Patients with chronic hepatitis C have a new option for treating the liver-damaging virus, with the approval of a combination treatment developed by AbbVie Inc.
The US Food and Drug Administration (FDA) on Friday approved the sale of a packaged treatment called Viekira Pak made by AbbVie of North Chicago, Illinois. It includes a combination pill, which contains the antiviral drugs ombitasvir, paritaprevir and ritonavir, along with a tablet of dasabuvir.
All the ingredients are new except for ritonavir, which works to increase blood levels of paritaprevir.
It is among several new pill-only hepatitis C treatments that are big improvements on earlier treatments that are less effective, require injections and cause flu-like side effects.
For decades, hepatitis C carriers had no options but older treatments centered on injections of interferon, a synthetic version of an immune system protein that caused many of the nasty side effects.
Much more effective treatments with easier side effects have come on the market in the past several years, including three others approved by the FDA since November last year.
Those are Johnson & Johnson’s Olysio and Gilead Sciences’ Sovaldi and Harvoni.
The latter two have drawn considerable criticism from patients and doctors for their exorbitant price — Sovaldi costs about US$1,000 per pill or US$84,000 for a course of treatment — though their maker points out that successful treatment is cheaper than a liver transplant.
AbbVie said the shortest approved course of therapy for Viekira, 12 weeks, is set to cost about US$83,320 at wholesale prices. Patients and insurers have been hoping the growing competition would start to reduce the prices.
Viekira Pak was tested in six patient studies involving 2,308 participants with chronic hepatitis C, some of them with cirrhosis.
The tests showed 91 percent to 100 percent of the participants receiving the new combination had no detectable levels of the virus in their blood 12 weeks after treatment ended, indicating they had been cured.
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