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| |  Efficacy Of Anti-HIV Drug, Viramune (Nevirapine), Confirmed By Experts TAORMINA, ITALY -- March 15, 2000 -- 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 percent of patients taking Viramune + Combivir and 60.3 percent 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 percent in the Viramune arm and 33.3 percent 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 percent of the Viramune patients versus 59.1 percent of the nelfinavir patients attained HIV viral load below 200 copies/mL, and 57.1 percent of VIRAMUNE patients compared to 22.7 percent 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. 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 analogues. "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 percent in the Viramune arm, 95 percent in the indinavir arm and 90 percent in the 3TC arm. The percentage with undetectable HIV viral load below 50 copies/mL was 82 percent in the Viramune arm, 90 percent in the indinavir arm and 78 percent 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 percent in the Viramune arm, 57 percent in the indinavir arm and 49 percent 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. *antiretroviral drugs mentioned in this release: Related Links: Viramune, Boehringer Ingelheim Pharmaceuticals, Inc., Roxane Laboratories, Combivir, Glaxo Wellcome Inc., Viracept, Agouron Pharmaceuticals Inc., Zerit, Videx, Bristol-Myers Squibb Co., Crixivan.htm and Merck & Co..
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