July Newsletters: 5 Things to Know About Hepatitis C, Sofosbuvir Cost, 2014 Drug Guide, and More...

July Newsletters: 5 Things to Know About Hepatitis C, Sofosbuvir Cost, 2014 Drug Guide, and More...

Hello folks, welcome to this months newsletters and updates. Before we get started, I have a bit of news to share. Over the course of the next few weeks I will be cruising northern Europe with my youngest son! I can't wait!

We will be visiting Baltic cities like Copenhagen, Stockholm, Helsinki, and Germany, with overnight calls in Russia's St. Petersburg. 

Last month I had the pleasure of traveling to Alaska with my eldest son, here we are atop the Mendenhall glacier.

Although I am excited to experience Europe, my younger son is somewhat more reserved than his older sibling.


Yesterday, he referred to this lovely Alaskan wildlife photograph as touristy →

Today, he requested that I try to refrain from acting like a tourist  on our upcoming travels.

Really? With all due respect, I think the bear looks real, a photo op NOT to be missed!

In addition, while traveling through Alaska, his older, much wiser brother, never once called me out for acting touristy. Well, unless one wishes to count the few times I was asked not to point.

Sadly, most of my favorite wildlife pics taken during our trip to Alaska, or any photo which included myself for that matter, never made it onto his big brothers Facebook page.

In any event, I shall be acting very aloof somewhere in northern Europe from the second week in July to around early August.

However, before I leave dry land with my intensely sophisticated kid, duty calls, check out this months edition of Hepatitis Newsletters, a rewind of hot topics and a bit of July's relevant news.  I promise to update the blog and website upon my return.

Some sites do not published their newsletters until the middle of the month, however, links are still provided in case you venture back later for a look see.  

For Your Viewing Pleasure

Published on Jul 8, 2014

Andrew Muir, MD, MHS, chief of the Duke Division of Gastroenterology, describes hepatitis C care and how to prepare for your first visit with a liver specialist.

 

Learn more about Dr. Muir at http://www.dukemedicine.org/find-doct....

Healthy You

Does Vitamin D Deficiency Affect SVR and Fibrosis?


In a recent meta-analysis over at Healio, researchers reported advanced fibrosis, and reaching SVR were both affected by low vitamin D levels in patients with hepatitis C. 
“This meta-analysis shows that a low vitamin D status in CHC patients is associated with a higher likelihood of having advance liver fibrosis (ALF) and lower odds of achieving SVR, suggesting the utility of vitamin D screening in HCV-infected patients,” the researchers wrote.

As a side note, it is never advised to start taking any supplements without first talking to your doctor, particularly fat-soluble vitamins, such as A, D, E, and K.
*Some supplements in high amounts can be dangerous.

Can Green Tea Be Bad for Your Liver?
You might be surprised to know that health experts caution against taking supplements that contain green tea extracts, pointing out their potential to hurt the liver.

Only 25 minutes of mindfulness meditation alleviates stress
PITTSBURGH—Mindfulness meditation has become an increasingly popular way for people to improve their mental and physical health, yet most research supporting its benefits has focused on lengthy, weeks-long training programs.
 
Proper Diet Is Critical for Patients with Liver Disease
For patients struggling with liver disease, diet can become a matter of life and death. Dr. Juan Gallegos talks about how daily food choices can impact the diseased liver. He also gives some tips for improving diet and prolonging the lives of patients with liver disease.

Overweight Hispanic female adolescents prone to hepatic steatosis
Hepatic steatosis was common among overweight and Hispanic adolescent and young adult females, according to new research data...

Oral Diseases Associated With hepatitis C
Hepatitis C virus can be frequently associated with potentially malignant and malignant oral diseases and could be a triggering factor of some of those disorders or at least influence their outcome. The association is very robust for oral lichen planus, while for Sjogren’syndrome it is strongly suspected and in oral squamous cell carcinoma indicated by recent large epidemiological data....

Inhaled Insulin for Diabetics
Medscape Blog-"Chief Complaint" Inhaled Insulin for Diabetics
Be on the lookout in the ED for patients taking a new, rapidly-acting inhalable form of insulin powder.  Known as Afrezza, it was approved by the FDA last week for treating types 1 and 2 diabetes.  In those with Type 1 Diabetes, Afrezza is taken with meals and is used as a supplement to long-acting insulin. Afrezza comes in cartridges of 4 and 8 units.
 

Hot Topics

World Hepatitis Day 
For the world's 8th biggest killer, viral hepatitis is remarkably neglected.

That's why in 2010 the World Health Organization made World Hepatitis Day one of only 4 official disease-specific world health days, to be celebrated each year on the 28th July.

Millions of people across the world now take part in World Hepatitis Day, to raise awareness about viral hepatitis, and to call for access to treatment, better prevention programs and governments action.
All across the world, World Hepatitis Day is our chance to call for a change in attitude to viral hepatitis.

We're got loads of ways for you to get involved; take a look below to find posters, the official WHD website and many more materials for you to hold your very own WHD event.

Visit the official World Hepatitis Day website
Download campaign materials
Get involved!

Senators Query Hepatitis C Drug’s High Costs
Two members of the Senate Finance Committee, including the chairman, Ron Wyden, Democrat of Oregon, on Friday asked Gilead Sciences to defend the more than $80,000 cost of its breakthrough treatment for hepatitis C, Sovaldi, citing the expense to federal health care programs. The lawmakers said in a release, “It is unclear how Gilead set the price for Sovaldi.” The drug’s cost can rise to $168,000 for patients who need longer treatment periods, the senators said. Gilead’s pill, which cures patients more quickly than older drugs, and with fewer side effects, generated $2.3 billion in sales during its first full quarter on the market this year, a record for the drug industry. The drug, which was acquired by Gilead from Pharmasset in 2012 for more than $11 billion, began to bear fruit after it produced stellar results in late-stage clinical trials and was approved by regulators late last year. Other companies, including Merck, are developing similar drugs. The liver disease affects more than three million Americans.

Gilead Faces New Pressure From U.S. Senators & Europe Over Hep C Pricing 
By Ed Silverman
The moves come amid tremendous controversy over pricing. The medication can cure about 90 percent of the patients who have the common form of hepatitis C, but costs about $1,000 a day for a 12-week course, or $84,000 for one patient. Given that there are about 3.2 million people in the U.S. who are chronically infected, and as many as 4 million people are infected each year, according to the World Health Organization, the potential sales have been exciting Wall Street.
Gilead has agreed to charge much less in some countries, such as Egypt, where the same treatment will cost $900, but several European nations, led by France, do not expect to receive a similar break. Numerous medical associations in France have reportedly issued a joint warning over the cost of Sovaldi and other forthcoming drugs.
Read the article in full, here

EU nations join forces against 'exorbitant' hepatitis C drug
(MENAFN - AFP) France said Thursday it has joined forces with 13 other European countries to negotiate a lower price for a promising new hepatitis C drug that has drawn controversy for its astronomical cost.

Sovaldi, made by US pharmaceutical firm Gilead Sciences, has shown huge potential at helping cure the liver disease but its price - more than 50,000 euros (68,000) for a 12-week course of treatment - has health authorities concerned.

"If we accept such a high price, firstly we won't be able to treat everyone and we will also be creating a risk for our social security system, which means for other patients," French Health Minister Marisol Touraine said Thursday.

She told BFMTV that Sovaldi would cost the country's already heavily-indebted welfare system billions of euros.

"So I launched an initiative... to mobilise all European countries and make sure we join forces to weigh on price negotiations with this US laboratory.

"For the first time, 14 European countries have made a commitment together. We will therefore negotiate country by country as that's how it's done, but we will exchange information and discuss things between European countries."

Hepatitis C is caused by a virus that can be transmitted through sharing needles, receiving contaminated blood transfusions or having sex with an infected person.

Some 350,000 people die of hepatitis C-related liver diseases annually, and as many as four million people are newly infected each year, according to the World Health Organization.

Most of the 185 million people infected worldwide do not know they have the disease, with diagnoses often only discovered after a person develops cirrhosis, end-stage liver disease or liver cancer.

There is no vaccine for the disease, but Sovaldi, recently approved in the United States and the European Union, has been shown to cure more than 90 percent of those treated, up from 50 to 60 percent for the previous generation of drugs.

Results published in January of a clinical trial that involved 211 people showed that a daily combination of Sovaldi and another drug still in the experimental phase cured 98 percent of participants.

Dozens of medical associations in France have issued a joint warning over the "exorbitant" cost of new generation hepatitis C drugs, including Sovaldi.

Medecins du Monde says the cost of treating just over half of France's 230,000 sufferers would amount to the annual budget of Paris' public hospital network.

Egypt, which has the world's highest infection rate of hepatitis C - at more than 10 percent of the population, because syringes are routinely re-used - has negotiated a 12-week treatment price of just 900 from Gilead.
Source

Related:
Reducing the cost of new hepatitis C drugs
An index of articles pointing the reader to current information and controversy over the high price of Solvadi.

Meeting Report: 20th International Symposium on Hepatitis C Virus and Related Viruses
Didn’t make it to the 20th International Symposium on HCV and Related Viruses last fall in Melbourne, Australia? No worriesyou can read a summary of the key findings presented at the meeting in the July issue of Gastroenterology. Michael R. Beard et al. report on the latest research into viral entry, replication, and assembly, as well as innate and adaptive immune responses in their detailed meeting report.

Cannabis Not Used to Develop Hepatitis C Vaccine or Suppositories
It seems like there’s another over-the-top headline about cannabis every other day, from studies proclaiming it is, in fact, dangerous, to those that claim cannabis can cure just about everything.

One popular story floating around right now sounds plausible. There has been a preventative vaccine for Hepatitis B for years, and now researchers at the Wyoming Institute of Technology have announced what they believe may be a breakthrough discovery: a hepatitis C vaccine based on cannabis.

Study Begins To Define How Long HCV Patients May Need Treatment 
“We found that HCV RNA decay in the liver lagged behind that in the peripheral blood, which has implications for how long the virus may persist in the body and the possible duration of treatment needed,” Talal says.

Researchers also found higher levels of telaprevir in blood than in the liver.

“These findings can affect the duration of therapy,” said Talal, adding that they can also help identify when drug-resistant variants of the virus emerge in the blood and liver.

The findings also may have relevance for the development of other methods of treating HCV, such as vaccines to control the infection, he adds.
 A new meta-analysis published online in PLOS ONE by infectious disease and epidemiology specialists from the Perelman School of Medicine at the University of Pennsylvania highlights significant gaps in hepatitis C care that will prove useful as the U.S. health care system continues to see an influx of patients with the disease because of improved screening efforts and new, promising drugs.
In the largest study of its kind, the team examined data culled from 10 studies between 2003 and 2013 and found that less than 10 percent of people infected with hepatitis C in the United States — 330,000 of nearly 3.5 million people — were cured (achieved viral suppression) with antiviral hepatitis C treatment. The researchers also found that only 50 percent of people were diagnosed and aware of their infection; 43 percent of those with the disease had access to outpatient care; and only 16 percent were prescribed treatment.
Continue reading here...

Related:
Study: Small percentage of hepatitis C patients got through past treatments 
A new analysis finds that a very low percentage of people chronically infected with hepatitis C over the last decade ever make it through treatment.

Hepatitis C is a common blood-borne disease that scars a patient's liver and can lead to cancer. People who inject drugs are at higher risk for it, as are baby boomers, in part because pre-1992 blood transfusion protocols didn't screen for it.

Baligh Yehia, a researcher at the University of Pennsylvania, recently reviewed thousands of available studies on hepatitis C treatment in the U.S., and concluded that of the some 3 million people chronically infected with the virus, fewer then 10 percent get all the way through treatment and are effectively cured.

"That number is low," he said. "And it represents an opportunity for us in the field to really strive to increase that number."

Until very recently, Yehia said, hepatitis C treatment has been difficult and not always effective. It also requires a patient to have access to a whole series of health services, including liver biopsies and regular checkups. But with a more effective drug hitting the market this past year, he said, the real challenge moving forward will be identifying people who have the disease and connecting them to care.

"Now the bottleneck is upstream," said Yehia. "So how can we get them diagnosed and aware of their infection and then get them into care? And then really make sure we have the appropriate ability to pay for these new therapies?"

The new therapies are expensive and, depending on a patient's insurance plan, may be difficult to access. In Pennsylvania's fee-for-service Medicaid program, for example, a patient must have advanced liver disease to qualify for the treatment.

Yehia said lessons are available from what happened with HIV. Once effective treatments came out, the challenge turned to successfully linking people to that care.

Research 

Clinical Care Options - ClinicalThought™ 
**You may need to register or log into Clinical Care Options to access all content. 

Are New HCV Therapies Ready for Use in Transplant Patients?
Paul Y. Kwo, MD - 7/10/2014
December 2013 marked the first drug approval from a new class of direct-acting antiviral (DAA) agents, the nucleotide polymerase inhibitors. Sofosbuvir was approved for use in combination therapy both with and without interferon. For genotype 1 patients, clinical trials demonstrated overall SVR rates of 90% when sofosbuvir was combined with peginterferon and ribavirin for 12 weeks and 70% SVR rates when sofosbuvir was given with ribavirin for 24 weeks. For genotype 2 and 3 patients, SVR rates were more than 85% with the interferon-free combination of sofosbuvir and ribavirin for 12-24 weeks. In addition, the approval of a once-daily protease inhibitor simeprevir has allowed clinicians to remove interferon and ribavirin from the equation in genotype 1 infection by combining sofosbuvir and simeprevir for 12-24 weeks; a regimen associated with SVR rates > 90% in genotype 1 individuals.

The Arrival of DAA Therapy in the Pretransplantation Setting
The prescribing information for sofosbuvir also included an indication for use in the pretransplantation setting when combined with ribavirin for cirrhotic patients with hepatocellular carcinoma, who meet Milan criteria. The regimen is given and virus suppressed for up to 24-48 weeks in an effort to eradicate virus prior to transplantation and prevent reinfection of the graft after transplantation. In our pretransplantation clinic, we are now able to suppress HCV viremia prior to transplantation with sofosbuvir and ribavirin in those with mild decompensation or with hepatoma. Whether suppression prior to transplantation will be the best strategy remains to be seen as it is not always possible to predict the timing of transplantation, especially without living related transplants. However, most patients we have treated tolerate this approach well, and we are noting that some patients have experienced clinical improvement that has allowed them to come off the transplantation list. Certainly longer-term follow-up will be required to see if this trend continues. I am interested to see if this approach can be applied to individuals who require orthotopic liver transplantation without hepatocellular carcinoma and who have Child-Turcotte-Pugh scores greater than 7; data evaluating this approach are still needed.

Interferon-Free Options in Posttransplantation Patients
The phase II COSMOS study combining sofosbuvir with simeprevir (without interferon or ribavirin) has demonstrated that SVR may be achieved in traditionally difficult-to-treat patient populations, including those with previous null response to peginterferon and ribavirin as well as those with F3 or F4 fibrosis. Although there are few data currently evaluating this regimen after transplantation, neither sofosbuvir nor simeprevir have meaningful drug–drug interactions with the calcineurin inhibitors tacrolimus and cyclosporine, and therefore, our center and others are now combining these 2 direct-acting antivirals after transplantation. We have found this gives genotype 1 HCV–infected posttransplantation patients a treatment option that removes agents that were difficult to tolerate due to the immunosuppression and poor tolerance of cytopenias.

Sofosbuvir combined with ribavirin is another option after transplantation that has demonstrated SVR rates of more than 70% in one study and, in another study, has shown efficacy as a salvage strategy for those with the dreaded complication of fibrosing cholestatic hepatitis C.

The combination regimen of ABT-450/ritonavir/ombitasvir plus dasabuvir and ribavirin, which is expected to become available for the treatment of HCV infection later this year, has also been evaluated in genotype 1 HCV liver transplantation recipients with recurrent infection. Among evaluable patients at the time of interim analysis, 96% had achieved SVR. Alterations in calcineurin inhibitors were required but were manageable.

These findings make me believe that the future for patients with advanced liver disease and posttransplantation hepatitis C infection is indeed bright. In fact, I think it is likely that with successful eradication of hepatitis C with therapies that are well tolerated, the hepatitis survival for orthotopic liver transplant for hepatitis C will match survival in those who are not HCV infected.

An Upcoming Discussion at the World Transplant Congress
Although the landscape for treating HCV in the transplantation setting has evolved dramatically during the past 6 months, we are still learning about best practices for managing HCV in this setting. Later this month, I will be gathering with my colleagues, Norah Terrault, MD, MPH, and Jean C. Emond, MD, in San Francisco, California, during the World Transplant Congress for a symposium addressing the key challenges and opportunities for managing HCV in transplant patients. I hope that you will join us for this exciting event.
Topics: HCV - Treatment, Transplantation - Treatment

What factors influence adherence in hepatitis-C infected patients?

Genotype 1 HCV–Infected Cirrhotic Patients: Still Hard to Treat?
After years of telling our patients that better HCV treatments are coming soon, we finally have access to potent, safe, oral direct-acting antivirals (DAAs) in our clinics and we expect more oral DAA regimens to be approved over the next 18 months. As clinicians, the ability to offer the opportunity for HCV cure to our patients with the greatest medical need—those with cirrhosis—is truly great news.

With more than 30 direct-acting antiviral agents (DAAs) in clinical trials, the hepatitis C community (scientists, physicians, patients) expect that the right combinations of DAAs will emerge, permitting treatment of hepatitis C virus (HCV) genotype 1 with interferon (IFN)-free regimens. 

Read the article here, or Watch a video presentation of this article, here
Watch a video interview with the author below or, here.



Persistent Infection Causes Hepatitis in Lyme Disease, Study Suggests
A new study suggests that persistent infection may cause hepatitis (inflammation of the liver) in Lyme disease. Full Text Article, here.  

Predicting the outcome of hepatitis C virus treatment
Full Text Available here
Millions of people throughout the world are infected with hepatitis C virus (HCV), which can lead to cirrhosis of the liver and cancer. Directly acting antiviral agents inhibit viral proteins and have been used to successfully treat HCV. Unfortunately, antiviral therapy fails in some patients, resulting in a relapse of HCV. A study published in the Journal of Clinical Investigation identifies a marker that can identify patients likely to have an HCV relapse after antiviral therapy.

Education  

This short activity looks at treatment options for a 55 year old female, with HCV genotype 1a, partial responder, presented by Projects In Knowledge. Case studies are easy to follow, and offer a clear understanding of various HCV treatment scenarios which may compare to your own. In addition, check out a new video reviewing the serious effects alcohol has on the liver, by Joe Galati, M.D.

This learning activity offered by ViralEd will focus on guidelines, diagnosis, and new all oral treatments for hepatitis C.  Although the CME is for the healthcare professional, patients will benefit greatly by viewing all three narrated presentations. The program is easy on the ears, and even easier to follow, especially because the CME is presented in a video and slide format. However, if the program is consuming too much of your time skip to the last presentation - you won't be disappointed.
Begin here.....

HCV July News: Noninvasive tests used to measure liver fibrosis 
Information about noninvasive tests used to measure severity of liver fibrosis in chronic hepatitis C infection
News 

Japan Approves HCV Daklinza® (daclatasvir) and Sunvepra® (asunaprevir) Dual Regimen
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Daklinza® (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), and Sunvepra® (asunaprevir), a NS3/4A protease inhibitor, providing a new treatment that can lead to cure for many patients in Japan who currently have no treatment options. The Daklinza+Sunvepra Dual Regimen is Japan’s first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis.

Australia New Zealand - TGA approves Gilead's Sovaldi®
Gilead Sciences, Australia New Zealand, On July 3 announced that the Therapeutic Goods Administration (TGA) has approved Sovaldi® (sofosbuvir), a new direct acting antiviral treatment, for the treatment of chronic hepatitis C (CHC) infection in adults as a component of a combination antiviral treatment regimen.

EU smiles on a key cog in Bristol-Myers' hep C combo
(CHMP) has recommended granting a marketing authorisation for Daklinza (daclatasvir) in combination with other medicines for the treatment of chronic (long-term) hepatitis C virus (HCV) infection in adults

Hepatitis C-Gilead Submits NDA to Japan for Sofosbuvir
-- If Approved, Sofosbuvir Would Be the First All-Oral Treatment Regimen for Patients in Japan with Genotype 2 HCV -- 

Split liver transplants as successful as whole organ transplants, study finds

And now, new research from the Cleveland Clinic has found that this split-liver technique has a five-year survival rate comparable to that of whole liver surgery.

“The main purpose of the procedure is to… increase the number of transplants,” Dr. Koji Hashimoto, a transplant surgeon at the Cleveland Clinic, told FoxNews.com. “The important thing is the liver is the only organ in the body that can regenerate— if you split the liver into two pieces, these pieces can regenerate and the size of the liver goes back to normal. This is a very unique organ.”

Some of the causes of liver failure include alcoholism, hepatitis B, hepatitis C and nonalcoholic steatohepatitis (NASH) – a common disease that causes fat in the liver.

From April 2004 to June 2012, researchers performed transplant surgery on a group of 25 split-liver recipients and a control group of 121 whole liver recipients. Split-liver recipients had an 80 percent five-year survival rate, while whole liver recipients had an 81.5 percent survival rate for the same period.

The complications for a split liver recipient are about the same as for a whole liver recipient and can include the development of small blood clots in the liver as well as primary nonfunction, or when the liver does not work after transplant.

Because of the liver’s anatomy, it cannot be split evenly for transplantation. With this procedure the organ is divided in two— 35 to 40 percent is the left lobe and 65 to 70 percent is the right lobe. One benefit of organ division is that it allows smaller patients who weigh between 100 and 160 pounds to receive needed surgery, since the split liver halves are smaller than the whole organ.

“Most of the time, these small recipients were bypassed, so let’s say we have a very small recipient on the top of the list and have a big donor. I think in this country, most centers bypass the small recipient and transplant the big liver to somebody lower on the waiting list,” Hashimoto said.

The split-liver procedure, which was first utilized by the Cleveland Clinic in 2004, is not widely done because of the technical challenge, Hashimoto noted. The process of splitting the liver is tricky, and surgeons must also divide the blood vessels, sometimes using a microscope to do so. All liver donations come from deceased donors and the splitting occurs in the donor body.

The most important factor for a successful split liver surgery is making good-sized matches between donors and recipients, which can be difficult because of the large waiting list.  Additionally, the process of identifying a donor and making the right matches has to happen within 24 hours.

“But you can increase the number of transplants, can save more people— can save two patients from one donor, which is a great concept I think,” he said. “If you choose the right donor and the right recipient, it works.”

Swimming past liver disease
BY REBECCA MORIN|
JULY 10, 2014 5:00 AM
Nine years ago, Klahn received a transplant after being diagnosed with hepatitis C and terminal liver cancer.

Klahn has competed in swimming for the Transplant Games of America and the World Transplant Games since he got his new liver. This weekend, Klahn will be in Houston to compete in his fifth Transplant Games of America. 

Big Pharma - Investment Commentary

The Risk Info is Where? FDA Scolds Gilead Over a Paid Search Link
By Ed Silverman
Last month, the FDA took a much-anticipated step by issuing guidelines for drug makers that want to use social media, including examples of how to run paid search links on Google. Around the same time, the agency chastised one drug maker, Gilead Sciences, for a paid search link and the infraction offers an example of what the FDA does not want the pharmaceutical industry doing on social media.
Continue reading @ WSJ

India's Sun Pharma recalls over 40,000 bottles of antidepressant
July 11

(Reuters) - India's Sun Pharmaceutical Industries Ltd is recalling 41,127 bottles of antidepressant venlafaxine hydrochloride in the United States after the drug failed to dissolve properly, the U.S. Food and Drug Administration said.

The voluntary recall was begun by Sun Pharma's unit Caraco Pharmaceutical Laboratories Ltd in June, and was classified by the FDA as Class II, meaning that use of or exposure to the drug may cause temporary or medically reversible adverse health consequences.

"Stability results found the product did not meet the drug release dissolution specifications," the FDA said in a post on its website on Friday. (1.usa.gov/1kcMaSF)

Hep C: What's Coming in the Pipeline, How Long Will the Disease Last?
Even if you're not a biotech or pharma investor, you've probably caught an earful of news lately about the virus called hepatitis C.

From last December's record-breaking launch of Gilead Sciences' wonder drug Sovaldi to the controversies about its $84,000 price tag to Merck 's recent $3.85 billion buyout of formerly neglected biotech Idenix Pharmaceuticals, hepatitis C has provided a constant supply of headlines this year.

Bloggers Corner

Lucinda K. Porter, RN
Hepatitis C Treatment and Undetectable Viral Load Results
Hepatitis C is curable. When hepatitis C is undetectable in the blood for six or more months after treatment ends, we say that person had a sustained virological response to treatment or SVR. Early studies repeatedly found that 95 to 100% of the time, hepatitis C does not return once there is an SVR. Using more sensitive tests, a study by Mark Swain and colleagues, and one by Sarah Maylin and colleagues, showed even better results with long-term SVRs in the 99.2 to 100% range...

BE INSPIRED Read Stories of Hope!
Here are some example of what people have dealt with while living with Hepatitis C.
Find support, here....

July Newsletters


http://www.projectinform.org 

Project Inform believes it is possible to create the first generation free of HIV and hepatitis C within the next decade. To achieve that dream, we focus our work in four areas: drug development, bio-medical prevention, education and health care access.

Project Inform is very pleased to announce the 2014 Hepatitis C Drug Guide, published by Positively Aware, a bi-monthly publication from Test Positive Aware Network in Chicago. The second drug guide offers a look at the standard of care for HCV in 2014. Be sure to bookmark the guide, here. HCV Drug guide begins on page 27......


FREE WEBINAR: Scaling Up Risk Based Hepatitis C Screening in the US
Project Inform will host the upcoming webinar: Scaling Up Risk Based Hepatitis C Screening in the US, presented by Andrew Reynolds, Hepatitis C Education Manager for Project Inform. Wednesday July 23, 2014 10:00–11:00am EDT 

Help Lines
HELP-4-HEP (hepatitis C helpline)
Toll-free at 1-877-435-7443 Monday–Friday, 9am–7pm (Eastern Time). 
Learn more.

HIV Health InfoLine
Toll-free at 1-800-822-7422 Monday–Friday, 10am–4pm (Pacific Time), call-back service only. English only. 

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Connect With Us


http://www.hcvadvocate.org/index.asp

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

HCV Advocate News & Pipeline Blog
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HCV Advocate Newsletter

July Issue

In This Issue:

HCV Drugs
Alan Franciscus, Editor-in-Chief

Snapshots
Lucinda K. Porter, RN

HEALTHWISE: Hepatitis C: A Global Pandemic
Lucinda K. Porter, RN


Patients First: The Right to Be Treated and Cured
Alan Franciscus, Editor-in-Chief

New At HCV Advocate
New and Improved Treatment Page! 
We have revised a portion of our fact sheet and guide page to make it easier for our audience to access all of our hepatitis C treatment information.

On the new hepatitis C treatment page you will find everything related to HCV treatment on one page— including Easy C Facts, HCSP Fact Sheets and our comprehensive Guides.
The new page features currently approved HCV medications as well as drugs in development to treat hepatitis C.

First Steps with HCV — for the Newly Diagnosed
Offers suggestions for managing the early phases of living with an HCV diagnosis.

HCV Advocate's own Alan Franciscus will host a; Hepatitis C Training Workshop in Cleveland, OH on September 25, 2014.

I heart Alan Franciscus, don't you?

HCV Advocate Eblast
Connect With HCV Advocate


http://www.hepmag.com
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and HepMag.com are the go-to source for educational and social support for people living with hepatitis.

Click below to read digital issue or use links provided to view HTML edition.

Summer Issue
In this current issue, hep C advocate Elizabeth Owens talks about grassroots activism, education and building up the courage to tackle the disease

Respect Yourself
by Oriol Gutierrez
The hep C treatment pipeline is starting to pick up at an increasing pace. 

Gilead Criticized for Sovaldi’s Sky-high Price
by Benjamin Ryan
A California medical panel has lambasted Gilead Sciences for its exorbitant, $1,000-a-pill pricing of Sovaldi.

Interferon-free Treatment Options Abound in the Hep C Pipeline
by Benjamin Ryan
Just a few years ago, treatment options were bleak for people living 
with hepatitis C virus (HCV)—especially those with advanced liver 
disease, who most urgently need a cure.

Baby Boomers Shoulder the Hep C Burden
by Benjamin Ryan
Eighty-one percent of U.S. hepatitis C cases are among baby boomers, according to new prevalence estimates from the Centers for Disease Control and Prevention.

No Link Between Hep C and Diabetes?
by Benjamin Ryan
New research has cast doubt on the presumed link between hep C and 
diabetes.

A Manifesto to Fight Viral Hepatitis
by Benjamin Ryan
In April, a consortium of federal agencies updated the Action Plan for the Prevention, Care and Treatment of Viral Hepatitis, originally drafted in 2011.

Facing Fears
by Kate Ferguson
Elizabeth Owens was frightened when she learned she had hepatitis C, but advocacy and education are building up her courage.

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

July 2014 Edition - Not Yet Published....View All Newsletters

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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.

July Newsletter  - Not Yet Published....View All Newsletters

Stay Connected

 
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. 

NYC Viral Hepatitis Monthly E-Newsletter

July Issue  

In this Newsletter
New Video PSA
Hep C: Get Tested, Get Cured!
Short video highlighting the risks of Hep C, and the importance of testing and treatment. Share widely! 
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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. 

View Current Issue (Vol. 8 No. 6 July 2014): PDF or Interactive Issue

In This Issue
Liver Diseases
Development of alcoholic hepatitis
HCC without cirrhosis is surprisingly common
Medicare to cover hep C screening 
HBV screening recommended for high-risk patients
Less risk of variceal bleed with rifaximin
Is NAFLD the cause?
NAFLD is associated with a significantly increased risk of HCC in the absence of cirrhosis, compared with hepatitis C or alcohol.

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Hep C Connections - Website
Our mission is to educate the general public about hepatitis C and to provide resources and support for those affected by the virus. Hep C Connection offers a helpline to answer your questions regarding hepatitis C (HCV). You can expect respect, patience & understanding, in clear, jargon-free language from our staff & volunteers. Call 1-800-522-HEPC (4372) today!

July Newsletter 

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Welcome to the new HCV Action website, the home of the UK’s hepatitis C professional community. Browse our tailored resource libraries, view our case study map or find out more information, here.

 The HCV Action network brings together health professionals from across the patient pathway, including GPs, specialist nurses, clinicians, drug action teams, public health practitioners, prison healthcare staff and commissioners. We provide resources for commissioners, medical and drug services professionals, promoting good practice in HCV care across the UK.Visit their new website, here. 

HCV Action Update:

Charles Gore: A Call to Action

HCV Action is committed to ensuring that hepatitis C is addressed effectively through prevention, early diagnosis, successful treatment and care. Watch our featured video for an introduction to HCV Action from Charles Gore, CEO of The Hepatitis C Trust.



People will be asked to send tweets to the hashtag #thinkhepatitis to help breakdown a wall of stigma and negative associations of the virus, which will be displayed on the world’s largest plasma screen in St Enoch’s square on the 27th and 28th of July.

Members of the public and VIP guests will be invited to come up and “press the button” to bring down the wall. When the wall comes down the screen will display key messages and the World Hepatitis Day video will be shown The event has been organised by the World Hepatitis Alliance, together with the World Health Organisation (WHO).

WHO will be running a Twitter chat on the same hashtag, with experts from around the glove answering questions from the public. Free testing will be provides on site and handing out information and answering questions. 

The event will take place between 9am – 7pm on the Sunday 27th July and 8am – 6pm on Monday 28th July.

It will be attended by Dr Stefan Wiktor, head of the hepatitis programme at WHO, as well as representatives of the Scottish government.
If you cannot make it to Glasgow, in order to make the event accessible worldwide the wall will be streamed on-line at www.worldhepatitisday.org/tweetwall. This live stream will be happening 24 hours a day over the two days.

Hepatitis Scotland, Waverly Care, Glasgow NHS and Haemophilia Scotland are also involved.

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Hepatitis C news, is an online community for those living with hepatitis C. Join us for news, views and features about hep C, read the real-life experiences of our guest bloggers, and learn about living well with the condition.

New In July

Silent and stealthy
I was diagnosed with lymphoma when I was 36 – and 24 weeks pregnant. After the birth of my son, who is now 22, I had two six-month rounds of chemotherapy before it was decided this wasn’t going to cut it with the cancer.

So I was prepared for a bone marrow transplant. My stem cells were harvested, I was given a high dose of chemo, and then I was “rescued” with my own stem cells. It was then that I was told – casually it seemed – that I had hepatitis C. It went in one ear and out the other. After all, I was about to go into an isolation room for several weeks and I had a 50% chance of ever coming out again.
Continue reading here.....

I will die of old age – not from hep C 
July 10th, 2014 Phil Younger is from Brooklyn in the US, and has had hepatitis C for more than 40 years.
Continue reading here.....

 View all HEP C News Videos, here

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Of Interest



A monthly newsletter from the National Institutes of Health, part of the U.S. Department of Health and Human Services

Featured In The July Issue

Sun and Skin 
The Dark Side of Sun Exposure
Sunlight is essential to many living things, but it also has a dangerous side. The good news is you can take simple steps to protect your skin from sun damage....
 
Too much exposure to UVB rays can lead to sunburn. UVA rays can travel more deeply into the skin than UVB rays, but both can affect your skin’s health. When UV rays enter skin cells, they upset delicate processes that affect the skin’s growth and appearance....
Read more about sun and skin

 Fight Off Food Poisoning
Food Safety for Warmer Weather
It can be hard to keep foods safe to eat during warmer weather. Learn how to handle food properly to avoid the misery of food poisoning.  

Each year, about 1 in 6 Americans get sick from tainted foods. Most foodborne illnesses arise suddenly and last only a short time. But food poisoning sometimes leads to more serious problems. Foodborne diseases kill about 3,000 people nationwide each year. Infants, older people, and those with compromised immune systems are especially at risk.
Read more about foodborne illness.

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

July/August 2014 Issue 

A Few Highlights
 
When will Medicaid begin to get the respect it deserves?
By Robert B. Doherty
Medicaid is the largest provider of government-funded health coverage in the United States, based on number of people enrolled, yet it doesn’t get as much attention as Medicare. That may soon change.
More

New drugs for diabetes, secondary prevention of CV events
By Stacey Butterfield
This update covers approval of a new drug to treat type 2 diabetes mellitus, along with diet and exercise, and of a drug to reduce risk of heart attack, stroke, cardiovascular death, and need for revascularization in patients with a previous heart attack or peripheral artery disease.
More

Understand patient expectations as part of a negotiation
By Ryan DuBosar
Both physicians and patients have a role in developing good communication.
More

Barking up the right tree
ACP Internist’s puzzle feature challenges readers to find clues placed horizontally in rows to reveal an answer written vertically.
More

Follow ACP On Twitter



What Next After Hepatitis C?
By Adrian M. Di Bisceglie, MD, FACP, AASLD President
A large amount of the growth in the field of hepatology has been spurred by developments related to hepatitis C. Thus in 1988, immediately prior to the discovery of the hepatitis C virus, AASLD had 1,103 members and approximately 1,250 attendees at our annual meeting. Last year, which in retrospect may have been the peak of interest in research on new treatments for hepatitis C, we had 4,043 members and 10,049 attendees at The Liver Meeting®.

So, will this growth continue? Certainly we will continue to see presentations and publications about new drug regimens for at least a few more years. Furthermore, I expect studies to be conducted in special populations such as those with decompensated cirrhosis, post-transplant (liver and kidney), and patients with HIV- and HBV co-infection. There will be a growing focus on public health attempts to identify individuals with hepatitis C and treat them in an efficient and cost-effective manner. Cases of HCC are expected to continue among patients with cirrhosis, albeit at a lower rate after effective antiviral treatment. 

But the leadership of AASLD has already begun to look beyond hepatitis C. The problem of NASH and NASH-related cirrhosis and hepatocellular carcinoma is staring us in the face – there appear to be promising treatments for the liver disease, but one wonders if the focus should not be more on risk modification so as to prevent NASH by more effectively treating and preventing diabetes and obesity. We have ongoing work for treatment of hepatitis B and a variety of rarer diseases.

It is my own personal view though, as a practicing hepatologist, that we have not paid enough attention to preventing and treating the complications of cirrhosis, whether caused by hepatitis C that was treated too late, or autoimmune diseases, alcohol, or NASH. Cirrhosis continues to be the leading cause of liver failure which results in either transplantation or death. Why do we not have more effective treatments for hepatorenal syndrome? Why is terlipressin not approved for this indication in the United States? Beta blockers are a decades-old innovation to prevent variceal bleeding but so many patients do not tolerate beta blockers at appropriate doses, so why have we not done more to find alternatives to this therapy? As another example, primary sclerosing cholangitis is an example of a condition that is not infrequent where we seem helpless when it comes to prevention and treatment, other than offering liver transplantation in its later stages.

Through programs and events such as The Liver Meeting®, AASLD will continue to support basic and clinical research in these areas, both by providing a forum for timely exchange of information and also through financial support for research in these areas, with the assistance of the AASLD Foundation. We are planning on establishing a colloquium with industry to talk about remaining problems in liver disease – this will start with an Emerging Trends Conference to be held in 2015 where AASLD will share the podium with researchers from the pharmaceutical industry as we seek new cures for neglected diseases.

Stay healthy and happy, see you all when I return.

Always Tina 

Factors Influencing Adherence in Hepatitis-C Infected Patients

Factors Influencing Adherence in Hepatitis-C Infected Patients

A Systematic Review

Tim Mathes, Sunya-Lee Antoine, Dawid Pieper

BMC Infect Dis. 2014;14(203)

Abstract
Background: Adherence is a crucial point for the successful treatment of a hepatitis-C virus infection. Studies have shown that especially adherence to ribavirin is important.

The objective of this systematic review was to identify factors that influence adherence in hepatitis-C infected patients taking regimes that containing ribavirin.

Methods: A systematic literature search was performed in Medline and Embase in March 2014 without limits for publication date. Titles and abstracts and in case of relevance, full-texts were screened according to predefined inclusion criteria. The risk of bias was assessed. Both process steps were carried out independently by two reviewers. Relevant data on study characteristics and results were extracted in standardized tables by one reviewer and checked by a second. Data were synthesized in a narrative way using a standardized procedure.

Results: Nine relevant studies were identified. The number of analyzed patients ranged between 12 and 5706 patients. The study quality was moderate. Especially the risk of bias regarding the measurement of influencing factors was mostly unclear.

"Psychiatric disorders" (N = 5) and having to take "higher doses of ribavirin" (N = 3) showed a negative influence on adherence. In contrast, a "HIV co-infection" (N = 2) and the "hemoglobin level" (N = 2) were associated with a positive influence on adherence. Furthermore, there is the tendency that male patients are more adherent than female patients (N = 6). "Alcohol consumption" (N = 2), "education", "employment status", "ethnic group","hepatitis-C virus RNA" (N = 4), "genotype" (N = 5), "metavir activity" (N = 1) and "weight" (N = 3) showed mostly no effect on adherence. Although, some studies showed statistically significant results for "age", "drug use", "genotype", "medication dose interferon", and "treatment experience" the effect is unclear because effect directions were partly conflicting.

The other factors were heterogeneous regarding the effect direction and/or statistical significance.

Conclusion There are some factors that seem to show an influence on adherence. However, due to the heterogeneity (e.g. patient characteristics, regimes, settings, countries) no general conclusions can be made. The results should rather be considered as indications for factors that can have an influence on adherence in hepatitis-C infected patients taking regimes that containing ribavirin. 

Discussion Only
Full Text Available @ Medscape 
This is the first review that systematically analyzes adherence influencing factors in hepatitis-C infected patients taking ribavirin. There are several factors that seem to influence adherence in hepatitis-C infected patients taking ribavirin. "Psychiatric disorders/depression", "higher doses ribavirin" seem to have a negative influence on adherence. In contrast "HIV co-infection" and "hemoglobin level" seem to have a positive influence on adherence. Furthermore, there is the tendency that male patients are more adherent than female patients. "Alcohol consumption", "education", "employment status", "ethnic group", "hepatitis-C virus RNA", "genotype", "metavir activity" and "weight" seem to have no effect on adherence. The remaining the results differed between studies.

The findings are in accordance with research findings for other indications. A meta-analysis found a statistically significant negative effect of depression on adherence in chronic conditions.[28] This might be attributable to a reduced motivation in depressed patients. The question is therefore, whether the treatment of the psychiatric disorder can help to increase adherence.

The negative influence of higher doses ribavirin on adherence is probably caused by the higher risk of side effects. For example, systematic reviews in HIV infected patients have shown that side effects are a predictor for non-adherence.[29,30] The assumption that ribavirin intake can be associated with depression is justified. A low hemoglobin level is associated with fatigue which can possibly result in low motivation to take medication. Furthermore, also a low hemoglobin level and respectively the associated fatigue is a possible side effect of ribavirin. Therefore, the hemoglobin level is perhaps also an indicator for side effects.

The two studies that analyzed the influence of an HIV-co-infection are adjusted for drug use.[8,24] The reason why this confounder is adjusted for the positive effect of an HIV-co-infection might be due to the experience in handling complex treatment regimens in HIV-infected individuals. Furthermore research has indicated, that access to care is higher in co-infected individuals.[31]

Due to the heterogeneity no general conclusions can be made that can be applied to all settings, countries, patient groups, etc. This pertains also for the factors that were highlighted as having an influence, The results should rather be considered explorative as indications for factors that can have an influence on adherence in hepatitis-C infected patients treated with regimes that contain ribavirin. To be of sufficient significance to make decisions in clinical practice, the factor/s has/have to be evaluated in detail for the specific context of the decision. The main reasons for heterogeneity between studies are the sample size, the analyses methods, different regimens and different patient characteristics. Furthermore, all studies revealed methodological flaws. In particular the measurement of influencing factors was mostly unclear. Also the time point of measurement can have an influence on adherence. A more recent study shows that at the first measurement time point younger age and African American ethnicity were statistically significant associated with lower ribavirin adherence. At the second measurement time point these factors were not statistically significant anymore, but publicly insured and employed patients showed a statistically significant effect in ribavirin adherence.

The measurement of adherence is performed with various instruments. All types of the applied adherence measurement instruments are associated with the tendency to overestimate adherence.[32] Most studies use self-reports. In particular for self-reporting instruments a higher estimation of intake rather than the true adherence rate has been shown.[32] Indeed pill counts and prescription refill are a more objective adherence measures but also these measurement methods imply the tendency to overestimate adherence (e.g. trashing tablets). In none of the included studies timing adherence was assessed. Thus, for example compensating one missing ribavirin tabled by double taking on another day would not have been revealed. However, for a more detailed and precise assessment usually additional effort is necessary which is often not feasible in clinical practice.

To have a substantial virologic response, patients have to reach a certain adherence level. Taking this into account, the proportion of patients reaching this cut-off value should be chosen as the operationalization of adherence, instead of the mean of the entire trial population, as the overall mean does not allow for a clinically significant estimation of how many patients can reach the required adherence. To our knowledge, a precise lower bound of required adherence (dose and timing) for an adequate suppression of RNA replication has not yet been proven.[7] Thus, the cut-off values used in the studies are not proven. It has to be taken into account that also the variation between patients and regimens should be analyzed in detail in this context because the needed adherence to reach a substantial virologic response probably depends on patient characteristics and/or the regimen. Furthermore, prior research has shown that a categorization of variables can result in different predictors in prognostic models and in poor performance of the model.[33] However, the mean adherence is only used as operationalization for adherence in two studies.[4,23] Apart from this, it is unlikely that adherence is influenced by only one factor but it is rather a multifactorial problem.[9]

The different adherence operationalization and measurements are furthermore a limitation for the comparability of results and probably one reason for different results regarding the statistical significance and effect direction between studies. But also the influencing factors differ regarding operationalization and measurement. For example in all studies age is operationalized in two categories or continuously. However, studies on other indications have shown that adherence presents a concave shape i.e. adherence is highest in the middle age and declines with younger or older age.[34] Such information is lost (no statistically significant results) if e.g. only two categories are used or age is treated as a continuous variable. The effect of different categorizations for the same influencing factor on the results is analyzed in none of the included studies (sensitivity analysis).

Another comparability limiting point is that the analyses are adjusted for different factors. Especially the unadjusted analysis should be interpreted with caution because confounders or effect modifiers are not accounted for. But also the multivariate analyses are adjusted for different factors and consequently the comparability is limited. Although, it was sought to consider confounding in the evidence synthesis, i.e. to identify factors that are independently associated with adherence, a risk of bias in the results cannot be excluded.

In two studies, variables that do not contribute to the explanation of the variance of adherence were not eliminated from the analysis. Consequently the probability of statistically non-significant results due to inter-correlation might be raised.[25,35] In the other multivariate analyses indeed the model is fitted by eliminating variables without a statistically significant influence on adherence. However, in none of the multivariate analysis the inter-correlations (e.g. drug use and alcohol use) between influencing factors were analyzed. Thus, variables that measure basically the same phenomena (e.g. mental illness) probably show no influence in the analysis, because most of the variance in adherence is explained by one factor (e.g. drug use) leaving little potential for explaining additional variance in adherence by adding the other factor (e.g. alcohol use). The actual influencing factor or underlying phenomena can therefore be concealed. In addition some factors that have shown an influence in other conditions like copayments and other barriers to access to care were not analyzed in any of the included studies.[36]

The observed high adherence rates in some studies suggest a "ceiling effect". A high overall adherence level implies that adherence differences become marginal. Probably the high adherence is due to the fact that patients participating in studies are often more adherent than those patients, who refuse study participation.[37] Furthermore, it can be presumed that access to medication is ensured for study participants. The high baseline adherence implies that a large sample size is needed to show statistical significance of the results. However, most studies were small and thus probably underpowered.

The presented systematic review has some limitations. Firstly, missing relevant literature published in other languages could not be excluded because we included only English and German literature.[38] Secondly, we did not evaluate the quality of registry data in register based studies. The extent of this source of bias is therefore unknown. Thirdly, we did not evaluate the risk of bias for each individual factor, because in most studies for none of the factors the measurement was described in detail and consequently all factors would have had to be rated with unclear risk of bias. But an unclear risk of bias was judged differently depending on the factor in the evidence synthesis (e.g. age vs. social support).

In this systematic review only implementation adherence to antiretroviral hepatitis-C therapy was considered because, persistence and implementation adherence should been analyzed separately.[15] It could be hypothesized that early implementation non-adherence is associated with discontinuation. However, in a study that analyzed many various potential influencing factors only younger age showed an influence on discontinuation and also on ribavirin implementation adherence. Another study showed no statistically significant association between adherence and cannabis users, but cannabis users were statistically significant more likely to continuing treatment.[25] Also other studies indicate that the factors influencing implementation adherence and discontinuation differ. Thus, this systematic review indicates an association between depression and adherence.[39] Again, a study on the influence of depression on discontinuation in intravenous drug users found not statistically significant association. Another study showed a statistically non-significant influence of drug addiction and a non-significant effect of psychiatric deterioration on discontinuation.[40] Also these results were contrary to the presented results for implementation adherence.

In clinical practice the factors can be an indication for non-adherence, especially if various factors pertain in one patient. Due to the explorative nature of our analysis, adherence influencing factors in hepatitis-C infected patients receiving combination therapy with ribavirin should further be investigated to get deeper insights into the reasons for non-adherence. Detailed knowledge of adherence influencing factors would facilitate the identification of patients at risk for non-adherence e.g. the development of screening tools for non-adherence. The knowledge of adherence influencing factors can also contribute to the development of tailored, multifactorial adherence enhancing interventions.

Continue reading @ Medscape