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High Price of Breakthrough Hepatitis C Drug Expected to Decline

Though the price potentially will drop, poorer countries will continue to suffer from the disease until a cheaper generic drug is available for sale.

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By Victoria Kim

04/18/14

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A new breed of hepatitis C virus (HCV) treatment has arrived, giving hope to the estimated 185 million people who are infected worldwide. But it’s yet unclear how it will be affordable to the general population at its current $1,000-a-pill price tag.

With the advent of the breakthrough HCV drug, which works by targeting the protein that makes the virus and stopping it from replicating, scientists writing in the New England Journal of Medicine declared that “it may now be possible to imagine the global eradication of [chronic hepatitis C].”

Traditional therapy of HCV involves up to a year of treatment with multiple drugs, including the injected immune-system modulator, interferon. Side effects include fatigue, nausea, and even depression. The new breed of HCV treatment is a game changer. It has been shown to boost cure rates and reduce the duration of treatment, with fewer side effects. In a study by University of Texas Health Science Center researchers, the leading new HCV drug Sovaldi cured 96 percent of patients of HCV after 24 weeks. Older drugs cure about 75 percent of those treated and take 24 to 48 weeks of treatment.

This is good news for the hundreds of millions of people around the world, including an estimated three million Americans who are infected with HCV. But the new drug’s hefty price tag is a turn-off for the majority of those hepatitis C positive who reside in low- and middle-income countries.

Last week, the World Health Organization (WHO) called for a “concerted effort” to reduce the price of HCV medicines in their new guidelines for treating HCV. Sovaldi, which is made by California-based Gilead Sciences, debuted last December at $1,000 a pill, or $84,000 for a 12-week course of treatment. The drug’s unattainably high price spurred Democrats in the House Energy & Commerce Committee to write to Gilead, asking for an explanation of the company’s pricing methodology.

But like what happened with HIV drugs, the price of these HCV drugs are expected to decrease over time, once factors like price competition and pressure from non-governmental agencies kick in. “We’ve been here before,” head of the global hepatitis program at WHO Stefan Wiktor said. “Competition and generic production really are the keys to reductions in prices,” he said.

The WHO guidelines confirm this trend. “The experience with HIV, where the price of antiretrovirals was reduced by nearly a hundred fold through the introduction of generic drugs, has shown that the key to achieving low prices for medicines is to use a multipronged approach."

Similar versions of Sovaldi — all-oral treatment regimens with the same high cure rate — are expected to be released over the next two years, which should also drive down the cost of the drugs. “We are going to go from a monopoly to seven or eight players,” said ISI Group analyst Mark Schoenebaum. “In my mind that is what will drive pricing down.”

And a generic version of sofosbuvir, of which Sovaldi is a brand name, may be in the works as well. Its maker, Gilead, is in negotiations with several Indian manufacturers to produce a generic version of the drug, according to executive vice president of corporate and medical affairs Gregg Alton. In March, the company confirmed that it will supply Sovaldi in Egypt at a reduced price of $900 for a 12-week course, or about one percent of the American price. Egypt has the world’s highest prevalence of HCV due to the use of contaminated needles in the 1970s.

For now, millions of people will have to wait. Pressure from non-governmental agencies, academics, and patients worked to drive down the price of antiretroviral drugs. In their guidelines, the WHO urged these entities to take action once more. "National governments, international agencies, donors, civil-society organizations, and the pharmaceutical industry will need to work together to help assure that hepatitis C treatment is affordable and accessible for all those who need treatment," the guidelines said.

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