Boosted Tipranavir versus Darunavir in Treatment-Experienced Patients

Abstract

Background: The POTENT trial compared the safety and efficacy of tipranavir/ ritonavir (TPV/r) to darunavir/ritonavir (DRV/r), each with an optimized background regimen (OBR) in triple-class experienced HIV-1-infected patients with resistance to more than one protease inhibitor (PI). Methodology/Principal Findings: POTENT was a prospective, open-label study of triple-class (PI, non-nucleoside reverse transcriptase inhibitors [NNRTI], nucleoside reverse transcriptase inhibitors [NRTI]), treatment-experienced, HIVpositive patients. Subjects were randomized to either TPV/r (500/200 mg twice daily) or DRV/r (600/100 mg twice daily) on a genotype-guided, investigatorselected OBR. CD4+ counts and HIV viral loads were assayed at key timepoints. The primary endpoint was time to virologic failure (viral load ‡500 copies/mL).POTENT was prematurely terminated due to slow enrollment. Thirty-nine patients were treated with either TPV/r (n = 19) or DRV/r (n = 20); 82% were male, 77% White, with mean age of 43.6 years. Mean baseline HIV RNA was 3.9 log 10 copies/mL. Median prior antiretrovirals was 11, with no prior raltegravir or maraviroc exposure. Raltegravir was the most common novel class agent in the OBRs (n = 14 TPV/r; n = 12 DRV/r). In both groups, patients achieved mean viral load decreases ‡2 log 10 copies/mL by week 8, and by week 12 mean CD4+ counts rose by 40-50 cells/mm

Tipranavir in the Protease Inhibitors Arena

“…The aim of the POTENT trial[16] was the head-to-head comparison of the safety and efficacy of TPV versus DRV plus a low dose of ritonavir, each with an optimized background regimen (OBR) in triple-class-experienced HIV-infected patients, being resistant to more than one PI.…”