INDIANAPOLIS — Lawmakers looking to prevent a repeat of an HIV outbreak that has rocked a southern Indiana county sent Republican Gov. Mike Pence a measure Wednesday that would allow communities to implement needle-exchange programs if they can prove they're in the midst of an epidemic tied to intravenous drug use.
Pence, who opposes needle exchanges as part of anti-drug policy, said in a statement Wednesday that he looks forward to signing the legislation into law.
He said his office worked with lawmakers to develop "a legal framework" that would give state health officials the resources and flexibility they need to handle health emergencies.
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Thursday, April 30, 2015
May 2015 Recognized as Hepatitis C Awareness Month: Chicago Lawmaker Continues to Bring the “Silent Epidemic” to the Forefront
Springfield, IL … Yesterday, the Illinois House of Representatives adopted House Resolution 214 which designates next month as "Hepatitis C Awareness Month. The initiative, which was led by State Representative Michael McAuliffe (R-Chicago), received unanimous support as it continues to shine light upon a disease which, up until recently, received very little attention.
"Hepatitis C has been affecting people for decades. However, due to a lack of awareness, there is large segment of the population that is considered at-risk of having unknowingly contracted the virus," explained McAuliffe. "Hepatitis C became known as the 'Silent Epidemic' due to a general lack of knowledge of the at-risk groups and treatment options, and in recent years, the medical community has identified veterans of the Vietnam-era and anyone born between the years of 1945 and 1965 to be at increased risk of carrying the virus."
McAuliffe has been a leader in tackling awareness, treatment and prevention issues for the Hepatitis C virus since 2013 when he pioneered the creation of the Hepatitis C Task Force in Springfield. The task force, which was the first of its kind in Illinois, was inspired by his own personal story of how he saw the effects of the disease on close family members. Since its creation, the bipartisan task force members have successfully recommended thoughtful legislation. The group was recently recognized by the House for their positive work by receiving an extension to continue their work until 2017.
Read more...
"Hepatitis C has been affecting people for decades. However, due to a lack of awareness, there is large segment of the population that is considered at-risk of having unknowingly contracted the virus," explained McAuliffe. "Hepatitis C became known as the 'Silent Epidemic' due to a general lack of knowledge of the at-risk groups and treatment options, and in recent years, the medical community has identified veterans of the Vietnam-era and anyone born between the years of 1945 and 1965 to be at increased risk of carrying the virus."
McAuliffe has been a leader in tackling awareness, treatment and prevention issues for the Hepatitis C virus since 2013 when he pioneered the creation of the Hepatitis C Task Force in Springfield. The task force, which was the first of its kind in Illinois, was inspired by his own personal story of how he saw the effects of the disease on close family members. Since its creation, the bipartisan task force members have successfully recommended thoughtful legislation. The group was recently recognized by the House for their positive work by receiving an extension to continue their work until 2017.
Read more...
Study results promising for hepatitis C patients awaiting or completing liver transplant
Public Release:
SAN ANTONIO (April 30 2015) -- A number of new, highly effective oral treatments for various types of hepatitis C have been approved in the past few years. However, two groups who have not benefitted from the new treatments are patients with hepatitis C who have advanced liver disease and patients who have received a liver transplant but the advanced liver disease has returned because of hepatitis C.
"The problem for these patients is that unless the hepatitis C is cured, the virus continues circulating in their blood infecting the new liver, usually within a few months of transplant. One-third of them have cirrhosis again within five years," explained Fred Poordad, M.D., clinical professor of medicine and chief of hepatology at The University of Texas Health Science Center at San Antonio.
"This puts these patients back at high risk of dying from chronic hepatitis C or liver disease," said Dr. Poordad, principal investigator of the ALLY-1 study, who presented the results April 25 at The International Liver CongressTM of the European Association for the Study of the Liver (EASL) in Vienna, Austria.
The Phase III clinical trial evaluated a 12-week course of daclatasvir - the new drug being evaluated - combined with sofosbuvir and ribavirin for patients with chronic hepatitis C. Patients accepted into the trial either had a liver transplant with returning hepatitis C or had hepatitis C with advanced cirrhosis (scarring of the liver).
Study results showed an overall cure rate of 94 percent for patients with a liver transplant and returning hepatitis C, and 83 percent for patients with advanced cirrhosis.
The study's primary endpoints also were reached, with 95 percent of post-transplant genotype 1 patients and 82 percent of genotype 1 patients with advanced cirrhosis being cured 12 weeks after treatment. Patients with other genotypes of the disease were enrolled as well, with benefits seen in all groups.
Genotypes are subgroups or strains of a disease, such as hepatitis C. There are many subtypes of hepatitis C based on the geographic regions where the strain is most prevalent. Over time, each strain evolved differently so that treatments are based on the genotype of the disease. For example, genotype 1 is the type of hepatitis C most common in the United States and is the most difficult to treat.
The study regimen was well tolerated and showed few serious side effects. "Transplant patients take a variety of medications to prevent organ rejection that can complicate the treatment of hepatitis C. In ALLY-1, we saw no drug-to-drug interactions between transplant and hepatitis C therapies and no need to make close adjustments to patients' transplant-related drugs while they received the hepatitis C regimen," Dr. Poordad said.
The ALLY-1 study was conducted at five major transplant centers in San Antonio and Houston, Texas; Miami, Fla.; Ann Arbor, Mich., and Seattle, Wash.
Hepatitis C is a liver disease found worldwide that is spread though contact with blood or semen, such as shared drug injection needles, inadequate sterilization of medical equipment, unscreened blood and blood products, accidental needle sticks in the health profession, and sexual intercourse with a person who has hepatitis C. The disease also can be passed from mothers to their children through the birthing process.
According to the U.S. Centers for Disease Control and Prevention, 3.2 million people in the U.S. have chronic hepatitis C, and 70 to 80 percent do not have symptoms. Nonetheless, it is a serious disease that can lead to long-term health problems such as liver damage, liver failure, liver cancer and death. It is often discovered later, after significant liver damage has occurred.
In the U.S., people born between 1945 and 1965 have the highest risk of hepatitis C due to higher drug use. People in this age group are urged to have a one-time blood test for hepatitis C to detect the virus and begin receiving treatment, if necessary, before significant liver damage occurs. There is no vaccine to prevent hepatitis C.
Daclatasvir, a drug developed by Bristol-Myers Squibb, was approved in Europe in 2014 for use with other medications for genotypes 1 through 4 for the treatment of chronic hepatitis C in adults. It is also approved in Japan as well as many countries in Central and South America, the Middle East and Asia Pacific. Daclatasvir regimens also have been included in the EASL's recommendations for the treatment of hepatitis C in Europe.
The U.S. Food and Drug Administration is reviewing daclatasvir for possible approval in the United States.
For current news from the UT Health Science Center San Antonio, please visit our news release website, like us on Facebook or follow us on Twitter.
The University of Texas Health Science Center at San Antonio, one of the country's leading health sciences universities, ranks in the top 13 percent of academic institutions receiving National Institutes of Health (NIH) funding. The university's schools of medicine, nursing, dentistry, health professions and graduate biomedical sciences have produced more than 29,000 graduates. The $787.7 million operating budget supports eight campuses in San Antonio, Laredo, Harlingen and Edinburg. For more information on the many ways "We make lives better®," visit http://www.
The Texas Liver Institute's mission is to set the standard of excellence in care and innovative research in the field of liver disease. The institute is affiliated with The University of Texas Health Science Center at San Antonio. The physicians are professors and teach at University Hospital of the University Health System and are involved with the liver transplantation program of the University Transplant Center, a partnership of the Health Science Center and the University Health System. For more information, visit http://www.
UT Health Science Center San Antonio doctor presents results of daclatasvir regimen
University of Texas Health Science Center at San Antonio
SAN ANTONIO (April 30 2015) -- A number of new, highly effective oral treatments for various types of hepatitis C have been approved in the past few years. However, two groups who have not benefitted from the new treatments are patients with hepatitis C who have advanced liver disease and patients who have received a liver transplant but the advanced liver disease has returned because of hepatitis C.
"The problem for these patients is that unless the hepatitis C is cured, the virus continues circulating in their blood infecting the new liver, usually within a few months of transplant. One-third of them have cirrhosis again within five years," explained Fred Poordad, M.D., clinical professor of medicine and chief of hepatology at The University of Texas Health Science Center at San Antonio.
"This puts these patients back at high risk of dying from chronic hepatitis C or liver disease," said Dr. Poordad, principal investigator of the ALLY-1 study, who presented the results April 25 at The International Liver CongressTM of the European Association for the Study of the Liver (EASL) in Vienna, Austria.
The Phase III clinical trial evaluated a 12-week course of daclatasvir - the new drug being evaluated - combined with sofosbuvir and ribavirin for patients with chronic hepatitis C. Patients accepted into the trial either had a liver transplant with returning hepatitis C or had hepatitis C with advanced cirrhosis (scarring of the liver).
Study results showed an overall cure rate of 94 percent for patients with a liver transplant and returning hepatitis C, and 83 percent for patients with advanced cirrhosis.
The study's primary endpoints also were reached, with 95 percent of post-transplant genotype 1 patients and 82 percent of genotype 1 patients with advanced cirrhosis being cured 12 weeks after treatment. Patients with other genotypes of the disease were enrolled as well, with benefits seen in all groups.
Genotypes are subgroups or strains of a disease, such as hepatitis C. There are many subtypes of hepatitis C based on the geographic regions where the strain is most prevalent. Over time, each strain evolved differently so that treatments are based on the genotype of the disease. For example, genotype 1 is the type of hepatitis C most common in the United States and is the most difficult to treat.
The study regimen was well tolerated and showed few serious side effects. "Transplant patients take a variety of medications to prevent organ rejection that can complicate the treatment of hepatitis C. In ALLY-1, we saw no drug-to-drug interactions between transplant and hepatitis C therapies and no need to make close adjustments to patients' transplant-related drugs while they received the hepatitis C regimen," Dr. Poordad said.
The ALLY-1 study was conducted at five major transplant centers in San Antonio and Houston, Texas; Miami, Fla.; Ann Arbor, Mich., and Seattle, Wash.
Hepatitis C is a liver disease found worldwide that is spread though contact with blood or semen, such as shared drug injection needles, inadequate sterilization of medical equipment, unscreened blood and blood products, accidental needle sticks in the health profession, and sexual intercourse with a person who has hepatitis C. The disease also can be passed from mothers to their children through the birthing process.
According to the U.S. Centers for Disease Control and Prevention, 3.2 million people in the U.S. have chronic hepatitis C, and 70 to 80 percent do not have symptoms. Nonetheless, it is a serious disease that can lead to long-term health problems such as liver damage, liver failure, liver cancer and death. It is often discovered later, after significant liver damage has occurred.
In the U.S., people born between 1945 and 1965 have the highest risk of hepatitis C due to higher drug use. People in this age group are urged to have a one-time blood test for hepatitis C to detect the virus and begin receiving treatment, if necessary, before significant liver damage occurs. There is no vaccine to prevent hepatitis C.
Daclatasvir, a drug developed by Bristol-Myers Squibb, was approved in Europe in 2014 for use with other medications for genotypes 1 through 4 for the treatment of chronic hepatitis C in adults. It is also approved in Japan as well as many countries in Central and South America, the Middle East and Asia Pacific. Daclatasvir regimens also have been included in the EASL's recommendations for the treatment of hepatitis C in Europe.
The U.S. Food and Drug Administration is reviewing daclatasvir for possible approval in the United States.
###
For current news from the UT Health Science Center San Antonio, please visit our news release website, like us on Facebook or follow us on Twitter.
The University of Texas Health Science Center at San Antonio, one of the country's leading health sciences universities, ranks in the top 13 percent of academic institutions receiving National Institutes of Health (NIH) funding. The university's schools of medicine, nursing, dentistry, health professions and graduate biomedical sciences have produced more than 29,000 graduates. The $787.7 million operating budget supports eight campuses in San Antonio, Laredo, Harlingen and Edinburg. For more information on the many ways "We make lives better®," visit http://www.
The Texas Liver Institute's mission is to set the standard of excellence in care and innovative research in the field of liver disease. The institute is affiliated with The University of Texas Health Science Center at San Antonio. The physicians are professors and teach at University Hospital of the University Health System and are involved with the liver transplantation program of the University Transplant Center, a partnership of the Health Science Center and the University Health System. For more information, visit http://www.
Hepatitis C: Drug Prices, Lack of Testing are Challenges
The tougher challenge, discussed at a closing day session led by the World Health Organization is finding a way to step up testing. “Treating patients is not difficult; finding them is,” Peck said, "You can't treat what you haven't found."
Despite the wealth of choices physicians have in finding drugs to treat hepatitis C infection, two challenges remain in eradicating the disease—drug price and lack of global screening for the virus.
“Price is solvable,” said Markus Peck, MD, the outgoing secretary of the European Society for the Study of the Liver (EASL) interviewed at the International Liver Congress in Vienna, Austria.
“Pharma has to make some money on these drugs,” Peck said, since their cost of developing them has been high, “but as there is more competition we are quite sure the price will go down.”
There are currently 7 different classifications of drugs that fight hepatitis C. Those are nucleoside and nucleotide NS5B polymerase inhibitors, nucleoside analogs, protease inhibitors, nucleoside analogs, pegylated interferon, NS5A inhibitors, non-nucleoside NS5B inhibitors, and combination drugs that draw on two or more of those classes.
Not counting interferon, there are also 7 drugs or drug combos approved by the US Food and Drug Administration and another 14 in phase 3 drug trials.
- See more at: http://www.hcplive.com/conference-coverage/easl-2015/Hepatitis-C-Price-Lack-of-Testing-are-Challenges#sthash.ggeNy7xf.dpuf
Tuesday, April 28, 2015
Patients infected with Hepatitis C after visiting Santa Barbara doctor
At least five patients tested positive for Hepatitis C after receiving injections at a Santa Barbara doctor’s medical office, public health officials said.
Now, the Santa Barbara County Public Health Department is urging any patients who visited the medical office of Allen Thomashefsky to get tested for Hepatitis B, Hepatitis C and HIV.
Public health officials performed two inspections at Thomashefsky’s office in November 2014 after they received information that a patient with no known risk factors developed Hepatitis C following a visit. The patient underwent multiple injections at his office.
Read more...
Now, the Santa Barbara County Public Health Department is urging any patients who visited the medical office of Allen Thomashefsky to get tested for Hepatitis B, Hepatitis C and HIV.
Public health officials performed two inspections at Thomashefsky’s office in November 2014 after they received information that a patient with no known risk factors developed Hepatitis C following a visit. The patient underwent multiple injections at his office.
Read more...
Living Liver Donors Report Lower Sexual Function in Early Months Post-Surgery
Donor Education Pre-Transplant May Help Improve Recovery, Reduce Concerns
A new study found that sexual function in adult living donors was lower at the evaluation phase and at three months following liver transplantation. Results published in Liver Transplantation, a journal of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society, suggest that donor education prior to surgery may improve recovery and ease concerns about sexual function following the transplant.
Living liver donors provide a healthy portion of their liver to an individual with end-stage liver disease. These donors make a personal sacrifice to help save another individual from certain death. Much of the medical literature focuses on the health-related quality of life of donors, but limited evidence is available regarding sexual function. A prior single-center study found that nearly 50% of donors reported a worsening of sexual function one week to one month following donation, returning to normal at three months post-operation.
“To further knowledge in this important area, our study sought to identify the extent of sexual concerns for liver donors,” said lead author Dr. Andrea DiMartini with Western Psychiatric Institute and Clinic in Pittsburgh, Pa. “Our investigation examined sexual functioning of liver donors before and after donation using data from a multi-site investigation, known as the Adult-to-Adult Living Donor Liver Transplantation Cohort Study (A2ALL).
For this study the team examined the sexual function of 208 liver donors and any changes that may occur during the first year following donation using self-reported surveys. A group of 155 non-donors also completed the survey that included questions regarding sexual desire, satisfaction, orgasm, and erectile function in men.
Analyses show that donor sexual performance was lower at the time of evaluation and three months after transplant surgery than at one year following donation. Researchers found that during the early recovery phase, abdominal pain was linked to difficulty reaching orgasm; concerns over appearance was associated with lower sexual desire; and not feeling back to normal correlated to a dissatisfaction with sexual life.
Dr. DiMartini concludes, “The goal of all donor teams is to create a positive experience, both mentally and physically, and reduce stress for organ donors. Our findings suggest that providing more information to donors about what to expect with sexual function will help ease concerns and prepare themselves for the early days following liver transplant surgery.”
This study was funded in part by the National Institute of Diabetes & Digestive & Kidney Diseases (grants U01-DK62444, U01-DK62467, U01-DK62483, U01-DK62484, U01-DK62494, U01-DK62496, U01-DK62498, U01-DK62505, U01-DK62531, U01-DK085587, U01-DK85515, and U01-DK62536), the Health Resources and Services Administration (HRSA), and the American Society of Transplant Surgeons (ASTS).
Access the full study on the Wiley Press Room here. (To access PDFs and embargoed stories you must be logged in to the Press Room before clicking the link. Request a login here.)
Full citation: “Patterns and Predictors of Sexual Function after Liver Donation: the Adult to Adult Living Donor Liver Transplantation Cohort Study (A2ALL).” AF DiMartini, MA Dew, Z Butt, MA Simpson, DP Ladner, AR Smith, P Hill-Callahan and BW Gillespie. Liver Transplantation; (DOI: 10.1002/lt.24108).
URL: http://doi.wiley.com/10.1022/lt.24108
Author Contact: Media wishing to speak with Dr. DiMartini may contact Jenya Abramovich with Arbor Research at jenya.abramovich@arborresearch.org.
About the Journal
Liver Transplantation is published by Wiley on behalf of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. Since the first application of liver transplantation in a clinical situation was reported more than twenty years ago, there has been a great deal of growth in this field and more is anticipated. As an official publication of the AASLD and the ILTS, Liver Transplantation delivers current, peer-reviewed articles on surgical techniques, clinical investigations and drug research — the information necessary to keep abreast of this evolving specialty. For more information, please visit http://wileyonlinelibrary.com/journal/lt.
About Wiley
Wiley is a global provider of knowledge and knowledge-enabled services that improve outcomes in areas of research, professional practice and education. Through the Research segment, the Company provides digital and print scientific, technical, medical, and scholarly journals, reference works, books, database services, and advertising. The Professional Development segment provides digital and print books, online assessment and training services, and test prep and certification. In Education, Wiley provides education solutions including online program management services for higher education institutions and course management tools for instructors and students, as well as print and digital content.
Full citation: “Patterns and Predictors of Sexual Function after Liver Donation: the Adult to Adult Living Donor Liver Transplantation Cohort Study (A2ALL).” AF DiMartini, MA Dew, Z Butt, MA Simpson, DP Ladner, AR Smith, P Hill-Callahan and BW Gillespie. Liver Transplantation; (DOI: 10.1002/lt.24108).
URL: http://doi.wiley.com/10.1022/lt.24108
Author Contact: Media wishing to speak with Dr. DiMartini may contact Jenya Abramovich with Arbor Research at jenya.abramovich@arborresearch.org.
About the Journal
Liver Transplantation is published by Wiley on behalf of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. Since the first application of liver transplantation in a clinical situation was reported more than twenty years ago, there has been a great deal of growth in this field and more is anticipated. As an official publication of the AASLD and the ILTS, Liver Transplantation delivers current, peer-reviewed articles on surgical techniques, clinical investigations and drug research — the information necessary to keep abreast of this evolving specialty. For more information, please visit http://wileyonlinelibrary.com/journal/lt.
About Wiley
Wiley is a global provider of knowledge and knowledge-enabled services that improve outcomes in areas of research, professional practice and education. Through the Research segment, the Company provides digital and print scientific, technical, medical, and scholarly journals, reference works, books, database services, and advertising. The Professional Development segment provides digital and print books, online assessment and training services, and test prep and certification. In Education, Wiley provides education solutions including online program management services for higher education institutions and course management tools for instructors and students, as well as print and digital content.
Monday, April 27, 2015
EASL 2015: Alcohol use disorders – stronger predictor of mortality than chronic hepatitis C virus infection
Chronic hepatitis C infection is associated with increased risk of mortality when severe comorbidities and/or alcohol use disorders are also present
April 25, 2015, Vienna, Austria: Results presented today at The International Liver Congress™ 2015, show that alcohol use disorders (AUD) have a serious, negative prognostic outcome with higher mortality risks in the general population and patients with hepatitis C virus (HCV) infection in particular.
The study found that chronic HCV infection has a limited impact on mortality, unless the patient also has other severe comorbidities, such as HIV infection, cancer or chronic kidney disease. In contrast, those with AUDs are at significant risk of death with a higher mortality risk observed across all the study subgroups.
Michaël Schwarzinger, Director, THEN (Translational Health Economics Network) and Vincent Mallet, Professor of Hepatology, Université Paris Descartes and Assistance Publique – Hôpitaux de Paris, France, commented: "There is an epidemiological relationship between chronic HCV infection and AUD. However, the burden of chronic HCV infection analyses barely take into account the potential confounding role of AUD on prognosis. Our primary aim was to study the confounding role of severe comorbidities and AUD on prognosis in Hep C patients in a real-life setting."
Between 2008 and 2012, 28,953,755 adults residing in Metropolitan France were hospitalised and 1,506,453 died at hospital. All hospitalised patients were characterised by severe comorbidities and their trajectory was tracked according to chronic HCV infection and/or AUD. Chronic HCV infection was present in 112,146 (0.39%) of hospitalised patients, AUD in 705,259 (2.44%), and both chronic HCV infection and AUD in 23,351 (i.e., 20.8% AUD recorded in Hep C patients).
The researchers found that:
This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Specialists share research studies and findings, and discuss the hottest topics related to liver disease. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. 2015 is a very special year for EASL and the hepatology community as they will celebrate the 50th annual meeting. The International Liver Congress™ takes place from April 22-26, 2015, Vienna, Austria.
About EASL
Since EASL's foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from more than 100 countries around the world. EASL is the leading liver association in Europe, it attracts the foremost hepatology experts and has an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.
Contact
For more information, please contact the ILC Press Office at:
ilc.press@easloffice.eu or
+44 (0)20 3580 5444
General session 3, Hall D Presentation time: 09:45-10:00 Presenter: Michaël Schwarzinger (France)
Abstract G16:THE COUNFOUNDING ROLE OF SEVERE COMORBIDITIES AND ALCOHOL USE DISORDERS ON PROGNOSIS IN CHRONIC HEPATITIS C VIRUS INFECTION: AN ANALYSIS OF THE 2008-2012 FRENCH NATIONAL HOSPITAL DISCHARGE DATABASE
Michaël Schwarzinger* 1, Sophie Thiébaut2, Vincent Mallet3, Jürgen Rehm4 1THEN (Translational Health Economics Network), Paris, Canada, 2THEN (Translational Health Economics Network), 3Hepatology, Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Paris, France, 4Social and Epidemiological Research (SER) Department, Centre for Addiction and Mental Health, Toronto, Canada
Background and Aims: There is an epidemiological relationship between chronic hepatitis C virus (HCV) infection and alcohol use disorders (AUD). AUD is a leading cause of liver disease and death. However, burden of chronic HCV infection analyses barely take into account the potential confounding role of AUD on prognosis. Our aim was to compare the prognostic value of chronic HCV infection and AUD in the general population.
Methods: In 2008-2012, 28,953,755 adult individuals residing in Metropolitan France were hospitalized and 1,506,453 died at hospital (51.6% and 55.7% of National Vital Statistics, respectively). We characterized all hospitalized patients by severe comorbidities (see Table), and tracked their trajectory according to chronic HCV infection and/or AUD (including withdrawal/abstinence). Age at death was analyzed in multivariate Cox proportional hazards model from January 2008 to last discharge or transplantation with stratification by gender, main French regions, and having received care in teaching hospitals.
Results: Chronic HCV infection was present in 112,146 (0.39%) of hospitalized patients, AUD in 705,259 (2.44%), both chronic HCV infection and AUD in 23,351(0.08%; i.e., 20.8% of HCV and 3.3% of AUD). Overall, the adjusted hazard ratio of in-hospital death (aHR) was 1.90 (95% confidence interval 1.86-1.94), for chronic HCV infection and 3.13 (3.10-3.15) for AUD, with a negative interaction effect between chronic HCV infection and AUD (aHR, 0.93; 0.90-0.97). Alcohol withdrawal or abstinence was significantly associated with lower mortality risks (HR, 0.66; 0.65-0.67). Subgroup analyses by severe comorbidities revealed that chronic HCV infection was only associated with higher mortality risks in presence of severe comorbidities (Table: groups 1 to 4, and 7 to 12). In absence of severe comorbidities, the prognostic value of chronic HCV infection at all liver disease stages was either not statistically significant among patients with cirrhosis and milder liver disease stage (groups 13 to 17). In contrast, AUD was associated with higher mortality risks in all prognostic subgroups, including all liver disease stages.
Conclusions: AUD has a dismal prognostic value in the general population and in the minority group of patients with chronic HCV infection. Alcohol withdrawal and abstinence increase survival regardless of HCV treatment.
Disclosure of Interest: None Declared
The study found that chronic HCV infection has a limited impact on mortality, unless the patient also has other severe comorbidities, such as HIV infection, cancer or chronic kidney disease. In contrast, those with AUDs are at significant risk of death with a higher mortality risk observed across all the study subgroups.
Michaël Schwarzinger, Director, THEN (Translational Health Economics Network) and Vincent Mallet, Professor of Hepatology, Université Paris Descartes and Assistance Publique – Hôpitaux de Paris, France, commented: "There is an epidemiological relationship between chronic HCV infection and AUD. However, the burden of chronic HCV infection analyses barely take into account the potential confounding role of AUD on prognosis. Our primary aim was to study the confounding role of severe comorbidities and AUD on prognosis in Hep C patients in a real-life setting."
Between 2008 and 2012, 28,953,755 adults residing in Metropolitan France were hospitalised and 1,506,453 died at hospital. All hospitalised patients were characterised by severe comorbidities and their trajectory was tracked according to chronic HCV infection and/or AUD. Chronic HCV infection was present in 112,146 (0.39%) of hospitalised patients, AUD in 705,259 (2.44%), and both chronic HCV infection and AUD in 23,351 (i.e., 20.8% AUD recorded in Hep C patients).
The researchers found that:
- Chronic HCV infection was mostly associated with higher mortality risks in the presence of severe comorbidities (e.g., HIV/AIDS, liver transplant receipt)
- In the absence of severe comorbidities, the prognostic value of chronic HCV infection was mostly explained by the presence of AUD (end-stage liver disease and mortality)
- More broadly, AUD was associated with higher mortality risks in all hospitalized patients, and alcohol withdrawal or abstinence was significantly associated with lower mortality risks
###
About The International Liver Congress™ This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Specialists share research studies and findings, and discuss the hottest topics related to liver disease. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. 2015 is a very special year for EASL and the hepatology community as they will celebrate the 50th annual meeting. The International Liver Congress™ takes place from April 22-26, 2015, Vienna, Austria.
About EASL
Since EASL's foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from more than 100 countries around the world. EASL is the leading liver association in Europe, it attracts the foremost hepatology experts and has an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.
Contact
For more information, please contact the ILC Press Office at:
ilc.press@easloffice.eu or
+44 (0)20 3580 5444
General session 3, Hall D Presentation time: 09:45-10:00 Presenter: Michaël Schwarzinger (France)
Abstract G16:THE COUNFOUNDING ROLE OF SEVERE COMORBIDITIES AND ALCOHOL USE DISORDERS ON PROGNOSIS IN CHRONIC HEPATITIS C VIRUS INFECTION: AN ANALYSIS OF THE 2008-2012 FRENCH NATIONAL HOSPITAL DISCHARGE DATABASE
Michaël Schwarzinger* 1, Sophie Thiébaut2, Vincent Mallet3, Jürgen Rehm4 1THEN (Translational Health Economics Network), Paris, Canada, 2THEN (Translational Health Economics Network), 3Hepatology, Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Paris, France, 4Social and Epidemiological Research (SER) Department, Centre for Addiction and Mental Health, Toronto, Canada
Background and Aims: There is an epidemiological relationship between chronic hepatitis C virus (HCV) infection and alcohol use disorders (AUD). AUD is a leading cause of liver disease and death. However, burden of chronic HCV infection analyses barely take into account the potential confounding role of AUD on prognosis. Our aim was to compare the prognostic value of chronic HCV infection and AUD in the general population.
Methods: In 2008-2012, 28,953,755 adult individuals residing in Metropolitan France were hospitalized and 1,506,453 died at hospital (51.6% and 55.7% of National Vital Statistics, respectively). We characterized all hospitalized patients by severe comorbidities (see Table), and tracked their trajectory according to chronic HCV infection and/or AUD (including withdrawal/abstinence). Age at death was analyzed in multivariate Cox proportional hazards model from January 2008 to last discharge or transplantation with stratification by gender, main French regions, and having received care in teaching hospitals.
Results: Chronic HCV infection was present in 112,146 (0.39%) of hospitalized patients, AUD in 705,259 (2.44%), both chronic HCV infection and AUD in 23,351(0.08%; i.e., 20.8% of HCV and 3.3% of AUD). Overall, the adjusted hazard ratio of in-hospital death (aHR) was 1.90 (95% confidence interval 1.86-1.94), for chronic HCV infection and 3.13 (3.10-3.15) for AUD, with a negative interaction effect between chronic HCV infection and AUD (aHR, 0.93; 0.90-0.97). Alcohol withdrawal or abstinence was significantly associated with lower mortality risks (HR, 0.66; 0.65-0.67). Subgroup analyses by severe comorbidities revealed that chronic HCV infection was only associated with higher mortality risks in presence of severe comorbidities (Table: groups 1 to 4, and 7 to 12). In absence of severe comorbidities, the prognostic value of chronic HCV infection at all liver disease stages was either not statistically significant among patients with cirrhosis and milder liver disease stage (groups 13 to 17). In contrast, AUD was associated with higher mortality risks in all prognostic subgroups, including all liver disease stages.
Conclusions: AUD has a dismal prognostic value in the general population and in the minority group of patients with chronic HCV infection. Alcohol withdrawal and abstinence increase survival regardless of HCV treatment.
Disclosure of Interest: None Declared
Saturday, April 25, 2015
EASL 2015: ALLY-1 Trial Results Show Investigational Daclatasvir-Based Regimen Cures 94% of Post-Liver Transplant Patients with Hepatitis C and Up to 94% of Hepatitis C Patients with Cirrhosis (Child-Pugh Class A or B)
- 97% of post-transplant patients with HCV genotype 1a achieved cure
- 91% of post-transplant patients with HCV genotype 3 achieved cure
- No need seen to alter existing transplantation medication regimens
Saturday, April 25, 2015 10:00 am EDT
(PRINCETON, N.J., APRIL 25, 2015) – Bristol-Myers Squibb Company (NYSE:BMY) today announced that primary endpoints were successfully met in ALLY-1, a Phase III clinical trial evaluating a 12-week regimen of daclatasvir and sofosbuvir once-daily with ribavirin for the treatment of patients with chronic hepatitis C virus (HCV) with either advanced cirrhosis or post-liver transplant recurrence of HCV. The data was presented as a late-breaker at The International Liver Congress™ 2015, the 50th annual meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria from April 22-26.
“The results of the ALLY-1 trial point to the potential of this investigational daclatasvir-based regimen in a patient population with high unmet needs despite recent advances in hepatitis C treatment,” said Fred Poordad, M.D., ALLY-1 Lead Investigator and Clinical Professor of Medicine, Chief, Hepatology, University of Texas Health Science Center and VP, Academic and Clinical Affairs Texas Liver Institute. “Transplant patients take a variety of immunosuppressive medications to prevent organ rejection; that complicates the treatment of hepatitis C. In ALLY-1, we saw no drug-drug interactions between transplant and hepatitis C therapies and no need to make dose adjustments to patients’ transplant-related drugs while they received the daclatasvir-based regimen that resulted in high SVR12 rates.”
The study’s primary endpoints were reached, with 95% of post-transplant genotype 1 patients and 82% of genotype 1 patients with advanced cirrhosis achieving SVR12. Among all ALLY-1 patients, 94% of those with post-transplant HCV recurrence and 83% of all participants with advanced cirrhosis achieved cure (sustained virologic response 12 weeks after treatment; SVR12).
The Child-Pugh scoring system is commonly used to assess the severity and prognosis of chronic liver disease and cirrhosis, and uses an A through C classification (C being the most advanced) to categorize disease progression. Patients with class C cirrhosis are decompensated, often with later-stage conditions such as ascites (the build-up of fluid in the abdomen), hepatic encephalopathy (confusion or altered level of consciousness due to the liver’s inability to remove toxins from the blood), and abnormal liver function, which can complicate treatment. The ALLY-1 trial included 16 patients with decompensated cirrhosis Child-Pugh class C; nine (56%) achieved SVR12.
Over the course of the study, four advanced cirrhotic patients received a liver transplant during treatment; 3 of 4 extended treatment post-transplant (see study design below), and all 4 achieved SVR12.
In the study, there were no serious adverse events related to study medications throughout the treatment phase. The most common adverse events (≥10%) were headache (15%, 36%), fatigue (18%, 28%), anemia (20%, 19%), diarrhea (8%, 19%), nausea (17%, 6%), and arthralgia (2%, 13%) in the advanced cirrhotic and post-transplant cohorts, respectively. One patient discontinued therapy after 31 days due to headache, but still achieved SVR12. Nine patients in the cirrhosis cohort relapsed post-treatment, and one had detectable HCV RNA at the end of treatment; there were no on-treatment virologic breakthroughs. Three patients (genotypes 1a, 1b, 3) in the post-transplantation cohort relapsed. All 12 patients with relapse are being retreated with daclatasvir and sofosbuvir with ribavirin for 24 weeks.
HCV is the leading indication for liver transplantation worldwide. Without treatment, HCV infection of the new liver after transplant is inevitable, and is associated with rapid progression to cirrhosis and death in up to 30% of patients within 5 years. The ALLY-1 study is the third study to report out of the Phase III ALLY program, which evaluates daclatasvir in combination with sofosbuvir in multiple high-unmet need patient populations and is at the center of Bristol-Myers Squibb’s HCV research focus. The ALLY-2 and ALLY-3 studies have previously been presented at the 2015 Conference for Retroviral and Opportunistic Infections and the 2014 American Association for the Study of the Liver’s The Liver Meeting, respectively, and subanalyses from each study with the ribavirin-free regimen of daclatasvir and sofosbuvir were presented as posters during EASL 2015.
Additionally, EASL issued 2015 Hepatitis C treatment guidelines that include a regimen of daclatasvir+sofosbuvir as the first 12-week treatment for patients with genotype-3 virus. The EASL guidelines now list daclatasvir+sofosbuvir regimens as options for treating all HCV genotypes and for use with patients coinfected with HCV/HIV. (Guidelines available here.)
Other Bristol-Myers Squibb presentations at The International Liver Congress included data from compassionate use programs in the EU that add to the real-world clinical evidence informing the use of daclatasvir-based regimens to treat patients with HCV conditions posing high unmet medical needs.
“The ALLY-1 trial results build off the ALLY-2 and ALLY-3 studies by demonstrating the versatility of the daclatasvir-based regimen to provide HCV cure in multiple patient populations that have been historically hard to manage, such as HCV genotype 3 patients, HIV/HCV coinfected patients, and patients with decompensated cirrhosis,” said Douglas Manion, M.D., Head of Specialty Development, Bristol-Myers Squibb. “Post-liver transplant and cirrhotic patients represent a still-unmet need and continue to present challenges to currently available regimens.”
About ALLY-1: Study Design
This Phase III open-label clinical trial enrolled treatment-naïve and treatment-experienced patients with HCV infection of any genotype in 2 cohorts: advanced cirrhosis (n=60) and post-liver transplant with HCV recurrence (n=53). All patients received daclatasvir 60 mg plus sofosbuvir 400 mg once-daily with ribavirin initially dosed at 600 mg/d (with potential for adjustment based on hemoglobin levels and creatinine clearance) for 12 weeks. Patients receiving a variety of immunosuppressive agents were permitted. In the cirrhosis cohort, patients transplanted during treatment could receive 12 weeks of extended treatment immediately post-transplant, regardless of treatment duration before transplant. The primary endpoint was the SVR12 rate (defined as HCV RNA <LLOQ (25 IU/mL) at post-treatment week 12) among genotype 1 patients in each cohort.
Read complete press release here....
EASL 2015: Statin use in HCV patients may lower risk of death, decompensation
VIENNA — Statin use in patients with hepatitis C virus and compensated cirrhosis seems to offer a protective effect against death and decompensation, according to a study presented at the 2015 International Liver Congress.
“In compensated HCV cirrhosis, statin users have a significantly lower incidence of decompensation and better overall survival compared to statin non-users,” Arpan Mohanty, MD, from Yale School of Medicine, New Haven, Conn., said during her presentation. “Risk of decompensation and death was reduced by over 40%.”
In this retrospective cohort study, Mohanty and colleagues used the U.S. Department of Veterans HCV Clinical Case Registry, and by doing so, she said all patients would have had an equal opportunity to receive statins.
EASL 2015: Use of direct-antiviral agents helps overcome hepatitis C recurrence in liver transplant patients
New data presented today at The International Liver Congress 2015, supports the use of sofosbuvir (SOF)- and daclatasvir (DCV)-based regimens in patients with recurrence of the hepatitis C virus (HCV) following liver transplantation (LT). The results are based on data from patients with HCV being treated with second-generation DAAs in the large French prospective ANRS CO23 CUPILT study. Among them, 296 patients were treated with a combination of SOF+DCV, with or without ribavirin.
SOF- and DCV-based regimens offered high rates of sustained virologic response (SVR) coupled with good tolerance. The presented results focus on 130 patients who achieved SVR12; end of treatment therapy and SVR12 rates are 98% and 96%, respectively.
"The use of interferon-free regimens using DAAs has dramatically improved the management of liver transplant patients infected with HCV. The outstanding efficacy and safety results that sofosbuvir- and daclatasvir-based regimens demonstrated in patients with recurrent hepatitis C are impressive and will help us identify optimal treatment strategies using these new therapies," said Audrey Coilly, MD, Paul Brousse Hospital, Villejuif.
Read more....
EASL 2015: Hepatitis C screening essential to help catch patients with advanced liver fibrosis
Research validates the current recommendation that screening for hepatitis C, particularly among high-risk groups, is vital.
April 25, 2015, Vienna, Austria: Study results presented today at The International Liver Congress™ 2015 show that the occurrence of advanced liver fibrosis is similar for patients infected with the hepatitis C virus (HCV), whether or not they have been diagnosed.
Most individuals with HCV remain asymptomatic, which makes the diagnosis difficult. The study authors used the hypothesis that individuals whose HCV is not diagnosed are less likely to have advanced fibrosis than those who have been diagnosed. They then compared liver fibrosis between respondents of the National Health and Nutrition Examination Survey (NHANES) in the USA, in patients with diagnosed and undiagnosed HCV infection.
Of the respondents with known HCV infection, the proportion with a high, intermediate and low probability of advanced fibrosis was 14.5%, 40.3%, 45.2%, respectively; in those with undiagnosed HCV the results were 19.1%, 30.9%, 50.0%, respectively.
The study highlights that even if people are unaware they are infected with HCV, the virus affects their liver in the same way, resulting in advanced fibrosis. These results validate the current recommendation that screening for HCV, particularly among high-risk groups, is vital.
Read complete press release here....
EASL 2015: Cancer rates among patients with hepatitis C are increased compared to those not infected
New results show that cancer rates in patients with the hepatitis C virus (HCV) were significantly increased compared to the non-HCV cohort. The researchers suggest an extrahepatic manifestation of HCV may be an increased risk of cancer.
Results recently announced at The International Liver CongressTM 2015 show that cancer rates in patients with the hepatitis C virus (HCV) were significantly increased compared to the non-HCV cohort. The researchers suggest an extrahepatic manifestation of HCV may be an increased risk of cancer. When all cancers are considered the rate is 2.5 times higher in the HCV cohort; when liver cancers are excluded, the rate is still almost 2 times higher.
The aim of the study was to describe the rates of all cancers in the cohort of HCV patients compared to the non-HCV population. Known cancer types associated with hepatitis C include non-Hodgkin's lymphoma, renal and prostate cancers, as well as liver cancer.
A retrospective study at Kaiser Permanente, Southern California, USA, was conducted. The study authors recorded all cancer diagnoses in patients over 18 years of age with or without HCV during 2008-2012. Within the timeframe of the study 145,210 patient years were included in the HCV cohort, and 13,948,826 patient years were included in the non-HCV cohort.
Read more...
Friday, April 24, 2015
India: Mylan Pharmaceuticals launches generic hepatitis C drug MyHep in India
NEW DELHI: Drugmaker Mylan Pharmaceuticals today launched generic Sofosbuvir tablets, indicated for the treatment of chronic hepatitis C, in the country.
US-based company's Indian arm Mylan NV has launched generic Sofosbuvir tablets in strength of 400 mg under the name MyHep in the country, it said in a statement.
"The launch of Mylan's MyHep offers hope to millions of hepatitis C patients in India who are in need of a high quality, effective and affordable treatment option."
US-based company's Indian arm Mylan NV has launched generic Sofosbuvir tablets in strength of 400 mg under the name MyHep in the country, it said in a statement.
"The launch of Mylan's MyHep offers hope to millions of hepatitis C patients in India who are in need of a high quality, effective and affordable treatment option."
Cape Cod Hepatitis C rates highest in state among young people
Users of heroin and other intravenous drugs face dangers beyond addiction, prison, and overdose. Deadly blood-borne diseases, transmitted through shared needles, are rampant among IV drug users.
For the past several years, Barnstable County has led Massachusetts in the rate of new infections of Hepatitis C among people aged 15 to 25. An especially dangerous virus that attacks its host’s liver, often resulting in cirrhosis or cancer, Hepatitis C infected 344.3 of every 100,000 residents of Barnstable County in 2012, the latest year for which figures are available. The incidence rate for Plymouth, the second leading county, was 194.57.
Read more...
For the past several years, Barnstable County has led Massachusetts in the rate of new infections of Hepatitis C among people aged 15 to 25. An especially dangerous virus that attacks its host’s liver, often resulting in cirrhosis or cancer, Hepatitis C infected 344.3 of every 100,000 residents of Barnstable County in 2012, the latest year for which figures are available. The incidence rate for Plymouth, the second leading county, was 194.57.
Read more...
CDC Issues Health Advisory Concerning HIV And Hepatitis C Co-Infection Outbreaks
Outbreak of Recent HIV and HCV Infections among Persons Who Inject Drugs
This is an official
CDC HEALTH ADVISORY
Distributed via the CDC Health Alert Network
April 24, 2015, 11:00 ET (11:00 AM ET)
CDCHAN-00377
April 24, 2015, 11:00 ET (11:00 AM ET)
CDCHAN-00377
Summary
The Indiana State Department of Health (ISDH) and the Centers for Disease Control and Prevention (CDC) are investigating a large outbreak of recent human immunodeficiency virus (HIV) infections among persons who inject drugs (PWID). Many of the HIV-infected individuals in this outbreak are co-infected with hepatitis C virus (HCV). The purpose of this HAN Advisory is to alert public health departments and healthcare providers of the possibility of HIV outbreaks among PWID and to provide guidance to assist in the identification and prevention of such outbreaks.Background
From November 2014 to January 2015, ISDH identified 11 new HIV infections in a rural southeastern county where fewer than 5 infections have been identified annually in the past. As of April 21, 2015, an on-going investigation by ISDH with assistance from CDC has identified 135 persons with newly diagnosed HIV infections in a community of 4,200 people; 84% were also HCV infected. Among 112 persons interviewed thus far, 108 (96%) injected drugs; all reported dissolving and injecting tablets of the prescription-type opioid oxymorphone (OPANA® ER) using shared drug preparation and injection equipment.1This HIV outbreak was first recognized by a local disease intervention specialist. In late 2014, interviews conducted with three persons newly diagnosed with HIV infections in three separate venues (i.e., an outpatient clinic, a drug rehabilitation program, during a hospitalization) indicated that two of these persons had recently injected drugs and had numerous syringe-sharing and sexual partners. Contact tracing identified eight additional HIV infections leading to the current outbreak investigation, which has demonstrated that HIV had spread recently and rapidly through the local network of PWID. Without an attentive health department, active case finding, and additional testing provided as part of this investigation, this cluster may not have been identified.
Urgent action is needed to prevent further HIV and HCV transmission in this area and to investigate and control any similar outbreaks in other communities.
Injection drug use accounts for an estimated 8%2 of the approximate 50,000 annual new HIV infections in the United States.3 & HCV infection is the most common blood-borne infection in the United States and percutaneous exposure via drug-injecting equipment contaminated with HCV-infected blood is the most frequent mode of transmission. Nationally, acute HCV infections have increased 150% from 2010 to 2013,4 and over 70% of long-term PWID may be infected with HCV.5 Abuse of prescription-type opioids is increasing nationally6 and opioid-analgesic poisoning deaths have nearly quadrupled from 1999 through 2011.7 Rates of acute HCV infection are increasing, especially among young nonurban PWID, often in association with abuse of injected prescription-type opioids. These increases have been most substantial in nonurban counties east of the Mississippi River.8
Recommendations for Health Departments
- Review the most recent sources of data on HIV diagnoses, HCV diagnoses (acute as well as past or present), overdose deaths, admissions for drug treatment, and drug arrests. Attributes of communities at risk for unrecognized clusters of HIV and HCV infection include the following:
- Recent increases in the:
- Number of HIV infections attributed to injection drug use,
- Number of HCV infections, particularly among persons aged < 35 years;
- High rates of injection drug use and especially prescription-type opioid abuse, drug-related overdose, drug treatment admission, or drug arrests.
- Recent increases in the:
- Ensure complete contact tracing for all new HIV diagnoses and testing of all contacts for HIV and HCV infection.
- Ensure persons actively injecting drugs or at high-risk of drug injection (e.g., participating in drug substitution programs, receiving substance abuse counseling or treatment, recently or currently incarcerated) have access to integrated prevention services,9 and specifically:
- Are tested regularly for HIV and HCV infection (consider more frequent testing based on frequency of injection drug usage or sharing of injection equipment);
- If diagnosed with HIV or HCV infection:
- Are rapidly linked to care and treatment services;
- If actively injecting drugs:
- Have access to medication-assisted therapy (e.g., opioid substitution therapy) as well as other substance abuse services, if not already engaged,
- Are counseled not to share needles and syringes or drug preparation equipment (e.g., cookers, water, filters),
- Have access to sterile injection equipment from a reliable source.
- If not HIV infected but actively injecting drugs:
- Remind venues that may encounter unrecognized infections, such as emergency departments and community-based clinical practices (e.g., family medicine, general medicine, prenatal care) of the importance of routine opt-out HIV testing as well as HCV testing per current recommendations13-15
- Local health departments should notify their state health department and CDC of any suspected clusters of recent HIV or HCV infection.
Recommendations for Healthcare Providers
- Ensure all persons diagnosed with HCV infection are tested for HIV infection,16 and that all persons diagnosed with HIV infection are tested for HCV infection.17
- Ensure persons receiving treatment for HIV and/or HCV infection adhere to prescribed therapy and are engaged in ongoing care.
- Encourage HIV and HCV testing of syringe-sharing and sexual partners of persons diagnosed with either infection.
- Report all newly diagnosed HIV and HCV infections to the health department.
- For all persons with substance abuse problems:
- Refer them for medication-assisted treatment (e.g., opioid substitution therapy) and counseling services,
- Use effective treatments (e.g., methadone, buprenorphine), as appropriately indicated.
- For any persons for whom opioids are under consideration for pain management:
- Discuss the risks and benefits of all pain treatment options, including ones that do not involve prescription analgesics.
- Note that long-term opioid therapy is not associated with reduced chronic pain.18
- Contact the state or local health department to report suspected clusters of recent HIV or HCV infection.
For more information:
- AASLD/IDSA/IAS–USA. HCV testing and linkage to care. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org/full-report/hcv-testing-and-linkage-care
- Centers for Disease Control and Prevention. Integrated Prevention Services for HIV Infection, Viral Hepatitis, Sexually Transmitted Diseases, and Tuberculosis for Persons Who Use Drugs Illicitly: Summary Guidance from CDC and the U.S. Department of Health and Human Services. 2012: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6105a1.htm?s_cid=rr6105a1_w.
- Centers for Disease Control and Prevention. HIV and Injection Drug Use fact sheet. (http://www.cdc.gov/hiv/pdf/g-l/cdc-hiv-idu-fact-sheet.pdf
- Centers for Disease Control and Prevention. Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings. 2006; http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm.
- Centers for Disease Control and Prevention and Association of Public Health Laboratories. Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations. http://dx.doi.org/10.15620/cdc.23447
- Centers for Disease Control and Prevention. Testing for HCV infection: an update of guidance for clinicians and laboratorians. MMWR Morb Mortal Wkly Rep. May 10 2013;62(18):362-365.
- Centers for Disease Control and Prevention. MMWR Integrated Services Report. (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6105a1.htm?s_cid=rr6105a1_w)
- Centers for Disease Control and Prevention. HIV and Injection Drug Use fact sheet. (http://www.cdc.gov/hiv/pdf/g-l/cdc-hiv-idu-fact-sheet.pdf)
- US Public Health Service. Preexposure prophylaxis for the prevention of HIV infection in the United States - 2014 clinical practice guideline. 2014; http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf.
- Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. 2015; http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.
References
- Spiller MW, Broz D, Wejnert C, Nerlander L, Paz-Bailey G. HIV Infection and HIV-Associated Behaviors Among Persons Who Inject Drugs - 20 Cities, United States, 2012. MMWR Morb Mortal Wkly Rep. Mar 20 2015;64(10):270-275.
- Centers for Disease Control and Prevention. HIV Surveillance Report, 2013; vol. 25. http://www.cdc.gov/hiv/library/reports/surveillance/, last accessed April 22, 2015.
- Prejean J, Song R, Hernandez A, et al. Estimated HIV incidence in the United States, 2006-2009. PLoS ONE. 2011;6(8):e17502.
- Hagan H, Des Jarlais DC, Stern R, et al. HCV synthesis project: preliminary analyses of HCV prevalence in relation to age and duration of injection. The International journal on drug policy. Oct 2007;18(5):341-351.
- Maxwell JC. The prescription drug epidemic in the United States: a perfect storm. Drug and alcohol review. May 2011;30(3):264-270.
- Chen LH HH, Warner M. Drug-poisoning deaths involving opioid analgesics: United States, 1999–2011. NCHS data brief, no 166. Hyattsville, MD: National Center for Health Statistics. 2014.
- Suryaprasad AG, White JZ, Xu F, et al. Emerging epidemic of hepatitis C virus infections among young nonurban persons who inject drugs in the United States, 2006-2012. Clin Infect Dis. Nov 15 2014;59(10):1411-1419.
- Centers for Disease Control and Prevention. Integrated prevention services for HIV infection, viral hepatitis, sexually transmitted diseases, and tuberculosis for persons who use drugs illicitly: summary guidance from CDC and the U.S. Department of Health and Human Services. MMWR Recomm Rep. Nov 9 2012;61(Rr-5):1-40.
- US Public Health Service. Preexposure prophylaxis for the prevention of HIV infection in the United States - 2014 clinical practice guideline. 2014; http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf.
- Centers for Disease Control and Prevention. Antiretroviral Postexposure Prophylaxis After Sexual, Injection-Drug Use, or Other Nonoccupational Exposure to HIV in the United States Recommendations from the U.S. Department of Health and Human Services. 2005; http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5402a1.htm.
- Kuhar DT, Henderson DK, Struble KA, et al. Updated US Public Health Service guidelines for the management of occupational exposures to human immunodeficiency virus and recommendations for postexposure prophylaxis. Infection control and hospital epidemiology. Sep 2013;34(9):875-892.
- Centers for Disease Control and Prevention. Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings. 2006; http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm. Accessed April 22, 2015.
- Centers for Disease Control and Prevention and Association of Public Health Laboratories. Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations. http://dx.doi.org/10.15620/cdc.23447. Accessed April 22, 2015.
- Centers for Disease Control and Prevention. Testing for HCV infection: an update of guidance for clinicians and laboratorians. MMWR Morb Mortal Wkly Rep. May 10 2013;62(18):362-365.
- AASLD/IDSA/IAS–USA. HCV testing and linkage to care. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org/full-report/hcv-testing-and-linkage-care. Accessed April 22, 2015.
- Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. 2015; http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed April 22, 2015.
- Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. 2015; http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed April 22, 2015.
- Chou R, Turner JA, Devine EB, et al. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. Feb 17 2015;162(4):276-286.
The Centers for Disease Control and Prevention (CDC) protects people's health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national and international organizations.
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HAN Message Types
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Merck’s Pivotal Phase 3 C-EDGE Program Evaluating Grazoprevir/Elbasvir Shows High Sustained Virologic Responses Across Broad Range of Patients with Chronic Hepatitis C Virus Infection
- Data Sets Include Treatment-Naïve, Treatment-Experienced and HIV Co-Infected Patients with Chronic Hepatitis C Virus Genotypes 1, 4 or 6 Infection
- Merck Remains on Track to Submit New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) in First Half of 2015
“Patients with co-morbidities and varying treatment experiences represent important segments of the chronic hepatitis C population in need of additional innovative treatment options,” said Dr. Eric Lawitz, vice president, scientific and research development, The Texas Liver Institute and clinical professor of medicine, The University of Texas Health Science Center, San Antonio. “These findings are important because they demonstrate that a single pill of grazoprevir/elbasvir taken once-daily achieved consistently high rates of SVR12 in the patient populations studied.”
| Summary of SVR12 findings: C-EDGE TN, C-EDGE CO-INFXN, C-EDGE TE | ||||||||||||
| C-EDGE TN | C-EDGE CO-INFXN | C-EDGE TE | ||||||||||
| Without RBV (n=316) | Without RBV (n=218) | Without RBV (n=105) | With RBV (n=104) | Without RBV (n=105) | With RBV (n=106) | |||||||
| Duration | 12 weeks | 12 weeks | 12 weeks | 12 weeks | 16 weeks | 16 weeks | ||||||
| All Patients: | 95% | 95% | 92% | 94% | 92% | 97% | ||||||
| SVR12 | (299/316) | (207/218) | (97/105) | (98/104) | (97/105) | (103/106) | ||||||
| Cirrhotic | 97% | 100% | 89% | 89% | 92% | 100% | ||||||
| (68/70) | (35/35) | (33/37) | (31/35) | (35/38) | (37/37) | |||||||
| Non-cirrhotic | 94% | 94% | 94% | 97% | 93% | 96% | ||||||
| (231/246) | (172/183) | (64/68) | (67/69) | (62/67) | (66/69) | |||||||
| Genotype 1a | 92% | 94% | 90% | 93% | 94% | 95% | ||||||
| (144/157) | (136/144) | (55/61) | (56/60) | (45/48) | (55/58) | |||||||
| Genotype 1b or | ||||||||||||
| other Genotype | 99% | 96% | 100% | 97% | 96% | 100% | ||||||
| 1 | (129/131) | (43/45) | (35/35) | (28/29) | (46/48) | (38/38) | ||||||
| Genotype 4 | 100% | 96% | 78% | 93% | 60% | 100% | ||||||
| (18/18) | (27/28) | (7/9) | (14/15) | (3/5) | (8/8) | |||||||
| Genotype 6 | 80% | 100% | 75% | 100% | ||||||||
| (8/10) | (1/1) | N/A | N/A | (3/4) | (2/2) | |||||||
C-EDGE TN Overview and Additional Findings
C-EDGE TN is a randomized, blinded, placebo-controlled trial evaluating the efficacy and safety of grazoprevir/elbasvir in treatment-naïve patients with or without cirrhosis infected with chronic HCV GT1, 4 or 6 who received therapy for 12 weeks. Patients were randomized to an immediate treatment group that received grazoprevir/elbasvir for 12 weeks or to a deferred treatment group that received placebo for 12 weeks, were followed for an additional four weeks, and then received open label grazoprevir/elbasvir for the next 12 weeks. The primary efficacy analysis included those patients who received immediate treatment with grazoprevir/elbasvir or placebo. Of the 316 patients who received immediate treatment with grazoprevir/elbasvir, 50 percent were infected with GT1a, 42 percent with GT1b, six percent with GT4 and three percent with GT6. Overall, 22 percent of patients had liver cirrhosis.
In this study, virologic failure occurred in 13 patients (4%) in the immediate treatment group, including one virologic breakthrough and 12 virologic relapses. Serious adverse events occurred in nine (3%) and three (3%) patients in the immediate treatment and corresponding placebo arms, respectively; none were considered drug-related. The most common adverse events reported (greater than 5% incidence) in the immediate treatment and corresponding placebo groups, were headache (17%, 18%), fatigue (16%, 17%), nausea (9%, 8%) and arthralgia (6%, 6%), respectively.
C-EDGE CO-INFXN Overview and Additional Findings
C-EDGE CO-INFXN is an open label, single-arm study evaluating the efficacy and safety of grazoprevir/elbasvir in treatment-naïve patients with or without cirrhosis infected with chronic HCV GT1, 4 or 6 and HIV who received therapy for 12 weeks. Of the 218 patients enrolled in the trial, 66 percent were infected with HCV GT1a, 21 percent with GT1b or other GT1, 13 percent with GT4, and one percent with GT6. Overall, 16 percent of patients had liver cirrhosis.
In this study, virologic failure occurred in seven patients (3%), including six virologic relapses and one reinfection. There were no reported drug-related serious adverse events. The most common (greater than 5% incidence) adverse events reported were fatigue (13%), headache (12%) and nausea (9%).
C-EDGE TE Overview and Additional Findings
C-EDGE TE is a randomized study evaluating the efficacy and safety of once-daily grazoprevir/elbasvir with or without twice-daily RBV in treatment-experienced (prior null response, partial response or relapse with peg-interferon/RBV) patients with or without cirrhosis infected with chronic HCV GT1, 4 or 6 who received therapy for 12 weeks or 16 weeks.
12 week arms
Of the 209 patients randomized to the 12 week arms, 105 patients received grazoprevir/elbasvir only and 104 patients received grazoprevir/elbasvir plus RBV. Patients in the grazoprevir/elbasvir only arm comprised 58 percent GT1a, 33 percent GT1b or other GT1 and nine percent GT4. Overall, 35 percent had liver cirrhosis. Among the 104 patients receiving grazoprevir/elbasvir plus RBV, 58 percent were infected with chronic HCV GT1a, 28 percent GT1b or other GT1, and 14 percent GT4. Overall, 34 percent had liver cirrhosis.
In the grazoprevir/elbasvir only and grazoprevir/elbasvir plus RBV arms, six patients in each arm (6%) were reported to have virologic relapse. No patients were reported to have virologic breakthrough or rebound. Serious adverse events were reported in four patients in the grazoprevir/elbasvir only arm (4%) and three patients in the grazoprevir/elbasvir plus RBV arm (3%). The most common (greater than 10% incidence) adverse events reported in the grazoprevir/elbasvir and grazoprevir/elbasvir plus RBV arms, respectively, were fatigue (19%, 27%), headache (21%, 20%) and nausea (9%, 14%).
16 week arms
Of the 211 patients enrolled in the 16 week arms, 105 patients received grazoprevir/elbasvir only and 106 patients received grazoprevir/elbasvir plus RBV. In the grazoprevir/elbasvir only arm, 46 percent were infected with chronic HCV GT1a, 46 percent with GT1b or other GT1, five percent with GT4 and four percent with GT6. Overall, 36 percent of patients had liver cirrhosis. Among those in the grazoprevir/elbasvir plus RBV arm, 55 percent were infected with chronic HCV GT1a, 36 percent with GT1b or other GT1, eight percent with GT4, and two percent with GT6. Overall, 35 percent had liver cirrhosis.
Among the patients receiving grazoprevir/elbasvir only, three patients (3%) were reported to have virologic breakthrough or rebound and four patients (4%) were reported to have virologic relapse. No virologic failures occurred in patients receiving grazoprevir/elbasvir plus RBV. Serious adverse events were reported in three patients in the grazoprevir/elbasvir only arm (3%) and four patients in the grazoprevir/elbasvir plus RBV arm (4%). The most common (greater than 10% incidence) adverse events reported in the grazoprevir/elbasvir and grazoprevir/elbasvir plus RBV arms, respectively, were fatigue (16%, 30%), headache (19%, 19%) and nausea (4%,17%).
About the C-EDGE Program
C-EDGE is the Phase 3 clinical development program for Merck’s investigational HCV treatment grazoprevir/elbasvir comprising five studies with more than 1,700 patients across more than 25 countries. These studies are evaluating grazoprevir/elbasvir in multiple genotypes (GT1, 4 and 6) and diverse patient populations, including difficult-to-treat patients such as: treatment-experienced, patients with cirrhosis, HIV/HCV co-infection, advanced chronic kidney disease, inherited blood disorders, and those receiving opiate substitution therapies.
Read complete press release here...
Merck oral hepatitis C regimen shows 95 pct cure rate
(Reuters) - Merck and Co Inc presented trial results on Friday showing that a once-daily combination of two experimental pills cured 95 percent of previously untreated hepatitis C patients after 12 weeks.
The trial included patients infected with the most common form of the liver-destroying virus, genotype 1, along with less common genotypes 4 and 6. It also involved patients with and without liver cirrhosis.
Cure rates, defined as sustained virologic response 12 weeks after treatment, were 92 percent for patients with genotype 1a; 99 percent for genotype 1b; 100 percent for genotype 4; and 80 percent for genotype 6. Cures were achieved in 97 percent of cirrhotic patients and 94 percent of non-cirrhotic patients.
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The trial included patients infected with the most common form of the liver-destroying virus, genotype 1, along with less common genotypes 4 and 6. It also involved patients with and without liver cirrhosis.
Cure rates, defined as sustained virologic response 12 weeks after treatment, were 92 percent for patients with genotype 1a; 99 percent for genotype 1b; 100 percent for genotype 4; and 80 percent for genotype 6. Cures were achieved in 97 percent of cirrhotic patients and 94 percent of non-cirrhotic patients.
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EU regulators warn against combining hepatitis C drugs with amiodarone
(Reuters) - European health regulators warned on Friday against using Gilead Sciences Inc's and Bristol-Myers Squibb Co's hepatitis C medicines along with amiodarone, a drug used to regulate the heartbeat of people with heart rhythm disorders.
The European Medicines Agency said there is a risk of severe bradycardia, or heart block, when Gilead's drug Harvoni or a combination of Gilead's Sovaldi and Bristol-Myers' Daklinza are used in patients who are also taking amiodarone. (bit.ly/1HvQg8n)
The agency's committee for medicinal products for human use recommended that amiodarone only be used in patients taking these hepatitis C medicines if other anti-arrhythmics cannot be administered.
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The European Medicines Agency said there is a risk of severe bradycardia, or heart block, when Gilead's drug Harvoni or a combination of Gilead's Sovaldi and Bristol-Myers' Daklinza are used in patients who are also taking amiodarone. (bit.ly/1HvQg8n)
The agency's committee for medicinal products for human use recommended that amiodarone only be used in patients taking these hepatitis C medicines if other anti-arrhythmics cannot be administered.
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Thursday, April 23, 2015
Canada: Williams Lake gets Hepatitis C clinic
Waiting times for people in the Cariboo seeking treatment to cure Hepatitis C will be shorter now that a new clinic has opened in Williams Lake.
Every month Dr. Alexandra King and clinical research nurse Shawn Sharma will run the clinic for a few days out of the Atwood Clinic in co-operation with local family doctor Jolien Steyl, who already runs an HIV-Aids clinic.
“As a family doctor it’s been a nightmare getting patients treated,” Steyl said. “They either have to travel really far or they don’t get started on treatment because the waiting lists are long.”
King and Sharma work at the Vancouver Infectious Diseases Centre (VIDC) where King is an internal medicine specialist.
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EASL 2015: CNIO Researchers Link Telomeres to the Origins of Liver Diseases such as Chronic Hepatitis and Cirrhosis
- Researchers have generated a mouse with dysfunctional telomeres in the liver and, as a result, it developed cellular alterations present in human diseases such as hepatitis or cirrhosis
- This study is the first to show that alterations in the functioning of telomeres lead to changes in the liver that are common to diseases such as hepatitis and cirrhosis, which are associated with an increased risk of liver cancer
- This finding provides the basis for understanding the molecular origin of these diseases, as well as identifying new therapeutic strategies for their prevention and control
In a study published in the Journal of Hepatology, Fabian Beier and Paula Martínez —from the Spanish National Cancer Research Centre´s (CNIO) Telomere and Telomerase Group led by Maria Blasco— have created a mouse model that recapitulates the origin of human diseases associated with long-term or chronic liver damage, such as hepatitis or cirrhosis of the liver which, in turn, can progress to liver cancer over time. This new mouse model reveals telomeric dysfunction as a potential factor in triggering these diseases.
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Janssen Announces SVR12 Rates with Twelve Weeks of Treatment with All-Oral, Once-Daily Regimen of Simeprevir Plus Sofosbuvir in Genotype 1 HCV Patients With and Without Cirrhosis
– Data from OPTIMIST-1 and OPTIMIST-2 Trials Showing SVR12 Rates of 97 Percent and 84 Percent to be Presented at The International Liver Congress™ 2015 of the European Association for the Study of the Liver -
– SVR12 Rates of up to 100 Percent Achieved Among Subgroups in Both Trials –
“The new data for simeprevir presented at The International Liver Congress™ confirms its efficacy when combined with sofosbuvir in an all-oral, ribavirin-free regimen for HCV patients, including those who are treatment-naïve and treatment-experienced, both with and without cirrhosis,” said Gaston Picchio, hepatitis disease area leader, Janssen. “These data further demonstrate the role of simeprevir within the HCV treatment landscape, as it provides patients with an important therapeutic option.”“Chronic HCV infection is a leading cause of cirrhosis, and once it is developed, these patients can be very difficult to cure. The results of the OPTIMIST-2 study demonstrate the safety and efficacy of the all-oral regimen of simeprevir and sofosbuvir for genotype 1 chronic HCV patients with cirrhosis”
The results from the OPTIMIST-1 and OPTIMIST-2 trials are the first Phase 3 data to be presented on simeprevir in combination with sofosbuvir (SMV/SOF) in patients with genotype 1 chronic HCV infection, both with and without cirrhosis. Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor developed by Gilead Sciences, Inc.
OPTIMIST-11
- OPTIMIST-1 is a Phase 3, randomised, open-label trial to investigate the efficacy and safety of the all-oral regimen of SMV/SOF among treatment-naïve and treatment-experienced genotype 1 chronic HCV-infected patients without cirrhosis. The primary objective was to show superior sustained virologic response (SVR) at 12 weeks after treatment (SVR12) with 12 and eight weeks of treatment with SMV/SOF versus a historical control (patients previously treated with approved regimens containing a direct-acting antiviral, pegylated interferon and ribavirin).
- Ninety-seven (97) percent of patients treated with SMV/SOF for 12 weeks (n=150/155) achieved SVR12, which was superior to the SVR12 rate of 87 percent among the historical control.
- SVR12 rates of 100 percent were seen among patients with IL28B CC genotype (n=43/43) and those with baseline NS5A and NS3 Q80K polymorphisms (n=9/9).
- Patients treated with eight weeks of SMV/SOF achieved an SVR12 rate of 83 percent (n=128/155), which was not superior to the SVR12 rate of 83 percent in the historical control.
- High SVR12 rates were seen among patients with baseline HCV RNA <4 million IU/mL (96 percent; n=46/48), IL28B CC genotype (93 percent; n=38/41), patients with genotype 1b HCV infection (92 percent; n=36/39) and patients without baseline NS5A and Q80K polymorphisms (89 percent; n=78/88).
- The most frequently reported adverse events in the 12-week and eight-week treatment arms were headache (14 and 17 percent, respectively), fatigue (12 and 15 percent, respectively) and nausea (15 and 9 percent, respectively).
- OPTIMIST-2 is a Phase 3, open-label, single-arm trial to investigate the efficacy and safety of SMV/SOF in treatment-naïve and treatment-experienced genotype 1 chronic HCV-infected patients with cirrhosis. The primary objective was to show superior SVR12 with 12 weeks of treatment with SMV/SOF versus a historical control.
- Twelve (12) weeks of treatment with SMV/SOF resulted in SVR12 rates of 84 percent (n=86/103), which was superior to the SVR12 rate of 70 percent in the historical control.
- Higher SVR12 rates were seen in patients with baseline NS5A polymorphisms with or without NS3 Q80K polymorphisms (100 percent; n=13/13), patients with albumin ≥4 g/dL (94 percent; n=47/50) and treatment-naïve patients (88 percent; n=44/50).
- The most common adverse events were fatigue (20 percent), headache (20 percent) and nausea (11 percent).
About Janssen’s HCV Development Programme
The goal of the Janssen hepatitis C virus (HCV) clinical development programme is to provide physicians with multiple treatment options in order to offer patients the best possible chance at successful therapy.
Ongoing studies focus on the investigation of the NS3/4A protease inhibitor simeprevir in a number of different treatment combinations and HCV patient populations, including those who are difficult to cure.
Janssen’s HCV pipeline also includes JNJ-56914845, an investigational NS5A replication complex inhibitor currently in Phase 2 studies, and following the acquisition of Alios BioPharma by Johnson & Johnson in November 2014, AL-335, a uridine-based nucleotide analog in Phase 1 development, and AL-516, a guanosine-based nucleotide analog NS5B polymerase inhibitor in pre-clinical development.
These compounds are being developed with the intent of targeting critical steps of the HCV replication cycle.
About Simeprevir (OLYSIO®)
Simeprevir is an NS3/4A protease inhibitor which has been developed by Janssen Sciences Ireland UC in collaboration with Medivir AB.
In November 2013, simeprevir was initially approved by the U.S. Food and Drug Administration, and in May 2014, it was granted marketing authorisation by the European Commission. Subsequent marketing authorisations have followed in several other countries around the world. Indications vary by market.
Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB retains marketing rights for simeprevir in these countries under the marketing authorisation held by Janssen-Cilag International NV.
Read complete press release here...
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