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Sofosbuvir Access Ex-USA
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"Gregg Alton, Gilead's executive vice president for corporate and medical affairs, wrote in an e-mail to Science that the company hopes "to develop an appropriate access and pricing strategy" and "greatly values" input from advocates. "Providing treatment in resource-limited settings presents complex challenges and we understand the concerns that have been raised," he wrote."
Sofosbuvir (Sovaldi) - Gilead U.S. Patient Assistance Program - (12/10/13)
Science 13 December 2013:
Advocates Protest the Cost of a Hepatitis C Cure
Jon Cohen
For disease advocates, the U.S. Food and Drug Administration's 6 December approval of what promises to become a blockbuster drug against the hepatitis C virus (HCV) was bittersweet news. Sofosbuvir, made by Gilead Sciences of Foster City, California, works better than anything on the market: It's effective against most HCV variants and will help rid the body of this liver-damaging virus more quickly and safely than existing drugs. What rankles advocates is its price-each pill costs $1000, and the drug must be used for at least 12 weeks-which will put it out of reach of most of the more than 100 million people in resource-limited countries who need it. "It doesn't matter how great these drugs are if no one can have them," says Tracy Swan, who works with the Treatment Action Group, a New York City nonprofit whose members successfully battled big pharma as leading AIDS activists in ACT UP.
In an unusual move, Swan and other HCV advocates have been imploring Gilead to offer a lower price to cash-strapped countries right from the start. They want to avoid a repeat of what happened during the early days of the AIDS epidemic, when it took years-and many protests and lawsuits-before the poor had access to lifesaving antiretroviral drugs. "We want the drug now-not in 15 years," says Isabelle Meyer-Andrieux, a clinician based in Geneva, Switzerland, who works for the Campaign for Access to Essential Medicines run by Doctors Without Borders (Medecins Sans Frontieres [MSF]). "We are really convinced that this drug can revolutionize the way we treat HCV in low- and middle-income countries."
Meyer-Andrieux says that Gilead seems receptive to differential pricing, a strategy the company uses for its anti-HIV drugs. Gregg Alton, Gilead's executive vice president for corporate and medical affairs, wrote in an e-mail to Science that the company hopes "to develop an appropriate access and pricing strategy" and "greatly values" input from advocates. "Providing treatment in resource-limited settings presents complex challenges and we understand the concerns that have been raised," he wrote.
HCV, which can cause life-threatening cirrhosis and liver cancer, infects an estimated 130 million to 185 million people-and 90% of them live in poorer countries (see map). It is mainly transmitted through contaminated blood transfusions or syringes shared by injecting drug users, but sexual transmission can occur, too. There are six main viral variants, called genotypes, which respond differently to treatments. New drugs are desperately needed.
Until 2011, the only treatment was an unpopular 48-week regimen that combined injections of interferon with ribavirin pills, which boosted the immune system and had some nonspecific antiviral effect but didn't directly attack HCV. The treatment often had severe side effects and cured fewer than 50% of those with genotype 1, which infects about 70% of the estimated 3 million people in the United States with hepatitis C. In the past 3 years, three drugs have come to market that directly attack HCV and reduce treatment regimens to 12 to 28 weeks, but they are approved only to treat genotype 1, some have serious side effects, and cure rates are, at best, 80%.
Gilead's sofosbuvir cripples an HCV enzyme, polymerase, that the virus needs to copy itself. The drug cures roughly 90% of genotype 1, 2, and 4 infections in 12 weeks with relatively minor side effects, when given with ribavirin and, for genotypes 1 and 4, interferon injections. It's also approved for use in combination with ribavirin for genotype 3, although efficacy is slightly lower and treatment takes 24 weeks.
The drug's performance in early studies led Gilead in January 2012 to pay a staggering $11.2 billion to purchase the small company that first made it. But Meyer-Andrieux argues that the full-price sales of the drug in wealthy countries will offer the company ample profit. "They don't have to treat so many patients to reimburse the $11 billion," she says. A 20 November investor report from Credit Suisse bank, subtitled "The HCV Revolution," suggests sofosbuvir's sales in wealthy countries in 2014 alone could total $3 billion.
"The drugs are extremely cheap to make," contends Andrew Hill, a pharmacologist at the University of Liverpool in the United Kingdom. Based on the raw ingredients, the steps in the chemical synthesis, and molecular similarities to anti-HIV drugs, Hill and his colleagues concluded that it costs $68 to $136 to manufacture enough sofosbuvir to treat a person for 12 weeks. MSF suggests that diagnosing and curing an HCV infection should cost developing countries no more than $500.
Hoping to pave the way for an inexpensive generic version of sofosbuvir, another nonprofit is challenging Gilead over its Indian patent application, a strategy that also proved successful with anti-HIV drugs. The Initiative for Medicines, Access & Knowledge (I-MAK) in New York City led an "opposition" to the Indian sofosbuvir patent application on 21 November, contending that sofosbuvir is a slight variation on an earlier patented drug that had activity against HCV and thus is not novel. Gilead did not respond to Science's question about the I-MAK opposition.
Many expect that sofosbuvir will prove even more powerful when combined with one of several other anti-HCV drugs in late-stage development. Meyer-Andrieux of MSF says the group is also trying to establish differential pricing for those drugs, and ultimately hopes to convince companies to coformulate one pill that works against all genotypes. "We would very much like to take the best drugs and combine them and escape from big pharma monopoly strategies," Meyer-Andrieux says.
When a short course of pills can cure all HCV infections, demand for treatment will intensify further, says David Thomas, who treats hepatitis C at Johns Hopkins University in Baltimore, Maryland. Says Thomas: "I can't imagine anyone who won't want the cure."
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