New Therapies, Programs Affect Hepatitis C Treatment within VA

By David Ross, MD, PhD, MBI, director, HIV, HCV and Public Health Pathogens Programs, Office of Public Health/Clinical Public Health

Lorenzo L. McFarland, DHA, MSW, PMP, senior manager, Public Health Program, HIV, Hepatitis and Public Health Pathogens Programs/Clinical Public Health

David Ross, MD, PhD, MBI

Chronic infection with hepatitis C virus (HCV) is the most common bloodborne infection in the United States, affecting more than three million Americans. HCV-infected patients are much more likely than the general U.S. population to develop life-threatening complications, such as cirrhosis, end-stage liver disease or hepatocellular carcinoma (HCC). Although antiviral treatment can cure HCV infection, these therapies have historically had low efficacy rates and significant toxicities.

The Department of Veterans Affairs (VA) is the largest provider of HCV care in the U.S., with more than 170,000 veterans with HCV in care in 2011. The prevalence of HCV is threefold higher among veterans in VA care than in the general U.S. population, and three-quarters of these patients have comorbid conditions, such as HIV infection or mental-health disorders (e.g., alcohol-use disorders or depression) that increase their risk for complications and make management of their HCV infection exceedingly complex. HCV is a particular issue for homeless veterans, with seroprevalence rates exceeding 40%.

Lorenzo L. McFarland, DHA, MSW, PMP

VA has been recognized as a national leader in HCV care since 2001, when its Office of Public Health (OPH) established a robust VA National HCV Program centered on field-based Hepatitis C Resource Centers (HCRCs). Under OPH’s direction, the HCRCs have produced authoritative guidelines on diagnosis and management of HCV and its complications, trained hundreds of VA HCV providers, produced dozens of clinical tools for VA clinicians and generated widely adopted print and Web-based educational materials for veterans and providers. Most importantly, HCRCs have developed novel integrated-care systems for addressing psychiatric comorbidities that would otherwise prevent veterans from receiving antiviral therapy. A 2010 Institute of Medicine report recognized VA as a leader in HCV care because of these innovations.

Additional improvements stem from OPH’s development of a VA National HCV Clinical Case Registry (CCR), which tracks all veterans in VA care with confirmed HCV. The CCR provides aggregate data at the national, regional and facility levels to guide initiatives to improve access to and quality of HCV care within VA. In addition, local VA facilities can use CCR software to adopt a population-health approach to HCV care, identifying HCV patients at particularly high risk for complications and those who may benefit from more intensive management.

These efforts are reflected in data showing that VA provides access to high-quality care to veterans with HCV, in accordance with guideline-recommended clinical preventive services. These include confirmation of hepatitis B immunity or vaccination (76% of HCV+ veterans), confirmation of hepatitis A immunity or vaccination (69%), HIV testing (68%), annual influenza vaccination (59%) and screening for HCC in veterans with chronic HCV and cirrhosis (57%).

Antiviral therapy in veterans with HCV has been a particular challenge. Because of the proportion of veterans with HCV who have contraindications to treatment, such as alcohol- or substance-use disorders, treatment rates in VA have historically been low, with only 22% of veterans with HCV in VA care having been treated as of December 2011. The situation is exacerbated by the number of veterans declining or delaying therapy because of the significant toxicities of available regimens.

However, this situation is rapidly changing. In the past year, VA researchers showed that veterans who receive antiviral therapy and achieve a sustained viral response (SVR), which is tantamount to cure, have significantly improved survival. In addition, approval by the U.S. Food and Drug Administration (FDA) in mid-2011 of new HCV antiviral therapies has led to a paradigm shift in drug treatment for this disease. Although these new drugs, which are added to standard treatments, have toxicities of their own and require complex protocols for effective use, they allow substantially higher SVR rates than older drugs alone and result in a much improved benefit/risk profile.

VA has promptly taken advantage of these developments. The National HCV Program worked closely with VA’s Pharmacy Benefits Management office to introduce new HCV antiviral therapies into VA practice by creating formal written guidelines for their appropriate use, educating providers about the complex technical requirements for successful treatment with these drugs and training hundreds of clinical pharmacists as HCV treatment providers. These initiatives resulted in the drugs being available for use in VA in record time, with addition to the VA national formulary within weeks after FDA approval. As of mid-2012, more than 3,500 HCV-infected veterans have been treated with these new regimens, representing a 10% increase in the number of treated veterans since December 2011.

Current and future initiatives by VA’s National HCV Program are focused on concrete efforts to improve access and quality of HCV care. Because of the need to address treatment-limiting comorbidities, the program has collaborated with the Office of Aca-demic Affiliations to establish a health psychology fellowship aimed at increasing VA capacity to address mental-health issues that are barriers to treatment among VA HCV patients. Currently, four VA sites are training psychologists specifically to treat mental-health conditions in HCV patients that are barriers to successful antiviral treatment. If successful, the training program may be expanded to additional VA sites.

Other efforts include collaboration with VA’s Office of Patient Care Services to increase access for HCV treatment through a transformational program called SCAN/ECHO, training primary-care providers to evaluate and treat HCV patients, especially those who live in rural areas. This innovative program will increase the number of VA providers providing HCV care and reduce travel and wait times for veterans with HCV.

Finally, the National HCV Program is making a major effort to support local quality improvement initiatives in HCV care. In 2011, funds were awarded to teams at 15 VA facilities to develop and execute quality improvement projects designed to improve chronic HCV care at their VA medical center or community-based outpatient clinics by improving HCV screening, treatment and/or access to care, patient education, provider education, administration and monitoring of new antiviral therapies, management of cirrhosis and end-stage liver disease, management of comorbid conditions and/or early diagnosis and treatment of HCC.

In summary, this is a very exciting time in the field of HCV care. Prospects for even more effective and less toxic HCV drugs may well allow cure of the majority of in¬fected veterans. At the same time, progress in managing treatment-limiting comorbidities carries the promise of increasing access to antiviral therapy, as well as addressing the problems caused by these conditions in their own right. VA will continue to make diagnosis, treatment and care of veterans with HCV a priority.

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