JOHANNESBURG, Tuesday 20th January: The Treatment Action Campaign (TAC), Doctors Without Borders (MSF) and SECTION27 applaud India’s decision to reject a patent application on sofosbuvir, an important new treatment for Hepatitis C. Last Wednesday’s decision paves the way for increased access to more affordable sofosbuvir in India and other countries who choose to implement legal flexibilities available under international law to increase access to the drug. However, existing patents on sofosbuvir in South Africa could block access to the cheaper generic versions that will become available due to the ruling. The government should therefore urgently finalise the national intellectual property policy to allow South Africa to better protect access to medicines.
Rejection of the patent in India will allow generic manufacturers that have not already signed restrictive licensing agreements with Gilead to produce sofosbuvir at much lower prices than currently available. Research conducted by Dr Andrew Hill at the University of Liverpool, for example, suggests that sofosbuvir can be profitably produced for as little as $102 (R1,182) per 12 week course.
However, patent protection in South Africa prevents open competition, and could block generic versions of sofosbuvir and other new HCV drugs from reaching the domestic market. The same sofosbuvir patent rejected in India was granted in South Africa, and will only expire in 2025. South Africa has also granted multiple ‘secondary’ patents on sofosbuvir, with the latest patent only expiring in 2034. If reforms proposed in South Africa’s draft intellectual property policy are implemented, the number of such secondary patents granted will be dramatically reduced.
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Tuesday, January 20, 2015
AASLD 2014: Ledipasvir and Sofosbuvir in African Americans —Alan Franciscus, Editor-in-Chief
This is the last of the AASLD 2014 conference coverage (I promise!), but there was one more study I thought was important to discuss.
The Safety and Efficacy of Ledipasvir and Sofosbuvir in African Americans: A Retrospective Analysis of Phase 3 Data – L Jeffers et al.
The information from the Phase 3 studies of ledipasvir plus sofosbuvir, and of ledipasvir, sofosbuvir plus ribavirin, was compiled, and the information about the African American patients was extracted. The treatment durations in these studies were 8, 12 or 24 weeks. The patient characteristics of the African American were generally older, higher Body Mass Index, more likely to have IL28B non-CC (a variation that is less likely to respond to treatment) and lower ALT (liver enzyme levels).
The information from the Phase 3 studies of ledipasvir plus sofosbuvir, and of ledipasvir, sofosbuvir plus ribavirin, was compiled, and the information about the African American patients was extracted. The treatment durations in these studies were 8, 12 or 24 weeks. The patient characteristics of the African American were generally older, higher Body Mass Index, more likely to have IL28B non-CC (a variation that is less likely to respond to treatment) and lower ALT (liver enzyme levels).
The combined results from all of the phase 3 studies showed the overall cure rates among African Americans to be similar to the non-Blacks in the study groups. The authors did note that “Although high SVR rates were observed, the limited number of black patients with cirrhosis precludes definitive conclusions in this subpopulation.” In other words it would be hard to draw conclusions regarding effectiveness of the drugs when comparing African Americans and the other groups because there were so few African Americans in the study who had cirrhosis.
Comments: When interferon-based therapy was the standard of care to treat hepatitis C, African Americans had much lower cure rates compared to most other races. Now that the standard of care is interferon-free therapies, African American cure rates are the same as the cure rates seen in other races. Many old ‘facts’ die hard; so let’s put this one to rest and get the message out that that African Americans respond just as well to interferon-free therapies as other populations.
This was a presentation that was posted to NATAP courtesy of Jules Levin.
http://hcvadvocate.org/news/newsLetter/2015/advocate0115_mid.html#2
After decades with hepatitis C, liver transplant gives man life back
Michael Trevino likely contracted hepatitis C during his military service in Vietnam. It was cured, but doctors told his wife, Ileana, just after his successful transplant that his old liver still had become cancerous.
The way J. Michael Trevino sees it, his life was saved twice.
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The way J. Michael Trevino sees it, his life was saved twice.
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Monday, January 19, 2015
UK: Apology is wanted by patients who are contaminated by tainted blood
IT WAS a transfusion that was supposed to help Sally Vickers deal with a blood condition, but she says it has given her a death sentence.
Those are the stern words from the 53-year-old who was pumped full of contaminated blood more than 30 years ago.
As a result she contracted hepatitis C – a condition that affects the liver – and has resulted in her giving up work, feeling tired and knowing it could one day kill her because the condition she was born with stops her getting treatment for the virus.
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Those are the stern words from the 53-year-old who was pumped full of contaminated blood more than 30 years ago.
As a result she contracted hepatitis C – a condition that affects the liver – and has resulted in her giving up work, feeling tired and knowing it could one day kill her because the condition she was born with stops her getting treatment for the virus.
Read more...
Are Anesthesiologists Finally Recognizing the Importance of Infection Control?
New York—When it comes to the delivery of anesthesia care, infection control matters—and infectious disease professionals think it is high time their counterparts in anesthesiology recognize that.
They should be pleased then that the issue was the topic of discussion during a session entitled “Infection Control Issues Impacting Anesthesia Practice: What’s the Evidence?” held here at the New York State Society of Anesthesiologists’ (NYSSA) 68th Annual PostGraduate Assembly (PGA) in Anesthesiology. The speakers emphasized the importance of infection control practices in the delivery of anesthesia by citing numerous examples. For instance, they noted that during anesthesia care Loftus RW et al (Anesth Analg. 2014 Jun 16. [Epub ahead of print]; PMID: 24937346) found a within- and between-case Enterococcus faecalis transmission rate of 11% to 23%; furthermore, several hepatitis B and C and other infectious outbreaks in health care settings over the past 15 years have been attributed to mishandling of medications, fluids, syringes, needles and cannulae by anesthesia professionals. However, the speakers also emphasized that some published infection control recommendations, including a provision of US Pharmacopeia (USP) Chapter <797>, for example, present unique challenges to anesthesia professionals.
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They should be pleased then that the issue was the topic of discussion during a session entitled “Infection Control Issues Impacting Anesthesia Practice: What’s the Evidence?” held here at the New York State Society of Anesthesiologists’ (NYSSA) 68th Annual PostGraduate Assembly (PGA) in Anesthesiology. The speakers emphasized the importance of infection control practices in the delivery of anesthesia by citing numerous examples. For instance, they noted that during anesthesia care Loftus RW et al (Anesth Analg. 2014 Jun 16. [Epub ahead of print]; PMID: 24937346) found a within- and between-case Enterococcus faecalis transmission rate of 11% to 23%; furthermore, several hepatitis B and C and other infectious outbreaks in health care settings over the past 15 years have been attributed to mishandling of medications, fluids, syringes, needles and cannulae by anesthesia professionals. However, the speakers also emphasized that some published infection control recommendations, including a provision of US Pharmacopeia (USP) Chapter <797>, for example, present unique challenges to anesthesia professionals.
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Canada: Vancouver man denied access to lifesaving new Hepatitis C drugs
A resident of Vancouver’s Downtown Eastside is speaking out about the cost of treatments for Hepatitis C. Brody Williams says the only effective options left cost close to $100,000.
Brody Williams has battled the disease for years, undergoing numerous treatments. He’s one of 200,000 Canadians struggling with the virus.
But Williams isn’t getting the drugs. They come with a price tag of $75,000 – $100,000 for a course, and neither the federal Ministry of Indian Affairs, nor B.C.’s medical system will pay because he’s had four different drug treatment protocols already.
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Brody Williams has battled the disease for years, undergoing numerous treatments. He’s one of 200,000 Canadians struggling with the virus.
But Williams isn’t getting the drugs. They come with a price tag of $75,000 – $100,000 for a course, and neither the federal Ministry of Indian Affairs, nor B.C.’s medical system will pay because he’s had four different drug treatment protocols already.
Read more...
Canada: Cape Breton medical officer calls for more hepatitis C screening
About 5,000 Nova Scotians have contracted the infection. In 2013, Cape Breton recorded the second-highest rate of hepatitis C in the province — or about 24 per cent of all hepatitis C cases.
SYDNEY — Cape Breton’s medical officer of health is encouraging the screening of patients for hepatitis C as a result of staggering rates of the disease.
Dr. Monika Dutt recently offered the advice to close to 60 doctors taking part in a family medicine gathering in Sydney.
“We have rates that are about double what we’re seeing in the rest of the province,” Dutt said in an interview with The Chronicle Herald on Sunday. “It’s something that been increasing over quite a few years now.”
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