Experts: Fight Hepatitis C epidemic with more testing, caps for co-pays

WASHINGTON, D.C. ( June 4, 2015 ) — With mounting evidence that many public and private health plans are deliberately rationing care for Americans with the hepatitis C virus (HCV), those on the front lines in fighting viral hepatitis and HIV/AIDS today urged lawmakers to overturn state Medicaid and managed care policies that discourage testing, add prior authorization requirements on clinicians, and create significant hurdles for patients to receive new curative treatments — all contributing to only 5% to 6% of individuals with HCV being successfully treated.

Assembling in Washington for the 2015 National Summit on HCV and HIV Diagnosis, Prevention and Access to Care, HCV and HIV specialists called on policymakers to pass state laws mandating that insurance plans follow evidence-based medical guidelines when covering HCV testing and treatment. These guidelines — published jointly by the American Association for the Study of Liver Diseases ( AASLD ) and the Infectious Diseases Society of America ( IDSA ) and also by the Department of Veterans Affairs — support treatment in all HCV-infected people except those with a life expectancy of less than a year due to non-liver medical conditions. Moreover, the advocates urged states to enact laws requiring Medicaid programs to offer first-line HIV medications and new HCV drugs on their formularies and to cap the co-payments for these therapies, ending system-wide practices by both public and private insurers that restrict access to these drugs.

These actions are necessary now that a just-issued review of ten state Medicaid programs from the Center for Health Law and Policy Innovation of Harvard Law School documents system-wide insurance restrictions that keep the majority of HCV-infected individuals from being treated with new and more expensive oral HCV drugs. While the practices vary from state to state, and even among different plans in the state, they are designed to be exclusionary by only allowing patients with advanced liver disease to receive the new drugs, authorizing only a small number of medical specialists to prescribe the drugs, excluding alcohol- and substance-using individuals, and restricting access based on HIV co-infection. These exclusionary practices also apply to a number of private health plans, resulting in a series of lawsuits in California.

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New Viral Hepatitis Numbers from the CDC, by Alan Franciscus, Editor-in-Chief

The Centers for Disease Control and Prevention (CDC) released new estimates on the acute and chronic cases of hepatitis A, B and C: 

Hepatitis A (HAV):

2013: Estimated acute cases and deaths from hepatitis A

• Acute:  3,500–range:  2,500 to 3,900
• Deaths:  80 (underlying contributing cause of death in most recent year available (2013))

Hepatitis B (HBV):

2013: Estimated acute, chronic and deaths from hepatitis B

• Acute:  19,800—range: 11,300 to 48,500
• Chronic:  700,000 to 1.4 million
• Deaths:  1,873

Hepatitis C (HCV):

2013:  Estimated acute, chronic and deaths from hepatitis C

• Acute:  29,700—range: 23,500 to 101,400
• Chronic: 2.7 to 3.9 million
• Deaths:  19,368*

NOTE: Current information indicates these represent a fraction of deaths attributable in whole or in part to chronic hepatitis C.”  

Editorial Comments:  The good news is that vaccination against hepatitis A and B and education efforts are working to keep new infections, chronic infections and deaths consistent with previous years.  Hepatitis A and B are in line with what have been previously reported and rates of new infections have leveled off.  I personally believe that hepatitis B may be under reported especially in some larger populations of immigrants who may be infected with hepatitis B.  Furthermore, we may not know the extent of chronic hepatitis B in the undocumented immigrant population. 

HCV however, seems be getting worse. The range of acute HCV population is much likely higher since we really don’t have an effective surveillance system in our country.  We have had large outbreaks of acute HCV in Wisconsin, Kentucky, Massachusetts, Indiana and elsewhere. I also believe the number of people with chronic hepatitis C is much higher and the deaths caused by hepatitis C is certainly higher.  The CDC has a * (see note) that captures the deaths which are most likely under reported.  Many times a death reported on a death certificate is listed as another cause when HCV or cirrhosis, liver cancer or a consequence of HCV may be listed instead.   

On a sad note, the age group that had the highest  rate of death was the 55 to 64 year old group with 51% of the total number of deaths—this is very young age for such a high death rate.


http://hcvadvocate.org/news/newsLetter/2015/advocate0615.html#4

HCV Viral Load Testing Not Useful As Measure of New Hepatitis C Drug Effectiveness

MedicalResearch.com Interview with:
Shyamasundaran Kottilil MBBS, PhD
Division of Infectious Diseases, Institute of Human Virology
University of Maryland, Baltimore
Laboratory of Immunoregulation
National Institute of Allergy and Infectious Diseases
National Institutes of Health, Bethesda, Maryland

Medical Research: What is the background for this study? What are the main findings?

Dr. Kottilil: During treatment with interferon-based therapies, hepatitis C viral load levels were clinically useful as on-therapy markers of treatment outcome. However, the standard-of-care for HCV treatment has recently evolved from interferon-based regimens to short-duration, all-oral, direct-acting antiviral (DAA) therapies. Therefore, it is important that we re-evaluate the utility of HCV viral loads during DAA regimens in guiding clinical decision-making.

We found that Hepatitis C viral loads on treatment and at end of treatment were not predictive of treatment success versus relapse with DAA therapy. Contrary to our experience with interferon-containing regimens, low levels of quantifiable HCV RNA at end of treatment did not preclude treatment success.

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As Minnesota insurers limit access to hepatitis C drugs, patients chafe

Kelly Krodel thought a miracle had arrived just in time — in a drug that could eliminate the hepatitis C infection she had carried for three decades before it started to wreck her liver.

Turns out, she’s going to have to live with the virus a bit longer. As long as the South St. Paul woman is reasonably healthy, her health insurance won’t pay the drug’s five- or even six-figure cost.

“Now there’s a cure and I can’t even touch it,” she said. “It makes you so angry.”

Krodel is one of a growing number of hepatitis C patients in Minnesota caught in a bind between the exorbitant cost of the year-old medications — Harvoni, Sovaldi and Viekira Pak — and the tight restrictions insurers have used to prevent the drugs from busting their budgets.

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Canada: Hep C at colonoscopy clinic: Taking measures to prevent a second outbreak

On Dec. 24, 2013, four patients at a Kitchener colonoscopy clinic became infected with hepatitis C.

It was several months before any of them realized it – and nearly a year before a second diagnosis allowed public health officials to link the cases to Tri-City Colonoscopy Clinic.

While nobody knows what happened to transmit the virus with complete certainty, it’s believed shared equipment is to blame.

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Snapshots, by Alan Franciscus, Editor-in-Chief

Article: Prevalence and risk factors for patient-reported joint pain among patients with HIV/Hepatitis C coinfection, Hepatitis C monoinfection, and HIV monoinfection—A Ogdie et al.
   Source:  BMC Musculoskeletal Disorders 2015, 16:93  doi:10.1186/s12891-015-0552-z

A common symptom that people with hepatitis C report is pain—liver pain, muscle and joint pain, fibromyalgia, headaches and the list goes on and on.  The aim of the current study was to determine the prevalence of patient reported joint pain among 3 groups (a total of 202 patients, mostly males): HCV mono-infection (93 patients); HIV-mono-infection (30 patients); and HIV/HCV co-infection (79 patients).  The ages and genders were similar across all three groups.  More than half were Black. 

The Multi-Dimensional Health Assessment Questionnaire was used to determine joint pain and any related symptoms. The patients were also interviewed and their charts were reviewed. 

The Bottom Line:  Joint pain was more commonly reported in HCV-monoinfected patients than in HIV/HCV-coinfected patients—71% vs. 56.  Joint paint was also more commonly reported in HCV mono-infected patients than in HIV-monoinfected patients—71% vs 50%.

The study found that a previous diagnosis of arthritis and current smoking were risk factors for joint pain among people who are infected with hepatitis C. 

Editorial Comment:  This is another reason why everyone with hepatitis C should be treated.  There are so many symptoms and conditions caused by hepatitis C.   

For more information see this month’s HealthWise.

Article: Liver-related death among HIV/hepatitis C virus-co-infected individuals: implications for the era of directly acting antivirals—D Grint et al. 
   Source: AIDS. 2015 Apr 13. [Epub ahead of print]

The new interferon-free therapies provide similar cure rates in people who are co-infected with HIV and hepatitis C as in people who are mono-infected with hepatitis C.  However, access is being restricted due the higher costs of the newer medications.  

In general, people who are co-infected with HIV and hepatitis C have a faster rate of HCV disease progression than someone with hepatitis C mono-infection.  Even so, treatment is being restricted to those with the greatest risk of liver-related death.  The current study sought to provide a degree of guidance on who should be prioritized for receiving the new direct acting antiviral medications (DAAs) or HCV inhibitor combination medications.  The study looked at the liver-related deaths of the people who were co-infected with HIV and hepatitis C.

In the current study 3,941 HCV antibody positive patients who were part of a European study (EuroSIDA) and who were followed-up after 1 January 2000 were included. 

Liver-related deaths accounted for 145 of 670 (21.6%) deaths in the study population. Liver-related death rates peaked in those aged 35-45 years, and occurred almost exclusively in those with at least F2 fibrosis at baseline.  Note: The Metavir scale is F0, no activity, F1 for inflammation, F2 for light scarring, F3 for moderate-severe scarring and F4 for cirrhosis. 

The Bottom Line: The authors reported that the 5- year probability of liver related death (LRD) was low for those with F0-F1, but substantial for those F2, F3 and F4. 

The authors also noted that “treatment with DAAs should be prioritized for those with at least a F2 fibrosis.  Early initiation of cART with the aim of avoiding low CD4 cell counts should be considered essential to decrease the risk of LRD and the need for HCV treatment.” 

Editorial Comment:  I wonder how many people coinfected with HIV/HCV are F0-F1, how quickly people progress from one stage to another, how often do you need to monitor people in stage F0/F1, how much does it cost to monitor, and would it be cheaper in the long run to treat everyone?  

Article: Hepatitis A and B among young persons who inject drugs—Vaccination, past, and present infection. MG Collier et al.
  Source:  Vaccine. 2015 Apr 15. pii: S0264-410X(15)00472-7. doi: 10.1016/j.vaccine.2015.04.019. [Epub ahead of print]

It is recommended that people who inject drugs (PWID) should be vaccinated against hepatitis A (HAV) and hepatitis B (HBV). There is some evidence that some young individuals who were vaccinated as children may have lost their immunity.  The current study sought to understand the current HAV and HBV immunity status among 519 persons who inject drugs.   The study group included 18 to 40 year olds who lived in San Diego—49% were non-Hispanic white, 7% were non-Hispanic Blank, 27% were White Hispanic, 4% were born outside of the U.S. 

The Bottom Line:  After being tested it was found that 47% were susceptible to HBV infection and 63% were susceptible to hepatitis A infection.  Additionally, 26% tested positive for HCV antibodies.  The authors reported that even though the participants believed that they had been vaccinated, many had not.  The authors commented that "Programs serving this population should vaccinate PWIDs against HAV and HBV and not rely on self-report of vaccination."

 
Editorial Comment:  This recommendation makes perfect sense. People forget about what vaccines they received as children or if they were vaccinated at all.  If you have hepatitis C it is even more important to be protected.  Becoming co-infected with another hepatitis virus such as HAV or HBV can lead to serious health consequences, even death.   The HAV vaccine can be given without serologic testing since it will do no actual harm.   It is important, however, to give the HBV serologic test to make sure that people are not already infected with the hepatitis B virus before giving the HBV vaccine.  The HBV vaccine doesn’t provide any benefit to people who have acute or chronic HBV and might just might give people a false sense of security and prevent much needed follow-up medical care.

http://hcvadvocate.org/news/newsLetter/2015/advocate0615.html#3

Southern Illinois sees shocking rise of Hepatitis C

Cases of Hepatitis C -- a blood borne virus that attacks the liver and is spread via shared drug needles, unsterile tattoos and other means -- are on the rise. It's a "silent epidemic" waiting to strike many unsuspecting Baby Boomers and young adults, health officials warn, because the liver has a long memory. Even if you have forgotten what you did this past weekend, or in the freewheeling 1970s, your liver did not.  

Hoping to stem the tide of premature deaths from liver-related complications, lawmakers narrowly passed a bill in recent days that would require doctors to offer screening tests for patients considered high-risk for Hepatitis C.

It is curable in most cases, but left undetected can lead to cirrhosis of the liver and death.

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