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December 3, 1999     Cape Gazette
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December 3, 1999

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40 - CAPE GAZETTE, Friday, December 3 - December 9, 1999 AIDSentr,: Ik U.S. FDA approves Agenerase for HIV treatment Protease inhibitor dosed twice daily Agenerase (amprenavir), a new protease inhibitor with proven antiviral activity, has been granted accelerated approval by the U.S. Food and Drug Administration for use in combination with other antiretrovirals for HIV infection treatment. Agenerase, the first protease inhibitor to be approved in more than two years, has been studied in clinical trials of previously untreated patients and patients who have received prior reverse transcriptase inhibitor and pro- tease inhibitor therapy. "There is a great need for dos- ing flexibility with antiretroviral therapy," said Dr. Jeff Goodgame, principal investigator, Central Florida Research Initiative. "Agenerase has a long half-life and can be dosed twice a day. This aspect of the drug, and the fact that it is generally well-toler- ated, make Agenerase an impor- tant new treatment for HIV. Agenerase increases the options for naive and treatment-experi- enced HIV patients and may help to simplify combination therapy by offering less restrictive dosing patterns." Briefly SCAC offers free legal clinic Jan. 22 A flee walk-in clinic sponsored by the Sussex County AIDS Committee and the SHARP Center will be held from 10 a.m. to 1 p.m., Jan. 22, at the Sussex County AIDS Committee office. Volunteer attorneys will be avail- able to clients of SCAC, the SHARP Center and the communi- ty at large for executing simple wills and powers of attorney, hav- ing wills-pursuant to Delaware law and for general questions. Light refreshments will be served. To make an appointment, call Jeanne at 644-1094. Laryngectomy group to meet Dec. 15 Let's Talk, a iaryngectomy sup- port group, meets the third Wednesday of each month from 3:15 to 4:30 p.m., in the Tunnell Cancer conference room at Beebe Medical Center. The next meet- ing is Wednesday, Dec. 15. Support group members are involved in educating the public about the hazards of tobacco and discuss the special needs of laryn- gectomes and their methods of communicating. For more information, call "The approval of Agenerase provides a significant new medi- cine for the treatment of HIV," said Dr. Lynn Smiley, vice presi- dent of HIV and opportunistic infections cinical development at Glaxo Wellcome, the company that holds the drug's license. Agenerase was discovered by Vertex Pharmaceuticals and is licensed to Glaxo Wellcome. Mutations conferring resistance to Agenerase have been selected in vitro and were also obtained from patients treated with Agenerase. The key mutation associated with resistance to Agenerase, 50V, has not been observed in protease inhibitor therapy-experienced patients or as a naturally occurring variant in people living with HIV. In addition, several mutations are required for significant resist- ance to occur. Varying degrees of cross-resistance have been observed between Agenerase- selected resistant variants and other protease inhibitors. Agenerase, in combination with other antiretroviral agents, is indi- cated for the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV RNA lev- els and CD4 cell counts in con- trolled studies up to 24 weeks in Kelly Crockett, speech therapist, at 645-3235. Bosom Buddies meets Dec. 21 at Beebe Beebe Medical Center sponsors Bosom Buddies at 3 p.m., Tuesday, Dec. 21, in the Tunnell Cancer Center conference room. The support group is for women living with breast cancer, whether they are newly diagnosed, are cur- rently undergo!ng treatment or are long-time survivors. Call 645-3770 for more infor- mation. SCAC seeks volunteers provide transportation Sussex County AIDS Committee (SCAC) is seeking volunteers for the SCAC trans- portation program. Hours are flexible. For more information, call Sharyn at 644-1090. Fitness Tip of the Week Watching your sium? Read food labels and avoid prod- rots that list sodium chloride as one of the first three items High sodium foods include cheesei ham, bacon, corned beef and luncheon meats. Try flavoring foods with herbs and spices rather than salt. Submined by the YMCA For more information, call 227-8018. duration. Currently, there are no results from controlled trials eval- uating long-term suppression of HIV RNA or disease progression with Agenerase. The recommended dose of Agenerase is eight, 150-milligram capsules, twice daily. Most other protease inhibitors are indicated for three times daily dosing. Agenerase can be taken with or without food, but high fat meals should be avoided. The safety of Agenerase was studied in more than 1,400 patients who received Agenerase in combination with a variety of other antiviral agents. The drug should not be used with some drugs, and it may cause serious and/or lifethreatening reactions with other drugs. The majority of adverse events were of mild to moderate intensi- ty. The most frequently reported adverse events were nausea, diar- rhea, vomiting, rash and perioral paresthesia. Severe and life-threatening skin reactions, including Stevens- Johnson Syndrome, have occurred in 1 percent of patients treated with Agenerase. As with other protease inhibitors, Agenerase may be associated with acute hemolytic anemia, diabetes melli- tus and hyperglycemia. In both Phase III studies, severe laboratory abnormalities occurred infrequently. Preliminary data suggest that there is no clinically significant effect on lipid profile with Agenerase. Agenerase has been available to FREE ANONYMOUS HIV TESTING Sussex County AIDS Committee, Inc. NO APPOINTMENT NECESSARY several thousand patients since September 1998 through three Early Access protocols. The Glaxo Wellcome price to whole- salers for Agenerase will be $16.80/day, or $6,132 annually. The price to patients could vary depending on where they get the prescription filled. FREE Health Seminar from Beebe Medical Center "Acute Coronary Syndrome" THURSDAY, DECEMBER 16, 1999 SPEAKER: LOCATION: TIME: Dr. Budi Bahureksa Internal Medicine, Cardiolog Beebe Medical Center's Gull House Rehoboth Beach (opposite Spring Lake) 7:00 to 8:00 p.m. Beebe Medical Center This is a free seminar. Please call 645-3337 to register or register online at and click onto the Focus on Health web banner. 424 Savannah Rd., Lewes, DE