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Data Shows VIRAMUNE(R) (nevirapine) Well Tolerated and Effective for Prevention of Mother-to-child Transmission of HIV - More than 1,300 South African Women Participate in Landmark SAINT Trial
Durban, South Africa (ots-PRNewswire) - Results demonstrating that VIRAMUNE(R) (nevirapine) is well tolerated and effective in the prevention of mother-to-child transmission (MTCT) of HIV were presented today at the 13th International AIDS Conference. While VIRAMUNE is not currently indicated for the prevention of MTCT, researchers have been investigating the drug for this important use. Study findings show that an inexpensive, simple regimen of VIRAMUNE is as effective as a seven-day course of two drugs, ZDV+3TC* at reducing MTCT of HIV. In the VIRAMUNE arm, one dose of VIRAMUNE was administered to HIV-infected mothers in labour followed by a second dose 24 to 48 hours after delivery, and one dose to their infants immediately after birth.
"These data demonstrate that VIRAMUNE can be a viable option in prevention of MTCT of HIV in the developing world. Intervention around the time of labor and delivery reduces HIV transmission significantly," explained Dr. Daya Moodley, University of Natal in Durban. "These interim findings confirm and extend the groundbreaking results of the similar HIVNET 012 study published last September in The Lancet."
The SAINT Trial is a large, multicenter study designed to evaluate the safety and efficacy of a simple regimen of VIRAMUNE versus ZDV+3TC in reducing MTCT of HIV. This randomized, open-label comparative trial enrolled more than 1,300 women who tested HIV-positive in labor or late in pregnancy (>38 weeks), and had not previously received and were not currently receiving other antiretroviral therapy for HIV-1.
The findings presented today show there was no significant difference in efficacy between the VIRAMUNE regimen and the ZDV+3TC regimen, and both arms appeared to be well tolerated. The overall rates of MTCT of HIV were 14.0 % and 10.8% for the VIRAMUNE and ZDV+3TC arms, respectively. The overall rates included the incidence of MTCT of HIV occurring during pregnancy (intra-uterine), around the time of birth (perinatal) and shortly after birth (early postpartum) by 8 weeks of age, as confirmed by two positive viral tests (DNA-PCR). The rate of MTCT occurring intrapartum or early postpartum was 6.3% and 4.3% for the VIRAMUNE and ZDV+3TC arms respectively.
"Considering that more than 60,000 South African infants are infected with HIV every year, these regimens can potentially save thousands of babies annually from HIV infection," explained Dr. Hoosen Coovadia, the Chairman of the 13th International AIDS Conference. "If widely implemented in the developing world, these regimens could prevent hundreds of thousands of HIV infections every year."
While both regimens were shown to be effective, the VIRAMUNE arm is a more simple regimen. Mother-infant pairs were randomised to receive either the VIRAMUNE regimen or the ZDV+3TC regimen. Women in the VIRAMUNE arm received a 200 mg dose during labor and a second 200 mg dose 24-48 hours after delivery. Infants in this arm were given a single 6 mg dose of VIRAMUNE at 24 to 48 hours after birth. For reasons of adherence, such a simple dosage regimen is eminently suitable for use in developing countries.
Women in the ZDV+3TC arm were given ZDV (600 mg, then 300 mg every three hours during labour and 300 mg twice-a-day for the next 7 days) plus 3TC (150 mg) twice-a-day during labour and for the next seven days. Infants in this arm received ZDV (12 mg) plus 3TC (6 mg) twice-a-day for 7 days after birth.
A safety analysis of the SAINT study was also presented at the conference today. This analysis evaluated the same patient population and found that there were no treatment related serious adverse events through 6 weeks, in either group.
Reducing MTCT of HIV is vital, particularly in areas most affected such as sub-Saharan Africa, where up to 30 percent of pregnant women are infected with HIV, and 25- to 35 percent of their infants will be born infected. 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.
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) 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 SAINT 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. None of these adverse events were seen in the SAINT trial.
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.
In MTCT, VIRAMUNE will provide an affordable approach to controlling a serious health problem in the developing world. The Company has initiated plans to develop educational programmes to assist health workers at the primary care level in the handling of the product in the MTCT area.
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 http://www.boehringer-ingelheim.com.
Judith von Gordon Maureen Byrne/Denise Connolly
Corporate Public Relations Division GCI Healthcare
Boehringer Ingelheim GmbH 114 Fifth Avenue
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* ZDV (zidovudine, AZT, Retrovir(R)) and 3TC (Epivir(R), lamivudine)
Tuesday, 11 July, 2000, 15:45; Session: B08 Mother-to-Child Transmission (Oral Presentation). Room: Hall ICC III
Moodley D et al. The SAINT Trial: Nevirapine (NVP) versus zidovudine (ZDV)+lamivudine (3TC) in prevention of peripartum HIV transmission.
McIntyre J et. al. Evaluation of safety of two simple regimens for prevention of mother to child transmission (MTCT) of HIV infection [Nevirapine (NVP) vs lamivudine (3TC) + ZDV] used in a randomised clinical trial (SAINT Trial). (Abstract No. Tu OrB356)
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Contact: Judith von Gordon, Corporate Public Relations Division of Boehringer Ingelheim GmbH, +49-6132-773582, fax - +49-6132-776601; Maureen Byrne or Denise Connolly, both of GCI Healthcare, on site - +27-082-370-0768, +27-082-370-0457, or 212-886-3312, 212-886-3117, fax - 212-886-3291, for Boehringer Ingelheim GmbH
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