Phase IIIb, open‐label single‐arm trial of darunavir/cobicistat (DRV/COBI): Week 48 subgroup analysis of HIV‐1‐infected treatment‐nave adults
Introduction COBI, a PK enhancer with no ARV activity is a more selective cytochrome P450 (CYP)3A inhibitor than ritonavir (RTV), does not induce CYP isozymes, and thus has less potential for drug‐drug interactions. COBI boosts DRV PK as effectively as RTV in healthy volunteers. Materials and Method...
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Veröffentlicht in: | Journal of the International AIDS Society 2014-11, Vol.17 (4 Suppl 3), p.19772-n/a |
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creator | Tashima, Karen Crofoot, Gordon Tomaka, Frank L Kakuda, Thomas N Brochot, Anne Vanveggel, Simon Opsomer, Magda Garner, William Margot, Nicolas Custodio, Joseph M Fordyce, Marshall W Szwarcberg, Javier |
description | Introduction
COBI, a PK enhancer with no ARV activity is a more selective cytochrome P450 (CYP)3A inhibitor than ritonavir (RTV), does not induce CYP isozymes, and thus has less potential for drug‐drug interactions. COBI boosts DRV PK as effectively as RTV in healthy volunteers.
Materials and Methods
This 48‐week, phase IIIb, open‐label, single‐arm, US multicentre study (NCT01440569) included HIV‐infected treatment‐nave and experienced adults with no DRV RAMs, viral load (VL) ≥1000 c/mL, eGFR ≥80 mL/min and genotypic sensitivity to investigator‐selected N[t]RTIs. Patients received DRV/COBI 800/150 mg qd (as single agents) plus two fully active N[t]RTIs. The primary endpoint was any treatment‐emergent grade 3 or 4 AEs through Week 24. We report 48‐week safety, efficacy and PK/PD results in treatment‐nave patients.
Results
Of 313 ITT patients, 295 were treatment‐nave (94%). In the treatment‐nave cohort, 90% were male, 60% white and 294 (99.7%) received a TDF‐containing regimen. Median baseline (BL) VL was 4.8 log10 c/mL and CD4+ 370 cells/mm3. Treatment‐emergent grade 3 or 4 AEs regardless of causality were reported in 21 (7%) patients. AEs regardless of causality (any grade; ≥10% of patients) were: diarrhoea (27%), nausea (23%), URTI (15%) and headache (12%). Sixteen (5%) patients had AEs leading to study drug discontinuation, most frequently rash (three patients), hypersensitivity and nausea (two patients each). Consistent with the known inhibition of tubular creatinine secretion by COBI, there was a mean increase from BL in serum creatinine by week 2 (0.09 mg/dL), remaining stable through week 48 (mean 0.10 mg/dL increase from BL). At week 48, 83% of patients achieved VL |
doi_str_mv | 10.7448/IAS.17.4.19772 |
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fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4225446</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3067631132</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3362-1ffe4c087747928b018bef032c0f6a61ee0571949567c7e3c09b6f5094fa423a3</originalsourceid><addsrcrecordid>eNqFkstu1DAUhiMEohfYskSW2LQSk_EtdswCaRguDapUxKUsLcdzMnXrJIOdFM2OR2DH-_EkeDqlKixgceTbdz7Z1p9ljwjOJefltJp9yInMeU6UlPROtktkUU6oKOjdW_OdbC_Gc4wFLbm6n-3QgilZELGb_Xh3ZiKgqqrqp6hfQffz23dvavAoum7pIS1NaNEQnPGob9DChLEzly5MbV876-JgBnTw8v3pdH7yojp8hj4DXCBeojjWy9CPK2Q649fRxU33UXWahCSV6xqwAyySGczQQjekzSQGZBajH-KD7F5jfISH1-N-9un1q4_zo8nxyZtqPjueWMYEnZCmAW5xKSWXipY1JmUNDWbU4kYYQQBwIYniqhDSSmAWq1o0BVa8MZwyw_az51vvaqxbWNh0kWC8XgXXmrDWvXH6z5POnellf6k5pQXnIgkOrgWh_zJCHHTrogXvTQf9GDURVKRSaoM--Qs978eQvidqhoUUjBBG_0VRWiqZipWJyreUDX2MAZqbKxOsN8nQKRmaSM31VTJSw-PbD73Bf0chAXwLfHUe1v_R6bfVjF55fwGd6seh</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2289728938</pqid></control><display><type>article</type><title>Phase IIIb, open‐label single‐arm trial of darunavir/cobicistat (DRV/COBI): Week 48 subgroup analysis of HIV‐1‐infected treatment‐nave adults</title><source>DOAJ Directory of Open Access Journals</source><source>Access via Wiley Online Library</source><source>EZB-FREE-00999 freely available EZB journals</source><source>Wiley Online Library (Open Access Collection)</source><source>PubMed Central</source><creator>Tashima, Karen ; Crofoot, Gordon ; Tomaka, Frank L ; Kakuda, Thomas N ; Brochot, Anne ; Vanveggel, Simon ; Opsomer, Magda ; Garner, William ; Margot, Nicolas ; Custodio, Joseph M ; Fordyce, Marshall W ; Szwarcberg, Javier</creator><creatorcontrib>Tashima, Karen ; Crofoot, Gordon ; Tomaka, Frank L ; Kakuda, Thomas N ; Brochot, Anne ; Vanveggel, Simon ; Opsomer, Magda ; Garner, William ; Margot, Nicolas ; Custodio, Joseph M ; Fordyce, Marshall W ; Szwarcberg, Javier</creatorcontrib><description>Introduction
COBI, a PK enhancer with no ARV activity is a more selective cytochrome P450 (CYP)3A inhibitor than ritonavir (RTV), does not induce CYP isozymes, and thus has less potential for drug‐drug interactions. COBI boosts DRV PK as effectively as RTV in healthy volunteers.
Materials and Methods
This 48‐week, phase IIIb, open‐label, single‐arm, US multicentre study (NCT01440569) included HIV‐infected treatment‐nave and experienced adults with no DRV RAMs, viral load (VL) ≥1000 c/mL, eGFR ≥80 mL/min and genotypic sensitivity to investigator‐selected N[t]RTIs. Patients received DRV/COBI 800/150 mg qd (as single agents) plus two fully active N[t]RTIs. The primary endpoint was any treatment‐emergent grade 3 or 4 AEs through Week 24. We report 48‐week safety, efficacy and PK/PD results in treatment‐nave patients.
Results
Of 313 ITT patients, 295 were treatment‐nave (94%). In the treatment‐nave cohort, 90% were male, 60% white and 294 (99.7%) received a TDF‐containing regimen. Median baseline (BL) VL was 4.8 log10 c/mL and CD4+ 370 cells/mm3. Treatment‐emergent grade 3 or 4 AEs regardless of causality were reported in 21 (7%) patients. AEs regardless of causality (any grade; ≥10% of patients) were: diarrhoea (27%), nausea (23%), URTI (15%) and headache (12%). Sixteen (5%) patients had AEs leading to study drug discontinuation, most frequently rash (three patients), hypersensitivity and nausea (two patients each). Consistent with the known inhibition of tubular creatinine secretion by COBI, there was a mean increase from BL in serum creatinine by week 2 (0.09 mg/dL), remaining stable through week 48 (mean 0.10 mg/dL increase from BL). At week 48, 83% of patients achieved VL<50 c/mL; FDA Snapshot); median increase in CD4+ was 169 cells/mm3. Eight patients met the criteria for resistance testing. M184V was detected in one pt receiving FTC. New primary RAMs were not detected in the other seven patients. The mean population PK‐derived DRV AUC24h was 100,620 ng.h/mL and C0h 2,105 ng/mL (n=281). There were no clinically relevant relationships between DRV exposure and virologic response, AEs or laboratory parameters.
Conclusions
The DRV PK of DRV/COBI was consistent with historical data for DRV/RTV. DRV/COBI 800/150 mg qd plus two N(t)RTIs had an 83% response and was well tolerated through Week 48. These results are similar to published data for DRV/RTV 800/100 mg qd, and support the use of DRV/COBI 800/150 mg qd in treatment‐nave patients.</description><identifier>ISSN: 1758-2652</identifier><identifier>EISSN: 1758-2652</identifier><identifier>DOI: 10.7448/IAS.17.4.19772</identifier><identifier>PMID: 25397516</identifier><language>eng</language><publisher>Switzerland: International AIDS Society</publisher><subject>Acquired immune deficiency syndrome ; AIDS ; Creatinine ; HIV ; Human immunodeficiency virus ; Hypersensitivity ; Ritonavir</subject><ispartof>Journal of the International AIDS Society, 2014-11, Vol.17 (4 Suppl 3), p.19772-n/a</ispartof><rights>2014 Tashima K et al; licensee International AIDS Society</rights><rights>2014. This work is published under http://creativecommons.org/licenses/by/3.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2014 Tashima K et al; licensee International AIDS Society 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3362-1ffe4c087747928b018bef032c0f6a61ee0571949567c7e3c09b6f5094fa423a3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4225446/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4225446/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,1417,11562,27924,27925,45574,45575,46052,46476,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25397516$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tashima, Karen</creatorcontrib><creatorcontrib>Crofoot, Gordon</creatorcontrib><creatorcontrib>Tomaka, Frank L</creatorcontrib><creatorcontrib>Kakuda, Thomas N</creatorcontrib><creatorcontrib>Brochot, Anne</creatorcontrib><creatorcontrib>Vanveggel, Simon</creatorcontrib><creatorcontrib>Opsomer, Magda</creatorcontrib><creatorcontrib>Garner, William</creatorcontrib><creatorcontrib>Margot, Nicolas</creatorcontrib><creatorcontrib>Custodio, Joseph M</creatorcontrib><creatorcontrib>Fordyce, Marshall W</creatorcontrib><creatorcontrib>Szwarcberg, Javier</creatorcontrib><title>Phase IIIb, open‐label single‐arm trial of darunavir/cobicistat (DRV/COBI): Week 48 subgroup analysis of HIV‐1‐infected treatment‐nave adults</title><title>Journal of the International AIDS Society</title><addtitle>J Int AIDS Soc</addtitle><description>Introduction
COBI, a PK enhancer with no ARV activity is a more selective cytochrome P450 (CYP)3A inhibitor than ritonavir (RTV), does not induce CYP isozymes, and thus has less potential for drug‐drug interactions. COBI boosts DRV PK as effectively as RTV in healthy volunteers.
Materials and Methods
This 48‐week, phase IIIb, open‐label, single‐arm, US multicentre study (NCT01440569) included HIV‐infected treatment‐nave and experienced adults with no DRV RAMs, viral load (VL) ≥1000 c/mL, eGFR ≥80 mL/min and genotypic sensitivity to investigator‐selected N[t]RTIs. Patients received DRV/COBI 800/150 mg qd (as single agents) plus two fully active N[t]RTIs. The primary endpoint was any treatment‐emergent grade 3 or 4 AEs through Week 24. We report 48‐week safety, efficacy and PK/PD results in treatment‐nave patients.
Results
Of 313 ITT patients, 295 were treatment‐nave (94%). In the treatment‐nave cohort, 90% were male, 60% white and 294 (99.7%) received a TDF‐containing regimen. Median baseline (BL) VL was 4.8 log10 c/mL and CD4+ 370 cells/mm3. Treatment‐emergent grade 3 or 4 AEs regardless of causality were reported in 21 (7%) patients. AEs regardless of causality (any grade; ≥10% of patients) were: diarrhoea (27%), nausea (23%), URTI (15%) and headache (12%). Sixteen (5%) patients had AEs leading to study drug discontinuation, most frequently rash (three patients), hypersensitivity and nausea (two patients each). Consistent with the known inhibition of tubular creatinine secretion by COBI, there was a mean increase from BL in serum creatinine by week 2 (0.09 mg/dL), remaining stable through week 48 (mean 0.10 mg/dL increase from BL). At week 48, 83% of patients achieved VL<50 c/mL; FDA Snapshot); median increase in CD4+ was 169 cells/mm3. Eight patients met the criteria for resistance testing. M184V was detected in one pt receiving FTC. New primary RAMs were not detected in the other seven patients. The mean population PK‐derived DRV AUC24h was 100,620 ng.h/mL and C0h 2,105 ng/mL (n=281). There were no clinically relevant relationships between DRV exposure and virologic response, AEs or laboratory parameters.
Conclusions
The DRV PK of DRV/COBI was consistent with historical data for DRV/RTV. DRV/COBI 800/150 mg qd plus two N(t)RTIs had an 83% response and was well tolerated through Week 48. These results are similar to published data for DRV/RTV 800/100 mg qd, and support the use of DRV/COBI 800/150 mg qd in treatment‐nave patients.</description><subject>Acquired immune deficiency syndrome</subject><subject>AIDS</subject><subject>Creatinine</subject><subject>HIV</subject><subject>Human immunodeficiency virus</subject><subject>Hypersensitivity</subject><subject>Ritonavir</subject><issn>1758-2652</issn><issn>1758-2652</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNqFkstu1DAUhiMEohfYskSW2LQSk_EtdswCaRguDapUxKUsLcdzMnXrJIOdFM2OR2DH-_EkeDqlKixgceTbdz7Z1p9ljwjOJefltJp9yInMeU6UlPROtktkUU6oKOjdW_OdbC_Gc4wFLbm6n-3QgilZELGb_Xh3ZiKgqqrqp6hfQffz23dvavAoum7pIS1NaNEQnPGob9DChLEzly5MbV876-JgBnTw8v3pdH7yojp8hj4DXCBeojjWy9CPK2Q649fRxU33UXWahCSV6xqwAyySGczQQjekzSQGZBajH-KD7F5jfISH1-N-9un1q4_zo8nxyZtqPjueWMYEnZCmAW5xKSWXipY1JmUNDWbU4kYYQQBwIYniqhDSSmAWq1o0BVa8MZwyw_az51vvaqxbWNh0kWC8XgXXmrDWvXH6z5POnellf6k5pQXnIgkOrgWh_zJCHHTrogXvTQf9GDURVKRSaoM--Qs978eQvidqhoUUjBBG_0VRWiqZipWJyreUDX2MAZqbKxOsN8nQKRmaSM31VTJSw-PbD73Bf0chAXwLfHUe1v_R6bfVjF55fwGd6seh</recordid><startdate>201411</startdate><enddate>201411</enddate><creator>Tashima, Karen</creator><creator>Crofoot, Gordon</creator><creator>Tomaka, Frank L</creator><creator>Kakuda, Thomas N</creator><creator>Brochot, Anne</creator><creator>Vanveggel, Simon</creator><creator>Opsomer, Magda</creator><creator>Garner, William</creator><creator>Margot, Nicolas</creator><creator>Custodio, Joseph M</creator><creator>Fordyce, Marshall W</creator><creator>Szwarcberg, Javier</creator><general>International AIDS Society</general><general>John Wiley & Sons, Inc</general><scope>24P</scope><scope>WIN</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>201411</creationdate><title>Phase IIIb, open‐label single‐arm trial of darunavir/cobicistat (DRV/COBI): Week 48 subgroup analysis of HIV‐1‐infected treatment‐nave adults</title><author>Tashima, Karen ; Crofoot, Gordon ; Tomaka, Frank L ; Kakuda, Thomas N ; Brochot, Anne ; Vanveggel, Simon ; Opsomer, Magda ; Garner, William ; Margot, Nicolas ; Custodio, Joseph M ; Fordyce, Marshall W ; Szwarcberg, Javier</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3362-1ffe4c087747928b018bef032c0f6a61ee0571949567c7e3c09b6f5094fa423a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Acquired immune deficiency syndrome</topic><topic>AIDS</topic><topic>Creatinine</topic><topic>HIV</topic><topic>Human immunodeficiency virus</topic><topic>Hypersensitivity</topic><topic>Ritonavir</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tashima, Karen</creatorcontrib><creatorcontrib>Crofoot, Gordon</creatorcontrib><creatorcontrib>Tomaka, Frank L</creatorcontrib><creatorcontrib>Kakuda, Thomas N</creatorcontrib><creatorcontrib>Brochot, Anne</creatorcontrib><creatorcontrib>Vanveggel, Simon</creatorcontrib><creatorcontrib>Opsomer, Magda</creatorcontrib><creatorcontrib>Garner, William</creatorcontrib><creatorcontrib>Margot, Nicolas</creatorcontrib><creatorcontrib>Custodio, Joseph M</creatorcontrib><creatorcontrib>Fordyce, Marshall W</creatorcontrib><creatorcontrib>Szwarcberg, Javier</creatorcontrib><collection>Wiley Online Library (Open Access Collection)</collection><collection>Wiley Online Library (Open Access Collection)</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of the International AIDS Society</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tashima, Karen</au><au>Crofoot, Gordon</au><au>Tomaka, Frank L</au><au>Kakuda, Thomas N</au><au>Brochot, Anne</au><au>Vanveggel, Simon</au><au>Opsomer, Magda</au><au>Garner, William</au><au>Margot, Nicolas</au><au>Custodio, Joseph M</au><au>Fordyce, Marshall W</au><au>Szwarcberg, Javier</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase IIIb, open‐label single‐arm trial of darunavir/cobicistat (DRV/COBI): Week 48 subgroup analysis of HIV‐1‐infected treatment‐nave adults</atitle><jtitle>Journal of the International AIDS Society</jtitle><addtitle>J Int AIDS Soc</addtitle><date>2014-11</date><risdate>2014</risdate><volume>17</volume><issue>4 Suppl 3</issue><spage>19772</spage><epage>n/a</epage><pages>19772-n/a</pages><issn>1758-2652</issn><eissn>1758-2652</eissn><abstract>Introduction
COBI, a PK enhancer with no ARV activity is a more selective cytochrome P450 (CYP)3A inhibitor than ritonavir (RTV), does not induce CYP isozymes, and thus has less potential for drug‐drug interactions. COBI boosts DRV PK as effectively as RTV in healthy volunteers.
Materials and Methods
This 48‐week, phase IIIb, open‐label, single‐arm, US multicentre study (NCT01440569) included HIV‐infected treatment‐nave and experienced adults with no DRV RAMs, viral load (VL) ≥1000 c/mL, eGFR ≥80 mL/min and genotypic sensitivity to investigator‐selected N[t]RTIs. Patients received DRV/COBI 800/150 mg qd (as single agents) plus two fully active N[t]RTIs. The primary endpoint was any treatment‐emergent grade 3 or 4 AEs through Week 24. We report 48‐week safety, efficacy and PK/PD results in treatment‐nave patients.
Results
Of 313 ITT patients, 295 were treatment‐nave (94%). In the treatment‐nave cohort, 90% were male, 60% white and 294 (99.7%) received a TDF‐containing regimen. Median baseline (BL) VL was 4.8 log10 c/mL and CD4+ 370 cells/mm3. Treatment‐emergent grade 3 or 4 AEs regardless of causality were reported in 21 (7%) patients. AEs regardless of causality (any grade; ≥10% of patients) were: diarrhoea (27%), nausea (23%), URTI (15%) and headache (12%). Sixteen (5%) patients had AEs leading to study drug discontinuation, most frequently rash (three patients), hypersensitivity and nausea (two patients each). Consistent with the known inhibition of tubular creatinine secretion by COBI, there was a mean increase from BL in serum creatinine by week 2 (0.09 mg/dL), remaining stable through week 48 (mean 0.10 mg/dL increase from BL). At week 48, 83% of patients achieved VL<50 c/mL; FDA Snapshot); median increase in CD4+ was 169 cells/mm3. Eight patients met the criteria for resistance testing. M184V was detected in one pt receiving FTC. New primary RAMs were not detected in the other seven patients. The mean population PK‐derived DRV AUC24h was 100,620 ng.h/mL and C0h 2,105 ng/mL (n=281). There were no clinically relevant relationships between DRV exposure and virologic response, AEs or laboratory parameters.
Conclusions
The DRV PK of DRV/COBI was consistent with historical data for DRV/RTV. DRV/COBI 800/150 mg qd plus two N(t)RTIs had an 83% response and was well tolerated through Week 48. These results are similar to published data for DRV/RTV 800/100 mg qd, and support the use of DRV/COBI 800/150 mg qd in treatment‐nave patients.</abstract><cop>Switzerland</cop><pub>International AIDS Society</pub><pmid>25397516</pmid><doi>10.7448/IAS.17.4.19772</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Acquired immune deficiency syndrome AIDS Creatinine HIV Human immunodeficiency virus Hypersensitivity Ritonavir |
title | Phase IIIb, open‐label single‐arm trial of darunavir/cobicistat (DRV/COBI): Week 48 subgroup analysis of HIV‐1‐infected treatment‐nave adults |
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