A Joint United Nations Program on HIV/AIDS (UNAIDS), World Health Organization (WHO), and United Nations Development Program (UNDP) policy brief affirms that the right of every human being to access the highest attainable standards of health is now fully recognized by numerous national constitutions and legally binding international human rights treaties, and observes that success to essential medicines is now established as a part of the right to health. In the context of HIV, this includes access to antiretroviral drugs and other medicines essential for HIV care, including medicines for the treatment of opportunistic infections such as tuberculosis, and the same principles can be applied to other not necessarily HIV-related pandemic and endemic diseases, such as the growing global plague of hepatitis C.

The brief reviews how countries can successfully use the flexibilities of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to increase access to HIV treatment. The World Health Organization (WHO) Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property urges governments to consider, whenever necessary, adapting national legislation in order to use to the full the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights, including those recognized by the Doha Declaration on TRIPS Agreement and Public Health and the WTO decision of 30 August 2003, that antiretroviral therapy significantly reduces morbidity and mortality among people living with HIV.

However, the authors note that despite progress, nearly 10 million of the estimated 15 million people needing antiretroviral therapy were without access to treatment as of 2010, making it absolutely critical to accelerate program delivery to reach universal access goals.

In a recent op-ed published in The Washington Post, Dr. Paul Farmer, Kolokotrones University Professor of Global Health and Social Medicine at Harvard University, an infectious disease physician with the Brigham and Women’s Hospital in Boston, and a cofounder of Partners in Health, notes that when he was training as an infectious disease physician in the mid-1990s, he frequently traveled between Boston’s teaching hospitals and rural Haiti. He observes that at the time, AIDS had become a leading cause of death in both places but was rapidly declining in Boston while soaring in Haiti, as it was across Africa — a divergence was underscored at a 1996 AIDS conference where researchers demonstrated data showing that combination antiretroviral therapy could transform HIV infection from a death sentence into a manageable chronic disease.

Dr. Farmer recalls that the conference’s theme that year was “One World, One Hope,” but that a coalition of activists, noting the $15,000 annual cost of the lifesaving drugs and the lack of an international plan for ensuring access among those living in poverty, displayed less sunnily optimistic signs reading “One World, No Hope.” By 2000, says Dr. Farmer, more than 6 million people were dying in poor countries annually from HIV, tuberculosis and malaria — all diseases for which effective therapeutics were available to those who could afford them. He observes that the failure was not of science but of delivery.

However, Dr. Farmer says thanks in no small part due to relentless efforts of AIDS activists, an “abiding cynicism” regarding purported limits inhibiting international response to the aforenoted treatable pandemics had given way to an unprecedented “delivery decade” that had been kickstarted in the early 2000s by the U.S. President’s Emergency Plan for AIDS Relief and the Global Fund to Fight AIDS, Tuberculosis and Malaria.

Today, Dr. Farmer says, the world is confronted with another “1996 moment” in the fight against hepatitis C, a disease for which he observes that as was the case in 1996, highly effective new therapies are coming online, in particular drugs containing the new polymerase inhibitor sofosbuvir, that he says have the potential to cure more than 90 percent of patients with common strains of the virus after just 12 to 24 weeks of once-daily pills.

According to the World Health Organization, there are an estimated 170 million people globally living with chronic hepatitis C, a contagious chronic liver disease the symptomatic presentation of which ranges from mild discomfort to liver failure, liver cancer, and death, and which the WHO calls a “viral time bomb.” There is no vaccine to prevent hepatitis C, but researchers have found drugs such as sofosbuvir, or a combination of drugs, that can cure many cases, and are looking for new ways to cure or prevent hepatitis C infections. Dr. Anthony Fauci of the National Institutes of Health cited by Voice of America notes that “Chronic hepatitis C infection is the leading reason why we have liver transplantation in the United States.”

A research paper by a team of researchers at the New Zealand Liver Transplant Unit, Auckland City Hospital, Auckland, New Zealand, and published in the New England Journal of Medicine (N Engl J Med. 2013 Jan 3;368(1):34-44. doi: 10.1056/NEJMoa1208953) notes that the standard treatment for hepatitis C virus (HCV) infection is interferon, which is administered subcutaneously and can have troublesome side effects. In their study (Funded by Pharmasset and Gilead Sciences; ClinicalTrials.gov number, NCT01260350.), the researchers evaluated sofosbuvir, in both interferon-sparing and interferon-free regimens for the treatment of HCV infection, and determined that, “sofosbuvir plus ribavirin for 12 weeks may be effective in previously untreated patients with HCV genotype 1, 2, or 3 infection.”

However, Dr. Farmer notes that sofosbuvir’s initial price has been approximately $80,000 to $90,000 for a single 12-week course — or about $1,000 per pill, and that like those infected with HIV, 90 percent of hepatitis C patients live in low-and middle-income countries; and typically would not earn $80,000 over the course of two lifetimes.

Last fall, the Open Society Foundations welcomed a challenge in India to the developer of sofosbuvir Gilead Sciences, Inc.’s patent application for sofosbuvir, by the Initiative for Medicines, Access & Knowledge.

The challenge, filed last November at the Kolkata Patent Office, would prevent Gilead from holding a monopoly on sofosbuvir’s production and pricing, and if successful would allow Indian manufacturers to produce a cheaper generic version of sofosbuvir as a first step toward making it available other low-and middle-income countries. The OSF notes that treatment with sofosbuvir is shorter than current treatments, has higher cure rates, can be taken orally, and is better tolerated., and contends that these benefits are not the basis for a patent in India, where the law states that products that are variants of existing chemical compounds are not patentable.

“Sofosbuvir is not innovative enough at the molecular level to warrant a patent,” maintains Els Torreele, director of the Open Society Foundations’ Access to Essential Medicines Initiative. “This is a battle over whether profits or the lives of patients will drive the hepatitis C response.”

The OSF also notes that sofosbuvir was expected to be approved in the U.S. and in Europe, where it could cost around $80,000 for a course of treatment, and concurs with Dr. Farmer that with some 90 percent of hepatitis C patients living in low- and middle-income countries, that price would put the treatment out of reach for most.

“Without generic competition from India, patent-holding companies will be too slow bringing down prices,” commented Tahir Amin, director of the Initiative for Medicines, Access & Knowledge — an international team of lawyers and scientists increasing access to affordable medicines by making sure the patent system works. “This medicine is a variant of known compounds, and Indian law will not allow a company to make billions on it.”

Dubbed a “viral time bomb” by the World Health Organization, there are an estimated 170 million people living with chronic hepatitis C globally—12 million of whom live in India. The disease infects nearly 4 million people each year and results in 350,000 deaths annually.

The Open Society Foundations is supporting patient groups and treatment advocates to increase access to hepatitis C treatment in many middle income countries—including Georgia, Ukraine, Vietnam, Thailand, Brazil, and Russia—where the price of even current hepatitis treatments place them beyond reach.

In his Washington Post op-ed, Dr. Farmer observes that drug prices are not carved in stone, and that price is not the same as cost. He notes that pharmacologists with Liverpool University who recently analyzed manufacturing processes for new hepatitis C treatments concluded that the drugs could be sold at profit in poor countries for less than $500 per course — still expansive given the volume of need, but a lot more affordable than $80,000 – $90,000. He affirms that a recent pledge by sofosbuvir developer Gilead Sciences, Inc. to work with generic pharmaceutical firms in India is a promising start, but it is just a start. However, he notes that precipitous drug price drops are not unprecedented, and that in “the delivery decade”, innovative partnerships through financing mechanisms such as UNITAID led to declines of as much as 99 percent in the effective price of antiretroviral therapy for the world’s poorest, and that investments in accurate diagnosis and in effective therapy for hepatitis C could save millions of lives in the coming years, radically cut transmission and pave the way to virus eradication. Or, he says, we could choose to ignore the lessons of the AIDS response and let outcomes improve solely among the fortunate few who enjoy ready access to the fruits of modern medicine and the ability to pay for them.

Dr. Farmer expanded on this topic in a thoroughgoing Shattuck Lecture on chronic infectious disease and the future of health care delivery, published in The New England journal of medicine December 19, 2013, which can be found here:
http://www.nejm.org/doi/full/10.1056/NEJMsa1310472

Sources:
World Health Organization, UNAIDS, and UNDP
The Open Society Foundations
The Washington Post
The Initiative for Medicines, Access & Knowledge
New England Journal of Medicine
Harvard University
Voice of America
NPR