TAORMINA, Italy (ots-PRNewswire) - More than 750 European
physicians convened here to discuss results of important clinical
trials confirming the efficacy of the anti-HIV drug VIRAMUNE(R)
(nevirapine) for the treatment of HIV-infected patients. Studies
relating to adult and paediatric HIV treatment, as well as
groundbreaking results on preventing mother-to-child transmission of
HIV in the developing world were presented at the one-day symposium.
A distinguished panel of international HIV researchers outlined
study findings that support the use of simplified, potent treatment
regimens including VIRAMUNE. VIRAMUNE is a non-nucleoside reverse
transcriptase inhibitor (NNRTI), which requires only two pills per
day -- the lowest daily intake of any NNRTI. It can be taken without
food restrictions and is generally well-tolerated.
"Today's clinical presentations provide physicians with updated
data on HIV/AIDS treatment options for their patients that are
powerful and require few pills," said Stefano Vella, M.D., Research
Director Antivirals, Chair, National HIV/AIDS Clinical Research
Program of the Instituto Superiore di Sanita in Rome and one of the
symposium chairs. "A combination of nevirapine + 3TC/ZDV* for
example, requires two pills twice daily."
VIRAMUNE + Combivir Shows Greater Response than nelfinavir +
Combivir Dr. Daniel Podzamczer presented preliminary findings of the
COMBINE study, which suggest that VIRAMUNE plus Combivir(TM)
(3TC/ZDV)* may achieve a greater virological response than a regimen
of Combivir plus the protease inhibitor nelfinavir*, even in patients
with high baseline levels of HIV. This ongoing, randomised trial of
142 patients in nine centres in Spain and three centres in Argentina
evaluates the efficacy and safety of these two regimens in HIV-
infected patients who have not been previously treated.
"At this point, a greater percentage of patients on the Viramune
plus Combivir regimen are maintaining viral suppression than those
taking nelfinavir plus Combivir," said Dr. Podzamczer, lead
investigator, of the Hospital Princeps d'Espanya in Barcelona, Spain.
"This is very important because the Viramune plus Combivir regimen is
also much simpler for patients -- requiring only two pills in the
morning and two in the evening."
After six months of follow-up, 74.5% of patients taking VIRAMUNE +
Combivir and 60.3% of patients taking nelfinavir + Combivir achieved
HIV suppression below the 200 copies/mL limit of detection. The
proportion of patients with HIV suppression below 20 copies/mL was
58.3% in the VIRAMUNE arm and 33.3% in the nelfinavir arm.
Researchers extrapolated results from patients with high baseline
levels (more than 100,000 copies/mL) of HIV in their blood. In this
analysis, 86.7% of the VIRAMUNE patients versus 59.1% of the
nelfinavir patients attained HIV viral load below 200 copies/mL, and
57.1% of VIRAMUNE patients compared to 22.7% of nelfinavir patients
had HIV viral load below 20 copies/mL. All analyses presented are
intent-to-treat, which accounts for all patients enrolled, including
those who stopped treatment before the end of the study. According to
study researchers, both regimens were well tolerated.
Atlantic Study Confirms Potent and Simple VIRAMUNE Strategy Dr.
Jose Gatell presented 48-week findings of the Atlantic Study, which
show that VIRAMUNE + two nucleoside analogues is as potent as a
protease inhibitor + two nucleoside analogues. A protease
inhibitor-based regimen has often been described as the "standard of
care" for HIV, but can require patients to take numerous pills. The
multi-center, international Atlantic Study is the first head-to-head
comparison trial of agents in the three currently available classes
of HIV/AIDS drugs: NNRTIs, protease inhibitors and nucleoside
"These long-term results demonstrate that treatment combinations
containing nevirapine are as effective as protease
inhibitor-containing regimens in reducing HIV viral loads to
undetectable levels in patients -- even in those who had higher
levels of HIV when they initiated treatment," said Dr. Gatell.
The treatment combinations evaluated in the Atlantic study consist
of the nucleoside analogues ddI and d4T combined with either
once-daily VIRAMUNE (an NNRTI), thrice-daily indinavir (a protease
inhibitor) or twice-daily 3TC (a nucleoside analogue). A total of 235
patients have completed 48 weeks of the study; HIV RNA measures are
available for 181 of these patients.
In the 'as-treated analysis,' which accounts for patients who did
not stop therapy due to toxicity or loss to follow-up, the percentage
of patients with HIV viral load below 500 copies/mL was 91% in the
VIRAMUNE arm, 95% in the indinavir arm and 90% in the 3TC arm. The
percentage with undetectable HIV viral load below 50 copies/mL was
82% in the VIRAMUNE arm, 90% in the indinavir arm and 78% in the 3TC
arm. Using an intent-to-treat analysis, the percentage of patients
with undetectable HIV (below 50 copies/mL) at 48 weeks was 51% in the
VIRAMUNE arm, 57% in the indinavir arm and 49% in the 3TC arm.
Researchers noted that the difference in results of the VIRAMUNE and
indinavir arms were not statistically significant.
Safety data indicated that all treatment arms were safe and
generally well tolerated with similar adverse events in all arms.
Researchers plan to follow patients for more than 144 weeks.
VIRAMUNE was the first member of the NNRTI class of anti-HIV/AIDS
drugs to be approved. VIRAMUNE tablets and oral suspension are
indicated as part of a combination therapy for the antiviral
treatment of HIV-1 infected adults and children with advanced or
progressive immunodeficiency. Additionally, some countries have
approved VIRAMUNE for the prevention of mother-to-child HIV
transmission when it is given as a single dose to an HIV-positive
mother during labor and to her newborn within 72 hours of birth. For
chronic care, combining three or more antiretroviral agents is the
standard of care for adults and children infected with HIV.
VIRAMUNE is generally well-tolerated. The most commonly reported
adverse events associated with VIRAMUNE are rash, fever, nausea,
headache and abnormal liver function tests. Severe and
life-threatening skin reactions and hepatotoxicity, including fatal
cases of each, have occurred in patients treated with VIRAMUNE.
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.
Recently, Boehringer Ingelheim acquired world-wide rights for the
investigational protease inhibitor, tipranavir. Tipranavir is a novel
new protease inhibitor currently in Phase II development.
The Boehringer Ingelheim group of companies, with headquarters in
Ingelheim (Germany) is one of the 20 leading pharmaceutical
corporations in the world. It reported revenues exceeding DEM 8.7
billion in 1998.
The corporation has more than 140 affiliated companies and it
conducts business on every continent. Its product range is focused on
human pharmaceuticals -- hospital, prescription and self-medication
-- as well as animal health.
Substantial research and development, production, and distribution
facilities are located around the globe. In 1998 Boehringer Ingelheim
spent DEM 1.6 billion on R&D, equivalent to 18% of total sales.
For more information on Boehringer Ingelheim and VIRAMUNE please
*antiretroviral drugs mentioned in this release: Combivir(TM) (3TC
150 mg/ZDV 300 mg), Glaxo Wellcome Inc. nelfinavir (Viracept(R)),
Agouron Pharmaceuticals Inc. d4T (Zerit(R), stavudine) and ddI
(Videx(R), didanosine), Bristol-Myers Squibb Co.
indinavir (Crixivan(R)), Merck & Co.
ots Original Text Service: Boehringer Ingelheim GmbH
Contact: Judith von Gordon, Corporate Public Relations Division of
Boehringer Ingelheim GmbH, +49-6132-773582, fax, +49-6132-776601; or
Maureen Byrne, 212-886-3312, or Denise Connolly, 212-886-3117, both
of GCI Healthcare, fax, 212-886-3291
Original-Content von: Boehringer Ingelheim GmbH, übermittelt durch news aktuell