About 3.5 million Americans live with hepatitis C virus (HCV) infection, according to CDC estimates, and many—including the majority of persons born between 1945 and 1965—are unaware of their infection status. Many others have been living for decades with the knowledge that there was a “time bomb” ticking inside of their livers and that there was little or nothing they could do about it.
Simply put, until about 3 years ago there were no therapies that could be relied upon to eradicate the virus in the majority of patients completing therapy. In addition, the therapies that were available were associated with many unpleasant and, occasionally, life-threatening adverse effects; 6 months or more of treatment was required; and the therapies often were associated with end-of-treatment relapses.
Increasing HCV-related Deaths
The number of annual US deaths associated with HCV (as reported on death certificates) increased to more than 19,000 in 2013, up from 11,000 in 2003, the CDC reported.1 Surprisingly, those 19,000 deaths exceeded the number of deaths associated with 60 other “nationally notifiable infectious conditions combined,” including HIV. The 6% annual increase in number of deaths observed between 2003 and 2013 is expected to continue for quite some time, despite the availability of effective treatments.
The current approach to treating patients who are monoinfected with HCV or coinfected with HCV and HIV uses a combination of 2 direct acting antiviral agents (DAAs). Often, these 2 drugs are coformulated into 1 pill that’s taken as infrequently as once daily for as little as 8 to 12 weeks. The first DAAs, telaprevir and boceprevir, were approved in May 2011, but both were withdrawn from the market voluntarily as newer DAA combinations (eg, Harvoni) were found to be more efficacious.
Entering the "Modern" Era
Harvoni received FDA approval for use in HCV monoinfected patients on October 10, 2014, ushering in the “modern” era of HCV treatment. The FDA-approved indication of Harvoni has been expanded since then to include the HCV/HIV coinfected population as well. Since Harvoni was approved, an additional 5 DAAs (or combinations of DAAs) have been FDA-approved.
Despite the widespread availability of these effective, safe, and well-tolerated products, substantial challenges remain in the effort to combat the HCV epidemic in the United States. Provider expertise in HCV treatment is lacking, and access to specialists is limited, especially in rural areas.2
An Expanding Role for Primary Care
Primary care physicians are positioned to offer comprehensive, long-term care and build a supportive relationship with patients.3 By collaborating effectively with specialists, they can play an expanding role in serving underserved populations and achieving all the benefits of HCV testing, care, and treatment.
This month, Patient Care looks in-depth at HCV and primary care’s role in managing the disease. Questions and topics that will be addressed include:
► How did so many Americans get infected, and why does the epidemic continue?
► Where did HCV come from?
► What is the natural history of untreated HCV?
► What therapies are currently available for treating HCV?
► How can HCV be managed by primary care physicians?
► Is there an easy, or at least logical, way of deciding which drugs to use?
► Is treating HCV cost effective?
► Who should be screened?
► Who should be treated?
► Does coinfection with HIV complicate treatment decisions and management of HCV?
First up: an HCV multiple-choice pretest aimed at primary care physicians. The questions will be answered in upcoming segments of this Special Report.
1. Ly KN, Hughes EM, Jiles RB, Holmberg SD. Rising mortality associated with hepatitis C virus in the United States, 2003-2013. Clin Infect Dis. 2016;62:1287-1288.
2. Mitruka K, Thornton K, Cusick S, et al. Expanding primary care capacity to treat hepatitis C virus infection through an evidence-based care model--Arizona and Utah, 2012-2014. MMWR Morb Mortal Wkly Rep. 2014;63:393-398.
3. Artenie AA, Bruneau J, Levesque A, Wansuanganyi JM. Role of primary care providers in hepatitis C prevention and care. Can Fam Physician. 2014; 60: 881-882.