PURPOSE: Public discourse regarding the hepatitis C virus (HCV) drug Sovaldi® 
(sofosbuvir) has become inflamed, generating much heat but little light 
concerning the clinical, health economic, and quality-of-life merits of 
Sovaldi®. The purpose of this article is to provide a factual basis for 
evaluating the claims regarding the benefits of Sovaldi® relative to its costs.
METHODS: A comprehensive review was conducted of news stories highlighted in the 
daily updates of the electronic newsletters BIO SmartBrief, FiercePharma, 
FierceBiotech and BioCentury Extra published from November 1, 2013, through 
December 31, 2014, on the topics of the HCV market, Sovaldi®, and other HCV 
therapeutics. Also reviewed were recent practice guidelines on the management of 
HCV infections, prescribing information on all HCV drugs approved by the US Food 
and Drug Administration, and health technology assessments of Sovaldi® and 
Harvoni(TM) (sofosbuvir/ledipasvir).
FINDINGS: Sovaldi® and Harvoni(TM) have provided significant improvements in the 
treatment of HCV, with all-oral regimens and cure rates exceeding 90% in some 
populations of patients with HCV. Sovaldi® prevents significant health care 
resource utilization in patients who would otherwise develop cirrhosis and 
require a liver transplant; however, only a small proportion of patients with 
HCV develop cirrhosis, and fewer require liver transplants. Because it is not 
possible to identify those patients whose HCV will progress to severe liver 
disease, it would be necessary to treat a large number of patients with HCV to 
prevent disease progression in this subpopulation, resulting in a considerable 
loss to health plans even over a 20-year horizon. The claim that treating all 
patients with HCV with Sovaldi® would cost nearly as much as the current total 
US expenditure on all prescription drugs, while factually correct, is not a 
realistic scenario. Many patients with HCV will continue to go undiagnosed. In 
addition, the medical expense for those who are treated will be spread out over 
many years. However, the unexpectedly large, up-front cost of covering these 
drugs has had a major impact on health plan budgets, resulting in losses for 
some plans.
IMPLICATIONS: Sovaldi® represents an enormous advance in the care of some 
populations of HCV-infected patients, but also a major cost burden to health 
plans. As the first of a number of anticipated, paradigm-changing drugs to treat 
medical conditions affecting large patient populations, Sovaldi® should act as a 
wake-up call for all health care stakeholders to engage in a meaningful, 
fact-based discussion about managing the cost of innovative new drugs to balance 
the needs of drug manufacturers, health plans, providers, and, above all, 
patients.