The Bay Area Reporter - September 10, 1999
Matt Sharp, ACT UP--Golden Gate Writers Pool

Community members have been in negotiations with PMPA's maker, Gilead Sciences in Foster City, for several months now, trying to broker a deal for broader access to PMPA. As with its sister drug, adefovir, also known as Preveon, the process of working with the company has not been easy. Gilead is in the midst of preparing for FDA approval hearings for adefovir and the results of clinical trails are not particularly favorable. So, the difficulty has been getting the company to pursue development of its newer drug given the unexciting data on adefovir. Promises made by Gilead for access to PMPA have gone undone and have only frustrated patients who need the drug now. Bringing out a newer more favorable drug, PMPA, in the shadow of the less favorable Preveon, has been unfortunate timing for the company.

Community members have been trying to persuade the company to back PMPA because it appears to be a more powerful antiviral than adefovir and so far less toxic. Adefovir causes serious kidney toxicity after 20 weeks of therapy that appears to be reversible upon discontinuation. Nevertheless, the side effects are a major concern to people in late stage disease who might be using this drug and will cast a shadow over the future of adefovir. The community mantra has been to explore the possibilities with the second line drug, PMPA because approval of adefovir appears to be less favorable.

Also, as with previous expanded access programs, including Gilead's adefovir program, the community has pressured for all-inclusive criteria so that anyone that cannot construct a viable treatment regimen could acquire new promising therapies. No one who is failing current regimens should just add one new drug in order to control virus replication. The best effect would be to add two or more new drugs, preferably from a new class. Therefore, the nucleotide family of drugs, made by Gilead, are important components to the equation. And, PMPA appearing to be more potent than adefovir and less toxic thus far, would be the preferred drug.

But the company has a dilemma in that it has poured precious funding into research and development for adefovir. And now that PMPA is nearing wider access, they have to make an important decision that has serious life saving implications for people who have few options with the available drugs. Obviously people in this boat would prefer the more powerful, less toxic drug, PMPA, but can the company afford to throw the baby (adefovir) out with the bath water?

So far in meetings with the Coalition for Salvage Therapy, a group of patient advocates supporting third line options, Gilead has acquiesced in several demands where details will have to be ironed out in implementation: They have agreed to look at PMPA in drug interaction trials with the new Abbott protease inhibitor, ABT-378 that will be the other important available drug to combine. (It is important that drug companies perform interaction studies so that combinations are safe and effective before widespread use.) Gilead has also promised compassionate use availability to PMPA for any individual who fits the requirements by September. Previously, desperate patients were not even afforded this possibility. An open label protocol will be another access mechanism for PMPA for patients who have broken through on their current regimen, at 30 sites in October. Gilead has also agreed to make PMPA available for people who were not close to the designated sites. Finally, a larger expanded access program was promised for the third quarter of 2000, one quarter behind the original promise they made in April. Hopefully, with more supply of the drug becoming available, more community pressure, and with good results in the open label protocol, the expanded access program will open sooner.

So, it is promising that PMPA will be made more available sooner to people who need new options. But the process of wider access has been a long road mired in typical pharmaceutical games that are only detrimental to patients Gilead hopes to eventually market their drug to, but now more lives may be saved with these important programs.
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