Hepatitis Awareness Month and National Hepatitis Testing Day — May 2015

MMWR Weekly Vol. 64, No. 17 May 8, 2015

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This month marks the 20th anniversary of Hepatitis Awareness Month and the 4th National Hepatitis Testing Day (May 19) in the United States. Although care and treatment can be life-saving, many of the 3 million persons estimated to be living with hepatitis C virus (HCV) infection are unaware of their infection and are not receiving preventive services and medical management. In addition, an emerging epidemic of HCV infection among a new demographic of persons who inject drugs is unfolding in several areas throughout the nation. Guided by the goals of the 2014 U.S. Department of Health and Human Services Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis (1), CDC continues its activities to expand access to HCV testing, care, and treatment to stem morbidity and mortality, and to reduce HCV infections caused by drug use behaviors. Efforts to address each of these strategic imperatives are highlighted by the two reports in this issue of MMWR.

The first report shows that trends in new cases of HCV infection are highly correlated with trends in substance abuse treatment admissions for opioid dependency and opioid injection in four states in the central Appalachian Region. The second report describes strategies for integrating HCV testing into primary care settings. These reports demonstrate how data can be used to identify patterns of risk for HCV transmission among persons who inject drugs and how programs can be successfully implemented to identify persons disproportionately affected by HCV infection and ensure they receive appropriate medical care and treatment.


Increases in Hepatitis C Virus Infection Related to Injection Drug Use Among Persons Aged ≤30 Years — Kentucky, Tennessee, Virginia, and West Virginia, 2006–2012
Jon E. Zibbell, PhD, Kashif Iqbal, MPH, Rajiv C. Patel, MPH, et al.
MMWR Morb Mortal Wkly Rep 2015;64:453-8


Identification and Linkage to Care of HCV-Infected Persons in Five Health Centers — Philadelphia, Pennsylvania, 2012–2014
Catelyn Coyle, MPH, Kendra Viner, PhD, Elizabeth Hughes, DrPH, et al.
MMWR Morb Mortal Wkly Rep 2015;64:459-63

 

 

Reference

1. US Department of Health and Human Services. Combating the silent epidemic of viral hepatitis: action plan for the prevention, care, and treatment of viral hepatitis. Updated 2014–2016. Washington, DC: US Department of Health and Human Services; 2015. Available at http://aids.gov/pdf/viral-hepatitis-action-plan.pdf .

 Source: http://www.cdc.gov/mmwr/mmwr_wk.html

HCV Drugs, by Alan Franciscus, Editor-in-Chief

This month’s edition of HCV Drugs will be short due to the upcoming European Association for the Study of the Liver (EASL) conference.  Join us for extensive coverage on www.hcvadvocate.org for the latest news and the next edition of the HCV Advocate newsletter.   There is, however, important news included in this issue:  Merck is granted Breakthrough Therapy designation; phase 2 study results of AbbVie’s combo to treat genotype 4; and, lastly not really drug-related, a new study that is being sponsored by the National Institutes of Health (NIH) that may finally help expand care and treatment to other medical providers. 

Merck
Just when we thought that the Food and Drug Administration (FDA) had rescinded Breakthrough Therapy designation for all HCV therapies – we were wrong—they have given it to Merck’s combination of grazoprevir plus elbasvir for the treatment of people with HCV genotype 1 who have end-stage renal (kidney) disease on hemodialysis and for people with HCV genotype 4.  The designation will allow for expedited review and approval. 

Comment:  These two groups are definitely in need of expedited review!  This is very good news for people living with hepatitis C.  Merck has this combination of medications in multiple studies. 

Source:  Company press release

AbbVie
Results from a small phase 2 trial was recently published in The Lancet.  The trial included 86 HCV genotype 4 patients who had never been treated (treatment naïve) as well as those who had been treated previously (treatment-experienced).  The patients were treated with ombitasvir (once-daily), paritaprevir/ritonavir—with and without ribavirin (twice daily) for 12 weeks. 

Forty-nine patients who had previously received treatment (treatment-experienced) received the AbbVie combination treatment plus ribavirin for 12 weeks. 

In the treatment-naïve group the cure rate was 100% in the group that received ribavirin and 91% in the group that did not receive ribavirin.  In the treatment-experienced group the cure rate was 100%.

Comment: More good news for patients—although genotype 4 is uncommon in the United States it is estimated that about 13% of the global population (mostly in Egypt) is infected with genotype 4.  However, when I conduct training workshops it always surprises me that there is usually one or more persons with genotype 4!

Source:  Hézode C et al. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): A randomised, open-label trial. Lancet 2015 Mar 30; [e-pub].

NIH
The NIH and the city of Washington, D. C., with support from the NIH Office of AIDS Research has launched a study that will include 600 patients with HCV or HIV/HCV coinfection.  Of the patients enrolled, 350 will continue with their current specialist, and 250 will be assigned to a primary care doctor, physician, physician assistant or nurse practitioner for treatment.  The treatment will be Harvoni for two to six months. 

Comments:  There has always been a lack of medical providers to manage and treat people with hepatitis C.  This is increasingly becoming a problem due to the increased awareness, testing and treatments that are easier to tolerate and more effective.   Hopefully, this will show that more medical providers can safely and effectively manage and treat people with hepatitis C. 

Source:  NIH News press release

http://hcvadvocate.org/news/newsLetter/2015/advocate0515.html#3

Putnam County Offering Free Hepatitis C Screening

BREWSTER, N.Y. —The Putnam County Department of Health is offering a full day of free Hepatitis C testing for all baby boomers on National Hepatitis Testing Day from 10 a.m. to 7 p.m. Tuesday, May 19 at the main health department office, 1 Geneva Road, Brewster.
No appointment is necessary.

Residents who can’t make the free testing day May 19 can call the health department at (845) 808-1390 for information about other free testing opportunities.

For more information, please visit the Putnam County Health Department here. 

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Hepatitis is a serious problem, warns the state of Tennessee

Hepatitis C is a deadly but treatable disease; that's why the Tennessee Department of Health is sharing a reminder about the importance of getting tested. May is Hepatitis Awareness Month, a perfect time to know your status and seek treatment if needed.

"There are three types of viral hepatitis: Hepatitis A, Hepatitis B, and Hepatitis C; each are transmitted uniquely and cause separate illnesses," said Carolyn Wester, MD, MPH, TDH Medical Director, HIV/STD/Viral Hepatitis. "Vaccines are available to prevent against Hepatitis A and Hepatitis B infection. There is currently no vaccine to prevent against Hepatitis C so it's very important to find out if you're at risk."

Test can be conducted if you feel like you may have Hepatitis. Locally, you should contact the Rutherford County Health Department. The main office is in Murfreesboro at 100 West Burton Street. The phone number is (615) 898-7880.

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For the Health of it: Hep C on the rise in Chenango

Submitted by the Chenango County Health Department

CHENANGO COUNTY – The Hepatitis C Virus (HCV) has been steadily increasing in Chenango County in recent years. In 2010 there were 20 reported cases of the potentially deadly virus, and the number has increased to a reported 66 in 2014 alone.

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Interferon-free therapy clears hepatitis C in 93 percent of patients in trial

Public Release: 5-May-2015

Duke University Medical Center

DURHAM, N.C. -- A 12-week dose of an investigational three-drug hepatitis C combination cleared the virus in 93 percent of patients with liver cirrhosis who hadn't previously been treated, according to a study in the May 5, 2015, issue of The Journal of the American Medical Association.

Bristol-Myers Squibb funded the trial of the combination of three drugs -- daclatasvir, asunaprevir, and beclabuvir. None of the three drugs are FDA-approved, but daclatasvir is currently under review by the FDA. Duke Medicine researchers collaborated on the design and analysis of the trial and authored the findings.

The trial recruited patients with hepatitis C-related cirrhosis, or scarring of the liver, 112 of whom had not previously been treated for hepatitis C, and 90 who had previous unsuccessful therapies. For those with past failed therapies and potential resistance, the drugs were slightly less successful, eliminating the virus in 87 percent.

However, for those with past failed therapies, incorporating a fourth drug, ribavirin, appeared to enhance results. Ribavirin is a commonly used hepatitis C treatment. When added to the investigational regimen, success rates in previously treated patients reached 93 percent -- on par with those receiving treatment for the first time.

No vaccine has been developed to protect patients from the hepatitis C virus, which is spread through blood and can lead to liver failure and death if untreated. Most who are infected don't know they have the disease until they have symptoms and have already sustained liver damage, said Andrew Muir, M.D., M.H.S., chief of the division of gastroenterology at Duke and the study's lead author. For this reason, Americans born between 1945 and 1965 -- baby boomers -- should automatically be tested, he urged.

For most of the past 20 years, therapies for hepatitis C relied on interferon drugs, which require regular injections for as long as one year and trigger miserable, flu-like side effects that prompt many patients to quit the regimen. Some patients aren't eligible for this treatment if they have anemia, low platelets or other conditions, Muir said.

"Those with more advanced disease were unlikely to tolerate interferons, and many patients would decide against even getting treatment," Muir said. "For those who could tolerate it, it was only moderately effective."

Since late 2013, several drug companies have released new, interferon-free regimens. In many cases, these have proven to be more effective than previous treatments.

"The development of interferon-free treatments has been a tremendous step forward in the standard of care," Muir said. "These drugs are highly effective and well-tolerated by patients at all stages of liver disease."

The trial was conducted between December 2013 and September 2014 at nearly 50 sites across the United States, Canada, France, and Australia. All patients were infected with genotype 1 hepatitis, a common strain of the C virus in North America, Western Europe and Australia.

The drugs had minimal side effects for most participants. Nine patients experienced serious adverse events three of which were considered related to treatment, the study states.

Among the study's limitations were the absence of a placebo group that could pinpoint the sources of side effects, and a lack of racial diversity, with 88 percent white participants. The study also did not statistically distinguish the impact of the addition of ribavirin to some participants' daily regimen.

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In addition to Muir, study authors include Fred Poordad; Jacob Lalezari; Gregory Everson; Gregory J. Dore; Robert Herring; Aasim Sheikh; Paul Kwo; Christophe Hézode; Paul J. Pockros; Albert Tran; Joseph Yozviak; Nancy Reau; Alnoor Ramji; Katherine Stuart; Alexander J. Thompson; John Vierling; Bradley Freilich; James Cooper; Wayne Ghesquiere; Rong Yang; Fiona McPhee; Eric A. Hughes; E. Scott Swenson; and Philip D. Yin.

Bristol-Myers Squibb sponsored the study. Muir received grant funding from Bristol-Myers Squibb during the conduct of the trial, as well as grant funding and personal fees from AbbVie, Achillion, Bristol-Myers Squibb, Gilead, and Merck, personal fees from Theravance, and grant funding from Roche outside of the work submitted for this JAMA article.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

Press Release Source: http://www.eurekalert.org/pub_releases/2015-05/dumc-itc043015.php

Canada: Contaminated vial likely cause of hepatitis C outbreak: report

KITCHENER — Region of Waterloo Public Health concluded its investigation into a hepatitis C outbreak at a Kitchener colonoscopy clinic in late 2013.

The final report presented to a regional council committee Tuesday said what most likely happened is hepatitis C was spread from a previously undiagnosed client to four other patients at Tri-City Colonoscopy Clinic on Dec. 24, 2013, when a bottle of medication was contaminated.

"There was a lapse in infection control related to the use of multi-dose vials," said regional medical officer of health Dr. Liana Nolan. 

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