July 2005
HCV Virus A Major Public Health Issue For Veterans Affairs -
Stephen Spotswood

VA furnishes hepatitis C information and guidelines to VA providers.

WASHINGTON-The history of hepatitis C care is a relatively short one as far as diseases go, but it is one that has had a tremendous impact on public health. The most common blood-borne infection in the United States, with approximately two per cent of the American public believed infected, the hepatitis C epidemic has taken center stage across nearly all health care systems.

For the Department of Veterans Affairs (VA) health care system especially, hepatitis C has become a high priority, with the prevalence rate among the VA patient population three times the rate of the general population. Currently, VA treats somewhere between 180,000 and 200,000 of its patients for hepatitis C-a prevalence rate of 5.4 per cent. Since the creation of diagnostic tests for hepatitis C in 1992, VA has quickly realized just how big an impact the virus has on its health care mission, and has moved to initiate strong prevention, education and treatment measures system-wide.

The Continuum Of Care
VA began confronting the hepatitis C epidemic on a national level in 1998, creating policies of universal risk factor screening and voluntary testing for those at risk. Around the beginning of 2002, VA's Public Health Strategic Health Care Group (PHSHCG), which also oversees VA's HIV strategies, took over the agency's hepatitis C efforts.

In an interview with U.S. MEDICINE, Dr. Michael Rigsby, director of VA's National HIV and Hepatitis C Program Office and associate professor at Yale University School of Medicine, along with Jane Burgess, an AIDS Certified Registered Nurse and VA's HIV/Hepatitis C National Clinical Coordinator, spoke about VA's response to the epidemic and the work currently being done.

"Largely because of the work we've done previously in HIV, it was recognized that a public health approach when dealing with hepatitis C was important because of a number of concerns and issues around hepatitis C and VA. At that point, these were issues of prevalence, risk factors and the size of the population in VA with hepatitis C," explained Dr. Rigsby. "So what we did was develop a program that was based on certain key organizing features. The first being screening and testing.

"Very shortly after getting responsibility for hepatitis C, we developed a national policy of screening all veterans in care for risk factors for hepatitis C and that's simply asking them about known risk factors, and testing those at risk," he said.

VA also began collecting data through a national chart review to help track their screening efforts.

"Over the course of several years now we've tracked that data and we've gotten to the point that well over 95 per cent of people coming into VA for care are screened for risk factors, and over 90 per cent of those have been tested for hepatitis C," Dr. Rigsby said.

The second element in VA's continuum of care is education, both patient education and provider education.

"VA patients with hepatitis C are cared for in a number of different settings other than in liver clinics where providers might already be informed about hepatitis C. So we began a broad effort to educate providers in primary care and other areas about hepatitis C that [incorporates] web-based materials, e-mails and print information. And we've also developed patient education materials that include pamphlets, videotape, electronic format, web-based information, and some direct mailings to patients as well," he explained.

The third element is clinical care, something VA was already excelling in before the PHSHCG took over hepatitis C efforts.

"We already had in place an excellent system for clinical care of patients with hepatitis C, but there were a number of obstacles to providing optimum care, some of which are largely out of our control," Dr. Rigsby explained.

Those obstacles included a large comorbidity in the VA patient population between hepatitis C and substance abuse disorders and mental illness, which precluded patients from getting many of the available therapies.

"The inherent lack of efficacy and the toxicity of many of the therapies is another barrier," Dr. Rigsby said. "And there were also issues of capacity-whether there was sufficient capacity in our system to deal with the number of patients that we have.

"So we've taken a number of steps to address all of those issues," he explained. "In terms of the issues of comorbidity with substance abuse disorders and mental health, we've encouraged clinics to develop multidisciplinary approaches that involve mental health and substance abuse professionals in hepatitis C care to increase the level of awareness and skill of those providers in doing consultation and managing those patients with hepatitis C, and also to develop the skills in mental health of our hepatitis C professionals."

Relying On The Midlevel
In working to combat the capacity problem-making sure that there were enough physicians to handle the hepatitis C patient population-VA made a significant realization: much of the work in caring for hepatitis C patients is not done by specialists.

"It seems to us that there are many aspects of hepatitis C care that do not require the attention of a highly-trained [gastroenterologist] or hepatologist, especially patient education, monitoring, counseling-all of the things that we consider part of hepatitis C care, but which don't require highly skilled specialty expertise. Those are often done best by midlevel providers, nurse practitioners, physician's assistants, clinical pharmacists and so forth," Dr. Rigsby explained. "We've developed programs to try to improve the skills of midlevel providers in hepatitis C care and really expand the pool of people who are providing the care to patients with hepatitis C."

Burgess added that, "the treatment of hepatitis C is long term, so when we talk about treatment, immediately people think of drug treatment, but in fact this is a slow-progressing disease and drug treatment is not necessarily an option or even the best option for a lot of folks. So a lot of work is being done with having a lot of people get into substance abuse treatment, helping folks decrease their alcohol, or stop their alcohol intake, which is a significant contributor to disease progression. So if we can do anything to turn that around, [we] can make a huge difference in a person's lifespan and the progression of their disease."

And sometimes that work is best done by those who see the patient on a more regular basis than the blood and liver specialists that are so often associated with hepatitis C clinical care. Hepatitis C issues frequently confront those health care professionals working in the areas that deal with hepatitis C risk factors such as mental health and substance abuse. And it works the other way around, with hepatitis C specialists needing to become knowledgeable with psychiatric disorders and substance abuse care.

Asked why the prevalence rate was higher among Vietnam vets, Dr. Rigsby explained, "If you look at the distribution of hepatitis C patients within the U.S. population, it's not uniform. This comes from CDC data. In fact, the highest prevalence is among men in the age group that corresponds very closely to the Vietnam era service age group. And there are also some racial and socioeconomic variables in terms of distribution of hepatitis C, all of which would favor a higher prevalence among Vietnam era veterans even if there were no other factors involved.

"In addition to that, I think it's probably been shown a number of times that certain risk factors for hepatitis C, including substance abuse disorders and mental health problems, are also highly prevalent in the population of veterans who served during the Vietnam era, and those things probably contribute to the higher prevalence, as well."

He added, "That population of veterans who served in the Vietnam era and especially those who are using VA care-that means that they tend to be of lower socioeconomic levels-have more medical problems than veterans in general, [and] the prevalence of known risk factors is high."

How Did I Get Infected?
One other reason that may contribute to the higher prevalence of hepatitis C among Vietnam vets is the higher risk of combat-related exposure.

"I think there's an area where we have to think that there are still some unknowns, and that's the question of whether there were any specific military-related exposures that could have contributed," Dr. Rigsby explained.

"There's no research evidence so far to support that, but we hear a lot of individual stories from veterans about the frequent exposure to blood on the battlefield, to living in conditions that would make it very difficult to avoid contact with potentially infected bodily fluids," he added. "All of those things, I think, are going to be difficult to ever tease out because there were no tests at that point for hepatitis C, and it's very difficult to document those exposures 30 or 40 years later. But, I think we need to listen to those stories with as much understanding and empathy and scientific curiosity as we can and try to answer those questions."

Another concern that has been voiced by veterans is possible exposure from the use of jet injectors (air gun injectors) in immunization during training-concerns that came to public attention frequently in the late 1990s. While VA says that there has been no documented case of hepatitis C being transmitted by a jet gun injection, they admit it is biologically plausible.

"In boot camps and basic training, apparently people stood in long lines to get inoculations and these jet injectors were used and people described bloody arms and it's easy to imagine that equipment that's misused could have become contaminated," Dr. Rigsby said. "There's been at least one documented transmission of hepatitis B by these devices. We do not know of any documented transmission of [hepatitis] C or HIV or any other blood-borne pathogens, although it seems to be biologically plausible. And again, it seems that it will be difficult to establish, because if it did happen, it probably happened sporadically under specific instances, circumstances that will be impossible now to replicate many years later."

It's important, he said, for VA to listen when veterans come forward with questions and concerns regarding how they were infected.

"It happens so frequently that veterans talk to us and say, 'I really don't have any of the known risk factors for hepatitis C,' and we have to acknowledge that we can't tell every single person how they got infected," Dr. Rigsby explained. "I think we have to keep an open mind about it. I think on one hand you have to be scientifically rigorous about these questions if at all possible, but on the other hand there's the possibility that science might not be able to answer all of the questions."

Burgess added, "I think the stories are repeated, and there's enough similarity between the stories that they need to be paid attention to. Even if we don't have a direct link, and we may never have a direct link, I think we need to take care of these folks and provide care to them and I think to some extent when they're here and we're providing care, to us it doesn't matter how they got it."

However, to the veterans it does matter, for both emotional and financial reasons.

"If it were only medical care that was an issue, it probably wouldn't be a big deal, but there's the potential for establishing a service-connection," Dr. Rigsby explained. "And a service-connected disability has a link to benefits. There's an importance to veterans to know which conditions resulted from military service as opposed to non-military exposure."

While Dr. Rigsby advocates an open mind when tracking down a patient's exposure possibilities, he does not endorse the immediate acceptance of hepatitis C claims for service connection.

"We've been very clear in saying that each one of those claims needs to be evaluated individually, adjudicated individually and in the context of all the known risk factors for hepatitis C," he said. "When no other risk factors can be identified and it seems to be plausible there was a chance of exposure during military service, an individual [disability] rater can decide that the evidence is as likely as not that exposure occurred during the military, and that can result in a person getting [a] service-connected disability [rating], but it is not a presumptive condition that automatically becomes service-connected."

One of the most frequent problems in trying to nail down a service-connected exposure is the lack of adequate environmental or medical records, especially from the Vietnam era.

"I think a lot of the conditions that we're talking about are ones that good records don't exist for in DoD (Department of Defense), and to date there has not been any effort that I know of jointly between the two agencies to look at specific instances in the Vietnam era. There certainly has been a lot of discussion of the use of air gun injectors, and it's my understanding that they're not being used in the same way that they were in the Vietnam era," Dr. Rigsby said. "And I think that cooperation between DoD and VA in transitioning of care and transitioning of medical records information, what's happening now is much, much better than what happened 30 years ago. But I think those are real-time improvements rather than retrospective."

In many cases, such records simply never existed.

"The kind of exposure we're talking about-'I picked up my friend's body who got shot and I got blood all over my hands'-there just aren't records for those things," Dr. Rigsby explained.

Research And Relationships
While VA has less to do with basic science and more to do with the delivery of health care, the agency has still found a way to involve itself in progressing research.

"We think research is critically important, especially for a field that's evolving as rapidly as hepatitis C," explained Dr. Rigsby. "Although our office is not hands-on responsible for research funding in VA or research itself, we do try to catalyze opportunities for research and help VA providers interested in doing hepatitis C research to develop partnerships within VA and with groups and partners outside of VA to make that research possible."

Some of those partnerships provide access to pharmaceuticals that would not otherwise be available to hepatitis C patients.

"In terms of therapeutics, we've developed and tried to maintain close, productive relationships with the manufacturers of all the licensed therapeutics for hepatitis C, and because of that we've been able to get things onto our national formulary very quickly and, in some cases, to make products available to veterans that have been difficult to access in the larger community because of shortage of the supply and because of cost," Dr. Rigsby said.

"That relationship we've built with the pharmaceutical companies has garnered multiple dividends for us. The most important [benefit to] our patients is that it keeps us well informed of what's coming along and makes it easy to get those things into clinics and into the hands of patients as quickly as possible," he said. "There are probably still a lot of opportunities, especially as new drug products come along, to do clinical trials work within the VA, because of the large patient load that we have. And there is some work ongoing to see how we can develop network or other systems for making clinical trials easier to do and make them more readily available to our patients with hepatitis C."

Other VA research into hepatitis C includes a study run out of the VA medical center in Decatur, Ga., that looked at the effect of HIV/hepatitis C coinfection on survival. The latest data from the study shows that for patients on highly-active antiretroviral therapy (HAART), hepatitis C infection worsens mortality.

One VA study, this one being funded by NIH (the National Institutes of Health), is currently looking at whether long-term treatment with peginterferon will reduce progression of hepatitis C in patients who do not respond to treatment with peginterferon and ribavirin.

The blind for the study is not scheduled to be broken until 2007, but one of the publications from the study states that reducing the dose of peginterferon or ribavirin during the first 20 weeks of treatment has minimal effects on the probability of achieving a sustained virologic response.

And another VA study currently underway is looking to identify genetic and biochemical markers that could indicate if a patient is susceptible to interferon-induced depression. There are currently no known predictors of such depression.

One thing that makes the VA system ripe for such research opportunities is its national database.

"[Our office,] in dealing with HIV, as well as hepatitis C has felt that it is very important to have good sources of data and information around which to build our programs and develop quality improvement activities, and so we have a national database of hepatitis C patients that automatically extracts information from the electronic medical records system about patients with hepatitis C and rolls it up into the national database," Dr. Rigsby explained. "It's helping us to count better, determine the caseload better, and look at the utilization of care by patients with hepatitis C."

One function of the system that is still in its early stages is using the database to find where there are gaps in the quality of care, or opportunities to improve quality of care, and then to use that information to build improvement programs.

"The case registry has allowed us to look at some of the variations across the system in terms of where those patients fall, where they're being seen, how they're being treated. And we're now beginning to go to the next level of normalizing that data across the system to look at excess variation, which may be signals to look for opportunities to improve quality," Dr. Rigsby explained.

VA also has ongoing partnerships with a number of other federal agencies.

"We've developed very good relationships with NIH and CDC in regards to hepatitis C work. We've sponsored a number of events with NIH, including a large conference on hepatocellular carcinoma last year, and participated with them in a consensus conference a couple of years ago about hepatitis C," Dr. Rigsby said. "But we also have a lot of very informal discussions back and forth with NIH about just what are the research priorities with hepatitis C. What can we as federal agencies be doing either jointly or separately to try to stimulate productive research in those areas?"

VA has also worked with the Bureau of Prisons on a conference about hepatitis C care. Estimates of prisoner prevalence rates vary from state to state, ranging from 20 per cent to 40 per cent.

"We helped create some newsletters directed at health care professionals that work with incarcerated populations," Dr. Rigsby said.

The Health Resources and Services Administration (HRSA) has also expressed interest in working with the VA in collaboration with that agency's work with the Ryan White CARE Act that supports HIV care. A conference call was scheduled for late in June between VA's Hepatitis C Program Office and people who received grants under the Ryan White Care Act to discuss treating HIV patients coinfected with hepatitis C.

"I think there is a good degree of collaboration and mutual purpose in what we're doing," Dr. Rigsby explained. "We're in a different mode than a lot of the other federal agencies since our mission is the delivery of health care rather than research or the setting of national public health policy. And I think a lot of those things are born of the experience in health care providers. The dialogue that we have with those groups, while often not recognized because it doesn't develop into any formal paper or product of any kind, the collaboration itself has been tremendously helpful.

"There's a lot going on," he said. "Much of it is just under the radar."