Study Shows AIDS Drug VIRAMUNE to be Highly Effective

in Preventing Mother-to-Child HIV Transmission During Labor INGELHEIM/Germany (PROTEXT) - Encouraging preliminary results of HIVNET 012, a trial conducted in Uganda by the HIV Prevention Trials Network (HIVNET), demonstrate that VIRAMUNE(R) (nevirapine) can be a safe and effective option in reducing HIV transmission from mother to child. A simple, inexpensive regimen of one oral dose of VIRAMUNE given to an HIV-infected woman in labor and another to her newborn within three days of birth was almost twice as effective in reducing mother-to-infant HIV transmission as a similar short course of AZT (ZDV, zidovudine). VIRAMUNE is the first member of a new class of drugs called non- nucleoside reverse transcriptase inhibitors (NNRTIs). The trial was sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID). NIAID researchers chose VIRAMUNE for the study because of its pharmacokinetic profile, potency and affordability. VIRAMUNE is rapidly absorbed and transferred across the placenta to the infant and is passed into breast milk. "This study marks a major advance in AIDS and an important step in helping control the worldwide epidemic," according to John L. Sullivan, MD, Professor of Pediatrics, University of Massachusetts Medical School, Worcester, an early proponent of using VIRAMUNE for the prevention of mother-to-child transmission of HIV. "These preliminary results suggest that VIRAMUNE may become the preferred therapeutic approach in preventing mother-to-infant transmission of HIV in developing countries," said another proponent of this regimen, Professor Joep Lange of the National AIDS Therapy Evaluation Centre, Amsterdam. "This news is especially important to those countries hit hardest by the epidemic, like sub-Saharan Africa, where up to 30 percent of pregnant women are infected with HIV and up to 25 to 35 percent of infants will be born infected." The United Nations Program on AIDS (UNAIDS) estimates that approximately 1,800 HIV-infected babies are born every day in developing countries. As NIAID officials say, the presently available standard of care, AZT or AZT + 3TC (lamivudine), is impractical for many developing countries because it is expensive and requires extended prenatal treatment. "We are committed to the continued evaluation of Viramune for this indication," said Dr. Andreas Barner, member of the Board of Managing Directors at Boehringer Ingelheim. "We plan to work closely with the appropriate authorities to expedite the registration of Viramune, especially in the developing countries." The role of VIRAMUNE in the prevention of mother-to-child transmission during labor is also being addressed in other ongoing clinical trials. In April 1999, Boehringer Ingelheim initiated the SAINT study in South Africa. It will compare the safety and efficacy of a similar two-dose regimen of VIRAMUNE, versus a combination regimen of ZDV + 3TC in preventing mother-to-child transmission. Approximately 200 mothers have been enrolled to date. In the United States and Europe, Boehringer Ingelheim is participating in a 1,900-patient study (ACTG 316), sponsored by NIAID, which is examining the efficacy of VIRAMUNE in preventing mother-to-child transmission when added to whatever current antiretrovirals the pregnant women are receiving. This trial has enrolled more than 700 mothers to date. HIVNET 012 The trial was conducted at Mulago Hospital, affiliated with Makerere University, in Kampala, Uganda by HIVNET, and was sponsored by NIAID. Enrollment was completed last April. All women entered into the study were in their ninth month of pregnancy and had not taken antiretroviral drugs while pregnant. The study compared the safety and efficacy of two different short-course regimens of antiviral drugs administered late in pregnancy. The VIRAMUNE regimen consisted of a single 200 mg tablet given to mothers in labor and a single 2 mg/kg dose of VIRAMUNE oral suspension to the newborns within 72 hours after delivery. The AZT regimen was 600 mg at the onset of labor, 300 mg every 3 hours during labor, and 4 mg/kg of AZT twice-daily to the newborn for the first 7 days after delivery. Both drugs appeared to be safe and well-tolerated. For the interim analysis, the study team looked at data from 618 mothers (308 receiving AZT and 310 receiving VIRAMUNE) and their infants. VIRAMUNE was markedly more effective. At 14 to 16 weeks of age, 13.1 percent of infants who received VIRAMUNE were infected with HIV, compared with 25.1 percent of those in the AZT group. The mothers and their children will continue to be actively followed until the babies are 18 months old. VIRAMUNE Boehringer Ingelheim recently received approval from the European Commission to market a pediatric formulation of VIRAMUNE to treat infants and children infected with HIV/AIDS. The oral suspension is currently approved in the U.S., Europe and Mexico and is awaiting approval in other countries. VIRAMUNE was the first member of the NNRTI class of anti- HIV/AIDS drugs to be approved. VIRAMUNE is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analysis of changes in surrogate end-points, such as viral load or changes in CD4+ count. When used in chronic therapy, VIRAMUNE should always be administered with at least one additional antiretroviral agent. VIRAMUNE tablets were approved for marketing in the U.S. in June 1996 and in Europe in February 1998. VIRAMUNE is currently approved in 56 countries. VIRAMUNE is generally well-tolerated. Due to the one single dose regimen of VIRAMUNE in the prevention of perinatal transmission in the HIVNET 012 study, only minor side-effects were seen. The most commonly reported adverse events associated with VIRAMUNE in the long-term combination treatment are rash, fever, nausea, headache and abnormal liver function tests. Severe and life-threatening skin reactions and hepatotoxicity, including fatal cases of each, have occurred in patients treated with VIRAMUNE. VIRAMUNE is a product of original research conducted at Boehringer Ingelheim Pharmaceuticals, Inc., a member of the Boehringer Ingelheim group of companies. VIRAMUNE is marketed world-wide by Boehringer Ingelheim and in the United States by Roxane Laboratories, also a member of the Boehringer Ingelheim group of companies. Boehringer Ingelheim, headquartered in Ingelheim, Germany ranks among the top 20 pharmaceutical companies in the world. It reported revenues exceeding DM 8.75 billion in 1998. The corporation has some 140 affiliated entities and it conducts business on every continent. Its product range is focused on human pharmaceuticals -- hospital, prescription and self- medication -- as well as animal health. The company has substantial research and development, production and distribution facilities around the globe. In 1998 Boehringer Ingelheim spent DM 1.6 billion on research and development, equivalent to 18% of total sales. ots Original Text Service: Boehringer Ingelheim GmbH Internet: http://www.newsaktuell.de CONTACT: Ulrich Bock, Corporate Public Relations Division of Boehringer Ingelheim GmbH, + 49- 6132-772012, or fax, + 49-6132-776601; or Maureen Byrne, 212-886- 3312 or Denise Connolly, 212-886-3117 of GCI Healthcare, or fax,212-886-3291, for Boehringer Ingelheim/ Subscribers please note that material bearing the slug "PROTEXT" is not part of CTK's news service and is not to be published under the "CTK" slug. 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