Limits...
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).

Show MeSH

Related in: MedlinePlus

Patient disposition flow chart. DRV/r = darunavir/ritonavir; TPV/r = tipranavir/ritonavir.
© Copyright Policy
Related In: Results  -  Collection


getmorefigures.php?uid=PMC3585832&req=5

Fig1: Patient disposition flow chart. DRV/r = darunavir/ritonavir; TPV/r = tipranavir/ritonavir.

Mentions: Figure 1 presents the complete patient disposition results. Of the 39 patients who received treatment, 19 were treated with TPV/r and 20 were treated with DRV/r. Seven patients were prematurely discontinued from the trial, six in the TPV/r arm and one in the DRV/r arm. Reasons for discontinuation included AEs (n = 1 in each group), lack of efficacy (n = 3, TPV/r group), lost to follow-up (n = 1, TPV/r group), and withdrawal of patient consent (n = 1, TPV/r group). Of the six patients in the TPV/r group who interrupted treatment, three were for loss of efficacy when they experienced increased viral loads on treatment, following initial drops on treatment. The mean and median duration of treatment among TPV/r and DRV/r patients was 15.3 and 13.0 weeks, respectively, with an overall range of 0.6–37.4 weeks.


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

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

Patient disposition flow chart. DRV/r = darunavir/ritonavir; TPV/r = tipranavir/ritonavir.
© Copyright Policy
Related In: Results  -  Collection

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

Fig1: Patient disposition flow chart. DRV/r = darunavir/ritonavir; TPV/r = tipranavir/ritonavir.
Mentions: Figure 1 presents the complete patient disposition results. Of the 39 patients who received treatment, 19 were treated with TPV/r and 20 were treated with DRV/r. Seven patients were prematurely discontinued from the trial, six in the TPV/r arm and one in the DRV/r arm. Reasons for discontinuation included AEs (n = 1 in each group), lack of efficacy (n = 3, TPV/r group), lost to follow-up (n = 1, TPV/r group), and withdrawal of patient consent (n = 1, TPV/r group). Of the six patients in the TPV/r group who interrupted treatment, three were for loss of efficacy when they experienced increased viral loads on treatment, following initial drops on treatment. The mean and median duration of treatment among TPV/r and DRV/r patients was 15.3 and 13.0 weeks, respectively, with an overall range of 0.6–37.4 weeks.

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