Boosted tipranavir versus darunavir in treatment-experienced patients: observational data from the randomized POTENT trial.
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).


RESULTS
POTENT was a prospective, open-label study of triple-class (PI, non-nucleoside reverse transcriptase inhibitors [NNRTI], nucleoside reverse transcriptase inhibitors [NRTI]), treatment-experienced, HIV-positive 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, investigator-selected OBR. CD4+ counts and HIV viral loads were assayed at key timepoints. The primary endpoint was time to virologic failure (viral load ≥500copies/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/mm3. Total observation time was 32 weeks. Drug-related adverse events were reported in 21% (TPV/r) and 25% (DRV/r) of patients.


CONCLUSIONS
TPV/r- and DRV/r-based regimens showed similar short-term safety and efficacy. These data support the use of next-generation PIs such as tipranavir or darunavir with novel class antiretroviral agents (integrase inhibitors, CCR5 antagonists, or fusion inhibitors).
Clinical Development and Medical Affairs, Boehringer Ingelheim (Canada) Ltd., Burlington, ON, Canada. mabrouk.elgadi@boehringer-ingelheim.com
Mabrouk M
MM
Elgadi
Peter J
PJ
Piliero
D000328:Adult; D000069454:Darunavir; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000276:immunology; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology; D015497:HIV-1 / Q000187:drug effects / Q000254:growth & development; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011725:Pyridines / Q000008:administration & dosage* / Q000009:adverse effects; D011753:Pyrones / Q000008:administration & dosage* / Q000009:adverse effects; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D019562:Viral Load / Q000276:immunology
D011725:Pyridines; D011753:Pyrones; D013449:Sulfonamides; D000069454:Darunavir; C107201:tipranavir