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| |  Drug May Impact Pediatric AIDS WASHINGTON, Jan. 25, 1997 -- New potential benefits from VIRAMUNE(R) (nevirapine) were revealed in two studies presented at the Fourth Conference on Retroviruses and Opportunistic Infections. The first study looked at the impact of VIRAMUNE on the transmission of HIV from mother to newborn. The second study reported on the impact of triple drug therapy on pediatric patients. These studies suggest a potential role for VIRAMUNE in both settings. The first of these studies (Pediatric ACTG 250) described the safety and pharmacokinetics (PK) of VIRAMUNE, on a background of ZDV, in neonates born to HIV-1 infected women. The current standard of care (ZDV from week 26 on) is based on ACTG 076 which demonstrated the utility of ZDV to reduce transmission from 25 percent to 8 percent. Since the majority of mother-child transmission occurs during labor and delivery, it was thought that increasing the potency of the anti-HIV regimen with the addition of VIRAMUNE might further reduce transmission. In this study, consisting of eight infants born to seven HIV positive women, the mothers were given one dose of VIRAMUNE during labor; the infants each received one dose between 48 and 72 hours after birth. PK analysis showed that this regimen was sufficient to keep a therapeutic level of the drug in the infants throughout the first week of life. No maternal or infant drug-related toxicity was noted. "This study paves the way for a new intervention trial to provide prophylaxis to infants born to HIV infected mothers, expected to begin enrolling patients in February," said Dr. John L. Sullivan, Professor of Pediatrics, University of Massachusetts Medical Center. "During this early stage of infection, the more potent the cocktail of antiretrovirals, the better the chance of preventing the virus from establishing itself," continued Dr. Sullivan. The second of these studies presented at the Conference (Pediatric ACTG 180) showed how potent triple therapy, including VIRAMUNE, early in infected infants continues to show great promise. A study of VIRAMUNE + ZDV + ddI in eight infants between 2-1/2 and 16 months of age showed durable reductions in viral RNA (0.5 - 3 logs) for seven out of the eight infants at six months of the study. Two of the infants had undetectable virus (viral load < 20 copies/ml) and HIV-1 could not be cultured from their blood 15 months into the trial. No maternal or infant drug-related toxicity was noted. "This study demonstrated sustained antiretroviral efficacy for longer term control and raises hope for the possible eradication of HIV-1 replication with early aggressive treatment, a finding similar to that of the BI 1046 (INCAS) trial with the same regimen in adults reported earlier at the 11th International Conference on AIDS in Vancouver," said Dr. Katherine Luzuriaga, Associate Professor of Pediatrics, University of Massachusetts Medical Center. VIRAMUNE is currently indicated for use in combination with nucleoside analogues for the treatment of HIV infected adults who have experienced clinical and/or immunologic deterioration. Pediatric data are being compiled to support an application to be submitted to the U.S. Food and Drug Administration this year. Recognizing the significant need for alternative treatments for children with AIDS, VIRAMUNE has been made available for children through an expanded access program since March 1996. VIRAMUNE is available to pediatric patients in this expanded access program as a suspension or in tablet form. More information on the VIRAMUNE Pediatric Expanded Access Program can be obtained by calling 1-800-595-5494. Roxane Laboratories Inc., of Columbus, Ohio, a subsidiary of Boehringer Ingelheim Corporation, is a leader in palliative care therapy. Roxane Laboratories manufactures a broad range of pharmaceuticals, including treatments for pain in AIDS and cancer, an antinauseant for cancer chemotherapy, and an appetite stimulant for AIDS. Boehringer Ingelheim Corporation is a member of the Boehringer Ingelheim, worldwide group of companies, based in Ingelheim, Germany. A privately held company founded in 1885, Boehringer Ingelheim is a major pharmaceutical, chemical, animal health, and bakery products manufacturer with operations in more than 100 countries around the world. VIRAMUNE(R) is a product of original research done at Boehringer Ingelheim Pharmaceuticals, Inc., located in Ridgefield, CT, which is a sister company of Roxane Laboratories Inc.
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