Harvoni, Sovaldi May Cause Cardiac Arrest When Taken With Amiodarone, Gilead Warns

  • Written by: Staff Writers

The makers of the hepatitis C drugs Harvoni and Sovaldi are warning that users may face an increased risk of heart problems or death if they combine the medications with the heart drug amiodarone and another direct acting antiviral medication. 

Gilead Inc. sent out a “Dear Health Care Provider” letter (DOCX) on March 20, warning about at least nine reported cases of bradycardia, including one fatal cardiac arrest, linked to the combined use of the hepatitis C and heart drugs. In addition to the one patient death, three of the patients required pacemakers.

According to the Gilead letter, six of the cases involving symptomatic bradycardia, which causes abnormally slow heartbeats, occurred within the first 24 hours of treatment. The other three cases happened within the first two to 12 days. In three of the incidents, the patients were taking Harvoni in combination with amiodarone. Five of the cases involved a combination of Sovaldi with the hepatitis C drug Bristol-Myers Squibb drug Daklinza and amiodarone; and there was one case involving a combination of Sovaldi, amiodarone and Johnson & Johnson’s hepatitis C drug Olysio.

The warning indicates that Gilead believes the combinations to avoid are Harvoni together with amiodarone, and Solvadi together with amiodarone and other hepatitis C drugs belonging to a class of medications known as direct acting antiviral (DAA) drugs.

“Coadministration of amiodarone with either Harvoni or with Sovaldi in combination with another DAA is not recommended,” the letter warns. “The mechanism of the potential interaction between amiodarone and Harvoni, or Sovaldi in combination with another DAA is unknonw. Because the number of patients taking amiodarone who have been exposed to Harvoni or Sovaldi in combination with another DAA is unknown, it is not possible to estimate the incidence of occurrence of these events.”

Both Harvoni and Sovaldi are blockbuster drugs for Gilead, making up more than half the company’s annual revenue. Harvoni raked in $2.11 billion in sales in the last quarter of 2014 alone, and Sovaldi generated $1.73 billion in sales in the same quarter.

The drugs are extremely expensive, with a standard two-week Sovaldi treatment course costing $84,000.

In a report published on January 28, the Institute for Safe Medication Practices (ISMP) warned that Gilead has a poor track record of filing complete adverse event reports to the FDA in cases involving Sovaldi (sofosbuvir). According to the report, only 39% of Sovaldi incident reports were reasonably complete.

“With limited pre-approval testing and weak adverse event reporting, the safety profile of sofosbuvir remains uncertain,” the ISMP warned at the time.

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  1. lisa Reply

    My husband took harvoni may June July. Never any problems with his heart. September 7th he had an aortic dissection. Now we are on the hospital Sept 15th with fluid around his heart. I will meet with the cardiologist in the morning to discuss what surgery he will have to correct this new problem. Is anyone having similar problems. The drs also mentioned bradycardia. I’m not sure what all this is. It’s very scary and confusing.

  2. Elizabeth Reply

    Took Harvoni (Started March 26 -2015, Stopped June 18-2015) Now I have severe spinal pain, severe lower back pain, nuropathy in my legs and feet, nerve and joint pain all over my body with severe fatigue, blurred vision . My nervous system feels shot. I use a walker ,cane ,back brace and a shower chair NOW to keep me from falling. I receive cortisone shots down my spine and hip regularly. I am also on pain and nerve medication constantly. I was never like this before Harvoni Treatment .I have head aches and I feel sick every day no energy at all. I feel so much worse now after treatment and it hasn’t stopped. There are so many of us with same side effects and no one cares. My daily function is severely limited now. Quality of life is so horrible. ITS WORSE AND ITS NOT GOING AWAY!!!!!!

  3. Deborah Reply

    My Husband passed away as soon as he stopped taking Harvoni This drug was not researched enough and would like to let everyone know about it. My husband would have had a better chance of living with Hepatitis C

  4. Deborah Reply

    My husband passed away of heart failure while taking Harvoni.. He did not have any heart issues prior to starting Harvoni.

  5. Gail Reply

    I took a 12 week Harvoni treatment in 2015. In February 2016 I had a ischaemic stroke effecting my left side. I have diabetes and high blood pressure. I would like to know if anyone else has had a stroke after takin g this drug.
    Thank you for responding.

  6. robert Reply

    started harvoni 2 weeks ago, I have shortness of breath, and blurred vision really bad, and chest pains

  7. Samuel Reply

    Of all those giving comments on here, most likely by coincidence your new medical conditions were already prevalent to happen, you don’t give your age, or other health conditions you probably already had, and or you could also be psychsomatic, but I do know 2 former Hep C patients in their 50’s that just recently had the Harvoni treatment, and they both told me, one female and male, that neither had any adverse reactions, that neither felt anything, and both were healed in 2 months, and now I in my 60’s am on the treatment, and I know I will be okay, because my blood count of the Virus showed to be low, buy one thing is for sure, I have always supplemented with Vitamins Especially Vitamin C since the age of 18, and I know that has a lot to do with that …..

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