The Lancet Publishes Landmark Mother-To-Child HIV

Transmission Study - Potent and Affordable VIRAMUNE(R) (nevirapine) Regimen Shown to Significantly Reduce HIV Transmission - INGELHEIM, Germany (PROTEXT) - This week's issue of The Lancet features encouraging preliminary results of HIVNET 012, a trial conducted in Uganda by the National Institute of Allergy and Infectious Disease's (NIAID) HIV Prevention Trials Network (HIVNET). Findings demonstrate that VIRAMUNE(R) (nevirapine) safely and effectively reduced HIV transmission from mothers to their infants. 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 short course ZDV (zidovudine, AZT, Retrovir(R)) regimen. Editors of The Lancet -- one of the world's most prestigious medical journals -- expedited review of the data due to the positive nature of the findings. The data was recently presented to worldwide public health officials and scientists at the second conference on Global Strategies for the Prevention of HIV Transmission From Mothers to Infants in Montreal. "The short course VIRAMUNE regimen was markedly more effective than a similar ZDV regimen. These findings are exciting, considering that the VIRAMUNE regimen is significantly less expensive than any regimen that's been studied," said Brooks Jackson, MD, lead investigator of the study and Vice Chairman of Pathology at Johns Hopkins School of Medicine. "The implications of this study for developing countries, where 95 percent of the AIDS epidemic is occurring, are profound." VIRAMUNE is a non-nucleoside reverse transcriptase inhibitor (NNRTI) commonly used in HIV combination therapy. It belongs to a different class of drugs than ZDV; however, it works against the same target HIV enzyme. NIAID researchers chose VIRAMUNE for the study because of its potency, pharmacokinetic profile and affordability. Additionally, it can be stored at room temperature, an important consideration in developing countries. VIRAMUNE tablets have been available since 1996 and a pediatric formulation was recently introduced. Data regarding the safety and efficacy of VIRAMUNE for prevention of perinatal HIV transmission has not been reviewed by the Food & Drug Administration (FDA). "VIRAMUNE has a potent and immediate antiviral effect. It is rapidly absorbed and transfused across the placenta to the infant and is passed into breast milk," said John L. Sullivan, MD, Professor of Pediatrics at the University of Massachusetts School of Medicine, an early proponent of using VIRAMUNE for the prevention of mother-to-child transmission of HIV. "This study marks a major advance in AIDS treatment and an important step in helping control the worldwide epidemic." HIVNET 012 The HIVNET 012 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 ZDV regimen was 600 mg at the onset of labor, 300 mg every three hours during labor, and 4 mg/kg of ZDV twice-daily to the newborn for the first seven days after delivery. All women entered into the study were in their ninth month of pregnancy and had not previously taken any antiretroviral drugs. For the interim analysis, the study team looked at data from 618 mothers (308 receiving ZDV and 310 receiving VIRAMUNE) and their infants. VIRAMUNE was nearly twice as effective than ZDV -- at 14 to 16 weeks of age, 13.1 percent of infants who received VIRAMUNE were found to be infected with HIV, compared with 25.1 percent of those in the ZDV group. Both drugs appeared to be safe and well-tolerated. The mothers and their infants will continue to be actively followed until the babies are 18 months old. Women were enrolled in the HIVNET 012 study between November 1997 and April 1999. The study was conducted at Mulago Hospital, the teaching hospital affiliated with Makerere University in Kampala, Uganda. Over 21,000 women deliver at this hospital annually and nearly 16 percent of those women are HIV infected. HIVNET-supported researchers from Makerere University and Johns Hopkins University in Baltimore conducted the study. HIV/AIDS IN AFRICA Africa is the epicenter of the global AIDS epidemic. An estimated 22 million people living in sub-Saharan Africa are HIV- infected. Since the start of the epidemic, 83 percent of all AIDS deaths have occurred in this region. The average income in sub- Saharan Africa is approximately US$500 per year, making the standard long course ZDV regimen used in the United States and Europe unaffordable. 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: Judith von Gordon, Corporate Public Relations Division of Boehringer Ingelheim GmbH, +49-61- 32-77-3582, fax, +49-6132-776601; or Karen Sutherland, 212-886- 3024, or Denise Connolly, 212-886-3117, both of GCI Healthcare, 212-886-3291 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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