If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  HIV-1 Therapy With Viramune Combination Works in Infants and Children COLUMBUS, Ohio, May 8, 1997 -- Triple combination therapy including Viramune(R) (nevirapine), a non-nucleoside reverse transcriptase inhibitor (NNRTI), was shown to be effective and well-tolerated in the treatment of infants and children vertically infected with HIV-1. Results of the first-ever published study to examine an NNRTI in combination with older AIDS therapies in this patient population will appear in today’s issue of The New England Journal of Medicine. This study confirms the efficacy and sustained tolerability of the triple drug regimen of Viramune, AZT (ZDV, zidovudine) and ddI (didanosine) in vertically infected infants and children. Viral loads dropped substantially in all but one participant over the six month course of the study. Durable suppression of HIV-1 replication was observed over six months of therapy in the majority of infants and children studied. Complete control of HIV replication was achieved in two infants who began therapy at 2.5 months of age. In these subjects, HIV-1 RNA became undetectable in the plasma and the active production of HIV-1 antibodies was not observed. In all patients, the percentage of CD4 cells remained stable or increased slightly. No clinically significant adverse side effects were observed in this study. The major clinical toxicity of Viramune is rash, with Viramune attributable rash occurring in 17 percent of adult patients in combination regimens in controlled studies. "Because this study demonstrated efficacy and absence of significant side effects, it represents an important step in controlling HIV replication in infants and children," said Katherine Luzuriaga, M.D., Department of Pediatrics, University of Massachusetts Medical School, Worcester and a lead investigator of the study, "It also provides insight into the benefit of early treatment of HIV infection." Methodology Over a six month period, oral administration of the triple drug regimen was given to eight infants and children aged 2.5 to 16 months with minimal or no prior antiretroviral therapy. Subjects were enrolled at two sites in the U.S. and received oral administration of Viramune, AZT and ddI for a six month period. All medications were supplied as suspensions or in syrup form. The following doses of study drugs were used: Viramune 120 mg/m2/dose given once daily for 28 days, followed by 200 mg/m2/dose given every 12 hours (study days 29-168) and AZT at 180 mg/m2/dose every 8 hours and ddI at 120 mg/m2/dose given every 12 hours. Conclusion The study demonstrated that therapy with a potent antiretroviral combination is most effective when administered early in HIV infection. The study also suggests that long-term control of viral replication and possible eradication of HIV-1 infection is feasible if a combination regimen of sufficient potency is employed early in vertical HIV-1 infection. Previously, antiretroviral monotherapy with a nucleoside analogue had been the primary treatment for vertically infected infants and children. However, efficacy was moderate with limited duration. "This study confirms that by administering Viramune with AZT and ddI early in the infection process, HIV viral load can be reduced to undetectable levels in these patients," said John L. Sullivan, M.D., Department of Pediatrics, University of Massachusetts Medical School, Worcester and a lead investigator of the study. "Additionally, the key to total viral eradication may rest with the ability of antiretrovirals to reach virus hidden in the sanctuary sites, such as the CNS (the brain in particular). Viramune in combination with AZT and ddI is an attractive treatment cocktail because it penetrates the CNS quite well." Viramune in Pediatrics The study was supported by the AIDS Clinical Trial Group (ACTG), the National Institute of Allergy and Infectious Diseases, National Institutes of Health and the National Center for Research Resources. It received funding from Boehringer-Ingelheim Pharmaceuticals, Inc. Boehringer-Ingelheim Pharmaceuticals, Inc has an ongoing pediatric clinical development program that was initiated concurrently with the adult program. Recognizing the significant need for alternative treatments for HIV infected children, 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. Viramune, the first NNRTI to receive marketing clearance by the Food and Drug Administration, 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. Viramune(R) (nevirapine) is marketed by Roxane Laboratories, Inc., a subsidiary of Boehringer-Ingelheim Corporation. Roxane Laboratories, Inc., headquartered in Columbus, OH, is engaged in the manufacture of palliative care therapy and 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.
|
