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Alan Franciscus

Editor-in-Chief

HCV Advocate



Thursday, August 6, 2015

Patients First: HCV and Depression, by Alan Franciscus, Editor-in-Chief

In January 2015, I wrote about HCV and Depression.  Since that time, I have thought a lot about the link between depression and hepatitis C.  There does seem to be a pretty strong link between the two.  Add on to that just having a chronic disease, such as hepatitis C, it is not surprising that many people with hepatitis C are depressed.   

If you think about it there are many additional issues that increase the level of anxiety and depression that people with hepatitis C are now facing even more than before:  
  • Will I be approved for the new medications by my insurance company?
  • Will I be approved for treatment through a patient assistance program?
  • Will I be able to afford the co-pays?
  • Will the treatment work?
  • What if I am not cured?
  • What does my future hold?
  • Will I be able to work?
There are also people, unfortunately, who have just given up and believe they have no choice at all—no insurance, no physician, no future. 

The list of uncertainties could go on and on and on. 

I’m bringing this up because I just recently ran across an article that startled me because it discussed Baby Boomers (without HCV) and the increased risk of suicide—Baby Boomers are at the highest risk for suicide and the risk increases as a Baby Boomer ages.   Additionally, the suicide rates were much higher in men than in women—In 2013, 78% of the 41,149 suicides in the U.S. were among men.  

Note:  Among Baby Boomer’s with HCV more than 2/3 are men.  

Remember, depression is an illness that is treatable.  There are resources at the end of this article and a link to the original article published in January 2015. 

I hope that people with HCV and their caregivers will be on the look-out for the signs of anxiety, depression and suicidal behavior to offer support.  Be sure to get professional help as needed.

Resources

Source:
Baby boomers are killing themselves at an alarming rate, raising question: Why?


http://hcvadvocate.org/news/newsLetter/2015/advocate0815.html#5

Wednesday, August 5, 2015

FDA Safety Alert: NSAIDS

The Food and Drug Administration (FDA) has issued a communication strengthening an existing warning label that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. This includes prescribed and over-the-counter non-aspirin NSAID labels.

Many people with hepatitis C suffer from extrahepatic conditions of hepatitis C and may take NSAIDs or medications that contain NSAIDs.

In a related story it was found there was an increased risk of intracranial bleeding when taking non-steroidal anti-inflammatory drugs (NSAIDs)—ibuprofen and aspirin—during the first 30 days of taking a new prescription of an anti-depressant.  This was more common in men than in women.  (BMJ. Published online July 14, 2015.)

Read this FDA communication carefully. Talk with your medical provider about what you should take, how often and what are the alternatives that are safe to take.

http://www.fda.gov/Drugs/DrugSafety/ucm451800.htm

Canada: Diane Parsons, who fought for hepatitis C victims, dead at 64

Diane Forsyth, better known under maiden name, Diane Parsons, famed for leading legal fight for those infected with hepatitis C from tainted blood transfusions.
 
HALIFAX — A Halifax woman who led a $1.18 billion class-action settlement for those infected with hepatitis C died Saturday at the age of 64.

Diane Forsyth became known nationally under her maiden name, Diane Parsons, for leading the legal fight for those infected with hepatitis C from blood transfusions.

Her family doctor, Patricia Beresford, said Forsyth, who had a bleeding disorder, became ill after getting a blood transfusion before dental surgery in 1989.

Snapshots, by Alan Franciscus, Editor-in-Chief

Article:  Treatment with ledipasvir and sofosbuvir improves patient-reported outcomes: Results from the ION-1, -2, and -3 clinical trials—ZM Younossi—et. al
   Source: Hepatology 2015 Jun;61(6):1798-808. doi: 10.1002/hep.27724. Epub 2015 Mar 18.

Results and Conclusions:  In the phase 3 clinical trials of ledipasvir and sofosbuvir with and without ribavirin patient report outcomes were measured.  There was a total of 1,952 patients in the study.  Patients were treated for 8, 12 or 24 weeks. In the groups that received ledipasvir and sofosbuvir (without ribavirin) who had early viral load suppression there was improved quality of life that was maximized by the end of treatment.  In the group that received ledipasvir/sofosbuvir and ribavirin their quality of life decreased regardless of treatment duration until the end of treatment. 

The Bottom Line:  Ribavirin during treatment reduced quality of life, but achieving a cure improved quality of life for all of the groups including the groups who received ribavirin.
 
Editorial Comments:  This is a no-brainer, but we need more of these studies to show that being cured improved quality of life and improved overall survival.  I hope that insurance companies are hearing this and loosen up the restrictions.

Article:  Antigenic cooperation among intrahost HCV variants organized into a complex network of cross-immunoreactivity—P Skums
  Source: Proc Natl Acad Sci USA. 2015 May 26;112(21):6653-8.doi:10.1073/pnas.1422942112. Epub 2015 May 4.
 
Results and Conclusions:
Most people who become acutely infected with hepatitis C become chronically infected – up to 85%.  The reason there is such a high rate of chronic infection is not completely understood, but there are many theories.  The current paper presented a mathematical model to show how the virus contributes to hepatitis C chronicity. 

What is interesting is that various proteins of the hepatitis C virus seem to act together to escape the human host—that is certain proteins of the virus work together to draw off parts of the immune system cells so that other parts of the hepatitis C virus can survive and persist in the body and infect liver cells. This enables the hepatitis C virus to act as a network of parts to establish a chronic infection.   

The Bottom Line:  As with any discovery in science these findings need to be replicated.  If the exact mechanism can be understood an effective protective vaccine could be developed. 

Editorial Comment:  Isn’t science interesting?  The hepatitis C virus is a wily little bugger and endlessly fascinating.  The key would be to understand why this strategy works for some and not others.   This could lead to the development of an effective vaccine.
 
Article: Differentiation of acute from chronic hepatitis C virus infection by nonstructural 5B deep sequencing: A population-level tool for incidence estimation—V. Montoya et. al
   Source:  Hepatology Volume 61, Issue 6, pages 1842–1850, June 2015
 
Results and Conclusions:  In the current study the authors examined the viral proteins from 13 acute and 54 chronic individuals by sequencing the NS5B region of the virus.  They were able to differentiate the viral diversity between the acute and chronic infection.  The viral diversity was significantly different between acute vs. chronic infection. 
 
Editorial Comment:  This and the last issue of the HCV Advocate have discussed the difficult task of trying to diagnose an acute infection of HCV.  If this study is replicated and IF the tool is made available at a reasonable cost it could be a game changer in the way we understand how many people are acutely infected with hepatitis C.

Source:  http://hcvadvocate.org/news/newsLetter/2015/advocate0815.html#3

House Passes Two Historic VA Reform Bills

WASHINGTON, DC – Today, the House passed two pieces of VA reform legislation. The VA Accountability Act of 2015 passed with a vote of 256 – 170. The Surface Transportation and Veterans Health Care Choice Improvement Act of 2015 passed with a vote of 385 – 34. Chairman Miller released the following statement:

“I applaud my colleagues for stepping up today to address the troubling lack of accountability eroding VA’s ability to care for our veterans. The VA Accountability Act will provide the Secretary of the Department of Veterans Affairs the ability to make real reforms and bring much needed accountability to the department. Today, we stand with our veterans because the status quo has failed them and the American people for far too long.

“Just over two weeks ago, the Department of Veterans Affairs announced that because of its inability to budget, VA hospitals around the country would be shutting down in August. Today, the House passed the Surface Transportation and Veterans Health Care Choice Improvement Act of 2015 to ensure that does not happen. The bill is designed to rescue a mismanaged VA, providing the resources to keep the doors open, expanding access and choice to veterans and setting the stage to consolidate VA’s uncoordinated and wasteful non-VA care programs into the Veterans Choice Program.

“I urge the Senate to take up both these measures immediately. We cannot allow VA’s incompetence to continue to harm America’s veterans. And I sincerely ask President Obama to sign both in to law – to take the money without the accountability will only lead to continued failure.” – Rep. Jeff Miller, Chairman, House Committee on Veterans’ Affairs


Related:
Chairman Miller’s Floor Statement on The VA Accountability Act of 2015

Chairman Miller’s Floor Statement on The Surface Transportation and Veterans Health Care Choice Improvement Act of 2015

Tuesday, August 4, 2015

Ireland: The psychological effects of hepatitis C: 'It was a dirty and uneasy feeling and it began to haunt me'

It was in the early noughties when I first got my bloods tested. I wasn't even thinking about hepatitis C at that time, that wasn't on my radar at all. To be honest, I only got tested because a number of other people in the methadone clinic I attended at that time were getting tested. I had no idea that test would turn out to be the turning point in my life and the reality check that I needed.

At this point, my lifestyle was chaotic. This was down to my misuse of drugs and the type of life that comes with taking that path.

My issues with addiction started very early on, when I was 14. Like many others from my area at the time, peer pressure to do drugs was a big issue - like many teenagers I suffered from low self-esteem and drugs were an appealing way to 'fit in'.

Read more...

A Brief Overview: Outbreaks of Acute HCV Infections in the U. S., by Alan Franciscus, Editor-in-Chief

In this review, I will discuss the outbreaks of acute infections of hepatitis C across the United States in urban and rural centers. 

Before I start discussing this very important issue, I would like to set the stage by going over the case definition of hepatitis C (HCV) acute infection as defined by the Centers for Disease Control and Prevention (CDC): 
“Laboratory-confirmed infection with infection with acute illness of discreet onsite.  An acute illness is considered as the presence of any sign or symptom of acute viral hepatitis plus either jaundice or elevated alanine aminotransferase >400 IU/L. In 2012, the surveillance case definition was expanded to include cases with negative HCV antibody followed by positive antibody within six months.”
To me there are problems with the CDC case definition.  Regarding the first part of the definition—an estimated two-thirds of people acutely infected have few or no symptoms.  This means that they are missing the majority of people who are acutely infected with HCV.  The new case definition regarding prior antibody testing is better, but it does not accurately capture people who are new to injecting drugs or people who have never been tested for hepatitis C.  However, it is understandable how difficult it is to set the criteria to define an acute infection.   Note:  In “Snapshots” this month there is a recap of a study that may provide a test to identify acute cases of HCV.

In the July 2015 HCV Advocate Mid-Monthly Edition, I wrote about an article published in the Annals of Internal Medicine titled “Underascertainment of Acute Hepatitis C Virus Infections in the U.S. Surveillance System: A Case Series and Chart Review,” by S Onofrey, MPH et. al.  The authors concluded that only 1% of acute infections has been reported to the CDC based on their case definition.  Keep the 1% in mind when reading the information below. 

Massachusetts
In July 2011 I wrote about the Massachusetts outbreak of acute HCV among young people who inject drugs.  In the CDC report Massachusetts initiated a comprehensive surveillance system and identified 1,925 new cases of HCV infections among people aged 15-24 years during 2007 to 2009.  Of these cases, 1026 were confirmed new hepatitis C infections and the remaining cases were classified as probable.  It was also interesting that the new hepatitis C infections were not just confined to the major metropolitan and suburban areas of Boston, but high rates were also found in smaller cities and rural areas.  It was also reported that the incidence of new HCV infections were similar in women and men and were seen mostly among non-Hispanic whites.  In the analysis, 72% of the people reported current or past injection drug use.  Among the people who self-disclosed that they injected drugs—85% used heroin, 29% cocaine, 1% methamphetamine and 4% had used other drugs.  Some of the characteristics seen in the Massachusetts outbreaks —rural, young, mostly White using heroin—were the beginning of a trend seen throughout the country. 

Massachusetts has an extensive network of needle exchanges.  One can only imagine what the number of acute infections would be without a needle exchange network.

Wisconsin
In “Notes from the Field:  Hepatitis C Virus Infections Among Young Adults—Rural Wisconsin, 2010,” a report from the CDC issued on May 18, 2012 /61(19);358-358 a number of outbreaks in rural counties of Wisconsin were discussed.  It was reported that in 6 contiguous rural counties of Wisconsin that in persons under 30 yo that the number of HCV infections had increased from an average of 8 cases per year during 2004 – 2008 to an average of 24 cases per year during 2009 – 2010. 

The CDC investigated 25 cases during 2010 of the adults under 30 years old who resided in the 6 counties.  Of these patients 7 had jaundice (a rare symptom of acute HCV).  All 21 had positive antibody tests.  Twenty-one had positive EIA with signal-to-cutoff ratio or had a test to confirm the presence of HCV RNA (viral load test).  Additionally, seventeen patients were interviewed. Of the patients who were interviewed (17 pts) 94% had either injected drugs, snorted drugs or both.
The age group that had the highest prevalence was those 20-29 yo, which is a national trend of people who inject drugs in rural areas. No information about the sex of the patients was given in the report.  

Ohio
In Ohio, the number of confirmed cases of acute cases HCV was 112 in 2013 and 105 in 2014.  The demographics are similar to the demographics in other outbreaks across the U.S. —mostly white, equally divided among gender and many of the acute cases occurred in rural settings. 

Indiana
The May 1st issue of the Morbidity and Mortality Weekly Report (MMWR), contained “Community Outbreak of HIV Infection Linked to Injection Drug Use of Oxymorphone—Indiana, 2015, by C Conrad,” which describes a recent outbreak of HIV and HCV in a rural community of Indiana.  On January 23, 2015 the Indiana State Department of Health began an investigation on an outbreak of HIV after 11 cases were reported and confirmed.  Although little attention was given to HCV there was a confirmed HIV/HCV coinfection rate of 84.4%!  All of the people who injected drugs reported crushing, dissolving and injecting oxymorphone tablets as well using other drugs including methamphetamine and heroin.  The total number of people who tested positive for HIV was 135.  The community in rural southeastern Indiana had a population of 4,200.  The age range was 18 to 57 yo (median 35 yo), 54.8% were male.  

The response to the outbreak is best summed up by a statement in the MMWR: “A public health emergency was declared on March 26 by executive order.  The response has included a public education campaign, establishment of an incident command center and a community outreach center, short-term authorization of syringe exchange, and support of comprehensive medical care including HIV and hepatitis C virus care and treatment as well as substance abuse counseling and treatment.”  Hopefully, the ‘short-term’ will be changed to ‘permanent.’

Maine
On July 6, 2015 the Portland Press Herald reported on a surge of hepatitis C cases: during 2013 to 2014 the incidence of acute HCV increased from 9 to 31 cases and there were 14 cases in the first 6 months of 2015.   The users who were interviewed stated that they had started with opiates like Oxycontin and switched to heroin. This is a recurring theme.   Maine has 5 needle exchange programs.  

Kentucky, Tennessee, Virginia and West Virginia (2006-2012)
The CDC released an MMWR report on May 8, 2015 titled “Increases in Hepatitis C Virus Infection Related to Injection Drug Use Among Persons Aged ≤ 30 Years –Kentucky, Tennessee, Virginia, and West Virginia, 2006—2012,” by J E Zibbell and Colleagues detailing the outbreaks in the Appalachia region of the U.S.   

A total of 1,377 cases of acute HCV were reported to the CDC during the period 2006-2012 from Kentucky, Tennessee, Virginia and West Virginia.  There were 1,374 cases reported where the age was available—616 (44.8%) were ≤ 30 yo (median age 25 yo—range in urban and non-urban 6-30 yo).

The number of persons who were non-Hispanic whites in non urban settings was 247 (78.4%); males, 156 (49.5%); in urban counties, 249 (82.7%) cases were non-Hispanic whites, and 155 (51.5%) were males. See Figure 1 below.   

Comments:  The trend of acute HCV outbreaks that started in Massachusetts is continuing across the United States.  This includes more adolescents and young adults injecting, infecting as many women as men and in rural more than urban settings.   What is even more disturbing is the reaction of the local and state governments—needle exchange being started post-outbreak rather than establishing needle exchange as prevention.  Almost every outbreak has resulted in the establishment of a needle exchange program after an outbreak.  If needle exchange programs had been in place before an outbreak many of the HIV and HCV infections could have been prevented. 

Figure 1
Figure 1.  Incidence of acute hepatitis C among persons ≤ 30, by urbanicity and year –Kentucky, Virginia, Tennessee, and West Virginia, 2006 –2012.

Source:  http://hcvadvocate.org/news/newsLetter/2015/advocate0815.html#1