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Clinical studies investigate reduction of NNRTI resistance following single-dose Nevirapine in Mother-to-Child-Transmission setting

Pressmeddelande   •   Jul 15, 2004 11:08 CEST

Clinical studies investigate reduction of NNRTI resistance following single-dose Nevirapine in Mother-to-Child-Transmission setting

Bangkok/Thailand, 15 July 2004 - New results of clinical research involving nevirapine (Viramune®) indicate a reduction of resistance following single doses given to mother and child to reduce Mother-to-Child Transmission of HIV-1 (MTCT) can be accomplished by the addition of Combivir (AZT+3TC) to the regimen.

Recent data1 has suggested that the development of NNRTI resistance2 in women receiving single-dose treatment in MTCT setting has the potential to affect future treatment response to nevirapine containing regimens.

Boehringer Ingelheim has supported and conducted several clinical studies to investigate the important issue of drug resistance in the MTCT setting. One of these studies conducted in South Africa assesses whether treating the mothers (and infants) with Combivir® (AZT + 3TC) for four or for seven days following a single-dose regimen of nevirapine could reduce the development of NNRTI- resistance in HIV-infected mothers.

A preliminary interim analysis indicates that the addition of Combivir for either 4 or 7 days after birth to the single-dose nevirapine regimen may significantly reduce the development of NNRTI-resistance in the HIV-infected mothers.

“The current research represents an important step in optimizing regimens to prevent MTCT of HIV-1 in the developing world while preserving future treatment options of HIV-infected women” said Dr. Barner, Member of the Board of Managing Directors of Boehringer Ingelheim. Boehringer Ingelheim expects that additional data available in near future will help evaluate these options.

In their most recently published pMTCT guidelines3, the World Health Organization (WHO) has noted that the concern about resistance should be balanced with the practicality of the single-dose nevirapine regimen compared with other regimens and the urgent need to expand programmes to prevent MTCT: “Although expanding access to programmes to prevent MTCT presents many challenges and single-dose maternal and infant nevirapine is the simplest regimen to deliver, programmes should consider introducing more complex ARV regimen where possible. The expansion of programmes to prevent MTCT using single-dose nevirapine should not be hindered while necessary improvements in health systems are taking place to enable more complex ARV regimens to be delivered.”

Boehringer Ingelheim will continue to supply nevirapine (Viramune® ) free of charge within the Viramune® Donation Programme for the prevention of mother to child transmission of HIV-1, as there is a special need in developing countries where chronic treatment is not yet readily available. Boehringer Ingelheim will furthermore continue to support research into new solutions to improve prevention of MTCT.

The Viramune® Donation Programme
In 2000 Boehringer Ingelheim announced that it would donate its non-nucleoside reverse transcriptase inhibitor (NNRTI) antiretroviral Viramune® in the developing world, to reduce Mother to Child Transmission (MTCT) of HIV-1. The use of Viramune® for the prevention of MTCT is supported by clinical trials that demonstrate the efficacy of single-dose nevirapine, in this setting. In this context, the product has been supplied free of charge to 110 MTCT prevention programmes in over 50 countries.

About Viramune
Viramune® (nevirapine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on a principle clinical trial that demonstrated prolonged suppression of HIV-RNA and on two smaller supportive studies. The most clinically important adverse events associated with Viramune are rash and hepatic events, which have included fatal cases. The greatest risk of severe rash and hepatic events occurs in the first 6 weeks of therapy. It is essential that patients be monitored for these reactions at all times, and intensively during the first few months of therapy. Viramune should be discontinued and not restarted following severe hepatic, skin or hypersensitivity reactions.

About Boehringer Ingelheim
Boehringer Ingelheim is committed to the research and development of novel antiretroviral agents. Viramune® (nevirapine) is a product of original research done at Boehringer Ingelheim. Viramune® was the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs. Boehringer Ingelheim is committed to the rapid development of the investigational non-peptidic protease inhibitor (NPPI) tipranavir in phase III clinical trials. The company is involved in basic research and is committed to improving HIV therapy by providing physicians and patients with innovative antiretrovirals.

Contact:
Boehringer Ingelheim GmbH
Corporate Division Communications
Julia Meyer-Kleinmann
55216 Ingelheim am Rhein
GERMANY
Phone: +49/6132/77 82 71
Fax: +49/6132/77 66 01