House Joint Resolution 68, introduced by Delegate M. Keith Hodges, was agreed to by the House of Delegates and Senate of Virginia in 2014. HJR 68 requested a study by the Joint Commission on Health Care of viral hepatitis in the Commonwealth in order to identify resources for and factors limiting the testing, treatment, and prevention of viral hepatitis and to identify opportunities for integration of viral hepatitis treatment within new or existing human immunodeficiency virus (HIV) treatment programs.

Background

Viral hepatitis, which is an inflammation of the liver caused by a virus, claims the lives of 12,000 to 18,000 Americans each year. It is estimated that between 3.2 and 5.3 million Americans are living with viral hepatitis, and as many as 75 percent do not know they are infected. In 2007, annual deaths in the U.S. due to viral hepatitis outpaced deaths due to HIV for the first time. Hepatitis B and C may result in chronic hepatitis, potentially causing cirrhosis, liver failure and liver cancer; chronic hepatitis is the most common cause of liver cancer and liver transplants in the U.S.

Hepatitis A and B. Although a vaccine is available for both hepatitis A and B, there are 17,000 new hepatitis A and 18,800 new hepatitis B infections each year in the U.S. While hepatitis A usually clears on its own without treatment, hepatitis B can result in a chronic infection with the likelihood of progression from acute to chronic hepatitis B based on the age at which the virus was acquired. Hepatitis B becomes chronic in more than 90 percent of infants, 25 to 50 percent of children one to five years of age and six to 10 percent of older children and adults. For the 90 percent of newborns infected with hepatitis B that develop chronic infection, as many as 25 percent will die of cirrhosis, liver failure or liver cancer later in life. The standard of care for pregnant women now includes hepatitis B testing during pregnancy since interventions are now available to prevent transmission to the infant during birth.

Hepatitis C. There are approximately 20,000 new hepatitis C infections each year in the U.S.; and for every 100 people infected with the hepatitis C virus, 75 to 80 will develop a chronic infection, 60 to 70 will develop chronic liver disease, five to 20 will develop cirrhosis and one to five will die of cirrhosis or liver cancer. The Centers for Disease Control and Prevention (CDC) and the U.S. Preventive Services Task Force (USPSTF) recommend that high-risk individuals be screened for hepatitis C and that health care professionals offer one-time screening to baby boomers (born in 1945 to 1965) since 75 percent of hepatitis C cases occur within that age group (primarily due to the lack of blood supply screening prior to 1987).

While there is no vaccine for hepatitis C, treatments are available. Prior to 2013, hepatitis C was treated with an interferon-based anti-viral regimen with long treatment durations, significant side effects, complicated dosing schedules and modest cure rates. Given these treatment problems and the fact that it can take years for chronic hepatitis to result in liver damage, many infected individuals chose to delay treatment until better medication was available; this resulted in significant pent-up demand.

In 2013, sofobuvir (Sovaldi) and simeprevir (Olysio) were approved by the Food and Drug Administration (FDA) as part of a combination anti-viral treatment regimen. These drugs still must be taken with at least one of the traditionally used anti-virals that can cause side effects; however, both sofosbuvir- and simeprevir-based treatment regimens offer significantly higher cure rates than traditional regimens and shorter treatment durations of 12 to 24 weeks. A 12-week supply is $84,000 for Sovaldi and $66,360 for Olysio. Combined with the cost of the other drugs used in the regimen, a 12-week treatment for hepatitis C can cost as much as $116,910. In October 2014, the FDA approved a new drug (Harvoni) for the treatment of hepatitis C. It is the first all-oral regimen and is expected to cost $95,000 for a 12-week treatment.

The Virginia Department of Health (VDH) offers a number of programs that focus on viral hepatitis prevention, immunization, and surveillance. While these programs provide important viral hepatitis tracking and care services, addressing the lack of dedicated funding streams for testing and the limitations of the State’s surveillance system would enable VDH to more effectively prevent the spread of viral hepatitis in the State.

Policy Options

Five policy options were presented; JCHC members voted to take no action. No public comments regarding the policy options were received.

Option 1: Take no action.

Option 2: Introduce a budget amendment (language and funding) for $615,000 GFs per year for VDH for viral hepatitis surveillance

Option 3: Introduce a budget amendment (language and funding) for $660,000 GFs per year for VDH for strategic viral hepatitis interventions

• Hepatitis C testing of 11,000 people per year
• Public and clinician education to increase awareness of the importance of hepatitis C testing among high-risk populations and baby-boomers
• Assistance with linkage to care for persons with hepatitis C.

Option 4: Introduce a budget amendment (language and funding) for $65,000 to increase funding for the Virginia HIV/AIDS Resource and Consultation Centers to provide information and training to HIV providers on HIV and hepatitis C co-infection, including the addition of a consulting hepatologist.

Option 5: Request by letter of the JCHC Chair that the Medical Society of Virginia encourage continuing medical education (CME) on viral hepatitis for physicians.

Free CME resources available at http://www.cdc.gov/hepatitis/Resources/Professionals/TrainingResources.htm