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Newer Hepatitis C Drugs Linked to Liver Damage

A report issued January 25, 2017 by the Institute for Safe Medication Practices (ISMP) has found that some of the newer drugs used to treat hepatitis C may put patients at risk for liver failure. The report is based on an analysis of 12 months of adverse events (side effects from drugs) reported to the U.S. Food and Drug Administration (FDA) from use of nine antiviral drugs from doctors around the world.

What did the research show?

The ISMP report found 524 incidences of liver failure associated with the drugs, and 165 of those 524 patients died from their liver failure. Another 1,058 patients had reports of severe liver injury. This report comes just after the FDA issued additional safety precautions in October 2016 of using these drugs in people with both hepatitis C and hepatitis B infections. The ISMP report states that while the antiviral drugs appear to suppress the hepatitis C virus, the treatment opens to the door to the reactivation of the hepatitis B virus. All of the 524 cases of liver failure included the direct-acting antiviral drugs, often in combination with each other or with ribavirin. In addition, the report found 761 cases in which the antivirals failed to work.

While the findings from the ISMP report show the need for additional research on the safety of these drugs, the report doesn’t give detailed information on the patients. These medications are approved for hepatitis C, a condition that already affects the liver. It is not clear whether the liver damage and liver failure cases would have existed whether or not the patients were treated with the antivirals.1-2

Expensive treatments get extra scrutiny

Two of the drugs mentioned in the ISMP report were Harvoni® (ledipasvir-sofosbuvir) and Sovaldi® (sofosbuvir), made by Gilead. These drugs are getting additional attention for the safety concerns as they are considered “blockbusters.” They have impressive cure rates and are expensive: ranging from $55,000 to $125,000 per patient, and bringing in significant revenues for Gilead. The ISMP report states the need for additional investigation into the possible “negative consequences of these expensive and important new drugs.” Other drugs included in the report were Daklinza™ (daclatasvir), Zepatier™ (elbasvir and grazoprevir), Viekira XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir), Viekira Pak (dasabuvir, ombitasvir, paritaprevir and ritonavir), Technivie™ (ombitasvir, paritaprevir and ritonavir), and Olysio® (simeprevir).1, 3

Things to consider when starting treatment

The antivirals are an important tool in the treatment of hepatitis C and have been shown to cure many patients. However, with the new safety data, it is important that patients be tested for hepatitis B before starting on one of these antiviral treatments. Patients should talk to their doctor about all medications they are taking, including both prescription and over-the-counter medications, vitamins, and supplements. In addition, patients can and should talk to their doctor about their prescriptions, including questions such as:

  • What are the risks and benefits of this drug?
  • What side effects should I watch for?
  • Are there any side effects that I should get emergency care for?
  1. ISMP Quarter Watch. Accessed online on 2/20/17 at http://www.ismp.org/quarterwatch/pdfs/2016Q2.pdf.
  2. Medscape. Accessed online on 2/20/17 at http://www.medscape.com/viewarticle/875010#vp_1
  3. FiercePharma. Accessed online on 2/20/17 at http://www.fiercepharma.com/pharma/new-hep-c-meds-carry-risk-for-liver-failure-death-report

Comments

  • Carleen McGuffey moderator
    2 years ago

    What a horribly misleading article…..these people all had liver disease PRIOR to taking the antivirals….

    https://www.hepmag.com/blog/new-york-times-article-cause-suffering-death-irresponsible-reporting

  • Nancypet67
    2 years ago

    On another note…this article has me worried, there’s not enough research or history on these new medications that cure HepC, and now that I’ve been approved, I’m seeing my approved meds as one of the possible fatal ones, if there’s a unknown heart trouble, or undetected Hepb….I had gotten the series of 3 shots to prevent HepA or B, tho B still shows up in my blood test results….the Dr. Said its because I had the shot, but, I am scared he may be wrong. Is he positive…does he know for sure?? These meds require an EKG before you start the treatment, and blood tests to rule out HepB…I didn’t get an EKG and I’m ready to start…I brought this to his attention, but he wasn’t concerned.
    I don’t have that much faith in ANY DR…..only God. And my instincts (I believe) is the small voice of God- I really want to make sure he does these tests before I start, but I don’t want to insult his intelligence, or question his experience and knowledge as a Dr.

  • Cas
    2 years ago

    Stand firm with your doctor.I told mine I wanted a base blood test and an ultrasound before starting and told him he needed to order that NOW…he did..I have had to remind him of the viral count bloodwork and when it needed done. Be your own advocate..I dont trust them either and I was leary of taking a drug that was so experimental. I did 12 weeks of Harvoni and so far have a sustained viral response for almost a year. I did end up with anemia. My advice take the drug and eat spinach to keep the anemia away. But first make the doc do what ya know ya need! Good luck and much love to ya!

  • Nancypet67
    2 years ago

    I have a friend who is now on the Vikiera pk. With Ribaviran as well, because she has the more difficult type to treat, though I am concerned because they approved her pain meds, which were Morphine 15mg, and now oxycodone…they told her it was ok, and wouldn’t interact with her treatment meds. But now she is back to sniffing heroin…she believes it’s the same thing (opiate). Is this true? Or could this be fatal, or stop the affect of the treatment medication?? She thinks an opiate is an opiate..and since they approved it, then heroin is ok…and she switched because the “H” kills her pain better than the prescribed medicine. (I know it’s not my business, but I’m very concerned, I suffer with this illness too, and feel she was lucky to get this medication, die hate to see her waste it..or worse, it be a fatal interaction. Please if anyone has any info that may help, I would appreciate it. Thank you…until then, asking for Prayers

  • Cas
    2 years ago

    Heroin is never good. As with any drug you have no way of knowing what its cut with and if ya wanna live and you are lucky enough to get a second chance ya don’t blow it with illegal drugs.

  • Stephen
    2 years ago

    I would like to know where the comments section is located on your site. Please advise. Thanks

  • Kelly McNamara moderator
    2 years ago

    Hi Stephen.

    Thanks for the question! You question appeared in the comments. In each article at the end of the it there is a comment section. If you have any additional questions, always feel free to ask!

    Best,

    Kelly, HepatitisC.net Team

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