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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.
Contacts:
Judith von Gordon                    Maureen Byrne/Denise Connolly
   Corporate Public Relations Division  GCI Healthcare
   Boehringer Ingelheim GmbH            114 Fifth Avenue
   55216 Ingelheim/Germany              New York, NY 10011
   Phone: + 49 - 6132 - 773582          On site: 9-14 July
   Fax: + 49 - 6132 - 77660       +27-082-370-0768/+27-082-370-0457 
                                  Phone: +1-212-886-3312/3117
                                  Fax: +1-212-886-3291
* 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)
ots Original Text Service: Boehringer Ingelheim GmbH
Internet: http://recherche.newsaktuell.de

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

Web site: http://www.boehringer-ingelheim.com

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