Warning After Heart Patient Takes Hep C Drug


Gilead Sciences Inc. said nine patients taking its hepatitis C drugs Harvoni or Sovaldi along with the heart treatment amiodarone developed abnormally slow heartbeats and one died of cardiac arrest. Three required a pacemaker to be inserted.

Gilead said in an e-mailed drug warning to health-care providers on Friday that six cases of symptomatic bradycardia occurred within the first 24 hours of treatment and the remaining three within the first two to 12 days. The patients were all taking amiodarone, with three also using Harvoni, five receiving Sovaldi with Bristol-Myers Squibb Co.’s daclatasvir and one on Sovaldi with Johnson & Johnson’s Olysio. Gilead said the combinations aren’t recommended and it will update its product labeling.

The warning might limit the use of Sovaldi and Harvoni, which have transformed how the liver infection hepatitis C is treated, with most patients being cured after 12 weeks. The drugs also have drawn criticism for their cost of more than $1,000 a day before discounts, or as much as $94,500 for a full course of treatment.

Harvoni generated $2.11 billion in sales in the fourth quarter of last year, and Sovaldi brought in $1.73 billion, together contributing more than half of the Foster City, California-based company’s total revenue of $7.31 billion. The drugs’ hefty profit margins helped boost fourth-quarter net income more than fourfold to $3.49 billion.

A competing treatment introduced late last year by AbbVie Inc. has put pressure on Gilead’s prices.

Source: BloombergBusiness

Facebooktwitterredditpinterestlinkedinmailby feather

John Macey

I was born, and principally educated, in the fields of biochemistry, and business management in the northeastern USA. However, my world-wide professional career has greatly expanded upon that US base to involve the many different segments of the Biotech / Life Science fields globally. – I have been dressed as a surgeon to view many, many surgical proceedures - The major players in the health care fields that I have worked for include: Johnson & Johnson, DuPont, Abbott Laboratories, and F. Hoffmann-La Roche. – Positions have included selling nuclear materials for both in-vivo & in-vitro (radio-pharmaceutical & radio-immunoassay) medical diagnostic purposes, in the four countries in Scandinavia, based south of Stockholm, to managing Ph. Ds at a global Swiss headquarters location. – At one time I held a position of Strategy Manager for Europe, Middle-East & Africa (EME&A) for a Chicago based company, but living in Germany. – I do speak fluent colloquial German. – In addition to having lived in multiple European countries, my professional career took me to Asia for well over a decade. There I had management control of Oceania, the Pacific Rim, Northern Asia, Japan, out to India. – Occasionally, management assignments have taken me to all of Latin America, and most of South America. – I am extremely culturally aware, a skilled negotiator, and a seasoned manager of men and science. – My one abiding passion has always been computing, data, and analysis. As such, my main computer operating system is Linux, and open-source computer applications. – I do also run Microsoft 7, and Mac OS X (all 3 operating systems on the same H-P Ultrabook). I hope you enjoy your time on the Blog, and should you have any comments / feedback please feel free to email me @ jjmacey@jjmacey.net, or visit my Linux Web Site @ www.jjmacey.net (always evolving) – John J. Macey – AKA Adler, which in German means Eagle – Wildwood, New Jersey - Together, we can expand your global markets - with our partnerships. The partnerships are global utlizing multiple Law, Regulatory, Seasoned Management, Employment, M&A and buidlers of Business. Contact use.