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). Methodology/Prin...
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| Published in | Drugs in R&D Vol. 11; no. 4; pp. 295 - 302 |
|---|---|
| Main Authors | , |
| Format | Journal Article |
| Language | English |
| Published |
Cham
Springer International Publishing
01.12.2011
Wolters Kluwer Health, Inc Springer Nature B.V |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1174-5886 1179-6901 1179-6901 |
| DOI | 10.2165/11596340-000000000-00000 |
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| 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 (500/200mg twice daily) or DRV/r (600/100mg twice daily) on a genotype-guided, investigatorselected OBR. CD4+ counts andHIV 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 baselineHIV RNA was 3.9 log10 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 = 12DRV/r). In both groups, patients achieved mean viral load decreases >-2 log10 copies/mL by week 8, and by week 12 mean CD4+ counts rose by 40–50 cells/mm
3
. 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).
Trial Registration:
Clinicaltrials.gov NCT00517192 |
|---|---|
| AbstractList | 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 (500/200mg twice daily) or DRV/r (600/100mg twice daily) on a genotype-guided, investigatorselected OBR. CD4+ counts andHIV 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 baselineHIV RNA was 3.9 log10 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 = 12DRV/r). In both groups, patients achieved mean viral load decreases >-2 log10 copies/mL by week 8, and by week 12 mean CD4+ counts rose by 40–50 cells/mm
3
. 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).
Trial Registration:
Clinicaltrials.gov NCT00517192 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 log10 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). Trial Registration: Clinicaltrials.gov NCT00517192 [PUBLICATION ABSTRACT] 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).BACKGROUNDThe 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).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.METHODOLOGY/PRINCIPAL FINDINGSPOTENT 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.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).CONCLUSIONS/SIGNIFICANCETPV/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). 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.sub.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.sub.10] copies/mL by week 8, and by week 12 mean CD4+ counts rose by 40-50 cells/[mm.sup.3]. Total observation time was 32 weeks. Drug-related adverse events were reported in 21% (TPV/r) and 25% (DRV/r) of patients. Trial Registration: Clinicaltrials.gov NCT00517192 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 ≥ 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.sub.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.sub.10] copies/mL by week 8, and by week 12 mean CD4+ counts rose by 40-50 cells/[mm.sup.3]. 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). Trial Registration: Clinicaltrials.gov NCT00517192 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). 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. 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). |
| Audience | Academic |
| Author | Elgadi, Mabrouk M. Piliero, Peter J. |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/22007990$$D View this record in MEDLINE/PubMed |
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| References_xml | – volume: 65 start-page: 1669 issue: 12 year: 2005 end-page: 77 ident: CR3 article-title: Tipranavir: a ritonavir-boosted protease inhibitor publication-title: Drugs doi: 10.2165/00003495-200565120-00005 – year: 2011 ident: CR6 publication-title: Darunavir (Prezista).HIVInSite.December 17 2010; University of California, San Francisco [online] – volume: 65 start-page: 2195 issue: 10 year: 2010 end-page: 203 ident: CR8 article-title: Efficacy, safety and pharmacokinetics of 900/100 mg of darunavir/ritonavir once daily in treatment-experienced patients publication-title: J Antimicrob Chemother doi: 10.1093/jac/dkq295 – volume: 53 start-page: 456 issue: 4 year: 2010 end-page: 63 ident: CR14 article-title: Long-term efficacy and safety of the HIV integrase inhibitor raltegravir in patients with limited treatment options in a phase II study publication-title: J Acquir Immune Defic Syndr doi: 10.1097/QAI.0b013e3181c9c967 – volume: 26 start-page: 1279 issue: 12 year: 2010 end-page: 85 ident: CR7 article-title: Darunavir outcomes study: comparative effectiveness of virologic suppression, regimen durability, and discontinuation reasons for threeclass experienced patients at 48 weeks publication-title: AIDS Res Hum Retroviruses doi: 10.1089/aid.2010.0059 – volume: 14 start-page: 1943 issue: 13 year: 2000 end-page: 8 ident: CR2 article-title: Tipranavir inhibits broadly protease inhibitor-resistant HIV-1 clinical samples publication-title: AIDS doi: 10.1097/00002030-200009080-00009 – volume: 359 start-page: 355 issue: 4 year: 2008 end-page: 65 ident: CR13 article-title: Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection publication-title: N Engl J Med doi: 10.1056/NEJMoa0708978 – volume: 24 start-page: 379 issue: 3 year: 2008 end-page: 88 ident: CR9 article-title: Resistance profile of darunavir: combined 24-week results from the POWER trials publication-title: AIDS Res Hum Retroviruses doi: 10.1089/aid.2007.0173 – volume: 29 start-page: 2309 issue: 11 year: 2007 end-page: 18 ident: CR1 article-title: Tipranavir: the first nonpeptidic protease inhibitor for the treatment of protease resistance publication-title: Clin Ther doi: 10.1016/j.clinthera.2007.11.007 – volume: 53 start-page: 500 issue: 4 year: 2010 end-page: 6 ident: CR11 article-title: High rates of survival, immune reconstitution, and virologic suppression on second-line antiretroviral therapy in South Africa publication-title: J Acquir Immune Defic Syndr doi: 10.1097/QAI.0b013e3181bcdac1 – volume: 47 start-page: 429 issue: 4 year: 2008 end-page: 40 ident: CR5 article-title: Pharmacokinetics, safety, and efficacy of tipranavir boosted with ritonavir alone or in combination with other boosted protease inhibitors as part of optimized combination antiretroviral therapy in highly treatment-experienced patients (BI Study 1182.51) publication-title: J Acquir Immune Defic Syndr doi: 10.1097/QAI.0b013e318160a529 – volume: 2 start-page: 130 issue: 2 year: 2007 end-page: 6 ident: CR10 article-title: Resistance to newly approved and investigational protease inhibitors publication-title: Curr Opin HIV AIDS doi: 10.1097/COH.0b013e3280287a38 – volume: 22 start-page: 2267 issue: 17 year: 2008 end-page: 77 ident: CR12 article-title: Continuous improvement in the immune system of HIV-infected children on prolonged antiretroviral therapy publication-title: AIDS doi: 10.1097/QAD.0b013e3283189bb3 – volume: 7 issue: 1 year: 2006 ident: CR4 publication-title: Drugs R D – volume: 65 start-page: 2195 issue: 10 year: 2010 ident: 11040295_CR8 publication-title: J Antimicrob Chemother doi: 10.1093/jac/dkq295 – volume: 53 start-page: 500 issue: 4 year: 2010 ident: 11040295_CR11 publication-title: J Acquir Immune Defic Syndr doi: 10.1097/QAI.0b013e3181bcdac1 – volume: 65 start-page: 1669 issue: 12 year: 2005 ident: 11040295_CR3 publication-title: Drugs doi: 10.2165/00003495-200565120-00005 – volume: 7 issue: 1 year: 2006 ident: 11040295_CR4 publication-title: Drugs R D – volume: 14 start-page: 1943 issue: 13 year: 2000 ident: 11040295_CR2 publication-title: AIDS doi: 10.1097/00002030-200009080-00009 – volume: 26 start-page: 1279 issue: 12 year: 2010 ident: 11040295_CR7 publication-title: AIDS Res Hum Retroviruses doi: 10.1089/aid.2010.0059 – volume: 47 start-page: 429 issue: 4 year: 2008 ident: 11040295_CR5 publication-title: J Acquir Immune Defic Syndr doi: 10.1097/QAI.0b013e318160a529 – volume: 22 start-page: 2267 issue: 17 year: 2008 ident: 11040295_CR12 publication-title: AIDS doi: 10.1097/QAD.0b013e3283189bb3 – volume: 2 start-page: 130 issue: 2 year: 2007 ident: 11040295_CR10 publication-title: Curr Opin HIV AIDS doi: 10.1097/COH.0b013e3280287a38 – volume: 24 start-page: 379 issue: 3 year: 2008 ident: 11040295_CR9 publication-title: AIDS Res Hum Retroviruses doi: 10.1089/aid.2007.0173 – volume-title: Darunavir (Prezista).HIVInSite.December 17 2010; University of California, San Francisco [online] year: 2011 ident: 11040295_CR6 – volume: 53 start-page: 456 issue: 4 year: 2010 ident: 11040295_CR14 publication-title: J Acquir Immune Defic Syndr doi: 10.1097/QAI.0b013e3181c9c967 – volume: 29 start-page: 2309 issue: 11 year: 2007 ident: 11040295_CR1 publication-title: Clin Ther doi: 10.1016/j.clinthera.2007.11.007 – volume: 359 start-page: 355 issue: 4 year: 2008 ident: 11040295_CR13 publication-title: N Engl J Med doi: 10.1056/NEJMoa0708978 – reference: 20713406 - J Antimicrob Chemother. 2010 Oct;65(10):2195-203 – reference: 20306554 - J Acquir Immune Defic Syndr. 2010 Apr 1;53(4):456-63 – reference: 10997398 - AIDS. 2000 Sep 8;14(13):1943-8 – reference: 18327986 - AIDS Res Hum Retroviruses. 2008 Mar;24(3):379-88 – reference: 18650513 - N Engl J Med. 2008 Jul 24;359(4):355-65 – reference: 20961276 - AIDS Res Hum Retroviruses. 2010 Dec;26(12):1279-85 – reference: 18981766 - AIDS. 2008 Nov 12;22(17):2267-77 – reference: 18176328 - J Acquir Immune Defic Syndr. 2008 Apr 1;47(4):429-40 – reference: 19838128 - J Acquir Immune Defic Syndr. 2010 Apr 1;53(4):500-6 – reference: 19372878 - Curr Opin HIV AIDS. 2007 Mar;2(2):130-6 – reference: 16060700 - Drugs. 2005;65(12):1669-77; discussion 1678-9 – reference: 18158073 - Clin Ther. 2007 Nov;29(11):2309-18 |
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| Snippet | Background:
The POTENT trial compared the safety and efficacy of tipranavir/ritonavir (TPV/r) to darunavir/ritonavir (DRV/r), each with an optimized 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... Background: The POTENT trial compared the safety and efficacy of tipranavir/ritonavir (TPV/r) to darunavir/ritonavir (DRV/r), each with an optimized background... 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%... |
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| SubjectTerms | Adult Complications and side effects Darunavir Drug therapy Female Gastrointestinal Diseases - chemically induced Gastrointestinal Diseases - immunology HIV infection HIV Infections - drug therapy HIV Infections - immunology HIV-1 - drug effects HIV-1 - growth & development Humans Internal Medicine Male Medicine Medicine & Public Health Middle Aged Pharmacology/Toxicology Pharmacotherapy Prospective Studies Pyridines - administration & dosage Pyridines - adverse effects Pyrones - administration & dosage Pyrones - adverse effects Short Communication Sulfonamides - administration & dosage Sulfonamides - adverse effects Treatment Outcome Viral Load - immunology |
| Subtitle | Observational Data from the Randomized POTENT Trial |
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| Title | Boosted Tipranavir versus Darunavir in Treatment-Experienced Patients |
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