Last month, the American Association for the Study of Liver Diseases (AASLD) annual meeting (The Liver Meeting®) took place, convening nearly 10,000 physicians, surgeons, researchers, allied health professionals and advocates from around the world to discuss the natural history, prevention, and cure of liver diseases. With the availability of new all-oral, direct-acting agents (DAAs), there was a major focus on advances in the management and cure of chronic hepatitis C virus (HCV) infection at The Liver Meeting®.
The improved, second generation DAA treatment regimens, which do not require interferon (IFN) or ribavirin (RBV) as part of the therapy have the potential to dramatically shift the treatment paradigm for HCV, and improve outcomes in patients who were previously difficult to treat. Clinical study of these newer agents suggests the potential to cure nearly all infected individuals with shorter, more tolerable, and IFN-free regimens in contrast to previous regimens with IFN/RBV and the first-generation DAAs.
The combination of the U.S. Centers for Disease Control and Prevention (CDC) guidelines for one-time HCV screening for all “baby boomer” adults (born between 1945 and 1965), the expanded access to health care provided by the Affordable Care Act (ACA), the emergence of improved, second generation DAAs, and the aging of Americans who are chronically infected with HCV, is creating both unique opportunities and complex challenges in managing HCV in the U.S. as an increasing proportion of patients with HCV are diagnosed and may be candidates for these more efficacious treatments. An evolving issue of great importance is understanding which patients should be considered for immediate antiviral treatment, a topic covered by a number of investigators at the Liver Meeting®.
- Most patients meet the AASLD/Infectious Disease Society of America (IDSA) high or highest HCV treatment need criteria: Using data from the long-term Chronic Hepatitis Cohort Study (CHeCS), researchers at the CDC determined that at least two-thirds of individuals chronically infected with HCV may meet the recently released criteria for those with “high” or “highest” need for treatment based on severity of liver disease and other co-morbid conditions. (Xu, et al. Abstract #LB-29)
- Many patients eligible for IFN-free treatment lacked medical coverage: An analysis of National Health and Nutrition Examination Survey (NHANES) data from 2005-2012 showed that nearly all (95.1%-97.7%) patients are eligible for IFN-free, RBV-free treatment, a significant increase compared to the 66.6%-74.1% eligibility for IFN-based treatments. Despite high clinical eligibility for treatment, only approximately two-thirds of patients were both eligible for IFN-free treatment and have access to medical coverage, highlighting insurance access* as an important barrier to address in ensuring treatment for as many individuals as possible. (Younossi, et el. Abstract #1575)
* With the outreach and enrollment efforts through the Affordable Care Act that began in 2013, after the study period, the rates of access to medical coverage are likely to change.
Several studies presented at AASLD investigated the impact of treatment beyond the cost of the medications themselves to more fully understand the health economics of these agents. These included:
- Managed care costs savings can be achieved within 10 years: Effective treatment of HCV and halting disease progression can result in relatively near-term cost savings to managed care plans. Less expensive ($50,000) therapy achieves costs savings if 30% of costs are avoided for at least 6 years, while 50% of costs need to be avoided for 10 years for a $150,000 treatment. (Wan, et al. Abstract #1439)
- Earlier HCV treatment may reduce Medicare and managed care costs. Between 2010 and 2024, over 1 million individuals with chronic HCV will enter into Medicare. While Medicare coverage provides an opportunity to maintain patients in HCV care, approximately 1/4 of those are likely to have advanced liver disease (cirrhosis, decompensation, hepatocellular carcinoma (HCC)) at entry, greater healthcare costs, and more complicated clinical outcomes. (Rein, et al. Abstract #73)
Other data presented at AASLD underscores the importance of curing chronic HCV infection as an approach to improving health outcomes.
- HCV seropositivity is associated with twice the hospitalization rate for any reason compared with those uninfected, suggesting benefits for HCV treatment beyond addressing liver-related conditions. (Teshale, et al. Abstract #1569)
- Treatment of patients with mild to moderate fibrosis results in improved outcomes versus delaying until advanced stages. Initiating treatment with ledipasvir/sofosbuvir before stage F3/F4 liver fibrosis/cirrhosis is estimated to dramatically reduce downstream sequelae (decompensation, HCC, transplantation) by up to 90%. (Ahmed, et al. Abstract #1751)
The coming years will provide continued opportunities and challenges. As Dr. Michael Fried, Director of Hepatology at the University of North Carolina at Chapel Hill, noted in the Hepatitis Debrief presentation on the final day of the conference, the field has succeeded in designing highly effective drugs for chronic HCV infection; thus, the next challenge is ensuring appropriate access for those in need of care and addressing the cost barriers associated with these very expensive new agents.
Meeting abstracts from this year’s AASLD annual meeting, held November 7-11, 2014 in Boston, MA, are available online for download.