Fuzeon fury: price of first FDA-approved HIV fusion inhibitor sparks protest in US

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Yesterday, the US Food and Drug Administration (FDA) approved the first HIV fusion inhibitor Fuzeon (enfuvirtide, also known as T-20), for use in combination with other anti-HIV medications to treat advanced HIV-1 infection in adults and children ages 6 years and older.

However, the drug’s anticipated U.S. price has sparked a war of words between the drug’s distributor, Roche, and US community activists. Roche have not yet released the actual U.S. price but said it will be close to the recently announced European annual cost of around £12,800 which is more than triple the cost of any other antiretroviral and 50% higher than the price predicted by financial analysts last summer (see news story)

The FDA based its approval of Fuzeon on an analysis of six months of data from one of two ongoing clinical studies of Fuzeon (TORO 1 and 2) involving approximately 1,000 patients. The New England Journal of Medicine (NEJM) yesterday posted the clinical results from the TORO 1 study on its web site, www.nejm.org, in advance of publishing the data in the May 29th issue.

Glossary

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

fusion inhibitor

Anti-HIV drug targeting the point where HIV locks on to an immune cell.

clinical trial

A research study involving participants, usually to find out how well a new drug or treatment works in people and how safe it is.

phase I

The first stage of human testing of a new drug or intervention, typically involving a small number (10-100) of participants who do not have the condition the drug is intended to treat. Phase I clinical trials evaluate safety, side-effects, dosage and how a drug is metabolised and excreted in the body.

advanced HIV

A modern term that is often preferred to 'AIDS'. The World Health Organization criteria for advanced HIV disease is a CD4 cell count below 200 or symptoms of stage 3 or 4 in adults and adolescents. All HIV-positive children younger than five years of age are considered to have advanced HIV disease.

The data from TORO 1 shows that the addition of Fuzeon to a combination of 3-5 optimised background antiretrovirals achieved more durable and larger reductions in HIV viral load than the background antiretrovirals alone (1.686 log10 copies/ml vs 0.764 log10 copies/ml) over 24 weeks, which was a highly significant difference. Increases in CD4 counts were also higher in the Fuzeon group (76 cells/mm3 vs 32 cells mm3). However, 98% of those on Fuzeon - which is self-injected subcutaneously twice daily - experienced injection site reactions, almost half of which required pain-alleviating treatment.

Whilst both the cost and the quality of life issues associated with the use of Fuzeon may affect both European approval, which is expected in May, and how the drug is used in the UK, US activists say that exorbitant price of Fuzeon will lead to chaos in the public health system. "Roche has priced Fuzeon at almost three times the price of the most expensive AIDS drug," said ACT UP/NY member Mark Milano. "This excessive price will force ADAP programs to cut other lifesaving drugs, restrict entry to their programs, or increase already long waiting lists. This will hasten the death of thousands of people with HIV in the U.S."

The AIDS Drug Assistance Programmes (ADAPs) - which pay for treatment for people with HIV who are un- or underinsured - are expected to experience a $140 million shortfall for this year unless new funds are available. Currently, ADAP programmes in 14 states are limiting enrolment or the drugs available on their formularies. ADAP directors are holding a series of meetings with pharmaceutical companies next week to negotiate discounts on all AIDS-related drugs, including Fuzeon, but it is doubtful these discounts will be enough to address the problem. "We don't think we can add Fuzeon (to our drug list) without cutting something else. We are excited about the drug, but we aren't sure we can afford it," Michael Montgomery, who oversees California's ADAP programme told the Associated Press (AP).

"Roche claims that Fuzeon is more expensive to produce than other anti-HIV drugs, but that doesn't justify this excessive price," says ACTUP/NY’s Eustacia Smith. "Roche claims it spent $600 million developing the drug, but they refuse to open their books to verify that. Our research suggests they spent closer to half that amount, and also that significant portions of the research costs were paid for by the NIH including the drug's discovery and the initial phase I clinical trial."

Fuzeon's manufacture is very complicated, requiring three times the normal number of ingredients and four times the average number of processing steps. Initially, only 12,000 to 15,000 patients world-wide will have access to Fuzeon due to production constraints. Roche's chairman and chief executive, Franz Humer, told the AP: "We need to make a decent rate of return on our innovations. This is a major breakthrough therapy. I can't imagine a society that doesn't want that innovation to continue."

References

Lalezari JP et al. Enfuvirtide, an HIV-1 Fusion Inhibitor, for Drug-Resistant HIV Infection in North and South America. NEJM 2003 click here for the full text article