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Bone mineral density changes in protease inhibitor‐sparing vs . nucleoside reverse transcriptase inhibitor‐sparing highly active antiretroviral therapy: data from a randomized trial *
Author(s) -
Hansen AB,
Obel N,
Nielsen H,
Pedersen C,
Gerstoft J
Publication year - 2011
Publication title -
hiv medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 79
eISSN - 1468-1293
pISSN - 1464-2662
DOI - 10.1111/j.1468-1293.2010.00864.x
Subject(s) - medicine , lopinavir , bone mineral , ritonavir , lamivudine , reverse transcriptase inhibitor , efavirenz , osteoporosis , confidence interval , randomized controlled trial , femoral neck , bone density , gastroenterology , surgery , urology , viral load , antiretroviral therapy , human immunodeficiency virus (hiv) , virology , hepatitis b virus , virus
Objective The aim of the study was to compare changes in bone mineral density (BMD) over 144 weeks in HIV‐infected patients initiating nucleoside reverse transcriptase inhibitor (NRTI)‐sparing or protease inhibitor‐sparing highly active antiretroviral therapy (HAART). Methods Sixty‐three HAART‐naïve patients were randomized to zidovudine/lamivudine+efavirenz or lopinavir/ritonavir+efavirenz. We performed dual energy X‐ray absorptiometry (DEXA) at baseline and at weeks 24, 48, 96 and 144 to evaluate lumbar spine and femoral neck (hip) BMD. Results At baseline, 33 patients (55.9%) had low BMD (T‐score < −1.0) and of these eight had osteoporosis (T‐score < −2.5). Spine BMD declined in both arms until week 24, before stabilizing. In the NRTI‐sparing arm, the mean percentage change from baseline was −2.7% [95% confidence interval (CI) −3.9 to −1.4] at week 24 and −2.5% (95% CI −5.4 to 0.3) at week 144, compared with −3.2% (95% CI −4.4 to −2.1) and −1.9% (95% CI −3.5 to −0.3) in the protease inhibitor‐sparing arm. Hip BMD declined until week 48 before stabilizing. In the NRTI‐sparing arm, BMD had decreased by −5.1% (95% CI −7.1 to −3.1) at week 48 and −4.5% (95% CI −6.9 to −2.1) at week 144, compared with −6.1% (95% CI −8.2 to −4.0) and −5.0% (95% CI −6.8 to −3.1) in the protease inhibitor‐sparing arm. There were no significant differences between arms. Low baseline CD4 cell count was independently associated with spine ( P =0.007) and hip ( P =0.04) BMD loss and low body mass index with hip BMD loss ( P =0.03). Conclusion Spine and hip BMD declined rapidly 24 to 48 weeks after initiating HAART, independent of the assigned drug class, but thereafter BMD values remained stable.