The Lancet Publishes Landmark Mother-To-Child HIV

Transmission Study - Potent and Affordable VIRAMUNE(R)(nevirapine) Regimen Shown to Significantly Reduce HIVTransmission - INGELHEIM, Germany (PROTEXT) - This week's issue of The Lancetfeatures encouraging preliminary results of HIVNET 012, a trialconducted in Uganda by the National Institute of Allergy andInfectious Disease's (NIAID) HIV Prevention Trials Network(HIVNET). Findings demonstrate that VIRAMUNE(R) (nevirapine)safely and effectively reduced HIV transmission from mothers totheir infants. A simple, inexpensive regimen of one oral dose ofVIRAMUNE given to an HIV-infected woman in labor and another toher newborn within three days of birth was almost twice aseffective in reducing mother-to-infant HIV transmission as ashort course ZDV (zidovudine, AZT, Retrovir(R)) regimen. Editors of The Lancet -- one of the world's most prestigiousmedical journals -- expedited review of the data due to thepositive nature of the findings. The data was recently presentedto worldwide public health officials and scientists at the secondconference on Global Strategies for the Prevention of HIVTransmission From Mothers to Infants in Montreal. "The short course VIRAMUNE regimen was markedly more effectivethan a similar ZDV regimen. These findings are exciting,considering that the VIRAMUNE regimen is significantly lessexpensive than any regimen that's been studied," said BrooksJackson, MD, lead investigator of the study and Vice Chairman ofPathology at Johns Hopkins School of Medicine. "The implicationsof this study for developing countries, where 95 percent of theAIDS epidemic is occurring, are profound." VIRAMUNE is a non-nucleoside reverse transcriptase inhibitor(NNRTI) commonly used in HIV combination therapy. It belongs to adifferent class of drugs than ZDV; however, it works against thesame target HIV enzyme. NIAID researchers chose VIRAMUNE for thestudy because of its potency, pharmacokinetic profile andaffordability. Additionally, it can be stored at roomtemperature, an important consideration in developing countries.VIRAMUNE tablets have been available since 1996 and a pediatricformulation was recently introduced. Data regarding the safetyand efficacy of VIRAMUNE for prevention of perinatal HIVtransmission has not been reviewed by the Food & DrugAdministration (FDA). "VIRAMUNE has a potent and immediate antiviral effect. It israpidly absorbed and transfused across the placenta to the infantand is passed into breast milk," said John L. Sullivan, MD,Professor of Pediatrics at the University of Massachusetts Schoolof Medicine, an early proponent of using VIRAMUNE for theprevention of mother-to-child transmission of HIV. "This studymarks a major advance in AIDS treatment and an important step inhelping control the worldwide epidemic." HIVNET 012 The HIVNET 012 study compared the safety and efficacy of twodifferent short course regimens of antiviral drugs administeredlate in pregnancy. The VIRAMUNE regimen consisted of a single 200mg tablet given to mothers in labor and a single 2 mg/kg dose ofVIRAMUNE oral suspension to the newborns within 72 hours afterdelivery. The ZDV regimen was 600 mg at the onset of labor, 300mg every three hours during labor, and 4 mg/kg of ZDV twice-dailyto the newborn for the first seven days after delivery. All womenentered into the study were in their ninth month of pregnancy andhad not previously taken any antiretroviral drugs. For the interim analysis, the study team looked at data from618 mothers (308 receiving ZDV and 310 receiving VIRAMUNE) andtheir infants. VIRAMUNE was nearly twice as effective than ZDV --at 14 to 16 weeks of age, 13.1 percent of infants who receivedVIRAMUNE were found to be infected with HIV, compared with 25.1percent of those in the ZDV group. Both drugs appeared to be safeand well-tolerated. The mothers and their infants will continueto be actively followed until the babies are 18 months old. Women were enrolled in the HIVNET 012 study between November1997 and April 1999. The study was conducted at Mulago Hospital,the teaching hospital affiliated with Makerere University inKampala, Uganda. Over 21,000 women deliver at this hospitalannually and nearly 16 percent of those women are HIV infected.HIVNET-supported researchers from Makerere University and JohnsHopkins University in Baltimore conducted the study. HIV/AIDS IN AFRICA Africa is the epicenter of the global AIDS epidemic. Anestimated 22 million people living in sub-Saharan Africa are HIV-infected. Since the start of the epidemic, 83 percent of all AIDSdeaths have occurred in this region. The average income in sub-Saharan Africa is approximately US$500 per year, making thestandard long course ZDV regimen used in the United States andEurope unaffordable. VIRAMUNE Boehringer Ingelheim recently received approval from theEuropean Commission to market a pediatric formulation of VIRAMUNEto treat infants and children infected with HIV/AIDS. The oralsuspension is currently approved in the U.S., Europe and Mexicoand 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 incombination with other antiretroviral agents for the treatment ofHIV-1 infection. This indication is based on analysis of changesin surrogate end-points, such as viral load or changes in CD4+count. When used in chronic therapy, VIRAMUNE should always beadministered with at least one additional antiretroviral agent.VIRAMUNE tablets were approved for marketing in the U.S. in June1996 and in Europe in February 1998. VIRAMUNE is currentlyapproved in 56 countries. VIRAMUNE is generally well-tolerated. Due to the one singledose regimen of VIRAMUNE in the prevention of perinataltransmission in the HIVNET 012 study, only minor side-effectswere seen. The most commonly reported adverse events associatedwith VIRAMUNE in the long-term combination treatment are rash,fever, nausea, headache and abnormal liver function tests. Severeand life-threatening skin reactions and hepatotoxicity, includingfatal cases of each, have occurred in patients treated withVIRAMUNE. VIRAMUNE is a product of original research conducted atBoehringer Ingelheim Pharmaceuticals, Inc., a member of theBoehringer Ingelheim group of companies. VIRAMUNE is marketedworld-wide by Boehringer Ingelheim and in the United States byRoxane Laboratories, also a member of the Boehringer Ingelheimgroup of companies. Boehringer Ingelheim, headquartered in Ingelheim, Germanyranks among the top 20 pharmaceutical companies in the world. Itreported revenues exceeding DM 8.75 billion in 1998. Thecorporation has some 140 affiliated entities and it conductsbusiness on every continent. Its product range is focused onhuman 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 1998Boehringer Ingelheim spent DM 1.6 billion on research anddevelopment, equivalent to 18% of total sales. ots Original TextService: Boehringer Ingelheim GmbH Internet:http://www.newsaktuell.de Contact: Judith von Gordon, CorporatePublic 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 bepublished under the "CTK" slug. Protext is a commercial serviceproviding distribution of press releases from clients, who areidentified in the text of Protext reports and who bear fullresponsibility for their contents.

PROTEXT