Prospective One-year Bone Loss in Treatment-naïve HIV+ Men and Women on Single or Multiple Drug HIV Therapies

Antiretroviral therapy has decreased the rate of HIV-related mortality and extended the life span of HIV patients. Current guidelines recommend the use of a 3-drug regimen, such as two nucleoside reverse transcriptase inhibitors and a protease inhibitor, boosted by ritonavir. Osteoporosis can be associated with the HIV disease itself or with antiretroviral therapy. Many trials have been conducted employing a single drug regimen to simplify antiretroviral therapy but few studies assessed the effect of the single drug regimen on bone mineral density (BMD). The objectives of the study were to assess and compare the relative (%) changes in lumbar spine and hip BMD over 48 weeks in HIV patients treated with mono or triple antiretroviral regimens The study was conducted using data from a randomized trial (MONARK) conducted in 136 antiretroviral-naïve HIV patients (89 men and 47 women) comparing the antiviral efficacy of a single-drug protease inhibitor regimen of lopinavir/ritonavir (LPV/r) versus LPV/r in combination with zidovudine (ZDV) and lamivudine (3TC). Lumbar spine and total hip BMD were assessed in 100 patients by dual-energy X-ray absorptiometry at baseline and 48 weeks. 48 week-BMD data were available for 43 patients (mean age 37years) with a mean baseline lumbar spine Z-score of -0.1 in the LPV/r monotherapy group and for 25 patients (mean age 35.8years) with a mean baseline lumbar spine Z-score of -0.2 in the LPV/r+ZDV+3TC group. After 48weeks, lumbar spine BMD significantly decreased by 4.4% (-5.1% to -2.1%, P≤0.001) in the LPV/r group and by 4.0% (-5.0% to -1.7%, P≤0.0001) in the LPV/r+ZDV+3TC group. There was no significant difference in BMD changes between the two groups. These results suggest that bone loss is observed 48 weeks after the initiation of antiretroviral therapy, whether the patients receive a single- or triple-drug antiretroviral regimen.