Efficacy of investigational anti-HIV agent tipranavir demonstrated by new data

02-Mar-2005

New data from multiple analyses support the efficacy of the investigational non-peptidic protease inhibitor tipranavir in treatment-experienced HIV-positive patients. In a 24-week analysis of the RESIST pivotal phase III studies, treatment regimens containing tipranavir boosted with low-dose ritonavir (tipranavir/r) were more effective than regimens containing lopinavir, the market leading protease inhibitor (PI) that is boosted with low-dose ritonavir (lopinavir/r or Kaletra®). In another recent 24-week analysis, tipranavir-containing regimens were consistently more effective than regimens containing a comparator PI of lopinavir, saquinavir, amprenavir or indinavir, regardless of the number and type of baseline protease mutations. These analyses also indicate that more patients achieved a treatment response whenever other active anti-HIV agents were added to tipranavir therapy.

In the RESIST studies, treatment response was defined as a confirmed 1 log10 drop in viral load at 24 weeks. Treatment response was achieved by 39.6% of patients who received tipranavir/r therapy compared to 21.4% of patients who received lopinavir/r (p<0.0001). Moreover, a greater proportion of patients receiving tipranavir therapy achieved a viral load below the level of quantification than those who were treated with lopinavir/r. At 24 weeks, 34.1% of patients in the tipranavir/r arm and 18.3% in the lopinavir/r arm achieved a viral load of less than 400 copies/mL.

An additional analysis of the RESIST data shows that a consistently greater proportion of patients taking tipranavir/r responded to treatment than patients taking a comparator PI/r, regardless of the number and type of baseline protease mutations. Treatment response was achieved by 50.4% vs. 29.8% of patients with 12 or fewer protease gene mutations in the tipranavir/r and comparator PI/r arms, respectively. In the presence of 19 or more mutations, 31.7% of patients taking tipranavir/r vs. 7.7% of patients taking a comparator PI/r achieved a treatment response.

https://www.bionity.com/en/news/43872/efficacy-of-investigational-anti-hiv-agent-tipranavir-demonstrated-by-new-data.html