Liver Specialist Refutes Study Claiming Hepatitis C Drug Dangers

Editor’s note: Responding to a report on dangers associated with taking direct-acting antiviral (DAA) agents for hepatitis C, Douglas Dieterich, MD, director of the Institute for Liver Medicine at the Mount Sinai Health System in New York City, voiced his opinions on the findings. The ISMP report cited 524 cases of liver failure and 1,058 cases of severe liver damage in patients taking one of nine DAAs.

What are some misconceptions that physicians and patients could take from the study?

That the two drugs mentioned Sovaldi and Harvoni are unsafe. It's quite the contrary, they are very safe and they are the safest drugs to use in patients with severely decompensated liver disease—which were the ones who had the complications in this study.

How can those misconceptions be harmful to patients’ health?

Patients who are really in need of treatment might see this information and be frightened of taking the medications which will lead to much worse consequences and more liver problems than if they did take medication.

Do you think this study is misleading in any way?

I definitely think this study is misleading. We've stated before the fatality rate is 0.066%, which is actually probably less than that of patients who have severe liver disease, for one. The data upon what [the report is based off of are] scattered reports from all over the world where medical records are not always adequate or accurate. Finally, it was presented pretty much just as a press release, it was not submitted to a peer reviewed journal—which is the way medical information is supposed to be released.

How do these newer hepatitis C drug findings on dangers compare with interferon treatment?

Interferon side effects are exponentially worse, causing many complications and deaths.

Will the study findings change the way you manage or treat patients with hepatitis C?

Absolutely not. I'm perfectly comfortable using these medications in the sickest of the sick liver patients and in the healthiest of our healthy liver patients. The only thing this article may do is prolong the discussion with the patient about the taking medicines that they so dearly need.

Do you have any other concerns about DAAs?

Only that we haven’t treated enough people yet to prevent complications of cirrhosis liver cancer and death or transplant.

What message should physicians take from the study results?

All physicians know that medications have side effects, but I think sometimes in patients minds, rare side effects get confused with the course of the disease. Many of these patients are severely ill and unless we intervene and treat the underlying illness, their prognosis will be grave. If this data cause even one patient to postpone therapy and wait until it's too late, then we will have violated the basic principle of medicine, first, do no harm.

Note: The three drugs suspected as primary drugs in the most liver cases in the report were: paritaprevir combinations (Viekira Pak, including Technivie and Viekira XR/AbbVie), ledipasvir-sofosbuvir (Harvoni/Gilead Sciences), and sofobuvir (Sovaldi/Gilead Sciences).

Related Coverage:

How Dual Hepatitis B, C Infection Differs from Single Infection

Head-to-Head Comparison of Two Hepatitis C Regimens Reveals Superior

Direct-Acting Antiviral Agents May Be Beneficial Beyond Hepatitis C Treatment