioequivalence studies for a leading hepatitis C medicine. Generic drug companies seeking prequalification by the WHO need to demonstrate that their generic version is equivalent to the originator drug.
According to a WHO official, the document provides technical guidance for the prequalification process as generics companies have to do bioequivalence studies to get prequalified.
The WHO has published an updated version (March 2015) of the patent situation for sofosbuvir in about 20 countries. This update, according to the WHO, is based on data received from national and regional patent offices, including the African Regional Intellectual Property Organization (ARIPO), Brazil, the Gulf Cooperation Council, Chile, Georgia, Morocco, The Organisation Africaine de la Propriété Intellectuelle (OAPI), the Philippines, and Tunisia.
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Thursday, April 2, 2015
Canada: Hepatitis C: breakthrough drug coverage a lifesaver for B.C. man
Kaslo resident Desmond McKilligan contracted hepatitis C more than 40 years ago from a tainted blood transfusion, and just got a call saying he qualifies for Sovaldi.
"My liver doesn't have anywhere to go but cirrhosis," he told CBC News. "It was a great thing to be called about that."
McKilligan says it's a new lease on life, and is thrilled he may actually see his grandchildren in Montreal.
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"My liver doesn't have anywhere to go but cirrhosis," he told CBC News. "It was a great thing to be called about that."
McKilligan says it's a new lease on life, and is thrilled he may actually see his grandchildren in Montreal.
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HealthWise: Hepatitis C: Giving a Liver, Getting a Liver Lucinda K. Porter, RN
Years of living with chronic hepatitis C virus infection (HCV) destroyed my friend Rick’s liver. Last year, a liver transplant saved his life. A motor vehicle accident killed a 19-year-old man, and now Rick is healthy. Not a day passes, that Rick doesn’t say thank you for the life of the man whose liver restored Rick’s health.
The same year Rick received his liver, I lost three friends who would have lived had hepatitis C been diagnosed earlier and they could have had a chance at liver transplantation. Rick was incredibly fortunate to have received a liver, because there is a major organ shortage in the U.S. According to the American Liver Foundation, approximately 17,000 people are on the liver transplant list. Of these, 6000 people were transplanted; 1500 to 1700 people died before they could receive a liver.
Chronic liver failure caused by complications from HCV is the most common reason for adult liver transplantation in the United States. Cirrhosis caused by long-term alcohol abuse is the second leading cause. The majority of people living with HCV will never progress to the point where transplantation will be necessary. Liver transplantation is a complicated surgery, requiring lifelong follow-up care. Liver transplant patients have an approximately 86% one-year and 78% three-year survival rate.
Most liver transplants use deceased donors. However, the liver’s remarkable ability to regenerate allows us to use partial livers from living donors. A living donor doesn’t have to be a blood relative, but must have a compatible blood type. About 40% to 60% of the donor’s liver is removed. Within eight weeks, the livers of both the donor and the recipient are usually completely regenerated. The average donor recovers in about two months; recipients recover in roughly six to 12 months.
Although living liver transplantation sounds like the perfect way to address the organ shortage, it isn’t. The potential risk to the donor is so high that live liver donations are done only when the potential risk to the donor is small and the potential benefit to the recipient is unquestionable. It is difficult to find current data on live liver transplantation, but it appears that there are 250 to 400 liver donor transplants a year. One in 300 donors die and about 30% suffer a complication. Many living donors who die are relatives of the recipients. One can only imagine how difficult it might be to live with the knowledge that you are alive, but your otherwise healthy donor is not.
Although increasing the donor organ pool is important, a better plan is to reduce the organ demand. Screening, linkage to care, and treating hepatitis C patients will reduce the number of liver transplant procedures needed. When I began working in this field, hepatitis C patients who were transplanted would still have HCV. This meant the transplanted liver was reinfected, and in some cases, it too would progress to cirrhosis. Now we can cure hepatitis C, which greatly cuts down on the stress to the transplanted organ and diverts the need for a second transplant.
Other strategies that will reduce the demand for livers are:
- Immunizing all children against hepatitis B
- Implementing awareness programs to reduce liver-injury risk, such as from alcohol, drug, and dietary supplement use
- Raise awareness of the impact of diet on the liver. Fatty liver disease is on the rise in the U.S., which in turn causes a decrease in the number of viable livers.
- Increase the organ donor pool. For instance, countries that use an “opt-out” strategy have much higher donor rates. “Opt-out” means that everyone is a potential donor unless otherwise indicated. For instance, Germany uses an opt-in system and 12% of its population consents to donate. Neighboring Austria uses an opt-out system, and has a consent rate of nearly 100%. The U.S. uses an “opt-in” strategy.
In some cases, patients whose hepatitis C is cured, may be potential organ donors. This situation is considered if the organ is in good shape, and the recipient would otherwise die. The recipient is given the option to decline the HCV antibody-positive organ. Compared to HCV antibody-negative organs, the long-term survival rate in patients who received an HCV antibody-positive/viral load-negative organ are similar. So, if you are cured of HCV, celebrate by filling out your organ donor card. Ask family and friends to fill theirs out too.
Lucinda K. Porter, RN, is a long-time contributor to them HCV Advocate and author of Free from Hepatitis C and Hepatitis C One Step at a Time. Her blog is www.LucindaPorterRN.com
Additional Resources
- Donate Life America
http://donatelife.net - OrganDonor.gov
www.organdonor.gov - Organ Procurement and Transplant Network
http://optn.transplant.hrsa.gov - Transplant Living
www.transplantliving.org - United Network for Organ Sharing
www.unos.org
Kidney transplant survival rate found worse in recipients with HCV vs. HIV
Kidney transplant recipients that were positive for HIV had a greater survival rate vs. kidney transplant recipients with hepatitis C virus infection and recipients coinfected with HIV and hepatitis C virus infection, according to new study data.
“These findings show that HIV patients are being unfairly perceived to have worse kidney transplant outcomes than noninfected groups, and as a result, they often have to wait the longest for transplants and there are fewer living donors,” Deirdre Sawinksi, MD, assistant professor in the division of renal, electrolyte and hypertension at the Perelman School of Medicine, University of Pennsylvania, said in a press release. “Our hope is that these study findings result in greater access to transplantation for HIV patients, while also inspiring the kidney transplant community to focus on eradicating hepatitis C in transplant patients — either pre-transplant or if that’s not possible, immediately post-transplant — to ensure better outcomes for these patients.”
“Under current U.S. kidney transplant practice, HIV monoinfection does not adversely affect recipient or allograft survival and is associated with superior outcomes compared with both HCV monoinfection and HIV/HCV coinfection in this population,” the researchers concluded. “Investigation of pretransplant or immediate post-transplant viral eradication with contemporary therapies should be prioritized as a strategy to improve post-transplant outcomes in HCV-infected kidney recipients.” – by Melinda Stevens
“These findings show that HIV patients are being unfairly perceived to have worse kidney transplant outcomes than noninfected groups, and as a result, they often have to wait the longest for transplants and there are fewer living donors,” Deirdre Sawinksi, MD, assistant professor in the division of renal, electrolyte and hypertension at the Perelman School of Medicine, University of Pennsylvania, said in a press release. “Our hope is that these study findings result in greater access to transplantation for HIV patients, while also inspiring the kidney transplant community to focus on eradicating hepatitis C in transplant patients — either pre-transplant or if that’s not possible, immediately post-transplant — to ensure better outcomes for these patients.”
“Under current U.S. kidney transplant practice, HIV monoinfection does not adversely affect recipient or allograft survival and is associated with superior outcomes compared with both HCV monoinfection and HIV/HCV coinfection in this population,” the researchers concluded. “Investigation of pretransplant or immediate post-transplant viral eradication with contemporary therapies should be prioritized as a strategy to improve post-transplant outcomes in HCV-infected kidney recipients.” – by Melinda Stevens
Sawinski D, et al. Kidney Int. 2015;doi:10.1038/ki.2015.74.
Read more...Wednesday, April 1, 2015
Canada: Province covers cost of new hepatitis C drugs
The Saskatchewan government says it will now provide new drug coverage for hepatitis C -- a viral disease that affects the liver.
Health Minister Dustin Duncan says the new drugs, Harvoni and Sovaldi, are better tolerated by patients than other therapies.
The drugs are said to cure 90 to 98 per cent of patients in as little as eight to 12 weeks.
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Health Minister Dustin Duncan says the new drugs, Harvoni and Sovaldi, are better tolerated by patients than other therapies.
The drugs are said to cure 90 to 98 per cent of patients in as little as eight to 12 weeks.
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Splashes & Sharps: Occupational Exposures in the Health Care Setting
Many risky, splash-creating activities are conducted without the proper PPE because there is a lower perceived risk.
When it comes to health care occupational risks, slips, trips, and falls are often the first to come to mind. Sharps also make the top of the list, but what is often overlooked is the cousin to sharps: splashes. Also known as mucocutaneous blood exposures, splashes are a notable risk for health care workers. Splashes—from routine activities such as cutting catheter bags, cleaning bedpans, and emptying suction cups—can land on a caregiver, where it can transfer a pathogen through the eyes, nose, or mouth.
Every year, the Centers for Disease Control and Prevention estimates that nearly 385,000 health care works in hospitals suffer sharps-related injuries. 1 By comparison, a study led by Doebbeling, et al. at the Veterans Administration found that in the previous three months, roughly 38 percent of all RNs had experienced a splash. Making the risk even more serious, they found that more than a quarter of these splashes went unreported. 2
Splashes, like sharps, can present serious risks to health care employees. This is because they can cause occupational-related infections, ranging from human immunodeficiency virus (HIV) to hepatitis B virus (HBV) to hepatitis C virus (HCV).3. Occupational exposures such as splashes can lead to lost work days, financial burden, and physical impairment. They also can take an emotional toll on those exposed.
*PPE = Personal protective equipment
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Hepatitis on the Hill —Lucinda K. Porter, RN
I have been doing hepatitis C advocacy for nearly 18 years. My hope and fury have never been greater. We can cure hepatitis C, but people are having a hard time getting the medications. The Centers for Disease Control and Prevention (CDC) recommends HCV testing for baby boomers, but we aren’t doing it. This is the sort of stuff that drives me wild.
HCV Advocate Editor-in-Chief Alan Franciscus asked me if I would attend “Hepatitis on the Hill,” held in Washington, DC on March 9 and 10. After years of complaining about the government’s anemic response to the hepatitis C epidemic, I automatically said “yes.”
Approximately 75 hepatitis advocates met in Washington, DC, for Hepatitis on the Hill. Hosted by the Hepatitis Appropriations Partnership, Hep B United and the National Viral Hepatitis Roundtable, and supported by the National Alliance of State and Territorial AIDS Directors, the event focused on increasing the federal response to the viral hepatitis epidemic in the United States.
Hepatitis C virus (HCV) is killing more Americans every year than HIV is, but dollar for dollar, hep C funding is pennies compared to HIV’s. State health departments’ Viral Hepatitis Prevention Coordinator programs receive less than $1 in federal funding for every person living with viral hepatitis. In the meantime, hep C infection and death rates continue to rise. Immunizing all children against hepatitis B virus (HBV) also continues to be a problem.
Advocates from hep B and C groups attended Hepatitis on the Hill. The first day focused on core issues, particularly why now is the time for this level of advocacy. President Obama’s budgetary request for viral hepatitis programs is double that of previous budgets, and the advocates learned how to ask for support from their senators and congressional representatives.
The next day, advocates visited the offices of their senators and representatives on Capitol Hill, educating their staff on the experiences of people living with hep B and C. At each office, the advocates requested the following:
- Signature of House/Senate letter in support of the president’s proposed FY2016 budget to increase funding of the CDC’s Division of Viral Hepatitis to $62.8 million, and include the request in the member appropriations submissions
- Support the repeal of the federal funding ban on syringe services programs
- That their elected official would join the Congressional Hepatitis Caucus
Senator Bill Cassidy (R-LA), MD, spoke during lunch on Capitol Hill. Cassidy is a hepatologist, committed to issues surrounding viral hepatitis. Ronald Valdiserri, MD (deputy assistant secretary for health, infectious diseases, at the Department of Health and Human Services), and John Ward, MD (director of the CDC’s division of viral hepatitis), also spoke at Hepatitis on the Hill. Ward emphasized the urgent nature of acting now, saying we can prevent approximately 300,000 deaths.
Presentations by Reps. Brett Guthrie (R-KY), Mike Honda (D-CA), Charlie Dent (R-PA) and Hank Johnson (D-GA) were televised at the event. These congressional representatives introduced the Viral Hepatitis Testing Act of 2015 (HR 1101). In addition to being an ally in Congress, Johnson has been public about his hepatitis C status, treatment and eventual cure.
For information about how to support efforts to improve viral hepatitis funding and services, visit Lucinda Porter’s blog (blogs.hepmag.com/lucindakporter). The National Viral Hepatitis Roundtable and Caring Ambassadors Hepatitis C provide ongoing coverage of the latest news and advocacy alerts related to viral hepatitis in the U.S.
Portions of this article by Lucinda K. Porter first appeared in Hep Magazine, March 16, 2015.
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