The medications that cure nearly 90 per cent of hepatitis C patients but come with wallet-busting prices have another downside, a report by the Institute for Safe Medication Practices in the United States has found.
In its quarterly report, it identified 1,582 cases in which direct-acting antiviral drugs for hepatitis C, such as Sovaldi and Harvoni, reactivated the patient’s hepatitis B and led to liver failure or severe liver injury.
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The Food and Drug Administration first identified the problem in October 2016, highlighting 24 cases, including five described in medical literature. The institute examined data from July 1, 2015 to June 30, 2016 in the FDA’s Adverse Event Reporting System.
However, the reinfections primarily occur when a patient has an active hepatitis B infection but isn’t being treated for it, says Mike Sullivan, president of Cubic Health Inc. in Toronto. “If they’ve got low or undetectable levels of hepatitis B, then there’s nothing you need to do,” he notes. “You just need to monitor them at a regular interval,” likely once a month. If a patient does have high levels of hepatitis B, they simply need to take medications for both conditions at the same time.
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“The narrative for a plan sponsor is really that this should be managed at the patient/physician level,” he adds, though those looking at pre-authorization claims should understand if a patient is concurrently prescribed medication for hepatitis B and C.
“This is another example of why you don’t just treat everybody with these medications right out of the gate, why you triage individuals for hep C therapy,” Sullivan says.
“You want to see how these things go, you want to see what impact they’re having, you want to see what kind of long-term sustainable cure rates you’ve got, and you want to understand what impact it has on the body . . . This is why you’ve got to keep a close eye on things so you’re not creating unanticipated issues down the road.”