Consensus Statement on the Further Development of Protease Inhibitors And Human Growth Hormone

[The following consensus statement is an excellent summary of what is needed today in AIDS treatment research. It also reflects new common ground, after the long-running, so-called "East Coast/West Coast" disputes among AIDS treatment activists (over whether to emphasize better "answers" through more rigorous clinical trials, or faster "access" to new treatments by patients and physicians). David Barr of Gay Men's Health Crisis and Martin Delaney of Project Inform organized and led the meeting that developed this statement. JSJ]

We, the undersigned individuals and organizations, represent hundreds of thousands of people with HIV infection in the United States. We are excited and hopeful that the therapies being reviewed for approval this week (two protease inhibitors and human growth hormone) can provide a substantial benefit for people with HIV. However, approval of these products is not the end of the process of drug development. In order to provide real access and information about how to use these drugs safely and effectively, we call on the Food and Drug Administration, the National Institutes of Health and the pharmaceutical industry and third-party payers to meet the demands outlined below. Failure to do so will seriously undermine the value that these therapies will offer to patients today and in the future.

1) Approve both indinavir and ritonavir for people with HIV infection for whom anti-viral treatment is indicated based on immunologic, clinical and biological markers. Approve human growth hormone for the treatment of wasting syndrome.

2) Whatever regulatory mechanism is used for approval, industry and government must agree to engage in post-marketing research to answer key unanswered questions about safety and efficacy. In order for this research to be effective, it will require a collaborative effort between industry, government, academia and community heretofore unseen in AIDS research. The commitment to engage in this effort quickly should be of paramount importance. We insist that a strategic plan be presented for achieving these goals by the time of the 11th International Conference on AIDS, to be held in Vancouver in June, 1996.

3) The following is a list of questions that we agree must be answered as soon as possible. The list is not meant to be exhaustive, but rather to highlight those issues we believe are of highest priority:

* When in the course of HIV disease should anti-viral treatment generally be initiated? * Which treatment regimens should be used as initial therapy? * What are the best strategies for using combinations of anti-viral drugs, including protease inhibitors, for nucleoside-experienced patients? * When should people switch or stop anti-viral treatment regimens * What is the pharmacokinetic and long-term safety profile on protease inhibitors? * To what level must viral load be reduced and sustained to successfully halt disease progression? * How will pediatric formulations of protease inhibitors be developed and studied? * What is the effect of protease inhibitors on perinatal transmission? * What is the optimal dose of human growth hormone, alone or in combinations?

4) Approve viral load test kits for clinical management now, not in six months. This is essential if we are going to be able to use these treatments effectively.

5) Provide protease drugs and growth hormone, at no cost, to all former and current clinical trial and expanded access program participants and collect long-term safety data from this group. This would provide the easiest and fastest way to get such information.

6) Promotional and educational materials must be developed and made available to doctors, patients, pharmacists and health educators immediately to inform them about safe and effective use of these products particularly around issues of compliance with treatment regimens and drug interaction problems. Community and consumer input into the development and distribution of such materials is essential.

7) Reimbursement decisions should be driven by clinical and/or surrogate data from controlled clinical studies.

8) Prices for these drugs must be fair, reasonable and sensitive to the current crisis in health care funding. Each company must guarantee treatments to those who have no other means of access or less than full coverage through patient assistance programs.

9) At minimum, pharmaceutical companies must agree to provide AIDS Drug Assistance Programs with similar rebates that are given to Medicaid programs.

[Over 30 organizations have already signed this statement, including AIDS Action Council, AIDS Research Alliance, AIDS Treatment News, American Foundation for AIDS Research, Center for AIDS Prevention Studies, Critical Path AIDS Project, Gay Men's Health Crisis, Healing Alternatives Foundation, National Association of People with AIDS, Pediatric AIDS Foundation, Project Inform, PWA Health Group, San Francisco AIDS Foundation, and Treatment Action Group.

Organizations can sign by contacting Ben Cheng or Brenda Lein at Project Inform, 415/558-8669 ext. 221 or 214, or David Barr at GMHC, 212/337-1904.]