DURBAN, South Africa (ots-PRNewswire) - Findings from the Atlantic
study indicate that VIRAMUNE + two nucleoside analogues has shown
comparable efficacy to a protease inhibitor + two nucleoside
analogues. The multi-centre, 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 analogues. Atlantic was presented as a "latebreaker" today
at the 13th International AIDS Conference.
A protease inhibitor-based regimen has often been described as the
"standard of care" for HIV/AIDS but can require patients to take
numerous tablets. VIRAMUNE is a non-nucleoside reverse transcriptase
inhibitor (NNRTI), which requires only two tablets per day -- the
lowest daily intake of any NNRTI.
"These long-term results demonstrate that HIV treatment
combinations containing VIRAMUNE can be as powerful as protease
inhibitor-containing regimens in reducing amounts of HIV in the body.
This is important because a VIRAMUNE combination can be taken in a
simple treatment regimen," said lead investigator and chair of the
Atlantic study, Dr. Joep Lange, professor of internal medicine at the
University of Amsterdam, The Netherlands.
The treatment combinations evaluated in the Atlantic study consist
of the nucleoside analogues ddI* and d4T* combined with either
once-daily VIRAMUNE, thrice-daily indinavir* (a protease inhibitor)
or twice-daily 3TC* (a nucleoside analogue). The approved dosing
regimen for VIRAMUNE is one tablet taken twice daily.
All of the 298 study participants have been analyzed through 48
weeks of the study; HIV RNA measures for the entire study population
were presented today. The three groups of patients were comparable
with respect to gender, risk factor for HIV-infection, disease stage,
CD4+ cell count (median baseline = 406 cells/mm3) and HIV RNA levels
(median baseline = 4.2 log10).
At 48 weeks, the 'intent-to-treat'analysis, which accounts for all
patients, including those who stopped treatment before the end of the
study, found that the percentage of patients who were successfully
treated [undetectable HIV levels (below 50 copies/mL) and still on
treatment] was 49% in the VIRAMUNE arm, 49% in the indinavir arm and
40% in the 3TC arm. Using an 'as-treated' analysis, which eliminates
patients who stopped therapy due to toxicity or loss to follow-up,
the percentage of patients with undetectable levels of HIV was 82% in
the VIRAMUNE arm, 91% in the indinavir arm and 67% in the 3TC arm.
The difference in the VIRAMUNE and indinavir response ratio was not
Safety data indicated that all regimens were similarly well
tolerated. No differences were found regarding treatment
discontinuation due to toxicities. Researchers plan to follow
patients for more than 144 weeks.
VIRAMUNE, the first member of the 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 generally well tolerated. The most clinically
important adverse events associated with VIRAMUNE are rash and
increases in liver function tests. 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.
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
* antiretroviral drugs mentioned in this release:
3TC (Epivir(R), lamivudine) Glaxo Wellcome Inc.
d4T (Zerit(R), stavudine) and ddI (Videx(R), didanosine),
Bristol-Myers Squibb Co.
indinavir (Crixivan(R)), Merck & Co.
Thursday, July 13 Latebreakers Posters Session
Squires K et.al. The Atlantic Study: a randomized, open-label
trial comparing two protease inhibitor (pi)-sparing antiretroviral
strategies versus a standard pi-containing regimen, final 48 week
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