Boehringer Ingelheim

New Three-Year Data Confirms Aptivus(R) (tipranavir) as Effective and Durable Treatment Option for Treatment-Experienced Patients

    Madrid, Spain (ots/PRNewswire) -

    - For Non-U.S. Media

    New data from the combined RESIST studies (RESIST-1 and RESIST-2) show  that Aptivus(R) (tipranavir), used with Norvir (ritonavir), provides a  superior and durable treatment response for up to three years in treatment- experienced HIV patients versus a comparator group of protease inhibitors.(1)  The research was presented at the 11th European AIDS Conference (EACS) in  Madrid, Spain.

    At 156 weeks, APTIVUS combined with ritonavir (APTIVUS/r), continues to outperform a group of ritonavir-boosted comparator protease inhibitors that includes low dose ritonavir boosted lopinavir, amprenavir, saquinavir and indinavir. When compared to these protease inhibitors, through three years of therapy, treatment response rates(2) were almost three times higher in the APTIVUS/r arm compared to the comparator arm (20.9% vs. 7.5%).

    Moreover, patients taking APTIVUS/r combined with first-time use of enfuvirtide achieved four-fold greater treatment response rates than patients with comparator protease inhibitors (37.9% vs. 8.2%). In this group, the proportion of patients who achieved a viral load of less than 50 copies/mL at week 156 was more than twice as high with APTIVUS/r as with comparator protease inhibitors (21.8% vs. 9.3%).

    "The new data show that for patients who achieve successful HIV suppression with tipranavir, the results are usually maintained over the long term. In a patient population for which treatment options are limited, this is an important achievement," said lead author Charles Hicks, M.D., associate professor of medicine at Duke University, USA.

    The adverse event profile for APTIVUS/r was comparable with what has been reported in previous analysis. The patient exposure years (PEY)-adjusted adverse event profile was similar between APTIVUS and the comparator protease inhibitors group.

    About RESIST

    The RESIST trials are randomised, controlled, open-label, Phase III trials designed to study APTIVUS combined with ritonavir versus a group of ritonavir-boosted comparator protease inhibitors. The RESIST clinical trial programme is one of the largest study programs undertaken with an investigational antiretroviral agent in patients previously treated with three classes of antiretrovirals, with Phase II and III data from more than 1,400 patients taking the 500 mg/200 mg dose of APTIVUS/r.

    About APTIVUS

    APTIVUS is a non-peptidic protease inhibitor which works by inhibiting the viral protease, an enzyme needed to complete the HIV replication process. It is approved for combination antiretroviral treatment of HIV-1 infected adults that are highly pre-treated with virus resistant to multiple protease inhibitors.

    Based on available clinical and in vitro data, APTIVUS is active against most strains of HIV-1 that are resistant to commercially available protease inhibitors.

    Currently, phase II and III studies in paediatric and other populations are fully enrolled and ongoing.

    The most commonly reported side effects of at least moderate intensity in patients enrolled in the RESIST studies taking APTIVUS are gastrointestinal, including diarrhoea, nausea, vomiting and abdominal pain. Fever, fatigue, headache, bronchitis, depression and rash also occurred. Elevated transaminase, cholesterol and triglycerides were more frequent in the APTIVUS/r arm than in the ritonavir boosted comparator group but only in a minority of cases treatment discontinuation was necessary.

    APTIVUS boosted with low-dose ritonavir has been associated with reports of hepatic adverse events, which have included some fatalities. These have generally occurred in patients with advanced HIV disease taking multiple concomitant medications. Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection, as these patients have an increased risk of liver toxicity. The most common moderate to severe laboratory abnormalities were elevated liver enzymes and elevated lipid levels. Most laboratory abnormalities were asymptomatic and most patients were successfully treated without discontinuation.

    APTIVUS-containing HAART regimens have been associated with reports of both fatal and non-fatal intracranial hemorrhage (ICH) in some highly treatment-experienced patients. Caution should be used when prescribing APTIVUS/r in patients who may be at risk of increased bleeding or who are receiving medications known to increase the risk of bleeding.

    APTIVUS does not cure HIV infection/AIDS or prevent the transmission of HIV to others. Patients may continue to develop opportunistic infections and other complications associated with HIV disease.

    Apart from the EU, APTIVUS received U.S. marketing authorization by the FDA and was launched there in June 2005. On 4 October 2007, the FDA granted traditional approval for APTIVUS. Additional marketing authorizations from different countries have been received or are expected.

    About Boehringer Ingelheim

    Boehringer Ingelheim is committed to the research and development of novel antiretroviral agents. Apart from Aptivus(R) (tipranavir), Viramune(R) (nevirapine) 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 on the market. The company is involved in basic research in that area and is committed to improving HIV therapy by providing physicians and patients with innovative antiretroviral treatment options.

    Boehringer Ingelheim is actively conducting clinical trial programs to further evaluate APTIVUS and VIRAMUNE for the treatment of HIV-1 infection. The APTIVUS clinical trial program is comprised of ongoing and planned studies in more than 1,400 treatment-experienced patients:

@@start.t1@@      -- In addition to the RESIST study, Boehringer Ingelheim is also
          conducting the SPRING trial to examine the benefits of APTIVUS/r in an
          ethnically and racially diverse highly treatment-experienced patient
          population.
      -- Enrollment also began for the POTENT study in August 2007. POTENT
          will compare the efficacy and safety of APTIVUS/r versus darunavir/r,
          both as part of combination antiretroviral therapy, for treatment-
          experienced patients.
      -- The VIRAMUNE clinical trial program includes the ArTEN trial, which
          aims to compare the efficacy and safety of VIRAMUNE dosed once or
          twice daily versus atazanavir boosted with ritonavir in HIV-positive
          antiretroviral-naive patients.@@end@@

    For more information on the Boehringer Ingelheim HIV Franchise, please see www.boehringer-ingelheim.com/hiv.

    Please be advised

    This release is from the Corporate Headquarters of Boehringer Ingelheim and is intended for all international markets. This being the case, please be aware that there may be some differences between countries regarding specific medical information including licensed uses. Please take account of this when referring to the material.

    References:

    (1) Hicks et al. Tipranavir/r (TPV/r) maintains long term virological suppression - Three year follow-up of RESIST; 11th annual European AIDS Conference (EACS); 24-27 October 2007, Madrid, Spain. Abstract number P4.3/70.

    (2) Treatment response rates are defined as a confirmed 1 log10 or greater decrease in viral load from baseline.

    Web site: http://www.boehringer-ingelheim.com/hiv

ots Originaltext: Boehringer Ingelheim
Im Internet recherchierbar: http://www.presseportal.ch

Contact:
Judith von Gordon, CD Communications, + 49-6132-773582, or fax,
+49-6132-776601, for Boehringer Ingelheim GmbH



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