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BI's Aptivus wins full US approval; SPRING Trial for Women tests TDM
 
 
  08/10/2007
www.pharmatimes.com
 
Boehringer Ingelheim has won full US Food and Drug Administration clearance to market its AIDS therapy Aptivus (tipranavir).
 
Aptivus, a protease inhibitor that works by inhibiting the enzyme needed to complete the HIV replication process, was approved under the accelerated approval process in 2005, which is designed to allow therapies for serious or life-threatening illnesses that are deemed to provide meaningful benefit to patients over existing treatments faster access to the market.
 
Following its traditional approval, Aptivus, co-administered with 200mg of ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infected adult patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor.
 
The green light is based largely on 48-week analyses of the Phase III pivotal clinical studies RESIST (Randomized Evaluation of Strategic Intervention in Multi-Drug ReSistant Patients with Tipranavir), which showed that more than twice the percentage of patients (33.8%) treated with a combination of Aptivus and ritonavir achieved a treatment response compared to those patients treated with a comparator PI regimen (14.9%), and that more 30.3% of patients in the Aptivus/r arm achieved a viral load of less than 400 copies/mL compared to 13.6% in the control group.
 
"Data show that Aptivus/r may provide treatment-experienced HIV patients with an effective treatment option through nearly one year of therapy," explained Dr Daniel Kuritzkes, associate professor of medicine at Harvard Medical School and director of AIDS research at the Brigham and Women`s Hospital in Boston. "Furthermore," he said, "longer-term safety data are now available for physician and patient consideration."
 
SPRING trial
Earlier this year, the company commenced enrolment of patients in a Phase IIIb trial of Aptivus to assess its efficacy across a wide range of race and gender.
 
The SPRING project "will be one of the largest racially and gender diverse international studies of highly treatment-experienced HIV-1 infected patients", the German-headquartered drugmaker said at the time, noting that it will examine the safety, efficacy and pharmacokinetics of Aptivus in a racially diverse group of 200 female and 200 male treatment-experienced patients across eight countries (at 72 sites) in three continents.
 
Clinical trials have shown that the efficacy of antiretroviral treatments may vary across races and genders, and SPRING is designed to further examine Aptivusf utility in a diverse subset of patients.
 
By Selina McKee Boehringer tests HIV drug Aptivus in racially-diverse trial
 
15/06/2007
 
Boehringer Ingelheim says that it has started enrolling patients for a Phase IIIb trial of its HIV drug Aptivus which will look at the efficacy of the drug across a wide range of race and gender.
 
The SPRING project "will be one of the largest racially and gender diverse international studies of highly treatment-experienced HIV-1 infected patients", the German-headquartered drugmaker said, noting that it will examine the safety, efficacy and pharmacokinetics of Aptivus (tipranavir) in a racially diverse group of 200 female and 200 male treatment-experienced patients across eight countries (at 72 sites) in three continents.
 
Boehringer noted that patients will be included in a randomised evaluation to assess the impact of therapeutic drug monitoring (TDM) on the efficacy and safety of Aptivus boosted with ritonavir, with a 500 mg/200 mg dose given twice daily for 48 weeks. TDM measures specific drug levels in the blood at certain times and is used to tailor dosages to fit the specific needs of the individual patient.
 
Clinical trials have shown that the efficacy of antiretroviral treatments may vary across races and genders, said SPRING investigator Sharon Walmsley, who noted that 48-week data from the firmfs RESIST studies a couple of years ago have already demonstrated the efficacy of Aptivus in treatment-experienced patients. "SPRING is designed to further examine its utility in diverse patients within this population," she concluded,
 
Worldwide, there are more HIV-positive women than ever before, with nearly 18 million currently living with the disease,
said Boehringer, noting that women of African and Latin American descent are disproportionately affected and account for a large number of infections in developed countries, including those in Europe. In the USA, half of patients diagnosed with HIV between 2001 and 2004 were African-Americans, while 20% were of Latin American descent, the company said.
 
 
 
 
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