Reinfection rates after hepatitis C cure among people who inject drug users, as well as past drug users, are relatively low, according to findings from studies from Norway and Canada presented at the International Liver Congress in Vienna in April.
The findings suggest that current and former injecting drug users who have been cured of hepatitis C require ongoing support to remain free of hepatitis C, but also indicate that fears of a high rate of reinfection should not be used as a reason to withhold hepatitis C treatment from people who inject drugs.
A meta-analysis of studies of hepatitis C treatment outcomes in people who inject drugs, published in 2013, found an incidence of between 2.4 and 6.4 per 100 person-years of follow-up, but a subsequent meta-analysis found that the reinfection rate could be as high as 8%. (Aspinall 2013, Hill 2014)
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Thursday, June 4, 2015
Hedge Fund Billionaires Are New Target for Hepatitis C Cure Protests
The New York City home and offices of former hedge fund manager Julian H. Robertson were targeted by protest groups in a series of simultaneous direct actions in early May. Robertson is ranked No. 512 on Forbes' list of "the world's billionaires" with a reported net worth of $3.4 billion. "Robertson is making a killing off of people with Hep C," read one sign.
The protests targeted high profile hedge fund investors who have reaped substantial profits from the California-based pharmaceutical giant Gilead Sciences. Hedge Clippers, a coalition of labor, community and social justice groups including VOCAL-NY, seeks to draw links between hedge funds and income inequality, mass imprisonment, climate change, health disparities, and other challenges. Gilead has been targeted because of what has been called "exorbitant" pricing for its groundbreaking new class of drugs that can cure hepatitis C virus (HCV), such as Sovaldi, and the enormous profits they have generated.
HCV infection "is the most common chronic blood borne infection in the United States [and] approximately 3.2 million persons are chronically infected," according to the U.S. Centers for Disease Control and Prevention (CDC). About 150 million people around the globe are living with HCV -- disproportionately the poor, uninsured and incarcerated -- which in its advanced stages can cause cirrhosis or liver cancer.
Read more...
The protests targeted high profile hedge fund investors who have reaped substantial profits from the California-based pharmaceutical giant Gilead Sciences. Hedge Clippers, a coalition of labor, community and social justice groups including VOCAL-NY, seeks to draw links between hedge funds and income inequality, mass imprisonment, climate change, health disparities, and other challenges. Gilead has been targeted because of what has been called "exorbitant" pricing for its groundbreaking new class of drugs that can cure hepatitis C virus (HCV), such as Sovaldi, and the enormous profits they have generated.
HCV infection "is the most common chronic blood borne infection in the United States [and] approximately 3.2 million persons are chronically infected," according to the U.S. Centers for Disease Control and Prevention (CDC). About 150 million people around the globe are living with HCV -- disproportionately the poor, uninsured and incarcerated -- which in its advanced stages can cause cirrhosis or liver cancer.
Read more...
Illinois doctors group wants Rauner to veto hepatitis C bill
CHICAGO (AP) - With three out of four Americans who are infected unaware they have hepatitis C, Illinois lawmakers last month approved a measure to fight what’s been called a silent epidemic.
The state’s largest doctors group is now urging Gov. Bruce Rauner to veto the bill that would require doctors to offer blood tests for the contagious liver disease to baby boomers - those born between 1945 and 1965. That’s been the recommendation of the U.S. Centers for Disease Control and Prevention since 2012.
Doctors don’t need lawmakers telling them to follow guidelines, the Illinois State Medical Society insists.
The legislation “intrudes on the physician’s judgment and relationship with the patient, and doesn’t guarantee that patients who do test positive for this liver disease will have access to treatment, which can cost tens of thousands of dollars,” said Illinois State Medical Society President Dr. Scott Cooper.
The state’s largest doctors group is now urging Gov. Bruce Rauner to veto the bill that would require doctors to offer blood tests for the contagious liver disease to baby boomers - those born between 1945 and 1965. That’s been the recommendation of the U.S. Centers for Disease Control and Prevention since 2012.
Doctors don’t need lawmakers telling them to follow guidelines, the Illinois State Medical Society insists.
The legislation “intrudes on the physician’s judgment and relationship with the patient, and doesn’t guarantee that patients who do test positive for this liver disease will have access to treatment, which can cost tens of thousands of dollars,” said Illinois State Medical Society President Dr. Scott Cooper.
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.
Read more...
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.
Read more...
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
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))
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
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
Wednesday, June 3, 2015
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.
Read more...
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.
Read more...
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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