INGELHEIM, Germany, January 31 /PRNewswire/ --
Long-term data from the Nevirapine/Efavirenz/Abacavir (NEFA) studydemonstrate that patients who switched from a protease inhibitor-basedregimen to a non-nucleoside reverse transcriptase inhibitor-based regimencontaining Viramune(R) (nevirapine) or efavirenz achieved comparable efficacyand safety to their previous regimen and were more likely to maintainvirologic suppression after three years of follow-up than patients whoswitched to an abacavir-containing regimen. These data were published in the30 January issue of AIDS.
"Patients may want to consider simpler regimens that can suppress thevirus long term but are more tolerable and have fewer side effects than someprotease inhibitor-based therapies. The findings of the NEFA study revealthat HIV-positive patients seeking effective alternatives can benefit from aswitch to a treatment regimen containing a non-nucleoside reversetranscriptase 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 switchstudy conducted to date. The NEFA study was a multicentre, randomized,open-label clinical trial initially designed for one-year follow up of 460HIV-positive adults who had previously been treated with at least oneprotease inhibitor plus two nucleoside reverse transcriptase inhibitors. Thefollow up was extended to three years following recommendations from theCommittee for Medicinal Products for Human Use (CHMP) of the EuropeanMedicines Agency (EMEA). Patients participating in the study were required tohave maintained the amount of HIV in their blood (viral load) to less than200 copies/mL for at least six months on their protease inhibitor-basedregimen containing indinavir (n=278), nelfinavir (n=135), ritonavir (n=15),saquinavir (n=13), or indinavir or saquinavir in combination with low-doseritonavir (n=19) prior to study entry. Patients were then randomized toreplace their protease inhibitor with VIRAMUNE twice daily (n=155), efavirenzonce daily (n=156) or abacavir twice daily (n=149).
An intent-to-treat (ITT) analysis of patients originally randomized toswitch from their protease inhibitor to VIRAMUNE, efavirenz or abacavirshowed that 93.5 percent of patients who switched to VIRAMUNE, 92.9 percentof patients who switched to efavirenz and 80.5 percent of patients whoswitched to abacavir achieved virologic success after three years. Thisanalysis was conducted to control for the effects of study discontinuationand switching from study medication.
In this study, the incidence of adverse events leading to discontinuationwas significantly lower in the abacavir (9 percent) and VIRAMUNE (19 percent)groups than the efavirenz (25 percent) group. The majority of adverse eventsthat led to discontinuation in the abacavir and VIRAMUNE arms occurred in thefirst weeks of the study. The most common adverse events experienced wereneuropsychiatric 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 theefavirenz group occurred steadily through three years of follow-up.
About VIRAMUNE
VIRAMUNE(R) (nevirapine) is a product of original research done atBoehringer Ingelheim. VIRAMUNE(R) was the first member of the non-nucleosidereverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs. VIRAMUNE(R)is indicated for use in combination with other antiretroviral agents for thetreatment of HIV-1 infection. This indication is based on one principalclinical trial that demonstrated prolonged suppression of HIV-RNA and severalsmaller supportive studies. Studies have also shown that patients switchingto VIRAMUNE(R) from a PI-based regimen demonstrate an improved lipid profilewhile maintaining viral suppression. The most clinically important adverseevents associated with VIRAMUNE(R) are rash and hepatic events, which haveincluded fatal cases. Any patient can experience hepatic events; however,female gender and higher CD4 counts at initiation of therapy place patientsat greater risk. Women with CD4+ cell counts >250 cells/mm3 are at thegreatest risk. By application of the VIRAMUNE(R) CD4+ guidelines the risk ofhepatic events can be dramatically reduced. VIRAMUNE(R) should not beinitiated in adult females with CD4+ cell counts greater than 250 cells/mm3or in adult males with CD4+ cell counts greater than 400 cells/mm3 unless thebenefit outweighs the risk. The greatest risk of severe rash and hepaticevents occurs in the first 6 weeks of therapy. It is essential that patientsbe monitored for these reactions at all times, and intensively during thefirst few months of therapy. VIRAMUNE(R) should be discontinued and notrestarted following severe hepatic, skin or hypersensitivity reactions.
Boehringer Ingelheim
Boehringer Ingelheim is committed to the research and development ofnovel antiretroviral agents. Apart from VIRAMUNE(R), APTIVUS(R) (tipranavir)is a new non-peptidic protease inhibitor, approved for combinationantiretroviral treatment of HIV-1 infected adults that are highly pre-treatedwith virus resistant to multiple protease inhibitors. The company is involvedin basic research and is committed to improving HIV therapy by providingphysicians and patients with innovative antiretrovirals.
For more information on Boehringer Ingelheim, please seehttp://www.boehringer-ingelheim.com/hiv.
Reference:
Martinez E. et al. Three-year Follow-Up of Protease Inhibitor-basedRegimen Simplification in HIV-infected Patients. AIDS 2007 21(3):367-369
Web site: http://www.boehringer-ingelheim.com/hiv
Boehringer Ingelheim GmbH
Judith von Gordon, CD Communications, Boehringer Ingelheim GmbH, +49-61-32-77-3582, Fax: +49-61-32-77-6601
