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Harvoni, a Hepatitis C Drug From Gilead, Wins F.D.A. Approval

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The first complete treatment for hepatitis C that requires taking only one daily pill won approval Friday from the Food and Drug Administration.

The drug, called Harvoni and developed by Gilead Sciences, could shorten the duration of treatment and provide the first all-oral regimen for many patients.

The new drug also appears to be a bit less expensive for some patients than Gilead’s existing hepatitis C drug, Sovaldi, which many insurers and state Medicaid programs have said is overpriced and threatens to bust their budgets.

Sovaldi costs $1,000 a pill, or $84,000 for a typical 12-week course of treatment, but it must be used with other drugs.

Harvoni will have a wholesale list price of $94,500 for a 12-week course of treatment, which is roughly in line with the total cost for Sovaldi and the drugs used with it. But many patients will be able to take Harvoni for only eight weeks, at a cost of about $63,000.

This will probably not mollify insurance companies and Medicaid programs, many of which have restricted the use of Sovaldi to the most seriously ill patients. But some patient advocates hope the pricing will persuade payers to reconsider restrictions.

“We’re talking about a much lower cost to Medicaid for a substantial number of people, and to me that’s a game changer,” said Ryan Clary, executive director of the National Viral Hepatitis Roundtable, a coalition of organizations that receives some funding from pharmaceutical companies.

Gilead defended the price. “We believe the price of Harvoni reflects the value of the medicine,” it said in a statement. “Unlike long-term or indefinite treatments for other chronic diseases, Harvoni offers a cure at a price that will significantly reduce hepatitis C treatment costs now and deliver significant health care savings to the health care system over the long term.”

Harvoni is a combination of sofosbuvir, the ingredient in Sovaldi, and a new medicine from Gilead called ledipasvir, that is not available as a stand-alone product. The two drugs attack the virus in different ways.

By combining drugs into a single pill, Gilead is repeating the strategy it used to become the leading supplier of drugs for H.I.V. Its drug Atripla, which combines three medicines, was the first daily single-pill treatment for that disease.

Gilead said that as many as half of patients might need to receive only eight weeks of treatment. If that were the case, the average cost of treatment would be a bit less than with Sovaldi.

But Harvoni’s label recommends that most patients take the drug for 12 weeks, with some tough-to-treat patients taking it for 24 weeks. It says only that eight weeks “can be considered” for patients being treated for the first time who have low virus levels and no cirrhosis, or liver scarring.

The approval is only for the main subtype of hepatitis, called genotype 1, which accounts for about 70 percent of cases in the United States.

In clinical trials, Harvoni eradicated the virus in more than 90 percent of the patients. That is considered an effective cure.

But Sovaldi is not supposed to be used by itself. Patients with genotype 1 were supposed to also take the older hepatitis C drugs, alpha interferon and ribavirin. Interferon in particular, which is given as a weekly injection, can have debilitating side effects such as flulike symptoms and depression.

In practice, many doctors this year have been avoiding the use of interferon by prescribing Sovaldi with another new pill, Johnson & Johnson’s Olysio. That combination has not been approved by the F.D.A. and has a list price of about $150,000.

Compared with that off-label combination, Harvoni is far less expensive.

Many insurers and state Medicaid programs have started to restrict the use of Sovaldi to patients who have more advanced liver disease. Some are requiring patients to demonstrate that they have not abused alcohol or illicit drugs in a number of months.

But some advocacy groups, led by the National Viral Hepatitis Roundtable, have started to push back.

They sent a letter last month to Sylvia Mathews Burwell, the secretary of health and human services, saying that such restrictions on use of Sovaldi were “discriminatory and violate the spirit and the intent of the Affordable Care Act to ensure access to quality, affordable health care regardless of pre-existing conditions.”

It can take 20 years or more for hepatitis C to cause noticeable cirrhosis or liver scarring, or liver cancer. Many people infected with the virus never suffer noticeable liver damage.

That is why in many cases it can be acceptable for patients without advanced liver damage to delay treatment. Many patients, on advice from their doctors, have been delaying treatment until Harvoni became available.

But Gilead and some doctors make the case that even if liver damage is not serious, people with a chronic virus infection can have various other health problems, including an increased risk of heart attack. Treating the disease early is better, they argue, because it avoids liver damage to begin with.

“The sooner you cure them, the more likely you are to have better long-term outcomes for these patients,” John F. Milligan, president and chief operating officer of Gilead, said at the Morgan Stanley health care conference last month. He said treating early would save Medicaid money over time.

Gilead recently agreed to allow several generic drug manufacturers in India to make and sell cheap copies of Sovaldi in about 90 poor countries. That agreement also applies to Harvoni.

Analysts think the introduction of Harvoni will keep Gilead in the lead in the market for hepatitis C treatments. Just this week, Bristol-Myers Squibb said it would essentially give up for now on fielding its own combination treatment, a tacit acknowledgment that its regimen would not be competitive.

The near-term competition for Gilead is expected from AbbVie, which could receive F.D.A. approval for its combination regimen by the end of this year.

Insurers hope to play Gilead and AbbVie against each other to obtain lower prices, but it is not clear that will work.

Read more at The New York Times.