What's
New?
November
2000
Excerpts From Hotline Memos of October 2000
From the Information
Department of Project Inform
view PDF
|
What's
New? Excerpts From Hotline Memos of October 2000 view PDF |
|
What's New in Treatment Information? Lopinavir Warning It's not possible to definitively say that people developed pancreatitis from taking lopinavir, as some were also taking other therapies known to cause pancreatitis like pentamidine, ddI (didanosine, Videx) and/or d4T (stavudine, Zerit). Additionally, some volunteers had very high triglyceride levels, which can result in pancreatitis. Nevertheless, people on lopinavir should carefully check their amylase levels (a marker for pancreatitis). Expanded Access for ddI
(enteric-coated) To qualify for the program, you must:
In order to participate in this expanded access program, your physician must call 1-877-418-3889 to register. New Women's Publication! DNP
Poly-A: The Glove Fits The reverse transcriptase enzyme, which converts HIV's RNA gene set into DNA before the virus inserts itself into cells nuclei, often has been compared to a hand, complete with a palm, fingers and thumb. The fingers and thumb grab a hold of the nucleotide building blocks and attach them to the growing strand of HIV DNA, lying in the "palm" of the enzyme. This analogy was first made several years back, when the three-dimensional structure of the reverse transcriptase enzyme was discovered. Knowing the enzyme's structure could have important implications in the design of new, more potent reverse transcriptase inhibitors. Ten years ago, discovery of the three-dimensional structure of the protease enzyme led to the discovery and development of protease inhibitors. A group at State University of New York (SUNY), Buffalo has used reverse transcriptase structure to design a chemical, DNP poly-A, that fills the entire nucleotide binding region of the enzyme, in a fashion similar to how protease inhibitors fill the active site of the protease enzyme. When DNP poly-A was added to HIV-exposed cells, the cells did not become infected. DNP poly-A is a sequence of nucleotides (an oligonucleotide). Usually, if strands of such material are found floating around in the blood or outside of protected areas like the cell nucleus or mitochondria, they are treated by the body as noxious garbage or enemy viral genes and quickly destroyed by special enzymes. Most oligonucleotide drugs similarly are broken down before they can reach their targets. The researchers from SUNY do not believe that this will be a problem with DNP poly-A, because the drug was stable even after prolonged incubation in cell cultures with a variety of enzymes known to cut up strands of nucleotides. Next, the researchers administered the drug as an injection to mice with murine leukemia virus, which has a reverse transcriptase enzyme very similar to HIV's. Viral load dropped to undetectable levels in the mouse blood, and there was little toxicity. One problem with the compound, is that even though the team has modified it to increase its absorption from the digestive tract, it still looks as though DNP poly-A will have to be administered as an injection. There is no word yet if any pharmaceutical company is interested in developing this compound. Activist Victory in Fair Pricing Efforts! Ben Cheng, Martin Delaney and Project Inform board member Linda Grinberg all played in-depth roles as leaders of the community process around this effort. Their involvement included participating in a series of meetings with Abbott and other community activists as well as in many smaller, private consultations. On a second front, Kaletra represents the growing success of the FAIR Pricing Coalition, a large ad-hoc coalition of activist groups and AIDS agencies organized by Martin Delaney and Linda Grinberg. The coalition works by creating position papers on any impending pricing of drugs, which are then used to collect support from hundreds of activist groups, agencies and individuals. When the sign-on process reaches its peak, meetings are demanded with the people at the companies who actually make the pricing decisions, usually the president and heads of marketing and public relations. Who Is the FAIR Pricing
Coalition and What Do They Do? The group's first success was with Glaxo Wellcome over the pricing of abacavir (Ziagen). Glaxo had been floating a figure of around $6,000 per year, wholesale, for the drug to various state agencies when the FAIR Pricing team went in. The team's first goal was to create a price freeze on new drugs so that as new drugs became available, they wouldn't exceed the existing price of other drugs in the same class. Glaxo cooperated with the team and the outcome was a price only slightly higher than AZT and thousands below the $6,000, protease inhibitor-like price the company had hoped for. The team was not as successful with Dupont, which priced efavirenz (Sustiva) well above other drugs in its class. However, subsequent action at least secured a three-year price freeze. At the initial meeting with Abbott over lopinavir (Kaletra), it was clear the company viewed the drug as a significant advance over all previous protease inhibitors and intended to price it accordingly. A price that would significantly exceed that of ritonavir (Norvir), already the highest priced protease inhibitor, was the expected result. The team did its thing, laying out the consequences of such a price on ADAP and Medicaid, as well private insurance. In the end, Abbott backed off and its president announced a price that was substantially lower than ritonavir, as well as lower than nelfinavir (Viracept) at around $6,700 per year. Ritonavir is nearly $1,000 higher, so this represents a reversal of direction on pricing at Abbott, plus it holds the line on the price of protease inhibitors. Unfortunately, it is still well above the price of indinavir (Crixivan), which has always been the lowest priced protease inhibitor by far (under $5,000). The success of this negotiating process is unique in the history of the pharmaceutical industry. It encourages us that we will be able to make a difference on international pricing as well. For people interested in participating by signing consensus statements and supporting the Fair Pricing Coalition, contact FAIRFoundation@aol.com. Project Access Project Inform was the lead advocacy group working with the California State Office of AIDS to make this program possible. The Information and Advocacy department at PI began to predict the growing utility of resistance testing in the management of HIV disease at least a year before it was included in the Federal Guidelines for the Standard of HIV Care. This prediction allowed the Policy department to partner with the State Office of AIDS, well in advance of the inclusion of resistance testing in the guidelines, to ensure that low income Californians who are not otherwise insured could get coverage for the tests. The program may be a model for other states in providing more access to resistance testing. Some states have already contacted the California State Office of AIDS and Project Inform to discuss setting up a similar program. ACTION ALERT: Congress decided to recess for the November elections before negotiating a final Labor-Health and Human Services appropriations bill for Fiscal Year 2001 (October 1, 2000 to September 30,2001). Within this bill is funding for HIV/AIDS care/treatment, prevention and research programs. Because the Fiscal Year has already started, Congress has approved a "continuing resolution" which funds programs at current levels until a final bill can be approved. Congress will reconvene on November 14 after the elections to continue its work on final bills, including the appropriations bill. HIV/AIDS advocates are very concerned about this delay. Until a final bill can be passed, HIV/AIDS programs will not receive the increases they need to maintain adequate levels of service. In addition, the uncertainty around potential increases will make it difficult for planning programs and services. Perhaps more concerning is the potential for this issue to become a victim of post-election politics. Depending on the outcome of the elections, Congress might continue to delay making final decisions until after the new Administration takes over in January. Continued delays in securing increases could cause major problems for many crucial HIV/AIDS programs. Even before Congress recessed, the funding increases for all HIV/AIDS programs being discussed were far below those needed to provide adequate services to people living with and at risk for HIV. Advocates for the AIDS Drug Assistance Program (ADAP) are particularly concerned about the inadequate funding levels being discussed for that program. ADAP provides HIV/AIDS treatments to under- or uninsured low income individuals who otherwise wouldn't be able to afford them. Experts have indicated that a $130 million increase over last year's funding is needed to maintain the current level of service, but Congress is discussing increases far below that amount. Your help is needed to make sure that Congress acts quickly on business that should have been completed by now! Please take a few minutes to contact your elected representatives and ask them to do everything in their power to pass a final appropriations bill quickly with the highest possible increases for HIV/AIDS programs. Action
needed:
Be sure to be personal in your message! If you or someone you care about uses federally-funding HIV/AIDS programs, let them know! You can reach your representatives through the Capitol switchboard at (202) 224-3121. You can also find websites with contact information for your Representative at http://www.house.gov/ and your Senators at http://www.senate.gov/.
Holiday Card Project Buy Project Inform Holiday
Cards Use the Project Inform
Holiday Card Service Ask your company to
participate For more information regarding this special program and others, please contact Julie Doherty at 415-558-8669 x223. You may also see examples of the cards and purchase them through our web site at www.projectinform.org/develop/card.html. |