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

Allison Martin, Cecilia Moore, Patrick W G Mallon, Jennifer Hoy, Sean Emery, Waldo Belloso, Praphan Phanuphak, Samuel Ferret, David A Cooper, Mark A Boyd, Second Line study team, Nagalingeswaran Kumarasamy, Sharne Foulkes, Robin Wood, Ploenchan Chetchotisakd, Praphan Phanuphak, Lerato Mohapi, Adeeba Kamarulzaman, Oscar Messina, Allison Martin, Cecilia Moore, Patrick W G Mallon, Jennifer Hoy, Sean Emery, Waldo Belloso, Praphan Phanuphak, Samuel Ferret, David A Cooper, Mark A Boyd, Second Line study team, Nagalingeswaran Kumarasamy, Sharne Foulkes, Robin Wood, Ploenchan Chetchotisakd, Praphan Phanuphak, Lerato Mohapi, Adeeba Kamarulzaman, Oscar Messina

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.

© 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins

Figures

Fig. 1
Fig. 1
Patient disposition of Second Line bone sub-study.
Fig. 2
Fig. 2
Mean percentage change (SE) from week 0 to 48 in proximal femur and lumbar spine bone mineral density (BMD) by treatment arm.

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Source: PubMed

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