Thursday, April 6, 2017

Hepatitis C Fatigue - What's that all about?

Hepatitis C Fatigue - What's that all about?
Fatigue is the most commonly experienced symptom in people with liver disease, and it has a significant impact on their quality of life.  Hepatitis C is a major cause of chronic liver disease in the United States, with fatigue reported as the most frequent disabling symptom - in over one-half of all people diagnosed with the virus.

In this post we look at available research and possible related conditions that may contribute to that all too familiar symptom.

Research
Let's start with a recent study which examined whether HCV fatigue, depression and health-related quality of life improves after successful HCV therapy. The result?  Well, not always.

Persistent neuropsychiatric impairment in HCV patients despite clearance of the virus?
Previous research has shown that fatigue from chronic hepatitis C usually decreases after achieving a sustained virologic response (SVR), however, occasionally fatigue may still persist after patients clear the hepatitis C virus. In a study published in Journal of Viral Hepatitis February 2017, researchers evaluated chronic fatigue after successful virus eradication. In the study researchers enrolled 159 individuals with HCV, without advanced liver disease. Patients answered a series of questions about fatigue, depression, coupled with various attention and memory tests. The patients were divided into 4 groups according to their viremia (presence of HCV virus in the blood) and interferon treatment history. Eighty-five per cent of the patients had chronic fatigue, 50-60% mild depression or anxiety, 45% memory deficits and 30% attention deficits, irrespective of their HCV viremia status or treatment history. The results suggest that HCV infection may cause long-standing cerebral dysfunction that significantly impairs health-related quality of life that may persist even after virus clearance. Commentary on the study written by Stephanie Finucane, MS, CMPP summed up the results nicely, the author wrote;
Disabling chronic fatigue is reported in approximately 60% of patients with confirmed hepatitis C virus (HCV) infection, as well as decreased quality of life and cognitive dysfunction (eg, deficits in attention and verbal learning). While these neuropsychiatric symptoms may be expected in patients with ongoing HCV infection, it is questionable whether these effects are also present in HCV-exposed patients who currently are cured of the infection.
A study recently published in the Journal of Viral Hepatitis found no evidence linking the presence of HCV infection with these neuropsychiatric symptoms. Instead, researchers suggest that the fatigue and impairment in health-related quality of life (HRQoL) and cognitive and mental function commonly found in HCV-exposed patients may be explained by either an HCV infection-triggered autoimmune response persisting beyond virus clearance or the development of a virus variant in the brain.  
Commentary here, full text article here.

Other Contributing Factors
Other contributing factors may include lifestyle, pre-existing conditions, coping with the diagnosis, loss of employment, medical coverage, and the cost of expensive HCV medications, all of which can cause depression and anxiety leading to fatigue, yet these conditions are frequently overlooked when patients seek out medical care.

Extrahepatic Manifestations
Fatigue can be caused by other conditions related to the virus, although hepatitis C infection primarily affects the liver, 40% of patients with HCV will develop at least one extrahepatic manifestation (conditions that affect organs other than the liver) during the course of their disease.

The most prevalent and most closely linked extrahepatic manifestation found in hepatitis C patients is essential mixed cryoglobulins causing dermatologic, neurologic, renal, and rheumatologic complications. Cryoglobulinemia happens when abnormal proteins in the blood solidify in cold conditions. In patients with mixed cryoglobulins, 35 to 54% reported various symptoms that include but not limited to fatigue, joint pain, muscle pain, itching, rashes, tingling in hands and feet. Non-cryoglobulin diseases with a less definite relationship to HCV include systemic vasculitis, splenic lymphoma, porphyria cutanea tarda, and the sicca syndromes.

Review
International therapeutic guidelines for patients with HCV-related extrahepatic disorders. A multidisciplinary expert statement
A paper published in Autoimmunity Reviews March 2017, set out to investigate what effects new HCV interferon-free and old interferon-based antiviral therapy may have on different HCV-extrahepatic manifestations (HCV-EHMs). The effect of Non-viral therapies on HCV-extrahepatic manifestations were also included in the article. In summary the article reported that compared to interferon-based therapy, interferon-free antiviral therapy caused minimal reduction in patient-reported outcomes during therapy and improvement of vitality and fatigue at SVR12. As stated in the abstract: In the era of interferon-free anti-HCV treatments, international recommendations for the therapeutic management of HCV-EHMs are needed. This implies the need to define the best criteria to use antivirals and/or other therapeutic approaches.
Full Text - Download PDF

Recommended Reading
Patient Reported Outcomes Critical in the Fight Against HCV
HCV Next, March 2017
Zobair M. Younossi, MD, MPH
When you look at the consequences of any chronic liver disease such as hepatitis C, three different types of impact emerge. The first impact is the clinical consequences of HCV infection. The clinical impacts of HCV can further be divided into hepatic manifestations like cirrhosis and liver cancer and extrahepatic manifestations of HCV infection such as cryoglobulinemia, chronic fatigue and diabetes. Both the hepatic and extrahepatic complications of HCV infection can lead to excess mortality and ultimately impact patient’s survival. In this context, clinical outcomes of HCV can be surrogates for survival.

The second type of impact of HCV infection is captured by patient reported outcomes, or PROs. PROs are reported directly by the patient without any changes or modifications by the physician or caregiver. PRO is an umbrella term that includes everything from health-related quality of life (HRQoL), functional status and even stigma associated with HCV infection. PROs are surrogates for the patients’ experience with their disease and its treatment. If you improve PRO scores, you are improving the patient experience with their disease.

The third type of impact of HCV infection is related to its economic consequences, which can include direct, indirect or intangible costs of the disease and its treatment. In this context, the economic impact represents a surrogate for resource utilization.

When you consider these three impacts of HCV infection together, you get a complete and comprehensive picture of HCV infection and its impact on the individual patient and the society.
Continue reading...

Links
An Overview of Extrahepatic Manifestations of Hepatitis
A patient friendly fact sheet explaining conditions associated with HCV including symptoms.
Direct-acting Antivirals Effective for HCV-related Mixed Cryoglobulinemia

Recently published in Journal of Advanced Research is a nice collection of review articles on the extrahepatic manifestations of HCV.

Thyroid Disease
According to the American Thyroid Association (ATA). About 20 million Americans—more of them women than men—are affected by a thyroid disease or disorder. In fact, an estimated one in eight women will develop a thyroid disorder at some time in her life.

Hypothyroidism & Hyperthyroidism: Symptoms
Hyperthyroidism - When your thyroid gland makes more thyroid hormones than your body needs.
Symptoms of Hyperthyroidism include nervousness, irritability, increased perspiration, heart racing, hand tremors, anxiety, difficulty sleeping, thinning of your skin, fine brittle hair and weakness in your muscles—especially in the upper arms and thighs.
Hypothyroidism - When your thyroid gland does not make enough thyroid hormones
Symptoms of Hypothyroidism may include feeling cold, fatigued, dry skin and forgetfulness.

Thyroid Disease And HCV
Before approved interferon-free medicines were available in the U.S. to treat HCV, thyroid dysfunction (interferon induced thyroiditis) was a common side-effect of interferon-based therapies. However, hepatitis C itself can cause thyroid changes, even in people that have never treated with interferon.

Chronic HCV infection is associated with several endocrine disorders (diseases related to the endocrine glands), for example the most frequent is thyroid disorders and type 2 diabetes. Thyroid imbalance and thyroid anti-bodies are much more common in patients with Hepatitis C virus infection than in people without the virus.  According to a 2016 study the hepatitis C virus shares some molecular similarities with the thyroid and this may make the immune system mistakenly attack the thyroid gland in response to the presence of foreign molecules coming from the virus. The virus could also be infecting the thyroid cells and that could trigger the attack of the immune system on the thyroid gland.

Thyroid Disturbance in Patients with Chronic Hepatitis C Infection: A Systematic Review and Meta-analysis
In a review article published in Journal of Gastrointestinal and Liver Diseases June 2016, researchers looked at literature dated up to August 2015 to identify observational studies which compared thyroid dysfunction in interferon naïve HCV-infected and non-HCV infected subjects. The study confirmed HCV infection may be an independent risk factor for thyroid disturbance independent of administration of interferon therapy. Download the article, here.

Recommended Reading
Hyperthyroidism
Hypothyroidism
Hashimoto’s disease

Depression
Depression and anxiety is often associated with a diagnosis of a chronic illness, especially with a serious chronic disease like hepatitis C. As a result of having HCV, symptoms may already exist, for example disturbed sleep, impaired appetite, and joint pain, these ongoing symptoms decrease quality of life and increase fatigue.

A Warning
Experts warn, if depression was present before being diagnosed with HCV a distinction between an adjustment reaction and a depressive illness should be determined by your health care provider.

Moving Forward
The phrase “knowledge is power” is a profound one to be sure, especially when applied to hepatitis C. Acquiring knowledge about hepatitis C can lead to an early diagnosis, a cure, and important management strategies to treat complications of this sometimes life-threatening virus.

Educating yourself about the virus will put control back into your life, test results become easier to understand, discussions with your health care professional about managing or treating the virus will be more productive, this is turn may elevate anxiety. Once all this is in place a plan of action begins. If treatment is considered, the next hurtle can prove to be difficult, many insurance companies and state Medicaid programs limit treatment to those with the most severe cases of HCV, the good news is that this is improving, but it's taking far too long.

Recommended Reading

Anxiety And Trump
At the moment possible changes in regard to the proposed replacement for the Affordable Care Act under the current administration is enough to cause a healthy person extreme anxiety, to say the least, here is the latest on the subject.

Recently, TAG-Treatment Action Group launched their spring issue of TAGline, with this informative article; Wrangling Affordable Drug Pricing and HCV Elimination Under the New White House Administration.

Baby Boomers
Personally, I consider age an important factor in relation to stress and fatigue, baby boomers, people born between 1945 (age 72) and 1965 (age 52) account for about 80 percent of chronic hepatitis C cases in the U.S.  This segment of the population are sandwiched between raising children and taking care of loved ones, including aging parents, the latter can be at times overwhelming, plagued with grave depression and severe anxiety. In addition, other health issues arise as we age; diabetes, arthritis and heart disease, to name a few.

Identifying Contributing Factors Associated With Fatigue
Depression can drain your energy, leading to lack of sleep which may start a vicious unhealthy cycle. As for anxiety, well that is just exhausting. By first identifying these possible contributing factors, you can then begin to use coping tools that help relax or even energize you. Setting limits on what you’re able to handle is probably the best advice - learn to say no. Eventually, try doing little things like going for a walk, or reading about ways to manage stress, these small steps go a long way on the road back to wellness and may improve fatigue.

Links
Education
Support

Until next time, wishing you all a safe and healthy journey.

Photo Credit - Created by Freepik

VA Official: Use of Cape Regional by Vets May Be Announced in 30-60 Days

VA Official: Use of Cape Regional by Vets May Be Announced in 30-60 Days
By Al Campbell
WILMINGTON, DEL. – Vietnam veterans who rallied on March 25 in Wildwood and Ocean View for health care facilities in Cape May County may be within 60 days of having their demands met.

Vincent Kane, interim associate director of operations, Wilmington Veterans Affairs (VA) Medical Center, confirmed March 29 that discussions of partnership with Cape Regional Medical Center have been ongoing.

Kane said he had discussions with some of the veterans who voiced concerns at the rally. One, in particular, who told of wanting to be tested for Hepatitis C, and told he had to wait until December, got Kane's attention....
Continue reading

Wednesday, April 5, 2017

TAGline Spring 2017 - Wrangling Affordable Drug Pricing and HCV Elimination Under the New White House Administration

TAGline Spring 2017
DOWNLOAD:
TAGline April 2017 FINAL.pdf

With every major election, particularly one that secures or fortifies Republican control of the White House, Senate, or House of Representatives, a certain amount of worry and strategy realignment is to be expected from public health activists and civil society. Following one of the biggest upsets in political history, in which Donald Trump rode a wave of populist and nationalist sentiments to become the 45th president of the United States and all but guaranteed a right-wing trifecta, the concern among health justice leaders has been unprecedented.

And rightfully so. Anxieties regarding government underinvestment in public health—basic and clinical research, international aid, domestic healthcare infrastructure, and various federally funded programs needed to support health outcomes—are heightened once again. In addition, we must now contend with executive and legislative branches bent on scaling back statutes and regulations that are key to human wellness and survival on the basis of, in no small part, willful disregard for science and evidence-based policy making.

Progress made in the arenas of HIV, tuberculosis (TB), and hepatitis C virus (HCV) over the past several years has been significant, to the point at which strategies to end all three epidemics have not only been envisioned, but actualized. But these gains are incredibly fragile and will diminish swiftly in the absence of federal nurturing and support.

TAG remains committed to the capacity building, coalition strengthening, and direct advocacy required to maintain forward momentum in a federal political climate that isn’t merely indifferent to public health, but is ultimately hostile to its efforts and the communities that it benefits.
In the April 2017 issue of TAGline, we chart the course ahead and touch on some of our overarching priorities in the coming months and years:

Lessons from History for Today’s HIV Response
Maintaining and expanding the accomplishments of the past depend on a fight for their survival and growth—now more than ever
By Mark Harrington

Just the Facts: Trump and the Devaluation of Science
Mobilizing to defend biomedical research investments and scientific integrity as essential for public health, safety, and well-being
By Kenyon Farrow and Mike Frick

Wrangling Affordable Drug Pricing and HCV Elimination Under the New White House Administration
Trump’s early tough talk on drug pricing is now a pro-industry, anti-regulation GOP dreamscape
By Bryn Gay

Resisting the Coming Austerity: Medicaid in the Crosshairs
Lingering Republican threats to the ACA and Medicaid do no favors for America’s working poor
By Annette Gaudino

Breaking Down Walls in Trump’s Anti-Immigrant Rhetoric
How the Trump administration’s anti-immigrant stance threatens human rights, public health, and the lives of people living with TB
By Erica Lessem and Suraj Madoori

The New War on Drugs
The 21st Century Cures Act and a right-wing war on regulations are direct threats to FDA evidentiary requirements for drugs, biologics, and devices
By Tim Horn and Suraj Madoori

We remain in solidarity with our allies who have long fought battles to secure funding for basic and clinical research, reverse stigmatizing and discriminatory policies, stare down pharmaceutical industry greed, and push for programs to ensure equitable access to treatment and care. Although the challenges now go broader and deeper than ever before, we stand stronger than ever in a fight that has yielded monumental victories in the past and will continue to do so in the future. A luta continua, a vitória é certa.

DOWNLOAD:
TAGline April 2017 FINAL.pdf

In Case You Missed It
April 4
Check out this month's collection of blog, journal and newsletter updates

The HepC Pill Bill An insight into the availability, pricing and accessibility of HCV treatment

The HepC Pill Bill An insight into the availability, pricing and accessibility of HCV treatment
By Mrinalini Anand
4 April 2017

Introduction to Direct Acting Antivirals

Hepatitis C treatment has remarkably evolved over the years. The previously known standard HCV regimen consisted of a course of pegylated interferon injections and ribavirin tablets, which all in all were expensive, toxic, and needed 24 to 28 weeks to act. With the advent of new Direct Acting Antivirals (DAAs) in 2011, HCV regimens changed significantly. Sofosbuvir became the first drug to be approved for the new generation HCV treatment. DAAs have an edge over the previous medications, in the aspects of, being better tolerated and being more efficient in a shorter duration (90% cure rates after the first 12 weeks of treatment).

There are four classes of DAAs: 1) NS3/4A protease inhibitors 2) NS5A inhibitors 3) NS5B nucleotide polymerase inhibitors and 4) NSFB non-nucleoside polymerase inhibitors. They all block essential proteins hence effecting various phases of the HCV life cycle.

DAAs being highly safe and secure are unfortunately not available to all. The WHO estimates that just over 1 million people were effectively treated in 2016 in low- and middle-income countries, with more than half of them in Egypt alone.

Continue reading....

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"

Enanta Announces Presentations at The International Liver Congress™ 2017

Enanta Pharmaceuticals Announces Data Presentations at The International Liver Congress™ 2017

WATERTOWN, Mass.--(BUSINESSWIRE)--
  • New data to be presented on Enanta’s FXR agonist EDP-305 for non-alcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC)
  • New data to be presented on AbbVie’s investigational, pan-genotypic, ribavirin-free HCV regimen that combines two distinct antiviral agents, including glecaprevir, Enanta’s second protease inhibitor
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that several abstracts regarding Enanta’s wholly-owned EDP-305 development program for NASH and PBC, as well as abstracts regarding AbbVie’s investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P) for the treatment of chronic hepatitis C virus (HCV) infection, have been accepted for presentation at The International Liver Congress™ (ILC) 2017, April 19-23, in Amsterdam.

Three poster presentations will demonstrate that EDP-305 is a potent Farnesoid X Receptor (FXR) agonist that has been shown to reduce fibrosis progression and improve non-alcoholic fatty liver disease (NAFLD) activity scores (NAS) in a variety of preclinical models.

In addition, several oral and poster presentations will report data from AbbVie’s G/P clinical development program. G/P is an investigational, pan-genotypic, once-daily regimen that combines two distinct direct-acting-antiviral (DAA) agents, glecaprevir, Enanta’s second protease inhibitor, and pibrentasvir, AbbVie’s NS5A inhibitor.

The following abstracts regarding EDP-305 and G/P will be presented during the International Liver Congress:
Enanta Presentations: EDP-305 FXR Agonist:
Thursday, April 20
Poster Presentation, 08:00 - 18:00
  • Poster #THU-377: A Novel Farnesoid X Receptor (FXR) Agonist, EDP-305, Reduces Fibrosis Progression in Animal Models of Fibrosis (Presenter: Bryan C. Fuchs)
Friday, April 21
Poster Presentation, 08:00 - 18:00
  • Poster #FRI-363: EDP-305, a Novel and Highly Potent Farnesoid X Receptor (FXR) Agonist, Improves Liver Steatosis, Ballooning and Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) in a Diet-Induced Murine Model of Non-Alcoholic Steatohepatitis (NASH) (Presenter: Li Juan Jiang)
Saturday, April 22
Poster Presentation, 08:00 - 18:00
  • Poster #SAT-459: A Novel FXR Agonist EDP-305 Potently Suppresses Liver Injury and Fibrosis in Mouse Models of Biliary and Metabolic Liver Disease (Presenter: Yury Popov)
AbbVie Presentations: glecaprevir/pibrentasvir (G/P) for HCV:
Thursday, April 20
Oral Presentation, 15:15 - 15:30
  • Abstract GS-006: EXPEDITION-I: Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults with Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis (Presenter: Xavier Forns)
Poster Presentations, 08:00 - 18:00
  • Poster #THU-263: Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir in Adults with Chronic Genotype 1-6 Hepatitis C Virus Infection and Compensated Cirrhosis: an Integrated Analysis (Presenter: Edward Gane)
  • Poster #THU-305: Resistance Selection Using Glecaprevir and Pibrentasvir in Replicons of Major Hepatitis C Virus Genotypes (Presenter: Teresa Ng)
Late Breaking Poster April 20-22, 08:00 - 18:00
  • Poster #LBP-522: Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Co-infected With Hepatitis C Virus and Human Immunodeficiency Virus-1: the EXPEDITION-2 Study (Presenter: Juergen Rockstroh)
Friday, April 21
Oral Presentation, 08:30 - 08:45
  • Abstract GS-007: ENDURANCE-3: Safety and Efficacy of Glecaprevir/Pibrentasvir Compared to Sofosbuvir Plus Daclatasvir in Treatment-Naïve HCV Genotype 3-Infected Patients without Cirrhosis (Presenter: Graham R. Foster)
Poster Presentations 08:00 - 18:00
  • Poster #FRI-205: Pooled Resistance Analysis in HCV Genotype 1-6-infected Patients Treated with Glecaprevir/Pibrentasvir in Phase 2 and 3 Clinical Trials (Presenter: Preethi Krishnan)
  • Poster #FRI-238: Safety of Glecaprevir/Pibrentasvir in Adults with Chronic Genotype 1-6 Hepatitis C Virus Infection: An Integrated Analysis (Presenter: Jean-Francois Dufour)
  • Poster #FRI-262: CERTAIN-1: Efficacy and Safety of Glecaprevir/Pibrentasvir in Japanese Patients with Chronic Genotype 1 Hepatitis C Virus Infection with and without Cirrhosis (Presenter: Kazuaki Chayama)
  • Poster #FRI-263: Efficacy and Safety of Glecaprevir/Pibrentasvir in Japanese Patients with Chronic Genotype 2 Hepatitis C Virus Infection with and without Cirrhosis (Presenter: Kazuaki Chayama)
Saturday, April 22
Oral Presentations
  • 08:45 - 09:00: PS-156: MAGELLAN-1, Part 2: Glecaprevir and Pibrentasvir for 12 or 16 weeks in Patients with Chronic Hepatitis C Virus Genotype 1 or 4 and Prior Direct-Acting Antiviral Treatment Failure (Presenter: Fred Poordad)
  • 16:30 - 16:45: LBO-03: MAGELLAN-2: safety and efficacy of Glecaprevir/Pibrentasvir in Liver or Renal Transplant Adults with Chronic Hepatitis C Genotype 1-6 Infection (Presenter: Nancy Reau)
Poster Presentations, 08:00 - 18:00
  • Poster #SAT-204: Resistance Analysis in the MAGELLAN-1 Study (Part 2): Glecaprevir/Pibrentasvir Therapy in HCV-infected Patients who had Failed Prior DAA Regimens Containing NS3/4A protease and/or NS5A Inhibitors (Presenter: Tami Pilot-Matias)
  • Poster #SAT-233: High SVR Rates with Eight and Twelve Weeks of Pan-Genotypic Glecaprevir/Pibrentasvir: Integrated Efficacy and Safety Analysis of Genotype 1-6 Patients without Cirrhosis (Presenter: Massimo Puoti)
  • Poster #SAT-273: Safety and Efficacy of Glecaprevir/Pibrentasvir in Adults with Chronic Hepatitis C Virus Infection Genotype 1 – 6 and Chronic Kidney Disease: an Integrated Analysis (Presenter: Stan Pol)
The full ILC 2017 scientific program can be found at http://ilc-congress.eu/.

About G/P
G/P is an investigational, pan-genotypic regimen that is being evaluated by AbbVie as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment with direct-acting antivirals (DAAs), who make up the majority of HCV patients. AbbVie is also studying G/P in patients with specific treatment challenges, such as patients with genotype 3 HCV, patients who were not cured with previous DAA treatment and those with chronic kidney disease, including patients on dialysis.
G/P is an investigational, once-daily regimen that combines two distinct antiviral agents in a fixed-dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor. G/P is dosed once-daily as three oral tablets.
Additional information on AbbVie’s clinical trials for G/P is available at www.clinicaltrials.gov.

Merck to Present New Data on (elbasvir and grazoprevir) and MK-3682B at International Liver Congress™ 2017

Merck to Present New Data on ZEPATIER® (elbasvir and grazoprevir) and Investigational Combination Therapy MK-3682B for the Treatment of Chronic Hepatitis C Infection at The International Liver Congress™ 2017

Merck (MRK), known as MSD outside of the United States and Canada, today announced that new data from the company’s chronic hepatitis C virus (HCV) clinical development programs as well as real-world studies on ZEPATIER® (elbasvir and grazoprevir) 50mg/100mg tablets will be presented at the upcoming International Liver Congress™ 2017. Seventeen scientific abstracts will be presented, including oral sessions featuring real-world data on chronic HCV-infected patients treated with ZEPATIER from the U.S. Department of Veterans Affairs Healthcare System and new results from the C-SURGE trial evaluating MK-3682B [uprifosbuvir (MK-3682)1/grazoprevir2/rusazvir3] in patients with chronic HCV infection who have previously failed a HCV direct-acting antiviral regimen. The International Liver Congress™ 2017 will take place in Amsterdam, Netherlands from April 19 – 23, 2017.

“We continue to generate new data on ZEPATIER while advancing our ongoing investigational program evaluating uprifosbuvir in combination with other assets, underscoring our continued commitment to chronic HCV research,” said Dr. Eliav Barr, senior vice president, global clinical development, infectious diseases and vaccines, Merck Research Laboratories. “Findings from both randomized clinical trials and real-world data analyses help us better understand the treatment of diverse patient types, including those who have been historically underserved or for whom unmet needs remain.”

In the United States, ZEPATIER is indicated for the treatment of chronic HCV genotype (GT) 1 or GT4 infection in adults. ZEPATIER is indicated for use with ribavirin (RBV) in certain patient populations. The U.S. Prescribing Information for ZEPATIER contains a Boxed Warning about the risk of hepatitis B virus (HBV) reactivation in patients co-infected with HCV and HBV.
Key presentations at The International Liver Congress™ 2017 will include:
ZEPATIER (elbasvir and grazoprevir)
Thursday, April 20
  • Real-World Use of Elbasvir/Grazoprevir and Outcomes in Patients With Chronic Hepatitis C: Retrospective Data Analyses From the TRIO Network (Poster presentation, Abstract THU-239, 8:00 a.m. – 6:00 p.m. CEST)
  • Prevention of Liver-Related Complications With Elbasvir/Grazoprevir in Hepatitis C Infected Patients who are Receiving Opioid Agonist Therapy (OAT) (Poster presentation, Abstract THU-246, 8:00 a.m. – 6:00 p.m. CEST)
  • Real-World Utilization of the New Fixed-Dose Combination Elbasvir/Grazoprevir in Adult Patients With Chronic Hepatitis C in Canada: Z-PROFILE Study (Poster presentation, Abstract THU-266, 8:00 a.m. – 6:00 p.m. CEST)
  • Clinically Meaningful Differences in Health-Related Quality of Life and Fatigue in Patients With Hepatitis C Virus (HCV) Infection Treated With Elbasvir/Grazoprevir (EBR/GZR) Compared to Sofosbuvir (SOF) With Pegylated Interferon and Ribavirin (PR) (Poster presentation, Abstract THU-245, 8:00 a.m. – 6:00 p.m. CEST)
  • Projected Long Term Impact of Elbasvir/Grazoprevir (EBR/GZR) Compared to Sofosbuvir Plus Pegylated Interferon/Ribavirin (SOF+PR) in Chronic Hepatitis C Virus Genotype 1 and 4 Patients in Italy: Translation of the C-EDGE Head-2-Head Study Findings (Poster presentation, Abstract THU-247, 8:00 a.m. – 6:00 p.m. CEST)
  • Safety and Efficacy of Elbasvir and Grazoprevir With or Without Ribavirin for the Treatment of Hepatitis C Virus Genotype 1: Results of the Hepatitis C Virus-TARGET Study (Poster presentation, Abstract THU-237, 8:00 a.m. – 6:00 p.m. CEST)
Friday, April 21
  • Real World Experience With Elbasvir/Grazoprevir in the Veterans Affairs Healthcare System (Oral presentation, Abstract PS-095, 4:00 – 4:15 p.m. CEST)
  • Efficacy and Safety of Elbasvir/Grazoprevir in Treatment-Naïve Patients With Chronic HCV GT 1, GT 4 and GT 6 Infection (C-CORAL): A Phase III Randomized Multinational Clinical Trial (Poster presentation, Abstract FRI-266, 8:00 a.m. – 6:00 p.m. CEST)
  • Elbasvir/Grazoprevir Plus Sofosbuvir in Treatment-Naive and Treatment-Experienced Cirrhotic Patients With Hepatitis C Virus Genotype 3 Infection Treated for 8, 12, or 16 weeks: Final Results of the C-ISLE Study (Poster presentation, Abstract FRI-213, 8:00 a.m. – 6:00 p.m. CEST)
  • Successful Treatment of Patients With HCV GT3 Infection and Cirrhosis with Elbasvir/Grazoprevir Plus Sofosbuvir Does Not Correct Insulin Resistance by 12 weeks Post-Treatment (Poster presentation, Abstract FRI-215, 8:00 a.m. – 6:00 p.m. CEST)
  • Impact of Elbasvir/Grazoprevir (EBR/GZR) on Health-Related Quality of Life (HRQOL) and Fatigue in Patients With Chronic Hepatitis C Virus (HCV) Infection and Inherited Blood Disorders (IBLD): Data From the C-EDGE IBLD Study (Poster presentation, Abstract FRI-251, 8:00 a.m. – 6:00 p.m. CEST)
Saturday, April 22
  • Elbasvir/Grazoprevir Effectiveness in Patients With Chronic Hepatitis C and Chronic Kidney Disease: Real-World Experience From the TRIO Network (Poster presentation, Abstract SAT-297, 8:00 a.m. – 6:00 p.m. CEST)
MK-3682B, INVESTIGATIONAL TRIPLE THERAPY
Thursday, April 20
  • Efficacy and Safety of the Fixed-Dose Combination Regimen of MK3 [MK-3682/Grazoprevir/Ruzasvir] With or Without Ribavirin in Non-Cirrhotic or Cirrhotic Patients With Chronic HCV GT1, 2, 3, 4 or 6 Infection (Parts A & B of C-CREST-1 & 2) (Poster presentation, Abstract THU-285, 8:00 a.m. – 6:00 p.m. CEST)
  • High Sustained Virologic Response Rates in Patients With Chronic HCV GT1, 2 or 3 Infection Following 16 Weeks of MK-3682/Grazoprevir/Ruzasvir Plus Ribavirin After Having Failed 8 Weeks of a Triplet Drug Regimen (Part C of C-CREST-1 & 2) (Poster presentation, Abstract THU-264, 8:00 a.m. – 6:00 p.m. CEST)
Saturday, April 22
  • Safety and Efficacy of the Fixed-Dose Combination Regimen of MK-3682/Grazoprevir/Ruzasvir in Cirrhotic or Non-Cirrhotic Patients With Chronic HCV GT1 Infection who Previously Failed a Direct-Acting Antiviral Regimen (C-SURGE) (Oral presentation, Abstract PS-159, 9:30 a.m. – 9:45 a.m. CEST)
For more information, including a complete list of abstract titles at the meeting, please visit: http://ilc-congress.eu/.

Tuesday, April 4, 2017

High Drug Prices Remain a Conundrum, Analysts Say


High Drug Prices Remain a Conundrum, Analysts Say

Possible solutions: government price negotiation, bundled payments
by Joyce Frieden
News Editor, MedPage Today

WASHINGTON -- The problem of high prescription drug costs has no easy solution, analysts said Tuesday at an event here sponsored by Johns Hopkins University.

"It's a major problem ... and there's no light at end of tunnel," said Joshua Sharfstein, MD, associate dean for practice and training at Johns Hopkins University's Bloomberg School of Public Health in Baltimore.

Overall drug costs are growing 10%-12% a year, "far quicker than wages or medical cost growth," he added. "And it inhibits our ability to address public health problems. When we have a challenge like hepatitis C, when people can't get treatment because of the [high cost], we're all at risk."

Although many ideas for solving the problem are being discussed, none are moving forward, Sharfstein said. He noted that things could get worse if, for example, Congress were to pass something like the House Republicans' American Health Care Act, which would have resulted in the loss of health insurance for an estimated 24 million people.
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HBV Reactivation During DAA Treatment of Chronic Hepatitis C: A Hidden Danger of an Otherwise Major Success Story

Hepatology
Reactivation of hepatitis B is an infrequent but not rare complication of DAA therapy in HBV/HCV coinfected patients.  The availability of curative treatments for hepatitis C has placed increased emphasis on diagnosing and treating this condition.   This is an apt time, however, to also remind ourselves of the importance of screening all HCV infected patients for HBV.   As with immunosuppressive drug therapy, HBV screening and early treatment  are the key elements in preventing HBVr during DAA therapy.
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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. The above link was tweeted on 4/4/17