Dataset Information

Antiretroviral Therapy, Especially Efavirenz, Is Associated with Low Bone Mineral Density in HIV-Infected South Africans.

ABSTRACT:

Purpose

We determined the prevalence and correlates of low bone mineral density (BMD) in HIV-infected South Africans as there is a paucity of such data from Africa.

Methods

BMD and serum 25-hydroxyvitamin D were measured in HIV-positive participants on antiretroviral therapy (ART) and in those not yet on ART (ART-naïve).

Results

We enrolled 444 participants [median age 35(IQR: 30, 40) years; 77% women]. BMD was low (z score <-2SD) in 17% and 5% of participants at the lumbar spine and total hip, respectively. Total hip [0.909 (SD 0.123) vs 0.956 (SD 0.124) g/cm2, p = 0.0001] and neck of femur BMD [0.796 (SD 0.130) vs 0.844 (SD 0.120) g/cm2, p = 0.0001] were lower in the ART, compared to the ART-naïve group. Vitamin D deficiency was present in 15% of participants and was associated with efavirenz use [adjusted OR 2.04 (95% CI 1.01 to 4.13)]. In a multivariate linear regression, exposure to efavirenz or lopinavir-based ART was associated with lower total hip BMD, whereas higher weight, being male and higher vitamin D concentration were associated with higher total hip BMD (adjusted R2 = 0.28). Age, weight, sex, and the use of efavirenz-based ART were independently associated with lumbar spine BMD (adjusted R2 = 0.13).

Conclusions

Vitamin D status, use of efavirenz or lopinavir/ritonavir, weight, age and sex are significantly associated with lower BMD in this young cohort of HIV-infected South Africans.

SUBMITTER: Dave JA

PROVIDER: S-EPMC4669137 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Publications

Antiretroviral Therapy, Especially Efavirenz, Is Associated with Low Bone Mineral Density in HIV-Infected South Africans.

Dave Joel A JA Cohen Karen K Micklesfield Lisa K LK Maartens Gary G Levitt Naomi S NS

PloS one 20151203 12

<h4>Purpose</h4>We determined the prevalence and correlates of low bone mineral density (BMD) in HIV-infected South Africans as there is a paucity of such data from Africa.<h4>Methods</h4>BMD and serum 25-hydroxyvitamin D were measured in HIV-positive participants on antiretroviral therapy (ART) and in those not yet on ART (ART-naïve).<h4>Results</h4>We enrolled 444 participants [median age 35(IQR: 30, 40) years; 77% women]. BMD was low (z score <-2SD) in 17% and 5% of participants at the lumbar ...[more]

PMID: 26633015

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Project description:Human immunodeficiency virus- (HIV-) infection and antiretroviral therapy (ART) exposure are associated with bone loss. African data are limited despite the region's HIV burden. Of 247 ART-naïve, premenopausal, urban, black African women aged 33.9?±?6.6?years from Soweto, South Africa, measured at baseline, 110 underwent anthropometry, DXA, and blood and urine collections at 12 and 24?months; 39 were HIV-negative (Nref), 28 were people with HIV (PWH) not ART-exposed for the duration of the study (ART-N), and 43 were PWH who were ART-exposed within the first 12?months (ART-Y). At baseline, the ART-Y group had lower BMI and fat mass than the Nref group. Within 12?months of ART initiation, areal bone mineral density (aBMD) had decreased at the lumbar spine and at the whole body less head, despite increased weight, and hip aBMD had not increased in line with the Nref group. There was no evidence of further bone changes between 12 and 24?months. By 24?months, the ART-Y women had gained weight and fat mass, but remained lighter with less fat than the Nref women. ART initiation normalized the low serum albumin of the ART-Y group at baseline, but was associated with elevated bone turnover markers at 12 and 24?months. Vitamin D status and renal phosphate handling were normal. ART-N had similar aBMD and other characteristics to the Nref group throughout, except unlike the Nref group, weight and fat mass did not increase and serum albumin decreased. This study in African women of childbearing age demonstrated that the bone loss that had occurred in these PWH after ART initiation did not continue after 12?months and that bone loss did not occur in ART-unexposed PWH over 2?years. At 24?months, despite gains in weight and fat mass, ART-exposed women remained lighter, with lower aBMD, fat mass, and higher bone turnover than women without HIV. More studies are required to establish if the bone loss and fat gain reverse, stabilize, or continue with further ART exposure, particularly during and after menopause. © 2020 The Authors. JBMR Plus published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research.

Project description:ImportanceAdvantages of using efavirenz as part of treatment for children infected with human immunodeficiency virus (HIV) include once-daily dosing, simplification of co-treatment for tuberculosis, preservation of ritonavir-boosted lopinavir for second-line treatment, and harmonization of adult and pediatric treatment regimens. However, there have been concerns about possible reduced viral efficacy of efavirenz in children exposed to nevirapine for prevention of mother-to-child transmission.ObjectiveTo evaluate whether nevirapine-exposed children achieving initial viral suppression with ritonavir-boosted lopinavir-based therapy can transition to efavirenz-based therapy without risk of viral failure.Design, setting, and participantsRandomized, open-label noninferiority trial conducted at Rahima Moosa Mother and Child Hospital, Johannesburg, South Africa, from June 2010 to December 2013, enrolling 300 HIV-infected children exposed to nevirapine for prevention of mother-to-child transmission who were aged 3 years or older and had plasma HIV RNA of less than 50 copies/mL during ritonavir-boosted lopinavir-based therapy; 298 were randomized and 292 (98%) were followed up to 48 weeks after randomization.InterventionsParticipants were randomly assigned to switch to efavirenz-based therapy (n = 150) or continue ritonavir-boosted lopinavir-based therapy (n = 148).Main outcomes and measuresRisk difference between groups in (1) viral rebound (ie, ≥1 HIV RNA measurement of >50 copies/mL) and (2) viral failure (ie, confirmed HIV RNA >1000 copies/mL) with a noninferiority bound of -0.10. Immunologic and clinical responses were secondary end points.ResultsThe Kaplan-Meier probability of viral rebound by 48 weeks was 0.176 (n = 26) in the efavirenz group and 0.284 (n = 42) in the ritonavir-boosted lopinavir group. Probabilities of viral failure were 0.027 (n = 4) in the efavirenz group and 0.020 (n = 3) in the ritonavir-boosted lopinavir group. The risk difference for viral rebound was 0.107 (1-sided 95% CI, 0.028 to ∞) and for viral failure was -0.007 (1-sided 95% CI, -0.036 to ∞). We rejected the null hypothesis that efavirenz is inferior to ritonavir-boosted lopinavir (P < .001) for both end points. By 48 weeks, CD4 cell percentage was 2.88% (95% CI, 1.26%-4.49%) higher in the efavirenz group than in the ritonavir-boosted lopinavir group.Conclusions and relevanceAmong HIV-infected children exposed to nevirapine for prevention of mother-to-child transmission and with initial viral suppression with ritonavir-boosted lopinavir-based therapy, switching to efavirenz-based therapy compared with continuing ritonavir-boosted lopinavir-based therapy did not result in significantly higher rates of viral rebound or viral failure. This therapeutic approach may offer advantages in children such as these.Trial registrationclinicaltrials.gov Identifier: NCT01146873.

Project description:This is the first study to report changes in BMD and related risk factors among Chinese patients with HIV after initiation of tenofovir disoproxil fumarate (TDF)-containing antiretroviral therapy. Greater bone mineral density (BMD) loss was observed in patients treated with TDF, compared to those on non-TDF-containing regimens. Our findings provide important knowledge regarding the risk factors in the long-term clinical management of patients with HIV in China.IntroductionPersons living with HIV (PLWH) are at increased risk for osteoporosis and fracture. Tenofovir disoproxil fumarate (TDF) has been associated with higher rates of bone mineral density (BMD) loss, osteoporosis, and fracture. Few studies have studied the impact among PLWH in Asia.MethodsWe analyzed retrospectively patients from the outpatient HIV clinic of a large tertiary hospital in Beijing, China, from March 2007 to May 2016. Patients who had dual-energy X-ray absorptiometry testing prior to antiretroviral initiation and at 48 and/or 96 weeks after initiation were included in this analysis.ResultsA total of 136 patients were included (mean age 36.0 ± 10.6 years) and over 90% participants were male and Han Chinese ethnicity. We observed greater declines in BMD at the spine from baseline to week 48 (-2.94% vs. -0.74%) and at the hip from baseline to week 96 (-4.37% vs. -2.34%) in the TDF group compared with the non-TDF group. With regard to HIV-specific parameters, longer duration since HIV diagnosis and undetectable viral load over time were associated with lower BMD at the hip [relative risk (RR) 0.97, 95% confidence index (CI) (0.95, 0.99) per 1 year increase and RR 0.96, 95%CI (0.94, 0.99), respectively] and femoral neck [RR 0.97, 95%CI (0.95, 0.99) per 1 year increase and RR 0.97, 95%CI (0.95, 0.998), respectively] over 96 weeks.ConclusionsThis is the first study to report changes in BMD among PLWH after initiation of TDF-based antiretroviral therapy in China. Our findings provide important knowledge for the long-term clinical management of PLWH from this region.

Dataset Information

Antiretroviral Therapy, Especially Efavirenz, Is Associated with Low Bone Mineral Density in HIV-Infected South Africans.

Purpose

Methods

Results

Conclusions

Publications

Antiretroviral Therapy, Especially Efavirenz, Is Associated with Low Bone Mineral Density in HIV-Infected South Africans.

Similar Datasets

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