Finding Truth in a World Full of Spin: Myth-Busting in the Case of Sovaldi.

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.

A literature review of the feasibility of glial fibrillary acidic protein as a biomarker for stroke and traumatic brain injury.

Traumatic brain injuries (TBIs) are potentially lethal medical conditions, with symptoms that can overlap with symptoms of injuries outside the brain. In many cases, current diagnostic methods do not fully distinguish acute brain injury from other organ damage. In the management of stroke patients, the choice of treatment depends on whether the stroke is ischemic or hemorrhagic; however, no quick lab diagnostic tests are available to distinguish between the two types of strokes. As a result, patient triage, disposition, and patient management decisions may be delayed for patients with suspected TBI and stroke. Glial fibrillary acidic protein (GFAP), a brain-specific biomarker that is released into the blood following TBI and stroke, is being explored for potential diagnostic and prognostic value in these indications. We therefore conducted a review of MEDLINE-indexed publications from 2004 to 2011 to evaluate the current status of GFAP as a prognostic and diagnostic tool for TBI and stroke within the context of current published guidelines. Our review suggests that GFAP could provide clinically valuable information for the prognosis of TBI and stroke, but it is still at an early stage of development as a biomarker. Several TBI studies have shown elevated GFAP levels following a TBI event to be associated with greater severity of injury, poorer outcomes, and increased mortality. Clinical studies also indicate that GFAP has potential clinical utility in the differential diagnosis of various types of stroke. However, more clinical research will be required to determine the ability of GFAP levels to diagnose TBI in heterogeneous patient populations, as well as the ability of GFAP to differentiate between ischemic stroke (IS), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH), and non-stroke conditions in populations of patients with suspected rather than confirmed stroke. Additional clinical studies will also be required to define the temporal patterns of GFAP release in IS, ICH, SAH, and TBI, and their potential use in the differential diagnosis of these conditions. Finally, such research could demonstrate the ability of GFAP test results to provide unique clinical information that informs management decisions for TBI and stroke patients.