Ingelheim, Germany (ots-PRNewswire) - Boehringer Ingelheim
announced today that VIRAMUNE(R) will be offered free of charge for a
period of five years for the prevention of mother-to-child
transmission (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 Organisation (WHO),
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.
"VIRAMUNE can fill a critical need in the developing world," said
Prof. Rolf Krebs, Vice Chairman of the Board of Managing Directors at
Boehringer Ingelheim. "We hope that our initiative for the prevention
of mother-to-child transmission will help make an impact on the
A recent publication in the June 17 issue of The Lancet presents
hope for reducing newborn HIV infections in the developing world.(1)
Findings indicated that antiviral intervention can have a significant
impact on the prevention of MTCT. Researchers projected that if all
pregnant women in South Africa took a short course of antiretroviral
medication during labor, as many as 110,000 infant HIV infections
could be prevented over the next five years.
Authors of The Lancet article cited that a single dose of VIRAMUNE
to mother-baby pairs is likely the most cost effective, efficacious
and most easily administered antiretroviral agent for the prevention
of MTCT to date. Researchers have been investigating the drug since
1997 for this important use. The outcome of these investigations
encouraged the WHO to place VIRAMUNE on its Model List of Essential
Drugs for MTCT in December 1999.
"VIRAMUNE, which has been studied in women in Uganda and South
Africa, holds great promise for reducing mother-to-child HIV
transmissions in the developing world because it represents a short
and simple regimen, which can be easily administered in a
resource-poor environment," said Dr. Brooks Jackson, principal
investigator, HIVNET 012, Johns Hopkins University, Baltimore.
Boehringer Ingelheim will adhere to the WHO guidelines for drug
donations to ensure that VIRAMUNE is donated to the developing
countries with the greatest need. The WHO guidelines require that
donations be based on an expressed need by the country in question.
Further, donations must be relevant to the needs of the recipient
country. Boehringer Ingelheim will rely on interested local
governments that approve the use of VIRAMUNE in MTCT and global
organisations, such as UNAIDS, UNICEF and the WHO to optimise
existing infrastructures so that safe and proper administration of
VIRAMUNE is possible.
Boehringer Ingelheim will make every effort to see that VIRAMUNE
is available in every country around the world. VIRAMUNE has now been
registered in more than 75 countries and registration packages have
been submitted in almost every country worldwide.
"Providing VIRAMUNE is only one component of making prevention of
HIV-1 mother-to-child transmission possible in the developing world,"
said Prof. Krebs. "However, a successful program to reduce MTCT of
HIV entails additionally education of mothers and health service
personnel, testing for infection, and counseling of infected
VIRAMUNE was shown to be a well-tolerated and effective option for
the prevention of MTCT in the Ugandan HIVNET 012 trial.(2) The study
was published in the September 4, 1999 issue of The Lancet and
demonstrated that a simple regimen of one oral dose of VIRAMUNE given
to an HIV-infected mother in labour and another dose to her newborn
within three days of birth was almost twice as effective in reducing
MTCT as a short course of zidovudine (AZT).
To date about 1700 mothers and babies have been treated with the
simple one-dose treatment regimen of nevirapine in MTCT and no safety
concerns have been raised. While there are still scientific questions
to be answered, the overwhelming opinion of experts is strongly in
favour of treatment.
The company acknowledges the importance of continued research into
the role of VIRAMUNE in preventing MTCT. Boehringer Ingelheim is
sponsoring the SAINT study, a large, multicenter trial designed to
further evaluate the safety and efficacy of two doses of VIRAMUNE
compared to a weeklong regimen of two drugs, ZDV+3TC, in reducing
MTCT. Preliminary results of this study, as well as twelve-month
HIVNET 012 data, will be presented at the 13th International AIDS
Conference in Durban, South Africa (9 - 14 July).
A critical area of research into the prevention of MTCT is the
extent to which HIV is transmitted during breastfeeding. Healthy
babies born to HIV-infected mothers may contract HIV through
breastmilk. This risk appears to be highest in the early months of
Another critical area of research is the development of drug
resistance after treatment. An abstract presented at the 7th
Conference on Retroviruses and Opportunistic Infections (HIVNET 006)
suggests that a minority of patients may develop resistance to
VIRAMUNE after a single dose.(4) At least in some patients this
resistance is transient.(5) Further studies are evaluating the
clinical relevance of these findings.
VIRAMUNE has been investigated for the MTCT indication because of
its potency, pharmacokinetic profile and affordability. VIRAMUNE is
rapidly absorbed and transferred across the placenta to the infant
and is passed into breast milk. VIRAMUNE can be stored at room
temperature, an important consideration in developing countries.
VIRAMUNE is registered for the chronic treatment of HIV-1
infection in combination with other antiretroviral agents. Major
adverse events associated with VIRAMUNE in the treatment of chronic
HIV infections are rash and increases in liver function enzymes.
Hypersensitivity reactions have also been observed. Severe and
life-threatening skin reactions and hepatotoxicity, with fatal
outcome, have occurred in chronically infected HIV patients treated
VIRAMUNE was the first member of the non-nucleoside reverse
transcriptase inhibitor (NNRTI) class of anti-HIV drugs to be
approved for combination HIV therapy. VIRAMUNE's approval is based on
analysis of changes in surrogate end-points, such as reduction in
viral load or increases in CD4+ cell 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 worldwide marketing rights to an
additional anti-HIV drug, an investigational protease inhibitor,
Boehringer Ingelheim has focused a number of years on HIV drug
research to prevent new infections and to treat HIV-infected people
around the world. In addition to high investments in research and
development and sponsoring initiatives (such as to the Elizabeth
Glaser Pediatric AIDS Foundation), Boehringer Ingelheim supports
training initiatives for the developing world as a partner of the
IAS-SHARE Treating Program for Physicians.
For more information on Boehringer Ingelheim or VIRAMUNE, please
1 Wood E et al. Extent to which low-level use of
antiretroviral treatment could curb the AIDS epidemic in
sub-Saharan Africa. Lancet 2000; 355:2095-2100.
2 Guay L et al. Intrapartum and neonatal single-dose
nevirapine compared with zidovudine for prevention of
mother-to-child transmission of HIV-1 in Kampala, Uganda:
HIVNET 012 randomised trial. Lancet 1999;354:795-802.
3 Miotti, Paolo, G. et al. HIV transmission through
breastfeeding. A study in Malawi, JAMA 1999, volume 282:
4 Becker-Pergola et al. Selection of the K103N Nevirapine
Resistance Mutation in Ugandan Women Receiving NVP
Prophylaxis to Prevent HIV-1 Vertical Transmission
(HIVNET-006). 7th Conference on Retroviruses and
Opportunistic Infections, Jan 30 - Feb 2, 2000. Abstract
5 Mofenson LM and McIntyre JA Advances and research
directions in the prevention of mother-to-child HIV-1
transmission Lancet 2000; 355: 2237-44
ots Original Text Service: Boehringer Ingelheim GmbH
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Boehringer Ingelheim GmbH
Web site: http://www.boehringer-ingelheim.com
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