HCV New Drugs

Tuesday, August 4, 2015

August Newsletter: This issue of Liver Lowdown is all about Research!

Just In
The August edition of "Liver Lowdown," a monthly newsletter published by "The American Liver Foundation" is now available for your viewing pleasure.

August - Index Of Hepatitis Newsletters
To read additional newsletters published this month, (the index is updated as newsletters are released) please click here.

Liver Lowdown is the monthly general interest e-newsletter of the American Liver Foundation.

In accordance with the Foundation’s mission, the e-newsletter is disseminated to provide information about the prevention, treatment and cure of liver disease, as well as the organization’s research and advocacy endeavors.

Liver Lowdown content includes updates about the Foundation’s educational and signature programs; an in-depth focus on specific types of liver disease, and profiles of liver patients’ and caregivers’ personal experiences.

FEATURE
The American Liver Foundation is pleased to announce its 2015 research award winners. These awards provide critical support to outstanding scientists early in their careers, promoting a new generation of liver disease researchers.

This year’s 11 award winners will join over 800 scientists and physicians who have pursued careers in liver disease research and treatment as a result of receiving these early-career grants. The program has provided over $25 million in research funding since 1979.

“ALF is delighted by the range and depth of applications that we received,” said Tom Nealon III, Esq, Chief Executive Officer and National Board Chair of ALF. The 2015 awardees are studying diverse liver diseases, including biliary and liver fibrosis, cholangiocarcinoma, hepatocellular carcinoma, hepatitis, and nonalcoholic steatohepatitis.”

Irwin M. Arias, MD, a Triple Emeritus: Professor of Medicine (Albert Einstein College of Medicine) Physiology (Tufts) and National Institutes, called ALF’s support for new researchers critical. “We continue to need bright young people who will further advance liver research, broaden our understanding of liver biology and make new discoveries that will lead to better diagnostics and treatments,” he said. Dr. Arias, through his work with the American Association for the Study of Liver Disease (AASLD), helped found the American Liver Foundation in 1976. He served for many years on the ALF National Board as well its New England Chapter Board.

The American Liver Foundaton’s research program is funded through the generous donations of individuals who want to eradicate liver disease. Awards recipients were selected by a committee of experts in the field of hepatology, co-chaired by Rohit Loomba, MD, MHSc and Jasmohan Bajaj, MD. You can find a list of our 2015 award winners and their projects here . See how we they changing the future.

July/August 2015 edition

Welcome to the July/August 2015 edition of the Liver Lowdown. Click on the links below and check out our featured stories for the month!

FEATURE- RESEARCH AWARD WINNERS
This issue of Liver Lowdown is all about Research! Learn more about ALF's 2015 research award recipients, and make sure you scroll down for highlights from the 2015 International Liver Congress, and an update on one of our 2014 Post-Doctoral Fellowship recipients.
READ MORE

INTERNATIONAL LIVER CONFERENCE HIGHLIGHTS- VIRAL HEPATITIS
News about hepatitis C is changing at a rapid pace. There are many treatments being investigated and more calls to action about testing.
READ MORE

INTERNATIONAL LIVER CONFERENCE HIGHLIGHTS- NAFLD/NASH
The emerging public health challenge of non-alcoholic fatty liver disease (NAFLD) was a hot topic at the meeting.

INTERNATIONAL LIVER CONFERENCE HIGHLIGHTS- PBC
In 2014, the American Liver Foundation provided funding to 11 early-career scientists from some of the nation’s leading academic institutions who are making the study of liver disease their life’s work. Read about grantee Zenobia Cofer, PhD.

RESEARCH
In 2014, the American Liver Foundation provided funding to 11 early-career scientists from some of the nation’s leading academic institutions who are making the study of liver disease their life’s work. Read about grantee Zenobia Cofer, PhD.

IN THE NEWS
ALF continues to make news around the country. Liver Life Walks and Flavors events, as well as education about topics such as fatty liver disease and the impact of alcohol on the liver are just a few.

CALENDAR OF EVENTS
ALF hosts a number of events throughout the year to support liver disease awareness. Check our events calendar and find one to participate in, including Liver Life Walks, Challenges and Flavors events in August and September.
READ MORE

View all newsletters

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Check Us Out On Twitter and Facebook

As mentioned in a previous post, a few websites publish their newsletters in the second or third week of the month, check back or watch Twitter and Facebook for updates.

Always

Tina

Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infection in the United States

In Case You Missed It

Medicine and Public Issues | 4 August 2015

Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infection in the United States
Soumitri Barua; Robert Greenwald, JD; Jason Grebely, PhD; Gregory J. Dore, MBBS, PhD; Tracy Swan; and Lynn E. Taylor, MD

[+] Article, Author, and Disclosure Information

This article was published online first at www.annals.org on 30 June 2015.

Discussion Only

Considerable heterogeneity is present in Medicaid reimbursement criteria for sofosbuvir across the United States. Restrictions based on liver disease severity are common, with three quarters of states restricting sofosbuvir to persons with advanced fibrosis (F3) or cirrhosis (F4). One quarter of states require that persons living with HIV receive ART or have suppressed HIV RNA levels, whereas two thirds restrict sofosbuvir on the basis of prescriber type. Drug or alcohol use is included in the eligibility criteria of 88% of state Medicaid committees, with half requiring a period of abstinence and two thirds requiring urine drug screening. The restrictions are not consistent with the FDA-approved labeling for sofosbuvir or evidence-based recommendations and should be reconsidered (23).

Most states restrict sofosbuvir reimbursement to persons with advanced fibrosis (F3) or cirrhosis (F4), which is inconsistent with recent AASLD/IDSA recommendations (20). These recommendations state that HCV treatment is indicated for all patients with chronic HCV (regardless of disease stage) because HCV therapy is curative; improves quality of life; slows liver disease progression; and reduces the risk for cirrhosis, end-stage liver disease, HCC, and all-cause mortality (21). The recommendations state that patients at highest priority for immediate treatment include those with advanced fibrosis (F3) or compensated cirrhosis (F4) because of the higher risk for severe complications (for example, hepatic decompensation or HCC). Patients with fibrosis (F2) are listed in the next priority group for treatment because of their high risk for complications (21). However, most states do not include persons with fibrosis (F2) in their Medicaid reimbursement criteria. Note that persons with advanced fibrosis remain at risk for HCC even after achieving sustained virologic response (SVR) and must have long-term surveillance (24). In contrast, once HCV is cured in persons with mild to moderate liver disease, liver disease progression is rare. Requiring liver biopsy may pose the highest risk for death in HCV care with all-oral regimens.

The requirement that HIV-infected persons receive ART or have suppressed HIV RNA levels is also inconsistent with AASLD/IDSA recommendations indicating that persons co-infected with HIV and HCV are also at high priority for treatment because of their high risk for complications (21). HIV accelerates the HCV disease course, with faster progression to cirrhosis, liver failure, and increased HCV-related mortality (25–27). The safety and efficacy of sofosbuvir-based, interferon-free combination therapy for co-infected persons are similar to those among patients with HCV monoinfection (21, 28–29). Reasons are varied about why co-infected persons may not receive ART (for example, normal CD4+ T-cell counts and low HIV RNA levels) or have suppressed HIV RNA levels (for example, drug-resistant HIV). Physicians who treat such co-infected persons may prefer to commence and complete HCV treatment first, before ART initiation, because HCV therapy is brief; further, DAA therapy often limits which antiretrovirals can be used concomitantly because of drug–drug interactions.

Two thirds of states have restrictions based on physician type, which is inconsistent with current practice whereby internists, other primary care physicians, HIV physicians not trained as infectious diseases specialists, nurse practitioners, and physician assistants treat HCV with pegylated interferon and ribavirin. The availability of sofosbuvir-based, interferon-free regimens simplifies therapy and reduces treatment-associated toxicities, which offers an opportunity for an expanded provider base for HCV treatment in patients without advanced cirrhosis (30).

The overwhelming majority of states restrict access to sofosbuvir for persons who inject drugs (PWID), those receiving treatment for drug dependency (for example, opioid substitution therapy), and those drinking alcohol. Most new and existing cases of HCV in the United States exist among current or former PWID (31). Since 2002, the National Institutes of Health HCV guidelines support HCV treatment regardless of injection drug use (32), and the AASLD/IDSA, European Association for the Study of the Liver, International Network on Hepatitis in Substance Users, and World Health Organization all advocate for inclusion of persons who use drugs in HCV treatment (21, 33–35). A growing body of evidence shows that there is no justification for systematically withholding HCV treatment from PWID (21, 33, 36). The SVR rates are similar in PWID with or without opiate replacement therapy (21, 33, 36–39). Drug use in the 6 months preceding HCV therapy initiation is not necessarily associated with poorer response to HCV therapy (40–42). Reported rates of reinfection after SVR among PWID are low—generally 1% to 5% per year, although concerns about reinfection rates in other subpopulations, such as surgeons, do not garner similar attention (33, 43). Rather than recommending the exclusion of PWID, AASLD/IDSA guidelines include PWID with earlier liver disease stages among a second-order priority group because of the prevention benefit of potential treatment; HCV treatment among PWID may decrease HCV transmission (21). In addition, evidence shows that HCV treatment of current and former PWID is cost-effective, particularly when the prevention benefits are considered (44). Further, Medicaid does not similarly deny medications for other diseases to persons who use or have used drugs or alcohol.

Alcohol misuse and HCV infection frequently coexist (45–48). Hepatitis C virus and alcohol act synergistically in causing more severe liver injury than seen with either disease alone (4, 48–49). Persons with coexisting alcohol disorders are at a higher risk for HCV-related complications (4, 48–49). Curing HCV is easier than curing alcohol disorders because pharmacotherapy for alcohol misuse is limited, and behavioral interventions are not always successful. The SVR rates are similar in drinkers and nondrinkers (49–50). Further, the AASLD/IDSA recommendations have no HCV treatment restrictions regarding alcohol use.

This study examined criteria in Medicaid fee-for-service programs only—not in Medicaid managed care organizations. Results therefore reflect a subset of overall state Medicaid reimbursement criteria for sofosbuvir rather than a comprehensive catalog of all restrictions in state Medicaid programs. Future research on reimbursement criteria in Medicaid managed care organizations will be important to develop a more thorough understanding of Medicaid enrollees' access to sofosbuvir.

Current restrictions may violate federal Medicaid law, which requires states to cover drugs consistent with their FDA labels. Under the federal Medicaid statute, virtually all drugs from pharmaceutical manufacturers that have rebate agreements with the Secretary of Health and Human Services (which includes the manufacturer of sofosbuvir) must be available under state Medicaid programs, with only limited methods of restricting coverage (19). None of the restrictions on sofosbuvir coverage detailed here seem to meet the criteria for permissible restrictions. Although the price of new therapies creates financial challenges for federal and state Medicaid budgets, decisions for prioritizing patients for more immediate therapy should be based on clinical criteria and medical evidence. It is recommended that the restrictions be removed; apart from potentially being a human rights violation, they do not make (economic) sense in terms of clinical, public, and long-term health. In setting restrictions as a concession to economic constraints, the significant longer-term public health and economic benefits of curing HCV should be considered and weighed against the upfront treatment costs.

Concerns include that full coverage for HCV treatment could, in the short term, mean less coverage for other conditions. It is unrealistic, however, to expect that all potential candidates will immediately seek HCV treatment. One example of this is Massachusetts. Despite relatively unrestricted sofosbuvir access in its Medicaid fee-for-service program, recent data indicate that only 14% of Massachusetts Medicaid enrollees known to be diagnosed with HCV are engaged in treatment (51).

Transparent, easily accessible, consistent, and evidence-based Medicaid criteria will permit greater and more equitable access to DAAs. As the HCV standard of care changes over time, it will be inefficient and costly to have differing treatment access protocols in the 51 fee-for-service programs and many more Medicaid managed care plans, with all of them being revised over time. More consistency is needed across the system so that where a Medicaid patient lives does not dictate what treatment she or he receives. Although this study examined sofosbuvir in particular, the first FDA-approved DAA as part of an interferon-free regimen, Medicaid may be setting a precedent as new DAAs are approved. Medicaid policies should be responsive to changes in standards of care and new treatment developments. State Medicaid pharmacy and therapeutics committees (or their equivalent) are generally responsible for implementing these policy changes and should be expected to act as expeditiously as possible to ensure that significant clinical changes are addressed in state Medicaid programs. These data suggest that state Medicaid policies for access to new DAAs should be reviewed and revised in line with national clinical recommendations.

http://annals.org/article.aspx?articleid=2362306

HCV Drug Wars - So doctors want Congress to force drug prices down? “What we’re fighting is the greed”

So doctors want Congress to force drug prices down?

By Brian McNicoll
Physicians and others complain Harvoni and Solvadi – miracle drugs that appear to cure Hepatitis C in most cases – can cost up to $90,000 for a full cycle of treatment.

They say oncology drugs, which account for $80 billion per year in sales – no others reach even $50 billion – have gone up five-fold to 10-fold in the last 15 years. And some of the newest therapies run to $150,000 per year and could double in cost in coming years.

“What we’re fighting is the greed,” said Ayalew Tefferi, a hematologist at the Mayo Clinic in Rochester, Minn., and a cosigner of the op-ed. “The greed and the additional maneuvering that is being exercised after you’ve already recoupled what you’ve invested. There is no control, no regulation.”

Continue reading....

Related

August Updates

Reducing the cost of new hepatitis C drugs

An index of articles pointing the reader to the current controversy over the high price of new HCV drugs.

Aging will affect Medicare’s Hepatitis C mortality and cost

By Bruce S. Pyenson, Gabriela Dieguez, Ryan Cannon | 16 July 2015

Baby Boomers make up the majority of HCV-infected people in the U.S. The nature of HCV infection means that if patients are not treated prior to Medicare eligibility, the disease will progress in some patients and future Medicare expenditures may rise. The future cost of treating medical complications due to HCV infection poses a burden not yet fully understood.
This report was commissioned by AbbVie.
Download the PDF

HCV DRUG Wars - The Federal & State Medicaid Deceit, Lies & Scandal..... Compare Prices - HCV Drug Pricing vs New Cholesterol Drugs

(08/03/15)
-federal govt is holding patients hostage------"each & every year the federal govt spends domestically $21 billion on HIV through medicaid & medicare BUT NOTHING essentially for HEPATITIS C a disease epidemic that can be cured with 12 weeks tolerable therapy - IT'S POLITICS -

Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infection in the United States

The aim of this study was to systematically evaluate state Medicaid policies for the treatment of hepatitis C virus (HCV) infection with sofosbuvir in the United States.

Monday, August 3, 2015

Hepatitis C - Janssen starts a study to evaluate simeprevir and odalasvir on AL-335 pharmacokinetics

Medivir announces that Janssen has started a phase I study to evaluate the effect of simeprevir and odalasvir on AL-335 pharmacokinetics

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announces that Alios Biopharma Inc., part of the Janssen Pharmaceutical Companies (Janssen) has started a phase I clinical trial to evaluate the potential effect of simeprevir and odalasvir (also known as ACH-3102), on the pharmacokinetics of AL-335 in healthy volunteers.

This phase I study is an open-label, two-group study of simeprevir, odalasvir, a hepatitis C virus (HCV) NS5A inhibitor, and of AL-335, a nucleotide-based HCV polymerase inhibitor. The primary objective of the study is to investigate the potential effect of simeprevir and odalasvir on the pharmacokinetics of AL-335 when administered in combination to healthy volunteers.

Approximately 150 million people are chronically infected with HCV globally*. When left untreated, HCV causes progressive liver disease in many of those who are chronically infected, and this can lead ultimately to cirrhosis, hepatocellular carcinoma and a requirement for liver transplantation. However, combinations of antiviral agents, including e.g. a protease inhibitor such as simeprevir, have shown the potential to be curative and convenient regimens for patients infected with HCV.

Further information about the study can be found at www.clinicaltrials.gov

For further information, please contact:
Ola Burmark, CFO Medivir AB, mobile: +46 (0)725-480 580.

Medivir is required under the Securities Markets Act to make the information in this press release public.
The information was submitted for publication at 8.30 CET on 3 August 2015.

About Simeprevir (OLYSIO®)
Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen Sciences Ireland UC and Medivir AB and indicated for the treatment of chronic hepatitis C infection as a component of a combination antiviral treatment regimen. Simeprevir efficacy has been established in HCV genotype 1 and HCV genotype 4 infected patients with compensated liver disease, including cirrhosis. Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB retains marketing rights for simeprevir in these countries under the marketing authorization held by Janssen-Cilag International NV. In November 2013, simeprevir was approved by the U.S. Food & Drug Administration and, in May 2014, it was granted marketing authorisation by the European Commission. Subsequent marketing authorisations have followed in several other countries around the world. Indications vary by market.

About Medivir
Medivir is a research based pharmaceutical company with a research focus on infectious diseases and oncology. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical need. Our commercial organization provides a growing portfolio of specialty care pharmaceuticals on the Nordic market. Medivir is listed on the Nasdaq Stockholm Mid Cap List.

*http://www.who.int/mediacentre/factsheets/fs164/en/

Sunday, August 2, 2015

August Newsletters: The Cure for Gilead, New drugs, Genotypes, Plus Hepatitis C and Nonalcoholic Fatty Liver Disease

August Newsletters: The Cure for Gilead, New drugs, Genotypes, Plus Hepatitis C and Nonalcoholic Fatty Liver Disease

Welcome to this months index of August "Newsletters" with a few updates from around the Web and today's news.

**All newsletters published page updated Aug 7

Remember that some websites publish their newsletters in the second or third week of the month, in this case updates will be added to this post as they become available with a reminder on both Twitter and Facebook.

Today's News
Big federal funding for vets' hep C treatments sneaked into highway bill

Doylestown researchers close in on hepatitis B treatment

Hepatitis C - Janssen starts a study to evaluate simeprevir and odalasvir on AL-335 pharmacokinetics

Doctor diagnosed with Hepatitis C mortgages home to pay for drugs

Pricing, Negotiations Should Be Open to Scrutiny

Olysio/Sovaldi combo yields high SVR in HCV with advanced cirrhosis

Efficacy and Safety of Daclatasvir for Chronic HCV

Improved long-term outcomes of liver transplantation in patients with HIV

We begin with an in-depth article on the steep price of Gilead's Sofosbuvir, and the insurers who are denying coverage to patients in dire need of treatment, published online at "The Blog" over at HuffPost Business.

The Cure for Gilead
Jeffrey Sachs

The bottom line must be access. Gilead's patent rights must not be construed as the right to leave millions to suffer or die from a disease for which a low-cost cure exists. By abusing patents in that way, Gilead and the US political system in recent years have turned the proper use of patents -- as an important tool to incentivize R&D -- into a veritable license to kill, which must never become acceptable in a sane society.

Continue reading....

Of Interest
Aging will affect Medicare’s Hepatitis C mortality and cost

By Bruce S. Pyenson, Gabriela Dieguez, Ryan Cannon | 16 July 2015

At the end of July the FDA approved two new drugs for hepatitis C, one for genotype 3 and the other for genotype 4. Provided in this post is the lowdown on both drugs with a few informational links and a video by Dr. Joseph Galati offering us a quick review of Daklinza "daclatasvir."

Genotype 4 - Technivie

Summary from "Medscape" article:

The first drug combination is AbbVie's Technivie/ombitasvir, paritaprevir, and ritonavir for use with ribavirin in adults with HCV genotype 4.

The safety and efficacy of Technivie with ribavirin were evaluated in 135 adults with chronic HCV genotype 4 infections without cirrhosis in the PEARL-I clinical trial.

SVR rates for Technivie with and without ribavirin
Out of 135 participants - 91 received Technivie with ribavirin once daily for 12 weeks and 44 received Technivie once daily without ribavirin for 12 weeks.

SVR rates for Technivie with ribavirin
All patients who received Technivie with ribavirin achieved sustained virologic response at 12 weeks (SVR12)

SVR rates for Technivie with out ribavirin
91% of those who received Technivie without ribavirin achieved sustained virologic response at 12 weeks (SVR12)

Common side effects with Technivie plus ribavirin include fatigue, asthenia, nausea, insomnia, pruritus, and other skin reactions.

More from "Medscape"
Elevations of liver enzymes to greater than five times the upper limit of normal occurred in approximately 1% of study patients, according to the FDA. This occurred more often in women taking contraceptives containing ethinyl estradiol. Contraceptives containing ethinyl estradiol must be discontinued prior to starting Technivie, the FDA says. They recommend that liver enzyme testing be performed during the first 4 weeks of starting treatment, and as clinically indicated thereafter.

The three drugs included in Technivie are also included in Viekira Pak (AbbVie), previously approved for the treatment of HCV genotype 1 infection.

Reference
PEARL-I: In the phase 2b PEARL-I study, investigators examined the efficacy of a 12-week course of ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in patients with chronic HCV genotype 4 infection; the study enrolled treatment-naive and treatmentexperienced patients, but excluded patients with cirrhosis. Note the regimen used in this trial did not include dasabuvir, because dasabuvir does not have activity against genotype 4 HCV. For the 86 treatment-naive patients, SVR12 was achieved in 40 (91%) of 44 patients who received ombitasvir plus paritaprevir-ritonavir without ribavirin and in 42 (100%) of 42 that received ombitasvir plus paritaprevir plus ritonavir with ribavirin. This study, showed an excellent treatment response with a 24-week regimen of ombitasvir plus paritaprevir plus ritonavir for genotype 4 infection, particularly if ribavirin is added to the regimen.
Source - Hepatitis C Online

Genotype 3 - Daklinza "Daclatasvir"
The other drug is Daklinza "daclatasvir" from Bristol-Myers Squibb, used with Gilead's sofosbuvir "Sovaldi" without ribavirin for HCV Genotype 3 infection.

According to Medscape's article;
In the clinical trial deemed ALLY-3 the safety and efficacy of daclatasvir 60 mg plus with sofosbuvir 400 mg once daily for 12 weeks were evaluated in 152 treatment-naive and treatment-experienced adults with chronic HCV genotype 3 infection. They were monitored for 24 weeks post treatment.

SVR rates for Daklinza in treatment-naive patients and treatment-experienced with and without cirrhosis

Treatment-naive - no cirrhosis
SVR12 was achieved in 98% of the treatment-naive patients with no cirrhosis of the liver

Treatment-naive - with cirrhosis
SVR12 was achieved in 58% of the treatment-naive patients with cirrhosis.

Treatment-experienced - no cirrhosis
In the treatment-experienced group, SVR12 was achieved in 92% of patients with no cirrhosis

Treatment-experienced - with cirrhosis
In the treatment-experienced group, SVR12 was achieved in 69% of patients with cirrhosis

Daclatasvir carries a warning that symptomatic bradycardia and cases requiring pacemaker intervention have been reported when amiodarone is given with sofosbuvir in combination with another HCV direct-acting antiviral, including daclatasvir. "Co-administration of amiodarone with Daklinza in combination with sofosbuvir is not recommended," the FDA advises.

Reference
ALLY-3
In this parallel-arm phase 3 trial, investigators assigned 101 treatment-naive genotype 3 patients and 51 treatment-experienced genotype 3 patients to a 12-week all-oral regimen of daclatasvir 60 mg once daily and sofosbuvir 400 mg once daily. Cirrhotic patients comprised 19% and 25% of these groups respectively. An SVR12 was achieved in 90% of treatment-naive and 86% of treatment-experienced GT 3 patients, with viral relapse responsible for nearly all the treatment failures. The presence of cirrhosis was associated with a lower SVR12 rate at 63% overall, regardless of treatment experience. This combination was generally safe and well tolerated with the most frequent adverse events being headache, fatigue and nausea.
Source - Hepatitis C Online

Links

Daklinza and TECHNIVIE
Package insert, dosage, warnings, drug interactions, side effects, news and research
Daklinza
TECHNIVIE.

Great summary of the two new approved drugs by Lucinda Porter
FDA Approves New Hepatitis C Medications to Treat Genotypes 3 and 4

To check out more information on all genotypes, click here.

Daclatasvir Approved for Genotype 3 Hepatitis C

Short patient video covering Daclatasvir, published a few days ago by Joe Galati, M.D.

Worth A Click
Video
Genotype in Hepatitis C Determines Treatment Course/Genotype 1 is Common with Increasingly Effective Treatment

Other News

FDA Acceptance of NDA for Merck's Grazoprevir/Elbasvir Treatment of Hepatitis C Genotypes 1, 4 and 6 Infection

Daclatasvir/Sofosbuvir Effective in HCV Patients with HIV, Cirrhosis

Kenneth E. Sherman, MD, PhD, of the University of Cincinnati College of Medicine, and colleagues investigated Sovaldi (sofosbuvir, Gilead Sciences) 400 mg and Daklinza (daclatasvir, Bristol Myers Squibb) 60 mg (which was dose adjusted for concomitant combination antiretroviral therapy [cART]: 30 mg with ritonavir-boosted protease inhibitors, 90 mg with non-nucleoside reverse transcriptase inhibitors except rilpivirine [Edurant, Janssen Therapeutics]) in patients coinfected with HIV/HCV coinfection.

Heather McCormack addressing the cycle that leads to high rates of viral hepatitis infection in Indigenous Australians and sharing materials to support them

Whats new around the Web?

Cases 1-10 Now Ready For Viewing
"ViralEd" has recently completed their launch of "HCV Virtual Patient."

The program is an easy to follow video CME with a look at different case scenarios. This activity is a helpful starting point for people who failed treatment, have cirrhosis or want to learn more about current treatment options for various HCV genotypes. This program is amazing folks, enjoy the follow-up questions.

After each detailed case is discussed a list of multiple choice questions will appear, in order to move forward the question must be answered correctly, if you don't know the answer click on the "curbside consult" button located in the bottom corner of the presentation. Instructions will be explained after launching the program.

Although this learning activity is clinical in nature and directed at physicians, patients will most certainly find the program beneficial, here is a screen shot of each case.

Begin here....

New at Healio: HCV Next

"HCV Next" offers information on a range of topics, which include diagnosis, new combination therapies, side effects, drug/drug interaction, guidelines, fatty liver disease and more.

Click here to read the following articles which appeared in the July 2015 print edition of "HCV Next" published online at "Healio."

Clinical Liver Disease (CLD)
Clinical Liver Disease (CLD) is the latest online learning resource of AASLD. Clinical in focus, CLD blends text, audio, video, webinars, and other interactive content into educational interventions launched every other month. These interventions are designed for any physician or health care provider caring for a patient with liver disease.

Special Issue: The Future in Liver Medicine & Palliative Care

Clinical Liver Disease
July 2015 Volume 6 , Issue 1 Pages 1–26

A Few Topics

Liver fibrosis: Therapeutic armory 40 years on (pages 1–4)

Histologic and noninvasive estimates of liver fibrosis (pages 5–8)

August Newsletters

HCV Advocate
The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education.

August Issue
A Brief Overview: Outbreaks of Acute HCV Infections in the U. S.
Alan Franciscus, Editor-in-Chief
In this review, I will discuss the outbreaks of acute infections of hepatitis C across the United States in urban and rural centers and why the numbers are (again) under reported.
Read more...

HealthWise: Hepatitis C and Nonalcoholic Fatty Liver Disease
Lucinda K. Porter, RN
Hepatitis C increases the risk of nonalcoholic fatty liver disease (NAFLD), a metabolic disease that generally occurs in overweight patients. You can do something about NAFLD, and this article suggests how.

Read more...

Alan Franciscus, Editor-in-Chief
Read about how treatment with Harvoni improves patient-reported outcomes, how HCV works to escape the immune system and become a chronic infection, and a new test to tell the difference between acute and chronic infection.

Read more...

FDA Safety Alert
The Food and Drug Administration (FDA) has issued a communication strengthening an existing warning label that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke.

Read more...

HCV and Depression
Alan Franciscus, Editor-in-Chief
There does seem to be a pretty strong link between HCV and Depression. Add on to that just having a chronic disease, such as hepatitis C, the difficulty of being approved for the new medications, being a baby boomer—and it is not surprising that many people with hepatitis C are depressed.

Read more...

Medicare at Age 65

Jacques Chambers, CLU
Unlike those on SSD who are enrolled automatically in Parts A & B of Medicare, people turning age 65 must actively choose whether or not to enroll in Medicare in addition to deciding which parts are appropriate for them. As well you must enroll in Medicare at the appropriate times or penalty surcharges can be added to the premiums, and they will last as long as you are on Medicare.

Read more...

Alan Franciscus, Editor-in-Chief

This month’s column discusses hepatitis C interferon-free regimes in the elderly, and hepatitis B virus reactivation during successful treatment of hepatitis C virus with sofosbuvir and simeprevir. Read more...

HCSP Events
Alan Franciscus, Editor-in-Chief
Check out what's coming to your neighborhood soon!

Connect With HCV Advocate

HepCBC Hepatitis C Education and Prevention Society

HepCBC’s MONTHLY NEWSLETTER
The hepc.bull, has been “Canada’s hepatitis C journal” since the late 1990′s and has been published nonstop since 2001. The monthly newsletter contains the latest research results, government policy changes, activities and campaigns you can get involved in, articles by patients and caregivers, and a list of support groups plus other useful links.

August HepC Bull Newsletter
hepc.bull -- 08 2015

Topics

WHD Events - Lighting up the BC Leg!

Presenting to HIV/AIDS - Legal experts Transit Ads

HepCBC Staff Changes

Letters to/from Fed. Health Minister Public Tests

Honour Roll Conferences

Treatment

Manifesto Care Programs

Compensation

View All Newsletters, Here

Stay Connected

Welcome to the July/August 2015 edition of the Liver Lowdown. Click on the links below and check out our featured stories for the month!

INTERNATIONAL LIVER CONFERENCE HIGHLIGHTS- NAFLD/NASH
The emerging public health challenge of non-alcoholic fatty liver disease (NAFLD) was a hot topic at the meeting.

To receive the newsletter when it's "hot off the press" please join our email list.

Check Us Out On Twitter and Facebook

Caring Ambassadors

The primary goal of the Caring Ambassadors Program is to help individuals with challenging health conditions to become ambassadors for their own health. We are here to help you—that is now and always will be our singular focus.

Monthly Pubmed Review of the most relevant research on HCV

Download: Literature Review Updates

Check back for July review.

Index

CLINICAL TRIALS, COHORT STUDIES, PILOT STUDIES
BASIC AND APPLIED SCIENCE, PRE-CLINICAL STUDIES
HIV/HCV COINFECTION
COMPLEMENTARY AND ALTERNATIVE MEDICINE
EPIDEMIOLOGY, DIAGNOSTICS, AND MISCELLANEOUS WORKS
LIVER CANCER

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Weekly News
Weekly news updates are currently posted on the Internet site and sent out via e-blast to provide up-to-date information on what has been covered in the news regarding hepatitis C in the previous week. Topics include all stories related to hepatitis C as well as personal stories and events.

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GI & Hepatology News
GI & Hepatology News is the official newspaper of the AGA Institute and provides the gastroenterologist with timely and relevant news and commentary about clinical developments and about the impact of health-care policy. The newspaper is led by an internationally renowned board of editors.

GI & Hepatology Newsletter

Download - August 2015 issue.

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Read breaking news stories now: visit the GI & Hepatology News website.

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

August 2015 Hep Free NYC Newsletter

Provider Guidance | Alcohol Screening and Counseling for Patients with Hepatitis. NYC Health Dept.

Tips for Patients | Alcohol and Hepatitis: Create an Action Plan (English & Spanish). NYC Health Dept.

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News
Today's Heroin Epidemic. CDC Vital Signs. Between 2002 and 2013, the rate of heroin-related overdose deaths nearly quadrupled, and more than 8,200 people died in 2013.

Addressing the Opioid Epidemic in the United States. NASTAD Blog. NASTAD has released a Statement of Urgency: Addressing the Opioid Epidemic in the United States. The Statement calls on the Nation for an immediate, comprehensive, effective and science-based approach to address the prevention, care and treatment needs of individuals at risk for or living with substance use disorders.

Obituaries Shed Euphemisms to Chronicle Toll of Heroin. NY Times. A group calledUNITE to Face Addiction, a coalition of advocacy groups, is planning a rally in Washington on Oct. 4, called “the day the silence ends.” The goal is to raise awareness about addiction being “treatable and preventable” for the estimated 22 million Americans in its grip.

Pregnancy Is the Best Time for Some Vaccines. NY Times. Article mentions Hep B vaccination during pregnancy.

FDA approves DAKLINZA in combination with Sofosbuvir for HCV genotype 3 infection.

NYC Council allocated funding to Hepatitis B & C Services in FY2016. Designations have yet to be named. In FY2015 NYC Council funded hepatitis B & C patient navigation services and clinical provider capacity building through the Check Hep B, Check Hep C, IDUHA Hep C Peer Navgation, and Empire Liver Foundation initiatives.

Hep C: The Facts Booklet with New Treatment Information (NYC Health Dept)The Hep C: The Facts booklet has been updated to reflect the advancements in Hep C treatment made in the last few years. Find treatment comparisons and information on the stages of Hep , types of liver tests, and resources. Download the booklet in English or Spanish or order free of cost by calling 311. Download the Hep C …

Continue reading Hep C: The Facts Booklet with New Treatment Information (NYC Health Dept)→

Project INSPIRE: NYC Hep C Care Coordination Program
Project INSPIRE is a comprehensive Hepatitis C Care Coordination Program. The program is open to people diagnosed with hepatitis C who have Medicaid or Medicare. Patients enrolled in Project INSPIRE will receive expert patient navigation and clinical care coordination services to help go through the hepatitis C medical evaluation and treatment for hepatitis C with ease. …

Continue reading Project INSPIRE: NYC Hep C Care Coordination Program→

New Release | Hep B & C Mobile App
New Release! The NYC Health Dept’s free Liver Health app now offers both Hep C and Hep B information. The NYC Liver Health App includes: Hep B and C risk assessment Hep B and C self management checklist Alcohol screening Site locator providing testing and medical care sites Connection to online support and resources News alerts Download …

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Blogs

Karen Hoyt

Hepatitis C Advocate
Time to get Listed for a Liver Transplant
Karen Hoyt
(2015-07-29 05:55:50)
The liver transplant team looked at 3 different areas of my life. Physical, Psycho-social, and Financial. It's like a 3 legged stool. If one leg is weak, the other two can't hold up.

What to Expect after a Liver Transplant

Karen Hoyt

This is an email to a Best Friend who is waiting on their liver transplant. I thought you might like to read about what to expect after a liver transplant. As always, pardon any errors. I’m 3 months post and still a lil goofy.

My Hep C Travel Diary, Hepatitis C Advocate

Greg Jefferys
Hepatitis C Treatment: Two Weeks to Go

(2015-08-02 14:06:48)
Well only two weeks to go until the end of my treatment. I guess it is time for a review of the last ten weeks.

A pseudonym for a person living with hepatitis C on Viekira Pak + Ribavirin
Grace Campbell
Hepatitis C, social media and me

(2015-08-01 19:25:18)
If you are looking for wise and knowledgeable tweets about hep C, I'm sure someone else will deliver far more intelligent tweets than I ever could.

Why Baby Boomers Should Be Tested for Hep C

Dr. Andrew Pugliese

(2015-07-24 08:42:56)
My mother's story is one of maybe millions that were typical of their time. None of it was done maliciously, but out of pure naivety, because they just didn't know about the risks.

What's New in Hepatitis C Treatment
By Lucinda K. Porter, RN on July 20, 2015

I have worked in the hepatitis C field for about eighteen years. In 1997, there was one hepatitis C treatment - interferon. Eventually, ribavirin was approved, and until 2011, I only had to remember the brand names of these two medications. In short, hepatitis C treatment didn't change much.

Everyday Health - Hepatitis C

President of the Hepatitis C Association
Infected with the virus for more than 40 years, Susan Simon spent years looking for a hepatitis C cure.

How I Beat Hepatitis C After a Liver Transplant
By Beth W. Orenstein
Reviewed by Farrokh Sohrabi, MD

Unexpected Hepatitis C Diagnosis Tests required for the insurance change revealed Roncari had a hepatitis C...

Hepatitis C Counselor Fights the Virus and Wins

By Madeline R Vann, MPH
Reviewed by Farrokh Sohrabi, MD

Health worker Paul Bolter was already counseling adults with hepatitis C when he found out that he was infected.

My Life With Hepatitis C: Paula's Story

By Beth W. Orenstein
Reviewed by Farrokh Sohrabi, MD

Today, thanks to the medical and... hard to help both women and men with hepatitis C, and...

Growing up With Childhood Hepatitis

By Karen Appold
Reviewed by Pat F. Bass, III, MD, MPH
positive for the hepatitis C virus. "Because only a small percent of children gets hepatitis C from their...

Healthy You

Full Text
Increased risk of hepatocellular carcinoma in chronic HCV patients with new onset diabetes
31 July 2015
A study published ahead of print the Alimentary Pharmacology & Therapeutics reports an increased risk of hepatocellular carcinoma in chronic HCV patients with new onset diabetes.

Statins Improve SVR Rates, Lower Cirrhosis, HCC risk in HCV Therapy

Researchers from the University of Pittsburgh, including Adeel A. Butt, MD, MS, FIDSA, and colleagues from the VA Pittsburgh, Hamad Healthcare Quality Institute of Hamad Medical Corporation in Doha, Qatar, and Harvard Medical School, investigated the effect of statins on antiviral therapy for HCV by analyzing data of 7,248 eligible patients who received HCV therapy and had a follow-up of at least 24 months. Forty-six percent of all the patients reviewed received statin therapy.

Online symptom-checkers are often wrong
(Reuters Health) - Online symptom checkers often misdiagnose patients’ problems, often encouraging people to seek care for minor issues that don’t need immediate attention and other times incorrectly telling people with true emergencies that treatment can wait, a U.K. study suggests

Is there really a middle-class drinking 'epidemic' in over-50s?

"Middle-class over-50s have become a generation of problem drinkers," the Mail Online reports – a headline that actually has little basis in fact.

Q&A With Robert S. Brown Jr. From Weill Cornell Medical College: Alternative and Complementary Medicine In Treating Hepatitis C
MD Magazine TV

Stay well

Tina

Contact hcvnewdrugs@gmail.com

Helpful Links
HCV Education
Research Articles
Fibrosis
Cirrhosis
Liver Cancer
Liver Transplants
Fatty Liver Disease
HCV-elderly
Possible Side Effects Of HCV Therapy
Other Conditions Related To HCV
HCV Genotypes/treatment
HCV Newsletters
Premier Hepatitis C Websites

The above links offer data about interferon-free regimens approved to treat HCV, with learning activities, editorials, and tips from patient bloggers who understand the ups and downs of liver disease, in addition to a list of outstanding hepatitis C websites, blogs and support forums.

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

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"

Latest Update Feb 12, 2019

Lancet Study:

Direct-acting antivirals reduce risk of premature mortality and liver cancer for people with chronic hepatitis C

These findings firmly counter those of a Cochrane review of direct-acting antiviral treatment trials that could neither confirm nor reject if direct-acting antivirals had an effect on long-term HCV-related morbidity and mortality. They also provide the best evidence to date to support guidance documents that recommend direct-acting antiviral treatment for all patients with chronic HCV infection.

The Controversy
Rebuttal over Cochrane Review of DAAs
A systematic review published by the Cochrane Collaboration suggested achieving SVR (cure) for patients using hepatitis C direct-acting antivirals (DAAs) doesn't correlate with any long term benefits. View each rebuttal and all ongoing media coverage.

Risk Of Developing Liver Cancer After HCV Treatment

Tuesday, August 4, 2015

August Newsletter: This issue of Liver Lowdown is all about Research!

Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infection in the United States

HCV Drug Wars - So doctors want Congress to force drug prices down? “What we’re fighting is the greed”

Monday, August 3, 2015

Hepatitis C - Janssen starts a study to evaluate simeprevir and odalasvir on AL-335 pharmacokinetics

Sunday, August 2, 2015

August Newsletters: The Cure for Gilead, New drugs, Genotypes, Plus Hepatitis C and Nonalcoholic Fatty Liver Disease