Wednesday, September 19, 2018

Louisiana developing ‘Netflix’ style subscription plan for HCV treatment

Louisiana developing ‘Netflix’ style subscription plan for HCV treatment
September 18, 2018
The Louisiana Department of Health is currently developing a “subscription style” payment plan with pharmaceutical manufacturers to provide state residents with access to hepatitis C treatment.

HCV Next spoke with the department’s chief of staff, Pete Croughan, MD, about the landscape of HCV in the state and the novel payment model designed to expand treatment despite the expensive cost of direct-acting antivirals.

The department estimates that this plan could increase treatment from approximately 3% of people on Medicaid and in correctional facilities up to nearly 60%.

“We’ve actually had conversations with all three hepatitis C manufacturers — AbbVie, Gilead and Merck — and all three have expressed interest in potentially partnering with us,” he said. “The plan is to ultimately select a partner through a request for proposal process, but we’re willing to work with any company that gives us the best deal.”

Continue reading: 

Read the September/October issue of HCV available online here:
https://www.healio.com/hepatology/news/print/hcv-next

On This Blog
The controversy over expensive new drugs for hepatitis C
Link to a collection of research articles addressing the high cost of HCV medications, insurance restrictions; private insurers/Medicaid and availability of generic versions/India, Egypt and other lower-income countries, or through online "buyers clubs".

Expand Screening for HCV infection in all adults living in the US?

MEDPAGE TODAY
Gastroenterology > Hepatitis 
Time to Expand Age Base for HCV Screening? 
Bargain price of $11,378 per QALY gained for one-time, universal testing
by Diana Swift, Contributing Writer September 15, 2018

Compared with currently recommended birth cohort screening, universal one-time screening for hepatitis C virus (HCV) for U.S. adults would be highly cost-effective, resulting in an expenditure of $11,378 per quality-adjusted life year (QALY) gained, researchers reported

The findings support broadening the current age cohort for one-time screening to all U.S. adults, concluded Mark H. Eckman, MD, of the University of Cincinnati, and colleagues. "A recommendation for HCV testing of all adults will support the national response to the epidemic of HCV infection among young persons in the United States."

Continue reading:

Primary Source
Clinical Gastroenterology and Hepatology

Tuesday, September 18, 2018

How Many Cases of Drug-Induced Liver Injury Are Caused by Herbal and Dietary Supplements?

AGA Journals 

Kristine Novak
Herbal and dietary supplement-induced liver injury is more severe than other types of drug-induced liver injury (DILI), and re-exposure is more likely, researchers report in the September issue of Clinical Gastroenterology and Hepatology

Increasing awareness of the hepatoxic effects of herbal and dietary supplements could help physicians make earlier diagnoses and reduce the risk of serious liver damage.

About the Author 
Dr. Kristine Novak is the science editor for Gastroenterology and Clinical Gastroenterology and Hepatology. She has worked as an editor at biomedical research journals and as a science writer for 15 years, covering advances in gastroenterology, hepatology, cancer, immunology, biotechnology, molecular genetics, and clinical trials. She has a PhD in cell biology and an interest in all areas of medical research.

Viking Therapeutics liver drug succeeds in mid-stage study

(Reuters) - Viking Therapeutics Inc said on Tuesday its experimental liver disease treatment met the main goals of a mid-stage trial by reducing cholesterol and liver fat in patients.
https://in.reuters.com/article/us-viking-study/viking-therapeutics-liver-drug-succeeds-in-mid-stage-study-idINKCN1LY1PM

Press Release
Viking Therapeutics Announces Positive Top-Line Results from Phase 2 Study of VK2809 in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Elevated LDL-Cholesterol

SAN DIEGO, Sept. 18, 2018 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced positive top-line results from a 12-week Phase 2 study of VK2809, its novel liver-selective thyroid receptor beta agonist, in patients with non-alcoholic fatty liver disease (NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C).  The study successfully achieved its primary endpoint, with patients receiving VK2809 demonstrating statistically significant reductions in LDL-C compared with placebo.  In addition, the trial's secondary endpoint was achieved, with VK2809-treated patients experiencing statistically significant reductions in liver fat content compared with placebo.  An abstract describing the results has been submitted for consideration for presentation at The Liver Meeting 2018, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), scheduled for November 9-13, 2018 in San Francisco, CA.

Top-line study results include:
Reduction in LDL-C
Patients receiving VK2809 demonstrated statistically significant reductions in LDL-C of 20% or more, compared with placebo-treated patients.  In addition, VK2809-treated patients demonstrated statistically significant improvements in other lipids, including atherogenic proteins apolipoprotein B and lipoprotein (a).

Reduction in Liver Fat Content
Patients receiving VK2809 experienced statistically significant reductions in liver fat content, as assessed by magnetic resonance imaging, proton density fat fraction (MRI-PDFF), relative to placebo after 12 weeks of treatment.


VK2809 10 mg
QOD
VK2809 10
mg QD
VK2809 combined
Placebo

Median relative
change in liver fat by
MRI-PDFF
-56.5%
(p<0.01)
-59.7%
(p<0.01)
-58.1%
(p<0.01)
-8.9%
Percentage of
patients experiencing
≥ 30% reduction in
liver fat
76.9%
(p=0.012)
90.9%
(p<0.01)
83.3%
(p<0.01)
18.2%


"This proof-of-concept study demonstrates robust improvement in liver fat by VK2809 versus placebo. The trial utilized a state-of-the-art method, MRI-PDFF, as a non-invasive quantitative biomarker of changes in liver fat content. Previous studies by our group have shown that a 30% or greater reduction in MRI-PDFF is associated with higher odds of histologic response in NASH. The quantum of liver fat reduction along with LDL-lowering properties of VK2809 are potentially likely to be beneficial in patients with non-alcoholic steatohepatitis (NASH) who have a significant risk of not only liver fibrosis progression but also cardiovascular disease," stated Rohit Loomba, MD, MHSc, Director, NAFLD Research Center, and Professor of Medicine, University of California at San Diego.

Safety and Tolerability
No serious adverse events (SAEs) were reported among patients receiving VK2809 or placebo.  Mean alanine aminotransferase (ALT) levels among patients receiving VK2809 were reduced from baseline relative to those of patients receiving placebo.  Among patients with elevated baseline ALT levels, those receiving VK2809 also demonstrated reduction relative to placebo.  There were no clinically or numerically meaningful differences in direct bilirubin, indirect bilirubin, alkaline phosphatase, or international normalized ration (INR) between patients treated with VK2809 or placebo.  In addition, no meaningful changes to the thyroid hormone axis were observed among VK2809-treated patients compared with placebo-treated patients.

VK2809 was also shown to be well-tolerated in this study.  Gastrointestinal-related side effects such as diarrhea and nausea were numerically higher in placebo-treated patients relative to VK2809-treated cohorts.  Further data on safety and tolerability from this study will be submitted for presentation at an upcoming medical conference.

"We are encouraged by the preliminary efficacy and safety profile VK2809 has shown in this study," stated Brian Lian, Ph.D., chief executive officer of Viking.  "VK2809's effect on liver fat at 12 weeks appears to exceed all other oral agents currently in development for NASH, supporting our view that VK2809 has a best-in-class profile.  Based on published data from multiple studies, we anticipate that these liver fat reductions would result in longer-term histologic benefit.  In addition, the improvement in lipid parameters observed in this study suggests potential benefits in cardiovascular health, an important consideration in this population.  We look forward to pursuing further development of VK2809 in NASH."

Study Design
The Phase 2 study was a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety and tolerability of VK2809 in patients with elevated LDL-C and NAFLD.  Patients were randomized to receive placebo (n = 14), 10 mg VK2809 dosed every other day (QOD, n = 15), or 10 mg VK2809 dosed daily (QD, n = 16) for 12 weeks followed by a four-week off-drug phase.  The trial's primary endpoint assessed the effect of VK2809 treatment on LDL-C after 12 weeks compared to placebo.  The secondary endpoint evaluated changes in liver fat content by MRI-PDFF in patients with a valid baseline and post-baseline MRI.

Conference Call Today at 8:00 a.m. ET
Viking will hold a conference call today at 8:00 a.m. ET to discuss the results of the Phase 2 study of VK2809.  To participate on the conference call, please dial 844-850-0543 from the U.S. or 412-317-5199 from outside the U.S.  In addition, following the completion of the call, a telephone replay will be accessible until September 25, 2018 by dialing 877-344-7529 from the U.S. or 412-317-0088 from outside the U.S. and entering conference ID 10124232.  Those interested in listening to the conference call live via the internet may do so by visiting the Investor Relations section of Viking's website at www.vikingtherapeutics.com.  An archive of the webcast will be available for 7 days on the company's website at www.vikingtherapeutics.com.

About VK2809
VK2809 is an orally available, tissue and receptor-subtype selective agonist of the thyroid beta receptor (TRβ) that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promising therapeutic potential in a range of lipid disorders. The compound successfully achieved primary and secondary endpoints in a Phase 2 study for the treatment of patients with elevated LDL-C and non-alcoholic fatty liver disease (NAFLD).  The company is also preparing to evaluate VK2809 in a Phase 1 study for the treatment of patients with GSD Ia.  VK2809 belongs to a family of novel prodrugs, which are cleaved in vivo to release potent thyromimetics.  Selective activation of the TRß receptor in liver tissue is believed to favorably affect cholesterol and lipoprotein levels via multiple mechanisms, including increasing the expression genes associated with lipid metabolism and clearance.

About Viking Therapeutics, Inc.
Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders.  The company's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives.  The company's clinical programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator.  In a Phase 2 trial in patients recovering from hip fracture, patients who received VK5211 experienced significant improvements in measures of lean body mass compared to patients who received placebo.  The company's second clinical program is evaluating VK2809, a small molecule thyroid beta agonist.  In a Phase 2 trial for the treatment of non-alcoholic fatty liver disease and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content.  VK2809 was shown to be safe and well-tolerated in the study.  The company is also developing VK0612, a first-in-class, orally available drug candidate in Phase 2 development for type 2 diabetes.  Additional programs include novel and selective agonists of the thyroid beta receptor for GSD Ia and X-linked adrenoleukodystrophy, as well as two earlier-stage programs targeting metabolic diseases and anemia.  Viking holds exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, including those noted above, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.
Follow Viking on Twitter @Viking_VKTX.

Forward-Looking Statements
This press release contains forward-looking statements regarding Viking Therapeutics, Inc., under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, timelines and milestones, as well as the company's goals and plans regarding VK2809 and its prospects. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of Viking's product candidate development activities and clinical trials, including those for VK5211 and VK2809; risks that prior clinical and preclinical results may not be replicated; risks regarding regulatory requirements; and other risks that are described in Viking's most recent periodic reports filed with the Securities and Exchange Commission, including Viking's Annual Report on Form 10-K for the year ended December 31, 2017, and subsequent Quarterly Reports on Form 10-Q, including the risk factors set forth in those filings. These forward-looking statements speak only as of the date hereof.  Viking disclaims any obligation to update these forward-looking statements except as required by law.

SOURCE Viking Therapeutics, Inc.
For further information: Viking Therapeutics, Inc., Greg Zante, Vice President of Finance and Operations, 858-704-4660, gzante@vikingtherapeutics.com; Vida Strategic Partners, Stephanie Diaz (Investors), 415-675-7401, sdiaz@vidasp.com; Tim Brons (Media), 415-675-7402, tbrons@vidasp.com

Audio Ask the Experts: Optimizing Cotreatment of HCV and HIV Infection


Ask the Experts: Optimizing Cotreatment of HCV and HIV Infection
Susanna Naggie, MD, MHS
Listen as expert faculty answer clinicians’ questions about specific challenges in managing HCV/HIV coinfection, including how to apply guideline-based strategies, avoid common DAA and ART interactions, incorporate recent therapy approvals, and more. 

Download: Optimizing Cotreatment of HCV and HIV Infection

Monday, September 17, 2018

HCV Next October Issue - Research continues to invalidate link between DAA treatment, liver cancer

HCV NEXT September/October Issue
Greetings, the following articles appeared in this months issue of HCV NEXT, published online over at Healio.

Table of Contents
HCV vaccine could reduce transmission in people who inject drugs

AASLD invests $4.06 million in liver disease research, development

Cover Story
HCV-Positive Organs: A Viable Option for Uninfected Transplant Patients

In the Journals
Research continues to invalidate link between DAA treatment, liver cancer

Novel ‘genotype 8’ surfaces among four patients with HCV

Treating HCV in prison ‘microenvironment’ reduces transmission

Heart transplant with HCV-positive organs successful, virus cleared

In the Journals Plus

Experimental nasal influenza vaccine tested in kids, teens

Monday, September 17, 2018
Experimental nasal influenza vaccine tested in kids, teens
NIH-supported Phase 1 trial of potential broadly protective vaccine.

An early-stage clinical trial testing the safety and immune-stimulating ability of an experimental nasal influenza vaccine in healthy 9- to 17-year-old children and teens has begun enrolling participants at a Vaccine and Treatment Evaluation Unit (VTEU) site at Saint Louis University, Missouri. The VTEU is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

Annual vaccination against influenza is recommended for everyone over six months of age. However, because the flu virus changes from year to year, vaccines must be reformulated annually to take account of those changes. When mismatches occur, vaccine effectiveness may suffer. “We are hopeful that newer kinds of influenza vaccines, such as the candidate being tested in this trial, will provide protection even if their components do not precisely match the currently circulating influenza virus strains,” said NIAID Director Anthony S. Fauci, M.D.

Principal investigator Daniel Hoft, M.D., Ph.D., leads the clinical trial, which will enroll 50 participants. Half will receive the candidate nasal vaccine and the other half will receive a dose of inactive saline solution delivered as nasal spray. Neither the study staff nor volunteers will know whether a participant has received the experimental vaccine or placebo saline solution. All volunteers will receive an intramuscular injection of a licensed, quadrivalent seasonal influenza vaccine three months after receiving the initial nasal vaccine or placebo. An important objective of the study is to determine whether the combination of the licensed and experimental vaccine leads to broader protection against influenza viruses compared with the licensed vaccine alone. Investigators will perform an array of tests on volunteer blood samples at four time points following the first vaccination as well as three weeks after the second vaccination. They will look for evidence of immune responses from antibody-producing cells as well as from the cellular arm of the immune system.

The investigational vaccine, developed by FluGen, Inc. of Madison, Wisconsin, is made from a strain of seasonal influenza virus (H3N2) that has been genetically designed to replicate only once in the body. Studies in animals showed that the “single replication” virus does not cause disease but nevertheless prompted a robust immune response akin to that of a natural influenza infection. Investigators hypothesize that volunteers who receive the candidate vaccine will have a robust immune response not only against H3N2 strains that match those in the vaccine but also against influenza strains that are mismatched to the vaccine strain. A previous Phase 1 trial of this candidate vaccine in healthy adults showed that it was safe and generated a robust immune response and a Phase 2 trial in healthy adults is currently underway (that trial is not supported by NIAID.)

For more information about this trial of an experimental influenza vaccine in older children and adolescents, visit clinicaltrials.gov and search on identifier NCT03553940. The VTEUs are funded by NIAID through contract number HHSN272201300021.

NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Children lose out on liver transplants, study finds

“Children with chronic liver disease who are in need of transplant may be at a disadvantage compared with adults in a similar situation,” they wrote in their report, published in the journal JAMA Pediatrics.

Children lose out on liver transplants, study finds
by Maggie Fox / Sep.17.2018
The system for allocating liver transplants is stacked against kids, a new study finds.

Children who need lifesaving liver transplants are losing out to adults, according to a new study released Monday.

A system used to determine who is most in need of a transplant significantly underestimates the risk of death for younger children with liver disease, the team at the University of Pittsburgh found
Continue reading....

Psychological relief is the most important benefit of a hepatitis C cure for patients

Psychological relief is the most important benefit of a hepatitis C cure for patients
Roger Pebody Published: 13 September 2018
When asked to describe what their hepatitis C cure meant to them, Australians who had recently completed treatment emphasised an improved sense of psychological wellbeing, according to a qualitative study recently published in Hepatology, Medicine and Policy.

They described their relief about no longer fearing the development of liver disease or cancer, or of infecting others. Interviewees who had a history of injecting drug use understood their cure as a way to break the connection with their past.

Jacqueline Richmond of La Trobe University and colleagues recruited people who had achieved a sustained virological response 12 weeks after completing treatment (SVR12) in order to be interviewed about their experience of treatment and of cure. All participants were recruited from clinics in Melbourne, Australia between October 2016 and April 2017. The interviews were conducted during an early phase of the roll-out of direct acting antiviral (DAA) treatment in Australia; those interviewed are therefore likely to be ‘early adopters’ who may have been more motivated and enthusiastic than some other people who are eligible for treatment.


Article source:
Richmond JA et al. Achieving a hepatitis C cure: a qualitative exploration of the experiences and meanings of achieving a hepatitis C cure using the direct acting antivirals in Australia. Hepatology, Medicine and Policy 3:8, 2018. (Full text freely available.)

Friday, September 14, 2018

Treatment of Chronic HCV: Patients’ experiences before, during, and up to one year after directing antiviral therapy”

Listen to experts discuss important HCV related topics in the following easy to access webinar programs presented by HepCure.

Listen
The Patient-Reported Outcomes Project (PROP-UP)
Date presented August 28, 2018
“The Patient-Reported Outcomes Project (PROP UP): A multi-site observational cohort study of patients’ experiences before, during, and up to one year after directing antiviral therapy”
Listen here
Access the slides here


Coming Soon
Date presented September 11, 2018
Presentation by Dr. Christian B. Ramers, MPH, AAHIVS. Dr. Ramers will be added soon.

View All Presentations 

Webinar Archive

Of Interest On This Blog
Psychological relief is the most important benefit of a hepatitis C cure for patients

Follow On Twitter
@hepcure

HepCure Patient App
The patient app is a free resource for patients with hepatitis C, which allows them to track medication adherence, symptoms, and gain access to resources. It is available to download for free on iOS (App Store) and Android (Google Play) operating systems. While the app can be used by patients independently from the dashboard, it can also be linked with the provider dashboard. Providers can push lab data to patients and track treatment adherence and symptom data input by patients in real time.
Learn more here...…

Gilead targets hep B in half a billion dollar deal with Precision BioSciences

Gilead targets hep B in half a billion dollar deal with Precision BioSciences
Gemma Jones
14th September 2018
Biopharma looks to genome editing platform to discover hepatitis B cure
Following its success in curing hepatitis C with therapies such as Sovaldi and Harvoni, Gilead is now enlisting a new partner in the fight against hepatitis B (HBV).

Inking a collaboration deal that would be worth half a billion dollars with genome editing specialists Precision Biosciences, Gilead is aiming to develop a cure for HBV, which is proving more difficult to eliminate than hep C.

Chronic Hepatitis C Patients with Obesity: Do we Need two Operators for Accurate Evaluation of Liver Stiffness?

In Case You Missed It

September - October, 2018
Vol. 17 Issue 5 

Gamal E. Shiha, Shahira El-Etreby, Mounir Bahgat, Magdy Hamed, Mohamed El Sherbini, Elsayed A. Ghoneem, Khaled Zalata, Reham E. Soliman, Mohamed A. ElBasiouny, Nabiel NH Mikhail Page 795-801

Full-Text

Abstract
Introduction and aim. 
Transient elastography is gaining popularity as a non-invasive method for predicting liver fibrosis, but inter observer agreement and factors influencing reproducibility have not been adequately assessed. Material and methods. This cross-sectional study was conducted at Specialized Medical Hospital and the Egyptian Liver Foundation, Mansoura, Egypt. The inclusion criteria were: age older than 18 years and chronic infection by hepatitis C. The exclusion criteria were the presence of ascites, pacemaker or pregnancy. Three hundred and fifty-six patients participated in the study. Therefore, 356 pairs of exams were done by two operators on the same day. Results. The overall inter observer agreement ICC was 0.921. The correlation the two operators was excellent (Spearman's value q = 0.808, p < 0.001). Inter-observer reliability values were κ = 0.557 (p < 0.001). A not negligible discordance of fibrosis staging between operators was observed (87 cases, 24.4%). Discordance of at least one stage and for two or more stages of fibrosis occurred in 60 (16.9%) and 27 cases (7.6%) respectively. Obesity (BMI ≥ 30 kg/m2) is the main factor associated with discordance (p = 0.002). Conclusion. Although liver stiffness measurement has had an excellent correlation between the two operators, TE presented an inter-observer variability that may not be negligible.

Hepatitis C; Does the old-fashioned sofosbuvir plus ribavirin treatment in genotype 2 still work for Koreans?

Clin Mol Hepatol. 2018 Sep 11. doi: 10.3350/cmh.2018.1009. [Epub ahead of print]
Does the old-fashioned sofosbuvir plus ribavirin treatment in genotype 2 chronic hepatitis C patients still works for Koreans?
Yeon JE

PMID: 30200750 DOI: 10.3350/cmh.2018.1009 

Full-Text

Editorial
According to the 2017 Korean Association for the Study of the Liver (KASL) treatment guidelines of chronic hepatitis C,1 treatment options for genotype 2 patients are sofosbuvir plus ribavirin (SOF+R), SOF plus daclatasvir, glecaprevir plus pibrentasvir, SOF plus velpatasvir and pegylated interferon alpha plus ribavirin (PEG-IFN+R). Except in cases where only patients who cannot use the direct acting antivirals (DAAs), PEG-IFN+R is replaced by DAAs.

Hepatitis C virus prevalence and estimated incidence among new injectors during the opioid epidemic in New York City, 2000 to 2017: Protective effects of non-injecting drug use

Drug and Alcohol Dependence
Available online 12 September 2018

Don C. Des Jarlais, K. Arasteh, J. Feelemyer, C. McKnight, David M. Barnes, David C. Perlman, A. Uuskula, H.L.F. Cooper, Susan Tross
DOI: https://doi.org/10.1016/j.drugalcdep.2018.07.034
Publication stage: In Press Accepted Manuscript

Published online: September 12, 2018

Highlights
•Reverse transitioning was strongly associated with lower HCV seroprevalence.
•HCV seropositivity was inversely associated with current non-injecting heroin use.
•Injecting cocaine was associated with behavior likely to transmit HCV.
•NYC has high rates of HCV infection among persons who began injecting since 2000.

Abstract
Objective
Assess hepatitis C virus (HCV) prevalence and incidence among person who began injecting drugs during the opioid epidemic in New York City (NYC) and identify possible new directions for reducing HCV infection among persons who inject drugs.

Methods
846 persons who began injecting drugs between 2000 and 2017 were recruited from persons entering Mount Sinai Beth Israel substance use treatment programs. A structured interview was administered and HCV antibody testing conducted. Protective effects of non-injecting drug use were examined among persons who “reversed transitioned” to non-injecting drug use and persons who used non-injected heroin in addition to injecting.

Results
Participants were 79% male, 41% White, 15% African-American, 40% Latinx, with a mean age of 35. Of those who began injecting in 2000 or later, 97 persons (11%) “reverse transitioned” back to non-injecting drug use. Reverse transitioning was strongly associated with lower HCV seroprevalence (30% versus 47% among those who continued injecting, p < 0.005). Among those who continued injecting, HCV seropositivity was inversely associated with current non-injecting heroin use (AOR = 0.72, 95%CI 0.52-0.99). HCV incidence among persons continuing to inject was estimated as 13/100 person-years. HCV seropositive persons currently injecting cocaine were particularly likely to report behavior likely to transmit HCV.

Conclusions
Similar to other locations in the US, NYC is experiencing high rates of HCV infection among persons who have begun injecting since 2000. New interventions that facilitate substitution of non-injecting for injecting drug use and that reduce transmission behavior among HCV seropositives may provide additional methods for reducing HCV transmission.

Wednesday, September 12, 2018

Greg Jefferys: Purchasing Hep C Generics

Hepatitis C advocate Greg Jefferys launched a new video providing an overview on how to purchase affordable Hepatitis C medicines, such as Harvoni or Epclusa through "Affordable Medical Access International".

His Story
Hi, my name is Greg Jefferys and this website was originally created to record my experiences after I discovered I was infected with Hepatitis C back in August 2014 and what happened as I progressed through the shock of the initial Hep C diagnosis to trying to find an effective and affordable Hepatitis C treatment such as generic Harvoni or Epclusa.

In May 2015 I found myself in India where I purchased generic Sovaldi (Sofosbuvir 400 mg) and twelve weeks later I was cured. Because I was the first person who publicly traveled to India to buy generic Hep C medication my journey received quite a lot of media attention around the world and soon I was getting hundreds of emails every day from people who needed reliable information about buying generic Hepatitis C medicine and about Hepatitis C treatment options generally.

As a direct result of these requests for assistance I started a business called Affordable Medical Access International. Through this business I can supply you with these new Hepatitis C medicines, such as Harvoni or Epclusa. I can deliver to anyone in any country at a fair price with shipping insurance and guaranteed delivery.

Published on Sep 11, 2018

Hep C Home Page

Facebook Page
https://www.facebook.com/greg.jefferys

Greg is also a blogger at Hep Blogs
https://www.hepmag.com/blogger/greg-jefferys 

On This Blog
The controversy over expensive new drugs for hepatitis C
Link to a collection of research articles regarding the effectiveness and safety of generic hepatitis C medicines. Read news articles addressing the high cost, insurance restrictions; private insurers/Medicaid and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs" 

Neuropsychiatric symptoms associated with hepatitis C virus (HCV)

September 12, 2018 
HCV Neuropsychiatric Symptoms Likely Linked to Virus' Effects on Brain Function
The neuropsychiatric symptoms associated with hepatitis C virus (HCV) infection are likely caused by the body's response to the virus' effects on brain function, according to a study recently published in the Journal of Viral Hepatitis. This neuro-inflammatory and systemic response is akin to that observed in patients with autoimmune diseases of the liver.

Reference 
Dirks M, Haag K, Pflugrad H, et al. 
[published online August 18, 2018]. J Viral Hepat. doi: 10.1111/jvh.12979

Abstract 
Chronic fatigue, mood alterations and cognitive impairment are frequent accessory symptoms of HCV‐infection. Fatigue and mood alterations have also been observed in autoimmune hepatitis (AIH) and primary biliary cholangitis (PBC), but not in hepatitis B virus (HBV)‐infection, thus indicating an autoimmune response as possible cause of HCV‐infection associated encephalopathy. Data, however, are sparse. This study aims to prove that HCV patients feature similar to those with autoimmune liver disease but contrary to HBV patients regarding neuropsychiatric symptoms.

132 non‐cirrhotic patients (HCV: 46, HBV: 22, AIH: 27, PBC: 29, AIH/PBC: 8) completed questionnaires addressing the domains mentioned above. Eighty‐eight underwent a comprehensive neuropsychological assessment. Patient groups were compared among each other and to 33 healthy controls.

Fatigue, anxiety and depression scores were significantly increased, and the SF‐36 mental score significantly decreased in all patient groups compared to controls. Fatigue was significantly more pronounced in HCV than in HBV patients. HCV patients scored significantly worse than HBV patients but not AIH and PBC patients in the SF‐36. HCV, AIH and PBC but not HBV patients did significantly worse than controls in word learning. Recognition of words was impaired in HCV, AIH and PBC patients and recognition of figures in HCV patients, exclusively (p≤0.002). HCV patients did also worse than controls and HBV patients concerning alertness and working memory (p≤ 0.001).

The neuropsychiatric profiles of HCV patients are similar to those of AIH and PBC patients but differ from those of HBV patients, suggesting an autoimmune response as a possible cause for these differences.

Hepatitis C - Generic sofosbuvir-based interferon-free direct acting antiviral agents: a real-world multicenter observational study

Generic sofosbuvir-based interferon-free direct acting antiviral agents for patients with chronic hepatitis C virus infection: a real-world multicenter observational study
Chen-Hua Liu, Yi-Jie Huang, Sien-Sing Yang, Chung-Hsin Chang, Sheng-Shun Yang, Hsin-Yun Sun, Chun-Jen Liu, Wen-Chun Liu, Tung-Hung Su, Hung-Chih Yang, Chun-Ming Hong, Tai-Chung Tseng, Pei-Jer Chen, Ding-Shinn Chen, Chien-Ching Hung & Jia-Horng Kao

Full-Text Article 
Scientific Reports volume 8, Article number: 13699 (2018)
Published: 12 September 2018 

Abstract
Real-world data regarding the effectiveness and safety of generic sofosbuvir (SOF)-based interferon-free direct acting antiviral agents (DAAs) for patients with chronic hepatitis C virus (HCV) infection remain limited. A total of 517 chronic HCV-infected patients receiving 12 or 24 weeks of SOF-based therapies were retrospectively enrolled in 4 academic centers in Taiwan. The rate of sustained virologic response at week 12 off-therapy (SVR12) and that of treatment completion were assessed. The baseline characteristics and on-treatment HCV viral kinetics to predict SVR12 were analyzed. By evaluable population (EP) analysis, the SVR12 rate was 95.4% (95% confidence interval [CI]: 93.2–96.9%). The SVR12 was achieved in 29 of 34 patients (85.3%, 95% CI: 69.6–93.6%), 130 of 139 patients (93.5%, 95% CI: 88.2–96.6%), 119 of 124 patients (96.0%, 95% CI: 90.9–98.3%) and 215 of 220 patients (97.7%, 95% CI: 94.8–99.0%) who received SOF in combination with ribavirin (RBV), ledipasvir (LDV), daclatasvir (DCV) and velpatasvir (VEL), respectively. Of 517 patients, 514 (99.4%) completed the scheduled treatment. All 15 patients with true virologic failures were relapsers. Two decompensated cirrhotic patients had on-treatment deaths which were not related to DAAs. All 7 patients who were lost to follow-up had undetectable HCV RNA level at the last visit. The SVR12 rates were comparable in terms of baseline patient characteristics and viral decline at week 4 of treatment. In conclusion, generic SOF-based regimens are well tolerated and provide high SVR12 rates in patients with chronic HCV infection.

Introduction
Hepatitis C virus (HCV) infection remains a challenging health problem in the world. It is estimated that approximately 71.1 million people, which account for 1.0% of the world’s population, are HCV carriers1. Among patients with chronic HCV infection, about 20% of them will evolve to cirrhosis over a period of 20–30 years. Once cirrhosis is established, the annual rates of developing hepatic decompensation and hepatocellular carcinoma (HCC) are 3–6% and 1–4%, respectively2,3. In addition to increasing the risks of liver-related morbidity and mortality, HCV infection is also associated with various extra-hepatic manifestations which further compromised the patients’ health outcome and quality of life4. On the other hand, the morbidity and mortality are significantly reduced once these patients achieve sustained virologic response (SVR) by anti-HCV agents5,6,7,8,9.

The use of interferon (IFN)-free direct acting antiviral agents (DAAs) has made a paradigm shift and become the standard of care for HCV infection. Sofosbuvir (SOF) is a pyrimidine nucleotide analogue that inhibits the HCV non-structural protein 5B (NS5B) ribonucleic acid (RNA)-dependent RNA polymerase, which is essential for viral replication. After intra-hepatic metabolism to active uridine triphosphate form, the GS-461203, it is incorporated to HCV RNA by NS5B polymerase and acts as the chain terminator10. Clinically, SOF is administered once-daily with pangenotypic potency, well tolerability, a high genetic barrier to drug resistance, and low rates of drug-drug interactions (DDIs). Furthermore, SOF can be used in combination with various kinds of NS3/4 A protease inhibitors (PIs), NS5A inhibitors, and/or ribavirin (RBV) to achieve high SVR rates11,12,13,14,15,16,17,18,19,20,21,22,23. Because of the excellent therapeutic profiles, treatment of HCV by SOF-based regimens is appealing to most health care providers.

Although SOF-based IFN-free DAAs are highly efficacious and well tolerated, many HCV-infected individuals have limited governmental reimbursement or private insurance support for brand-name agents24,25,26. Allowing generic SOF-based DAAs through voluntary or compulsory licensing can scale up the HCV treatment to facilitate more efficient HCV control, particularly for patients in resource-constrained countries. Regarding the effectiveness and safety of generic SOF in combination with ledipasvir (LDV), daclatasvir (DCV), and/or RBV, several reports from China, India, Egypt and Argentina indicated that the SVR rates were >90% and most patients tolerated the treatment well27,28,29,30,31. On the basis of these encouraging results, we aimed to evaluate the performance of generic SOF-based DAAs for HCV and factors potentially affecting the treatment response in a multicenter cohort in Taiwan.

Open Access
Full-Text Article Available Online:

Epclusa® (Sofosbuvir/Velpatasvir) with or without ribavirin in patients with decompensated cirrhosis

Journal of Gastroenterology - September 10, 2018 

Efficacy and safety of sofosbuvir–velpatasvir with or without ribavirin in HCV-infected Japanese patients with decompensated cirrhosis: an open-label phase 3 trial
Tetsuo Takehara Naoya Sakamoto Shuhei Nishiguchi Fusao IkedaTomohide TatsumiYoshiyuki UenoHiroshi Yatsuhashi Yasuhiro Takikawa Tatsuo Kanda Minoru Sakamoto Akihiro Tamori Eiji MitaKazuaki Chayama Gulan Zhang Shampa De-Oertel Hadas Dvory-SobolTakuma Matsuda Luisa M. Stamm Diana M. Brainard Yasuhito Tanaka Masayuki Kurosaki

Sofosbuvir –velpatasvir for 12 weeks provides a highly effective and well-tolerated therapy for Japanese patients with HCV and decompensated cirrhosis. Ribavirin did not improve efficacy but increased toxicity.

Open Access 
First Online: 10 September 2018
Full text article available online: 

Abstract
Background
In Japan, hepatitis C virus (HCV)-infected patients with decompensated cirrhosis currently have no treatment options. In this Phase 3 study, we evaluated sofosbuvir–velpatasvir with or without ribavirin for 12 weeks in patients with any HCV genotype and decompensated cirrhosis [Child–Pugh–Turcotte (CPT) class B or C] in Japan.

Methods
Patients were randomized 1:1 to receive sofosbuvir–velpatasvir with or without ribavirin for 12 weeks. Randomization was stratified by CPT class and genotype. Sustained virologic response 12 weeks following completion of treatment (SVR12) was the primary efficacy endpoint.

Results
Of the 102 patients enrolled, 57% were treatment naive, 78% and 20% had genotype 1 and 2 HCV infection, respectively, and 77% and 20% had CPT class B and C cirrhosis, respectively, at baseline. Overall, 61% of patients were female and the mean age was 66 years (range 41–83). SVR12 rates were 92% (47/51) in each group. Among patients who achieved SVR12, 26% had improved CPT class from baseline to posttreatment week 12. Most adverse events (AEs) were consistent with clinical sequelae of advanced liver disease or known toxicities of ribavirin. Four patients (8%) who received sofosbuvir–velpatasvir and seven (14%) who received sofosbuvir–velpatasvir plus ribavirin experienced a serious AE. The 3 deaths (bacterial sepsis, gastric varices hemorrhage, hepatocellular carcinoma) were attributed to liver disease progression.

Conclusion
Sofosbuvir–velpatasvir for 12 weeks provides a highly effective and well-tolerated therapy for Japanese patients with HCV and decompensated cirrhosis. Ribavirin did not improve efficacy but increased toxicity.

Tuesday, September 11, 2018

Hepatitis C virus genotype 3: clinical features, current and emerging viral inhibitors, future challenges

Ann Gastroenterol. 2018 Sep-Oct;31(5):541-551. doi: 10.20524/aog.2018.0281. Epub 2018 Jun 4.

REVIEW ARTICLE
Hepatitis C virus genotype 3: clinical features, current and emerging viral inhibitors, future challenges
Vahe Shahnazariana, Daryl Ramaia,b, Madhavi Reddya, Smruti Mohantyc

Download full article: http://www.annalsgastro.gr/files/journals/1/earlyview/2018/ev-06-2018-01-AG_3988-0281.pdf
Article available online: Europe PMC (Open Access)

Abstract
Hepatitis C virus (HCV) represents a global burden on healthcare that affects over 150 million people worldwide. In the past, HCV genotype 3 was considered difficult to treat relative to other genotypes. Genotype 3 has been associated with a higher rate of complications, including fatty liver disease, fibrosis, hepatocellular carcinoma and mortality. However, with the advent of first- and second-generation direct-acting antivirals, genotype 3 can be treated effectively. Additionally, these new drugs are well tolerated by patients and have significantly fewer side effects compared to ribavirin and interferon-based regimens. However, while great strides have been made in overcoming biological barriers, our next challenge lies in overcoming economic and financial obstacles if we are to eradicate HCV genotype 3. Herein, we review the clinical features associated with HCV genotype 3, current and emerging treatment regimens, and challenges associated with treatment.

Keywords Hepatitis C, genotype 3, sustained viral response, direct acting antivirals, treatment Ann Gastroenterol 2018; 31 (4): 1-11

Continue to article online.....

Groups call for end to Gilead’s hepatitis C drug monopoly in Europe which blocks access

MSF and groups call for end to Gilead’s hepatitis C drug monopoly in Europe which blocks access 
-Pharmaceutical company Gilead has a patent monopoly on hepatitis C drug sofosbuvir in Europe
--The patent results in exorbitant prices, meaning people are unable to afford treatment 
--MSF and other organisations are urging the European Patent Office to overturn the patent in a hearing this week. 

Munich/Paris– This week in Munich, the European Patent Office is hearing a legal challenge filed by groups in 17 countries in March 2017, against an unmerited patent that allows US pharmaceutical corporation Gilead Sciences to charge exorbitant prices in Europe for the key hepatitis C drug sofosbuvir. Médecins du Monde (MdM), Médecins Sans Frontières (MSF) and Just Treatment are among the patient and treatment provider organisations that challenged the validity of a Gilead patent on sofosbuvir, on the grounds that it does not fulfill the requirements to be a patentable invention from a legal or scientific perspective. The groups urged the European Patent Office (EPO), which will hold a public hearing on 13 and 14 September, to rethink its decision that gives Gilead this monopoly.

If the patent challenge is successful, a major step will have been taken toward allowing the production and importation of affordable generic versions of sofosbuvir in Europe. Generic versions would protect health systems across Europe from financial burden due to the excessive price of this drug. The extremely high prices in Europe of newer hepatitis C medicines—called direct-acting antivirals, or DAAs—has led civil society organisations to investigate and subsequently challenge the monopoly status and legitimacy of such patents. 

Medical Activities
Hepatitis C
Worldwide, an estimated 71 million people are infected with the hepatitis C virus, double the number living with HIV. While hepatitis C can be cured, few people have access to treatment.

Governments forced to ration treatment
“I have been through an extremely agonising wait for three years to get access to sofosbuvir”, said Clare Groves, Just Treatment patient leader who was treated and cured of hepatitis C through the National Health Service (NHS) in the United Kingdom. The NHS was forced to ration supply of the medicine due to its high price. “I was repeatedly told by my doctor that I am sick, but not sick enough to qualify for the treatment under the public health programme. I don’t want other people to be denied sofosbuvir because its price is exorbitant, so I will continue to fight for their access to this cure.”

The World Health Organization estimates that 15 million people in Europe—approximately one in 50 people—are chronically infected with hepatitis C, leading to approximately 112,500 deaths per year from related liver cancer and cirrhosis. The advent of DAA drugs, which offer a safer, shorter and more effective cure compared to older treatments, has marked a major breakthrough in the treatment of the disease, with cure rates higher than 90 percent, compared to around 50 percent previously. Sofosbuvir forms the backbone of most hepatitis C combination treatments, yet access to these newer treatments remains very limited globally because of high prices, with governments and treatment providers in many countries forced to ration treatment and limit access only to people with advanced forms of the disease.

Exorbitant prices in Europe, but affordable elsewhere
Gilead charges as much as €43,000 for one person’s 12-week treatment of sofosbuvir in Europe. Meanwhile, in countries where the drug is not patented, competition among generic producers has driven the price to just €52 for the same treatment course. Studies have shown that it costs about €0.50 per daily pill to manufacture the drug. “Financial barriers in access to medicines and healthcare have become a challenge for high-income countries in Europe”, said Olivier Maguet, of MdM’s drug pricing campaign. “Because unmerited patents are the key driver for these excessive prices, it’s time to challenge these patents in Europe.”

More scrutiny of patents needed
While the high prices charged for medicines are a well-known problem in many parts of the world, the recent excessive pricing of DAAs has brought Europe’s attention for the first time on the impact that monopolies have both on health budgets and on people’s access to many other essential medicines. Legal challenges against patents on sofosbuvir and other DAAs have been filed in several countries, and key patents on sofosbuvir have already been rejected in Egypt, China and Ukraine. Decisions are pending in other countries, including Argentina, Brazil, India, Russia and Thailand.

 “Every day, MSF witnesses first-hand how monopolies on medicines restrict people’s access to life-saving medicines,” said Gaelle Krikorian, Head of Policy at MSF’s Access Campaign. “MSF was only able to start scaling up treatment for people with hepatitis C in countries like Cambodia and India once more affordable quality-assured generics became readily available.”

“It’s high time that the European Patent Office and patent offices around the world apply greater scrutiny when granting monopolies on medicines, recognising the negative impact that unmerited patents have on people’s health”, said Gaelle Krikorian. “Revoking Gilead’s patent would end the corporation’s monopoly in Europe, and allow countries to access sofosbuvir from multiple generic manufacturers at affordable prices. It would also send a strong signal to other countries to challenge unmerited patents when people’s health and survival are at stake.”
https://www.msf.org/msf-and-groups-call-end-gileads-hepatitis-c-drug-monopoly-europe-which-blocks-access

Unapproved kratom products: FDA issuing new warning letters

September 11, 2018
Epidemics don’t occur overnight. As we deal with the devastating crisis of opioid abuse and overdose plaguing our nation, the U.S. Food and Drug Administration must remain vigilant and aggressive against trends that threaten to reverse our progress, or substances that have the potential to cause new epidemics of abuse.

Mitragyna speciosa, known more commonly as kratom, is a plant native to Thailand, Malaysia, Indonesia and Papua New Guinea. While it is important to generate more evidence, there is evidence that certain substances found in kratom are opioids and data suggest that one or more may have a potential for abuse. And its use has been on the rise and is of concern to the FDA. We’re not alone in our concern about the opioids found in kratom – it’s already illegal or controlled in several other countries including Australia, Denmark, Germany, Malaysia and Thailand. The substance is also banned in a number of states and municipalities in the U.S.

Science and evidence matter in demonstrating medical benefit, especially when a product is being marketed to treat serious diseases like opioid use disorder (OUD). However, to date, there have been no adequate and well-controlled scientific studies involving the use of kratom as a treatment for opioid use withdrawal or other diseases in humans. Nor have there been studies on how kratom, when combined with other substances, may impact the body, its dangers, potential side effects, or interactions with other drugs. Today’s action is based on these concerns. The FDA issued warning letters to two more unscrupulous vendors, Chillin Mix Kratom and Mitra Distributing, for marketing kratom products with scientifically unsubstantiated claims including to “relieve opium withdrawals” and to “treat a myriad of ailments including but not limited to: diarrhea, depression, diabetes, obesity, high blood pressure, stomach parasites, diverticulitis, anxiety, alcoholism, and opiate withdrawal.” Simply, selling these unapproved kratom products with claims that they can treat opioid withdrawal and addiction and other serious medical conditions is a violation of federal law.

Yet despite our warnings and previous regulatory and enforcement actions, we continue to find marketers actively selling kratom with unsubstantiated claims.

Fraudulent health claims can pose serious health risks. They may keep some patients from seeking appropriate, FDA-approved therapies. Reliance on products with unsubstantiated claims may delay those who suffer from OUD from entering recovery and may put them at greater risk of overdose and death. We know that patients receiving FDA-approved medication-assisted treatment (MAT) cut their risk of death in half, according to the Substance Abuse and Mental Health Services Administration.

As U.S. Department of Health and Human Services and the others in the federal government work to reduce the number of Americans who are addicted to opioids ad other substances, the FDA will continue to promote innovation and more widespread access to FDA-approved treatments for OUD. While HHS is taking new steps to make safe and effective MAT available to those who suffer from OUD, we must also work to reduce the stigma that is sometimes associated with use of these therapies. In parallel, we cannot allow kratom products with unsubstantiated claims to prevent those with OUD from seeking treatments that have been demonstrated to be safe and effective.

At HHS and within the FDA, we have great concern for the many Americans who misuse any drugs, especially opioids. In support of the public health, we continue to urge consumers not to consume kratom and to seek appropriate medical care from their health care provider. We will also continue to take action against those who put the safety of Americans at risk and who violate federal law by making unsubstantiated health claims about products that they seek to sell.

The Food and Drug Administration, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA keeps warning about the controversial supplement kratom, but companies keep deceptively selling it  
Published: Sept 11, 2018 12:42 p.m. ET
“Simply, selling these unapproved kratom products with claims that they can treat opioid withdrawal and addiction and other serious medical conditions is a violation of federal law,” the FDA said in a Tuesday statement. “Yet despite our warnings and previous regulatory and enforcement actions, we continue to find marketers actively selling kratom with unsubstantiated claims.”

The two companies in question, Chillin Mix Kratom and Mitra Distributing, also claimed that their kratom products could treat conditions like obesity, depression, alcoholism and high blood pressure, according to the FDA. Continue reading: https://www.marketwatch.com/story/fda-keeps-warning-about-the-controversial-supplement-kratom-but-companies-keep-deceptively-selling-it-2018-09-11

Archives
Poisonings from kratom, sold as an herbal supplement, are rising. But no one knows how much 
Mari A. Schaefer Tuesday, August 21, 2018 

Kratom is an unregulated herbal product that has been linked to at least four deaths in the Philadelphia region. 

PHILADELPHIA — An unregulated herbal product that advocates say can relieve pain and help with opioid withdrawal has been linked to at least four deaths in the Philadelphia region, but with many authorities failing to track kratom poisonings, there’s no way to know if there are more deaths related to the substance.

Kratom, derived from the leaves of a Southeast Asian tree that is part of the coffee family, has gained popularity in recent years. It is sold online, in gas stations and in smoke shops, and is typically brewed as a tea, chewed, smoked or ingested in capsules.

An estimated 3 million to 5 million people use kratom, according to the American Kratom Association, a Colorado-based nonprofit founded in 2014 to promote the herbal product. It has become a billion-dollar business, according to the Botanical Education Alliance, another kratom advocacy group.

Read more: Boston Herald 

Monday, September 10, 2018

HCV Newsletters & Updates: Obesity in liver disease, Nasal spray for opioid overdose and Fast-acting flu drug

HCV Newsletters & Updates
Welcome, check out the latest news, review this months collection of newsletters, and finish off by reading a handful of well written blogs focused on living well with hep B or C.

In The News
MSF and groups call for end to Gilead’s hepatitis C drug monopoly in Europe which blocks access 
--Pharmaceutical company Gilead has a patent monopoly on hepatitis C drug sofosbuvir in Europe
--The patent results in exorbitant prices, meaning people are unable to afford treatment
--MSF and other organisations are urging the European Patent Office to overturn the patent in a hearing this week.

With an award-winning newsroom, STAT gives you indispensable insights and exclusive stories on the technologies, personalities, power brokers, and political forces driving massive changes in the life science industry — and a revolution in human health.
Fast-acting flu drug shows strong potential - An experimental, fast-acting flu drug showed strong promise in two newly published trials — but it also led to some surprising and even concerning results. The drug cut the time people were sick with flu symptoms by just over a day, but didn’t make people feel better faster than Tamiflu.

Reuters
California-based Opiant earlier this year was awarded a $7.4 million grant by the U.S. National Institutes of Health’s National Institute on Drug Abuse for the development of a nasally-applied version of overdose treatment nalmefene.

Associated Press 
Doctors explore lifting barriers to living organ donation
WASHINGTON — Surgeons turned down Terra Goudge for the liver transplant that was her only shot at surviving a rare cancer. Her tumor was too advanced, they said — even though Goudge had a friend ready to donate, no matter those odds.

HepCBC 
HepCBC is a Canadian non-profit organization offering awareness with basic information about HCV and a weekly digest of news.
Read the latest issue of the highly successful Weekly Bull.

September Updates
Hepatology - Top Story From Healio 
Healio features the industry’s best news reporting, dynamic multimedia, question-and-answer columns, educational activities in a variety of formats, blogs, and peer-reviewed journals.

HCV NEXT September/October Issue - The following articles appeared in this months issue of HCV NEXT, published online over at Healio

September 7, 2018
Physicians and researchers have noted the increase in liver disease over the last couple decades, especially nonalcoholic fatty liver disease, correlates significantly…

NATAP
NATAP is a New York State non-profit corporation with 501(c)3 Federal tax-exempt status. Our mission is to educate individuals about HIV and Hepatitis treatments and to advocate on the behalf of all people living with HIV/AIDS and HCV. Our efforts in these areas are conducted on local, national, and international levels.
Global Hepatitis Summit A Few Selected Highlights 
Reported by Jules Levin, NATAP
In June the Global Hepatitis Summit took place in Toronto. Here are 3 selected talks highlighted of particular interest to me. The first talk by Andrew Hill he says we have a bleak scenario regarding the possibility of global HCV elimination. He says in many countries new HCV infections outstrip HCV cures and new diagnoses. New diagnoses are much lower in all poorer countries compared to high income countries. Screening is too low, all of which he uses to say the outlook is bleak for global HCV elimination unless we make changes.

The 2nd talk I chose to highlight was by Maria Prims from the Netherlands where she reports high HCV infection & reinfection rates among people taking PrEP to prevent HIV infection. She highlights an increasing HCV incidence among MSM. 376 started PrEP either daily or on demand and there were 12 HCV infections: 6 new infections & 6 reinfections.

The 3rd report below is on the use of a new broader type of model in India for HCV screening & care. A more comprehensive clinic model where IDUs can under 1 roof get a variety of services for IDU and HCV care. Sunil Solomon highlights how big & diverse the HCV epidemic is India, much bigger even only among IDUs compared to the entire HCV epidemic in Western Europe. 
Read it here...…

In Case You Missed It
'A long life with HIV' is now available to read online. The booklet provides information on living well with HIV as you get older, including things you can do to look after your health, health issues and preparing for the future.

Sept 4, 2018
Inovio Pharmaceuticals (NSDQ:INO) and its partner, GeneOne Life Science (KSE:011000), said today that the companies have dosed the first patient in a Phase I study designed to test a preventive vaccine against hepatitis C infection. The companies plan to recruit 24 study participants to evaluate Inovio’s GLS-6150 candidate. Participants will include people who have a sustained virologic response following treatment for Hep. C, as well as healthy controls. They are slated to receive one of two doses of vaccine, administered intra-dermally and followed by electroporation with Inovio’s Cellectra device.

Risk of Liver Cancer in Patients with NAFLD 
(Reuters Health) - People with advanced cases of nonalcoholic fatty liver disease (NAFLD) may need to be monitored for liver cancer, a large U.S. study suggests.

Vosevi Beats Hepatitis C Regardless of Drug Resistance 
In a recent study of people whose previous hep C regimen failed to cure their infection, Vosevi cured almost all of them.

Will an opt-out organ transplant law save lives?
The recent decision in England to change the organ donation law from voluntary consent (opt-in) to presumed consent (opt-out) highlighted the debate around the best approach to organ donation.

Routine oral care to treat gum disease may improve cognitive function in cirrhosis patients
Routine oral care to treat gum disease may play a role in reducing inflammation and toxins in the blood and improving cognitive function in people with liver cirrhosis.

In The Journals 
Hepatitis B Virus and Risk of Non-Hodgkin Lymphoma
Journal of Viral Hepatitis

Chronic Hepatitis C Association with Diabetes Mellitus and Cardiovascular Risk in the Era of DAA Therapy.
Most likely, DAA treatment and subsequently SVR achievement decrease cardiovascular risk. This fact is another reason for early treatment of patients, including those with a lower grade of liver fibrosis. Yet, chronic hepatitis C treatment remains inaccessible not only in developing countries but also in countries with high quality of life..

Newsletters
HCV Advocate
The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education.
In this month’s HCV Advocate newsletter, the following noteworthy articles are available to read and educate:
-SnapShots by Alan Franciscus Risk factors, mortality, and cardiovascular outcomes in patients with type 2 diabetes—A. Rawshani, et. al.
-Incidence of hepatocellular carcinoma after direct antiviral therapy for HCV in patients with cirrhosis included in surveillance programs—P. Nahom, et. al.
-Safety and efficacy of ledipasvir‐sofosbuvir with or without ribavirin for chronic hepatitis C in children ages 6‐11—K. F. Murry, et. al
Briefly……..
-Commentary: A review of the risk of hepatitis B and C transmission through biting or spitting—H. Pintilie, et. al.
-Hepatitis C virus infection in children in the era of direct-acting antivirals—M. Pawlowska, et. al
HealthWise – A Buffet of Health Information – as the title of the article implies, Lucinda discusses the various substances that may or may not be good for your health.
Hepatitis Headlines – Three interesting news stories about hepatitis C that our readers will find interesting including heart transplants, eliminating hepatitis in the U.S. and WHO and HCV treatment guidelines.
Hep C 101 – Overview of Hepatitis C by Alan Franciscus – A new series of article for people who are new to hepatitis C or for those people who want basic information.
What’s Up – We’ve updated several of the HCV Advocate Factsheets. Use the links provided in this section to get current information on several subjects that relate to Hep C, including nutrition, alcohol, co-infection, and motherhood.
Watch our patient video about treating and curing HCV. 

The New York City Hepatitis C Task Force
The New York City Hepatitis C Task Force is a city-wide network of service providers and advocates concerned with hepatitis C and related issues. The groups come together to learn, share information and resources, network, and identify hepatitis C related needs in the community. Committees form to work on projects in order to meet needs identified by the community.
Review all news updates.

HCV Action
HCV Action brings together hepatitis C health professionals from across the patient pathway with the pharmaceutical industry and patient representatives to share expertise and good practice.
HCV Action e-update

World Hepatitis Alliance
We run global campaigns, convene high-level policy events, build capacity and pioneer global movements, ensuring people living with viral hepatitis guide every aspect of our work.
View Recent Newsletters 
World Hepatitis Alliance (WHA) presents hepVoice, a monthly magazine with updates on the latest projects, news from WHA members and key developments in the field of hepatitis.

GI & Hepatology News
Over 17,000 gastroenterologists and hepatologists rely on GI & Hepatology News every month to cover the world of medicine with breaking news, on-site medical meeting coverage, and expert perspectives both in print and online. 
Hot topics
Amy Karon MDedge News 
Modest alcohol consumption was associated with significantly less improvement in steatosis and significantly lower odds of NASH resolution.
View all updates here....

Hep-Your Guide to Hepatitis
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and HepMag.com are the go-to source for educational and social support for people living with hepatitis.
View - all issues
Read the news

Hepatitis Victoria
Hepatitis Victoria is the peak not-for-profit community organisation working across the state for people affected by or at risk of viral hepatitis.
Latest Podcast: Karen Hoyt a HEP Hero and she is unique in being our first international recipient!
Speaking from Oklahoma in the United States, Karen talks about her diagnosis with hepatitis C and how she experienced the full gamut of conditions leading to a liver transplant.



View the Latest Newsletter, or relax and listen to a short podcasts interviewing health experts and practioners on topics related to viral hepatitis - come have a listen!

British Liver Trust
The British Liver Trust is the leading UK liver disease charity for adults – we provide information and support; increase awareness of how liver disease can be prevented and promote early diagnosis; fund and champion research and campaign for better services. 
News: Less Survivable Cancer Taskforce calls for government to double the survival rate of deadliest cancers by 2029
The combined five-year survival rate for people with either liver, brain, lung, oesophageal, pancreatic or stomach cancers stands is currently just 14%. Today, six charities …
View Recent Newsletters, here.

The National Viral Hepatitis Roundtable
The National Viral Hepatitis Roundtable (NVHR) is national coalition working together to eliminate hepatitis B and C in the United States.
View all NVHR newsletters

The Hepatitis C Trust
The Hepatitis C Trust is run by patients with the goal of eliminating HCV in the United Kingdom. The Trust’s mission is to reverse the rapidly increasing death toll caused by hepatitis C in the UK until no-one dies from this preventable and treatable disease and, ultimately, it is all but eradicated in this country.

National Institutes of Health
A monthly newsletter from the National Institutes of Health, part of the U.S. Department of Health and Human Services
September Newsletter
Topics
Body Odor May Be Sign of Disease
Breathe Easier
Dealing with Bad Air Quality

Harvard Health
Lipoprotein(a) is a fatty particle in the blood that invades artery walls, causing atherosclerosis. Also known as Lp(a), the particles are similar to “bad” LDL cholesterol molecules but with an extra protein attached. High blood levels of Lp(a)—which is largely determined by genetics—may explain some unexpected, premature heart attacks. Widespread testing for Lp(a) is not recommended because both the prevalence and the definition of what constitutes a dangerously high level are not yet clear. In addition, there are no FDA-approved treatments proved to lower heart disease risk in people with high Lp(a) levels.

Inspirational Bloggers
Karen Hoyt is devoted to offering support and accurate information to people coping with the effects of hepatitis C.
I hear a lot from people seeking help for autoimmune liver disease. Trying to figure it out is hard, but most symptoms are the same as any type of liver disease. I know, we can’t lump them all into one specific area, but they are in the same region.

Lucinda K. Porter
Lucinda Porter is a nurse, speaker, advocate and patient devoted to increasing awareness about hepatitis C.
Latest blog entry: Happiness: Purging Self-Help Advice

Hep 
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis.
Latest blog entry: By Connie M. Welch
Patient Experience Living With Cirrhosis With John M., Part 2 Part 2 of Connie Welch’s interview with John M, a patient with hepatitis C and cirrhosis, who was successfully treated with Harvoni.

By Greg Jefferys -How Big Pharma Corrupts Health Services 
A look at how bribing bureaucrats and buying doctors brings about bad outcomes for public health.
Check out the talented people who blog at Hep.

We provide information, support, referral and advocacy for people affected by viral hepatitis in NSW. We also provide workforce development and education services both to prevent the transmission of viral hepatitis and to improve services for those affected by it.
Latest blog entry: Pharmacists key in harm reduction

Life Beyond Hepatitis C
Life Beyond Hep C is where faith, medical resources and patient support meet, helping Hep C patients and their families navigate through the entire journey of Hep C.
Latest blog entry: Relief from Itching with Hepatitis C and Cirrhosis

Canadian Liver Foundation 
We strive to improve prevention and the quality of life of those living with liver disease by advocating for better screening, access to treatment, and patient care.
Latest blog entry: Who Gives a Sliver of a Liver to a Stranger?

Hepatitis B Foundation 
The Hepatitis B Foundation is a national nonprofit organization dedicated to finding a cure and improving the quality of life for those affected by hepatitis B worldwide.
Latest blog entry: - Be Your Own Advocate in the Medical Room
The hepatitis B virus (HBV) can be transmitted two ways: 1) through direct contact with blood and 2) infected body fluids. Some risks for direct blood contact are obvious, such as touching an open wound to another open wound or cleaning up someone’s blood without any protective gear. However, other methods of blood transmission are harder to catch. Common activities like sharing razors, earrings, or toothbrushes are simple, innocent actions, yet they all have the potential for blood exchange.

HepatitisC.net
At HepatitisC.net we empower patients and caregivers to take control of Hepatitis C by providing a platform to learn, educate, and connect with peers and healthcare professionals.
Latest blog entry: Ask the Advocate: What Were Your First Symptoms of Hep C?
There are several common symptoms of chronic HCV, including fatigue, joint pain, muscle aches, low-grade fever, decreased appetite..

HIV and ID Observations 
An ongoing dialogue on HIV/AIDS, infectious diseases, all matters medical, and some not so medical.
Latest blog entry: Doravirine Sets a New Standard for NNRTIs — But What Role in HIV Treatment Today?

KevinMD
Kevin Pho is a practicing physician and most known for his blog KevinMD. Thousands of authors contribute to his blog: primary care doctors, surgeons, specialist physicians, nurses, medical students, policy experts. And of course, patients, who need the medical profession to hear their voices.
One of the aspects of depression that’s particularly difficult is the sleep disturbance which accompanies it and often continues after the traditional symptoms of depression have finally gotten better.

On The Radio
Presented by Dr Norman Swan
Genetic test predicts dementia risk. Warning over new genetic tests on Medicare Benefits Schedule. Colonoscopy standards to reduce unnecessary treatment, risk of complications. Scan your heart to save your life...

Healthy You
This type of observational study is useful for comparing what happens to groups of people in different situations (in this case, people over 75 who have or haven't been prescribed statins), but it can't show cause and effect. So in this case, it can't show whether living longer or having strokes or heart attacks are a direct effect of taking or not taking statins...

Osteoporosis is often called "soft bones." "Osteoporosis is thinning of the bone to the point where the bones can break," says Dr. Bart Clarke, a Mayo Clinic endocrinologist. https://youtu.be/fLS1tDriG3k Watch: The Mayo Clinic Minute Journalists: Broadcast-quality video pkg (1:00) is in the downloads. Read the script. Dr. Clark says common breaks from thinning bones occur in the spine, wrist, shoulder and hip. "Women, in general, past menopause — past the mid-50s — are at high risk for this because of the…

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