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Data Published in AIDS Show Viramune(R) (nevirapine) Achieves Durable Benefit in Switch Patients
Ingelheim, Germany (ots/PRNewswire) -
Long-term data from the Nevirapine/Efavirenz/Abacavir (NEFA) study demonstrate that patients who switched from a protease inhibitor-based regimen to a non-nucleoside reverse transcriptase inhibitor-based regimen containing Viramune(R) (nevirapine) or efavirenz achieved comparable efficacy and safety to their previous regimen and were more likely to maintain virologic suppression after three years of follow-up than patients who switched to an abacavir-containing regimen. These data were published in the 30 January issue of AIDS.
"Patients may want to consider simpler regimens that can suppress the virus long term but are more tolerable and have fewer side effects than some protease inhibitor-based therapies. The findings of the NEFA study reveal that HIV-positive patients seeking effective alternatives can benefit from a switch to a treatment regimen containing a non-nucleoside reverse transcriptase inhibitor such as VIRAMUNE," said Esteban Martinez, M.D., Ph.D., professor of medicine, University of Barcelona.
The NEFA study has been the largest prospective protease inhibitor switch study conducted to date. The NEFA study was a multicentre, randomized, open-label clinical trial initially designed for one-year follow up of 460 HIV-positive adults who had previously been treated with at least one protease inhibitor plus two nucleoside reverse transcriptase inhibitors. The follow up was extended to three years following recommendations from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). Patients participating in the study were required to have maintained the amount of HIV in their blood (viral load) to less than 200 copies/mL for at least six months on their protease inhibitor-based regimen containing indinavir (n=278), nelfinavir (n=135), ritonavir (n=15), saquinavir (n=13), or indinavir or saquinavir in combination with low-dose ritonavir (n=19) prior to study entry. Patients were then randomized to replace their protease inhibitor with VIRAMUNE twice daily (n=155), efavirenz once daily (n=156) or abacavir twice daily (n=149).
An intent-to-treat (ITT) analysis of patients originally randomized to switch from their protease inhibitor to VIRAMUNE, efavirenz or abacavir showed that 93.5 percent of patients who switched to VIRAMUNE, 92.9 percent of patients who switched to efavirenz and 80.5 percent of patients who switched to abacavir achieved virologic success after three years. This analysis was conducted to control for the effects of study discontinuation and switching from study medication.
In this study, the incidence of adverse events leading to discontinuation was significantly lower in the abacavir (9 percent) and VIRAMUNE (19 percent) groups than the efavirenz (25 percent) group. The majority of adverse events that led to discontinuation in the abacavir and VIRAMUNE arms occurred in the first weeks of the study. The most common adverse events experienced were neuropsychiatric events in the efavirenz arm and rash in the VIRAMUNE arm. While in the VIRAMUNE group adverse events occurred within the first year, neuropsychiatric adverse events that led to late discontinuation in the efavirenz group occurred steadily through three years of follow-up.
VIRAMUNE(R) (nevirapine) is a product of original research done at Boehringer Ingelheim. VIRAMUNE(R) was the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs. VIRAMUNE(R) 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(R) from a PI-based regimen demonstrate an improved lipid profile while maintaining viral suppression. The most clinically important adverse events associated with VIRAMUNE(R) are rash and hepatic events, which have included fatal cases. Any patient can experience hepatic events; however, female gender and higher CD4 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(R) CD4+ guidelines the risk of hepatic events can be dramatically reduced. VIRAMUNE(R) 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 6 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(R) 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), 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 involved in basic research and is committed to improving HIV therapy by providing physicians and patients with innovative antiretrovirals.
For more information on Boehringer Ingelheim, please see http://www.boehringer-ingelheim.com/hiv.
Martinez E. et al. Three-year Follow-Up of Protease Inhibitor-based Regimen Simplification in HIV-infected Patients. AIDS 2007 21(3):367-369
Web site: http://www.boehringer-ingelheim.com/hiv
ots Originaltext: Boehringer Ingelheim
Im Internet recherchierbar: http://www.presseportal.ch
Judith von Gordon, CD Communications, Boehringer Ingelheim GmbH,
+49-61-32-77-3582, Fax: +49-61-32-77-6601