Bulletin of Experimental Treatments for AIDS, No. 30; September, 1996
Mark Bowers, Managing Editor of BETA.

Hoffman-La Roche, Inc. has announced the initiation of a multisite, randomized, open-label comparative clinical study of 2 formulations of saquinavir. The 48-week study will recruit 140 volunteers to receive either 1,200 mg of soft gel capsules or hard gel capsules in combination with one or more Food and Drug Administration (FDA) approved nucleoside analog antiretroviral drugs as chosen by the investigator and the volunteer. Use of saquinavir as monotherapy or in combination with other protease inhibitors will not be permitted. Volunteers will be 13 years of age or older and will not have been exposed to any protease inhibitor for more than 2 weeks. Contact information: Los Angeles - Pacific Oaks Medical Group (818-906-6279) or UCLA AIDS Clinical Research Center (310-206-8359); Sacramento - UC Davis Medical Center (916-734-3741); San Diego - UC San Diego Treatment Center (619-543-8080); Boston - Massachusetts General Hospital (617-726-3815) or New England Medical Center (61! 7-636-7008); Stanford - AIDS Research Center (415-852-3408); San Francisco - Veterans Administration Medical Center (415-750-6960) or Mount Zion Hospital (415-885-7737); New York - Beth Israel Medical Center (212-420-4432); Galveston - University of Texas Medical Branch (409-772-4979); and Denver - University of Colorado (303-270-7233).

**Food and Drug Administration Approvals

*FDA Approves Expanded Access for Nelfinavir

Beginning on September 16, 1996, an FDA-approved expanded access program will make Agouron Pharmaceuticals' protease inhibitor nelfinavir (Viracept) available to people with CD4 counts below 51 cells/mm3. Viracept will be provided free-of-charge to persons who cannot take the 3 commercially available protease inhibitors, saquinavir, indinavir and ritonavir. Physicians, health care professionals and patients may call 1-800-621-7111 Monday through Friday between 8:00 a.m. and 6:00 p.m. EST.

*FDA Approves Serostim

In August 1996, Serono Laboratories was granted accelerated approval to market recombinant human growth hormone (Serostim) for the treatment of AIDS wasting or cachexia. Approval was based on data from studies that showed significant gains in lean body mass or weight, with decreases in body fat. The impact of Serostim treatment on survival and morbidity still is not known, but will be addressed in post-marketing studies. Serono will also conduct studies to evaluate whether the drug improves physical performance and to substantiate previous findings of increased lean body mass in persons who receive injections of Serostim. Under pressure from activists, including ACT UP/Golden Gate, Serono agreed to a price cap on Serostim of $36,000 per year. Serono expects that Serostim will be available in pharmacies in November; until then, the Serono treatment IND program will accept new enrollments. For additional information, call the Serostim Access Line at 1-800-714-2437 Monday throu! gh Friday between 8:30 a.m. and 5:00 p.m. EST.

*FDA Approves Azithromycin for MAC Prophylaxis

In June 1996, Pfizer, Inc. was granted FDA approval to market azithromycin (Zithromax) for the prevention of disseminated Mycobacterium avium complex (MAC) disease in people with advanced HIV infection. A 1,200 mg dose (two 600 mg tablets) of azithromycin once a week was shown to reduce the risk of developing MAC in 2 randomized, double-blind studies. Azithromycin reduced by one half the risk of developing MAC, compared to rifabutin. One study also showed that the combination of azithromycin and rifabutin was more effective than rifabutin alone at preventing MAC. The new once-weekly azithromycin regimen is also more convenient and is expected to be cheaper than daily rifabutin (two 150 mg capsules per day at approximately $2,600 per year). For patient assistance and further information, physicians may call 1-800-869-9979 Monday through Friday between 9:00 a.m. and 5:00 p.m. EST. Allow 3-4 weeks for shipment of drug, and reapply every 15 weeks to assure continued supply.

*FDA Approves Nevirapine

In June 1996, Boehringer Ingelheim won accelerated approval to market nevirapine (Viramune) in combination with nucleoside analog drugs for the treatment of HIV-infected adults who have experienced clinical or immunologic deterioration. The recommended dosing schedule is one 200 mg tablet per day for 2 weeks, followed by one 200 mg tablet twice daily. This schedule reduces the likelihood of developing rash, which developed in 17% of patients on combination regimens that included nevirapine in clinical studies. FDA approval was based on studies that combined AZT and ddI with this new, non-nucleoside reverse transcriptase inhibitor. For patient assistance, call 1-800-595-5494.

*FDA Approves Cidofovir

In July 1996, Gilead Sciences of Foster City, CA, was granted FDA approval to market cidofovir (Vistide) for the treatment of cytomegalovirus (CMV) retinitis in persons with AIDS. The dosing schedule for induction is 1 infusion per week for 2 weeks. Maintenance infusions are done every other week. The main side effect of the drug is renal (kidney) impairment, which can be minimized with the administration of probenecid tablets and hydration on the day of each infusion. The catalog price is $589 for a 1-week course of induction therapy or a 2-week course of maintenance therapy. For reimbursement or financial assistance, call the Support Services Program at 1-800-GILEAD 5 (1-800-445-3235).

*FDA Approves Urine Test to Detect HIV Antibodies

In August 1996, Caltype Biomedical of Berkeley, CA, won FDA approval to market the first urine test to detect antibodies to HIV. The accuracy of the urine test differs from HIV blood tests in that the false negative rate is estimated at 1 or 2 in every 100 tests, while blood tests for antibodies miss 1 or 2 in every 1,000 tests. Studies also show that 1 or 2 in every 100 tests will falsely register positive for antibodies. The new urine test may only be administered by a physician, and positive test results must be verified with a follow-up blood test (Western blot). Evidence of pre-test counseling is required before any sample will be evaluated for the presence of HIV antibodies.

*FDA Approves Home Access HIV Testing and Counseling Systems

On July 14, 1996, Home Access Health Corporation won FDA approval to market 2 HIV testing and counseling systems. Home Access Express and Home Access allow people to collect blood samples, access professional pre-test and post-test counseling, and receive test results in either 3 days or 1 week, depending on which system is purchased. Counseling is available in connection with both systems 24 hours a day, 7 days a week. For more information or to order a test system, call 1-800-HIV-TEST.

*Other News

One Percent of Caucasians Immune to HIV

Reports by researchers at the Aaron Diamond AIDS Research Center published in the August 9, 1996 issue of Cell and by researchers in Brussels, Belgium published in the August 22, 1996 issue of Nature provide insight as to why some people who are repeatedly exposed to HIV through sex do not become infected. A newly discovered gene called CKR-5 makes a protein that is located on the surface of some immune cells. This protein is necessary for HIV to enter and infect CD4 cells. People inherit 2 copies of the gene, 1 from each parent. If both inherited copies of the gene are mutants, no CKR-5 protein is made, and HIV cannot infect immune cells where it is lacking. Some people inherit 1 copy of the mutant gene. Belgian researchers suspect that these are often the slow progressors who, although they may be HIV-infected, do not progress to AIDS.

Aaron Diamond researchers predict that 1% of people of Western European heritage have 2 copies of the mutant gene. The Belgian team found 1 copy of the mutant gene in 20% of 700 healthy Caucasians and in a much smaller percentage of people who were HIV-infected. Central Africans and Japanese who were studied did not show evidence of the genetic mutation. The lack of CKR-5 apparently makes infection with the most common sexually transmitted varieties of HIV unlikely, but the effect on the incidence of transmission through blood is not known.

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Copyright © 1996 - San Francisco AIDS Foundation. Reproduced by permission. Reproduction of this article (other than one copy for personal reference) must be cleared through BETA: PO Box 426182, San Francisco, CA 94142-6182. Tel: 415 487 8060 Fax: 415 487 8069 URL: http://www.sfaf.org/beta E-mail: beta@sfaf.org

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