Short Course: Notes on HIV Drugs in Development
Chiron Corporation has decided to stop funding its 2,000-person SILCAAT trial of IL-2, a potential therapy for increasing CD4 counts in people with HIV. The SILCAAT trial has been costing Chiron $20 million a year. With the company's patents beginning to expire in 2006, Chiron's president explained that stopping the trial was a business decision. Although the trial had been accumulating primary events (AIDS defining events) at the expected rate, its proposed conclusion in 2007 was no longer felt to be financially tenable.
During a planned interim analysis last spring, the trial's data and safety monitoring board observed CD4 count increases as expected. However, they saw no change in viral load, a secondary endpoint. Although no change in VL would be expected from the action of IL-2, apparently the company had suspended disbelief in a kind of a gamble. Evidence of an ability to reduce viral load would have greatly speeded FDA approval of IL-2, which will otherwise require the continued slow accumulation of clinical events to demonstrate a benefit.
Clifford Lane, of the National Institutes of Health, representing the SILCAAT Scientific Committee, is formulating an alternate plan to keep the trial going for about $5 million per year. This would involve fewer endpoint collections and sharing resources with another large IL-2 trial called ESPRIT. Chiron says they will consider this plan and make a final decision after consultation with the FDA.
Hoffmann-La Roche is set to launch two promising new treatments in the next few months for people living with HIV and/or hepatitis C (HCV). T-20 (Fuzeon) is the first of a new class of anti-HIV drugs called fusion inhibitors. The other new drug, called Pegasys, is an important improvement over the standard interferon used to treat HCV infection.
The price of Pegasys has already been announced at roughly $14,000 per year. This drug must be used in combination with another antiviral drug, ribivirin, which may boost the cost an additional $14,000 to $21,000 per year depending on dosage. The price of Roche's T-20 is almost certain to be priced somewhere above $10,000 per year with some estimates reaching a figure as high as $17,000.
These prices will have a tremendous impact on public health programs facing fiscal problems, such as the AIDS Drug Assistance Program (ADAP) and Medicaid, which are already struggling to meet basic needs.
Project Inform's Treatment Action Network is calling for individuals to contact Roche directly with personal letters: "If the proposed costs of these drugs will affect your ability to access either one, let Roche CEO, George Abercrombie, know it. It is important that he hear from those who will be impacted by his decision. Your letter will also let him know that people are paying attention and care enough about this issue to take action."
This article was provided by Gay Men's Health Crisis. It is a part of the publication GMHC Treatment Issues. Visit GMHC's website to find out more about their activities, publications and services.