New Data Demonstrate Efficacy of Two Leading Anti-HIV Treatments
Dublin, Ireland, November 21 (ots/PRNewswire)
- New hope for HIV/AIDS patients: APTIVUS(R) outperforms several commonly prescribed drugs in the protease inhibitor (PI) class
DUBLIN, Ireland, November 21 /PRNewswire/ --
- Experts Emphasize Need for Effective Therapy in Response to Increased Prevalence of HIV/AIDS throughout Europe
At the 10th European AIDS Clinical Society (EACS) conference, experts presented new data that support physicians' ability to effectively treat the individual needs of diverse HIV patients. Researchers presented data demonstrating that the newly approved anti-HIV drug APTIVUS(R) (tipranavir) provides a convincing and lasting benefit for patients whose virus has developed resistance to other anti-HIV medications.(1) In addition, researchers presented new safety and efficacy analyses from a head-to-head study of VIRAMUNE(R) (nevirapine) and efavirenz, for patients with less advanced HIV.
HIV/AIDS rates are increasing across Europe due to major shifts in demographic, social and economic factors, according to leading European HIV/AIDS researchers. Over the last four years, new HIV diagnoses have increased 23 percent in the E.U., with 69 percent in the U.K. alone.(2) UNAIDS estimates that more than 2 million people were living with HIV in Europe at the end of 2004.(3)
"The growing population of newly infected HIV patients in Europe, coupled with the steady population of those already diagnosed, present a diverse range of considerations that physicians and patients must weigh in selecting appropriate treatments," said Dr. William Powderly, head of the School of Medicine and Medical Science at University College Dublin (UCD), who presented at the press briefing. "Therapies need to be tailored to patients' individual needs and, fortunately, there are now convincing treatment options available to meet the needs of patients across the spectrum -- whether they are newly diagnosed or have been on treatment for some time."
APTIVUS(R): Convincing Treatment for Resistant HIV
Combined findings from two studies, RESIST-1 and RESIST-2, demonstrate that APTIVUS(R) continues to outperform several commonly prescribed drugs in the protease inhibitor (PI) class through 48 weeks of treatment, achieving greater decreases in the amount of HIV present in a patient's blood and greater increases in the patient's immune (CD4 T-lymphocytes) cells.
Additional study results presented at EACS show that earlier treatment with APTIVUS(R), when other active drugs are still available for combination, leads to better patient outcomes. APTIVUS consistently achieved a superior treatment outcome -- measured in viral load decreases and immune cell increases -- over comparator treatment, regardless of the number of protease inhibitors patients had taken previously. Treatment response with APTIVUS(R) is further improved when other active anti-HIV medications are given.(4,5,6,7)
APTIVUS(R), co-administered with low-dose ritonavir as a boosting agent, was granted marketing approval in the European Union on 25 October 2005 for the combination treatment of HIV in adult patients who have previously taken other anti-HIV therapies and have developed resistance to more than one drug in the PI class.
"The availability of APTIVUS(R) provides new hope for patients whose virus does not respond well to other anti-HIV drugs," said Dr. Jurgen Rockstroh, professor of medicine and head of the HIV Outpatient Clinic at the University of Bonn in Germany. "APTIVUS(R) enables physicians to once again provide convincing treatment against HIV for these patients with limited treatment options."
Efficacy and Safety of VIRAMUNE(R)
At this conference, data on another class of HIV drugs, NNRTIs (non-nucleoside reverse transcriptase inhibitors,) were presented. NNRTIs are more commonly used in earlier stage patients. The data presented dealt with a post-hoc analysis of the safety data of VIRAMUNE(R) (nevirapine) in the 2NN study. Due to a potential center affect detected in one of the 65 participating centers, this center has been excluded in the re-analysis. The result of the analysis of the data of the remaining 64 centers demonstrated improved hepatic safety of VIRAMUNE in the study. In addition, the re-analysis revealed that when the recently updated label changes were applied, a reduction in the incidence of hepatic adverse events could be shown for both VIRAMUNE(R) arms. "These data show that when used according to the updated label VIRAMUNE(R) continues to be a good treatment choice for patients with HIV infection. VIRAMUNE(R) is, one of the most widely prescribed antiretroviral drugs. The therapeutic value of VIRAMUNE(R) has been proven in more than 800,000 patient years worldwide," said Dr. Powderly. Patient years are a commonly used denominator for the accumulated treatment time for all patients receiving the specific treatment in a non-clinical setting.
VIRAMUNE for the Prevention of Mother-to-Child Transmission of HIV in the Developing World
Boehringer Ingelheim, through the Viramune Donation Programme (VDP), donates VIRAMUNE(R) to developing countries for use in the prevention of mother-to-child transmission of HIV where one dose can be administered to the mother during labour and one to the infant after birth in a resource limited setting. To date 140 programmes in 58 countries have been approved to participate in the VDP.
In total, Boehringer Ingelheim has provided drug sufficient to treat approximately 640,000 mother-infant pairs.
"Boehringer Ingelheim is committed not only to the research and development of new drugs against HIV/AIDS, but also to providing access to antiretroviral treatment for HIV patients in the developing world by the Viramune Donation Programme, by providing VIRAMUNE(R) at reduced prices for chronic therapy and by granting voluntary licences to generic manufacturers in emerging economies," said Helmut Leuchten, Head of Corporate Department Consumer Group, HIV-Specialists/Virologists at Boehringer Ingelheim.
APTIVUS(R)
APTIVUS(R), a new non-peptidic protease inhibitor, works by inhibiting protease, an enzyme needed to complete the HIV replication process. Based on available clinical and in vitro data, APTIVUS(R) is active against most strains of HIV-1 that are resistant to commercially available protease inhibitors.
In studies to date, APTIVUS(R) has been well tolerated by most patients and has a safety profile similar to other PIs. The most commonly reported side effects of at least moderate intensity in patients enrolled in the RESIST studies taking APTIVUS(R) are gastrointestinal, including diarrhoea, nausea, vomiting and abdominal pain. Fever, fatigue, headache, bronchitis, depression and rash also occurred.
APTIVUS(R), boosted with low-dose ritonavir, has been associated with reports of liver-related adverse events, which have included some fatalities. 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.
Apart from the EU, APTIVUS(R) has received US marketing authorization by the FDA and was launched there in June 2005. Additional marketing authorizations from different countries have been received or are expected.
VIRAMUNE(R)
VIRAMUNE(R) (nevirapine) is a non-nuceloside reverse transcriptase inhibitor (NNRTI) indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principal clinical trials that demonstrated prolonged suppression of HIV-RNA and on two 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.
Boehringer Ingelheim
Boehringer Ingelheim is committed to the research and development of novel antiretroviral agents. 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. APTIVUS(R), a non-peptidic protease inhibitor with a unique resistance profile, has been granted marketing authorisation in the U.S., Mexico, Switzerland and the European Union. 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.
References:
(1.) Cahn P. and Hicks C. 48 Week Meta-Analyses Demonstrate Superiority
of Protease Inhibitor (PI) Tipranavir + Ritonavir (TPV/r) Over an
Optimized PI (CPI/r) Regimen in Antiretroviral (ARV) Experienced
Patients. 10th European AIDS Conference, Dublin, Ireland. Abstract
# PS 3/8.
(2.) EuroHIV. HIV/AIDS Surveillance in Europe. End-year Report 2003.
Saint-Maurice: Institut de veille sanitaire, 2004. No. 70.
(3.) UNAIDS/WHO AIDS epidemic update, December 2004.
(4.) Rockstroh et al. 24-Week Analysis of the Efficacy of Tipranavir
Boosted With Ritonavir (TPV/r) in HIV Patients Stratified by
Previous Protease Inhibitor (PI) Use. 10th European AIDS
Conference, Dublin, Ireland. Abstract # PE7.9/11.
(5.) Farthing C. Superior Efficacy of Tipranavir Boosted With Ritonavir
(TPV/r) vs Comparator Boosted Protease Inhibitors (CPI/r) in
Patients Stratified by Viral Load (VL) and CD4+ Cell Count. 10th
European AIDS Conference, Dublin, Ireland.
Abstract # PE7.3/22.
(6.) Moreno et al. Impact of Including Genotypically Sensitive
Antiretrovirals in a Tipranavir Boosted With Ritonavir (TPV/r)
Regimen on Viral Load Response. 10th European AIDS Conference,
Dublin, Ireland. Abstract # PE3.3/4.
(7.) Kohlbrenner at al. Tipranavir Boosted With Ritonavir (TPV/r)
Combined with an NNRTI Shows Superior Antiviral Activity Than TPV/r
Without an NNRTI. 10th European AIDS Conference, Dublin, Ireland.
Abstract # PE7.7/2.Web site: http://www.boehringer-ingelheim.com/hiv
Contact:
Judith von Gordon of CD Communications, +49-6132-773582, or Fax:
+49-6132-776601, for Boehringer Ingelheim GmbH
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