Boehringer Ingelheim GmbH

Latebreaking Results of Mother-to-child HIV Transmission Study Shows Promise - VIRAMUNE Significantly Reduces HIV Transmission in Simple Regimen -

    INGELHEIM, Germany (ots-PRNewswire) - One-year results of HIVNET 012, a trial conducted in Uganda by the National Institute of Allergy and Infectious Diseases (NIAID) HIV Prevention Trials Network (HIVNET), confirm preliminary findings that VIRAMUNE(R) (nevirapine) 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-child transmission (MTCT) as a short course ZDV (zidovudine, AZT, Retrovir(R)) regimen. Both regimens appeared to be well tolerated. Results were presented today at the 13th International AIDS Conference in Durban, South Africa.

    "These results are important because they demonstrate that VIRAMUNE may be the most viable option studied to date for the developing world," said Brooks Jackson, MD, lead investigator of the study and Vice Chairman of Pathology at Johns Hopkins School of Medicine.

    "Through eighteen months, the reduction of HIV transmission from mother-to-infant -- even in a breast feeding population -- is still significant. This regimen has the potential to reduce HIV-1 MTCT by 42 percent or more in places where other prevention regimens are impractical," added Dr. Thomas Fleming, Chairman of Biostatistics at University Washington and Fred Hutchinson Cancer Research Center and protocol statistician for HIVNET 012.

    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. VIRAMUNE is not currently indicated for the prevention of perinatal HIV transmission.

    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 twelve month analysis, the study team looked at data from 619 mothers (308 receiving ZDV and 311 receiving VIRAMUNE) and their infants. VIRAMUNE continued to be significantly more effective than ZDV. Transmission rates were 11.8 percent and 20 percent at 6-8 weeks and 15.7 percent versus 24.1 percent at 12 months for the VIRAMUNE and ZDV arms, respectively. The mothers and their infants will continue to be actively followed for five years.

    Resistance mutations associated with VIRAMUNE were detected after delivery in a minority of women in the VIRAMUNE arm.  Mutations were not detectable in the long term in all of the women who have been tested for resistance to date. "This suggests that VIRAMUNE for use in the prevention of MTCT is likely to be effective in future pregnancies," explained Dr. Jackson. "It's also important to note that there is currently no evidence that resistance to VIRAMUNE will affect clinical progression of HIV-infection."

    Both regimens appeared to be well tolerated, with similar rates of adverse events in both arms. According to HIVNET 012 researchers, no adverse event was definitely or probably related to the study drugs.

    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.


    Boehringer Ingelheim recently announced that VIRAMUNE will be offered free of charge for a period of five years for the prevention of MTCT of HIV-1 in developing economies. This initiative is part of Boehringer Ingelheim's commitment to the collaborative effort with five companies (Boehringer Ingelheim, Bristol-Myers Squibb, F. Hoffman-La Roche, Glaxo Wellcome and Merck & Co., Inc.), United Nations agencies (World Health Organization, World Bank, UNICEF, UNFPA and UNAIDS) and committed governments to explore practical ways of working together to make HIV/AIDS care available and affordable to a significantly greater number of people in developing countries.

    Data regarding the safety and efficacy of VIRAMUNE for prevention of MTCT of HIV has not been reviewed by the Food & Drug Administration (FDA) or the European Medicines Evaluation Agency (EMEA). The Medicines Control Council of South Africa is currently evaluating the use of VIRAMUNE for MTCT of HIV.

    VIRAMUNE is generally well tolerated. Due to the short period of dosing with VIRAMUNE in the prevention of MTCT in the HIVNET 012 study, only minor side-effects were seen.

    The most clinically important reported adverse events associated with chronic dosing of VIRAMUNE are rash and increases in liver function tests, which are rarely encountered when the product is used in the MTCT indication. On longer term use, hypersensitivity reactions have been observed. Severe and life-threatening skin reactions and hepatotoxicity, including fatal cases of each, have occurred in patients treated long-term with VIRAMUNE.

    VIRAMUNE, the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs to be approved, 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. VIRAMUNE should always be administered in combination with other antiretroviral agents.

    VIRAMUNE is a product of original research done 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 recently acquired world-wide marketing rights to an additional anti-HIV drug, an investigational protease inhibitor, tipranavir.

    For more information on Boehringer Ingelheim or VIRAMUNE, please see

    Thursday, 13 July, 2000, 14:45 Latebreaker Slide Session: Hall ICC II

    The one year safety and efficacy data of the HIVNET 012 trial (Owor, M; Deseyve, M; Duefield, C; Fleming, T; Musoke, P; Guay, L; Mmiro, F; Jackson, JB)

    Thursday, 13 July, 2000, 16:30 Latebreaker Slide Session: Hall ICC II

    The one year safety and efficacy data of the HIVNET 012 trial (Jackson, JB; Mracna, M; Guay, L; Dileanis, JA; Musoke, P; Mmiro, F; Eshleman, SH)

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