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Gilead's Sovaldi Tied to Slow Heartbeat in Hepatitis C Patients
Michelle Cortez
Fay Cortez

November 4, 2015 — 5:00 PM EST

Gilead Sciences Inc.’s blockbuster hepatitis C medicine Sovaldi may trigger an abnormally slow heartbeat and put patients at risk of passing out, according to French doctors who said treatments containing the drug should be used with caution.

The report, in a letter to the New England Journal of Medicine, detailed episodes of a slowing heart rate that developed within the first 10 days of Sovaldi therapy in three of 415 patients treated in 2014 at the Hopital Cochin’s hepatology and cardiology group in Paris. All three received pacemakers within a week to ensure their hearts maintained a healthy rhythm.

“The potential cardiac toxicity of sofosbuvir-containing regimens suggests the need for caution with the use of such regimens, including review of other medications, consideration of risk factors for bradyarrhythmias, and possibly monitoring of cardiac rhythm during the initiation of therapy,” said the authors, led by Helene Fontaine of Hopital Cochin.

Isolated Cases

Gilead officials said it’s premature to make generalized recommendations, such as monitoring the heart rhythm of all patients as they start Sovaldi, based on isolated case reports. The three cases covered by the letter in NEJM were quickly reported to regulators and are included in the nine reports seen among more than 613,000 patients who have taken Sovaldi or the next-generation treatment Harvoni to date, the company said.

http://www.bloomberg.com/news/articles/2015-11-04/gilead-s-sovaldi-tied-to-slow-heartbeat-in-hepatitis-c-patients?cmpid=yhoo.headline