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Doctors question wider hepatitis c screening despite cures

by Sonja Elmquist

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(Bloomberg) — Doctors should resist the urge to screen a wider group of patients for hepatitis C, a group of physicians said today in the British Medical Journal, despite the introduction of new drugs that can cure the liver disease.

Expanded screening would flag the disease in people who are unlikely to die from it, leading to unnecessary treatment that may itself be harmful, said the group, including Kenneth Lin, an associate professor at Georgetown University School of Medicine.

In 2012, the U.S. Centers for Disease Control and Prevention recommended testing for the virus for everyone born between 1945 and 1965 — the Baby Boomer generation — along with people who used intravenous drugs or got blood transfusions before 1992. Since then, the Food and Drug Administration has approved treatments from Gilead Sciences Inc. (Nasdaq:GILD) and AbbVie Inc. (NYSE:ABBV) that eliminate traces of the virus.

“If you look at the way the treatments are being promoted, they’re saying practically everyone who has hepatitis C ought to have the treatment,” Lin said in an interview today. “That’s a step too far right now.”

Gilead and AbbVie are counting on more patients to use their hepatitis C drugs, which cost as much as $1,000 a day, to expand revenue.

Most people infected with hepatitis C don’t die from the disease as only about 20 percent come down with fatal symptoms, the doctors said in their analysis. More testing will lead people with the virus, which can cause fatal liver cancer and cirrhosis, to pursue treatment whether or not they feel unwell or show signs of liver disease, they said.

Changing treatment

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Gilead’s Sovaldi changed hepatitis C treatment when it was approved in 2013. Previous therapies relied on shots given weekly for a year and cured only about half of patients with the most common U.S. strain, called genotype 1. The drugs also caused side effects that include fatigue and flu-like symptoms. Sovaldi is a pill taken once a day, with fewer side effects, though patients can still get fatigue, headache and nausea.

The cost of the drugs has been controversial. Gilead’s Sovaldi carries a price of $84,000 for a 12-week course of treatment. Harvoni, which combines Sovaldi with another medication in a single pill, costs $94,500 for 12 weeks. Viekira Pak’s 12-week price is $83,319.

Morry Smulevitz, a spokesman for AbbVie, didn’t respond to a voice message and e-mails seeking comment. Gilead press officials didn’t respond to e-mails seeking comment.

Lin and the other physicians said clinical trials are needed to determine whether widespread screening benefits more than it hurts the population.

That type of study is impractical, said Angelos Hatzakis, co-chairman of the Hepatitis B and C Public Policy Association. The doctors’ concern may be overblown because screening doesn’t necessarily equate to treatment, he said.

“The majority of clinical recommendations suggest treatment in a relatively advanced fibrosis stage,” Hatzakis said in an interview today. “We have a criterion to treat those who really need the treatment.”