ANC accuses US of using Africans to promote nevirapine AIDS drug

18 Dec 2004

Thabo Mbeki's ruling party of South Africa, the ANC (African National Congress), has attacked top US officials and accused them of using African women and babies as human guinea pigs to promote nevirapine, a controversial AIDS drug.

They have accused US officials of lying.

Doctors and health professionals in Africa fear the use of nevirapine may be halted as a result.

Nevirapine is said to protect thousands of babies in Africa from getting AIDS from their mothers.

US health officials are accused of withholding negative evidence regarding nevirapine from the Bush administration just before President Bush launched a 2002 plan to distribute nevirapine in Africa.

Nevirapine is made by Boehringer Ingelheim.

Boehringer Ingelheim provides key background on nevirapine

Statement issued by Boehringer Ingelheim Pharmaceuticals, Inc., USA

In light of recent interest in the use of Viramune® (nevirapine), Boehringer Ingelheim (BI) provides the following background information on the drug and key events that have been revisited by the media.

Viramune has played a vital role in the fight against HIV/AIDS since its U.S. regulatory approval in 1996. The first drug in its class (non-nucleoside reverse transcriptase inhibitor), Viramune has been an important component in the effort to improve HIV drug therapy.

Research supporting Viramune has helped evolve clinical management standards and has defined the current role of this drug both in chronic combination therapy and in the prevention of mother to child transmission (pMTCT) during childbirth in resource-limited settings.

Viramune for pMTCT in the developing world

The use of Viramune has been shown in clinical studies to reduce HIV transmission rates to infants from infected mothers by 40% or more, by giving a simple regimen of Viramune that includes a single dose to the mother during labor and a single dose to the infant after delivery.1

This regimen has earned the support of the public health and HIV/AIDS treatment communities, who recognize its value as an alternative option in the developing world and understand the clinical research that has clearly defined its utility in this setting.2 In resource-limited settings, single-dose Viramune is often the most feasible treatment to prevent HIV transmission from mother to child.

The 2004 World Health Organization guidelines continue to recommend its use as a practical option in the developing world.3 Through the Viramune Donation Program, BI has expanded global access to this important medication to 122 programs in 57 developing countries.

In 1997, the National Institutes of Health (NIH) requested BI's support for a study (HIVNET 012) to determine what had not yet been clearly defined: whether a simple, inexpensive, single-dose regimen of Viramune could effectively block mother-to-infant HIV transmission.

BI provided support as requested by NIH and supplied the drug for a study in Uganda. Based on the very positive results of this study, BI submitted an NDA supplement to obtain an indication for pMTCT in 2001.

Subsequently, BI conducted a site review of this NIH study in 2002 to assess the site's readiness for an FDA audit. The company provided preliminary findings of this site review to the NIH to signal potential issues requiring follow up.

BI distributed multiple copies of its findings to key study team members at the NIH, the study's contract monitor, and Ugandan and U.S. investigators to validate our preliminary assessment and to encourage prompt correction of observed procedural deficiencies prior to the planned FDA audit.

The FDA audit was cancelled because the Ugandan study site could not correct these procedural deficiencies in the regulatory timeframe of the FDA supplement. Accordingly, BI withdrew its supplemental filing in March 2002.

Following multiple reviews by NIH and the National Institute of Allergies and Infectious Diseases (NIAID), overall study conclusions regarding the safety and efficacy of single-dose Viramune in this setting have remained intact and have contributed to the evidence provided by other studies regarding the role of Viramune in pMTCT.4

Viramune as part of combination therapy for the treatment of HIV/AIDS in the developed world

Viramune as treatment for chronic HIV/AIDS in combination with other HIV (antiretroviral) drugs has been used in more than 600,000 patient years worldwide since its approval in 1996.

As knowledge about HIV infection and its treatment evolves, the understanding of Viramune's role in combination therapy also has increased, and BI continues to educate and support physicians' efforts to identify those patients most likely to benefit from treatment with Viramune.

Treatment with Viramune as part of combination therapy needs to be managed differently than the single-dose regimen administered in the developing world for pMTCT.

Because HIV is a serious and life-threatening disease it requires treatment with potent medicines, all of which can cause serious adverse events.

The most clinically important adverse events associated with Viramune are rash and liver-related events, which in rare cases may be severe and life threatening.

The greatest risk of these events occurs within the first six weeks of therapy. Events are usually managed adequately if careful monitoring takes place throughout the course of therapy.

BI's commitment to the fight against HIV/AIDS

BI is a steadfast partner to professionals, patients, government and non-governmental organizations (NGOs) in the fight against HIV/AIDS.

With our partners we are working toward a goal of ensuring that the next generation of infants in the developing world are born HIV-free. It is important that media reports preserve accuracy to ensure that people in AIDS-ravaged countries are not unnecessarily discouraged from continuing to use Viramune and other treatments to prevent the transmission of HIV during childbirth.

Contact for queries from European journalists:

Contact:

Boehringer Ingelheim GmbH

Judith von Gordon

55216 Ingelheim am Rhein

GERMANY

Phone: +49/6132/77 35 82

Fax: +49/6132/77 66 01

References:

1 Guay LA. Musoke P. Fleming T. Bagenda D. Allen M. Nakabiito C. Sherman J. Bakaki P. Ducar C. Deseyve M. Emel L. Mirochnick M. Fowler MG. Mofenson L. Miotti P. Dransfield K. Bray D. Mmiro F. Jackson JB. 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.[see comment]. [Clinical Trial. Clinical Trial, Phase III. Journal Article. Randomized Controlled Trial] Lancet. 354(9181):795-802, 1999 Sep 4.

Jackson JB. Musoke P. Fleming T. Guay LA. Bagenda D. Allen M. Nakabiito C. Sherman J. Bakaki P. Owor M. Ducar C. Deseyve M. Mwatha A. Emel L. Duefield C. Mirochnick M. Fowler MG. Mofenson L. Miotti P. Gigliotti M. Bray D. Mmiro F. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: 18-month follow-up of the HIVNET 012 randomised trial. [Clinical Trial. Journal Article. Randomized Controlled Trial] Lancet. 362(9387):859-68, 2003 Sep 13

Lallemant M, Jourdain G, Le Coeur S, Mary JY, Ngo-Giang-Huong N, Koetsawang S, Kanshana S, McIntosh K, Thaineua V, and the Perinatal HIV Prevention Trial Group (PHPT). (LB-40) A Randomized, Double-Blind Trial Assessing the Efficacy of Single-Dose Perinatal Nevirapine Added to a Standard Zidovudine Regimen for the Prevention of Mother-to-Child Transmission of HIV-1 in Thailand. Presented at 11th Conference on Retroviruses and Opportunistic Infections. 8-11 Feb 04, San Francisco, CA.

SAINT study: Moodley D, Moodly J, Coodavia H, Gray G, McIntyre J, Hofmyer J, Nikodem C, Hall D, Gigliotti M, Robinson P, Boshoff L, Sullivan JL, for the South African Intrapartum Nevirapine Trial (SAINT) Investigators. A multicenter randomized controlled trial of nevirapine versus a combination of zidovudine and lamivudine to reduce intrapartum and early postpartum mother-to-child transmission of human immunodeficiency virus type 1. Journal of Infectious Diseases 2003;187:725-735.

2 WHO: Antiretroviral drugs for treating pregnant women and prevention HIV infection in infants: guidelines on care, treatment and support for women living with HIV/AIDS and their children in resource-constrained settings. World Health Organization; July 2004.

3 Elizabeth Glaser Pediatric AIDS Foundation On Issue Of Prevention Of Mother-To-Child Transmission Of HIV/AIDS And Single-Dose Nevirapine [statement]. Elizabeth Glaser Pediatric AIDS Foundation; December 14, 2004.

4 NIAID & NIH: The HIVNET 012 Study and the Safety and Effectiveness of Nevirapine in Preventing Mother-to-Infant Transmission of HIV [press release]; December 14, 2004.