According to the Centers for Disease Control and Prevention (CDC), an estimated 4.4 million Americans live with viral hepatitis, the leading cause of liver transplantation in the United States, but most do not know they have it.
“Viral hepatitis is tough because these are very quiet diseases, and patients are unlikely to show up declaring that they have symptoms,” said Andrew Muir, FACP, associate professor of medicine and clinical director of hepatology at the Duke University Medical Center's gastroenterology division in Durham, N.C. “And if you wait until the patients have symptoms, then the disease has reached a point in its course where you really cannot do a whole lot about it. So there really is a time that screening to identify patients in an earlier course of the disease where it's treatable is critical. But that is the step where we need to improve.”
Experts hope a new plan launched in May by the U.S. Department of Health and Human Services, “Combating the Silent Epidemic of Viral Hepatitis: Action Plan for the Prevention, Care and Treatment of Viral Hepatitis,” will target this stealthy condition from a number of fronts. The report is online.
Developed through the collaboration of a number of agencies working with various organizations and professional societies, the action plan was created in response to the Institute of Medicine's 2010 report “Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C,” reporting deficiencies in preventing and controlling chronic hepatitis B and C and outlining recommendations. The action plan seeks to promote better education, treatment and prevention by boosting awareness; increasing training of clinicians to diagnose and treat hepatitis and immunize patients; and building on the 2010 Patient Protection and Affordable Care Act, enabling more patients to access viral hepatitis prevention and treatment services through expanded insurance coverage.
On the front lines
Primary care physicians will play a large role in implementing the plan, which is not a clinical guide on hepatitis treatment but focuses on improving screening, diagnosis, linkage of patients to care and treatment after diagnosis, and public health management. It includes six parts:
- educating clinicians and the public,
- improving testing, care and treatment,
- strengthening surveillance,
- eliminating transmission of vaccine-preventable viral hepatitis,
- reducing viral hepatitis caused by drug use, and
- protecting patients and workers from health care-associated viral hepatitis.
Many clinicians have applauded the initiative. “It's a call to action for primary care doctors to improve screening for hepatitis,” said Sammy Saab, MD, MPH, associate professor of medicine and surgery at the University of California, Los Angeles's David Geffen School of Medicine. “And it highlights that patients don't carry badges saying that they have viral hepatitis. So this plan encourages primary care doctors to screen for viral hepatitis not based on just elevated liver enzymes, but to screen patients with risk factors.”
Groups with higher rates of viral hepatitis include injection-drug users, men who have sex with men, and persons who received blood, tissue, or organs prior to 1992. Baby boomers and African-Americans have higher rates of chronic hepatitis C. and Asian/Pacific Islanders have higher rates of chronic hepatitis B.
Past educational efforts have fallen short, said Kevin Fenton, MD, PhD, director of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention at the CDC.
“We actually have a dually compounded situation when providers aren't offering the screening for hepatitis,” he said, “and patients, especially those who are at risk, are not educated about hepatitis and therefore not demanding the screening from their providers. So we're left with people being undiagnosed.”
Education of clinicians and the public is a key strategy. “We're also going to be working with agencies such as Health Resources and Services Administration [HRSA] and the Bureau of Primary Health Care to ensure that HRSA-funded grantees and partners are also receiving this additional information on what physicians can actually do to promote better education, better screening, and linkage to care for people living with viral hepatitis,” Dr. Fenton said.
New treatment options
Knowing a patient's infection status opens the door to effective treatment. “For HCV [hepatitis C virus] and HBV [hepatitis B virus], you can actually eradicate or control the infection,” Dr. Fenton said. “So this makes it really important for us to get the message out.”
Seven drugs have been licensed to treat hepatitis B, and the timing of this initiative roughly coincides with the release of two new protease inhibitors used to treat hepatitis C. Although ribavirin combined with interferon is able to cure about 40% to 50% of patients with hepatitis C, the combination is difficult to tolerate and requires 6 to 12 months of treatment, said Brian McMahon, MACP, director of the Liver Disease and Hepatitis Program at the Alaska Native Medical Center in Anchorage. The new drugs, Incivek (telaprevir) and Victrelis (boceprevir), which are given with interferon or ribavirin, attack the virus itself, increasing the cure rate for hepatitis C to about 70% and shortening treatment for most patients.
Dr. McMahon sees a bright future in treating hepatitis C. “There are over 50 of these direct-acting agents that are in clinical trials right now, and what we think is going to happen in the next five to seven years is we'll have regimens of two to three oral drugs with a lot less side effects with high cure rates in the 70% to 100% cure rate level,” he said.
Technological advances will help, too. For example, a new rapid point-of-care test will allow clinicians to test for hepatitis C and electronic medical records will assist in testing high-risk patients and following up on care. Furthermore, the 2010 Patient Protection and Affordable Care Act will expand health care coverage and increase patient access to viral hepatitis prevention and treatment services.
The plan also focuses on the low-hanging fruit, areas where infectious disease and primary care physicians need to do a much better job, Dr. Fenton said. “I'm specifically thinking about opportunities to eliminate mother-to-child transmission of HBV infection in the U.S. by doing a much better job of screening pregnant women for hepatitis and showing that those who are HBV-positive receive the appropriate management and care in the perinatal period to prevent onward transmission of the infection to their infants.”
With the plan, specific quality measures will need to be established to identify progress in screening, linkage to care, treatment, and cures, as well as measures that will help physicians in their clinical levels of intervention, Dr. Fenton said.
“HRSA-funded health centers will begin reporting on the prevalence of HBV and HCV among its patients through the Uniform Data System,” said Martin Kramer, HRSA director of communications. “This will assist program- and policymakers in understanding the impact of hepatitis and the care needs.” However, quality measures will not affect physician reimbursement, he explained.
Viral hepatitis is complex, encompassing a multitude of viruses with different modes of transmission and prevention. “The diseases are all in different phases, so for vaccine-preventable conditions, such as hepatitis A and B, we're seeing real sustained declines in the United States,” Dr. Fenton said. With HCV, he explained, the CDC is concerned about emerging outbreaks and the aging cohort of people born before 1965, who are at higher risk.
“I think that this is one of the exciting things about the viral hepatitis action plan, which for the first time the United States has an overarching strategy across the Department of Health and Human Services that leverages the collective expertise and technical areas of focus for the different federal agencies to say what all the agencies are going to be doing individually and collectively to address viral hepatitis in the United States,” Dr. Fenton said. “The plan also impacts what key milestones need to be achieved for hepatitis A, HBV, and HCV separately but also talks about what overarching things we need to do to move forward our response of viral hepatitis prevention and control.”
Dr. Fenton explained that the CDC is already beginning to implement components of the plan, such as developing a national education campaign for clinicians and the public, improving surveillance, reevaluating hepatitis C screening guidelines, and working with HRSA to develop ways to engage clinicians and prevention training centers to provide better training.
Looking to the future
Primary care physicians will need to prepare for their role in this plan, experts said. “We need more doctors, especially primary care doctors and therefore internists, to be aware of these conditions because they have a unique role and ability to identify patients early on,” Dr. Muir said. “So my hope is that awareness of the condition, awareness of the effective therapies that are now available for both HBV and HCV, will lead physicians to consider these diseases, to encourage their patients to have screening and to be evaluated by a specialist for treatment.”
As more cases are detected and patients are referred for treatment, Dr. McMahon predicts specialists will become overwhelmed and treatment may sometimes shift to primary care clinicians. (For more on one version of that care model, see the related article, “Project ECHO expands the reach of primary care.”) “If this action plan is successful, what we'll see happen is that these specialists become more advisors than they are actual treaters, and the primary care providers will be much more involved in the actual treatment of chronic HBV and HCV,” he said.