F.D.A. Approves Pill to Treat Hepatitis C - The New York Times
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`F.D.A. Approves Pill to Treat Hepatitis C
`
`By ANDREW POLLACK DEC. 6, 2013
`
`Tom Espinosa, a building inspector in Oakland, Calif, has tried the existing drugs for hepatitis C and
`Thor Swift for The New York
` Times
`
` some experimental ones, without success.
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`The Food and Drug Administration on Friday approved a pill that is
` expected to make the treatment of hepatitis C less onerous, shorter in
` duration and more effective.
`
`The drug, Sovaldi, from Gilead Sciences, will allow at least some
` patients infected with the liver-destroying virus to be treated with pills
` only, doing away with weekly injections of a drug that can have
`debilitating side effects.
`
`“Today’s approval represents a significant shift in the treatment
` paradigm for some patients with chronic hepatitis C,” said Dr. Edward
` Cox, director of the office of antimicrobial products at the F.D.A.
`
`But the greater convenience and effectiveness comes at a price.
`
`Gilead said the wholesale cost of Sovaldi, which is known generically as
` sofosbuvir, would be $28,000 for four weeks — or $1,000 per daily pill.
` That translates to $84,000 for the 12 weeks of treatment recommended
` for most patients, and $168,000 for the 24 weeks needed for a hard-to-
`treat strain of the virus.
`
`“This is unbearable to the health care system and it is completely
` unjustified,” said Michael Weinstein, president of the AIDS Healthcare
` Foundation, which runs treatment clinics in the United States and
`
`http://www.nytimes.com/2013/12/07/business/fda-approves-pill-to-treat-hepatitis-c.html[6/22/2015 9:31:02 PM]
`
`Gilead 2007
`I-MAK v. Gilead
`IPR2018-00125
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`F.D.A. Approves Pill to Treat Hepatitis C - The New York Times
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` abroad and has previously clashed with Gilead on the price of its drugs
` for H.I.V.
`
`The Initiative for Medicines, Access and Knowledge, a legal group based
` in New York, recently filed a motion to try to block patenting of the
` drug in India. If it succeeds, generic manufacturers in India will be able
` to manufacture cheap copies of the drug for distribution there and in
` some other developing countries.
`
`Gilead said the price was fair given the drug’s higher cure rate and that
` the total cost for the 12-week regimen was “consistent with, and in
` some cases lower than” the cost of some other regimens for hepatitis C.
` It said it would offer financial assistance to some patients.
`
`Some three million to four million Americans, many of them in middle
` age, are believed to have a chronic hepatitis C infection, though many
` do not know it. The virus slowly damages the liver, leading to cirrhosis
` and in some cases to liver cancer. But it often takes decades before any
` damage is noticeable, and many people never experience a problem.
`
`Globally, at least 150 million people have hepatitis C.
`
`Sovaldi was obtained by Gilead in an $11 billion acquisition of a smaller
` company, Pharmasset. The high purchase price raised eyebrows when
` the deal was announced in 2011, but it has vaulted Gilead to the lead in
` a heated race to develop all-oral treatments for hepatitis C.
`
`AbbVie, Bristol-Myers Squibb, Merck, Johnson & Johnson and others
` are also developing all-oral regimens for hepatitis C that could reach
` the market in the next one to three years.
`
`Some analysts expect Sovaldi to become one of the best-selling drugs in
` the world. Matthew Roden, an analyst at UBS, said in a note on Friday
` that annual sales could surpass the record of around $13 billion
` achieved by Lipitor, from Pfizer, in its peak year.
`
`Sales are expected to be strong from the start, because many patients,
` on the advice of their doctors, have been putting off starting treatment
` until Sovaldi became available.
`
`One person waiting is Tom Espinosa, a building inspector in Oakland,
` Calif. He has tried the existing drugs and some experimental ones,
` without success, so this drug might be his last chance. His liver is
` already deteriorating badly, but he is hoping the new drug will stop the
` progression.
`
`Other companies are trying to get at least a little piece of Gilead’s
` bounty. Merck, Roche and Idenix Pharmaceuticals are separately
` claiming that Sovaldi infringes on patents they hold. Should any of
` those companies prevail, it is expected they will receive royalties, not
` keep the drug off the market.
`
`Until two years ago, the treatment for hepatitis C consisted of 24 to 48
` weeks of weekly injections of interferon alfa combined with daily
` tablets of ribavirin. Neither drug was developed specifically to treat
` hepatitis C. The combination cured about half of patients, but the side
` effects, including flulike symptoms, anemia and depression, could be
` severe.
`
`Sovaldi and newer drugs work by inhibiting enzymes produced by the
` hepatitis C virus. This is the same approach that was used to make
` drugs for H.I.V. As in H.I.V., two or more of these drugs for hepatitis C
`
`http://www.nytimes.com/2013/12/07/business/fda-approves-pill-to-treat-hepatitis-c.html[6/22/2015 9:31:02 PM]
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`F.D.A. Approves Pill to Treat Hepatitis C - The New York Times
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` must be used together, to prevent the virus from developing resistance.
`
`Cure rates with Sovaldi, a polymerase inhibitor, are over 80 percent,
` though success and treatment duration depend in part on which strain,
` or genotype, of the virus is involved.
`
`For genotypes 2 and 3, which together account for about 20 to 25
` percent of cases in the United States, Sovaldi’s label recommends the
` drug be used with ribavirin. This will constitute the first all-oral,
` interferon-free treatment for hepatitis C. Genotype 2 will require 12
` weeks of treatment and genotype 3 will need 24 weeks.
`
`For genotype 1, which accounts for more than 70 percent of American
` cases, Sovaldi is supposed to be used with injected interferon and
` ribavirin. But the treatment is for only 12 weeks instead of 24 or 48,
` and the cure rate is about 90 percent for newly treated patients.
`
`The label, however, says that genotype 1 patients who are ineligible for
` interferon can be treated for 24 weeks with Sovaldi and ribavirin. Wall
` Street analysts had not been expecting an all-oral regimen to be
` endorsed for genotype 1 patients.
`
`The side effects seem mild, though the clinical trials to date have not
` been able to distinguish the effects of Sovaldi from the drugs it was
` taken with.
`
`Ribavirin requires several pills taken more than once a day. Gilead
` hopes to combine Sovaldi with another drug it is developing into a
` single pill that can be taken once a day and cure most cases of genotype
` 1.
`
`Results of clinical trials testing how that combination pill works are
` expected in the coming weeks. If all goes well, that drug could get to
` market by the end of next year.
`
`A version of this article appears in print on December 7, 2013, on page B1 of the New York edition with
` the headline: New Hope In Hepatitis As F.D.A. Allows Pill. Order Reprints | Today's Paper | Subscribe
`
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