Once-daily darunavir/ritonavir vs. lopinavir/ritonavir in treatment-naive, HIV-1-infected patients: 96-week analysis
Identifieur interne : 008183 ( Main/Exploration ); précédent : 008182; suivant : 008184Once-daily darunavir/ritonavir vs. lopinavir/ritonavir in treatment-naive, HIV-1-infected patients: 96-week analysis
Auteurs : Anthony M. Mills ; Mark Nelson [Royaume-Uni] ; Dushyantha Jayaweera [États-Unis] ; Kiat Ruxrungtham [Thaïlande] ; Isabel Cassetti [Argentine] ; Pierre-Marie Girard [France] ; Cassy Workman [Australie] ; Inge Dierynck [Belgique] ; Vanitha Sekar [États-Unis] ; Carline Vanden Abeele [Belgique] ; Ludo Lavreys [Belgique]Source :
- AIDS : (London) [ 0269-9370 ] ; 2009.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
Abstract
Objective: Present 96-week data from ongoing ARTEMIS (AntiRetroviral Therapy with TMC114 ExaMined In Naive Subjects) trial. Methods: Randomized, open-label, phase III trial of antiretroviral-naive patients with HIV-1 RNA at least 5000copies/ml (stratified by HIV-1 RNA and CD4 cell count) receiving darunavir/ritonavir (DRV/r) 800/100mg once daily or lopinavir/ritonavir (LPV/r) 800/200mg total daily dose (twice daily or once daily) and fixed-dose tenofovir/emtricitabine. Primary outcome measure was noninferiority of DRV/r vs. LPV/r in virologic response (<50copies/ml, time-to-loss of virologic response) at 96 weeks (secondary outcome: superiority). Results: Six hundred eighty-nine patients were enrolled. At week 96, significantly more DRV/r (79%) than LPV/r patients (71 %) had viral load less than 50 copies/ml, confirming statistical noninferiority (estimated difference: 8.4%; 95% confidence interval 1.9-14.8 ; P<0.001; per-protocol) and superiority (P=0.012; intent-to-treat) in virologic response. Median CD4 cell count increases from baseline were 171 and 1 88 cells/μl for DRV/r and LPV/r, respectively (P=0.57; noncompleter=failure). Overall, 4% of DRV/r patients and 9% of LPV/r patients discontinued treatment due to adverse events. Lower rates of grade 2-4 treatment-related diarrhea were seen with DRV/r (4%) vs. LPV/r (11%; P<0.001), whereas grade 2-4 treatment-related rash occurred infrequently in both arms (3 vs. 1%, respectively; P=0.273). DRV/r patients had smaller median increases in triglycerides (0.1 and 0.6 mmol/l, respectively, P < 0.0001 ) and total cholesterol (0.6 and 0.9 mmol/l, respectively; P < 0.0001 ) than LPV/r patients; levels remained below National Cholesterol Education Program cut-offs for DRV/r. Conclusion: At week 96, once-daily DRV/r was both statistically noninferior and superior in virologic response to LPV/r, with a more favorable gastrointestinal and lipid profile, confirming DRV/r as an effective, well tolerated, and durable option for antiretroviral-naive patients.
Affiliations:
- Argentine, Australie, Belgique, France, Royaume-Uni, Thaïlande, États-Unis
- Angleterre, Grand Londres, Île-de-France
- Londres, Paris
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Mills</name></author><author><name sortKey="Nelson, Mark" sort="Nelson, Mark" uniqKey="Nelson M" first="Mark" last="Nelson">Mark Nelson</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Chelsea and Westminster Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>2 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Jayaweera, Dushyantha" sort="Jayaweera, Dushyantha" uniqKey="Jayaweera D" first="Dushyantha" last="Jayaweera">Dushyantha Jayaweera</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>University of Miami</s1><s2>Miami</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>University of Miami</wicri:noRegion></affiliation></author><author><name sortKey="Ruxrungtham, Kiat" sort="Ruxrungtham, Kiat" uniqKey="Ruxrungtham K" first="Kiat" last="Ruxrungtham">Kiat Ruxrungtham</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>HIVNAT, Thai Red Cross AIDS Research Centre and Department of Medicine, Faculty of Medicine, Chulalongkorn University</s1><s2>Bangkok</s2><s3>THA</s3><sZ>4 aut.</sZ></inist:fA14><country>Thaïlande</country><wicri:noRegion>Bangkok</wicri:noRegion></affiliation></author><author><name sortKey="Cassetti, Isabel" sort="Cassetti, Isabel" uniqKey="Cassetti I" first="Isabel" last="Cassetti">Isabel Cassetti</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Helios Salud</s1><s2>Buenos Aires</s2><s3>ARG</s3><sZ>5 aut.</sZ></inist:fA14><country>Argentine</country><wicri:noRegion>Helios Salud</wicri:noRegion></affiliation></author><author><name sortKey="Girard, Pierre Marie" sort="Girard, Pierre Marie" uniqKey="Girard P" first="Pierre-Marie" last="Girard">Pierre-Marie Girard</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>St Antoine Hospital and Pierre et Marie Curie University</s1><s2>Paris</s2><s3>FRA</s3><sZ>6 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Workman, Cassy" sort="Workman, Cassy" uniqKey="Workman C" first="Cassy" last="Workman">Cassy Workman</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>AIDS Research Initiative</s1><s2>Darlinghurst</s2><s3>AUS</s3><sZ>7 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>AIDS Research Initiative</wicri:noRegion></affiliation></author><author><name sortKey="Dierynck, Inge" sort="Dierynck, Inge" uniqKey="Dierynck I" first="Inge" last="Dierynck">Inge Dierynck</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Tibotec BVBA</s1><s2>Mechelen</s2><s3>BEL</s3><sZ>8 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Tibotec BVBA</wicri:noRegion></affiliation></author><author><name sortKey="Sekar, Vanitha" sort="Sekar, Vanitha" uniqKey="Sekar V" first="Vanitha" last="Sekar">Vanitha Sekar</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Tibotec Inc.</s1><s2>Yardley</s2><s3>USA</s3><sZ>9 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Tibotec Inc.</wicri:noRegion></affiliation></author><author><name sortKey="Vanden Abeele, Carline" sort="Vanden Abeele, Carline" uniqKey="Vanden Abeele C" first="Carline" last="Vanden Abeele">Carline Vanden Abeele</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Tibotec BVBA</s1><s2>Mechelen</s2><s3>BEL</s3><sZ>8 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Tibotec BVBA</wicri:noRegion></affiliation></author><author><name sortKey="Lavreys, Ludo" sort="Lavreys, Ludo" uniqKey="Lavreys L" first="Ludo" last="Lavreys">Ludo Lavreys</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Tibotec BVBA</s1><s2>Mechelen</s2><s3>BEL</s3><sZ>8 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Tibotec BVBA</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">AIDS : (London)</title><title level="j" type="abbreviated">AIDS : (Lond.)</title><idno type="ISSN">0269-9370</idno><imprint><date when="2009">2009</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">AIDS : (London)</title><title level="j" type="abbreviated">AIDS : (Lond.)</title><idno type="ISSN">0269-9370</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>AIDS</term><term>Antiretroviral agent</term><term>Antiviral</term><term>Chemotherapy</term><term>Clinical trial</term><term>Comparative study</term><term>Darunavir</term><term>Human immunodeficiency virus</term><term>Lopinavir</term><term>Protease inhibitor</term><term>Ritonavir</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>SIDA</term><term>Darunavir</term><term>Ritonavir</term><term>Lopinavir</term><term>Etude comparative</term><term>Antirétroviral</term><term>Antiviral</term><term>Virus immunodéficience humaine</term><term>Chimiothérapie</term><term>Essai clinique</term><term>Inhibiteur protease</term><term>Traitement initial</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Objective: Present 96-week data from ongoing ARTEMIS (AntiRetroviral Therapy with TMC114 ExaMined In Naive Subjects) trial. Methods: Randomized, open-label, phase III trial of antiretroviral-naive patients with HIV-1 RNA at least 5000copies/ml (stratified by HIV-1 RNA and CD4 cell count) receiving darunavir/ritonavir (DRV/r) 800/100mg once daily or lopinavir/ritonavir (LPV/r) 800/200mg total daily dose (twice daily or once daily) and fixed-dose tenofovir/emtricitabine. Primary outcome measure was noninferiority of DRV/r vs. LPV/r in virologic response (<50copies/ml, time-to-loss of virologic response) at 96 weeks (secondary outcome: superiority). Results: Six hundred eighty-nine patients were enrolled. At week 96, significantly more DRV/r (79%) than LPV/r patients (71 %) had viral load less than 50 copies/ml, confirming statistical noninferiority (estimated difference: 8.4%; 95% confidence interval 1.9-14.8 ; P<0.001; per-protocol) and superiority (P=0.012; intent-to-treat) in virologic response. Median CD4 cell count increases from baseline were 171 and 1 88 cells/μl for DRV/r and LPV/r, respectively (P=0.57; noncompleter=failure). Overall, 4% of DRV/r patients and 9% of LPV/r patients discontinued treatment due to adverse events. Lower rates of grade 2-4 treatment-related diarrhea were seen with DRV/r (4%) vs. LPV/r (11%; P<0.001), whereas grade 2-4 treatment-related rash occurred infrequently in both arms (3 vs. 1%, respectively; P=0.273). DRV/r patients had smaller median increases in triglycerides (0.1 and 0.6 mmol/l, respectively, P < 0.0001 ) and total cholesterol (0.6 and 0.9 mmol/l, respectively; P < 0.0001 ) than LPV/r patients; levels remained below National Cholesterol Education Program cut-offs for DRV/r. Conclusion: At week 96, once-daily DRV/r was both statistically noninferior and superior in virologic response to LPV/r, with a more favorable gastrointestinal and lipid profile, confirming DRV/r as an effective, well tolerated, and durable option for antiretroviral-naive patients.</div></front></TEI><affiliations><list><country><li>Argentine</li><li>Australie</li><li>Belgique</li><li>France</li><li>Royaume-Uni</li><li>Thaïlande</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Grand Londres</li><li>Île-de-France</li></region><settlement><li>Londres</li><li>Paris</li></settlement></list><tree><noCountry><name sortKey="Mills, Anthony M" sort="Mills, Anthony M" uniqKey="Mills A" first="Anthony M." last="Mills">Anthony M. Mills</name></noCountry><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Nelson, Mark" sort="Nelson, Mark" uniqKey="Nelson M" first="Mark" last="Nelson">Mark Nelson</name></region></country><country name="États-Unis"><noRegion><name sortKey="Jayaweera, Dushyantha" sort="Jayaweera, Dushyantha" uniqKey="Jayaweera D" first="Dushyantha" last="Jayaweera">Dushyantha Jayaweera</name></noRegion><name sortKey="Sekar, Vanitha" sort="Sekar, Vanitha" uniqKey="Sekar V" first="Vanitha" last="Sekar">Vanitha Sekar</name></country><country name="Thaïlande"><noRegion><name sortKey="Ruxrungtham, Kiat" sort="Ruxrungtham, Kiat" uniqKey="Ruxrungtham K" first="Kiat" last="Ruxrungtham">Kiat Ruxrungtham</name></noRegion></country><country name="Argentine"><noRegion><name sortKey="Cassetti, Isabel" sort="Cassetti, Isabel" uniqKey="Cassetti I" first="Isabel" last="Cassetti">Isabel Cassetti</name></noRegion></country><country name="France"><region name="Île-de-France"><name sortKey="Girard, Pierre Marie" sort="Girard, Pierre Marie" uniqKey="Girard P" first="Pierre-Marie" last="Girard">Pierre-Marie Girard</name></region></country><country name="Australie"><noRegion><name sortKey="Workman, Cassy" sort="Workman, Cassy" uniqKey="Workman C" first="Cassy" last="Workman">Cassy Workman</name></noRegion></country><country name="Belgique"><noRegion><name sortKey="Dierynck, Inge" sort="Dierynck, Inge" uniqKey="Dierynck I" first="Inge" last="Dierynck">Inge Dierynck</name></noRegion><name sortKey="Lavreys, Ludo" sort="Lavreys, Ludo" uniqKey="Lavreys L" first="Ludo" last="Lavreys">Ludo Lavreys</name><name sortKey="Vanden Abeele, Carline" sort="Vanden Abeele, Carline" uniqKey="Vanden Abeele C" first="Carline" last="Vanden Abeele">Carline Vanden Abeele</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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