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

Elgadi MM, Piliero PJ - Drugs R D (2011)

Bottom Line: Total observation time was 32 weeks.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).

View Article: PubMed Central - PubMed

Affiliation: Clinical Development and Medical Affairs, Boehringer Ingelheim (Canada) Ltd., Burlington, ON, Canada. mabrouk.elgadi@boehringer-ingelheim.com

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, 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/significance: 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).

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Related in: MedlinePlus

Baseline sensitivities to tipranavir/ritonavir (TPV/r) and darunavir/ritonavir (DRV/r)
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Tab2: Baseline sensitivities to tipranavir/ritonavir (TPV/r) and darunavir/ritonavir (DRV/r)

Mentions: Of the newer drug classes, raltegravir was the agent most commonly included in the OBR for patients in both arms of the study (n = 14 and n = 12, TPV/r and DRV/r groups, respectively). Maraviroc was the next most common novel drug included as part of OBR (n = 4 and n = 2, TPV/r and DRV/r groups, respectively). Enfuvirtide was included in the OBR of three patients in each arm of the study. Resistance testing by virtual phenotypic analysis at baseline identified baseline sensitivities to TPV/r and DRV/r (table II).


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

Elgadi MM, Piliero PJ - Drugs R D (2011)

Baseline sensitivities to tipranavir/ritonavir (TPV/r) and darunavir/ritonavir (DRV/r)
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3585832&req=5

Tab2: Baseline sensitivities to tipranavir/ritonavir (TPV/r) and darunavir/ritonavir (DRV/r)
Mentions: Of the newer drug classes, raltegravir was the agent most commonly included in the OBR for patients in both arms of the study (n = 14 and n = 12, TPV/r and DRV/r groups, respectively). Maraviroc was the next most common novel drug included as part of OBR (n = 4 and n = 2, TPV/r and DRV/r groups, respectively). Enfuvirtide was included in the OBR of three patients in each arm of the study. Resistance testing by virtual phenotypic analysis at baseline identified baseline sensitivities to TPV/r and DRV/r (table II).

Bottom Line: Total observation time was 32 weeks.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).

View Article: PubMed Central - PubMed

Affiliation: Clinical Development and Medical Affairs, Boehringer Ingelheim (Canada) Ltd., Burlington, ON, Canada. mabrouk.elgadi@boehringer-ingelheim.com

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, 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/significance: 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).

Show MeSH
Related in: MedlinePlus