Limited Generalizability of Registration Trials in Hepatitis C: A Nationwide Cohort Study

Limited Generalizability of Registration Trials in Hepatitis C: A Nationwide Cohort Study

Floor A. C. Berden, Robert J. de Knegt, Hans Blokzijl, Sjoerd D. Kuiken, Karel J. L. van Erpecum, Sophie B. Willemse, Jan den Hollander, Marit G. A. van Vonderen, Pieter Friederich, Bart van Hoek, Carin M. J. van Nieuwkerk, Joost P. H. Drenth , Wietske Kievit

PLOS Published: September 6, 2016 http://dx.doi.org/10.1371/journal.pone.0161821

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Abstract
Background
Approval of drugs in chronic hepatitis C is supported by registration trials. These trials might have limited generalizability through use of strict eligibility criteria. We compared effectiveness and safety of real world hepatitis C patients eligible and ineligible for registration trials.

Methods
We performed a nationwide, multicenter, retrospective cohort study of chronic hepatitis C patients treated in the real world. We applied a combined set of inclusion and exclusion criteria of registration trials to our cohort to determine eligibility. We compared effectiveness and safety in eligible vs. ineligible patients, and performed sensitivity analyses with strict criteria. Further, we used log binomial regression to assess relative risks of criteria on outcomes.

Results
In this cohort (n = 467) 47% of patients would have been ineligible for registration trials. Main exclusion criteria were related to hepatic decompensation and co-morbidity (cardiac disease, anemia, malignancy and neutropenia), and were associated with an increased risk for serious adverse events (RR 1.45–2.31). Ineligible patients developed significantly more serious adverse events than eligible patients (27% vs. 11%, p< 0.001). Effectiveness was decreased if strict criteria were used.

Conclusions
Nearly half of real world hepatitis C patients would have been excluded from registration trials, and these patients are at increased risk to develop serious adverse events. Hepatic decompensation and co-morbidity were important exclusion criteria, and were related to toxicity. Therefore, new drugs should also be studied in these patients, to genuinely assess benefits and risk of therapy in the real world population.

View Complete Research Article: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0161821

Letter to Gilead Sciences on attempts to remove generic sofosbuvir from Ukraine

Letter to Gilead Sciences on attempts to remove generic sofosbuvir from Ukraine
Mr. Gregg Alton
Executive Vice President
Corporate and Medical Affairs
Gilead Sciences Inc.
333 Lakeside Dr Foster City, CA 94404

Re: Gilead Sciences attempts to remove generic sofosbuvir from Ukraine

Dear Mr. Alton,

On behalf of Médecins Sans Frontières (MSF), I am writing to express our serious concerns and strong opposition to Gilead’s on-going efforts to remove the only existing source of generic sofosbuvir in Ukraine.

MSF is in the process of planning and beginning to deliver hepatitis C treatment to patients in Ukraine, a country suffering from the highest hepatitis C prevalence in the region - and which has one of the world’s highest rates of hepatitis C infection. The availability of multiple sources of new DAAs - and, in particular, sofosbuvir - is critical for treatment providers, including MSF, to manage a sustainable and affordable supply for medical operations.

With the continued reduction of API prices for sofosbuvir and other DAAs, treatment providers and countries can anticipate much lower prices from generic producers in the next few years. Availability of generic versions of DAAs is critical for reducing prices (and ensuring that such prices remain affordable) and increasing availability of hepatitis C treatment to all patients.

Multiple suppliers for DAAs and other medicines are also critical to avoid shortages and stock outs. In our experience, having only one registered supplier of an essential medicine per country can lead to shortages and stock outs, including recent shortages and stock-outs of critical medicines to treat HIV and AIDS.

There are no patent barriers to the introduction of more affordable generic versions of sofosbuvir in Ukraine. In fact, Gilead did not file for the primary patents on sofosbuvir in Ukraine, and weak secondary patents have not been granted in the country.

We are now concerned to learn that Gilead is attempting to remove the only existing source of generic sofosbuvir in Ukraine, by legally challenging the market authorization of the generic company, the distributor and multiple government agencies, pressuring them to withdraw the generic sofovbuvir from the market. The current attempt to remove the existing generic source of sofosbuvir could limit our ability to scale-up hepatitis C treatment in Ukraine. We consider that this attempt was initiated without consideration of the serious public health consequences.

Over the past two years, MSF has requested that Gilead revise its commercial strategies on many occasions. These strategies threaten sustainable access to hepatitis C treatment in a number of countries where MSF is treating patients. Our requests have included asking Gilead to revise the current voluntary license agreements with generic manufacturers to include high-burden middle-income countries including Ukraine, and to eliminate its restrictive anti-diversion DAA distribution programme.

Once again, MSF urges Gilead to drop the case in Ukraine, and reconsider its business strategy in high-burden middle-income countries, especially Ukraine since it has been excluded from relevant voluntary license agreements.

We look forward to upcoming discussions with company representatives.

Yours sincerely,
Rohit Malpani Director of Policy & Analysis Médecins Sans Frontières - Access Campaign

http://www.msfaccess.org/content/letter-gilead-sciences-attempts-remove-generic-sofosbuvir-ukraine

Cost-effectiveness of screening for hepatitis C virus: a systematic review of economic evaluations

Cost-effectiveness of screening for hepatitis C virus: a systematic review of economic evaluations
Stephanie Coward, Laura Leggett, Gilaad G Kaplan, Fiona Clement + Author Affiliations Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada

Received 8 March 2016
Revised 29 June 2016
Accepted 18 August 2016
Published 6 September 2016

Abstract
Objectives With the developments of near-cures for hepatitis C virus (HCV), who to screen has become a high-priority policy issue in many western countries. Cost-effectiveness of screening programmes should be one consideration when developing policy. The objective of this work is to synthesise the cost-effectiveness of HCV screening programmes.

Setting A systematic review was completed. 5 databases were searched until May 2016 (NHSEED, MEDLINE, the HTA Health Technology Assessment Database, EMBASE, EconLit).

Participants Any study reporting an economic evaluation (any type) of screening compared with opportunistic or no screening for HCV was included. Exclusion criteria were: (1) abstracts or commentaries, (2) economic evaluations of other interventions for HCV, including blood donors screening, diagnosis tests for HCV, screening for concurrent disease or medications for treatment.

Primary and secondary outcome measures Data extraction included type of model, target population, perspective, comparators, time horizon, discount rate, clinical inputs, cost inputs and outcome. Quality was evaluated using the Consolidated Health Economic Evaluation Reporting Standards checklist. Data are summarised using narrative synthesis by population.

Results 2305 abstracts were identified with 52 undergoing full-text review. 30 papers met inclusion criteria addressing 7 populations: drug users (n=6), high risk (n=5), pregnant (n=4), prison (n=3), birth cohort (n=8), general population (n=5) and other (n=6). The majority (77%) of the studies were high quality. Drug users, birth cohort and high-risk populations were associated with cost-effectiveness ratios of under £30 000 per quality-adjusted-life-year (QALY). The remaining populations were associated with cost-effectiveness ratios that exceeded £30 000 per QALY.

Conclusions Economic evidence for screening populations is robust. If a cost per QALY of £30 000 is considered reasonable value for money, then screening birth cohorts, drug users and high-risk populations are policy options that should be considered.

Discussion Only

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The studies performed regarding screening for HCV are generally of good quality and a robust body of evidence has developed. Generally, screening drug users, birth cohorts, high-risk populations and the general population appear to be good value for money if a cost per QALY of £30 000 is used as the threshold for reasonable value. The current evidence suggests screening programmes may not be good value for money in high-risk groups and pregnant women, although the evidence is heterogeneous focusing on a variety of populations and economic outcomes. Surprisingly, screening programmes for prisoners appears not to be good value for money. A variety of other screening programmes have been assessed in the literature targeting genito-urinary clinics, individuals who had minor or major surgery, patients presenting to the emergency room, recently deployed military, those with the history of gastroscopy and visitors to public STD clinics. None of these programmes appear to be good value for money.

                            

Recently, a study evaluating economic evaluations of hepatitis B and HCV evaluating screening and testing strategies was performed.41 The focus of our study was to assess the cost-effectiveness of only screening programmes. Further, our study was able to attain the most recent studies and also divided the studies based on population studied; this allows stakeholders to better evaluate the applicable studies based on population. Each of these populations is a unique group that have different challenges for screening programmes. Therefore, through summarising the studies by screened population, we are able to gain a better summary of the cost-effectiveness of these screening programmes and the variation seen within each group.

                            

Several variables affected the findings of the reported economic evaluations, in particular, the prevalence of asymptomatic HCV, the acceptability of screening and the acceptability of treatment. Of these, prevalence has the largest impact on the outcomes of the economic evaluations. In general, one would expect the cost-effectiveness of screening to be inversely correlated to prevalence; the higher the prevalence in the targeted group, the lower the cost per QALY as more cases would be identified per person screened. Our synthesis supports this finding with data that demonstrates screening populations with higher prevalence of HCV (ie, drug users) generally resulting in better value for money.

                            

However, there is little information about how prevalence, the acceptability of screening and the acceptability of treatment may drive the required implementation plans.

The expected budget impact remains unknown and would be substantially impacted by the proposed implementation plan. A thorough budget impact analysis, particularly for the large birth cohort and general population screening programmes where the overall cost may be large, must be completed.

Limitations

While this systematic review includes robust studies with good quality, several limitations should be considered. The systematic review is limited by the available data in the literature. The results may not be generalisable to all jurisdictions; for example, only one cost-utility analysis has been conducted in Canada and this study only evaluated a birth cohort. Cost analyses differed by time periods that would not have accounted for all currently available drugs such as simeprevir and sofosibvir. Further, none of the studies addressed the implementation of a screening programme and the costs associated with it, which is paramount in choosing the appropriate screening programme.

Conclusion

Screening birth cohorts, drug users and high-risk populations would be good value for money, and should be evaluated as a possibility for implementation. Further evaluations need to be performed regarding the best methods for implementation, with subsequent budget impact analysis.

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Experts calling for removal of restrictions preventing people who use drugs from accessing new hepatitis C cures.

New research supports hep C treatment for people who use drugs

No treatment, No elimination says INHSU

International Network for Hepatitis C in Substance Users

Global health experts are today are calling for the removal of restrictions preventing people who use drugs from accessing new hepatitis C cures. So long as these restrictions exist, the goal of disease elimination will remain out of reach, they say.

They are gathered in Oslo for the 5th International Symposium on Hepatitis Care in Substance Users, where new research continues to highlight not just the pivotal role treatment for people who use drugs plays in reducing hepatitis C transmission, but also how it can be rolled out to achieve best results.

"The science is clear. We now need to focus on overcoming barriers to access, and harness latest research to implement programs that work," said President of the International Network of Hepatitis C in Substance Users (INHSU), Associate Professor Jason Grebely, the Kirby Institute, UNSW Australia.

"To delay further is unethical and undermines public health," he added.

Hepatitis C - which if left untreated can lead to cirrhosis and liver cancer - affects approximately 64-103 million people around the world, resulting in around 700 000 deaths per year. In countries such as the US and Australia, hepatitis C now kills more people than HIV. In the UK, the number of annual deaths due to hepatitis C has quadrupled since 1996.

New, highly effective curative treatments have sparked hope of a world free of hepatitis C. The World Health Organisation (WHO) has set ambitious elimination targets of 90% diagnosed, 80% treated and a 65% reduction in hepatitis C-related mortality by 2030. In most high income countries, the vast majority (80%) of new infections are in people who inject drugs, but this group has faced widespread exclusion from the new therapies.

Reasons given for this exclusion include the price of new medications, fears of poor adherence, fears of reinfection and concerns over efficacy. However, international research debunks these myths.

The world's largest study of new hepatitis c curative therapies - the C-EDGE CO-STAR Clinical Trial - has now found that illicit drug use prior to and during hepatitis C therapy had no impact on the effectiveness of the therapy, and that reinfection is low, at 4%. The results also showed excellent treatment adherence. Cure rates were comparable to results in hepatitis C populations that exclude people who use drugs.

Further, mathematical modelling suggests that even moderate levels of treatment uptake in people who use drugs could offer considerable prevention benefits.

One study looking at settings in Scotland, Australia and Canada indicated a 3-5 fold increase in treatment uptake among people who inject drugs could halve hepatitis C prevalence in 15 years.

Other studies modelled on people who inject drugs in the UK and France concluded realistic treatment scale-up could achieve 15-50% reduction in chronic hepatitis C prevalence in a decade.

To add to the benefits, treating people who use drugs with moderate or mild hepatitis C with new therapies is cost-effective in most settings compared to delaying until cirrhosis.

Several countries have introduced hepatitis C elimination programs, with Australia, France and Iceland offering unrestricted access. All eyes are now turned on Australia, where over 20 000 people (10% of the chronic HCV population) have initiated treatment in the first four months since subsidised treatment has become available.

"Countries such as Australia and France have taken the lead in adopting evidence-based policies that will save lives. Now it's time for other countries, including the US and Norway, to follow their lead and allow all patients with chronic hepatitis C to be treated with the new drugs," said Professor Olav Dalgard, Chair of the INSHU 2016 Symposium.

"We strongly recommend that all restrictions on access to new hepatitis C treatments based on drug or alcohol use or opioid substitution treatment be removed. There is no good ethical or health based evidence for such discriminations. Nor do the restrictions make clinical, public health or health economic sense," he said.

"Providing treatment to people who inject drugs, integrated with harm reduction programs and linkage to care, is the key to hepatitis C program success. And our experience in Copenhagen shows this can work. Such efforts need to be initiated and scaled up globally," added Professor Jeffrey Lazarus, Centre for Health and Infectious Disease Research, Rigshospitalet, University of Copenhagen, Denmark, who is presenting at the Symposium.

ABOUT THE INTERNATIONAL SYMPOSIUM ON HEPATITIS CARE IN SUBSTANCE USERS

This symposium is the leading International conference focused on the management of hepatitis among substance users. It is organized by the International Network for Hepatitis in Substance Users (INHSU). The symposium is held biennially and was first held in Zurich, Switzerland, in 2009, Brussels, Belgium, in 2011, Munich, Germany, in 2013 and Sydney, Australia, in 2015.

DEBUNKING THE MYTHS: Why treatment works

Adherence and Efficacy: Emerging data suggests that people who use drugs and people receiving opioid substitution therapy have high rates of adherence and response to new hepatitis C curative treatments (interferon-free DAA HCV therapy) - comparable to people without a history of drug use.

Reinfection: While HCV reinfection can occur, data suggests that the rate of reinfection among people who inject drugs is low and should not be a reason for withholding hepatitis C therapy. The expansion of programs for enhancing drug user health (including opioid substitution therapy and needle and syringe programs) will be essential to ensure that HCV reinfection risk is minimized.

Cost: It has been demonstrated that treatment of people who inject drugs is cost-effective, given the potential for preventing onward transmission.

INHSU 2016: NEW RESEARCH SUPPORTING THE TREATMENT OF PEOPLE WHO INJECT DRUGS WITH HEPATITIS C

The research below is being presented at INHSU 2016 and provides further evidence that treating people who inject drugs (PWID) is effective.

HIGH RATES OF SUSTAINED VIROLOGICAL RESPONSE IN PEOPLE WHO INJECT DRUGS TREATED WITH ALL-ORAL DIRECT ACTING ANTIVIRAL REGIMENS

This study demonstrates that all PWID completed therapy with high rates of viral cure despite significant rates of drug use. This data demonstrates support for the treatment of PWID. Read the abstract.

REAL WORLD OUTCOMES OF DIRECT ACTING ANTIVIRAL (DAA) THERAPY FOR HEPATITIS C (HCV) AMONGST PERSONS WHO INJECT DRUGS TREATED IN AN INNER-CITY HEPATITIS C TREATMENT PROGRAM, VANCOUVER, CANADA

Outcomes attained using DAA therapies are high in a real world setting. Strategies to improve retention in care post therapy will be important to ensure appropriate monitoring for treatment failure and re-infection. Read the abstract.

CHANGES IN RISK BEHAVIOURS DURING AND FOLLOWING TREATMENT FOR HEPATITIS C VIRUS INFECTION AMONG PEOPLE WHO INJECT DRUGS: THE ACTIVATE STUDY

Recent injecting drug use and hazardous alcohol use decreased, while OST increased during and following HCV treatment among participants with on-going injecting drug use. These findings support further expansion of HCV care among PWID. Read the abstract.

OPTIMAL ADHERENCE DURING HCV TREATMENT AMONGST ACTIVE DRUG USERS AT A COMMUNITY BASED PROGRAM IN TORONTO, CANADA

This study provides insight into the adherence patterns of marginalized people living with HCV and demonstrates that despite high rates of substance use, a community- based model of HCV treatment can support positive HCV treatment outcomes. Read the abstract.

CC-EDGE CO-STAR: RISK OF REINFECTION FOLLOWING SUCCESSFUL THERAPY WITH ELBASVIR (EBR) AND GRAZOPREVIR (GZR) IN PERSONS WHO INJECT DRUGS (PWID) RECEIVING OPIOID AGONIST THERAPY (OAT)

Data on HCV reinfection rates after successful treatment are limited. This study is the largest on reinfection post-interferon-free therapy to date. Several HCV reinfection cases were detected among PWID on OAT following successful EBR/GZR therapy. Further follow-up is required to determine the natural course of HCV reinfection in the setting of interferon-free HCV treatment and the impact of viral persistence following reinfection on long-term response rates in this population. Read the abstract.

COMBINING THE EXPANSION OF MEDICATED ASSISTED THERAPIES AND HCV TREATMENT AMONG PWID IN UKRAINE: INSIGHTS FROM NETWORK MODELING

Combining antiviral HCV treatment with continued OST expansion are crucial for the reduction of HCV prevalence in the longer run. Substantial scale up of HCV treatment is a necessary condition for effective treatment in the context of high HCV prevalence and complex networks structures among PWID. Read the abstract.

Hepatitis C Drugs: Is Next Generation the Last Generation?

Hepatitis C Drugs: Is Next Generation the Last Generation?
Pawlotsky JM, et al. Gastroenterology. 2016

DOI: http://dx.doi.org/10.1053/j.gastro.2016.08.043

Publication stage: In Press Uncorrected Proof

Published online: August 30, 2016

Much has been written about the “hepatitis C virus (HCV) drug revolution.” For an individual who started to work on the newly discovered HCV in 1990, at the time happy to describe rates of sustained virologic response (SVR) on the order of 6% with standard interferon (IFN)-α administered 3 times per week for 6 months,¹ the current HCV treatment landscape could look miraculous. It is simply the result of an enormous intellectual, scientific, and financial effort of the publicly funded academic and the industrial sectors to solve a major public health problem, building on the experience accumulated in the fight against the human immunodeficiency virus.

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HEP Fall 2016 Newsletter - Hepatitis C activist Shirley Barger is fighting so everyone can access treatment

HEP Fall 2016 - Special Issue
In every issue of HEP, you'll find the hottest topics of interest to our readers along with cutting-edge health information.

Also Available On: ISSUU

Newsletter
Fall 2016

Feature
Paying It Forward
Hepatitis C activist Shirley Barger is fighting so everyone can access treatment.
By Tim Murphy

From the Editor
With a Little Help From My Friends
As a result of learning how to advocate for herself, Shirley Barger became an HCV advocate for all people living with the virus.
By Oriol R. Gutierrez Jr.

News
Hep C Treatment Access Increases Nationwide
Massachusetts is the latest state to lift restrictions on hepatitis C virus (HCV) treatment under its Medicaid program.
By Casey Halter

Telemedicine: The Future of Hepatitis C Care?
A bill introduced in Congress hopes to implement a video clinic platform to help expand hep C treatment access across the country.
By Casey Halter

HHS Plans to Combat the U.S. Opioid Epidemic
The U.S. Department of Health and Human Services has announced an expansion to the government’s official plan to combat the opioid epidemic.
By Casey Halter

Hep C Testing Could Soon Be Easier
Currently, testing for hepatitis C virus (HCV) involves two steps.
By Casey Halter

War on Drugs Fuels Spread of HIV, Hep C and TB
Mass imprisonment of drug users worldwide, contributes to the spread of HIV, hepatitis B and C viruses and tuberculosis.
By Casey Halter

Treatment News
FDA OKs Gilead’s Epclusa for All Genotypes
This is the first approved therapy that treats all six major genotypes of the virus.
By Benjamin Ryan

Promise for AbbVie’s All-Genotype Treatment
AbbVie’s combination treatment of ABT-493 and ABT-530 has boasted high cure rates among all genotypes of hepatitis C virus.
By Benjamin Ryan

Treat Hep C, Free Up Livers for Transplants
Expanding the testing and treatment of hepatitis C virus (HCV) would free up many livers for transplantation.
By Benjamin Ryan

Hep C Is Globe’s Biggest Infectious Disease Killer
Hepatitis C virus (HCV) now kills more Americans than any other infectious disease.
By Benjamin Ryan

Good Second Chances for Hep C Cures
A second try at hep C treatment likely offers an excellent chance of success at a cure.
By Benjamin Ryan

Begin here....

September Updates
View This Months Viral Hepatitis Newsletters From Around The Web:
September HCV Newsletters and Headlines

September HCV Newsletters and Headlines

September HCV Newsletters and Headlines
Hello everyone, welcome to the start of September, fall is in the air.

Sit back and enjoy this months issue of HCV newsletters, blog updates with a look at todays headlines. 

News & Research

All You Need to Know: September’s Crucial Verdict on the Sofosbuvir Patent Saga
Some countries have already protested Gilead’s patent on sofosbuvir. For example, China and Ukraine have rejected the patent on the pro-drug form of sofosbuvir. In Egypt, the primary patent application was reject even as a company named Pharco developed a generic version of sofosbuvir and applied for WHO pre-qualification for it. More patent oppositions on sofosbuvir have been filed in Argentina, Brazil, France, Russia and Thailand....

Women at greater risk for developing ALD, liver injury vs. men - Healio

Women  may be more likely to develop alcoholic liver disease, even among those who drink less alcohol than men...

Competition Works Best to Control Drug Prices

If you haven’t heard about EpiPen’s unconscionable price increases, you have probably been in an ashram.

Liver transplants' effect on patients' health insurance post-Medicaid expansion

September 2, 2016
Findings published in Liver Transplantation suggest the number of patients who switched from private insurance to Medicaid post-liver transplant was greater in Medicaid expansion states than non-expansion ones.

Trending News Today: Hepatitis C Drug Access Lawsuit by Mumia Abu-Jamal Denied
The opioid epidemic has been an ongoing concern with the synthetic opioid, fentanyl, Prince's cause of death being the latest. However, Ohio officials have ...

Jerry Bagel: Starting the Treatment Process for Plaque Psoriasis
MD Magazine - Sept 2
Or for example if someone has hepatitis C or Crohn's disease, you could opt for another avenue of treatment. “You need to clearly know the adverse event profile ...

US veterans have increased frequency of HCC at autopsy

United States military veterans had an increased frequency of hepatocellular carcinoma at autopsy compared with the general population, according to recent findings published in Clinical Gastroenterology and Hepatology.

Cancer screening guidelines 'largely inconsistent' for solid-organ transplant recipients

Six guidelines recommended screening for liver malignancies in kidney transplant recipients, especially those with cirrhosis, liver disease, or hepatitis B or C..

RNA Assessment Predicts Hepatitis C Relapse Two Weeks into Treatment

Aug 31, 2016 | Caitlyn Fitzpatrick
Published in the Journal of Hepatology, the results showed that hepatitis C RNA levels in people with HCV genotype 3 who achieved sustained virologic response (SVR) were significantly lower during the first four weeks of SOF/RBV treatment than the levels observed in those who ended up relapsing.

Exploring Treatment Failure Among Hepatitis C Patients
Although direct acting antivirals (DAAs) have revolutionized the treatment of hepatitis C virus (HCV), a small fraction of patients still experience treatment failure

Studying Faldaprevir and Deleobuvir Use in NS3/4A and NS5B Amino-acid Variants of Hepatitis C
Faldaprevir and deleobuvir resistance-associated variants (RAVs) are more common among virologic failures than at baseline in patients with treatment emergent NS3/4A and NS5B amino-acid variants of hepatitis C virus (HCV), according to the results of a recent study. Published on the website PLOSOne, the study was conducted by Kristi Berger, PhD, of Boehringer Ingelheim Pharmaceuticals, in Ridgefield Connecticut, and colleagues.

U. of Minnesota sues Gilead
The Biological SCENE-16 hours ago
The University of Minnesota filed a complaint in federal court on Aug. 29 charging that Gilead Sciences' multi-billion-dollar hepatitis C drugs Sovaldi, Harvoni, ...

Colorado to expand coverage for Hep C patients, but some still won’t get the expensive drug
By Jennifer Brown | jbrown@denverpost.com
Colorado will increase access to a life-saving, expensive hepatitis C drug, covering needy patients in earlier stages of liver disease than were previously considered, the state Medicaid department said Thursday.

Publication Updates

Clinical Liver Disease

View recently published articles in the latest issue of Clinical Liver Disease (CLD).
CLD is the official digital educational resource from the American Association for the Study of Liver Diseases.

Of Interest - Velpatasvir and sofosbuvir: How will we use a new drug when the old agents work well?
The rapid development of highly efficacious and well-tolerated regimens for treatment of chronic hepatitis C virus (HCV) infection has been a remarkable advance. Direct-acting antiviral combinations are available for each of the six HCV genotypes (GTs). Because sustained virological response (SVR) rates are greater than 95% for most patient populations, it may be questioned why new regimens are under development.​
Watch a video presentation of this article

Begin here...

Journal Of Hepatology

Resurrection of response-guided therapy for sofosbuvir combination therapies

Harel Dahari, Phillippe Halfon, Scott J. Cotler

DOI: http://dx.doi.org/10.1016/j.jhep.2016.05.028

Journal of Hepatology, Vol. 65, Issue 3, p462–464

The concept of response-guided therapy (RGT) was developed to limit duration of exposure to interferon (IFN) alpha-based treatment in order to reduce side effects while optimizing response rates.

The recent approval of sofosbuvir (SOF) and other direct acting antivirals (DAAs) has resulted in a shift in the treatment paradigm [[4]x[4]Feld, J.J., Kowdley, K.V., Coakley, E., Sigal, S., Nelson, D.R., Crawford, D. et al. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014; 370: 1594–1603

Crossref | PubMed | Scopus (322)See all References, [5]x[5]Koff, R.S. Review article: the efficacy and safety of sofosbuvir, a novel, oral nucleotide NS5B polymerase inhibitor, in the treatment of chronic hepatitis C virus infection. Aliment Pharmacol Ther. 2014; 39: 478–487

Crossref | PubMed | Scopus (56)See all References]. Sofosbuvir-based regimens achieve high (>90%) sustained-virological response (SVR or cure) rates with limited side effects and relatively short duration of therapy (8–24 weeks). The initial clinical trials data with SOF did not indicate an association between on-treatment virus levels and SVR due to high cure rates, lack of on-treatment viral breakthrough, and rapid viral decline kinetics that give rise to much earlier viral suppression compared to IFN ± ribavirin (RBV) therapy [6x[6]Pawlotsky, J.M. New hepatitis C therapies: the toolbox, strategies, and challenges. Gastroenterology. 2014; 146: 1176–1192

Abstract | Full Text | Full Text PDF | PubMed | Scopus (203)See all References[6]. In the initial clinical trials with SOF, HCV RNA suppression by week 4 was nearly universal and was not associated with cure, including patients infected with HCV genotype-3 who are currently considered the most difficult to treat [[7]x[7]Lawitz, E., Mangia, A., Wyles, D., Rodriguez-Torres, M., Hassanein, T., Gordon, S.C. et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013; 368: 1878–1887

Crossref | PubMed | Scopus (19)See all References, [8]x[8]Wyles, D.L., Nelson, D.R., Swain, M.G., Gish, R.G., Ma, J., McNally, J. et al. On treatment HCV RNA as a predictor of virologic response in sofosbuvir-containing regimens for genotype 2/3 HCV infection: Analysis of the FISSION, POSITRON, and FUSION studies. Hepatology. 2013; 58: 140ASee all References]. Subsequent studies did not find an association between early viral kinetics and treatment outcomes [[9]x[9]Zeuzem, S., Dusheiko, G.M., Colombo, M., Flisiak, R., Hyland, R.H., Illeperuma, A. et al. Early viral kinetics do not predict treatment outcome with sofosbuvir + ribavirin for 12 or 24 weeks in HCV genotype 2/3 patients in the Valence trial. J Hepatol. 2014; 60: S452

Abstract | Full Text | Full Text PDF | Scopus (8)See all References, [10]x[10]Hezode, C., Chevaliez, S., Scoazec, G., Bouvier-Alias, M., Ruiz, I., Francois, M. et al. On-treatment viral kinetics do not predict SVR in patients with advanced liver disease receiving sofosbuvir in combination with daclatasvir or simeprevir for 12 weeks. J Hepatol. 2015; 62: S654–S655

Abstract | Full Text PDFSee all References]. As a result, on-treatment HCV RNA measurements (weeks 2 and/or 4) are currently recommended by both the European Association for the Study of the Liver (EASL) (www.easl.eu) and the AASLD/IDSA (www.hcvguidelines.org) only as a means to monitor adherence and a fixed duration of DAA therapy has eclipsed the RGT approach....

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New England Journal Of Medicine

Review Article

Treatment of Patients with Cirrhosis
August 25, 2016 | P.S. Ge and B.A. Runyon
N Engl J Med 2016;375:767-77. DOI: 10.1056/NEJMra1504367
This guide to the practical treatment of patients with cirrhosis summarizes recent developments. It includes advice on medical management, invasive procedures, nutrition, prevention, and strategies to protect the cirrhotic liver from harm.
Full Text - Download PDF

Newsletters

Welcome to this months collection of viral hepatitis newsletters.

HCV Advocate
HCV Advocate Newsletter
The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education.
In addition check out; HCV Medications Blog with easy to find information; listed clearly by HCV genotype. ​Easy to navigate, easy to read.

Newsletter
September Issue
HCV Advocate Clinical Trials Reference Guide is now available to search for hepatitis C (HCV) and HIV/HCV coinfected trials. There are instructions on the front page of the Reference Guide to search for clinical trials. The Reference Guide will be updated on a regular basis.

A companion piece—How to Evaluate a Clinical Trial—provides simple tips to help decide whether a particular clinical trial is right for you.

HealthWise—The Tragic Tale of Hemophilia, Hepatitis, and HIV
by Lucinda K. Porter, RN
Lucinda probes the history of ‘bad blood’ scandals, and the people and communities affected.

Under the Umbrella—No Man is an Island:
Part 1, Hepatitis C in Rural Southern Indiana by Matthew Zielske. Matthew discusses the HIV and hepatitis C outbreak in Indiana and the community response.

HCV Advocate Monthly Pipeline has been updated with more information about the results from Gilead’s phase 2 study of sofosbuvir, velpatasvir and voxilaprevir to treat hepatitis C.

What’s Up!
We have updated the following fact sheets:
HCSP Fact Sheets—HCV Populations:
African Americans and hepatitis C
Genotype 2
Genotype 3
Easy C:
What is Drug Resistance?
Easy B’s
HBV Transmission and Prevention – the entire series of our hepatitis B fact sheets have been reviewed and updated.
HCV Medications Blog has been updated with information about Viekira XR a time-released formulation of Viekira Pak that was recently approved by the Food and Drug Administration.
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HEP

HEP Fall 2016 - Special Issue
In every issue of HEP, you'll find the hottest topics of interest to our readers along with cutting-edge health information.

Hep C Treatment Access Increases Nationwide
Telemedicine: The Future of Hepatitis C Care?
Hep C Testing Could Soon Be Easier
View all topics
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AGA Institute
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.

This Months Issue
September 2016 PDF
Deals likely the way to pay for HCV drugs

‘I still think the challenge we are going to face now is it’s still not gotten down to a price that’s low enough to really make it affordable to cover a million people in the Medicaid program.’

Clues found to fibrosis progression in chronic HCV

The investigators wrote that the association between genotype 3 and cirrhosis should be “interpreted cautiously” because of the low number of these patients in their study.

8 weeks of sofosbuvir/ledipasvir found real world effective

Clinical trials of sofosbuvir, ledipasvir/sofosbuvir, and paritaprevir/ritonavir/ombitasvir and dasabuvir (PrOD) have reported SVR rates well above 90%, “with the exception of certain subgroups, such as patients with Child’s B or C cirrhosis and those infected with genotype 3 HCV,” the researchers noted. However, older interferon-based regimens did not perform as well in the real world as in trials, and “it is unclear if this is the case for current interferon-free regimens.”

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The National Viral Hepatitis Roundtable 

The National Viral Hepatitis Roundtable is a broad coalition working to fight, and ultimately end, the hepatitis B and hepatitis C epidemics. We seek an aggressive response from policymakers, public health officials, medical and health care providers, the media, and the general public through our advocacy, education, and technical assistance.

NVHR Newsletter - August 2016

Join us for Friday, September 9, 2016 from 1:00–2:30 pm Eastern for a webinar highlighting the work of advocates who have led successful efforts to expand access to hepatitis C treatment in their states.

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HCV Action

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

Latest Newsletter

HCV Action: August 2016

Hepatitis C in the UK 2016 report released

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The New York City Hepatitis C Task Force

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.

September 2016 Hep Free NYC Newsletter

September News: Hepatitis & Liver Cancer Resources, Hep C Screening & Linkage to Care Trainings, NYC Conference on African Immigrant Health

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

Help ALF Celebrate 40!

2016 marks our 40th Anniversary as the only nonprofit dedicated exclusively to liver health and disease. Join us in raising awareness and eliminating the stigma as part of our virtual celebration!

Latest Newsletter

August 2016

Additional Resources

Brochures & Handouts

Education Resources

Support Services

Helpful Links

FINAL HepCBC’s MONTHLY NEWSLETTER
The hepc.bull, has been “Canada’s hepatitis C journal” since the late 1990’s and was published nonstop since 2001. The last print edition was Issue #200: Summer, 2016.

It contained the latest research results, government policy changes, activities and campaigns, articles by patients and caregivers, and a list of support groups plus other useful links–all of which can now be found on this website and on our Facebook page: Hepcbc Hepatitis C Education-Prevention.

Download The Final Edition of the hepc.bull

Blog Updates

Creating a World Free of Hepatitis C

by LUCINDA PORTERWelcome to my website and blog. My name is Lucinda Porter and I am a nurse committed to raising awareness about hepatitis C. I believe that we can create a world free of hepatitis C. We do this together, one step at a time.

New Entry

Crossroads

By Lucinda Porter

Lately, I feel like I am sitting at the crossroads of health, illness, life and death. These four concepts intersect all of our lives.

HEPATITISC.NET

Stay up to date on Hepatitis C news, hear from our patient advocates and physician experts. The HepatitisC.net Headlines will provide tips and tools for living with and managing Hepatitis C.

Read other recent HepatitisC.net headlines

Hep C Daily Blog

Why Is Hepatitis C Treatment So Expensive?

By Jenelle Marie Davis - September 1, 2016
It is estimated that there are over 3 million Americans living with hepatitis C at this very moment. Of course, there are millions more if you consider the entire world’s population.

READ MORE

Beginner’s Guide to Hepatitis C

By Karen Hoyt - August 31, 2016
So you’ve come here to learn about the hepatitis C virus. I’ll bet you’ve found that this can lead to that, and if you take this, then something else will happen.

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Beginner’s Guide to Hepatitis C
By Karen Hoyt - August 31, 2016
So you’ve come here to learn about the hepatitis C virus. I’ll bet you’ve found that this can lead to that, and if you take this, then something else will happen. There is so much to learn in the beginning about the hepatitis C virus. Here are some tips to get you going and keep your focus as you learn about hep C and how it will affect your life.
READ MORE

How to Manage Ascites In Patients With Cirrhosis

By Jenelle Marie Davis - August 30, 2016
What is ascites? Ascites is the accumulation of fluid within the abdominal or peritoneal cavity. The fluid is typically serous fluid, which looks clear or very pale yellow. Ascites can exist in...

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I Help C 

Karen Hoyt, is an inspirational woman, HCV advocate, and author who is committed to sharing information about hepatitis C. 

New Post

Take it Easy: Advice From My Sister

By Karen Hoyt

HEP
Your Guide To  Hepatitis 
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and Hep Magazine are the go-to source for educational and social support for people living with hepatitis.

Latest Blog Updates
Health literacy's role in the HCV Treatment Cascade
By Matthew Zielske  

Hep C Treatment and Recovery: One Way Up 
By Connie M. Welch

Hepatitis C and Harmony
By Lucinda Porter
Getting Generic Harvoni Into Canada

By Greg Jefferys 

View All Blogs At Hep

The Hepatitis B Foundation

The Hepatitis B Foundation is a national nonprofit organization dedicated to finding a cure for hepatitis B and helping to improve the lives of those affected worldwide through research, education and patient advocacy.

HBV Blog

Advocates Raise Awareness About African Immigrants’ High Risk of Hepatitis B

By Christine Kukka
For years, public health advocates have struggled to educate both doctors and Asian-Americans about the high risk of hepatitis B that this ethnic group faces. It’s been a slow, uphill battle marked by moderate success.
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Healthy You

NIH News in Health

Check out the September issue of NIH News in Health, the monthly newsletter bringing you practical health news and tips based on the latest NIH research.

New In September
Curb Your Eating
Help Your Brain Fight the Urge to Splurge

Out-of-control eating can look and feel remarkably similar to an addiction to drugs. Scientists are analyzing the brain’s role in binge eating.
Read more about out-of-control eating.

ACP Internist

ACP Internist provides news and information for internists about the practice of medicine and reports on the policies, products and activities of ACP.

Fibromyalgia characterized by controversy

Much research is currently delving into the pain mechanisms of fibromyalgia, a disorder defined by widespread muscle pain that many patients find debilitating and that has such associated symptoms as fatigue, lack of restorative sleep, and memory difficulties. But there remains considerable dissent among the medical community about the condition's cause.

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News

FDA Bans 19 Chemicals Used In Antibacterial Soaps
Consumers don't need to use antibacterial soaps, and some of them may even be dangerous, the Food and Drug Administration says.

FDA requires new warnings on danger of combining opioids ...

The Centers for Disease Control and Prevention warned doctors in the spring against prescribing opioids with benzodiazepines, except for ...

Research

Effects of Dark Chocolate on NOX-2-Generated Oxidative Stress in Patients With Non-alcoholic Steatohepatitis  

Can chocolate be any more awesome? New research finds that cocoa polyphenols may reduce oxidative stress in NASH.

September 02, 2016

Even Light Drinking Spikes Cancer Risk in Hepatitis C-Related Cirrhosis

Aug 29, 2016 | ARTICLES | Caitlyn Fitzpatrick
It’s no secret that excessive alcohol consumption is dangerous to the liver; that’s exactly why patients with hepatitis C are advised to steer clear of it.

In Case You Missed It

Serious Infections Skyrocket In People Who Inject Illegal Drugs
Bloodstream and heart valve infections are on the rise in people who inject drugs (PWID), more commonly known as IV drug users (IVDU).

Off The Cuff

Hep C On Reddit
A community for those with Hep C, those that want to learn more about Hep C and everyone else.

Stay well, see you soon.

Tina

Colorado to expand coverage for Hep C patients, but some still won’t get the expensive drug

Colorado to expand coverage for Hep C patients, but some still won’t get the expensive drug

By Jennifer Brown | jbrown@denverpost.com

Colorado will increase access to a life-saving, expensive hepatitis C drug, covering needy patients in earlier stages of liver disease than were previously considered, the state Medicaid department said Thursday.

The state has paid for the 12-week drug treatment with a 90 percent cure rate only for patients who were in the final two stages of liver disease. Under the new policy, Medicaid patients can receive the drug if their liver damage has advanced to the second out of five stages — zero meaning no liver damage and four diagnosed as cirrhosis.

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