PRNewswire - Thursday November 30, 2000

VIRAMUNE is not approved for use in neonates or for the prevention of MTCT in the United States. VIRAMUNE 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 CD4+ count. At present there are no results from controlled clinical trials evaluating the effect of VIRAMUNE in combination with other antiretrovirals on the clinical progression of HIV-1 infection. Resistant virus emerges rapidly when it is administered alone. For the treatment of HIV-1 infection, VIRAMUNE should always be administered with at least one additional antiretroviral agent. Boehringer Ingelheim, health officials in the Congo and the French Croix Rouge (Red Cross) are working together to ensure the VIRAMUNE MTCT regimen is properly implemented in the Republic of Congo. As a first step, the national government will administer the VIRAMUNE MTCT regimen in eight hospitals -- five in Brazzaville and three in Pointe Noire in the Congo. This effort will include implementation of HIV prevention campaigns, counselling initiatives for pregnant women and the setting-up of new HIV test centres.

The national government also will discuss with the World Health Organization (WHO) and World Bank plans to acquire formula milk to prevent infection via breastfeeding and to outline necessary details so that they can participate in the "Accelerated Access Initiative" for chronic treatment.

"We are delighted that our country has the chance to embark upon this important initiative to reduce mother-to-child transmission of HIV," said Dr. Alfred Opimbat, Congo Health Minister. According to the Congolese government, 100,000 adults and children were estimated to be living with HIV/AIDS in the Congo at the end of 1999.

The second country to receive VIRAMUNE free of charge for use in the prevention of MTCT is Senegal. The first shipment will be provided to the Senegalese government on World AIDS Day, December 1.

"We're confident that our initiative will continue to increase access to this important drug and make an impact in the developing world where up to 30 percent of pregnant women are infected with HIV," said Prof. Rolf Krebs, Vice Chairman of the Board of Managing Directors at Boehringer Ingelheim.

Boehringer Ingelheim is following 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 and be relevant to the needs of the recipient country. Boehringer Ingelheim is working with interested local governments that have approved the use of VIRAMUNE tablets and suspension and are interested in participating in the drug donation program, and with global organizations, such as UNAIDS, UNICEF and the WHO to optimise existing infrastructures so proper administration of VIRAMUNE is possible.

Clinical Studies

Although VIRAMUNE is not indicated for the prevention of MTCT in the United States, results of two recent studies examining the use of VIRAMUNE for the prevention of MTCT of HIV -- the HIVNET 012 and SAINT trials -- were presented this year at the 13th International AIDS Conference in Durban, South Africa. "It is estimated that there are approximately 600,000-700,000 infants infected with HIV every year, and the number of new infections is increasing. The HIVNET 012 and SAINT studies are critical studies which evaluate different methods for preventing MTCT of HIV in the developing world," said Brooks Jackson, MD, lead investigator of the HIVNET 012 study and Vice Chairman of Pathology at Johns Hopkins School of Medicine.

The HIVNET 012 study, which took place in Uganda, compared two different short-course regimens of either VIRAMUNE or ZDV* administered late in pregnancy(1). At twelve months the study team looked at data from 619 mothers (308 receiving ZDV and 311 receiving VIRAMUNE) and their infants. Transmission rates were 11.8 percent and 20 percent at 6-8 weeks and 15.7 percent versus 24.1 percent at 12 months for the VIRAMUNE and ZDV arms, respectively. Serious adverse events were not significantly different between the VIRAMUNE and ZDV groups in either the mothers or infants. The mothers and their infants will continue to be actively followed for five years.

The SAINT study is a large, multicenter trial conducted in South Africa sponsored by Boehringer Ingelheim(2). A short course of VIRAMUNE was compared to a seven-day course of two drugs, ZDV+3TC at reducing MTCT of HIV. Similar results of the two drug regimens were observed. The overall rates of MTCT of HIV were 14.0 percent and 10.8 percent for the VIRAMUNE and the ZDV+3TC arms respectively. The overall rates account for transmission that occur 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 percent and 4.3 percent for the VIRAMUNE and ZDV+3TC arms respectively. The differences between the arms were not statistically significant.

A SAINT study safety analysis found that there were no treatment-related serious adverse events in either group through 6 weeks(3).

VIRAMUNE

VIRAMUNE tablets for chronic treatment of HIV-1 in combination with other antiretroviral agents have been registered in 77 countries. VIRAMUNE tablets have been available since 1996 and a pediatric formulation was introduced in 1998. Data regarding the safety and efficacy of VIRAMUNE for the prevention of MTCT of HIV have not been reviewed by the Food & Drug Administration (FDA). VIRAMUNE should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

VIRAMUNE is a non-nucleoside reverse transcriptase inhibitor. The most clinically important adverse events associated with VIRAMUNE are rash (16%) and hepatic events. Other commonly reported events include fever, nausea and headache. Cases of hypersensitivity reactions have been observed. Severe and life-threatening skin reactions and hepatotoxicity, including fatal cases of each, have occurred in patients treated with VIRAMUNE. Some events have occurred after short-term exposure. The first 12 weeks of therapy with VIRAMUNE are a critical period during which it is essential that patients be intensively monitored. The most frequently reported adverse events related to VIRAMUNE in pediatric patients were similar to those observed in adults, with the exception of granulocytopenia, which was more commonly observed in children. Resistant virus emerges rapidly and uniformly when VIRAMUNE is administered alone. For the treatment of HIV-1 infection, VIRAMUNE should always be administered with at least one additional antiretroviral agent. The safety profile of VIRAMUNE in neonates has not been established.

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.

For more information on VIRAMUNE, please see http://www.VIRAMUNE.com. ZDV (zidovudine, AZT, Retrovir«) and 3TC (Epivir«, lamivudine) are registered trademarks of Glaxo Wellcome, Inc.

1. The one year safety and efficacy data of the HIVNET 012 trial, Owor, M; Deseyve, M; Duefield, C; Fleming, T; Musoke, P; Guay, L; Mmiro, F; Jackson, JB, International AIDS Conference, 2000 Durban (Abstract No. LbOr1)

2. The SAINT Trial: Nevirapine (NVP) versus zidovudine (ZDV)+lamivudine (3TC) in prevention of peripartum HIV transmission, D. Moodley et. al, International AIDS Conference, 2000 Durban (Abstract No. LbOr2)

3. 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), McIntyre J et. al. International AIDS Conference, 2000 Durban (Abstract No. Tu OrB356)

SOURCE: Boehringer Ingelheim Pharmaceuticals, Inc.
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