Throughout 2016, the remarkable success of direct-acting agents was confirmed and extended. Several new drugs — including Epclusa (Gilead), Zepatier (Merck), Daklinza (Bristol-Myers Squibb), Technivie (AbbVie), Viekira Pak (AbbVie) and Viekira XR (AbbVie) — were approved, representing continued remarkable potency of the DAA agents with the added bonus of extension into more pangenotypic activity. While there are still many other new drugs in development with the same trend toward increased potency and pangenotypic activity, it seems that drug development is starting to plateau. This ultimately will leave us with a strong armamentarium from which to choose the best agents for each of our individual patients.
So where does that leave us for 2017? This coming year will be a year of transition. We will move from the heavy focus of drug development and use of these agents in clinical practice to the implementation of drug access for populations at risk. Drawing lessons from the HIV experience, we hope to zero in on identifying all individuals at risk for infection, getting them into care and initiating therapy to prolong their lives and reduce the risk for transmission to others. These exact same principles apply to hepatitis c, and we will see them being stressed throughout 2017 and beyond.
The concept of an HCV treatment cascade will be further emphasized in 2017. We will see widespread testing efforts implemented throughout a number of populations, particularly those in high-risk populations. For example, testing should increase in emergency departments, in places where opioid drug use is rampant, at methadone treatment centers and other locations where people at highest risk are present. We will also see an emphasis on universal testing of everyone, not just baby boomers. All adults should be tested, at least once, for HCV. Once someone tests positive, the next trick will be to get them into a facility where their hepatitis c infection can be eradicated.
Historically, hepatologists, gastroenterologists and infectious disease providers provided most of the services of testing and treatment. In the next year, we will see more of a focus on primary care providers treating HCV patients. Ideally, this will allow individuals to receive their treatment at the same location where their HCV test was performed. This will create a smoother transition from a positive test into cure in a setting where the patient is most comfortable.
To make this happen in the best possible way, the hepatology and ID communities need to continue to pull together with outreach and education programs for primary care providers to help them feel comfortable treating HCV and providing backup support. In the case of the hepatologist, this will entail support for those patients identified with advanced fibrosis and decompensated cirrhosis.
The biggest barrier, however, will not be education or backup. The biggest barrier is gaining access to therapy through third party payers. Continued effort needs to be made to compel payers to cover medications for all individuals who test HCV positive who are not in the midst of acute seroconversion syndrome or who have a short life expectancy. Through continued efforts in this regard, we can move closer to eradicating hepatitis c in the United States and beyond. At the same time, we need to also focus on compelling pharmaceutical companies to continue to lower prices that third party payers are required to pay. Clearly, there has been a move toward this over the last couple of years, somewhat through competition, but also because of the outcry from payers, providers and patients to make HCV drugs more affordable, especially to those of us in the US, Canada, and Europe.
I have great hopes for 2017. By pulling together and focusing on getting treatment to those who need it, we can have a tremendous impact on the epidemic that is hepatitis c, and, ultimately eradicate it. I believe by working together we can make this a reality.
To view a timeline of 2016’s HCV milestones — drug approvals, access improvements, FDA news and more — click here
- For more information:
- Michael S. Saag, MD, can be reached at University of Alabama at Birmingham, 845 19th Street South/BBRB 256, Birmingham, AL 35294-2170; email: firstname.lastname@example.org.
Disclosure: Saag reports no relevant financial disclosures.