AbbVie's Investigational HCV Regimen Receives U.S. FDA Breakthrough Therapy Designation
Sep 30, 2016
- Breakthrough Therapy Designation granted based on Phase 2 clinical data for genotype 1 (GT1) patients who failed previous therapy with direct-acting antivirals (DAAs)
- Currently in Phase 3 clinical trials, glecaprevir/pibrentasvir (G/P) is an investigational, pan-genotypic regimen being evaluated for the treatment of chronic hepatitis C virus (HCV) genotypes 1-6
- Breakthrough Therapy Designation is granted to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence that may demonstrate substantial improvement over existing therapies
NORTH CHICAGO, Ill., Sept. 30, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor.
The BTD is supported by positive results seen in AbbVie's Phase 2 MAGELLAN-1 clinical study. According to the FDA, BTD is intended to expedite the development and review of therapies for serious or life threatening conditions.1
"AbbVie is committed to advancing HCV care and addressing areas of continued unmet need for people living with chronic HCV," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "The FDA's Breakthrough Therapy Designation is an important step in our effort to bring our pan-genotypic regimen to market, which we are also investigating as an eight week path to virologic cure for the majority of patients."
AbbVie will present new Phase 3 data evaluating the safety and efficacy of G/P across all major HCV genotypes (genotypes 1-6) at an upcoming scientific congress. Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov.
About AbbVie's Clinical Development Program
AbbVie's HCV clinical development program is intended to advance scientific knowledge and clinical care of people with chronic HCV infection by investigating a pan-genotypic (genotypes 1-6) regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P). G/P is currently in Phase 3 of clinical development.
AbbVie's investigational regimen includes glecaprevir (GLE), an NS3/4A protease inhibitor, and pibrentasvir (PIB), an NS5A inhibitor dosed once daily as three oral tablets.
GLE was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
1 U.S. Food and Drug Administration. Fact Sheet: Breakthrough Therapies.
http://www.fda.gov
Accessed September 1, 2016.
Friday, September 30, 2016
On eve of rollout, fears under-funding may restrict hep C treatment
Regular news from the New Zealand Doctor newsroom
On eve of rollout, fears under-funding may restrict hep C treatment
Cliff Taylorctaylor@nzdoctor.co.nz
Friday 30 September 2016, 3:20PM
The RNZCGP fears under-funding threatens a ground-breaking hepatitis C treatment even as GPs prepare to start prescribing it from tomorrow.
The college has written an urgent letter to the Ministry of Health saying it supports the treatment, but extensive GP input is needed and the cost “will have a significant impact on patient’s ability to obtain a cure”.
It is urging the ministry to consider funding options, including direct funding for free GP visits.
GPs have been preparing for three months for the rollout of Viekira Pak, shown in trials to cure more than 95 per cent of patients with hepatitis C genotype 1. The drug was financially out of reach for most people, until it was funded by Pharmac from 1 July.
Patients will be knocking on GPs’ doors
Pharmac and drug company Abbvie have been preparing GPs for the rollout with educational materials and seminars. Pharmac’s deputy medical director for primary care, GP Bryan Betty, says it is one of the biggest changes in general practice prescribing in decades.
Auckland liver specialist Ed Gane says GPs should expect to have patients “knocking on their door” from tomorrow.
“GPs need to ensure they are educated about this new treatment,” Professor Gane says in a media release. “This is our chance to offer a life-changing cure to many people living with hepatitis C.”
College endorses training but queries cost
RNZCGP chief executive Helen Morgan-Banda is in Australia today and unable to be interviewed. She sent an email saying the college is endorsing both face-to-face training via DHBs and an online module for GPs prescribing Viekira Pak. It is also promoting the training via its weekly e-newsletter to members.
Ms Morgan-Banda wrote to the ministry last Friday saying the college welcomes the new treatment as a great development that will have positive benefits for a large number of New Zealanders.
But she says the college is very concerned the cost of GP visits will present a barrier to patients. She suggested two alternative avenues for funding:
* direct funding for free visits, such as the ministry currently provides for dioxin exposed people, and
* funding through a DHB Primary Options for Acute Care (POAC) programme.
“Our view is that whichever model is deemed appropriate, action needs to be taken urgently to ensure that it is in place and funding is available as soon as possible after the 1 October date when access to treatment becomes available,” she wrote in the letter.
In today’s email, Ms Morgan-Banda says the medicines have been funded, but GP appointments have not. The college is concerned this will affect the success of the programme.
She says patients with hepatitis C tend to be more deprived than the general population and are also often transient. She is concerned the lack of funding will result in inequity of access to treatment.
New Zealand Doctor sought comment from the ministry, but did not receive a reply before deadline.
‘Game-changing’ – despite the cost
ProCare associate clinical director and GP Jamie Shepherd says the issue of cost has been discussed at the PHO and he understands why the college has concerns.
But he says he and colleagues are well prepared and excited about being able to offer the treatment.
“We would love to have it funded, but we recognise as a GP it’s our role to deliver this as best we can. We have been aware of the rollout since July. It will be a big change for general practice, but it’s been well highlighted.
“This is game-changing for people with hepatitis C in New Zealand.”
Huge improvement in treatment
Professor Gane is hailing the new drug’s efficacy. Viekira Pak is taken orally, usually for 12 weeks and will cure over 95 per cent of patients, he says. It is also well tolerated, with 99 per cent of people completing treatment.
“This is a huge improvement compared to previous Interferon treatments, which consisted of weekly injections for a year, associated with bad side effects. Almost 20 per cent of people had to stop the treatment and less than half were cured.”
However, he says an effective oral treatment is still needed for almost half of the New Zealanders infected with hepatitis C who have other genotypes (2, 3, 4, 5 and 6).
Buyers’ Club an option for some
He is calling for Pharmac to fund other pan-genotypic drugs, but says in the meantime personal importation of generic versions could be a viable option.
He says to date more than 500 New Zealanders and Australians have accessed generics through the Fix Hep C Buyers’ Club run by Australian GP James Freeman.
“The generic medications cured more than 95 per cent of patients and were extremely safe, proving that these generic drugs are the real deal,” Professor Gane says. “These medications cost less than five per cent of the price of brand drugs — which is about $2,100.”
Related link
October 1: a momentous day for many people living with hepatitis C in New Zealand - The Hepatitis Foundation of New Zealand
October 1: a momentous day for many people living with hepatitis C in New Zealand - The Hepatitis Foundation of New Zealand
Thursday, September 29, 2016
Baby Boomers - Get Your Flu Shot
We begin with a link to the CDC's 2016-2017 influenza vaccination recommendations, which will take forever to read, if you just want the facts why not start by watching a few videos explaining this years vaccine options offered further down the page.
Information From The CDC
Information From The CDC
During week 42 (October 16-22, 2016), flu activity was low in the United States.
Viral Surveillance: The most frequently identified influenza virus type reported by public health laboratories during week 42 was influenza A. The percentage of respiratory specimens testing positive for influenza in clinical laboratories was low.
Pneumonia and Influenza Mortality: The proportion of deaths attributed to pneumonia and influenza (P&I) was below the system-specific epidemic threshold in the National Center for Health Statistics (NCHS) Mortality Surveillance System.
Influenza-associated Pediatric Deaths: No influenza-associated pediatric deaths were reported.
Outpatient Illness Surveillance: The proportion of outpatient visits for influenza-like illness (ILI) was 1.3%, which is below the national baseline of 2.2%. All 10 regions reported ILI below region-specific baseline levels. New York City, Puerto Rico, and all 50 states experienced minimal ILI activity and the District of Columbia had insufficient data.
Geographic Spread of Influenza: The geographic spread of influenza in Guam was reported as widespread; Puerto Rico reported regional activity; one state reported local activity; the District of Columbia, the U.S. Virgin Islands and 41 states reported sporadic activity; and eight states reported no activity.
Stay updated; CDC
Weekly U.S. Influenza Surveillance Report
Who Should Get A Flu Shot?
The bottom line is the CDC recommends a yearly flu vaccine for everyone 6 months and older. The upcoming season's flu vaccine will protect against the influenza viruses that research indicates will be most common during the season. This includes an influenza A (H1N1) virus, an influenza A (H3N2) virus, and one or two influenza B viruses, depending on the flu vaccine. After vaccination, it takes a person about two weeks to build up immunity against the flu.
Changes and Updates
In June the CDC released a statement stating the “nasal spray” flu vaccine; live attenuated influenza vaccine (LAIV) should not be used during the 2016-2017 flu season.
Show Me A Video
Adults Ages 18 And Older - The flu shot for patients, 2016 - 2017
David Z Hirsch, MD
Children
No more needle-free flu vaccine for now.
FOX 5 Atlanta
Medscape Videos
Medscape published three videos with Lisa Grohskopf from CDC's Influenza Division discussing changes and updates in the recommendations for this influenza season.
Free registration is required to view the following videos
1 - CDC Provides Vaccine Recommendations for the 2016-2017 Influenza Season
News Article
The nose is out. The arm is in
A federal agency and a national pediatric association are pushing pediatricians and other doctors not to provide the nasal spray influenza vaccination, FluMist, and instead to rely only on shots.
Of Interest
Commentary - Healio
FOX 5 Atlanta
Medscape Videos
Medscape published three videos with Lisa Grohskopf from CDC's Influenza Division discussing changes and updates in the recommendations for this influenza season.
Free registration is required to view the following videos
1 - CDC Provides Vaccine Recommendations for the 2016-2017 Influenza Season
Recommended 2016-2017 influenza vaccines include a number of inactivated injectable vaccines as well as recombinant influenza vaccine. Both trivalent and quadrivalent injectable vaccines will be available this season. Trivalent vaccines are designed to protect against three different influenza viruses. Quadrivalent influenza vaccines protect against the same three viruses plus an additional B virus from a different lineage of influenza B viruses.
2 - No LAIV (Nasal Spray) Flu Vaccine This Season
In this commentary, I will discuss an important change in the US 2016-2017 influenza vaccine recommendations. Specifically, I will explain why we are recommending that only injectable influenza vaccines (inactivated influenza vaccine [IIV] or recombinant influenza vaccine [RIV]) should be used during the upcoming influenza season.
3 - Flu Vaccine for People With Egg Allergies
People with egg allergies no longer need to be observed for an allergic reaction for 30 minutes after receiving a flu vaccine; and people with a history of severe allergic reaction to egg (ie, any symptom other than hives) can now be vaccinated in a medical setting, under the supervision of a healthcare provider who is able to recognize and manage severe allergic conditions.
2 - No LAIV (Nasal Spray) Flu Vaccine This Season
In this commentary, I will discuss an important change in the US 2016-2017 influenza vaccine recommendations. Specifically, I will explain why we are recommending that only injectable influenza vaccines (inactivated influenza vaccine [IIV] or recombinant influenza vaccine [RIV]) should be used during the upcoming influenza season.
3 - Flu Vaccine for People With Egg Allergies
People with egg allergies no longer need to be observed for an allergic reaction for 30 minutes after receiving a flu vaccine; and people with a history of severe allergic reaction to egg (ie, any symptom other than hives) can now be vaccinated in a medical setting, under the supervision of a healthcare provider who is able to recognize and manage severe allergic conditions.
News Article
The nose is out. The arm is in
A federal agency and a national pediatric association are pushing pediatricians and other doctors not to provide the nasal spray influenza vaccination, FluMist, and instead to rely only on shots.
Of Interest
Commentary - Healio
Citing a lack of evidence of efficacy, the AAP’s Committee on Infectious Diseases recommends that clinicians not administer the FluMist quadrivalent live-attenuated vaccine during the upcoming influenza season.
In The News
The importance of vaccination in persons with chronic liver disease, cirrhosis, transplant receipts and people 65 years and older is provided on this page as well. Just yesterday the CDC reported a decrease in people 50 to 64 getting out to get vaccinated and a drop in people 65 and older, read the story here.
The Flu In People 50 And Over
Persons that are 50 and over may be more likely to have chronic medical conditions that put them at higher risk of severe influenza illness, especially in people 65 and over. According to the CDC; "In recent years, it’s estimated that between 71 percent and 85 percent of seasonal flu-related deaths have occurred in people 65 years and older and between 54 percent and 70 percent of seasonal flu-related hospitalizations have occurred among people in that age group. So influenza is often quite serious for people 65 and older."
In The News
The importance of vaccination in persons with chronic liver disease, cirrhosis, transplant receipts and people 65 years and older is provided on this page as well. Just yesterday the CDC reported a decrease in people 50 to 64 getting out to get vaccinated and a drop in people 65 and older, read the story here.
The Flu In People 50 And Over
Persons that are 50 and over may be more likely to have chronic medical conditions that put them at higher risk of severe influenza illness, especially in people 65 and over. According to the CDC; "In recent years, it’s estimated that between 71 percent and 85 percent of seasonal flu-related deaths have occurred in people 65 years and older and between 54 percent and 70 percent of seasonal flu-related hospitalizations have occurred among people in that age group. So influenza is often quite serious for people 65 and older."
High-dose Flu Shot For People 65 And Older
There are two vaccines designed specifically for people 65 and older:
Fluzone and FLUAD
Fluzone - The high dose vaccine has been approved for use in the United States since 2009.
The “high dose vaccine fluzone” is designed specifically for people 65 and older and contains 4 times the amount of antigen as the regular flu shot. It is associated with a stronger immune response following vaccination (higher antibody production).
A 2014 study published in the New England Journal of Medicine of more than 30,000 participants showed that adults 65 years and older who received Fluzone High-Dose vaccine had 24% fewer influenza infections as compared to those who received the standard dose Fluzone vaccine.
FLUAD - vaccine will be available for the first time in the United States during the 2016-2017 season.
The high dose and adjuvanted flu vaccines may result in more of the mild side effects that can occur with standard-dose seasonal shots. Mild side effects can include pain, redness or swelling at the injection site, headache, muscle ache and malaise.
The “high dose vaccine fluzone” is designed specifically for people 65 and older and contains 4 times the amount of antigen as the regular flu shot. It is associated with a stronger immune response following vaccination (higher antibody production).
A 2014 study published in the New England Journal of Medicine of more than 30,000 participants showed that adults 65 years and older who received Fluzone High-Dose vaccine had 24% fewer influenza infections as compared to those who received the standard dose Fluzone vaccine.
FLUAD - vaccine will be available for the first time in the United States during the 2016-2017 season.
The adjuvanted flu vaccine, Fluad, is made with MF59 adjuvant which is designed to help create a stronger immune response to vaccination. In a Canadian observational study of 282 persons aged 65 years and older conducted during the 2011-12 season, Fluad was 63% more effective than regular-dose unadjuvanted flu shots.
*There are no randomized studies comparing Fluad with Fluzone High-Dose.
*There are no randomized studies comparing Fluad with Fluzone High-Dose.
Over 65? Is Timing Important?
The CDC recommends that you should try to get your flu vaccine anytime between now and the end of October. Flu activity typically peaks between December and March . However, immunologist Laura Haynes suggests people over 65 wait until Halloween to get their flu shots to make sure the immunity lasts through the flu season, read the article over at NPR. Along with this piece by Kaiser Health News; Yes, It Is Possible To Get Your Flu Shot Too Soon. Or check out this new article; CDC Urges Americans To Get A Flu Shot As Soon As Possible.
Liver Disease
Evidence suggests people living with chronic liver disease, cirrhosis and liver transplant recipients are particularly at risk from the flu and its complications.
Cirrhotic Patients
Multiple studies indicate that vaccination might be beneficial for persons with chronic liver disease. In a prospective 2007 study influenza vaccination decreased influenza-related complication rates in patients with liver cirrhosis. The study included 311 persons with cirrhosis, 198 of whom were vaccinated with a trivalent influenza vaccine and the rest were not vaccinated. Most of the cirrhotic patients with influenza had fever (91.6%) and complained of myalgia (83.3%) without respiratory symptoms, which were not typical clinical presentations of influenza. Influenza vaccination decreased influenza-related complication rates in patients with liver cirrhosis (14% versus 23%).
Transplant Recipients
Influenza is one of the common endemic viral diseases that is associated with higher morbidity and mortality in solid organ transplant (SOT) recipients than in immunocompetent patients.
This review summarizes current information and the evidences regarding the efficacy and safety of immunization in adult solid organ transplant candidates and recipients.
Read the 2016 article, here.
Viral Hepatitis
In a more recent 2015 study, data from Taiwan’s National Health Insurance program was reviewed from 2000 through 2009 to evaluate hospitalization and mortality in patients with chronic hepatitis B who received an annual influenza vaccination vs those who did not. The study concluded that not only was there a lower hospitalization rate among persons with chronic hepatitis B infection who had been vaccinated against the flu compared with those who had not, but annual influenza vaccination can lower the risk of mortality in patients with chronic HBV infection.
Remember getting your flu shot not only protects you, it also helps protect the people you love.
Stay well, until next time.
Tina
This review summarizes current information and the evidences regarding the efficacy and safety of immunization in adult solid organ transplant candidates and recipients.
Read the 2016 article, here.
Viral Hepatitis
In a more recent 2015 study, data from Taiwan’s National Health Insurance program was reviewed from 2000 through 2009 to evaluate hospitalization and mortality in patients with chronic hepatitis B who received an annual influenza vaccination vs those who did not. The study concluded that not only was there a lower hospitalization rate among persons with chronic hepatitis B infection who had been vaccinated against the flu compared with those who had not, but annual influenza vaccination can lower the risk of mortality in patients with chronic HBV infection.
Remember getting your flu shot not only protects you, it also helps protect the people you love.
Stay well, until next time.
Tina
Record numbers accessing hepatitis C treatment, but who is missing out?
10th Australasian Viral Hepatitis 2016 Conference
Thursday 29 September - Saturday 1 October 2016, Gold Coast, Australia
View Updates: Conference Reports
Record numbers accessing hepatitis C treatment, but who is missing out?
A mistrust of the health system and ongoing stigma from health workers against injecting drug users are two significant barriers that could prevent people living with hepatitis C from accessing and continuing life-saving treatment, according to a new report by UNSW's Centre for Social Research in Health.
The Annual Report of Trends in Behaviour Supplement 2016 on viral hepatitis, released today at the 10th Australasian Viral Hepatitis 2016 Conference, found some sections of the community are unaware that a cure is now available for hepatitis C.
The report, which also examines risks factors, attitudes and knowledge regarding hepatitis B, highlighted that about one third of people living with the diseases are yet to be diagnosed and only 6% have been treated.
A survey of 416 Australians, who acquired hepatitis C through use of non-sterile injecting equipment, found experiencing discrimination from health workers lessened their likelihood of engaging in future treatment.
UNSW Professor Carla Treloar, Director of the Centre for Social Research, said with record numbers of people in 2016 seeking new hepatitis C treatments, the impact of stigma as a treatment barrier was now clearer.
"To capitalise on the opportunities provided by these new treatments, we need to keep working to make sure we understand who isn't coming forward for treatment and why, and how we can deliver services that best address these barriers," Professor Treloar said.
Only one in five (22%) people living with hepatitis C at the end of 2015 had ever received treatment.
A survey of 405 gay and bisexual men found a lack of knowledge regarding testing and treatment for hepatitis C, with only 35% indicating awareness of a treatment that could cure hepatitis C.
Further, in a study of 534 men (86 HIV positive men; 347 HIV negative men; 101 men who had not had HIV testing), the UNSW researchers found an individual's HIV status influenced their knowledge and attitudes towards people who inject drugs and people with hepatitis C.
The finding suggests hepatitis C education and prevention for gay men would not be best served by a 'one size fits all approach', but should be tailored according to their HIV status.
In a survey of 203 Aboriginal people living with hepatitis C, those who felt more attached to their Aboriginal community were more likely to show greater resilience and reported having a better quality of life and less hepatitis C-related stigma than those who were not as attached to their Aboriginal community.
Attachment to an Aboriginal community was associated with positive lifestyle changes such a changed diet, reduced alcohol or illicit drug use, increased exercise and more regular check-ups after a hepatitis C diagnosis.
According to the report, Hepatitis B also remains a significant concern. The Kirby Institute's Hepatitis B and C in Australia Annual Surveillance Report Supplement 2016, released alongside the Annual Report of Trends in Behaviour Supplement 2016, found one third of the estimated 232,600 people living with chronic hepatitis B infection remain undiagnosed, with only 6% receiving treatment.
"Analysis of the evidence regarding best practice in hepatitis B from around the world suggests that management in Australia's general practice setting can be improved through greater community-based outreach programs and education programs for health professionals," Professor Treloar said.
"Stigma should also be recognised as a factor influencing decisions about care and treatment for people living with hepatitis B."
More information: The Annual Report of Trends in Behaviour Supplement 2016 can be found here: csrh.arts.unsw.edu.au/research/publications/reports-trends-in-behavior/
Provided by: University of New South Wales
Thursday 29 September - Saturday 1 October 2016, Gold Coast, Australia
View Updates: Conference Reports
Record numbers accessing hepatitis C treatment, but who is missing out?
A mistrust of the health system and ongoing stigma from health workers against injecting drug users are two significant barriers that could prevent people living with hepatitis C from accessing and continuing life-saving treatment, according to a new report by UNSW's Centre for Social Research in Health.
The Annual Report of Trends in Behaviour Supplement 2016 on viral hepatitis, released today at the 10th Australasian Viral Hepatitis 2016 Conference, found some sections of the community are unaware that a cure is now available for hepatitis C.
The report, which also examines risks factors, attitudes and knowledge regarding hepatitis B, highlighted that about one third of people living with the diseases are yet to be diagnosed and only 6% have been treated.
A survey of 416 Australians, who acquired hepatitis C through use of non-sterile injecting equipment, found experiencing discrimination from health workers lessened their likelihood of engaging in future treatment.
UNSW Professor Carla Treloar, Director of the Centre for Social Research, said with record numbers of people in 2016 seeking new hepatitis C treatments, the impact of stigma as a treatment barrier was now clearer.
"To capitalise on the opportunities provided by these new treatments, we need to keep working to make sure we understand who isn't coming forward for treatment and why, and how we can deliver services that best address these barriers," Professor Treloar said.
Only one in five (22%) people living with hepatitis C at the end of 2015 had ever received treatment.
A survey of 405 gay and bisexual men found a lack of knowledge regarding testing and treatment for hepatitis C, with only 35% indicating awareness of a treatment that could cure hepatitis C.
Further, in a study of 534 men (86 HIV positive men; 347 HIV negative men; 101 men who had not had HIV testing), the UNSW researchers found an individual's HIV status influenced their knowledge and attitudes towards people who inject drugs and people with hepatitis C.
The finding suggests hepatitis C education and prevention for gay men would not be best served by a 'one size fits all approach', but should be tailored according to their HIV status.
In a survey of 203 Aboriginal people living with hepatitis C, those who felt more attached to their Aboriginal community were more likely to show greater resilience and reported having a better quality of life and less hepatitis C-related stigma than those who were not as attached to their Aboriginal community.
Attachment to an Aboriginal community was associated with positive lifestyle changes such a changed diet, reduced alcohol or illicit drug use, increased exercise and more regular check-ups after a hepatitis C diagnosis.
According to the report, Hepatitis B also remains a significant concern. The Kirby Institute's Hepatitis B and C in Australia Annual Surveillance Report Supplement 2016, released alongside the Annual Report of Trends in Behaviour Supplement 2016, found one third of the estimated 232,600 people living with chronic hepatitis B infection remain undiagnosed, with only 6% receiving treatment.
"Analysis of the evidence regarding best practice in hepatitis B from around the world suggests that management in Australia's general practice setting can be improved through greater community-based outreach programs and education programs for health professionals," Professor Treloar said.
"Stigma should also be recognised as a factor influencing decisions about care and treatment for people living with hepatitis B."
More information: The Annual Report of Trends in Behaviour Supplement 2016 can be found here: csrh.arts.unsw.edu.au/research/publications/reports-trends-in-behavior/
Provided by: University of New South Wales
Wednesday, September 28, 2016
Hep C virus RNA persists in liver explants awaiting liver transplantation
Hep C virus RNA persists in liver explants awaiting liver transplantation
October's issue of Gastroenterology reports that hepatitis C Virus RNA persists in liver explants of most patients awaiting liver transplantation treated with an interferon-free regimen.
Dr Xavier Forns and colleagues from Spain assessed the presence of hepatitis C virus (HCV) RNA in liver explants from 39 patients awaiting liver transplantation.
The patients were treated with an interferon-free regimen and had undetectable serum HCV RNA at the time of liver transplantation.
The team found that HCV RNA was detected in 67% of liver explants.
Patients with HCV RNA–positive explants had received shorter courses of treatment, and HCV RNA was undetectable in serum for shorter periods before transplantation compared to patients with HCV RNA–negative explants.
The team noted that levels of HCV RNA in explants were significantly higher in patients with a relapse of HCV infection than patients who responded to treatments.
Dr Forns' team comments, "Most patients with residual HCV-RNA in the explant achieved a sustained virologic response after receiving their liver transplant."
October's issue of Gastroenterology reports that hepatitis C Virus RNA persists in liver explants of most patients awaiting liver transplantation treated with an interferon-free regimen.
Dr Xavier Forns and colleagues from Spain assessed the presence of hepatitis C virus (HCV) RNA in liver explants from 39 patients awaiting liver transplantation.
The patients were treated with an interferon-free regimen and had undetectable serum HCV RNA at the time of liver transplantation.
The team found that HCV RNA was detected in 67% of liver explants.
Patients with HCV RNA–positive explants had received shorter courses of treatment, and HCV RNA was undetectable in serum for shorter periods before transplantation compared to patients with HCV RNA–negative explants.
The team noted that levels of HCV RNA in explants were significantly higher in patients with a relapse of HCV infection than patients who responded to treatments.
Dr Forns' team comments, "Most patients with residual HCV-RNA in the explant achieved a sustained virologic response after receiving their liver transplant."
Source - http://www.gastrohep.com/news/news.asp?id=112120
Gastroenterol 2016: 151(4): 633–636.e3
28 September 2016
Gastroenterol 2016: 151(4): 633–636.e328 September 2016
A Fighter by Nature – Tatjana Reic and the Viral Hepatitis Story
A Fighter by Nature – Tatjana Reic and the Viral Hepatitis Story
The experts in the European Liver Patients Association (ELPA) Hep-CORE advisory group provide a window on the broad range of hepatitis activities and perspectives in Europe today. Hep-CORE PI Jeffrey Lazarus has been interviewing some of them about how they came to work with viral hepatitis, how the field has been changing, and what new research is called for.
Jeffrey V. Lazarus 26 Sep 2016
The ninth interview in the series is with Tatjana Reic, President of the European Liver Patients Association (ELPA).
The experts in the European Liver Patients Association (ELPA) Hep-CORE advisory group provide a window on the broad range of hepatitis activities and perspectives in Europe today. Hep-CORE PI Jeffrey Lazarus has been interviewing some of them about how they came to work with viral hepatitis, how the field has been changing, and what new research is called for.
Jeffrey V. Lazarus 26 Sep 2016
The ninth interview in the series is with Tatjana Reic, President of the European Liver Patients Association (ELPA).
How did you initially get involved with viral hepatitis?
Today when I look back it seems like it must have been somehow written in the stars – me and the viral hepatitis story.
36 years ago, at the age of 20 in the middle of the summer of 1980, I was hospitalized with a diagnosis of Acute Hepatitis B (HBV). At that time in my medical record, besides positive so-called Australian antigen, the clinicians also had written “NON A NON B.” I didn’t know what that meant. The doctors also did not pay a lot of attention to non A non B. After 35 days spent in the hospital I simply continued with my life; as a reconvalescent I was not the best model of patient. However, per the doctor’s instructions I regularly checked my liver enzymes for the next 5-6 years and then practically forgot about my illness.
So at the age of 34 I got married and pregnant – the most exciting period in my life – I was going to become a mother, oh how great that feeling was! Although by that time it was 1994 – and there was war in Croatia. Because of my history of hepatitis B, I was referred for a blood test on viral hepatitis during my pregnancy. And that’s how I became aware of my diagnosis: Chronic Hepatitis C (cHCV). The illness was unknown to me at the time so I tried to find out more about it but found little help even from close family members who were medical professionals.
My daughter was born anti-HCV positive, PCR undetectable. Although I was advised by my treating physician that her antibodies should be eliminated in 6-12 months it did not happen. Instead it took 4 years and gave me sleepless nights for the first 4 years of her life. I thought, “Oh my God, what have I done to the most precious person in my life, I transmitted her a deadly threat disease”.
In the meantime, I lost my job and started my first treatment with interferon monotherapy – injections 3 times per week for 52 weeks. That was really tough. At that time the was war coming to the end and I was looking for a job as doctor of veterinary medicine. But with a small child, at the age of almost 40 and with a chronic (stigmatized) disease, it was practically impossible. On top of this I was still going through multiple strenuous treatments. Deep depression overtook me.
However, since I am a fighter by nature I decided to do take things into my own hands, so I completed my degree as a Master of Science. In 2000 my life started to completely change. I established the first Croatian hepatitis patient group, joined the European Liver Patients Association (ELPA) in 2005, became ELPA Vice-President in 2007 and since 2011 have been the ELPA President.
I was a patient highly motivated to fight for my life, integrity, dignity, dissent job and the future of my children
Finally, in 2010, when WHO endorsed World Hepatitis Day as only the fourth disease-specific official day, coincidentally appointing it to the day of my birthday – July 28, I began to truly realize my mission and my passion on this Earth – to contribute in the global fight for hepatitis patients’ rights and the right to not be neglected any more.
So my short answer to your question is – I was a patient highly motivated to fight for my life, integrity, dignity, decent job and the future of my children.
How has the viral hepatitis field, especially HCV, been changing?
I can easily speak about that topic from my own experience as I failed 6 very, very tough interferon treatments: 4 out of 6 treatments were with “old” non-pegylated IFN and 1 was a 72-week PEG/RIBA treatment. In total I have spent 5-6 years of my life on IFN treatment. This is the equivalent of 292 weeks, or 2,044 days – after all that the treatments still failed.
Going through treatment with DAAs was like chewing gum compared with IFN treatments.
Later, luckily, I spent 12 more weeks dedicated to my 7th treatment, this time with direct-acting antivirals (DAAs), and today I am cured. Going through treatment with DAAs was like chewing gum compared with IFN treatments.
But I have no regrets. I am sure that the interferon helped postpone the progression of liver fibrosis and kept my liver damage at a comparatively mild level for all those decades, about 22 years after being diagnosed and 35 years since I initially contracted the virus, helping me survive.
Besides my own experience it is evident that viral hepatitis, in particular the field of HCV, has significantly changed.
We have seen revolutionary achievements in the field of treatment. The dreams of every patient who went under IFN treatments finally came true – drugs that can cure almost 100% of patients with almost no side-effects during 4 times shorter duration of treatment. That’s real perfectavir.
Additionally, global awareness of viral hepatitis in general is much higher since the WHO endorsement of World Hepatitis Day.
At the end it is important to stress that with recent 69th World Health Assembly’s adoption of first-ever Global Health Sector Strategy (GHSS) on Viral Hepatitis in Geneva has generated strong political will. The GHSS states a goal to eliminate hepatitis B and C by 2030 and includes prevention and treatment targets to reduce annual deaths by 65% and increase treatment by 80%. It was unanimously adopted by 194 Member States in a historic commitment, signaling the greatest global policy development in the field of viral hepatitis ever.
What areas of viral hepatitis research do you think are still being neglected?
Let’s not fool ourselves – in the past decade a lot has been done in the viral hepatitis field, but a lot more is still on our TO DO list.
In the research area – a treatment to cure cHBV,
In the research area – a vaccine to prevent HCV
Diagnosis and screening – case finding of the undiagnosed HCV population; which is the majority of cases
Secure global access to the best care and treatment options for all patients
Development of national strategies for viral hepatitis
Implementation of national strategies, especially in terms of prevention
Let’s not forget ‘prevention as prevention’ ; interview with Eberhard Schatz
The task now is identifying people who don’t know they’re infected and connecting them to care ; interview with Luis Mendão
Without a vaccine, eliminating HCV will be a huge challenge ; interview with Antons Mozalevskis
The same debates, 25 years later ; interview with Marie Jauffret-Roustide
Outside the biomedical box of hepatitis C research ; interview with Magdalena Harris
Changing to a holistic approach towards hepatitis policy ; interview with Achim Kautz
Patient associations: a key catalyst for hepatitis advocacy and impact ; interview with Charles Gore
A clinician’s career in viral hepatitis: a powerful history and optimistic future ; interview with Mojca Maticic
Tuesday, September 27, 2016
Eradication of Hepatitis C Virus Infection in Patients With Cirrhosis Reduces Risk of Liver and Non-Liver Complications
Eradication of HCV infection in patients With cirrhosis reduces risk of liver and non-liver complications
In this prospective study patients with cirrhosis treated with interferon-based therapy or interferon-free regimens who achieved sustained virologic response (SVR) reduced; overall mortality and risk of death from liver-related and non–liver-related causes.......
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In addition I highly suggest you follow Henry E. Chang on Twitter if you are interested in reading full text articles about the treatment and management of hepatitis C. A link to the above mentioned article was tweeted by Mr. Chang this morning.
Abstract
Eradication of Hepatitis C Virus Infection in Patients With Cirrhosis Reduces Risk of Liver and Non-Liver Complications
Abstract
Background & Aims
We performed a prospective study to investigate the effects of a sustained viral response (SVR) on outcomes of patients with hepatitis C virus (HCV) infection and compensated cirrhosis.
Background & Aims
We performed a prospective study to investigate the effects of a sustained viral response (SVR) on outcomes of patients with hepatitis C virus (HCV) infection and compensated cirrhosis.
Methods
We collected data from 1323 patients included in the prospective ANRS CirVir cohort, recruited from 35 clinical centers in France from 2006 through 2012. All patients had HCV infection and biopsy-proven cirrhosis, were Child Pugh class A, and had no prior liver complications. All patients received anti-HCV treatment before or after inclusion (with interferon then direct antiviral agents) and underwent ultrasound examination every 6 months, as well as endoscopic evaluations. SVR was considered as a time-dependent covariate; its effect on outcome was assessed by the Cox proportional hazard regression method. We used a propensity score to minimize confounding by indication of treatment and capacity to achieve SVR.
We collected data from 1323 patients included in the prospective ANRS CirVir cohort, recruited from 35 clinical centers in France from 2006 through 2012. All patients had HCV infection and biopsy-proven cirrhosis, were Child Pugh class A, and had no prior liver complications. All patients received anti-HCV treatment before or after inclusion (with interferon then direct antiviral agents) and underwent ultrasound examination every 6 months, as well as endoscopic evaluations. SVR was considered as a time-dependent covariate; its effect on outcome was assessed by the Cox proportional hazard regression method. We used a propensity score to minimize confounding by indication of treatment and capacity to achieve SVR.
Results
After a median follow-up period of 58.2 months, 668 patients (50.5%) achieved an SVR. SVR was associated with a decreased incidence of hepatocellular carcinoma (HCC; hazard ratio [HR] compared to patients without an SVR=0.29; 95% CI, 0.19–0.43; P< .001) and hepatic decompensation (HR=0.26; 95% CI, 0.17–0.39; P<.001). Patients with SVRs also had a lower risk of cardiovascular events (HR=0.42; 95% CI, 0.25–0.69; P=.001) and bacterial infections (HR=0.44; 95% CI, 0.29–0.68; P<.001). Metabolic features were associated with higher risk of HCC in patients with SVRs, but not in patients with viremia. SVR affected overall mortality (HR=0.27 compared to patients without SVR; 95% CI, 0.18–0.42; P<.001) and death from liver-related and non–liver-related causes. Similar results were obtained in a propensity score-matched population.
After a median follow-up period of 58.2 months, 668 patients (50.5%) achieved an SVR. SVR was associated with a decreased incidence of hepatocellular carcinoma (HCC; hazard ratio [HR] compared to patients without an SVR=0.29; 95% CI, 0.19–0.43; P< .001) and hepatic decompensation (HR=0.26; 95% CI, 0.17–0.39; P<.001). Patients with SVRs also had a lower risk of cardiovascular events (HR=0.42; 95% CI, 0.25–0.69; P=.001) and bacterial infections (HR=0.44; 95% CI, 0.29–0.68; P<.001). Metabolic features were associated with higher risk of HCC in patients with SVRs, but not in patients with viremia. SVR affected overall mortality (HR=0.27 compared to patients without SVR; 95% CI, 0.18–0.42; P<.001) and death from liver-related and non–liver-related causes. Similar results were obtained in a propensity score-matched population.
Conclusions
We confirmed a reduction in critical events, liver-related or not, in a prospective study of patients with HCV infection and compensated cirrhosis included in the CirVir cohort who achieved an SVR. We found an SVR to reduce overall mortality and risk of death from liver-related and non–liver-related causes. A longer follow-up is required to accurately describe and assess specific risk factors for complications in this population.
We confirmed a reduction in critical events, liver-related or not, in a prospective study of patients with HCV infection and compensated cirrhosis included in the CirVir cohort who achieved an SVR. We found an SVR to reduce overall mortality and risk of death from liver-related and non–liver-related causes. A longer follow-up is required to accurately describe and assess specific risk factors for complications in this population.
Monday, September 26, 2016
A Review of Daclatasvir Drug-Drug Interactions
Review article
A Review of Daclatasvir Drug-Drug Interactions.
Garimella T, et al. Adv Ther. 2016
Adv Ther. 2016 Sep 23. [Epub ahead of print]
Download - Full text review article
Abstract
The treatment of hepatitis C virus (HCV) infection has been revolutionized in recent years by the development of direct-acting antiviral regimens that do not contain peginterferon (pegIFN) and/or ribavirin (RBV). While direct-acting antiviral-based regimens have been shown to be greatly superior to pegIFN/RBV-based regimens in terms of efficacy and safety, they have a greater susceptibility to drug–drug interactions (DDIs).
Daclatasvir (DCV)—the benchmark pangenotypic nonstructural protein 5A inhibitor—has been shown to be efficacious and generally well tolerated in partnership with other HCV direct-acting antivirals, including sofosbuvir, asunaprevir (ASV), and ASV plus beclabuvir. DCV may be the object of a DDI via the induction or inhibition of cytochrome P450 (CYP) 3A4 and/or P-glycoprotein (P-gp) by the concomitant medication, or the precipitant of a DDI via DCV-based induction/inhibition of CYP 3A4 or inhibition of P-gp, organic anion transporting polypeptide 1B1/B3, and/or breast cancer resistance protein.
This article presents an overview of the drug interaction studies conducted during the clinical development of DCV, the findings of these studies that led to the guidance on concomitant medication use and dosage along with any required DCV dose modifications, and the use of the known metabolic pathway of DCV to guide concomitant dosing where direct drug–drug studies have not been conducted. The robust characterization of the DCV clinical pharmacology program has demonstrated that DCV has few or no clinically relevant DDIs with medications with which it is likely to be co-administered, and the majority of DDIs that do occur can be predicted and easily managed.
Funding: Bristol-Myers Squibb.
KeywordsConcomitant medications Daclatasvir Drug–drug interactions Hepatitis C virus Infectious diseases
Link To - Full text review article
A Review of Daclatasvir Drug-Drug Interactions.
Garimella T, et al. Adv Ther. 2016
Adv Ther. 2016 Sep 23. [Epub ahead of print]
Download - Full text review article
Abstract
The treatment of hepatitis C virus (HCV) infection has been revolutionized in recent years by the development of direct-acting antiviral regimens that do not contain peginterferon (pegIFN) and/or ribavirin (RBV). While direct-acting antiviral-based regimens have been shown to be greatly superior to pegIFN/RBV-based regimens in terms of efficacy and safety, they have a greater susceptibility to drug–drug interactions (DDIs).
Daclatasvir (DCV)—the benchmark pangenotypic nonstructural protein 5A inhibitor—has been shown to be efficacious and generally well tolerated in partnership with other HCV direct-acting antivirals, including sofosbuvir, asunaprevir (ASV), and ASV plus beclabuvir. DCV may be the object of a DDI via the induction or inhibition of cytochrome P450 (CYP) 3A4 and/or P-glycoprotein (P-gp) by the concomitant medication, or the precipitant of a DDI via DCV-based induction/inhibition of CYP 3A4 or inhibition of P-gp, organic anion transporting polypeptide 1B1/B3, and/or breast cancer resistance protein.
This article presents an overview of the drug interaction studies conducted during the clinical development of DCV, the findings of these studies that led to the guidance on concomitant medication use and dosage along with any required DCV dose modifications, and the use of the known metabolic pathway of DCV to guide concomitant dosing where direct drug–drug studies have not been conducted. The robust characterization of the DCV clinical pharmacology program has demonstrated that DCV has few or no clinically relevant DDIs with medications with which it is likely to be co-administered, and the majority of DDIs that do occur can be predicted and easily managed.
Funding: Bristol-Myers Squibb.
KeywordsConcomitant medications Daclatasvir Drug–drug interactions Hepatitis C virus Infectious diseases
Link To - Full text review article
UK patients who have liver transplants abroad get poorer management
UK patients who have liver transplants abroad get poorer management
News Type: Clinical News
A small number of UK citizens are undergoing liver transplants abroad but their management is of a lower standard than in the UK.
These were the conclusions of researchers at Sheffield’s Royal Hallamshire Hospital, who sent questionnaires to all seven UK liver transplant units enquiring about liver patients receiving transplant abroad. Six of the seven centres responded.
A total of 12 patients were identified as having undergone liver transplantation overseas. The top destinations were India, China and Egypt.
Four units responded to questions regarding pre-transplant screening. One unit reported HBV and HCV screening not taking place. Four units responded to questions regarding post-transplant antimicrobial therapy. This revealed examples of patients inappropriately not receiving valganciclovir, co-trimoxazole, anti-fungal treatment and HBV immunoglobulins.
The researchers add that information transfer between overseas and UK based transplant teams is poor.
Reference
A questionnaire based assessment of numbers, motivation and medical care of UK patients undergoing liver transplant abroad. Winter BK, Odedra A, Green S. Travel Med Infect Dis. 2016 Sep 14 [Epub ahead of print]
Abstract
A questionnaire based assessment of numbers, motivation and medical care of UK patients undergoing liver transplant abroad.
Travel Med Infect Dis. 2016 Sep 14. pii: S1477-8939(16)30122-3. doi: 10.1016/j.tmaid.2016.09.004. [Epub ahead of print]
A questionnaire based assessment of numbers, motivation and medical care of UK patients undergoing liver transplant abroad.
Kerr Winter B1, Odedra A2, Green S2.
1Department of Infection and Tropical Medicine, Royal Hallamshire Hospital, Sheffield, S10 2JF, England, UK. Electronic address: Ben.kerrwinter@gmail.com.
2Department of Infection and Tropical Medicine, Royal Hallamshire Hospital, Sheffield, S10 2JF, England, UK.
Abstract
BACKGROUND:
Medical tourism, where patients travel abroad intentionally to access medical treatment, is a growing trend. Some of these patients travel to undergo organ transplantation. This study aims to quantify the number of UK patients who undergo liver transplantation abroad, assessing their motivations and management.
METHODS:
Questionnaires were sent to all seven UK liver transplant units enquiring about liver patients receiving transplant abroad. Included were questions on destination, motivation, and pre and post-transplant care.
Questionnaires were sent to all seven UK liver transplant units enquiring about liver patients receiving transplant abroad. Included were questions on destination, motivation, and pre and post-transplant care.
RESULTS:
Responses were received from six of the seven transplant centres (86%). A total of 12 patients were identified as having undergone liver transplantation overseas. The top destinations were India, China and Egypt. Four units responded to questions regarding pre-transplant screening. One unit reported Hepatitis B and C screening not taking place. Four units responded to questions regarding post-transplant antimicrobial therapy. This revealed examples of patients inappropriately not receiving valganciclovir, co-trimoxazole, anti-fungal treatment and Hepatitis B immunoglobulins.
Responses were received from six of the seven transplant centres (86%). A total of 12 patients were identified as having undergone liver transplantation overseas. The top destinations were India, China and Egypt. Four units responded to questions regarding pre-transplant screening. One unit reported Hepatitis B and C screening not taking place. Four units responded to questions regarding post-transplant antimicrobial therapy. This revealed examples of patients inappropriately not receiving valganciclovir, co-trimoxazole, anti-fungal treatment and Hepatitis B immunoglobulins.
CONCLUSIONS:
UK patients are undergoing liver transplant abroad, albeit in small numbers. Pre and post-transplant management of these patients is of a lower standard than that provided to those undergoing transplantation in the UK. Information transfer between overseas and UK based transplant teams is poor.
Copyright © 2016. Published by Elsevier Ltd.
KEYWORDS:
Hepatology; Infectious diseases; Medical tourism; Transplantation
PMID: 27640117 DOI: 10.1016/j.tmaid.2016.09.004
UK patients are undergoing liver transplant abroad, albeit in small numbers. Pre and post-transplant management of these patients is of a lower standard than that provided to those undergoing transplantation in the UK. Information transfer between overseas and UK based transplant teams is poor.
Copyright © 2016. Published by Elsevier Ltd.
KEYWORDS:
Hepatology; Infectious diseases; Medical tourism; Transplantation
PMID: 27640117 DOI: 10.1016/j.tmaid.2016.09.004
Drugmakers racing each other on treatment for liver disease
Drugmakers racing each other on treatment for liver disease
By CAROLINE CHEN and JARED S. HOPKINS BLOOMBERG NEWS
Nonalcoholic steatohepatitis occurs when fat accumulates in the liver along with inflammation and damage, and as much as a quarter of the U.S. population may have a precursor condition called nonalcoholic fatty liver disease. The ailment develops slowly, and patients often don't show symptoms until their livers are heavily damaged. It's most common in people who are overweight or have diabetes, and doctors mainly prescribe diet changes and weight loss.
While doctors need to perform a biopsy to diagnose nonalcoholic steatohepatitis, between 6 and 15 million people in the U.S. alone are estimated to have the condition, and about 20 percent of them will go on to develop life-threatening cirrhosis. It will be the leading cause of liver transplants by 2020, according to Allergan. Drugs that treat it will likely command high prices, said Elizabeth Krutoholow, an analyst at Bloomberg Intelligence.
Continue reading...
By CAROLINE CHEN and JARED S. HOPKINS BLOOMBERG NEWS
Nonalcoholic steatohepatitis occurs when fat accumulates in the liver along with inflammation and damage, and as much as a quarter of the U.S. population may have a precursor condition called nonalcoholic fatty liver disease. The ailment develops slowly, and patients often don't show symptoms until their livers are heavily damaged. It's most common in people who are overweight or have diabetes, and doctors mainly prescribe diet changes and weight loss.
While doctors need to perform a biopsy to diagnose nonalcoholic steatohepatitis, between 6 and 15 million people in the U.S. alone are estimated to have the condition, and about 20 percent of them will go on to develop life-threatening cirrhosis. It will be the leading cause of liver transplants by 2020, according to Allergan. Drugs that treat it will likely command high prices, said Elizabeth Krutoholow, an analyst at Bloomberg Intelligence.
Continue reading...
We should aim to achieve complete elimination of hepatitis C
We should aim to achieve complete elimination of hepatitis C
Clinical Pharmacist
Clinical Pharmacist
26 SEP 2016
Chair of the British Viral Hepatitis Group and Consultant in Infectious Diseases, North Manchester General Hospital
I read the letters from Charles Gore (Clinical Pharmacist 2016;8:232) and Anja St. Clair Jones (Clinical Pharmacist 2016;8:264) on the therapies and new services for hepatitis C with interest. The points made are valid and important.
The key issues highlighted by Gore were related to the fact that there are real restrictions placed on accessing the newer therapies for this infection that have not been imposed in other disease areas, with other medicines, in other patients. Resources are limited; however, denying individuals timely access to National Institute for Health and Care Excellence-approved, evidence-based, cost-effective therapies is, indeed, exceptional.
Continue reading: We should aim to achieve complete elimination of hepatitis C
Sunday, September 25, 2016
New Perspectives in HCV Infection
Journal Of Hepatology
New Perspectives in HCV Infection
New Perspectives in HCV Infection
Edited by Thomas Berg, Xavier Forns
Highlights
Assessment of HCV Disease
Treatment and Remaining Challenges
Reversion of disease manifestations after HCV eradication
Assessment of HCV Disease
DOI: http://dx.doi.org/10.1016/j.jhep.2016.07.023
S67–S81
Published in issue: October 2016
Treatment and Remaining Challenges
Reversion of disease manifestations after HCV eradication
DOI: http://dx.doi.org/10.1016/j.jhep.2016.07.039
S95–S108
Published in issue: October 2016
DOI: http://dx.doi.org/10.1016/j.jhep.2016.08.001
S120–S129
Published in issue: October 2016
HCV Perspectives
DOI: http://dx.doi.org/10.1016/j.jhep.2016.07.007
S130–S142
Published in issue: October 2016
Full-Text HTML PDF
Future landscape of hepatitis C research – Basic, translational and clinical perspectives
Future landscape of hepatitis C research – Basic, translational and clinical perspectives
DOI: http://dx.doi.org/10.1016/j.jhep.2016.07.026
S143–S155
Published in issue: October
Friday, September 23, 2016
Epclusa - NICE says yes to another hepatitis C drug
Also read - NICE backs Gilead’s hepatitis C drug Epclusa published today by The Pharma Letter.
NICE says yes to another hepatitis C drug
A new drug which effectively treats more genotypes of hepatitis C has been recommended for use in the NHS.
NICE has published new draft guidance which recommends sofosbuvir-velpatasvir – an anti-viral drug that offers patients with chronic hepatitis C a potential cure.
Sofosbuvir-velpatasvir – a tablet taken once daily – works by blocking the virus from multiplying and infecting new cells. Trials of the drug showed cure rates of 89% and above for all genotypes.
People who have genotype 3 are currently treated with an older type of anti-viral drug, which can cause unwanted side effects. Sofosbuvir-velpatasvir will be the first drug that offers more effective treatment to this group of patients – who make up 44% of the patient population with chronic hepatitis C.
The NICE appraisal committee concluded that sofosbuvir-velpatasvir was clinically and cost-effective, and should be routinely available on the NHS.
Professor Carole Longson, director of the NICE centre for health technology evaluation, said: “The decision by the independent NICE appraisal committee to recommend sofosbuvir-velpatasvir is great news. The drug provides considerable health benefits to patients with hepatitis C, in particular, those with genotype 3 who can become very ill, very quickly.
“Sofosbuvir-velpatasvir, a newer type of direct acting anti-viral medicine, can be used to treat all genotypes of hepatitis C. Other drugs currently available treat only certain genotypes or can cause unwanted side effects if they have to be taken in combination with earlier anti-viral treatments.”
“Our positive recommendation of sofosbuvir-velpatasvir means that more tolerable treatment options will become available to all patients with hepatitis C.”
Sofosbuvir-velpatasvir costs £38,980 for a 12 week treatment course. The drug may also be taken in combination with ribavirin costing around £40,000 – also for a 12 week course of treatment. But the NHS will pay less than these prices because a confidential discount has been agreed with the company.
The draft guidance recommends that decisions to treat patients with sofosbuvir-velpatasvir are made by multidisciplinary teams in the operational delivery networks put in place by NHS England, and to prioritise treatment for people with the highest unmet clinical need.
The preliminary recommendations are now out for public consultation. Consultees, including the company, healthcare professionals and members of the public can comment until 14 October 2016.
https://www.nice.org.uk/news/article/nice-says-yes-to-another-hepatitis-c-drug
NICE says yes to another hepatitis C drug
A new drug which effectively treats more genotypes of hepatitis C has been recommended for use in the NHS.
NICE has published new draft guidance which recommends sofosbuvir-velpatasvir – an anti-viral drug that offers patients with chronic hepatitis C a potential cure.
Sofosbuvir-velpatasvir – a tablet taken once daily – works by blocking the virus from multiplying and infecting new cells. Trials of the drug showed cure rates of 89% and above for all genotypes.
People who have genotype 3 are currently treated with an older type of anti-viral drug, which can cause unwanted side effects. Sofosbuvir-velpatasvir will be the first drug that offers more effective treatment to this group of patients – who make up 44% of the patient population with chronic hepatitis C.
The NICE appraisal committee concluded that sofosbuvir-velpatasvir was clinically and cost-effective, and should be routinely available on the NHS.
Professor Carole Longson, director of the NICE centre for health technology evaluation, said: “The decision by the independent NICE appraisal committee to recommend sofosbuvir-velpatasvir is great news. The drug provides considerable health benefits to patients with hepatitis C, in particular, those with genotype 3 who can become very ill, very quickly.
“Sofosbuvir-velpatasvir, a newer type of direct acting anti-viral medicine, can be used to treat all genotypes of hepatitis C. Other drugs currently available treat only certain genotypes or can cause unwanted side effects if they have to be taken in combination with earlier anti-viral treatments.”
“Our positive recommendation of sofosbuvir-velpatasvir means that more tolerable treatment options will become available to all patients with hepatitis C.”
Sofosbuvir-velpatasvir costs £38,980 for a 12 week treatment course. The drug may also be taken in combination with ribavirin costing around £40,000 – also for a 12 week course of treatment. But the NHS will pay less than these prices because a confidential discount has been agreed with the company.
The draft guidance recommends that decisions to treat patients with sofosbuvir-velpatasvir are made by multidisciplinary teams in the operational delivery networks put in place by NHS England, and to prioritise treatment for people with the highest unmet clinical need.
The preliminary recommendations are now out for public consultation. Consultees, including the company, healthcare professionals and members of the public can comment until 14 October 2016.
https://www.nice.org.uk/news/article/nice-says-yes-to-another-hepatitis-c-drug
Watch Summary Presentation - EASL Recommendations on Treatment of Hepatitis C 2016
EASL- AASLD Special ConferenceNew perspectives in hepatitis C virus infection - The roadmap for cure
Source - EASLEurope
Online now - EASL Recommendations on Treatment of Hepatitis C
Download 2016 - Update of the HCV EASL recommendations
Watch the livestreamed EASL updated HCV recommendations with a follow-up Q&A session.
If video will not play please click here.....
Source - EASLEurope
Online now - EASL Recommendations on Treatment of Hepatitis C
Download 2016 - Update of the HCV EASL recommendations
Watch the livestreamed EASL updated HCV recommendations with a follow-up Q&A session.
If video will not play please click here.....
Epidemiology and Outcomes of Hepatitis C Infection in Elderly US Veterans
Epidemiology and Outcomes of Hepatitis C Infection in Elderly US Veterans
The chronic hepatitis C (CHC) cohort in the United States is getting older. Elderly patients with CHC may be at a high risk of cirrhosis and hepatocellular carcinoma (HCC), but also other nonhepatic comorbidities that negatively impact their likelihood of receiving or responding to antiviral treatment. There is little information on the clinical epidemiology or outcomes of CHC and its treatment in the elderly.
We conducted a retrospective cohort study of 1 61 744 patients with a positive Hepatitis C virus RNA in the Veterans Health Administration Hepatitis C Clinical Case Registry to examine the association between age subgroups (20–49, 50–64, 65–85 years) and risk of cirrhosis, HCC or death using Cox proportional hazards models. We also examined the effect of treatment with a sustained viral response (SVR) on these outcomes in each age subgroup.
The age distribution was 36.8% 20- to 49-year-olds, 57.6% 50- to 64-year-olds and 5.6% 65- to 85-year-olds (i.e. elderly). Risk of cirrhosis, HCC and death was significantly elevated in elderly patients [HR cirrhosis = 1.14 (1.00–1.29), HR HCC = 2.44 (1.99–2.99); HR death 2.09 (1.98–2.22)] compared with younger patients. The incidence of HCC was than 8.4 per 1000 PY in the elderly compared with 2.6 per 1000 PY and 5.7 per 1000 PY, among the 20–49 and 50–64 age groups, respectively. Elderly patients were significantly less likely to receive antiviral treatment (3.8% vs 14.8% and 19.1%, P < 0.0001), but among those who received treatment SVR was not different among the age groups (33.5% vs 33.2% and 32.1%).
In an analysis limited to those who received treatment, SVR compared to treatment receipt with no SVR was associated with a reduction in risk of developing cirrhosis (HR = 0.34; 0.18–0.66) and HCC (HR = 0.60; 0.22–1.61) and all-cause mortality risk (HR = 0.52, 0.33–0.82).
Elderly patients with CHC are more likely to develop HCC than younger patients but have traditionally received less antiviral treatment than younger patients. However, receipt of curative treatment is associated with a benefit in reducing cirrhosis, HCC and overall mortality, irrespective of age.
Methods
Results
Discussion
The chronic hepatitis C (CHC) cohort in the United States is getting older. Elderly patients with CHC may be at a high risk of cirrhosis and hepatocellular carcinoma (HCC), but also other nonhepatic comorbidities that negatively impact their likelihood of receiving or responding to antiviral treatment. There is little information on the clinical epidemiology or outcomes of CHC and its treatment in the elderly.
We conducted a retrospective cohort study of 1 61 744 patients with a positive Hepatitis C virus RNA in the Veterans Health Administration Hepatitis C Clinical Case Registry to examine the association between age subgroups (20–49, 50–64, 65–85 years) and risk of cirrhosis, HCC or death using Cox proportional hazards models. We also examined the effect of treatment with a sustained viral response (SVR) on these outcomes in each age subgroup.
The age distribution was 36.8% 20- to 49-year-olds, 57.6% 50- to 64-year-olds and 5.6% 65- to 85-year-olds (i.e. elderly). Risk of cirrhosis, HCC and death was significantly elevated in elderly patients [HR cirrhosis = 1.14 (1.00–1.29), HR HCC = 2.44 (1.99–2.99); HR death 2.09 (1.98–2.22)] compared with younger patients. The incidence of HCC was than 8.4 per 1000 PY in the elderly compared with 2.6 per 1000 PY and 5.7 per 1000 PY, among the 20–49 and 50–64 age groups, respectively. Elderly patients were significantly less likely to receive antiviral treatment (3.8% vs 14.8% and 19.1%, P < 0.0001), but among those who received treatment SVR was not different among the age groups (33.5% vs 33.2% and 32.1%).
In an analysis limited to those who received treatment, SVR compared to treatment receipt with no SVR was associated with a reduction in risk of developing cirrhosis (HR = 0.34; 0.18–0.66) and HCC (HR = 0.60; 0.22–1.61) and all-cause mortality risk (HR = 0.52, 0.33–0.82).
Elderly patients with CHC are more likely to develop HCC than younger patients but have traditionally received less antiviral treatment than younger patients. However, receipt of curative treatment is associated with a benefit in reducing cirrhosis, HCC and overall mortality, irrespective of age.
Free registration is required
AbbVie Presents Data on Eight-Week Treatment of VIEKIRAX® for Genotype 1b
AbbVie Presents Data on Eight-Week Treatment of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) in Patients with Genotype 1b Chronic Hepatitis C
- 98 percent of previously untreated genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected patients without cirrhosis achieved SVR12 in Phase 3b GARNET study1
- First study evaluating 8 weeks of VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets)1
- GT1b is the most common subtype globally,2 accounting for 47 percent of the nine million people infected with chronic HCV in Europe alone3,4
- GARNET study results on 8-week treatment duration included in newly published 'EASL Recommendations on Treatment of Hepatitis C'
NORTH CHICAGO, Ill., Sept. 23, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced new data showing high response rates with just eight weeks of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) treatment. In the Phase 3b GARNET study, 98 percent (n=160/163) of previously untreated patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection without cirrhosis achieved sustained virologic response rates at 12 weeks post-treatment (SVR12).1 These data were presented today at the 2016 EASL Special Conference: New Perspectives in Hepatitis C Virus Infection – The Roadmap for Cure, in Paris, France and included in the newly published 'EASL Recommendations on Treatment of Hepatitis C.' VIEKIRAX + EXVIERA is currently approved in the European Union for GT1b patients without cirrhosis or with compensated cirrhosis for 12 weeks.
"VIEKIRAX + EXVIERA has already achieved high cure rates with 12 weeks of treatment," said Stefan Zeuzem, M.D., study author and Chief of the Department of Medicine at the J.W. Goethe University Hospital in Frankfurt, Germany. "These results now show the potential for cure in just eight weeks with VIEKIRAX + EXVIERA in HCV genotype 1b infected patients without liver cirrhosis. The efficacy in this population is particularly important as GT1b is the most common subtype of hepatitis C virus globally."
Approximately 160 million people worldwide are infected with HCV.5 Genotype 1 is the most prevalent of the six major HCV genotypes, affecting an estimated 83 million people worldwide.6 In Europe, GT1b is the most predominant subtype accounting for 47 percent of the nine million people infected with chronic HCV.3,4,6
"AbbVie remains focused on continuing to explore and understand the expectations of HCV care, including a shorter treatment duration with VIEKIRAX + EXVIERA in GT1b patients," said Rob Scott, M.D., Vice President, Development and Chief Medical Officer, AbbVie.
In the GARNET study, the most commonly reported adverse events (≥5 percent) were headache (21 percent), fatigue (17 percent), nasopharyngitis (8 percent), pruritus (8 percent), nausea (6 percent) and asthenia (5 percent). These adverse events were mostly mild, with one patient discontinuing treatment due to adverse events.1
About the GARNET Study1
The Phase 3b GARNET study is a multicenter, open-label, single-arm study, investigating the safety and efficacy of eight weeks of treatment with VIEKIRAX + EXVIERA without ribavirin in treatment-naïve patients with GT1b chronic HCV infection without cirrhosis.1 The study enrolled 166 patients across 20 sites around the world. Of the 166 patients enrolled, 163 patients had GT1b chronic HCV infection without cirrhosis and three patients with other HCV genotypes were excluded from the efficacy analysis. The primary endpoint is the percentage of patients who achieved a sustained virologic response 12 weeks after treatment (SVR12).
Two patients experienced post-treatment relapse and one subject discontinued due to noncompliance. Less than one percent of patients experienced serious adverse events or clinically significant (Grade ≥3) laboratory abnormalities. One patient discontinued treatment on Day 45 due to an adverse event but achieved SVR12.
Additional information about the GARNET study can be found on www.clinicaltrials.gov.
VIEKIRAX® + EXVIERA®
VIEKIRAX + EXVIERA is approved in the European Union for the treatment of genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection.
VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA tablets consist of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily. VIEKIRAX + EXVIERA are taken with or without ribavirin (RBV), dosed twice daily based on patient type. VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV, except in genotype 1a patients with compensated cirrhosis (Child-Pugh A), who should take it for 24 weeks with RBV.
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.
Additional information about AbbVie's hepatitis C development program can be found on www.clinicaltrials.gov.
EU Indication
VIEKIRAX is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. EXVIERA is indicated in combination with other medicinal products for the treatment of CHC in adults.
Important EU Safety Information
Contraindications:
VIEKIRAX + EXVIERA are contraindicated in patients with severe hepatic impairment (Child-Pugh C). Patients taking ethinyl estradiol-containing medicinal products must discontinue them and switch to an alternative method of contraception prior to initiating VIEKIRAX + EXVIERA. Do not give VIEKIRAX with certain drugs that are sensitive CYP3A substrates or strong inhibitors of CYP3A. Do not give VIEKIRAX and EXVIERA with strong or moderate enzyme inducers. Do not give EXVIERA with certain drugs that are strong inhibitors of CYP2C8.
Special warnings and precautions for use:
VIEKIRAX and EXVIERA are not recommended as monotherapy and should be used in combination with other medicinal products for the treatment of hepatitis C infection.
Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis
VIEKIRAX and EXVIERA are not recommended in patients with moderate hepatic impairment (Child-Pugh B). Patients with cirrhosis should be monitored for signs and symptoms of hepatic decompensation, including hepatic laboratory testing at baseline and during treatment.
ALT elevations
Transient elevations of ALT to >5x ULN without concomitant elevations of bilirubin occurred in clinical trials with VIEKIRAX + EXVIERA and were more frequent in a subgroup who were using ethinyl estradiol-containing contraceptives.
Pregnancy and concomitant use with ribavirin
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when VIEKIRAX with or without EXVIERA is taken in combination with ribavirin, see section 4.6 and refer to the Summary of Product Characteristics for ribavirin for additional information.
Use with concomitant medicinal products
Use caution when administering VIEKIRAX with fluticasone or other glucocorticoids that are metabolized by CYP3A4. A reduction in colchicine dosage or interruption in colchicine is recommended in patients with normal renal or hepatic function. VIEKIRAX with or without EXVIERA is expected to increase exposure of statins so certain statins need to be discontinued or dosages reduced. Low dose ritonavir, which is part of VIEKIRAX, may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy. HIV co-infected patients without suppressive antiretroviral therapy should not be treated with VIEKIRAX.
Adverse Reactions
Most common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with RBV were fatigue and nausea.
Full summary of product characteristics is available at www.ema.europa.eu
- 98 percent of previously untreated genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected patients without cirrhosis achieved SVR12 in Phase 3b GARNET study1
- First study evaluating 8 weeks of VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets)1
- GT1b is the most common subtype globally,2 accounting for 47 percent of the nine million people infected with chronic HCV in Europe alone3,4
- GARNET study results on 8-week treatment duration included in newly published 'EASL Recommendations on Treatment of Hepatitis C'
NORTH CHICAGO, Ill., Sept. 23, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced new data showing high response rates with just eight weeks of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) treatment. In the Phase 3b GARNET study, 98 percent (n=160/163) of previously untreated patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection without cirrhosis achieved sustained virologic response rates at 12 weeks post-treatment (SVR12).1 These data were presented today at the 2016 EASL Special Conference: New Perspectives in Hepatitis C Virus Infection – The Roadmap for Cure, in Paris, France and included in the newly published 'EASL Recommendations on Treatment of Hepatitis C.' VIEKIRAX + EXVIERA is currently approved in the European Union for GT1b patients without cirrhosis or with compensated cirrhosis for 12 weeks.
"VIEKIRAX + EXVIERA has already achieved high cure rates with 12 weeks of treatment," said Stefan Zeuzem, M.D., study author and Chief of the Department of Medicine at the J.W. Goethe University Hospital in Frankfurt, Germany. "These results now show the potential for cure in just eight weeks with VIEKIRAX + EXVIERA in HCV genotype 1b infected patients without liver cirrhosis. The efficacy in this population is particularly important as GT1b is the most common subtype of hepatitis C virus globally."
Approximately 160 million people worldwide are infected with HCV.5 Genotype 1 is the most prevalent of the six major HCV genotypes, affecting an estimated 83 million people worldwide.6 In Europe, GT1b is the most predominant subtype accounting for 47 percent of the nine million people infected with chronic HCV.3,4,6
"AbbVie remains focused on continuing to explore and understand the expectations of HCV care, including a shorter treatment duration with VIEKIRAX + EXVIERA in GT1b patients," said Rob Scott, M.D., Vice President, Development and Chief Medical Officer, AbbVie.
In the GARNET study, the most commonly reported adverse events (≥5 percent) were headache (21 percent), fatigue (17 percent), nasopharyngitis (8 percent), pruritus (8 percent), nausea (6 percent) and asthenia (5 percent). These adverse events were mostly mild, with one patient discontinuing treatment due to adverse events.1
About the GARNET Study1
The Phase 3b GARNET study is a multicenter, open-label, single-arm study, investigating the safety and efficacy of eight weeks of treatment with VIEKIRAX + EXVIERA without ribavirin in treatment-naïve patients with GT1b chronic HCV infection without cirrhosis.1 The study enrolled 166 patients across 20 sites around the world. Of the 166 patients enrolled, 163 patients had GT1b chronic HCV infection without cirrhosis and three patients with other HCV genotypes were excluded from the efficacy analysis. The primary endpoint is the percentage of patients who achieved a sustained virologic response 12 weeks after treatment (SVR12).
Two patients experienced post-treatment relapse and one subject discontinued due to noncompliance. Less than one percent of patients experienced serious adverse events or clinically significant (Grade ≥3) laboratory abnormalities. One patient discontinued treatment on Day 45 due to an adverse event but achieved SVR12.
Additional information about the GARNET study can be found on www.clinicaltrials.gov.
VIEKIRAX® + EXVIERA®
VIEKIRAX + EXVIERA is approved in the European Union for the treatment of genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection.
VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA tablets consist of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily. VIEKIRAX + EXVIERA are taken with or without ribavirin (RBV), dosed twice daily based on patient type. VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV, except in genotype 1a patients with compensated cirrhosis (Child-Pugh A), who should take it for 24 weeks with RBV.
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.
Additional information about AbbVie's hepatitis C development program can be found on www.clinicaltrials.gov.
EU Indication
VIEKIRAX is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. EXVIERA is indicated in combination with other medicinal products for the treatment of CHC in adults.
Important EU Safety Information
Contraindications:
VIEKIRAX + EXVIERA are contraindicated in patients with severe hepatic impairment (Child-Pugh C). Patients taking ethinyl estradiol-containing medicinal products must discontinue them and switch to an alternative method of contraception prior to initiating VIEKIRAX + EXVIERA. Do not give VIEKIRAX with certain drugs that are sensitive CYP3A substrates or strong inhibitors of CYP3A. Do not give VIEKIRAX and EXVIERA with strong or moderate enzyme inducers. Do not give EXVIERA with certain drugs that are strong inhibitors of CYP2C8.
Special warnings and precautions for use:
VIEKIRAX and EXVIERA are not recommended as monotherapy and should be used in combination with other medicinal products for the treatment of hepatitis C infection.
Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis
VIEKIRAX and EXVIERA are not recommended in patients with moderate hepatic impairment (Child-Pugh B). Patients with cirrhosis should be monitored for signs and symptoms of hepatic decompensation, including hepatic laboratory testing at baseline and during treatment.
ALT elevations
Transient elevations of ALT to >5x ULN without concomitant elevations of bilirubin occurred in clinical trials with VIEKIRAX + EXVIERA and were more frequent in a subgroup who were using ethinyl estradiol-containing contraceptives.
Pregnancy and concomitant use with ribavirin
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when VIEKIRAX with or without EXVIERA is taken in combination with ribavirin, see section 4.6 and refer to the Summary of Product Characteristics for ribavirin for additional information.
Use with concomitant medicinal products
Use caution when administering VIEKIRAX with fluticasone or other glucocorticoids that are metabolized by CYP3A4. A reduction in colchicine dosage or interruption in colchicine is recommended in patients with normal renal or hepatic function. VIEKIRAX with or without EXVIERA is expected to increase exposure of statins so certain statins need to be discontinued or dosages reduced. Low dose ritonavir, which is part of VIEKIRAX, may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy. HIV co-infected patients without suppressive antiretroviral therapy should not be treated with VIEKIRAX.
Adverse Reactions
Most common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with RBV were fatigue and nausea.
Full summary of product characteristics is available at www.ema.europa.eu
Thursday, September 22, 2016
EASL Recommendations on Treatment of Hepatitis C 2016
Watch
Summary Presentation - EASL Recommendations on Treatment of Hepatitis C 2016
Watch the livestreamed EASL updated HCV recommendations with a follow-up Q&A session.
More on EASL HCV recommendations
The new recommendations add Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) and Zepatier (grazoprevir/elbasvir, Merck) to the arsenal of treatments
Continue reading...
EASL Recommendations on Treatment of Hepatitis C 2016
Download 2016 - Update of the HCV EASL recommendations
Summary Presentation - EASL Recommendations on Treatment of Hepatitis C 2016
Watch the livestreamed EASL updated HCV recommendations with a follow-up Q&A session.
More on EASL HCV recommendations
The new recommendations add Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) and Zepatier (grazoprevir/elbasvir, Merck) to the arsenal of treatments
Continue reading...
EASL Recommendations on Treatment of Hepatitis C 2016
Download 2016 - Update of the HCV EASL recommendations
Hepatitis C virus (HCV) infection is one of the main causes of chronic liver disease worldwide [1]. The long-term impact of HCV infection is highly variable, ranging from minimal histological changes to extensive fibrosis and cirrhosis with or without hepatocellular carcinoma (HCC).
The number of chronically infected persons worldwide is estimated to be about 180 million [2], but most are unaware of their infection. Clinical care for patients with HCV-related liver disease has advanced considerably during the last two decades, thanks to an enhanced understanding of the pathophysiology of the disease, and because of developments in diagnostic procedures and improvements in therapy and prevention.
Wednesday, September 21, 2016
Surprise: Gilead's hep C wonder Harvoni costs less in U.S. than in EU, Japan
Surprise: Gilead's hep C wonder Harvoni costs less in U.S. than in EU, Japan
by Tracy Staton
It’s no secret that Gilead Sciences’ ($GILD) slowdown in hepatitis C sales growth has caused consternation among investors, to the point where the company is under intense pressure to make some deals.
It's also no secret that Gilead had to offer some steep discounts to win formulary spots for its blockbuster hep C meds Sovaldi and Harvoni, which initially enjoyed a monopoly on the next-gen hep C market--a key reason for the crimp in their sales growth.
Now, we have some numbers that illustrate just how big Gilead’s discounts are--and how its U.S. hep C prices after those discounts compare with similar figures overseas.
Continue reading..
by Tracy Staton
It’s no secret that Gilead Sciences’ ($GILD) slowdown in hepatitis C sales growth has caused consternation among investors, to the point where the company is under intense pressure to make some deals.
It's also no secret that Gilead had to offer some steep discounts to win formulary spots for its blockbuster hep C meds Sovaldi and Harvoni, which initially enjoyed a monopoly on the next-gen hep C market--a key reason for the crimp in their sales growth.
Now, we have some numbers that illustrate just how big Gilead’s discounts are--and how its U.S. hep C prices after those discounts compare with similar figures overseas.
Continue reading..
New study to discover how “super” immune system can prevent HCV-infection
New study to discover how “super” immune system can prevent HCV-infection
New study launched to discover how “super” immune system can prevent hepatitis c
The scientists will seek the genetic basis for resistance to the virus (HCV). They invite all women who received HCV-contaminated anti-D in 1977-79 to volunteer.
20 September 2016
Scientists from Trinity College Dublin are seeking volunteers who were exposed to anti-D contaminated with hepatitis C virus (HCV) between 1977 and 1979 as they attempt to discover why some people are naturally protected from HCV infection, while others are not.
In 1977-79, hundreds of Irish women fell victim to HCV infection when they were given virus-contaminated anti-D. Usually anti-D is a blood product of great benefit given to women with blood groups incompatible with their new-born baby. It prevents the mother from building cells and molecules that would attack and destroy the foetus during a second pregnancy. Hence, it saves the life of the unborn child that would otherwise become ill or perhaps die.
However, in 1977-79 this normally beneficial product was unknowingly contaminated with HCV, which can invade and gradually destroy the liver. Until recently, researchers believed that receiving HCV-contaminated blood products, where high viral loads directly enter the blood stream, would inevitably lead to infection.
But in the aftermath of the 1977-79 outbreak, researchers made an interesting discovery: when screened for HCV almost half of the women who clearly had contact with the virus showed no signs of infection.
Professor of Comparative Immunology at Trinity College Dublin, Cliona O’Farrelly, said: “That means these women must have been naturally protected from the virus. We believe these women have an extra-special ‘super’ immune system that is able to fight viral invaders. We now want to find out why – and how – this system does such a good job.”
To do this, Professor O’Farrelly and her team will look at the information stored within the genes of naturally resistant people. The team will then compare it to the information from the genes of people who are unable to resist infection. If they uncover the mechanism behind the mystery of natural HCV-resistance, they can exploit this knowledge to find new ways to make vaccines and anti-viral drugs.
For this research project, the team seek volunteers who were exposed to HCV via contaminated anti-D in 1977-79 to help with the study. Women who became infected with HCV as well as those who show no signs of infection are invited to participate. Participation in the study is easy, and non-invasive, but could have a major impact on fighting viruses. All that is needed is a saliva sample, which can be easily collected at home and mailed to the team.
If you are interested in participating or would like to receive further information, please contact us by phone (087-791-3600) or email (TCDStudy2016@tcd.ie). Visit our website for more information: https://www.tcd.ie/Biochemistry/research/cig_hepatitisc.php
The project is funded by Science Foundation Ireland and is led by Cliona O’Farrelly, Professor of Comparative Immunology at Trinity College Dublin.
About hepatitis C-contaminated anti-D immunoglobulin
New study launched to discover how “super” immune system can prevent hepatitis c
The scientists will seek the genetic basis for resistance to the virus (HCV). They invite all women who received HCV-contaminated anti-D in 1977-79 to volunteer.
20 September 2016
Scientists from Trinity College Dublin are seeking volunteers who were exposed to anti-D contaminated with hepatitis C virus (HCV) between 1977 and 1979 as they attempt to discover why some people are naturally protected from HCV infection, while others are not.
In 1977-79, hundreds of Irish women fell victim to HCV infection when they were given virus-contaminated anti-D. Usually anti-D is a blood product of great benefit given to women with blood groups incompatible with their new-born baby. It prevents the mother from building cells and molecules that would attack and destroy the foetus during a second pregnancy. Hence, it saves the life of the unborn child that would otherwise become ill or perhaps die.
However, in 1977-79 this normally beneficial product was unknowingly contaminated with HCV, which can invade and gradually destroy the liver. Until recently, researchers believed that receiving HCV-contaminated blood products, where high viral loads directly enter the blood stream, would inevitably lead to infection.
But in the aftermath of the 1977-79 outbreak, researchers made an interesting discovery: when screened for HCV almost half of the women who clearly had contact with the virus showed no signs of infection.
Professor of Comparative Immunology at Trinity College Dublin, Cliona O’Farrelly, said: “That means these women must have been naturally protected from the virus. We believe these women have an extra-special ‘super’ immune system that is able to fight viral invaders. We now want to find out why – and how – this system does such a good job.”
To do this, Professor O’Farrelly and her team will look at the information stored within the genes of naturally resistant people. The team will then compare it to the information from the genes of people who are unable to resist infection. If they uncover the mechanism behind the mystery of natural HCV-resistance, they can exploit this knowledge to find new ways to make vaccines and anti-viral drugs.
For this research project, the team seek volunteers who were exposed to HCV via contaminated anti-D in 1977-79 to help with the study. Women who became infected with HCV as well as those who show no signs of infection are invited to participate. Participation in the study is easy, and non-invasive, but could have a major impact on fighting viruses. All that is needed is a saliva sample, which can be easily collected at home and mailed to the team.
If you are interested in participating or would like to receive further information, please contact us by phone (087-791-3600) or email (TCDStudy2016@tcd.ie). Visit our website for more information: https://www.tcd.ie/Biochemistry/research/cig_hepatitisc.php
The project is funded by Science Foundation Ireland and is led by Cliona O’Farrelly, Professor of Comparative Immunology at Trinity College Dublin.
About hepatitis C-contaminated anti-D immunoglobulin
- In Ireland two hepatitis C virus (HCV) outbreaks have occurred due to HCV-contaminated anti-D immunoglobulin – the first occurred between 1977 and 1979, and the second between 1991 and 1994
- Anti-D immunoglobulin is a blood-derived medical product given to women who have the rhesus negative (Rh-) blood group and who have a rhesus positive (Rh+) baby. The anti-D immunoglobulin prevents the development of rhesus haemolytic disease of the newborn, which arises in subsequent pregnancies
- Over 1,000 women were infected with HCV in Ireland due to HCV-contaminated anti-D immunoglobulin. Of these women, approximately half had evidence of past infection (antibodies) but no circulating virus, while the other half developed chronic infection
- During the 1977-1979 outbreak ~50% of women who received high-risk HCV-contaminated anti-D batches were infected, but the rest of the women who received these high-risk batches were able to resist this infection
- Hepatitis C was not discovered until 1989. Prior to this, it was known in medicine as non-A, non-B viral hepatitis
- The hepatitis C virus is a blood-borne virus. The most common mode of infection prior to the discovery of the virus was via medical equipment that had been inadequately sterilized, and via the transfusion of unscreened blood and blood products. This mode of infection remains a problem in developing countries.
- Presently, the most common mode of infection in developed countries is via unsafe injection practices
- Hepatitis C is a virus that targets, invades and gradually damages the liver. This irreversible liver damage is called liver cirrhosis
- Up to 20% of chronically infected individuals will develop cirrhosis of the liver over a 20 to 25-year period. Approximately 3% - 4% of patients with cirrhosis will develop hepatocellular carcinoma (HCC) per year
- Over 1% of the world’s population is chronically infected with HCV
- Approximately 700,000 people die each year from HCV-related liver diseases
- New antiviral medicines available in the last 2-3 years can cure up to 90% of persons with hepatitis C infection, but these therapies are extremely expensive.
- There is currently no vaccine for hepatitis C
Watch - Hepatitis C Medication Update
Hepatitis C Medication Update
Abigail Yancey, '02/'03, associate professor of pharmacy practice, provides an update on Hepatitis C medications and their place in therapy.
Highlights
Therapy Options
2016 Therapy Updates
Therapy Options: Which one to use?
Hepatitis C: Other Helpful Tips
Safety Of Statins
Aches and Pains? What OTC is Safe?
Pricing
Uploaded Sept 21, 2016
By STLCOP 1864
Abigail Yancey, '02/'03, associate professor of pharmacy practice, provides an update on Hepatitis C medications and their place in therapy.
Highlights
Therapy Options
2016 Therapy Updates
Therapy Options: Which one to use?
Hepatitis C: Other Helpful Tips
Safety Of Statins
Aches and Pains? What OTC is Safe?
Pricing
Uploaded Sept 21, 2016
By STLCOP 1864
Hepatitis Australia - Pharmaceutical Benefits Advisory
First pan-genotypic, interferon-free regimens for hepatitis C a step closer
20 September 2016
Hepatitis Australia will be gathering information from people living with hepatitis C who will benefit from the latest medicines to be considered by the Pharmaceutical Benefits Advisory Committee. In particular we would like input from people living with hepatitis C genotypes 2, 3, 4, 5 and 6.
Hepatitis Australia will be making a submission and would welcome your input ahead of the November PBAC meeting.
20 September 2016
Hepatitis Australia will be gathering information from people living with hepatitis C who will benefit from the latest medicines to be considered by the Pharmaceutical Benefits Advisory Committee. In particular we would like input from people living with hepatitis C genotypes 2, 3, 4, 5 and 6.
Hepatitis Australia will be making a submission and would welcome your input ahead of the November PBAC meeting.
The medicines being considered at the November meeting of PBAC include:
Further details
Add your voice for the upcoming PBAC submission in November
- Sofosbuvir (400mg) + velpatasvir (100mg) – Epclusa® by Gilead Sciences
- Ledipasvir (90mg) + sofosbuvir (400mg) – Harvoni® by Gilead Sciences
- Paritaprevir (75mg) + ritonavir (50mg) + ombitasvir (12.5mg) – Technivie® by AbbVie
Further details
Add your voice for the upcoming PBAC submission in November
Tuesday, September 20, 2016
La. Officials Say Several Hundred People Now Getting Life-Saving Treatment Through Medicaid
La. Officials Say Several Hundred People Now Getting Life-Saving Treatment Through Medicaid
Louisiana health officials point to specific examples of treatment for breast cancer, diabetes and colon cancer screening to highlight Medicaid expansion efforts. In other news, the ACLU sues Colorado for its policy denying some Medicaid enrollees hepatitis C treatment, and insurers sue Pennsylvania over a Medicaid contract.Louisiana leaders say that hundreds of residents newly added to the state's Medicaid rolls have received potentially life-saving treatment since the health care program was expanded earlier this year. Twenty-four women are getting breast cancer treatment after positive screenings, 160 adults have been diagnosed with diabetes and are receiving treatment and more than 100 patients had polyps removed after they were found during colonoscopies. ... More than 305,000 adults have been been added to Medicaid since the state expanded eligibility for the health care program in July. (Crisp, 9/19)
Two and half months after Medicaid expansion came to Louisiana, Gov. John Bel Edwards' administration is touting figures that show people are taking advantage of broader access to health care. ... Louisiana is the first state in the Deep South to implement Medicaid expansion, but the 31st state in the nation to adopt the program. (O'Donoghue, 9/19)
Colorado’s Medicaid department was slapped with a federal class-action lawsuit Monday led by a Denver man denied treatment for the life-threatening hepatitis C virus because he has government insurance. ... Colorado covers the 12-week, $40,000 prescription only for people whose livers have reached stage two in scarring, on a scale of zero to four. (Brown, 9/19)
Four losing bidders have protested the Pennsylvania Department of Human Services' award last month of three-year contracts to manage long-term care for Medicaid beneficiaries, the agency said Monday. Pennsylvania's Community HealthChoices represents a major overhaul of how the state pays for nursing home stays, home care, and other supports for the elderly and the physically disabled older than 21. The affected population totals about 420,000, including 120,000 to 130,000 seniors. (Brubaker, 9/19)
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