There’s a new drug on the market that is making headlines in the Hepatitis C spectrum: Harvoni, made by Gilead Sciences Inc. has made a massive impact this past year. 99% of patients taking one pill QD (once daily) for twelve weeks were completely cured of Hepatitis C according to a recent study of 865 patients with genotype 1 Hepatitis C with or without advanced liver disease. In a separate study, 96% of patients were completely cured, meaning that no detection of the hepatitis C virus could be found in the blood after 3 months post treatment.
Before delving further into the innovations of Harvoni and its associated drive in Medicare costs, let’s discover a little more about this particular viral infection. Hepatitis C is a liver infection caused by the hepatitis C virus (HCV). Hepatitis C is a blood-borne virus that can be transmitted through exposure to infectious blood usually by needle stick or sex (“Viral Hepatitis- Hepatitis C Information”, Center for Disease Control and Prevention, Division of Viral Hepatitis, 2015).
There are also certain stigmas associated with Hep C. Lucinda K. Porter, RN describes the stigmas surrounding patients living with Hepatitis C (HCV) in her article “A Guide to: Stigmas & Hepatitis C” from the HCV Advocate. She eloquently reports how hepatitis C patients feel as if the disease is misunderstood and people misinterpret why it happens and how it is prevented. Two stigmas associated with HCV are that HCV is easily transmittable and HCV patients have a history of injection drug abuse. These damaging stigmas lead to HCV patients with “reduced self-esteem, diminished mental health, less access to medical care, and fear of disclosing a positive status (“Stigma: Hepatitis C and Drug Abuse”, Janetta Astone-Twerell, Ph. D., Shiela M. Strauss, Ph.D., and Corrine Munoz-Plaza, M.PH. National Development and Research Institutes, Inc. 2006).”
Instead of nurturing these negative connotations of living with HCV, patients with HCV are able to support research by donating blood. Physicians Plasma Alliance has strong ties with research facilities at East TN State University that continuously conduct HCV research. Dr. Moorman and Dr. Yao lead this research through cell isolation laboratory technology and strive to make a difference in the treatment and prevention of HCV. They focus on the role of the immune system in the pathogenesis of hepatitis C infection. The goal of this research is to explain the mechanisms by which hepatitis C can enter the immune system and further investigate its specific pathology in infected patients. An additional goal is the translational application of research findings to patient care, thus studies involving patients infected with hepatitis C as well as co-infected with HIV are ongoing (“Immune Evasion by Hepatitis C Infection”, Department of Internal Medicine Research, 2015).
Making the lives of patients suffering from HCV is a common thread among advocates as well as researchers and healthcare providers looking for easier and more effective treatments. Unlike Hepatitis C treatments in the past, Harvoni combines two drugs- ledipasvir and sofosbuvir- without the addition of interferon and rivaviron treatment. This oral combination targets Hep C proteins to keep the virus from reproducing.
However, the cost of producing such drugs has skyrocketed. According to the Washington Post, Medicare’s prescription drug program spent almost $4.6 billion just this year alone on hepatitis C treatments, a cost which reflects the breakthrough of a cure. The market leaders for hepatitis C cures have a list price of $95,000 for the twelve-week treatment, averaging $1,100 for the once daily pill. An astronomical price that researchers are comparing to the long-term estimated costs of living with Hepatitis C (i.e. failed treatments, hospital stays, liver transplants, etc).
But who is picking up the tab? Taxpayers are the majority funder for Medicare Part D Program and a translated spike in higher deductible and maximum out-of-pocket spending will help cover the cost of this breakthrough. However, many patients are already seeing the benefits. A recently cured hepatitis C, Medicare patient in Texas reported that spending a monthly $35 co-pay for the treatment, a price well worth it.