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Drugs approved in recent years that can cure hepatitis C may have severe side effects, including liver failure, a new report suggests.
The number of adverse events appears relatively small, and the findings are not conclusive. But experts said the report was a warning that should not be ignored. It involves nine widely used antiviral drugs that were heralded as a huge advance because they greatly increased cure rates, seemingly with few side effects.
The report will be published online on Wednesday by the Institute for Safe Medication Practices, a nonprofit in Horsham, Pa., that studies drug safety. Its findings are based on the group’s analysis of the Food and Drug Administration’s database of reports from doctors around the world of adverse events that might be related to medications.
Dr. Robert S. Brown, the director of the center for liver disease and transplantation at NewYork-Presbyterian/Columbia, who was not involved in the study, said that there had been other, scattered accounts of problems with the new drugs and that they should be investigated further.
Dr. Brown added that problems might arise from some doctors’ prescribing incorrectly, giving the drugs to patients with liver function too poor to tolerate them or benefit from them.
Read the rest of this article here: https://www.nytimes.com/2017/01/24/health/hepatitis-c-antiviral-drug-study.html?_r=0
Comments: For some very interesting comments on the Institute for Safe Medication Practices’ report, see http://hepatitisc.hcvadvocate.org/2017/01/new-drugs-hepatitis-c-safe-report-raises-concerns.html, where Alan Franciscus analyzes the numbers and gives a clearer picture of the actual data. As Alan says: “Importantly, we do not know if the drugs caused the liver failures or deaths. Maybe a more thoughtful approach is to be more vigilant about the people being treated—both starting on and during treatment. This is even more important for people with cirrhosis.”
As well, as Dr. Alam says in an article reviewing the report in the Infectious Disease Special Edition (Jan 26, 2017): “There are a lot of variables here….But it’s important to note that patients with decompensated cirrhosis are at much higher risk for complications in any case, because of their advanced disease. In my own personal experience, we’ve treated almost 2,000 patients with these agents since 2013, and have not had any significant problems. The biggest issue we have here is that this is a curative treatment, but half of all people infected with hepatitis C do not know they have it, and 60% of those who do know they are infected never show up for treatment. This is a failure of screening and linkage to care.”