FDA approves AbbVie combo hepatitis C treatment

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TRENTON, N.J. (AP) — 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.

The Food and Drug Administration on Friday approved the sale of a packaged treatment called Viekira Pak made by AbbVie Inc. 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's among several new pill-only hepatitis C treatments that are big improvements over earlier treatments that are less effective, require injections and cause flu-like side effects.

About 3.2 million Americans are infected with hepatitis C, which generally doesn't cause noticeable symptoms until the liver is damaged.

Without proper treatment, up to 30 percent of those people will eventually develop cirrhosis, an advanced liver disease in which excessive alcohol, fat and other substances kill off liver cells, causing scarring of the liver tissue. The virus can cause liver failure and liver cancer, resulting in the need for a liver transplant.

For decades, patients 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. Those treatments could last a year or more, were so unpleasant that many patients dropped out and still barely cured one-half of patients.

Much more effective treatments with easier side effects have hit the market in the last several years, including three others approved by the FDA since November 2013. Those are Johnson & Johnson's Olysio and two from Gilead Sciences: Sovaldi and Harvoni.

The latter two have drawn considerable criticism from patients and doctors for their exorbitant price — Sovaldi costs about $1,000 per pill or $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, will cost about $83,320 at wholesale prices. Patients and insurers have been hoping the growing competition will start to reduce the prices.

"The new generation of therapeutics for hepatitis C virus is changing the treatment paradigm for Americans living with the disease," Dr. Edward Cox, director of the FDA's Office of Antimicrobial Products, said in a statement.

Viekira Pak was tested in six large patient studies involving 2,308 participants with chronic hepatitis C, some of them with cirrhosis. The testing showed 91 percent to 100 percent of the participants getting the new combination had no detectable levels of the virus in their blood 12 weeks after treatment ended, indicating they had been cured.

The treatment regimen involves taking two of the combination pills in the morning, plus one dasabuvir tablet in the morning and evening. The most common side effects in the study were fatigue, itching, weakness or lack of energy, nausea and trouble sleeping.

The drug's paritaprevir component was developed in collaboration with Enanta Pharmaceuticals Inc. of Watertown, Massachusetts, which will receive a $75 million payment for the approval.


Follow Linda A. Johnson https://twitter.com/lindaj\_onpharma

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