Hepatitis C drugs reporting ‘flawed and misleading’

3 minute read

Lay media coverage has wildly overplayed the adverse risks of the new hepatitis C drugs, an expert says


The mainstream media has been slammed over its coverage of a recent report linking the new hepatitis C medications with liver failure and other serious side-effects.

Professor Gregory Dore, head of the viral hepatitis clinical research program at the Kirby Institute, said the story was a “beat up”, based on a “completely flawed” report of post-licensing adverse event data.

But outlets such as the New York Times, which ran the story with the headline “Are new drugs for hepatitis C safe? A report raises concerns”, were misleading patients and their reporting would spark unnecessary fears, he said.

Looking at FDA adverse data for the 12 months ending on June 30, 2016, the Institute for Safe Medication Practices report found 761 reports in which antivirals failed to work.

There were also 524 cases of liver failure and 1058 cases of severe liver injury globally linked to the direct-acting antivirals, such as Gilead’s Harvoni
and Sovaldi.

Almost one in three patients who experienced liver failure died, the report said.

While the New York Times article acknowledged that in absolute numbers the risk was small, and that the report was not conclusive, “experts said the report was a warning that should not be ignored”, they wrote.

“We don’t want people to ignore it and lead to risks to patients,” Dr Robert Brown, director of the Center for Liver Disease and Transplantation, at New York-Presbyterian at Columbia University Medical Center, was quoted as saying.

“We don’t want people to overreact and not treat patients who should be treated.

“A lot of doctors are unclear about it, and if doctors are unclear, patients are too.”

But the report included no clinical information on stage of liver disease nor the presence of liver failure at time of drug commencement, Professor Dore pointed out.

“Patients with liver failure get put onto those drugs, and the reality is that not everyone can be rescued from advanced liver failure,” he said.

It was well known that a significant proportion, possibly around a third, of patients with existing liver failure had either no significant improvement or further progression, Professor Dore added.

“So to then attribute that to a toxicity of the therapies is an incredibly poor evaluation of the existing evidence,” he said.

“It’s misleading, it’s concerning to patients obviously and it is just not consistent with any of the evidence from trial studies that have evaluated these medicines safety.

“Not only were they not necessarily related, they almost certainly weren’t,” he said.

A spokesperson from Gilead said that the company continuously monitored safety information and had found no suggestion of a causal relationship between Sovaldi or Harvoni and liver failure.

“To date, more than 1.2 million HCV-infected patients have been prescribed sofosbuvir-containing regimens worldwide, with the United States accounting for the largest number of patients treated from any country (more than 500,000 patients).

“We have worked closely with the FDA and other regulatory agencies to share our data and analyses on cases of liver failure, and no product updates have been deemed necessary by Gilead,” the spokesperson said.

Professor Dore has received research grants, honoraria and served on advisory boards for Gilead, Bristol Myers Squibb, Abbvie, Merck, and Janssen.

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