Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
PRNewswire - December 18, 2001
"The results presented here today show that both doses of tipranavir studied suppress viral load for patients in whom one protease inhibitor based regimen has failed," said Dr. Charles Farthing, medical director at AIDS Healthcare Foundation in Los Angeles. "Further evaluation from ongoing trials will help to determine tipranavir's role in the single PI failure patients as well as in more advanced patients."
Preliminary 16-week data presented today suggest that the two tipranavir-based treatment regimens evaluated in the study effectively reduced viral load in patients who had previously experienced failure with their first PI-containing regimen.
Study Results
The open-label parallel group randomized patients to combination therapy of two doses of tipranavir [TPV] with ritonavir* [RTV] vs. saquinavir* [SQV] with RTV in single PI-experienced patients. Sixty-three patients were randomized to the following combination regimens: TPV 1250 mg + RTV 100 mg (TPV1250; 21 patients); TPV 500 + RTV 100 mg (TPV500; 21 patients); SQV 400 mg + RTV 400 mg (SQV; 21 patients). All patients randomized also received two new nucleoside reverse transcriptase inhibitors. Treatment combinations in this study were taken twice daily (bid).
In a preliminary intent-to-treat analysis at 16 weeks, 55% in the TPV1250 group, 39% of patients in the TPV500 group and 40% of patients in the SQV group achieved HIV levels (HIV RNA) in the blood below the limit of detection (<400 copies/mL). The proportion of patients with HIV RNA <50 copies/mL was 35% in TPV1250, 22% in TPV500 and 30% in SQV. This represents a mean reduction from baseline in HIV RNA of 1.40 log10 copies/mL, 1.30 log10 copies/mL and 1.36 log10 copies/mL in the TPV1250, TPV500 and SQV groups, respectively.
"In this study and in others, tipranavir has been shown to reduce viral load in patients who have experience with one or more protease inhibitor based regimen. As additional data becomes available, the use of tipranavir for patients in more advanced stages of disease will be further clarified," noted Dr. Farthing.
The most common drug related adverse events were gastrointestinal and tended to occur within the first 28 days of treatment and resolved spontaneously or with the use of over-the-counter remedies.
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 Pharmaceuticals, Inc, a member of the Boehringer Ingelheim group of companies.
VIRAMUNE was the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs. Last year, Boehringer Ingelheim acquired the worldwide marketing rights to the investigational non-peptidic protease inhibitor tipranavir. 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: http://www.boehringer-ingelheim.com/hiv
41st ICAAC ORAL LATE BREAKER SESSION II: Tuesday, December 18, 12:00 - 1:30 PM
Abstract LB15, Safety and Efficacy of Tipranavir, A Non-Peptidic Protease Inhibitor, in PI-Failure Patients, L. Slater, C. Farthing, J. Jayaweera, M. Para, D. Haas, C. Dohnanyi, V. Kohlbrenner, S. McCallister, D. Mayers & the BI 1182.4 study team.
* Antiretroviral agents referenced in this release: ritonavir (Norvir(R)),
Abbott Laboratories; saquinavir (Invirase(R)), Roche Laboratories
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PR011238
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