Clinical Issues

Hepatitis trends

IOM findings to aid in improved HBV/HCV awareness

The Centers for Disease Control and Prevention (CDC) posted the key findings and recommendations from the Institute of Medicine’s (IOM) January 11, 2010, pre-publication version of a report on the prevention and control of viral hepatitis infections in the U.S. The CDC, along with other partners, commissioned the IOM to examine the topic, and the CDC Foundation has launched a Viral Hepatitis Action Coalition to respond to the IOM report and support CDC research and programs.

The committee’s report — entitled "Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C" (HBV, HCV) — found major underlying factors that impede current efforts to prevent and control the diseases:

• a lack of knowledge and awareness about chronic viral hepatitis on the part of healthcare and social-service providers, as well as among at-risk populations, members of the public, and policymakers; and
• an insufficient about the extent and seriousness of the public-health problem, so inadequate public resources are being allocated to prevention, control, and surveillance programs.

Surveillance recommendations included a comprehensive evaluation by the CDC of the national HBV/HCV public-health surveillance system, as well as development by the CDC of specific cooperative viral hepatitis agreements with all state and territorial health departments to support core surveillance for acute and chronic HBV/HCV. In addition the CDC is charged with supporting and conducting targeted active surveillance (including serologic testing) to monitor incidence and prevalence of HBV/HCV infections in populations not fully captured by core surveillance.

The committee suggested the CDC, working with other key stakeholders (e.g., other federal agencies, state and local governments, professional organizations, healthcare organizations and educational institutions), develop educational programs about HBV/HCV for healthcare and social-service providers. Additionally, the CDC and these stakeholders should develop, coordinate, and evaluate "innovative and effective outreach and education programs" to target the at-risk populations and to increase awareness among the general U.S. population about hepatitis B and C.

Other recommendations involve immunization of infants born to HBV surface antigen-positive women; HBV immunization as a requirement for school attendance; increased HBV vaccination of at-risk adults; expansion of immunization-information systems to include adolescents and adults; expansion of private and public insurance coverage for HBV vaccination; and ensuring an adequate, accessible, and sustainable hepatitis vaccine supply.

Further, viral-hepatitis services recommendations include incorporating guidelines for risk-factor screening for HBV/HCV as a component of preventive care for at-risk and chronically-infected patients. Recommendations also suggest providing resources for expansion of community-based programs to provide HBV screening, testing, and vaccination services that target foreign-born populations and injection-drug users to reduce the spread of hepatitis C virus infection.

More details about the IOM report and other information about the prevention and control of viral hepatitis infections are available at www.cdc.gov/hepatitis/IOMnews.htm.

Effective, cost-effective QC in an ever-changing environment

"Serology tests (for infectious-disease antibodies and antigens) are showing up more and more on large automated systems that used to be just for chemistry tests. Tests for pathogen nucleic acids (called NAT in blood banks) have their own automated systems; and before too long, systems will likely be developed that can test for small molecule, protein, and nucleic-acid analytes. Test-method and ordering-pattern changes are a constant in clinical laboratorians’ lives, making it more important than ever to be able to validate and monitor their results over time. Independent controls for hepatitis, HIV, and other infectious diseases, are carefully designed to be solid negatives or low positives for specific test methods, and we work with laboratorians to monitor test performance and spot trends. Evaluating a new method’s performance when it is implemented, and monitoring that performance over time, allows laboratorians to detect changes before they become bad results — saving time, money and, perhaps most importantly, the lab’s credibility."

—Patricia E. Garrett, PhD, D(ABCC)
Senior Director, Science and Technology
SeraCare Life Sciences
Milford, MA
Maker of ACCURUN Controls and BBI Panels

Thousands exposed to HCV by hospital tech

Reminiscent of other news stories in recent years is the case in Denver, CO, of Kristen D. Parker, 27, a former employee of Rose Medical Center there. Parker admitted to police on videotape that while she worked at the facility in 2008 and 2009, she stole pain-medication syringes from operating room trays, replacing them at times with needles she had already used to inject herself.

According to The New York Times, 17 Rose Medical Center patients have so far been found to have a strain of hepatitis C linked through genetic sequencing to the strain in Parker’s blood. These results were found by the Colorado Department of Public Health and Environment.

On January 22, 2010, the federal judge sitting on the case, Robert E. Blackburn, rejected a plea agreement for Parker, suggesting that 20 years in prison contained in the plea agreement was not enough punishment for the crime; legal experts say it is unusual for a judge to reject a plea agreement. Parker may maintain her guilty plea, giving the judge discretion as to her sentencing next month, or she could attempt to reach another plea agreement with prosecutors or change her plea to not guilty and demand a jury trial.

Parker pleaded guilty to tampering with a consumer product and obtaining a controlled substance by deceit or subterfuge.

She admitted stealing syringes filled with Fentanyl from operating carts while employed at Rose and at Colorado Springs’ Audubon Surgery Center.

Parker told prosecutors she stole the syringes filled with the narcotic and intended to replace them with saline-filled syringes with clean needles but became careless.

Prosecutors say her scheme may have exposed nearly 6,000 patients at two hospitals to hepatitis C.

Parker said she began stealing syringes from medical carts within days of starting at Rose, at first taking care to replace them with clean needles, then losing track.

She came under suspicion after a syringe in her pocket pricked a co-worker. Parker was hired a few weeks later at Audubon, where she worked until she was arrested in June 2009 after Colorado health officials linked her to hepatitis C cases at Rose.

Investigations were launched in Mount Kisco, NY, and in Houston, where Parker previously worked. Parker told prosecutors she stole no syringes at her first job in Houston.

She had started the practice at her second job at Northern Westchester Hospital in New York, where said she filled clean, unused syringes with saline to replace the Fentanyl-filled syringes.

About 2,800 patients at Northern Westchester were advised to get tested for hepatitis C. In Houston, an investigation found no hepatitis cases linked to Parker.

Hepatitis numbers

According to Centers for Disease Control and Prevention (CDC), hepatitis C virus (HCV) infection is the most common chronic bloodborne infection in the United States. The CDC reports the following hepatitis statistics:

• An estimated 1.2 million Americans are living with chronic hepatitis B and 3.2 million are living with chronic hepatitis C. Many do not know they are infected.
• More than 100 million people worldwide are infected with HCV.
• The incubation period from the time of exposure to the hepatitis B virus (HBV) to the onset of symptoms is six weeks to six months.
• HCV RNA can be detected in blood within 1-3 weeks after exposure. The average time from exposure to antibody to HCV (anti-HCV) seroconversion is 8-9 weeks, and anti-HCV can be detected in >97% of persons by six months after exposure.
• Asians and Pacific Islanders make up 4.5% of the U.S. population but account for more than 50% of chronic hepatitis B cases.
• About 17,000 Americans become infected with hepatitis C each year.
• In the U.S. about 12,000 people die each year from hepatitis C-related illnesses.
• Chronic hepatitis B and C cause thousands of cases of liver cancer, liver disease, and death each year — taking the heaviest toll among Asians, Pacific Islanders, and blacks in the United States.
• Effective treatment can eradicate the virus in about 40% of patients.
• HVB and HVC infections account for nearly half of the liver transplantations performed annually in the U.S.
• Although the availability of an effective vaccine against hepatitis B has significantly reduced its spread, some 1,000 infants born to infected mothers develop chronic infections each year, a number that has not declined over the past decade.
• Three states — Alabama, Montana, and South Dakota — do not require that children be vaccinated against hepatitis B before entering daycare or school.
• Each year, roughly 40,000 to 45,000 people emigrate to the United States from countries where hepatitis B is endemic.

Visit www.cdc.gov/hepatitis .