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Latebreaker Presentation on Atlantic Study Shows VIRAMUNE(R) (nevirapine) in a Simple Treatment Combination is Potent and Durable Against HIV
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 statistically significant.
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, tipranavir.
For more information on Boehringer Ingelheim or VIRAMUNE, please see http://www.boehringer-ingelheim.com.
* 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 data.
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