|
AIDS Treatment News
But thousands of blood tests now being analyzed will likely provide important information for making better vaccines. Some of this work will be reported at the "HIV Vaccine Development: Immunological and Biological Challenges" meeting beginning March 29 in Banff, Canada. Many scientists did not expect AIDSVAX to work, because this vaccine only produces antibodies against HIV and does not stimulate another branch of the immune system called cellular immunity. Recently, however, there has been renewed interest in antibodies -- partly because of growing knowledge about how to select the right antibodies, and also because cellular immunity alone may not prevent infection but only slow disease development. HIV vaccines might need to use both. The VaxGen report led to controversy because of suggestions that AIDSVAX might work partially in Blacks, or Asians. In Black volunteers, only 4 of 203 who received the vaccine later became infected with HIV, compared to 9 of 111 who received the placebo; in Asians the numbers were 2 of 20 vs. 2 of 53. There is a widespread consensus that no conclusions about human effectiveness can be drawn from such small numbers -- although more research is needed to look for possible racial differences, and this work has started. (This vaccine is not relevant to Africa because it was made specifically for the clade B virus, which causes the AIDS epidemic in the U.S., Europe, and some other areas, but is not common in Africa, where AIDS is caused by clade C and other clades of HIV.) For more information on the science and controversy around the February 24 VaxGen report, see:
T-20: Most Expensive AIDS Drug Ever at $25,000 Per Year? By John S. James On February 24 Hoffmann-La Roche Ltd. announced a European price for T-20, an experimental drug expected to be approved soon by the U.S. FDA, probably in March 2003 [it was approved March 13]. The price, 52 Euros per day or almost $21,000 per year, is expected to be close to the U.S. price, which will not be announced until the drug is approved. If so, U.S. retail prices are likely to be around $25,000 per year, several times the cost of other AIDS drugs. Roche said that the price "reflects the structural complexity of Fuzeon and its highly sophisticated manufacturing process" requiring more than 100 production steps. Trimeris, Inc. and Hoffmann-La Roche Inc. (the U.S. branch of the Swiss company) said that "U.S. patients currently enrolled in the FUZEON Early Access Program will continue receiving FUZEON for free until it is commercially available and participants' reimbursement can be achieved." (Trimeris, Inc. is the small company that initially developed T-20. It was then was acquired by Roche, which financed the improved manufacturing, large clinical trials, and other work needed for commercialization.) The AIDS Treatment Activist Coalition (http://www.atac-usa.org) said, "It is a tragic state of affairs in drug development when an encouraging breakthrough drug cannot be accessed by the people who need it most." Comment T-20 (also called FUZEON(TM), or enfuvirtide) is not a miracle drug. It is about equally effective as other AIDS drugs, and considerably more difficult to use, because it must be carefully mixed by the patient, and injected twice per day. The advantage is that T-20 is in a different class of drugs and works entirely differently than other approved HIV treatments, so virus that has become resistant to the other drugs is still susceptible to T-20. Patients whose virus has become resistant need two or more highly active antiretrovirals as a basis for a combination that may get the virus under control again, and T-20 could be one of those. But only a minority of patients would use T-20 even if price were not an issue. It is true that T-20 is difficult to manufacture and has been expensive to develop. But how can the company get its investment back if the price is so high that few of those who need the drug (already a small market) can obtain it? Private insurance has years of experience in getting rid of persons with HIV and other expensive patients, who then end up in public programs. These programs, like Medicaid and ADAP, are facing unprecedented financial pressures and already cutting back. When they must choose between providing T-20 or providing antiretrovirals to four or five other patients who need them just as much, they are unlikely to pay for T-20. Much of the research and development cost of T-20 is really the expense of developing expertise in a new field of pharmaceuticals that is likely to be important in many areas of medicine, not just HIV. Roche should accept that it is not going to make all the money back on this one drug at any price. In the future T-20 will likely be replaced by one or more small- molecule drugs (from Roche, Trimeris, or others) that do the same job with much less difficulty and expense. T-20 itself has already provided the proof of principle, by showing that patients can benefit from its action. Activists may need to make sure that patent technicalities do not impede the development of these different drugs by any companies. Meanwhile, we fear that the cost of T-20 will force an issue people wanted to avoid -- class differences in medical care. Will we be moving toward separate treatment guidelines for those who can and cannot pay? AIDS Treatment News Published twice monthly Subscription and Editorial Office: 1233 Locust St., 5th floor Philadelphia, PA 19107 800/TREAT-1-2 toll-free email: aidsnews@critpath.org useful links: http://www.aidsnews.org/ Editor and Publisher: John S. James Associate Editor: Tadd T. Tobias Statement of Purpose: AIDS Treatment News reports on experimental and standard treatments, especially those available now. We interview physicians, scientists, other health professionals, and persons with AIDS or HIV; we also collect information from meetings and conferences, medical journals, and computer databases. Long-term survivors have usually tried many different treatments, and found combinations that work for them. AIDS Treatment News does not recommend particular therapies, but seeks to increase the options available. AIDS Treatment News is published 24 times per year, on the first and third Friday of every month, and print copies are sent by first class mail. Email is available (see below). Back issues are available at http://www.aidsnews.org/ To subscribe, you can call 800-TREAT-1-2 or 415-255-0588: |
|
The first "phase III" trial -- one large enough to determine
whether a treatment works -- of an AIDS vaccine in humans found
that the vaccine (called AIDSVAX, produced by VaxGen in
Brisbane, California) failed to protect people from HIV
infection.