Hepatitis C: The Problem with Numbers, by Alan Franciscus, Editor-in-Chief

Originally Published July 15, 2015

A recently released journal article estimated that the real number of acute hepatitis C cases are much higher than the figures published by the Centers for Disease Control and Prevention (CDC).  This is not a revelation to those who work in HCV.  In this article, I will discuss the published numbers of acute and chronic HCV and what some experts believe is a better estimate of the number of acute, chronic and annual deaths caused by hepatitis C.

Acute
The CDC estimated that there were 29,700 acute cases of HCV in 2013 (range 23,500 to 101,400).  In the article, “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., published in the Annals of Internal Medicine, the authors challenged the way the CDC defined an acute case and compared the actual diagnosed cases to the number of diagnosed cases that fit the CDC definition. 

Note:  There are many problems with diagnosing acute HCV—there are no viral markers to distinguish acute vs. chronic.  Another issue is that most people acutely infected have no symptoms.

The current study took place in Massachusetts from 2001 to 2011.  There were 183 patients diagnosed with acute HCV, but only 149 cases were reported to the Massachusetts Department of Public Health.  Of these, 130 were classified as potential acute infection.  But only ONE met the national case definition that was reported to the CDC.  

This means that only 1% of acute HCV cases were ever reported to the CDC.  We know that there have been outbreaks of acute HCV around the country including recent outbreaks in regions in or near the Appalachia area. 

Chronic Hepatitis C
The CDC estimated that in 2013 there were 2.7 to 3.9 million people who were chronically infected with hepatitis C.  However, the NHANES survey doses not count certain populations such as prisoners, homeless, nursing home residents, people in mental institutions, nor active duty military—many of these populations have a very high incidence of hepatitis C.  If the populations that were excluded from the NHANES survey were to be included the number of people with chronic hepatitis C could reach 5 million Americans. 

Also if you include the surge of the new acute infections that would turn chronic this would also increase the total chronic infections.  It is all connected. 

HCV Deaths
The CDC estimated that there were 19,368 deaths caused by HCV in 2013.  There was also a footnote that read “Current information indicates these represent a fraction of deaths attributable in whole or in part to chronic hepatitis C.” 

Another article, “Mortality among Persons in Care with Hepatitis C Virus Infection—The Chronic Hepatitis Cohort Study (CHeCS), 2006–2010,” by R Mahajan and colleagues, was published in Clin Infect Disease 2014 Jun; 59(12)1792.  The study estimated the number of deaths caused by hepatitis C

In the study, 2,143,369 patients (MCOD group—all patients) seen between 2006 – 2010 at the CHeCS clinics were included in the analysis.  There were 11,703 (0.5%) HCV patients.  A total of 1,590 (14%) died and had HCV listed as the cause of death.  The majority were born between 1945 and 1965 (75%), white (50%), and male (68%).  The mean age was 59 yo. 

To illustrate why HCV is under reported on death certificates the following was mentioned in the study:

“Among the 1590 CHeCS members who died, only 306 (19%) had HCV infection listed as an underlying cause on their death certificate. Among people who died of liver cancer, only 32% had HCV listed as an underlying cause. Death certificates did not list HCV for most deaths regardless of whether the deaths were liver-related or not. Among CHeCS members who died, medical records (ICD-9 codes) noted liver disease in 63%, and FIB-4 scores indicated liver disease in 76%.”

The conclusion of the authors was that in 2010 listed deaths from hepatitis C only represent 1/5 of the 80,000 people with HCV who died that year—this figure includes 53,000 patients who had indications of chronic liver disease in their medical records. It’s important to remember that behind all these numbers are real people who have family, friends and loved ones.  As such they deserve to have medical care and treatment. And no one should die of hepatitis C!

http://hcvadvocate.org/news/newsLetter/2015/advocate0715_mid.html#1

'Sensational' HCV response rates in HIV coinfection trial

Researchers in the C-EDGE study found that a combination of a protease inhibitor and an NS5A inhibitor led to a sustained virologic response in patients infected with both HIV and hepatitis C virus (HCV).

Researchers in the C-EDGE study found that a combination of a protease inhibitor and an NS5A inhibitor led to a sustained virologic response in patients infected with both HIV and hepatitis C virus (HCV). Jurgen Rockstroh, MD, of the University of Bonn in Germany, reported that the sustained virologic response was 96.3% overall after stopping treatment for 12 weeks. The response rate for the 35 patients with cirrhosis at baseline was 100%. Of the study's 218 patients, two experienced a relapse after stopping therapy, but both had been reinfected with HCV. The Phase III study included patients infected with HCV genotypes 1, 4, or 6, and HIV. All patients received grazoprevir 100 mg and elbasvir 50 mg, which were coformulated by Merck into one tablet that was taken once daily for 12 weeks. No patients experienced any serious drug-related adverse events during the study. The results were presented at the International AIDS Society Conference in Vancouver.

Read more...

Urban ERs see high rates of hepatitis C infection

American College of Emergency Physicians

WASHINGTON --An urban emergency department that set up a hepatitis C testing protocol saw high rates of infection among intravenous drug users and Baby Boomers, with three-quarters of those testing positive unaware they were infected. The results of a screening and diagnostic testing program for hepatitis C were reported online Tuesday in Annals of Emergency Medicine ("Results of a Rapid Hepatitis C Virus Screening and Diagnostic Testing Program in an Urban Emergency Department").

"Given skyrocketing rates of injection heroin use around the country, we expect the already high rates of hepatitis C infection to explode," said lead study author Douglas White, MD, of Highland Hospital, Alameda Health System in Oakland, Calif. "Intervention by emergency departments, in the form of screening and referral for treatment, could help slow the spread of this potentially deadly, communicable disease."

Researchers tested 10 percent of emergency department patients for hepatitis C virus (HCV), mostly but not exclusively focusing testing on those considered high-risk, such as intravenous drug users, Baby Boomers and patients with unspecified liver disease. Of patients tested, 10.3 percent tested positive for HCV, with 70 percent of those confirmed as chronically infected. Only 24 percent of patients who tested positive for the virus had prior knowledge of HCV infection.

Hepatitis C virus is the most common chronic blood-borne infection in the U.S., affecting an estimated 3 million people and is a leading cause of end-stage liver disease, liver cancer and liver transplants. It is estimated that HCV prevalence in the United States among people born between 1945 and 1965 (the "Baby Boom") is as high as 4 percent. Baby Boomers account for 75 percent of people living with HCV infection and as many as 1.75 million of them do not know they are infected.

"In addition to the myriad public health functions they already perform, urban emergency departments may play an important role as safety net providers for HCV screening," said Dr. White. "We have a better than even chance of reaching many of the three million people who are infected since they tend to be heavy emergency department users already. It gives us a chance to connect these people to ongoing care at HCV clinics or elsewhere in the health care system."

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Annals of Emergency Medicine is the peer-reviewed scientific journal for the American College of Emergency Physicians, the national medical society representing emergency medicine. ACEP is committed to advancing emergency care through continuing education, research, and public education. Headquartered in Dallas, Texas, ACEP has 53 chapters representing each state, as well as Puerto Rico and the District of Columbia. A Government Services Chapter represents emergency physicians employed by military branches and other government agencies. For more information, visit http://www.acep.org.

Press Release Source:  http://www.eurekalert.org/pub_releases/2015-08/acoe-ues080615.php

World Hepatitis Day: The transformation and enduring struggles of HCV treatment

In August 2012, the big news in the hepatitis community was a new set of CDC guidelines recommending that all Baby Boomers (those born between 1945 and 1965) receive a hepatitis C test. According to the CDC, at that time, more than two million U.S. baby boomers were infected with hepatitis C (HCV), representing approximately 75% of all HCV-infected individuals and the vast majority of the 15,000 people who would die of HCV-related causes that year.

The goal of universal testing for this age cohort was to help identify more than 800,000 additional HCV-infected individuals, who had not yet been diagnosed.

A lot has changed in the last two and a half years. "With the new treatments, people are excited about being treated and cured," Alan Franciscus, founder and executive director of the Hepatitis C Support Project and editor-in-chief of the HCV Advocate, told BioPharma Dive in an interview. "Prior to the approval of interferon-free therapies, there was usually a reluctance from patients—maybe a better word is fear—of treatment."

Read more...

AASLD/IDSA release updated HCV treatment guidelines

The AASLD and IDSA HCV Guidance Panel has released updated guidelines for the treatment of hepatitis C virus infection, according to newly published data in Hepatology.
AASLD/IDSA HCV Guidance Panel. Hepatology. 2015;doi:10.1002/hep.27950.
 
“The goal of the hepatitis C guidance is to provide up-to-date recommendations for HCV care practitioners on the optimal screening, management, and treatment for adults with HCV infection in the United States, using a rigorous review process to evaluate the best available evidence,” the researchers wrote. “This review provides a condensed summary of recommendations from the guidance.”

The panel, which included HCV Next Editorial board members Arthur Y. Kim, MD, and Michael R. Charlton, MD, and HCV Next Co-Chief Editor Michael S. Saag, MD, used an evidence-based approach to review available information for the HCV guidance. Sources of information included peer-reviewed research; FDA research and safety information on products; manufacturer information; drug interaction data; prescribing information from FDA-approved products; and more.

Key recommendations were outlined in various topics: HCV testing and linkage to care, when and in whom to begin HCV therapy, the initial treatment of HCV, treating unique patient populations, HIV/HCV coinfection and acute HCV.

Download the Practice Guidance here (PDF)

Source:  http://www.healio.com/hepatology/hepatitis-c/news/online/%7Bb26d77d8-268d-49de-b524-e5e01d669a71%7D/aasldidsa-release-updated-hcv-treatment-guidelines

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

• HCV and Depression: HCV Advocate, January 2015
• Easy C Guide to Depression
• Help‑4‑Hep
• Coping with Depression and Hepatitis C. 
• Overview of Depression
• Depression: Self-Help Tips
• HCV and Depression
• HCV and Mental Health Resources
• Managing Depression
• Medical Treatment for Depression

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

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

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