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Title: Tipranavir + Ritonavir Superior to Optimized Comparator Regimen in Antiretroviral Experienced Patients: Presented at EACS

"Tipranavir + Ritonavir Superior to Optimized Comparator Regimen in Antiretroviral Experienced Patients: Presented at EACS"

By Ted Bosworth DUBLIN, IRELAND -- December 9, 2005 -- The 48-week results from the phase 3 trials with ritonavir-boosted tipranavir (TPV/r) demonstrated sustained viral suppression in highly treatment-experienced patients. The findings were anticipated by the 24-week data which have already led to approval of TPV/r in several countries, including the United States. The data were presented here on November 18[^th in the late breaker scientific sessions of the 10^th European AIDS Conference (EACS) as a meta-analysis of the 2 phase 3 studies, RESIST-1, conducted in North America and Australia, and RESIST-2, conducted in Europe and Latin America.

"Boosted tipranavir is a potent therapeutic option for treatment-experienced patients. At 48 weeks more than twice as many patients had sustained undetectable viremia whether measured by less than 400 or less than 50 copies [per mL]," reported Pedro Cahn, MD, president, Fundación Huésped, chief of infectious diseases, Hospital Fernández, Buenos Aires, Argentina.

"However," he added, "it is important to note that the best responses were achieved when tipranavir was combined with at least 1 other active antiretroviral therapy."

In the combined RESIST studies, 1483 patients were enrolled who were at least triple-class experienced and had at least 1 primary protease inhibitor (PI) mutation. The investigators selected a comparator boosted PI (CPI/r) and an optimized background regimen before the patients were randomized to receive TPV/r plus the optimized regimen or the CPI/r and optimized regimen.

Based on the anticipation that this heavily treatment experienced population would be likely to respond to the entry inhibitor enfuvirtide (T-20), an analysis of the combined effects of these drugs was prespecified.

The viral load was reduced by an average of 1.14 log10 RNA copies/mL in those receiving TPV/r versus 0.54 log₁₀ in the CPI/r group (P < .0001).

The proportion of patients achieving a viral load < 400 copies/mL was 30.4% in the TPV/r arm versus 13.8% (P < .0001) in the CPI/r arm. The proportion of patients with < 50 copies were 22.8% and 10.2%, respectively (P < .0001).

Among patients who also received enfuvirtide, the proportion with a viral load < 50 copies/mL rose to 35.8% in the TPV/r group versus 14.4% in the CPI/r group. Immune reconstitution was also twice as great in the arms receiving TPV/r.

Serious adverse events were less common in the TPV/r arm than in the CPI/r arm (23.9 vs 27.8 per 100 patient years).

"The results show that the benefits achieved at 24 weeks were sustained at 48 weeks. This therapy appears to provide an opportunity to regain control of HIV infection in patients who are highly treatment experienced," Dr. Cahn concluded.

This study was funded by Boehringer-Ingelheim, the manufacturers of tipranavir.

[Presentation title: RESIST-1 and RESIST-2 48 Week Meta-Analyses Demonstrate Superiority of Protease Inhibitor (PI) Tipranavir+Ritonavir (TPV/R) Over an Optimized Comparator PI (CPI/R) Regimen in Antiretroviral Experienced Patients. Abstract LSPS3/8]

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