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About Just out. (Portland, OR) 1983-2013 | View Entire Issue (June 21, 1996)
10 ▼ juiM 21. 1090 ▼ ju s t o u t news A new option The F D A admits nevirapine onto the AID S-drug roster, New on the market... while a herpes drug is nixed due to serious risks The Bender Properties real estate team welcomes the talent and promise of our newest associate, Gail Davis. Buying or selling a home? Come take advantage of our encyclopedic knowledge. office (503) 653-8378 residence (503) 659-1515 fax (503) 786-1227 4725 Southeast Washington Street Milwaukie, Oregon 97222 Serving the entire Portland metro area since 1979. The Perfect Limousine for Every Occasion Tiffany L im ousine 235-2341 VSK FOR THE ju st out SPECIAL! IF YOU A R E IL L A N D M O N E Y HAS BECOME A CONCERN . . . We understand the financial difficu lties that occur when living with a life threatening illness. (VBF) secures purchasers for your life insurance policy, provid ing you with the funds you need today. We simplify the entire pro cess, creating the least amount of stress on you. Our clients peace of mind and well being is our NUMBER ONE CONCERN. We are committed to securing the absolute highest possible pur chase price for your policy, while maintaining the utmost in confi dentiality. . R ENEFITS I ATICA I Please c a ll fo r m ore inform ation. Gay Owned and Operated Food and Drug Administration ad visory panel unanimously recom mended approval o f the AIDS drug nevirapine at its June 7 meeting at Silver Spring, Md. Final approval seems assured, and the drug may be available in pharmacies as early as the end o f June. Nevirapine was developed by Boehringer Ingelheim Pharmaceuticals and will be marketed under the trade name Viramune. It disrupts the HIV virus at the same point in its replication cycle as do the nucleoside analogs (A ZT , 3TC, d4T, ddl, ddC). But it is the first in a new class o f drugs known as non- nucleoside reverse transcriptase inhibi- tors. It binds to adif- ferem -* *® *«**< K ' RNA to cation. C lin ic a l trials show the drug to be easily absorbed and tolerated by the body. The most sig nificant side effect is skin rash, though it is seldom severe enough to discon tinue use. Resistance q u ick ly d e v e lo p s when used as a monotherapy, as is often the case with AIDS drugs. The drug is being recommended for use in combination. Trials o f nevirapine in triple combination with A ZT and ddl have produced sustained elevations in CD4 count and drops in viral load that approach those o f combinations using protease inhibitors. It appears to have its greatest effect on those with a CD4 count between 50 and 350 and lesser impact on either side o f that range. There is no clinical data on combination use with other nucleoside analogs. However, the chemical profile o f nevirapine leads researchers to believe it is safe and will have parallel synergy in those combinations. There is, however, poten tial for harmful drug interactions with protease inhibitors. Patients and physicians are advised not to try these combinations until clinical data becom e available. Martin Delaney o f Project Inform in San Francisco called nevirapine “ another pathway towards that goal o f undetectable virus, one that has very low side effect risk.” Spencer C ox o f the Treatment Action Group in New York City called nevirapine “ an impor tant option without very much information on how to use it.” He believes that “ people are going to be making decisions [on whether to use it or not] based on everything from toxicity profile, prior anti-viral history and cost.” A Delaney sees “ the issues are shifting away from active therapies. Now the goal is to sort out clinical management o f the disease.” The company has not said how it will price the new drug, but indications are that it will be comparable to the nucleoside analogs and sig nificantly lower than the protease inhibitors. Ernest Hopkins o f the National Association o f People with AIDS, calls it “ a significant fund ing challenge. Health care access will be the issue for us as more and more people begin to enroll in treatment therapy.” Delaney says, “ It will actually offer some relief in the [govern ment A ID S Drug A ssista n ce P ro- grams]. There may p r a ; be a way to get to the ___ goal o f suppressing the virus without ini tially incurring the cost o f the protease ’ £&'■$ inhibitors.” C ox warns, “ It is probably going to require some com promise from activ ists that we haven’ t had to make in the past— figuring out when it is time to let a drug fall o ff the formulary, as well as hopefully bringing in some new money to pay for new products.” He cites the use o f expensive growth hormone in people with very advanced disease as “ a hard question that sounds mean just [in] asking it.” ai O n June 6 the panel considered and rejected the application for Sorvudine, a treatment for herpes zoster. The drug is as effective as current medications and offers the convenienc taking a pill once a day as opposed to four pills five times a day. The problem is a fatal interaction with an anti- cancer drug. Experience in Japan, where the drug is commercially available, has resulted in numer ous cases o f patients obtaining the medications from different physicians who were unaware o f the other prescription. The patients died from the drug interaction. “ I know there were people in the community, particularly the AIDS community, who were looking forward to that one-dose drug,” said N A PW A ’ s Hopkins. Buthe applauded the panel’ s recommendation as appropriate. “There was no way they could agree to put the drug on the market because o f the potential for fatalities.” The panel recommended further study to see if there is a way to approve restricted distribution so as to safeguard the public. 1 800 871-9440 - F< OUNDATION. I nc . by Bob Roehr - 24 HOURS FT. 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