INGELHEIM, Germany (ots-PRNewswire) - One-year results of HIVNET
012, a trial conducted in Uganda by the National Institute of Allergy
and Infectious Diseases (NIAID) HIV Prevention Trials Network
(HIVNET), confirm preliminary findings that VIRAMUNE(R) (nevirapine)
effectively reduced HIV transmission from mothers to their infants. A
simple, inexpensive regimen of one oral dose of VIRAMUNE given to an
HIV-infected woman in labor and another to her newborn within three
days of birth was almost twice as effective in reducing
mother-to-child transmission (MTCT) as a short course ZDV
(zidovudine, AZT, Retrovir(R)) regimen. Both regimens appeared to be
well tolerated. Results were presented today at the 13th
International AIDS Conference in Durban, South Africa.
"These results are important because they demonstrate that
VIRAMUNE may be the most viable option studied to date for the
developing world," said Brooks Jackson, MD, lead investigator of the
study and Vice Chairman of Pathology at Johns Hopkins School of
"Through eighteen months, the reduction of HIV transmission from
mother-to-infant -- even in a breast feeding population -- is still
significant. This regimen has the potential to reduce HIV-1 MTCT by
42 percent or more in places where other prevention regimens are
impractical," added Dr. Thomas Fleming, Chairman of Biostatistics at
University Washington and Fred Hutchinson Cancer Research Center and
protocol statistician for HIVNET 012.
VIRAMUNE is a non-nucleoside reverse transcriptase inhibitor
(NNRTI) commonly used in HIV combination therapy. It belongs to a
different class of drugs than ZDV; however, it works against the same
target HIV enzyme. NIAID 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. VIRAMUNE is not currently indicated for the prevention of
perinatal HIV transmission.
The HIVNET 012 study compared the safety and efficacy of two
different short course regimens of antiviral drugs administered late
in pregnancy. The VIRAMUNE regimen consisted of a single 200 mg
tablet given to mothers in labor and a single 2 mg/kg dose of
VIRAMUNE oral suspension to the newborns within 72 hours after
delivery. The ZDV regimen was 600 mg at the onset of labor, 300 mg
every three hours during labor and 4 mg/kg of ZDV twice-daily to the
newborn for the first seven days after delivery. All women entered
into the study were in their ninth month of pregnancy and had not
previously taken any antiretroviral drugs.
For the twelve month analysis, the study team looked at data from
619 mothers (308 receiving ZDV and 311 receiving VIRAMUNE) and their
infants. VIRAMUNE continued to be significantly more effective than
ZDV. 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. The mothers and their infants will
continue to be actively followed for five years.
Resistance mutations associated with VIRAMUNE were detected after
delivery in a minority of women in the VIRAMUNE arm. Mutations were
not detectable in the long term in all of the women who have been
tested for resistance to date. "This suggests that VIRAMUNE for use
in the prevention of MTCT is likely to be effective in future
pregnancies," explained Dr. Jackson. "It's also important to note
that there is currently no evidence that resistance to VIRAMUNE will
affect clinical progression of HIV-infection."
Both regimens appeared to be well tolerated, with similar rates of
adverse events in both arms. According to HIVNET 012 researchers, no
adverse event was definitely or probably related to the study drugs.
Women were enrolled in the HIVNET 012 study between November 1997
and April 1999. The study was conducted at Mulago Hospital, the
teaching hospital affiliated with Makerere University in Kampala,
Uganda. Over 21,000 women deliver at this hospital annually, and
nearly 16 percent of those women are HIV infected. HIVNET-supported
researchers from Makerere University and Johns Hopkins University in
Baltimore conducted the study.
Boehringer Ingelheim recently announced that VIRAMUNE will be
offered free of charge for a period of five years for the prevention
of 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 Organization, 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.
Data regarding the safety and efficacy of VIRAMUNE for prevention
of MTCT of HIV 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 HIVNET 012
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.
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.
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,
For more information on Boehringer Ingelheim or VIRAMUNE, please
Thursday, 13 July, 2000, 14:45 Latebreaker Slide Session:
Hall ICC II
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)
Thursday, 13 July, 2000, 16:30 Latebreaker Slide Session:
Hall ICC II
The one year safety and efficacy data of the HIVNET 012 trial
(Jackson, JB; Mracna, M; Guay, L; Dileanis, JA; Musoke, P; Mmiro, F;
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