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January 30, 2012

Hepatitis C and the Damage Done
By Leslie Feldman
For The Record
Vol. 24 No. 2 P. 24

Research forges ahead in the fight to combat a disease affecting millions of Americans.

Often silent, often deadly, hepatitis C infects more people than HIV does and is the leading cause of liver disease in the United States. The hepatitis C virus (HCV) is also the primary reason for liver transplants in the United States.

Many people are finding themselves blindsided by HCV’s destructiveness. The American Liver Foundation estimates that more than 4 million people in the United States are or have been infected with HCV, and about 10 million will contract the disease in the next couple decades. Unfortunately, only about 30% who have the virus know that they do.

HCV kills between 10,000 and 12,000 Americans each year, but the future holds even grimmer prospects. According to some estimates, approximately 10 million Americans will have hepatitis C within the next couple decades.

It may seem unbelievable that so many people are unaware they have such a serious health problem, but the virus progresses slowly—often over the course of decades. It does much of its damage silently without displaying symptoms that would normally indicate something is wrong. The damage eventually takes the form of cirrhosis, in which healthy liver cells are injured and scar tissue forms in their place. Over time, cirrhosis can affect the liver’s ability to perform some critical functions and reduces the amount of blood flowing through the organ.

Despite the sobering numbers, there appears to be a heightened awareness of HCV’s destructiveness.

“Fortunately, I have been seeing a significant increase in patients with diverse liver diseases, especially with those with chronic hepatitis C and nonalcohol fatty liver disease,” says Kellen Kovalovich, MD, a gastroenterologist at the PMA Gastroenterology Center in Limerick, Pennsylvania. “Physicians are treating increasingly well-informed patients who utilize a host of information services from health magazines, medical websites, Internet search engines, and even social media outlets. These astute patients then ask themselves the right questions regarding personal risk factors for liver disease. If concerns are raised, then often they will flag their personal physicians to screen them or will request a consultation with a gastroenterologist/hepatologist.”

Who Is at Risk?
HCV is transmitted from a person who is infected through blood or body fluids. Therefore, those infected with HCV should not donate blood, organs, tissues, or semen. Not everyone with HCV exhibits symptoms. In fact, 80% of those who are infected have no signs or symptoms.

High-risk individuals include injection drug users and those who have received blood-clotting factors made before 1987. Those at intermediate risk include hemodialysis (kidney) patients, recipients of blood and/or solid organs before 1992, people with undiagnosed liver problems, and infants born to infected mothers.

It’s important to note that HCV is not spread by sneezing, coughing, hugging, food or water, sharing eating utensils or drinking glasses, or casual contact.

The Importance of Testing
People who are at risk of contracting hepatitis C should talk to their doctor about being tested for the virus as soon as possible. After initial exposure, the virus can be detected in the blood within one to three weeks and is present at the onset of symptoms. Blood tests given as part of a routine physical examination can miss up to 40% of patients with liver dysfunction resulting from hepatitis C, another reason patients need to ask their doctor to be tested for the virus. The tests can determine how well the liver is functioning and whether there is inflammation of or injury to the liver.

In addition to routine testing, there are more detailed exams available for determining a hepatitis C diagnosis. For example, one test can detect whether someone has developed HCV antibodies. However, that test alone doesn’t provide all the answers; a positive result doesn’t necessarily mean someone has an active hepatitis C infection, only that it was present at some point in time.

To determine whether there is an active hepatitis C infection, an RNA blood test must be administered. While a qualitative HCV RNA test can determine whether a person has an active hepatitis C virus, a quantitative HCV RNA test indicates how much of the virus is in the blood (known as the viral load), important data that can be used during and after treatment.

A liver biopsy may also be performed to help assess whether the virus was caught early or whether it has reached an advanced state.

Once a hepatitis C diagnosis has been confirmed, the type of virus strain must be determined. Most Americans with hepatitis C have the HCV genotype 1 strain (there are six genotypes), which tends to respond poorly to treatment compared with the other genotypes. It is recommended that people who test positive for HCV also be evaluated for liver disease.

Interferon and ribavirin are popular options for treating chronic hepatitis C. Interferon can be taken alone or in combination with ribavirin. This combination therapy is the current treatment of choice for many physicians working with HCV patients, according to Fred Poordad, MD, chief of hepatology and liver transplantation at the Comprehensive Transplant Center at Cedars-Sinai Medical Center in Los Angeles, who adds that interferon-based therapies have many manageable side effects.

Two new antiviral oral medications, boceprevir and teleprevir, received FDA approval in May 2011. Both drugs work by blocking an enzyme that helps the virus reproduce and are intended to improve on standard treatments using the injected drug pegylated interferon alpha and the pill ribavirin.

"So far, the new drugs have shown promise in clearing the virus from the body and almost doubling the cure rate of the disease," said Allan Wolkoff, MD, chief of the division of gastroenterology and liver diseases at the Albert Einstein College of Medicine in a press release about the dangers of hepatitis C.

Because there is no cure for hepatitis C, the best outcome is being “clear” of the virus six months after treatment. In addition to drug therapy, doctors recommend hepatitis C patients get plenty of rest and refrain from alcohol consumption.

Patients whose disease has progressed may be candidates for a liver transplant. “Although the majority of HCV-infected [patients] will not need transplant or will not be eligible for transplant due to other medical conditions, HCV is in fact the single most common liver disease leading to transplant in the US, with roughly 40% of all transplants done in HCV-infected patients,” says Poordad.

The Quest for a Brighter Future
Research has been moving forward in the laboratory since 2005, when researchers were first able to replicate the HCV virus, regarding the development of a hepatitis C vaccine similar to those available for hepatitis A and B. But more work needs to be done to advance possible treatment options.

“I am seeing more patients due to the recent approval of boceprevir and telaprevir, the first direct-acting antiviral agents for HCV,” says Poordad, who was instrumental in the clinical development of both drugs and involved in multiple other research projects investigating emerging therapies. “HCV research over the next five to 10 years is going to focus on interferon-free, less toxic regimens with higher cure rates and more applicability.”

Researchers at the La Jolla Institute for Allergy & Immunology are using mouse models of a chronic infection that closely resemble several features of a human hepatitis C infection to explore ways to boost the body’s ability to fight the disease.

“In chronic hepatitis C, the immune system is not able to eradicate the virus, and we are using this mouse model to try to understand the reasons for this failure,” says Matthias von Herrath, MD, the study’s lead scientist.

The La Jolla scientists have found that a molecule called interleukin-10 (IL-10) is activated during the chronic viral infection. “This molecule is known to suppress immune responses, which is a good thing in autoimmune diseases where the immune system is overactive. However, in the case of a viral infection, we need just the opposite: a strong and powerful immune response. Consequently, we needed to shut off this molecule’s action to rev up the disease-fighting response,” von Herrath says.

The team found that when it blocked the IL-10 molecule and infected mice with a virus that typically induces a chronic infection, the rodents were able to clear the infection. von Herrath says the research is promising and could one day lead to new treatments although more study is needed.

“The identification of molecules that heavily influence disease courses is always the first step in designing new therapeutic approaches,” he explains. “Hopefully, our findings will be helpful in developing such new approaches for hepatitis C infection.”

Communication Is Key
The Centers for Disease Control and Prevention recently reported that from 1999 to 2007 more people in the United States died of the consequences of HCV than HIV infection, with nearly three-fourths of these deaths in the 45-to-64 age range. “Although we have a better understanding of the molecular make-up of the HCV virus, its ability to mutate and develop resistance to treatment and the cellular interactions between the host's immune system and the virus, it is clear that unless we treat HCV in a timely fashion, more patients will suffer and die,” Kovalovich says.

Discussing any health concerns with a family physician can be one of the best defenses against HCV. “Primary physicians at the frontlines of care play an essential role in screening their patients for liver disease and referring them sooner to a specialist for definitive diagnosis and treatment,” Kovalovich says. “I often tell my patients that liver disease acts much like a stealth bomber in that it flies under the radar and is often asymptomatic or has only vague, nonspecific symptoms such as fatigue. However, like a stealth bomber, sooner or later undiagnosed liver disease inflicts a damaging blow to their health. A simple inquiry to their primary physician may save them from much suffering from an undiagnosed liver disease.”

— Leslie Feldman is a freelance healthcare writer and marketing communications consultant in Philadelphia.


Do Nail Salons, Barbershops Harbor Hepatitis?
The risk of hepatitis transmission through non–single-use instruments, such as nail files, nail brushes, finger bowls, foot basins, buffers, razors, clippers, and scissors, during nail salon and barbershop visits cannot be excluded, according to the results of a new report discussed at the American College of Gastroenterology’s annual scientific meeting held this past fall.

David A. Johnson, MD, FACG, of Eastern Virginia Medical School, presented an abstract that analyzed a report developed by the Virginia Department of Health, “Assessment of the Risk of Bloodborne Pathogen Transmission in Nail Salons and Barber Shops and Regulatory Requirements in Virginia.” Johnson’s assessment of the report indicated that bloodborne pathogens such as the hepatitis B virus (HBV) and hepatitis C virus (HCV) may be transmitted if non–single-use instruments are not fully cleaned and disinfected according to the state regulations. The Virginia Department of Health found that the current state regulations (dated September 1, 2011), which require intermediate-level disinfection for non–single-use items in nail salons or barbershops, are sufficient to prevent bloodborne pathogens transmission if there is full compliance.

“Whether there is sufficient compliance with disinfection requirements is an important variable in the safety of salon and barbershop services from a public health perspective,” Johnson said. “The risk of transmission of infectious disease, particularly hepatitis B and C, in personal care settings is significantly understudied in the United States.”

Johnson explained that a reported case of acute HCV that was “clearly related to a manicure/pedicure treatment” prompted this evaluation of the current patient risks associated with salon exposures.

A group coordinated by the Office of Epidemiology at the Virginia Department of Health conducted the aforementioned study. This study included a comprehensive literature search on PubMed and Google using relevant key words such as “nail salon,” “manicure,” “pedicure,” “barber,” “razor,” and “hepatitis.” Additionally, the group reviewed the safety regulations in Virginia and compared them with those in 13 other states and the District of Columbia.

The review of the published literature identified 18 papers, including nine case-control studies, three case-series studies, and six population-based surveys that assessed manicure, pedicure, or barbering as potential risk factors for HBV and/or HCV infection. Of the nine case-control studies, five evaluated HBV and/or HCV in nail salon settings, and three of the five showed an association with HBV and one of the five showed an association with HCV. Eight of the nine case-control studies evaluated HBV and/or HCV in barbershop settings, and five showed an association with HBV and two showed an association with HCV.

The case-series studies and surveys are less indicative of an association for HBV and HCV in nail salon or barbershop settings. Caution is required in interpreting these findings because there are substantial heterogeneities in the population studied, sample size, case and control selection, analytic method, and control of confounding variables across studies. Furthermore, none of the nine case-control studies was conducted in the United States.

The federal Occupational Safety and Health Administration does not have specific guidelines for the prevention of HBV or HCV infection in nail salons and barbershops, according the Virginia Department of Health, and neither the current Centers for Disease Control and Prevention case report form for HBV or HCV nor the National Electronic Disease Surveillance System captures barbering, manicures, or pedicures as risk factors for the transmission of hepatitis infection.

“The absence of infection control guidelines from federal health agencies … for the prevention of hepatitis infections in nail salons and barbershops implies that barbering, manicure, and pedicure have not emerged as significant risk factors for HBV and HCV infections in the United States,” Johnson said. “The true magnitude of this risk has yet to be defined and clearly needs further study.”

In the meantime, Johnson urged nail salon and barbershop customers to be aware of the potential risks for hepatitis transmission and to take precautions, including asking questions to determine whether the nail salon or barbershop is properly cleaning and disinfecting tools and equipment. He also suggested that customers bring their own equipment, including clippers, razors, and nail files.

— Source: American College of Gastroenterology