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Bone mineral density in HIV participants randomized to raltegravir and lopinavir/ritonavir compared with standard second line therapy

Identifieur interne : 005070 ( Main/Exploration ); précédent : 005069; suivant : 005071

Bone mineral density in HIV participants randomized to raltegravir and lopinavir/ritonavir compared with standard second line therapy

Auteurs : Allison Martin [Australie] ; Cecilia Moore [Australie] ; Patrick W. G. Mallon [Irlande (pays)] ; Jennifer Hoy [Australie] ; Sean Emery [Australie] ; Waldo Belloso [Argentine] ; Praphan Phanuphak [Thaïlande] ; Samuel Ferret [France] ; David A. Cooper [Australie] ; Mark A. Boyd [Australie]

Source :

RBID : Pascal:13-0322836

Descripteurs français

English descriptors

Abstract

Objective: To compare changes over 48 weeks in bone mineral density (BMD) between participants randomized to lopinavir/ritonavir (LPV/r) + raltegravir (RAL) or LPV/r + 2-3 nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTIs) as second line therapy. Design: 48-week open-label sub-study of the Second Line trial conducted in South Africa, India, Thailand, Malaysia and Argentina. Methods: Dual energy X-ray absorptiometry scans of proximal femur and lumbar spine were performed at baseline and week 48. Linear regression was used to compare means of differences between arms. McNemars test compared osteopenia and osteoporosis. Associations between percentage BMD changes and baseline variables were assessed by multivariate linear regression. Results: Two hundred and ten participants were randomized. Analyses were adjusted for sex, BMI and smoking status. Mean (95% CI) proximal femur BMD% reduced over 48 weeks by -5.2% (-6.7 to -3.8%) in the LPV/r+2-3N(t)RTIs arm and by -2.9% (-4.3 to -1.5%) in the LPV/r+RAL arm (P=0.0001). Lumbar spine BMD reduced by -4.2% (-5.7 to -2.7%) in the LPV/r+2-3N(t)RTIs arm and by -2.0% (-3.5 to -0.6%) in the LPV/r+RAL arm (P=0.0006). The incidence of osteopenia (7.6%) and osteoporosis (2.0%) assessed over 48 weeks were similar between arms. Reduced BMD over 48 weeks was significantly associated with longer duration of tenofovir on study [% change (SE) -1.58 (0.38) femur, -1.65 (0.38) spine, P=0.0001] and low baseline BMI [% change (SE) 0.5 (0.13) femur, 0.17 (0.07) spine; P<0.01]. Conclusion: An N(t)RTI-sparing antiretroviral regimen of LPV/r and raltegravir as second line therapy is associated with less bone loss than a LPV/r regimen containing N(t)RTIs.

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<name sortKey="Emery, Sean" sort="Emery, Sean" uniqKey="Emery S" first="Sean" last="Emery">Sean Emery</name>
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<term>AIDS</term>
<term>Absorptiometry, Photon</term>
<term>Adult</term>
<term>Antiretroviral agent</term>
<term>Antiviral</term>
<term>Argentina (epidemiology)</term>
<term>Bone Density (drug effects)</term>
<term>Bone Diseases, Metabolic (complications)</term>
<term>Bone Diseases, Metabolic (epidemiology)</term>
<term>Bone mineral density</term>
<term>Chemotherapy</term>
<term>Comparative study</term>
<term>Female</term>
<term>Femur (diagnostic imaging)</term>
<term>HIV Infections (complications)</term>
<term>HIV Infections (drug therapy)</term>
<term>HIV Protease Inhibitors (administration & dosage)</term>
<term>HIV Protease Inhibitors (adverse effects)</term>
<term>Human immunodeficiency virus</term>
<term>Humans</term>
<term>India (epidemiology)</term>
<term>Lopinavir</term>
<term>Lopinavir (adverse effects)</term>
<term>Lumbar Vertebrae (diagnostic imaging)</term>
<term>Malaysia (epidemiology)</term>
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<term>Osteoporosis (complications)</term>
<term>Osteoporosis (epidemiology)</term>
<term>Prevalence</term>
<term>Pyrrolidinones (adverse effects)</term>
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<term>Ritonavir (adverse effects)</term>
<term>South Africa (epidemiology)</term>
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<term>Fémur (imagerie diagnostique)</term>
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<term>Inde (épidémiologie)</term>
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<term>Infections à VIH (traitement médicamenteux)</term>
<term>Inhibiteurs de la transcriptase inverse (administration et posologie)</term>
<term>Inhibiteurs de la transcriptase inverse (effets indésirables)</term>
<term>Inhibiteurs de protéase du VIH (administration et posologie)</term>
<term>Inhibiteurs de protéase du VIH (effets indésirables)</term>
<term>Lopinavir (effets indésirables)</term>
<term>Maladies osseuses métaboliques ()</term>
<term>Maladies osseuses métaboliques (épidémiologie)</term>
<term>Malaisie (épidémiologie)</term>
<term>Mâle</term>
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<term>Ostéoporose (épidémiologie)</term>
<term>Prévalence</term>
<term>Pyrrolidones (effets indésirables)</term>
<term>Raltégravir de potassium</term>
<term>Ritonavir (effets indésirables)</term>
<term>République d'Afrique du Sud (épidémiologie)</term>
<term>Résultat thérapeutique</term>
<term>Thaïlande (épidémiologie)</term>
<term>Vertèbres lombales (imagerie diagnostique)</term>
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<term>HIV Protease Inhibitors</term>
<term>Reverse Transcriptase Inhibitors</term>
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<term>HIV Protease Inhibitors</term>
<term>Lopinavir</term>
<term>Pyrrolidinones</term>
<term>Reverse Transcriptase Inhibitors</term>
<term>Ritonavir</term>
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<term>Inhibiteurs de la transcriptase inverse</term>
<term>Inhibiteurs de protéase du VIH</term>
</keywords>
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<term>Bone Diseases, Metabolic</term>
<term>HIV Infections</term>
<term>Osteoporosis</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnostic imaging" xml:lang="en">
<term>Femur</term>
<term>Lumbar Vertebrae</term>
</keywords>
<keywords scheme="MESH" qualifier="drug effects" xml:lang="en">
<term>Bone Density</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en">
<term>HIV Infections</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr">
<term>Inhibiteurs de la transcriptase inverse</term>
<term>Inhibiteurs de protéase du VIH</term>
<term>Lopinavir</term>
<term>Pyrrolidones</term>
<term>Ritonavir</term>
</keywords>
<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en">
<term>Argentina</term>
<term>Bone Diseases, Metabolic</term>
<term>India</term>
<term>Malaysia</term>
<term>Osteoporosis</term>
<term>South Africa</term>
<term>Thailand</term>
</keywords>
<keywords scheme="MESH" qualifier="imagerie diagnostique" xml:lang="fr">
<term>Fémur</term>
<term>Vertèbres lombales</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr">
<term>Infections à VIH</term>
</keywords>
<keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr">
<term>Argentine</term>
<term>Inde</term>
<term>Maladies osseuses métaboliques</term>
<term>Malaisie</term>
<term>Ostéoporose</term>
<term>République d'Afrique du Sud</term>
<term>Thaïlande</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Absorptiometry, Photon</term>
<term>Adult</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Prevalence</term>
<term>Raltegravir Potassium</term>
<term>Risk Factors</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Absorptiométrie photonique</term>
<term>Adulte</term>
<term>Densité osseuse</term>
<term>Facteurs de risque</term>
<term>Femelle</term>
<term>Humains</term>
<term>Infections à VIH</term>
<term>Maladies osseuses métaboliques</term>
<term>Mâle</term>
<term>Ostéoporose</term>
<term>Prévalence</term>
<term>Raltégravir de potassium</term>
<term>Résultat thérapeutique</term>
<term>SIDA</term>
<term>Raltégravir</term>
<term>Lopinavir</term>
<term>Ritonavir</term>
<term>Densité minérale osseuse</term>
<term>Etude comparative</term>
<term>Norme</term>
<term>Virus immunodéficience humaine</term>
<term>Traitement</term>
<term>Antirétroviral</term>
<term>Antiviral</term>
<term>Chimiothérapie</term>
<term>Ténofovir</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Norme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">Objective: To compare changes over 48 weeks in bone mineral density (BMD) between participants randomized to lopinavir/ritonavir (LPV/r) + raltegravir (RAL) or LPV/r + 2-3 nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTIs) as second line therapy. Design: 48-week open-label sub-study of the Second Line trial conducted in South Africa, India, Thailand, Malaysia and Argentina. Methods: Dual energy X-ray absorptiometry scans of proximal femur and lumbar spine were performed at baseline and week 48. Linear regression was used to compare means of differences between arms. McNemars test compared osteopenia and osteoporosis. Associations between percentage BMD changes and baseline variables were assessed by multivariate linear regression. Results: Two hundred and ten participants were randomized. Analyses were adjusted for sex, BMI and smoking status. Mean (95% CI) proximal femur BMD% reduced over 48 weeks by -5.2% (-6.7 to -3.8%) in the LPV/r+2-3N(t)RTIs arm and by -2.9% (-4.3 to -1.5%) in the LPV/r+RAL arm (P=0.0001). Lumbar spine BMD reduced by -4.2% (-5.7 to -2.7%) in the LPV/r+2-3N(t)RTIs arm and by -2.0% (-3.5 to -0.6%) in the LPV/r+RAL arm (P=0.0006). The incidence of osteopenia (7.6%) and osteoporosis (2.0%) assessed over 48 weeks were similar between arms. Reduced BMD over 48 weeks was significantly associated with longer duration of tenofovir on study [% change (SE) -1.58 (0.38) femur, -1.65 (0.38) spine, P=0.0001] and low baseline BMI [% change (SE) 0.5 (0.13) femur, 0.17 (0.07) spine; P<0.01]. Conclusion: An N(t)RTI-sparing antiretroviral regimen of LPV/r and raltegravir as second line therapy is associated with less bone loss than a LPV/r regimen containing N(t)RTIs.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Argentine</li>
<li>Australie</li>
<li>France</li>
<li>Irlande (pays)</li>
<li>Thaïlande</li>
</country>
<region>
<li>Nouvelle-Galles du Sud</li>
<li>Victoria (État)</li>
<li>Île-de-France</li>
</region>
<settlement>
<li>Melbourne</li>
<li>Paris</li>
<li>Sydney</li>
</settlement>
</list>
<tree>
<country name="Australie">
<region name="Nouvelle-Galles du Sud">
<name sortKey="Martin, Allison" sort="Martin, Allison" uniqKey="Martin A" first="Allison" last="Martin">Allison Martin</name>
</region>
<name sortKey="Boyd, Mark A" sort="Boyd, Mark A" uniqKey="Boyd M" first="Mark A." last="Boyd">Mark A. Boyd</name>
<name sortKey="Cooper, David A" sort="Cooper, David A" uniqKey="Cooper D" first="David A." last="Cooper">David A. Cooper</name>
<name sortKey="Emery, Sean" sort="Emery, Sean" uniqKey="Emery S" first="Sean" last="Emery">Sean Emery</name>
<name sortKey="Hoy, Jennifer" sort="Hoy, Jennifer" uniqKey="Hoy J" first="Jennifer" last="Hoy">Jennifer Hoy</name>
<name sortKey="Moore, Cecilia" sort="Moore, Cecilia" uniqKey="Moore C" first="Cecilia" last="Moore">Cecilia Moore</name>
</country>
<country name="Irlande (pays)">
<noRegion>
<name sortKey="Mallon, Patrick W G" sort="Mallon, Patrick W G" uniqKey="Mallon P" first="Patrick W. G." last="Mallon">Patrick W. G. Mallon</name>
</noRegion>
</country>
<country name="Argentine">
<noRegion>
<name sortKey="Belloso, Waldo" sort="Belloso, Waldo" uniqKey="Belloso W" first="Waldo" last="Belloso">Waldo Belloso</name>
</noRegion>
</country>
<country name="Thaïlande">
<noRegion>
<name sortKey="Phanuphak, Praphan" sort="Phanuphak, Praphan" uniqKey="Phanuphak P" first="Praphan" last="Phanuphak">Praphan Phanuphak</name>
</noRegion>
</country>
<country name="France">
<region name="Île-de-France">
<name sortKey="Ferret, Samuel" sort="Ferret, Samuel" uniqKey="Ferret S" first="Samuel" last="Ferret">Samuel Ferret</name>
</region>
</country>
</tree>
</affiliations>
</record>

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