New drugs raise HCV cure rate
New drugs raise HCV cure rate
Another reason to follow needlesticks
Safer sharps do not eliminate the risk of hepatitis C for health care workers, but new drugs can spare them from a dire prognosis.
With the Food and Drug Administration approval of Victrelis, produced by Merck of Whitehouse Station, NJ, and Incivek, from Vertex in Cambridge, MA, health care workers with HCV have a greater chance of a complete cure. Both drugs boost the effectiveness of interferon and ribavirin by blocking the virus' ability to replicate. They can reduce the viral load to undetectable levels and enable many people to cut the difficult HCV treatment regimen from 48 to 24 weeks.1This is a time of unprecedented medical advances for people with HCV, says Douglas Dieterich, MD, professor of medicine in the Division of Liver Disease at Mount Sinai Medical Center in New York. There are about 50 hepatitis C drugs under development, some with the potential for post-exposure prophylaxis.
"[The new drugs] changed the cure rate from 40% to 80%. They made the risk-benefit ratio [of treatment] hugely different," he says.
It's also a new reason for health care workers at risk for blood exposures to get tested, he says. "Frankly, I think everybody should be tested for hepatitis A, B and C, but health care workers in particular should be getting tested for hepatitis C," he says.
A fateful stick
Dieterich knows the importance of these new treatments from the perspective of a patient and a provider. He developed acute hepatitis C after a needlestick when he was a third-year medical student.
It was 1977 before HIV/AIDS and before the widespread use of needle safety devices. Hepatitis C had not been identified, but it was called non-A, non-B hepatitis. Dieterich was taking blood from an ICU patient who had severe liver disease and pancreatitis when he was stuck with a 14-gauge hollow bore needle. "I knew I was in trouble right away," he says.
At that time, there was little that could be done after a needlestick. "When I stuck myself, there was nothing available to treat it," he says. "I got a gamma globulin shot. That was about it. After I got sick, there was nothing really to do except use prednisone."
Only about 20% to 30% of people with newly acquired HCV infection develop symptoms of acute disease, according to the Centers for Disease Control and Prevention. Dieterich was one of them. He became sick, but struggled to continue his medical studies. He had originally planned to specialize in ophthalmology, but instead switched to gastroenterology with a specialty in liver disease.
When interferon and ribavirin treatment became available, Dieterich took it twice, because the first regimen didn't work. He suffered from fatigue, irritability, depression, nausea, and diarrhea.
So Dieterich understands what HCV-positive health care workers go through when he prescribes the treatment. He is optimistic about the benefits of these new drugs, but knows the challenges that remain. Patients with chronic hepatitis C may have no symptoms, but enduring the treatment can prevent serious liver disease or the need for an eventual liver transplant, he says.
That's why it's so important to prevent needlesticks, Dieterich says. "This should not reassure them. Taking the treatment is not a panacea. The side effects are difficult," he says. "But if something happens and they do get hepatitis C, we can treat it and cure it almost all the time."
Higher occupational risk?
How many health care workers acquire HCV from a needlestick? CDC estimates the risk to be 1.8%, but a review of studies indicated a seroconversion rate of about .5% after an exposure to HCV.2 Seroprevalence studies did not show a higher rate for health care workers, but an analysis of death certificates by researchers at the Centers for Disease Control and Prevention indicated that health care workers have an occupational risk. Twenty years of data (1984 to 2004) from the National Occupational Mortality Surveillance System found that female health care workers have a 20% greater risk of dying from hepatitis C than women in other occupations. Male health care workers have a 50% elevated risk.3
Overall, hepatitis C is a "hidden epidemic." An estimated 3.2 million Americans have the chronic infection but most aren't aware of it. "Most people who are identified are those who have an abnormal liver enzyme on a routine physical," says Miriam Alter, PhD, director of the infectious disease epidemiology program at the University of Texas Medical Branch in Galveston.
The CDC is reviewing its screening recommendations to improve detection of chronic HCV. "CDC is currently working to evaluate whether one-time routine hepatitis C screening for anyone born from 1945 to 1965 is warranted," says CDC spokesperson Jennifer Horvath. "This extensive process is underway now and any forthcoming recommendations would add to, not replace, current risk-based screening recommendations.
Did you know?
For every 100 persons infected with HCV, approximately:
75 to 85 will go on to develop chronic infection
60 to 70 will go on to develop chronic liver disease
5 to 20 will go on to develop cirrhosis over a period of 20–30 years
1 to 5 will die from the consequences of chronic infection (liver cancer or cirrhosis)
In the event of a needlestick:
Perform baseline testing for anti-HCV on the source patient.
Perform baseline and follow-up testing for health care workers exposed to an HCV-positive source, including baseline testing for anti-HCV and ALT activity AND
Conduct follow-up testing for anti-HCV at 4 to 6 months and ALT activity. If earlier diagnosis of HCV infection is desired, testing for HCV RNA may be performed at 4 to 6 weeks.
Seek confirmation by supplemental anti-HCV testing of all anti-HCV results reported as positive by enzyme immunoassay.
Source: Centers for Disease Control and Prevention: http://1.usa.gov/sltyD1
"Baby boomers are disproportionately affected by hepatitis C in the U.S., and many of them were infected decades ago," she says. "Reaching this population with screening is critical to slowing and stopping the serious health consequences that are already taking place."
By the time chronic HCV patients develop symptoms, they already have significant liver damage, says Alter. Chronic HCV infection is the most common reason for liver transplants.
Meanwhile, health care workers should report and follow up on needlesticks to determine if the source patient is positive and to detect seroconversion, she says. "It's extremely likely that you could cure your HCV infection," she says.
Taking the drugs is not easy, however. "The new treatments are very promising, but they come with a price," says Alter. "They have quite substantial side effects associated with them."
Despite the reduction in needlesticks nationwide, Dieterich still sees a steady stream of health care workers from around the country who have acquired HCV from a needlestick. "I'm treating one now, a house officer with acute hepatitis C from a needlestick," he says. "The good news is that it happens relatively rarely now because of all the safeguards. The bad news is it still sometimes happens."
References
1. Food and Drug Administration. News release: FDA approves Incivek for hepatitis C. May 23, 2011:http://1.usa.gov/v5DsgR
2. Jagger J, Puro V, De Carli G. Occupational transmission of hepatitis C virus. (letter) JAMA 2002;288:1469; author reply 1469-71.
3. Luckhaupt S, Calvert G. Deaths due to bloodborne infections and their sequealae among health care workers. Am Jrl Ind Med 2008; 51:812-814.
Safer sharps do not eliminate the risk of hepatitis C for health care workers, but new drugs can spare them from a dire prognosis.Subscribe Now for Access
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