25.07.2007 – 03:03
Data Presented at International AIDS Society (IAS) Conference Shows Long-Term Viramune(R) (nevirapine) Efficacy and Increase in Good Cholesterol
Sydney, Australia (ots/PRNewswire)
New data from two new studies of Viramune(R) (nevirapine) were presented at the 4th International AIDS Society (IAS) in Sydney, Australia. Results from an extended three-year follow-up analysis of the 2NN study demonstrated that HIV-positive patients taking VIRAMUNE (nevirapine) achieved a comparable virologic and immunologic response to patients taking efavirenz. The second study, NILE, examined the mechanism by which VIRAMUNE increases the level of high-density lipoprotein cholesterol (HDLc, also called "good cholesterol" because of its cardioprotective character) and confirmed again that VIRAMUNE increases HDL-cholesterol through 24 weeks.
"These studies show how to further maximise the benefits of treatment with VIRAMUNE. The findings of the NILE study are particularly encouraging as it was thought that some therapies for HIV may increase cardiovascular risk. What NILE has shown is that VIRAMUNE may increase good cholesterol in a manner which might be expected to reduce cardiovascular risk, and therefore, the study may help us identify promising novel targets for increasing good cholesterol," Peter Reiss, Professor of Medicine, Academic Medical Centre, Amsterdam, Netherlands.
NILE (Nevirapine Intensive Lipid Evaluation)
The NILE study examined the way that VIRAMUNE increases HDL-cholesterol in 13 HIV positive patients with viral loads of <50 copies/mL. Patients who had been on treatment containing zidovudine, lamivudine and abacavir for six months added VIRAMUNE to their regimes and were evaluated at six and twenty four weeks for enzymes that alter HDLc levels. The results showed that VIRAMUNE increased HDLc by 19% through an increase of apolipoprotein A1 by 14% The findings may help identify new promising novel targets for increasing good cholesterol.
The 2NN study was an open-label, comparison trial of first-line antiretroviral therapy that randomized 1,216 patients in 17 countries. Inclusion criteria was a plasma HIV-1 viral load greater than 5,000 RNA copies/mL without CD4 restriction. The median baseline CD4 count was 190 cells/mm3, and median viral load was 4.7 log10, with no significant differences among treatment arms.
"The 2NN analysis provides long-term evidence that patients taking an NNRTI-containing regimen can achieve a good treatment response with either VIRAMUNE or efavirenz for at least three years," said Joep Lange, M.D., Professor of Internal Medicine, Academic Medical Centre, University of Amsterdam, Netherlands. "As treatment strategies continue to grow more complex, these findings demonstrate that VIRAMUNE and efavirenz can offer simple, effective and durable options for long-term treatment success."
A retrospective intent-to-treat (ITT) analysis of the study examined 567 patients randomly assigned to receive VIRAMUNE 400 mg once daily (n=120), VIRAMUNE 200 mg twice daily (n=224) or efavirenz 600 mg once daily (n=223), and a nucleoside background containing stavudine and lamivudine, from 49 to 144 weeks of therapy. The primary endpoint was the percentage of treatment failures between week 49 and 144, defined as the occurrence of CDC-B/C events(i), virologic failure, or a change in allocated NNRTI. Secondary endpoints included the percentage of patients with virologic failure, change in CD4 cell count, incidence of CDC-B/C events, and incidence of laboratory grade 3/4 adverse events.
Among patients included in the ITT analysis, the following was observed from week 49 to 144:
There were no statistically significant differences with regard to the primary endpoint, treatment failure.
-- Treatment response was comparable across all three study arms: 55% for VIRAMUNE once daily, 64% for VIRAMUNE twice daily, and 65% for efavirenz. Comparisons for all secondary analyses yielded no significant differences. -- The rates of virologic failure were similar for all three study arms: 4.9% for efavirenz, 5.8% for VIRAMUNE BID and 8.3% for VIRAMUNE QD. The authors concluded: -- Change of medication was the most frequent reason for treatment failure; -- There was a low incidence of virologic failure during the 2nd and 3rd year; -- There was a continued increase in CD4+ T-cell counts;
VIRAMUNE is a product of original research done at Boehringer Ingelheim. VIRAMUNE was the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs. VIRAMUNE is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principal clinical trial that demonstrated prolonged suppression of HIV-RNA and several smaller supportive studies. Studies have also shown that patients switching to VIRAMUNE from a PI-based regimen demonstrate an improved lipid profile while maintaining viral suppression. The most clinically important adverse events associated with VIRAMUNE are rash and hepatic events, which have included fatal cases. Any patient can experience hepatic events; however, female gender and higher CD4+ cell counts at initiation of therapy place patients at greater risk. Women with CD4+ cell counts >250 cells/mm3 are at the greatest risk. By application of the VIRAMUNE CD4+ guidelines the risk of hepatic events can be dramatically reduced. VIRAMUNE should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm3 or in adult males with CD4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk. The greatest risk of severe rash and hepatic events occurs in the first six weeks of therapy. It is essential that patients be monitored for these reactions at all times, and intensively during the first few months of therapy. VIRAMUNE should be discontinued and not restarted following severe hepatic, skin or hypersensitivity reactions.
Boehringer Ingelheim is committed to the research and development of novel antiretroviral agents. Apart from Viramune(R) (nevirapine), Aptivus(R) (tipranavir) is a new non-peptidic protease inhibitor, approved for combination antiretroviral treatment of HIV-1 infected adults that are highly pre-treated with virus resistant to multiple protease inhibitors. The company is committed to improving HIV therapy by providing physicians and patients with innovative antiretrovirals.
Boehringer Ingelheim is actively conducting clinical trial programs to further evaluate VIRAMUNE and APTIVUS for the treatment of HIV-1 infection. Boehringer Ingelheim recently announced the initiation of the ArTEN trial, which will compare the efficacy and safety of VIRAMUNE dosed once-or twice-daily versus atazanavir boosted with ritonavir in HIV-positive antiretroviral-naive patients. The APTIVUS clinical trial program is comprised of ongoing and planned studies in more than 1,400 treatment-experienced patients, including the SPRING study, which is examining the benefits of APTIVUS in an ethnically and racially diverse highly treatment-experienced patient population and the POTENT study, which will compare the efficacy and safety of APTIVUS versus darunavir.
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Wit, F. et al. Three-year extended follow-up of the 2NN study: a randomised comparative trial of first-line antiretroviral therapy with regimens containing either nevirapine, efavirenz or both drugs combined, together with stavudine and lamivudine. 4th International AIDS Society (IAS) Conference on HIV Pathogenesis and Treatment; Sydney, Australia. Abstract #WEPEB032
Sankatsing, R. et al. Nevirapine increases High Density Lipoprotein-cholesterol by stimulation of apolipoprotein AI synthesis. 4th International AIDS Society (IAS) conference on HIV Pathogenesis and Treatment; Sydney, Australia. Abstract #WEPEB120LB
(i) The U.S. Centers for Disease Control and Prevention (CDC) disease staging system assesses the severity of HIV disease by CD4 cell counts and by the presence of specific HIV-related conditions. Category B events are symptomatic conditions of HIV infection in adolescents or adults. Category C events are AIDS-indicator conditions, such as recurrent bacterial pneumonia, coccidioidomycosis and histoplasmosis. (Source: AIDS Education and Training Centers (AETC) National Resource Center)
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Judith von Gordon, CD Communications, Boehringer Ingelheim
+49-61-32-77-3582, or fax: +49-61-32-77-6601
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