Wednesday, April 26, 2017

Q&A: First U.S. state-by-state analysis of hepatitis C cases

Media Coverage
Q&A: First U.S. state-by-state analysis of hepatitis C cases
By Jon Cohen
Apr. 26, 2017 , 12:00 PM
In the infectious disease world, the liver-damaging hepatitis C virus (HCV) long has lived in the shadows of killers such as HIV/AIDS, tuberculosis, and malaria. But curative—and expensive—HCV drugs that have come to market over the past 5 years have focused new attention on the deadly disease.

Now, for the first time, researchers have mapped its U.S. prevalence state-by-state. They hope their model ultimately will help improve targeting of efforts to screen for the virus and treat the more than 3 million people in the country who are living with the infection.
Estimation of State-Level Prevalence of Hepatitis C Virus Infection, US States and District of Columbia, 2010
Eli S. Rosenberg Eric W. Hall Patrick S. Sullivan Travis H. Sanchez Kimberly A. Workowski John W. Ward Deborah HoltzmanClin Infect Dis cix202.

DOI: https://doi.org/10.1093/cid/cix202
Published: 26 April 2017

Full Text

Abstract
Background.
Hepatitis C virus (HCV) infection is the most common chronic blood-borne infection in the United States and a leading cause of morbidity and mortality. Previous analyses of the US National Health and Nutrition Examination Survey (NHANES) indicated approximately 3.6 million noninstitutionalized persons with antibody to HCV (anti-HCV). However, state-level prevalence remains less understood and cannot be estimated reliably from NHANES alone.
Methods.
We used 3 publicly available government data sources to estimate anti-HCV prevalence in each US state among noninstitutionalized persons aged ≥18 years. A small-area estimation model combined indirect standardization of NHANES-based prevalence with logistic regression modeling of mortality data, listing acute or chronic HCV infection as a cause of death, from the National Vital Statistics System during 1999–2012. Model results were combined with US Census population sizes to estimate total number and prevalence of persons with antibody to HCV in 2010.
Results.
National anti-HCV prevalence was 1.67% (95% confidence interval [CI], 1.53–1.90), or 3 911 800 (95% CI, 3 589 400– 4 447 500) adults in 2010. State-specific prevalence ranged from 0.71% (Illinois) to 3.34% (Oklahoma). The West census region had the highest region-specific prevalence (2.14% [95% CI, 1.96–2.48]); 10 of 13 states had rates above the national average. The South had the highest number of persons with anti-HCV (n = 1561600 [95% CI, 1 427 700–1 768 900]). The Midwest had the lowest region-specific prevalence (1.14% [95% CI, 1.04%–1.30%]).
Conclusions.
States in the US West and South have been most impacted by hepatitis C. Estimates of HCV infection burden are essential to guide policy and programs to optimally prevent, detect, and cure infection.
Continue to full text article

International Liver Transplantation Society Consensus Statement on Hepatitis C Management in Liver Transplant Candidates

International Liver Transplantation Society Consensus Statement on Hepatitis C Management in Liver Transplant Candidates
Terrault, Norah A. MD, MPH1; McCaughan, Geoff W. MD, BS, PhD2; Curry, Michael P. MD3; Gane, Edward MD4; Fagiuoli, Stefano MD5; Fung, James Y. Y. MD6; Agarwal, Kosh MD7; Lilly, Les MD8; Strasser, Simone I. MBBS, MD9; Brown, Kimberly A. MD10; Gadano, Adrian MD11; Kwo, Paul Y. MD12; Burra, Patrizia MD13; Samuel, Didier MD14; Charlton, Michael MD15; Pessoa, Mario G. MD16; Berenguer, Marina MD17

Transplantation: May 2017 - Volume 101 - Issue 5 - p 945–955
doi: 10.1097/TP.0000000000001708

An expert panel from ILTS reviews the approach to management of HCV in the transplant recipient in the era of direct-acting anti-virals. Considerations range from preemption of recurrence to the treatment of fibrosing cholestatic hepatitis

Article

Full Text Articles
I highly suggest you follow Henry E. Chang on Twitter if you are interested in reading full text articles about the treatment and management of hepatitis C. A link to the above consensus statement was provided by Henry E. Chang.

Factors that predict HCV vertical transmission - Mother to Child Transmission

Factors that predict HCV vertical transmission
The latest issue of  Liver International investigates what factors should be optimized using data mining computational analysis to predict HCV vertical transmission. Neonates born to hepatitis C virus (HCV)-positive mothers are usually not screened for HCV. 

Unscreened children may act as active sources for social HCV transmission, and factors contributing for vertical HCV transmitting still remained controversial and needed optimization. 

Dr Abd Elrazek and colleagues from Egypt investigated the factors contributing for vertical HCV transmission in Egypt, which has the highest HCV prevalence worldwide.

The researchers prospectively followed the neonates born to HCV-positive mother in the child-bearing period, to identify mother-to-child transmission factors from 2015 to 2016. 

HCV vertical transmission was identified in 18% of neonates Liver International Data mining computational analysis was used to quantify the findings. The team found that among 3000 randomized pregnant women, prevalence of HCV was 2%.  HCV vertical transmission was identified in 18% of neonates. 

The researchers identfied that only high viral load at 975.000 IU was the predictor risk for mother-to-child transmission.

Dr Elrazek's team concluded, "Hepatitis C virus in pregnancy has substantial risk for vertical HCV transmission." "High viral load in HCV-positive women increases the risk of HCV transmission to neonates."

"Screening pregnant women during early stage of pregnancy, and optimizing the HCV viral load in HCV-positive women might prevent vertical HCV transmission to neonates.
GastroHep

"Liver International
Volume 37, Issue 4
April 2017
Pages 529–533
Prediction of HCV vertical transmission: what factors should be optimized using data mining computational analysis
Authors Abd Elrazek, Mohamed Amer, Bahaa El-Hawary, Altaher Salah, Akshaya S. Bhagavathula, M. Alboraie, Samy Saab First published: 16 June 2016Full publication history DOI: 10.1111/liv.13146

Abstract
Background & Aims
Neonates born to hepatitis C virus (HCV)-positive mothers are usually not screened for HCV. Unscreened children may act as active sources for social HCV transmission, and factors contributing for vertical HCV transmitting still remained controversial and needed optimization. We aimed to investigate the factors contributing for vertical HCV transmission in Egypt; the highest HCV prevalence worldwide.

Methods
We prospectively followed the neonates born to HCV-positive mother in the child-bearing period, to identify mother-to-child transmission (MTCT) factors from January 2015 to March 2016. Data mining computational analysis was used to quantify the findings.

Results
Among 3000 randomized pregnant women, prevalence of HCV was 46/3000 (1.53%). HCV vertical transmission was identified in eight neonates (17.39%). Only high viral load identified at 975.000 IU was the predictor risk for MTCT.

Conclusions
Hepatitis C virus in pregnancy has substantial risk for vertical HCV transmission: High viral load in HCV-positive women increases the risk of HCV transmission to neonates. Screening pregnant women during early stage of pregnancy and optimizing the HCV viral load in HCV-positive women might prevent vertical HCV transmission to neonates.

HCV Viral Load test can detect active infection from a finger-stick sample

Point-of-care hep C test developed
By LabOnline Staff
Monday, 24 April, 2017
A research team led by UNSW’s Kirby Institute has evaluated a new test that enables diagnosis of hepatitis C infection in a single visit, with promising results. Their study has been published in The Lancet Gastroenterology & Hepatology.

The researchers conducted the first evaluation of the Xpert HCV Viral Load test, manufactured by molecular diagnostics company Cepheid — a point-of-care hepatitis C virus test that can detect active infection from a finger-stick sample of blood. They established that the test demonstrated good sensitivity and specificity in blood tests collected by finger-stick in participants attending drug health and homelessness services in Australia.

“This test represents a major advance over point-of-care antibody-based tests, which only indicate previous exposure to the virus but cannot detect whether you are actively infected,” said Associate Professor Jason Grebely from The Kirby Institute. “We really need to scale up testing for active hepatitis C infection in order to enhance diagnosis, get people linked to appropriate care and provide highly curative treatment with direct-acting antivirals to prevent advanced liver disease and onward transmission of the virus.”

Importantly, new point-of-care platforms enable detection of hepatitis C virus and diagnosis of active infection in a single visit, rather than having to come back for a second visit to obtain test results. As noted by Associate Professor Grebely, “Requiring people to come back for a second appointment to receive their results can present significant barriers, especially for people living in remote areas and for vulnerable and marginalised populations… who are the people we need to reach the most in order to eliminate hepatitis C.”

The finger-stick test is not yet registered in Australia, but international clinical trials are underway to evaluate this point-of-care assay as a diagnostic test for the detection of active HCV infection.

Read more: Point-of-care hep C test developed

Abstract
Evaluation of the Xpert HCV Viral Load point-of-care assay from venepuncture-collected and finger-stick capillary whole-blood samples: a cohort
study
Dr Jason Grebely, PhD Francois M J Lamoury, EiCNAM, Behzad Hajarizadeh, PhD, Yasmin Mowat, BSc, Alison D Marshall, MA, Sahar Bajis, MIPH, Philippa Marks, MPH, Janaki Amin, PhD, Julie Smith, RN, Michael Edwards, MBBS, Carla Gorton, MPH, Nadine Ezard, PhD, David Persing, PhD, Marika Kleman, PhD, Philip Cunningham, PhD, Beth Catlett, BSc, Prof Gregory J Dore, PhD, Tanya L Applegate, PhD on behalf of the LiveRLife Study Group

Published: 21 April 2017
DOI: http://dx.doi.org/10.1016/S2468-1253(17)30075-4

Summary
Background
Point-of-care hepatitis C virus (HCV) RNA testing offers an advantage over antibody testing (which only indicates previous exposure), enabling diagnosis of active infection in a single visit. In this study, we evaluated the performance of the Xpert HCV Viral Load assay with venepuncture and finger-stick capillary whole-blood samples.

Methods
Plasma and finger-stick capillary whole-blood samples were collected from participants in an observational cohort enrolled at five sites in Australia (three drug and alcohol clinics, one homelessness service, and one needle and syringe programme). We compared the sensitivity and specificity of the Xpert HCV Viral Load test for HCV RNA detection by venepuncture and finger-stick collection with the Abbott RealTime HCV Viral Load assay (gold standard).

Findings
Of 210 participants enrolled between Feb 8, 2016, and July 27, 2016, 150 participants had viral load testing results for the three assays tested. HCV RNA was detected in 45 (30% [95% CI 23–38]) of 150 participants based on Abbott RealTime. Sensitivity of the Xpert HCV Viral Load assay for HCV RNA detection in plasma collected by venepuncture was 100·0% (95% CI 92·0–100·0) and specificity was 99·1% (95% CI 94·9–100·0). Sensitivity of the Xpert HCV Viral Load assay for HCV RNA detection in samples collected by finger-stick was 95·5% (95% CI 84·5–99·4) and specificity was 98·1% (95% CI 93·4–99·8). No adverse events caused by the index test or the reference standard were observed

Implications
The Xpert HCV Viral Load test can detect active infection from a finger-stick sample, which represents an advance over antibody-based tests that only indicate past or previous exposure.

Funding
National Health and Medical Research Council (Australia), Cepheid, South Eastern Sydney Local Health District (Australia), and Merck Sharp & Dohme (Australia).
Lancet

Xpert HCV Viral Load Test Can Detect Active Hepatitis C Infection From Fingerstick
Posted on April 25, 2017
Jason Grebely PhD
Associate Professor
Senior Research Fellow (UNSW)
Viral Hepatitis Clinical Research Program

MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Globally, testing and diagnosis of hepatitis C virus infection remain low. Although point of care tests for HCV infection exist, but many of these tests only measure HCV antibodies (previous exposure), not HCV RNA (active infection). Given that 25% of individuals spontaneously clear HCV infection, efforts to enhance diagnosis of chronic HCV infection and improve the HCV care cascade requires enhanced uptake of HCV RNA testing.
We conducted the first evaluation of the Xpert HCV Viral Load test (manufactured by Cepheid) – a point-of-care hepatitis C virus test that can detect active infection – from a finger-stick sample of blood. We established that there is good sensitivity and specificity of the Xpert HCV Viral Load point-of-care test using blood samples collected by finger-stick in participants attending drug health and homelessness services in Australia.

MedicalResearch.com: What should readers take away from your report?
Response: This test represents a major advance over point of care antibody-based tests, which only indicate previous exposure to the virus but cannot detect whether you are actively infected. This new point of care platform enables detection of hepatitis C virus and diagnosis of active infection in a single visit, rather than having to come back for a second visit to obtain test results. Data have shown that on-site HCV testing with integrated care improves linkage to HCV care.
We really need to scale up testing for active hepatitis C infection in order to enhance diagnosis, get people linked to appropriate care, and provided highly curative treatment with direct-acting antivirals to prevent advanced liver disease and onward transmission of the virus.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Further validation studies are needed to further evaluate the performance of this assay in different settings and populations (eg, patients given DAA therapy, those with a sustained virological response, or those with HIV/HCV co-infection). Also, future research should evaluate the effectiveness of integrating point of care testing into interventions to enhance linkage to HCV care and treatment.

Disclosures: JG is a consultant and adviser and has received research grants from AbbVie, Bristol-Myers Squibb, Cepheid, Gilead Sciences, and Merck/MSD.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Interview Source

Tuesday, April 25, 2017

Achillion Presents Mixed Trial Results – May, Hep C “Awareness Month”


By Mitchell Young
New Haven: Achillion Pharmaceuticals [Nasdaq: ACHN] presented data on its three drug combination to treat Hepatitis C, at The International Liver Congress in Amsterdam in late April, just a week before the national kick-off of Hep C Awareness Month.
Jansen is financially responsible for all clinical trials and they initiated the Phase II clinical trial, last May of 300 participants of the drug combination, simeprevirodalasvir and AL-335.
Jansen previously developed simeprevir and odalasvir, but required Achilion’s A-335 to achieve the effectiveness needed to cure Hep C.
The clinical results presented could be described as really good and really not so good....
 Continue reading

Timing Is Everything: Managing Hepatitis C Virus in Liver Transplant Candidates

Of Interest
The European Association for the Study of the Liver (EASL) International Liver Congress (ILC 2017)

Timing Is Everything: Managing Hepatitis C Virus in Liver Transplant Candidates
Aronsohn, Andrew MD1
doi: 10.1097/TP.0000000000001703
Transplantation: May 2017 - Volume 101 - Issue 5 - p 898–899

Commentaries
Direct-acting antiviral regimens have revolutionized the treatment of Hepatitis C Virus (HCV) yet controversy exists regarding the optimal timing for treating HCV infected liver transplant candidates. This commentary addresses the complexities of treating these patients at the appropriate time given the unpredictable nature of liver transplant timing.

Article Outline
Direct-acting antiviral (DAA) regimens have revolutionized our approach to hepatitis C virus (HCV) management. Guidance from American Association for the Study of Liver Diseases/Infectious Diseases Society of America, European Association for the Study of the Liver, and Asian Pacific Association for the Study of the Liver1-3 now outline simple and highly effective pathways to cure for nearly all patients with HCV. Safety and efficacy of DAA regimens, even among those with decompensated cirrhosis, creates new opportunities for cure in patients who would have been previously ineligible for treatment.4 Although HCV remains a leading indication for liver transplant worldwide, there has been a paucity of data and subsequent guidance for management of liver transplant candidates with HCV. Paradoxically, we have found that simple, effective treatment regimens have spawned perhaps unanticipated complexities of HCV management in liver transplant candidates. These complexities arise because goals of therapy span beyond solely targeting viral eradication but require a comprehensive understanding of the dynamic and sometimes unpredictable nature of liver transplantation (LT) candidacy. Anticipated wait time, risk of hepatocellular carcinoma (HCC) recurrence or progression, physiologic response to cure as well as availability of HCV-positive donors all impact decisions to treat. In this issue of Transplantation, Terrault et al5 define these issues and offer much needed guidance by addressing clinical questions of interest in the International Liver Transplant Society Consensus Statement in Management of Liver Transplantation Candidates.

Data remains sparse and, at times, conflicting regarding the management of HCV in patients with HCC who are awaiting LT. In the single published study evaluating DAA-based treatment outcomes in waitlisted patients with HCV and HCC, duration of time with a negative viral load was found to be a significant predictor of HCV recurrence posttransplant.6 This concept has not yet been validated in newer DAA regimens and minimum duration of an undetectable viral load required before transplant to ensure posttreatment eradication has yet to be defined. Timing matters in HCV treatment pre-LT; however, we are still unsure of how much time we need and how much time we have. In addition, recent controversy regarding a potentially negative impact DAA treatment may play in aggressive cancer recurrence has added another wrinkle in complexity of the decision to treat waitlisted patients with HCC.7,8 Terrault et al5 describe the quality of data that associates a link between HCC recurrence and DAA therapy as low and insufficient to withhold therapy; however, pending further data, they recommend the association should at least be considered. Although the consensus statement recommends HCV treatment in waitlisted patients with HCC, severe limitations of data require this recommendation to be conditional and should be individualized based on patient characteristics and transplant center.

HCV treatment in the setting of waitlisted patients with decompensated cirrhosis is also thoughtfully addressed. Successful HCV treatment may improve survival on the waiting list and may allow for avoidance of OLT altogether.9 These benefits must be balanced with potential unintended negative consequences of treatment. This includes reduced SVR rates in CTP B and C cirrhosis with risk of resistant variant generation as well as negligible clinical benefit achieved after SVR in patients who lack hepatic regenerative capacity. Finally, it may be disadvantageous to treat and create a small improvement in Model for End Stage Liver Disease (MELD)/Child-Turcotte-Pugh (CTP) resulting in a demotion of priority on the waitlist, yet insufficient clinical improvement to avoid LT.4 What remains elusive is a true understanding of the “point of no return,” that is, the degree of liver dysfunction where HCV therapy does not yield any clinical benefit. The consensus statement frames this question based on available metrics, such as MELD, CTP, and transplant center characteristics; however, due to limitations in available data, the strength of these recommendations remain weak. Why is a point of no return so difficult to define? First, HCV treatment in patients with decompensated cirrhosis is only a recently available option, and experience remains limited. Second, the point of no return is simple in theory, but complex in practice. MELD and CTP scores were not designed to answer this question, and we may be using imprecise tools to predict a clinical outcome that relies on regenerative capacity of the liver after viral eradication. Finally, the point of no return is intrinsically related to regional transplant landscape and policy. Waitlist time, DAA availability and allocation schemes will all impact how much benefit HCV treatment will yield. The consensus statement has provided a useful foundation for consideration of this topic, but further study will be necessary to identify more precise, site-specific tools to guide us in this difficult decision to treat.

Finally, the consensus statement supports selective use of anti–HCV-positive grafts in HCV-positive recipients as well as early treatment for all LT patients with HCV.5,10 The efficacy and safety of DAA therapy post-LT has also allowed Terrault and colleagues to boldly offer consideration to use HCV-positive grafts in HCV negative recipients. The Consensus Statement stresses the need for comprehensive informed consent and defines appropriate settings for use such as high medical urgency and severe limitations in organ availability. Although data are limited and firm guidelines for use cannot yet be made, innovative thought leveraging DAA therapy such as this may significantly increase access and optimize use of available organs. However, the concept of knowingly transmitting an infectious disease into an unexposed patient is subject to some degree of moral relativism and thus may not be universally applied even though there is some precedent with infections, such as cytomegalovirus. Nonetheless, routine use of HCV-positive grafts in any recipient underscores the importance of universal access to HCV therapy post-LT.

The new era of DAA therapy has expanded candidacy for HCV treatment to include our sickest patients who are in need of LT. The consensus statement in this issue of Transplantation marks unprecedented progress in HCV therapy and also defines where our understanding is limited. Our tools to determine the optimal timing for therapy seem rudimentary in comparison to the technologically advanced DAAs, and further study to equilibrate the two is crucial. We know how to treat our patients with HCV who are awaiting transplantation, now we just need to know when to treat them.

REFERENCES
1. AASLD-IDSA. HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. http://www.hcvguidelines.org/. Accessed February 13, 2017.
Cited Here...
2. European Association for Study of Liver. EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol. 2015;63:199–236.
Cited Here... |
PubMed | CrossRef
3. Omata M, Kanda T, Wei L, et al. APASL consensus statements and recommendation on treatment of hepatitis C. Hepatol Int. 2016;10:702–726.
Cited Here... |
PubMed
4. Curry MP, O’Leary JG, Bzowej N, et al. Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis. N Engl J Med. 2015;373:2618–2628.
Cited Here... |
View Full Text | PubMed | CrossRef

5. Terrault NA, McCaughan GW, Curry MP, et al. International Liver Transplantation Society Consensus Statement on hepatitis C management in liver transplant candidates. Transplantation. 2017;101:945–955.
Cited Here... |
View Full Text | CrossRef
6. Curry MP, Forns X, Chung RT, et al. Sofosbuvir and ribavirin prevent recurrence of HCV infection after liver transplantation: an open-label study. Gastroenterology. 2015;148:100–107.e1.
Cited Here... |
PubMed | CrossRef
7. Pol S. Lack of evidence of an effect of direct-acting antivirals on the recurrence of hepatocellular carcinoma: data from three ANRS cohorts. J Hepatol. 2016;65:734–740.
Cited Here... |
PubMed | CrossRef
8. Reig M, Mariño Z, Perelló C, et al. Unexpected high rate of early tumor recurrence in patients with HCV-related HCC undergoing interferon-free therapy. J Hepatol. 2016;65:719–726.
Cited Here... |
PubMed | CrossRef
9. Belli LS, Berenguer M, Cortesi PA, et al. Delisting of liver transplant candidates with chronic hepatitis C after viral eradication: a European study. J Hepatol. 2016;65:524–531.
Cited Here... |
PubMed | CrossRef
10. Northup PG, Argo CK, Nguyen DT, et al. Liver allografts from hepatitis C positive donors can offer good outcomes in hepatitis C positive recipients: a US National Transplant Registry analysis. Transpl Int. 2010;23:1038–1044.
Cited Here... |
View Full Text | PubMed | CrossRef

Illegal Cancer Treatments: FDA Warning - Fraudulent Claims of Diagnosis, Treatment, Prevention or Cure

Illegal Cancer Treatments: FDA Warning - Fraudulent Claims of Diagnosis, Treatment, Prevention or Cure

AUDIENCE: Oncology, Patient, Consumer

ISSUE: FDA issued warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer.

It is a violation of the Federal Food, Drug and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate or cure diseases without first demonstrating to the FDA that they are safe and effective for their labeled uses. The illegally sold products cited in the warning letters include a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas and diagnostics (such as thermography devices). They include products marketed for use by humans or pets that make illegal, unproven claims regarding preventing, reversing or curing cancer, killing/inhibiting cancer cells or tumors, or other similar anti-cancer claims. See the list of illegally sold cancer treatments.

BACKGROUND: The products are marketed and sold without FDA approval, most commonly on websites and social media platforms.

RECOMMENDATION: Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment. Avoid purchasing products marketed to treat cancer without any proof they will work. Patients should consult with their health care professional about proper prevention, diagnosis and treatment of cancer.

FDA News Release
FDA takes action against 14 companies for selling illegal cancer treatments
The U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites and social media platforms.

“Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment,” said Douglas W. Stearn, director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs. “We encourage people to remain vigilant whether online or in a store, and avoid purchasing products marketed to treat cancer without any proof they will work. Patients should consult a health care professional about proper prevention, diagnosis and treatment of cancer.”

It is a violation of the Federal Food, Drug and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate or cure diseases without first demonstrating to the FDA that they are safe and effective for their labeled uses. The illegally sold products cited in the warning letters posted today include a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas and diagnostics (such as thermography devices). They include products marketed for use by humans or pets that make illegal, unproven claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims.

The FDA has requested responses from the 14 companies stating how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure, injunction and/or criminal prosecution.

As part of the FDA’s effort to protect consumers from cancer health fraud, the FDA has issued more than 90 warning letters in the past 10 years to companies marketing hundreds of fraudulent products making cancer claims on websites, social media and in stores. Although many of these companies have stopped selling the products or making fraudulent claims, numerous unsafe and unapproved products continue to be sold directly to consumers due in part to the ease with which companies can move their marketing operations to new websites. The FDA continues to monitor and take action against companies promoting and selling unproven treatments in an effort to minimize the potential dangers to consumers and to educate consumers about the risks.

The FDA encourages health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.

The FDA, 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.

Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the FDA news release, health fraud web page, Q&As, and Consumer Update, at:
http://links.govdelivery.com/track?

Hepatitis B Virus Reactivation Associated With Direct-Acting Antiviral Therapy for Chronic Hepatitis C Virus

No Consistent Pattern of HBV Reactivation With Direct-acting Antivirals for HCV
NEW YORK (Reuters Health) - The largest case review to date of hepatitis B virus (HBV) reactivation associated with direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection found no consistent pattern in terms of which patients are likely to develop this adverse event.

There was also no consistency with regard to the DAA regimen most likely to lead to HBV reactivation, suggesting a potential class-effect with DAA agents, researchers from the U.S. Food and Drug Administration (FDA) report in a paper online today in Annals of Internal Medicine.

HBV reactivation associated with DAA therapy is a “newly identified safety concern in patients previously infected with HBV. Patients with a history of HBV infection require clinical monitoring while receiving DAA therapy,” write Dr. Susan Bersoff-Matcha and colleagues.

They reviewed 29 cases of HBV reactivation in patients receiving DAAs reported to the FDAs adverse event reporting system between 2013 and 2016.
Continue reading.....

Full Text Article
Annals of Internal Medicine

Hepatitis B Virus Reactivation Associated With Direct-Acting Antiviral Therapy for Chronic Hepatitis C Virus
Susan J. Bersoff-Matcha, MD; Kelly Cao, PharmD; Mihaela Jason, PharmD; Adebola Ajao, PhD; S. Christopher Jones, PharmD, MS, MPH; Tamra Meyer, PhD, MPH; and Allen Brinker, MD, MS

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Abstract
Background:
Direct-acting antiviral agents (DAAs) are used increasingly to treat hepatitis C virus (HCV) infection. Reports were published recently on hepatitis B virus (HBV) reactivation (HBV-R) in patients with HBV–HCV co-infection. Hepatitis B virus reactivation, defined as an abrupt increase in HBV replication in patients with inactive or resolved HBV infection, may result in clinically significant hepatitis.

Objective: To assess whether HBV-R is a safety concern in patients receiving HCV DAAs.

Design: Descriptive case series.

Setting: U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).

Patients: 29 patients with HBV-R receiving HCV DAAs.

Results:
The FDA identified 29 unique reports of HBV-R in patients receiving DAAs from 22 November 2013 to 15 October 2016. Two cases resulted in death and 1 case in liver transplantation. Patients in whom HBV-R developed were heterogeneous regarding HCV genotype, DAAs received, and baseline HBV chacteristics. At baseline, 9 patients had a detectable HBV viral load, 7 had positive results on hepatitis B surface antigen (HBsAg) testing and had an undetectable HBV viral load, and 3 had negative results on HBsAg testing and had an undetectable HBV viral load. For the remaining 10 patients, data points were not reported or the data were uninterpretable. Despite provider knowledge of baseline HBV, HBV-R diagnosis and treatment were delayed in 7 cases and possibly 7 others.

Limitations:
The quality of information varied among reports. Because reporting is voluntary, HBV-R associated with DAAs likely is underreported.

Conclusion:
Hepatitis B virus reactivation is a newly identified safety concern in patients with HBV–HCV co-infection treated with DAAs. Patients with a history of HBV require clinical monitoring while receiving DAA therapy. Studies would help determine the risk factors for HBV-R, define monitoring frequency, and identify patients who may benefit from HBV prophylaxis and treatment. DAAs remain a safe and highly effective treatment for the management of HCV infection.
Continue to full text article.....

In The Media
Direct-acting antiviral therapy for hepatitis C virus associated with hepatitis B virus reactivation in co-infected patients
April 25, 2017 | Deepti Shroff and Evelyn Nguyen
HBV-R is a manageable adverse event, and DAAs continue to be a safe and very effective treatment for infection with HCV.

Full Text Articles
I highly suggest you follow Henry E. Chang on Twitter if you are interested in reading full text articles about the treatment and management of hepatitis C.

ReACH Center encourages testing and treatment for Hepatitis C to avoid cirrhosis of the liver




Published on Apr 24, 2017
Hepatitis C program helps fund treatment of Hep C through Dr. Turner's CDC grant. Brenda Westbrooks gives a testimonial on being treated for Hepatitis C and now being Hep C free.

Find out more information at http://stop-hcv-hcc.com/

Hepatitis B virus infection and alcohol consumption

World J Gastroenterol. Apr 21, 2017; 23(15): 2651-2659
Published online Apr 21, 2017.
 doi: 10.3748/wjg.v23.i15.2651

Hepatitis B virus infection and alcohol consumption

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Abstract
Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer, and the second most common cause of cancer deaths worldwide. The top three causes of HCC are hepatitis B virus (HBV), hepatitis C virus (HCV), and alcoholic liver disease. Owing to recent advances in direct-acting antiviral agents, HCV can now be eradicated in almost all patients. HBV infection and alcoholic liver disease are expected, therefore, to become the leading causes of HCC in the future. However, the association between alcohol consumption and chronic hepatitis B in the progression of liver disease is less well understood than with chronic hepatitis C. The mechanisms underlying the complex interaction between HBV and alcohol are not fully understood, and enhanced viral replication, increased oxidative stress and a weakened immune response could each play an important role in the development of HCC. It remains controversial whether HBV and alcohol synergistically increase the incidence of HCC. Herein, we review the currently available literature regarding the interaction of HBV infection and alcohol consumption on disease progression.

Vitamin D does not prevent cardiovascular disease

Vitamin D does not prevent cardiovascular disease
Monday 24 April 2017

Previous research has suggested that cardiovascular disease might be more common in people with low levels of Vitamin D.

But trials using Vitamin D as a supplement haven't shown any benefit - and it's been argued that this is because they were using too low a dose.

And now, The Vitamin D Assessment Study - a large trial of monthly, high dose supplementation - has found no benefit in preventing cardiovascular disease.

Read - Transcript

Guest
Professor Robert Scragg
School of Population Health, The University of Auckland
(view full episode)

Effectiveness and Safety of Sofosbuvir-based Regimens Plus an NS5A Inhibitor for Patients With HCV Genotype 3 Infection and Cirrhosis Results of a Multicenter Real-life

Effectiveness and Safety of Sofosbuvir-based Regimens Plus an NS5A Inhibitor for Patients With HCV Genotype 3 Infection and Cirrhosis Results of a Multicenter Real-life
Cohort S. Alonso; M. Riveiro-Barciela; I. Fernandez; D. Rincón; Y. Real; S. Llerena; F. Gea; A. Olveira; C. Fernandez-Carrillo; B. Polo; J. A. Carrión; A. Gómez; M. J. Devesa; C. Baliellas; Á. Castro; J. Ampuero; R. Granados; J. M. Pascasio; A. Rubín; J. Salmeron; E. Badia; J. M. M. Planas; S. Lens; J. Turnes; J. L. Montero; M. Buti; R. Esteban; C. M. Fernández-Rodríguez

J Viral Hepat. 2017;24(4):304-311.

Abstract and Introduction
Abstract
Patients with HCV genotype 3 (GT3) infection and cirrhosis are currently the most difficult to cure. We report our experience with sofosbuvir+daclatasvir (SOF+DCV) or sofosbuvir/ledipasvir (SOF/LDV), with or without ribavirin (RBV) in clinical practice in this population. This was a multicenter observational study including cirrhotic patients infected by HCV GT3, treated with sofosbuvir plus an NS5A inhibitor (May 2014-October 2015). In total, 208 patients were included: 98 (47%) treatment-experienced, 42 (20%) decompensated and 55 (27%) MELD score >10. In 131 (63%), treatment was SOF+DCV and in 77 (37%), SOF/LDV. Overall, 86% received RBV. RBV addition and extension to 24 weeks was higher in the SOF/LDV group (95% vs 80%, P=.002 and 83% vs 72%, P=.044, respectively). A higher percentage of decompensated patients were treated with DCV than LDV (25% vs 12%, P=.013). Overall, SVR12 was 93.8% (195/208): 94% with SOF+DCV and 93.5% with SOF/LDV. SVR12 was achieved in 90.5% of decompensated patients. Eleven treatment failures: 10 relapses and one breakthrough. RBV addition did not improve SVR (RR: 1.08; P=.919). The single factor associated with failure to achieve SVR was platelet count <75×10E9/mL (RR: 3.50, P=.019). In patients with MELD <10, type of NS5A inhibitor did not impact on SVR12 (94% vs 97%; adjusted RR: 0.49). Thirteen patients (6.3%) had serious adverse events, including three deaths (1.4%) and one therapy discontinuation (0.5%), higher in decompensated patients (16.7% vs 3.6%, P<.006). In patients with GT3 infection and cirrhosis, SVR12 rates were high with both SOF+DCV and SOF/LDV, with few serious adverse events.

View Full Text @ Medscape
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Management of Cirrhotic Patients After Successful HCV Eradication

Management of Cirrhotic Patients After Successful HCV Eradication
Kwok, R.M. & Tran, T.T.
Curr Treat Options Gastro (2017).
doi:10.1007/s11938-017-0134-2

First Online: 24 April 2017

Chronic hepatitis C (HCV) is a hepatotropic virus which, when untreated, can lead to progressive inflammation and fibrosis resulting in cirrhosis, hepatocellular carcinoma (HCC), and decompensations related to end-stage liver disease. The relatively recent introduction of all oral, interferon-free, direct-acting antiviral medications against HCV has transformed the management of these patients. Previous treatment regimens were prolonged, poorly tolerated, and frequently did not result in cure. Current therapies achieve sustained viral response (SVR) in the vast majority of patients including those with decompensated liver disease; a previously challenging population to treat. These successes will result in significant numbers of cirrhotic patients requiring management after SVR. Although many complications of cirrhosis are improved in this setting, regular follow-up of HCC, esophageal varices, and other sequelae of cirrhosis will be necessary. This chapter will review the management of cirrhosis in HCV patients achieving cure.

Generic hepatitis C drugs continue to produce high cure rates

Generic hepatitis C drugs continue to produce high cure rates
Keith Alcorn
Published: 24 April 2017
Treatment with generic versions of direct-acting antiviral drugs continues to produce similar cure rates to those reported in clinical trials, Dr James Freeman reported last week at the International Liver Congress in Amsterdam.

Dr James Freeman, an Australian general practitioner based in Hobart, Tasmania, was reporting on the outcomes of people with hepatitis C who imported generic versions of direct-acting antivirals manufactured in India and elsewhere because they couldn’t afford treatment in their own country, or were denied treatment on grounds of cost.

Importation of medicines for personal use is permitted under customs regulations in Australia and the United Kingdom, and many other countries have regulations permitting the importation of small amounts of medicines for personal use or their carriage through customs in personal luggage. The FixHepC buyer’s club provided advice and information on how to do this safely and legally, starting in Australia, but soon responding to enquiries from people in Europe, North America, New Zealand and South East Asia.
Continue reading.....

Meeting Updates
NAM aidsmap
Updates On This Blog
Hep C 5-minute videos - Summary Of The International Liver Congress™ (ILC) 2017

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

Monday, April 24, 2017

A Good Deal For Eliminating Hepatitis C: Saving Money And Lives

A Good Deal For Eliminating Hepatitis C: Saving Money And Lives
Neeraj Sood, Gillian Buckley, and Brian Strom
April 24, 2017
A cure is in hand, but is out of reach for many because it costs tens of thousands of dollars per patient. The problem is most acute in state Medicaid programs and prisons, where 700,000 people need treatment but only 20,000 a year will get it.....

A recent consensus committee of the National Academies of Sciences, Engineering, and Medicine proposed a novel strategy to improve access to hepatitis C medicines. Their report recommends that the firms producing the hepatitis C treatments compete to license their patent to the federal government for use in neglected patients, such as Medicaid beneficiaries and prisoners. Such a deal would protect the innovator companies’ market share in the lucrative private markets, while allowing the government to save billions of taxpayer dollars and reach more poor patients....

How Would The Deal Work?

Continue reading.......

Of Interest
The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Solving the hepatitis C epidemic among people with substance abuse disorders

Solving the hepatitis C epidemic among people with substance abuse disorders
Innovations in HCV treatment at methadone clinics, corrections facilities
Date:April 24, 2017
Source:University at Buffalo
Summary:
One of the most dramatic medical success stories in recent years has been the introduction of new drugs that eradicate hepatitis C virus (HCV). But it's a different story among HCV patients with substance use disorders. This population typically does not have easy access to conventional health care so it is difficult to screen, diagnose and treat these individuals.

One of the most dramatic medical success stories in the past few years has been the introduction of new drugs that eradicate hepatitis C virus (HCV). But it's a different story among HCV patients with substance use disorders.

As an editorial published online on April 25 in the Annals of Internal Medicine notes, this population typically does not have easy access to conventional health care so it is difficult to screen, diagnose and treat these individuals.

"People with substance use disorders can account for as much as 80 percent of infected individuals in developed countries, a direct result of the opioid epidemic in the U.S.," said Andrew H. Talal, MD, the lead author of the editorial and professor, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo.

Talal, a leading expert in liver disease, is a researcher with the Clinical and Translational Science Institute at the University at Buffalo, funded by a National Institutes of Health Clinical and Translational Science Award. He is currently principal investigator with other UB faculty on a $7 million Patient-Centered Outcomes Research Institute award dedicated to developing innovative ways to treat HCV in persons with substance use disorders. The award funds efforts with these patients throughout New York State, including New York City, Buffalo, Rochester, Syracuse and the Hudson Valley.

According to Talal, a combination of factors all work to prevent these patients from receiving the diagnoses and care they need. Such factors range from discomfort in conventional health care settings and lack of HCV-related knowledge to fear of stigmatization that can result from an HCV diagnosis. That's in addition to insurance barriers and physicians' general reluctance to treat this population.

According to the editorial, "New approaches for persons with substance use disorders are required at every step in the HCV care paradigm."

The reason is that following a decade of fairly steady declines in this population, there have been recent sharp increases in HCV.

"We're seeing infection hotspots," Talal said, noting that this is partly a result of the opioid epidemic, particularly where needle exchange programs, for example, are not available.

Such programs are key, Talal said, citing a report issued earlier this month by the National Academies that found that people who inject drugs account for approximately 75 percent of all new HCV infections.

To better reach persons with substance use disorders, the editorial states, HCV screening and linkage to care must improve. Screening can be especially problematic because it typically requires two steps: confirmation that the person has been exposed to HCV through an antibody test followed by additional blood work to determine if the infection is active. Currently, the second step must be conducted in a conventional laboratory, a setting these patients rarely access. Recent advances, however, are designed to assess whether all of required analyses could be done onsite.

Once a diagnosis is made, getting patients connected with providers is another major hurdle.

"At best, only 20 percent of these patients connect with a provider for treatment," Talal explained, "and often it's far less than that."

Talal and his colleagues at UB and other institutions and care facilities have been developing promising ways to better connect these patients with the care that they need by integrating HCV screening and treatment into methadone clinics that these patients already regularly attend and by reaching patients in the corrections system via telehealth techniques.

Story Source:
Materials provided by University at Buffalo. Note: Content may be edited for style and length.

Journal Reference:
Gregory J. Dore, Frederick Altice, Alain H. Litwin, Olav Dalgard, Edward J. Gane, Oren Shibolet, Anne Luetkemeyer, Ronald Nahass, Cheng-Yuan Peng, Brian Conway, Jason Grebely, Anita Y.M. Howe, Isaias N. Gendrano, Erluo Chen, Hsueh-Cheng Huang, Frank J. Dutko, David C. Nickle, Bach-Yen Nguyen, Janice Wahl, Eliav Barr, Michael N. Robertson, Heather L. Platt. Elbasvir–Grazoprevir to Treat Hepatitis C Virus Infection in Persons Receiving Opioid Agonist Therapy. Annals of Internal Medicine, 2016; DOI: 10.7326/M16-0816

https://www.sciencedaily.com/releases/2017/04/170424170814.htm

Statins May Benefit Cirrhotic Patients with Hepatitis B or C Infections

Related 
Statins reduce risk of decompensation for people with HCV- and HBV-related cirrhosis
Michael Carter / 18 April 2017
NO registration required to read the following article
Treatment with statins reduces the risk of decompensated liver disease for people with cirrhosis caused by hepatitis B virus (HBV) and hepatitis C virus (HCV), investigators from Taiwan report in the online edition
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Full Text
Statins May Benefit Cirrhotic Patients with Hepatitis B or C Infections
Registration or payment required to read full text article
Infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) can lead to cirrhosis as well as liver cancer. A Hepatology study from Taiwan has found that statins may provide benefits to patients with HBV- or HCV-related cirrhosis.

When the liver fails to compensate for the functional overload resulting from disease, a situation called decompensation occurs. Decompensation significantly lowers the survival rate among patients with cirrhosis, and very few effective drugs are available. This latest study assessed information on 1350 cirrhotic patients identified from a representative group of Taiwan National Health Insurance beneficiaries from 2000 to 2013. Statin use was linked with a decreased the risk of decompensation in a dose-dependent manner.

"The study demonstrates a favorable outcome that should be re-confirmed by future prospective and large-scaled studies," said senior author Dr. Ching-Liang Lu. "Moreover, future investigations should also explore whether the favorable effect of statin use can also be extended to cirrhosis due to other causes, such as alcohol."

Additional Information
Link to Study: http://onlinelibrary.wiley.com/doi/10.1002/hep.29172/full

NASH: The next untapped pharma market gives investors many options

Medpage - Meeting Coverage
NASH: It's Fibrosis, Not Fat, that Matters
Analysis sheds new light on what drives disease progression
AMSTERDAM -- It isn't fat but rather fibrosis that drives disease progression in people with advanced non-alcoholic steatohepatitis (NASH), a researcher said here

Investment Commentary
Drugmakers are taking a wide range of approaches to treat the complex disease, given multiple health issues among NASH patients that contribute to the liver damage, such as heart disease and diabetes. There are drugs targeting inflammation to prevent or reduce fibrotic scarring. Some address lipid regulation to reduce liver fat, while others attempt to directly halt or reverse fibrosis. And some companies are testing diabetes treatments to assess their ability to also improve NASH.

NASH: The next untapped pharma market gives investors many options
By Bill Berkrot
Large drugmakers with piles of cash are on the hunt for promising medicines being developed by small companies to treat NASH, a progressive fatty liver disease poised to become the leading cause of liver transplants by 2020.   

Pfizer currently has three early-stage drugs in the clinic aiming to block or reverse fat accumulation in the liver. "We believe that even though we're a bit behind, we still might come out with the best-in-class molecules," Birnbaum said.
    
Bristol-Myers Squibb (BMY.N) also confirmed it is looking for additional assets to enhance its internally-developed NASH drugs. It presented promising data for its lead NASH candidate at the big European liver meeting in Amsterdam that ended on Sunday.
Continue reading....

New hepatitis C screening guidelines will lead to avoidable deaths and soaring costs to health care system


New hepatitis C screening guidelines will lead to avoidable deaths and soaring costs to health care system

Reliance on risk-based testing will perpetuate low diagnosis rates and increases in cirrhosis and liver cancer 

Toronto, April 24, 2017: They may not look sick. They may not feel sick. And yet many Canadians in the prime of their lives are living with a potentially fatal liver disease -- hepatitis C. An estimated 44 percent of Canadians with hepatitis C have no idea that they have it. Unfortunately, the Canadian Task Force on Preventive Health Care’s  (CTFPHC) new screening guidelines released today recommend against screening of adults without identifiable risk factors which may result in the bulk of the age group most at risk of having chronic hepatitis C (those born between 1945 and 1975) remaining undiagnosed.

“Liver cancer rates are rising in Canada due in large part to late diagnosis and lack of treatment of hepatitis C,” says Dr. Morris Sherman, Chairperson of the Canadian Liver Foundation and a practicing hepatologist. “While we congratulate CTFPHC’s commitment to hepatitis C testing, the truth is that risk-based testing, which was first recommended in 2009  has only been effective in identifying a small proportion of adults with recognized risk factors. If you or your doctor don’t think you have any risk factors then according to these guidelines you won’t be tested.  We are disappointed that, despite widespread support among medical experts and advocacy groups, the CTFPHC failed to establish new  guidelines which would encourage widespread screening not just based on risk factors but also by age.”

In August 2012, the U.S. Centers for Disease Control and Prevention issued its recommendation that all adults born between 1945 and 1965 should have a one-time hepatitis C test. Based on the prevalence data in Canada and taking into account immigration from countries where hepatitis C is endemic, the Canadian Liver Foundation believed the age bracket should be expanded and issued its own recommendations that same year that adults born between 1945 and 1975 be tested. In 2013, the Public Health Agency of Canada (PHAC) began reviewing its screening guidelines for hepatitis C, but no new guidelines were issued. Subsequently, PHAC tasked the CTFPHC with reviewing evidence and coming up with recommendations.

The new CTFPHC guidelines call for screening of adults with known risk factors including blood transfusions prior to 1992, past or present injection drug use, and coming from certain countries where hepatitis C is endemic. The  guidelines strongly recommend against screening for those without recognized risk factors meaning that if a person is not aware of a situation in which they may have been exposed to hepatitis C (i.e. from contaminated medical equipment, a common source of transmission in other countries) then they will not qualify for testing.

“The CTFPHC expressed concern over the costs of testing such a large group, the potential for false positives and the mental distress that a diagnosis might cause,” says Dr. Sherman. “But don’t we have an obligation to inform people if they have a potentially fatal but curable disease?”

Data suggests that age-based screening of adults born between 1945 and 1975 could capture as much as 77 percent of the population living with undiagnosed hepatitis C.1  Age-based screening is also cost-effective based on a reduction in deaths due to hepatitis C,  increases in quality of life years and savings in acute care costs for those with advanced disease.2  While the cost of treatment has previously been an obstacle, recent negotiations by the Pan-Canadian Pharmaceutical Alliance (pCPA) have successfully reduced the cost of several of the leading hepatitis C drug therapies.

“The CTFPHC guidelines wrongly assume that the majority of those with hepatitis C would only have early stage disease,” says Dr. Sherman, “when in fact most have been living with it for decades. They do not adequately acknowledge the tragic personal costs and the health system costs of these individuals being diagnosed only when they have progressed to cirrhosis, liver cancer or liver failure. They over-estimate the potential harms of screening and fail to recognize the potential harms of not screening – the missed opportunities to save lives and to save downstream costs  to the health care system for liver transplants and acute care for those suffering from advanced hepatitis C.”

In 2016, the federal Health Minister Dr. Jane Philpott publicly committed to the World Health Organization’s goal of eliminating hepatitis C by 2030. Canada’s dismal diagnosis rates are due in part to risk-based screening which has been in place for years. The CTFPHC’s  long-awaited screening guidelines maintain the status quo which will leave tens of thousands still undiagnosed. We therefore call upon Minister Philpott to ask CTFPHC to reconsider their guidelines or justify how the continued reliance on risk-based screening only will achieve her commitment to eliminate hepatitis C.
http://www.liver.ca/newsroom/press-releases/04-24-2017_Hep_C_screening_guidelines.aspx

Update on the Development of Simeprevir as Part of the Triple Combination With AL-335 and Odalasvir (JNJ-4178)

Update on the Development of Simeprevir as Part of the Triple Combination With AL-335 and Odalasvir (JNJ-4178)

STOCKHOLM, April 24, 2017 /PRNewswire/ --Medivir AB (Nasdaq Stockholm: MVIR) today communicates an update on the status of the development of JNJ-4178, the triple combination of simeprevir, odalasvir and AL-335, following The International Liver Congress™ 2017 of the European Association for the Study of the Liver (EASL), which was held in Amsterdam, on 19-23 April.

Data from an ongoing phase II study presented at The International Liver Congress™ 2017 demonstrate that this regimen has the potential to shorten treatment duration, offer high efficacy and is generally well tolerated in those whose disease is caused by hepatitis C virus (HCV) genotype 1 (GT1), one of the most prevalent causes of hepatitis C globally. The three-drug regimen achieved 100% SVR12 for 6- and 8-week treatment duration in treatment-naïve, GT1, non-cirrhotic patients. The three-drug combination did not have sufficient efficacy in patients with HCV genotype 3 to justify further development in this patient population. All-oral combination regimens, containing odalasvir, AL-335 with or without simeprevir were generally safe and well tolerated. The safety and efficacy of JNJ-4178 in cirrhotic patients is currently under investigation as part of this phase II study. Further information on this trial can be found at www.clinicaltrials.gov (NCT02569710).
                          
Enrolment has recently been completed into the global phase IIb OMEGA-1 study of JNJ-4178. This open-label study is assessing the efficacy and safety of JNJ-4178 in non-cirrhotic patients with HCV genotypes 1, 2, 4, 5 and 6. Further information on the study can be found at www.clinicaltrials.gov (NCT02765490).

Meeting Updates
Updates On This Blog
Hep C 5-minute videos - Summary Of The International Liver Congress™ (ILC) 2017

AbbVie takes aim at Gilead and BMS with 8-week hep C treatment

Of Interest

AbbVie takes aim at Gilead and BMS with 8-week hep C treatment

AbbVie is aiming to steal sales from hep C drugs from Gilead and BMS with a new combination offering a shorter, eight-week treatment for the most difficult-to-treat form of the disease.

Results presented at the International Liver Congress (ILC) in Amsterdam showed 95% of genotype 3 patients on its pan-genotypic regimen of glecaprevir+pibrentasvir were free of disease, 12 weeks after completing an eight-week treatment course.

The results were based on a previously untreated, cirrhosis-free, 157-patient arm of the ENDURANCE-3 study.

Another arm of the trial also met its goal, matching the performance of BMS’ Daclinza(daclatasvir) plus Gilead’s Sovaldi (sofosbuvir) over 12 weeks in genotype 3.

The Daclinza and Sovaldi combination is current standard of care for genotype 3 hepatitis, but AbbVie is attempting to produce a more patient-friendly alternative with a shorter regimen.
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Meeting Updates
Updates On This Blog
Hep C 5-minute videos - Summary Of The International Liver Congress™ (ILC) 2017

Hepatitis C: New Canadian guidelines recommend against screening low-risk adults

New hepatitis C screening guidelines will lead to avoidable deaths and soaring costs to health care system
New hepatitis C screening guidelines will lead to avoidable deaths and soaring costs to health care system. Reliance on risk-based testing will perpetuate low diagnosis rates and increases in cirrhosis and liver cancer

Hepatitis C: New Canadian guidelines recommend against screening low-risk adults

The Canadian Task Force on Preventive Health Care recommends against screening for chronic hepatitis C virus (HCV) in adults at low risk in a guideline published in CMAJ (Canadian Medical
Association Journal).

“Given the lack of direct evidence that mass screening is beneficial and that patients identified by screening will either never develop symptoms of hepatitis C, or will remain well for decades after infection, we have recommended against screening for HCV in adults who are not at elevated risk,” said Dr. Roland Grad, member of the task force and chair of the guideline work group.

This is the first hepatitis C screening guideline from the task force. The task force looked for the highest-quality scientific evidence available about the effectiveness (benefits and harms) of screening to develop its recommendation. The recommendation is based on the following:
  • the low prevalence of hepatitis C in Canada among the general adult population not at elevated risk for chronic infection;
  • the lack of direct evidence on the benefits and harms of screening;
  • many individuals with chronic hepatitis C identified by screening would not have timely access to anti-viral treatment;
  • the potential for harms caused by screening could include labeling, stigma, and difficulties with insurance;
  • the low risk of household and sexual transmission of HCV among individuals not at elevated risk, as well as the low risk of transmission through blood products given routine screening of blood and organs; and
  • the anticipated increase in harm resulting from diagnosing and treating individuals who screen positive, but would have never developed HCV-related disease during their lifetime.
This recommendation is for people who are not at increased risk of hepatitis C. It does not apply to pregnant women or people at increased risk, including:
  • people with current or past history of injection drug use;
  • people who have been in jail;
  • people who were born, travelled or lived in hepatitis C endemic countries;
  • people who have received health care where there is a lack of universal precautions to protect against viral transmission;
  • recipients of blood transfusions, blood products or an organ transplant before 1992 in Canada;
  • hemodialysis patients;
  • people who have had needle stick injuries;
  • people who have engaged in other behaviours associated with hepatitis C exposure such as high-risk sexual behaviour, homelessness, intranasal and inhalation drug use, tattooing, body piercing or sharing sharp instruments or personal hygiene materials with someone who is hepatitis C-positive; and
  • anyone with clinical clues suspicious for hepatitis C infection.
“The HCV prevalence in most adults in the general Canadian population is low and direct evidence examining the benefits and harms of screening for HCV is not available,” write the authors. “Not screening for HCV [in the general population] will help focus our limited health care resources to test (and treat) individuals at elevated risk for HCV and to provide other medical interventions that are of proven to be of benefit.”

http://outbreaknewstoday.com/hepatitis-c-new-canadian-guidelines-recommend-screening-low-risk-adults-31699/

Sunday, April 23, 2017

Hep C 5-minute videos - Summary Of The International Liver Congress™ (ILC) 2017

Hep C Summary - The International Liver Congress™ (ILC) 2017

After each conference this blog links to a series of education-related information on important findings related to ongoing challenges of managing and treating viral hepatitis. Listed below are programs  reviewing key HCV data presented at the International Liver Congress™, with links to additional coverage.

Although the following video/lecture program is aimed at clinicians, it's pretty cut and dry; easy to comprehend. In addition Viral Ed will be launching an expert review of the meeting on May 1, 2017.

This page will be updated as new learning activities become available, with a dated reminder on the sidebar of this blog.


Hepatitis C - 5-minutes videos each day from The International Liver Congress™ available at Practice Point Hepatitis

In this video series, Dr. Tran will present "what you need to know in 5 minutes" offering us a quick review of  clinical studies on new antiviral therapy, data on drug toxicity/adverse events, drug interactions, and strategies for HCV management.

Free registration is required to view videos, sign up here...
After you register scroll down before clicking on "Access Video"

Main Menu
Click here to view videos each day from The International Liver Congress™ (ILC) 2017, 52nd annual meeting of the European Association for the Study of the Liver (EASL).

*This conference coverage is not sanctioned by the conference organizers (European Association for the Study of the Liver) and is not an official part of the conference proceedings from ILC 2017.

Video Highlights

Day One
Expedition-1 Glecaprevir/Pibrentasvir HCV Genotypes 1,2,4,5,6 and compensated cirrhosis
HCC reoccurrence after interferon-free therapy
Day Two
Endurance 3 Glecaprevir/Pibrentasvir treatment naïve genotype 3 without cirrhosis
HBV/HCV Coinfected - Ledipasvir/Sofosbuvir 12weeks
Real-World Observational Study in the U.S. Veterans Affairs System Evaluating Use of Merck’s (Elbasvir and Grazoprevir)
German Registry - SVR 12 rates with interferon-free therapies in advanced HCV-associated cirrhosis
Direct-acting antiviral treatment in children
Day Three
Magellan-1 Part 2:  Glecaprevir/Pibrentasvir  HCV Genotype 1 or 4 Prior DAA Failures
Magellan-2 Glecaprevir/Pibrentasvir  in liver or renal transplant recipients with HCV genotype 1-6 
Day Four
Re-treatment in HCV-associated cirrhosis
Begin here....



Coming Soon
May 1 over @ Viral Ed
The Advances in Chronic Hepatitis C: Management and Treatment program is a comprehensive, expert review of the 52nd Annual Meeting of the European Association for the Study of the Liver (EASL 2017). This program will feature HCV experts reviewing and discussing the most important studies on chronic hepatitis C presented at EASL 2017. This review and discussion will provide a comprehensive overview of each of the posters and presentations as selected by our faculty panel. In addition, the faculty will provide unique insights into how knowledgeable experts review and analyze data from EASL and an in-depth understanding of the scientific quality and clinical relevance of the posters and presentations reviewed.
Begin here......

ViralEd - Daily Highlights from EASL 2017

Helpful Links

International Liver Congress™ 2017
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Slides available @ NATAP

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Healio

Meeting Updates
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Liver Cancer
Oncology Conference Multimedia
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Abstract Book
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EASL YouTube Channel
Published on April 20
ILC 2017 - Press conference 1
HCV Post SVR Management and Complications



EASL In The Press
Press Room

Coverage
HIV and Hepatitis
Hep

Of Interest
Published on Apr 20
Raquel Peck, CEO World Hepatitis Alliance, speaks at opening ceremony at EASL's International Liver Congress April 2017. She casts the wide vision of worldwide hepatitis elimination, and challenges medical professionals to be partners in the effort. And she shares a bit of her own amazing story.

HCV Resource Links
Premier Hepatitis C Websites, Blogs and Support Forums

Elevated Liver Cancer Risk for Older Hep B-Cleared Patients

Medscape Coverage from the
International Liver Congress (ILC) 2017

Elevated Liver Cancer Risk for Older Hep B-Cleared Patients
Damian McNamara
April 21, 2017
AMSTERDAM — Older people who are functionally cured of hepatitis B are at a significantly higher risk for hepatocellular carcinoma, a new study warns.

Even after the seroclearance of hepatitis B surface antigen, "there is still risk of developing hepatocellular carcinoma," particularly when clearance occurs after the age of 50, said Henry Chan, MD, director of the Institute of Digestive Disease at The Chinese University of Hong Kong.
Previous studies have demonstrated that patients in this age group who spontaneously experience seroclearance are at increased risk for hepatocellular carcinoma, he explained here at the International Liver Congress 2017. However, small cohort sizes and low event rates have limited clinical interpretation of the findings.

Confirmation of this risk could lead to closer cancer surveillance for this subgroup of patients, Dr Chan told Medscape Medical News.
Continue reading...