Sökning: id:"swepub:oai:lup.lub.lu.se:47133e93-3d29-45a1-8765-51284c5b8569" >
Bone mineral densit...
Bone mineral density and inflammatory and bone biomarkers after darunavir-ritonavir combined with either raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults with HIV-1 : a substudy of the NEAT001/ANRS143 randomised trial
-
- Bernardino, Jose I (författare)
- University Hospital La Paz
-
- Mocroft, Amanda (författare)
- Birkbeck, University of London
-
- Mallon, Patrick W (författare)
- University College Dublin
-
visa fler...
-
- Wallet, Cedrick (författare)
- University of Bordeaux
-
- Gerstoft, Jan (författare)
- Copenhagen University Hospital
-
- Russell, Charlotte (författare)
- University College London
-
- Reiss, Peter (författare)
- Academic Medical Center of University of Amsterdam (AMC)
-
- Katlama, Christine (författare)
- Pitié-Salpêtrière University Hospital
-
- De Wit, Stephane (författare)
- Saint-Pierre University Hospital
-
- Richert, Laura (författare)
- University of Bordeaux
-
- Babiker, Abdel G. (författare)
- University College London
-
- Buño, Antonio (författare)
- University Hospital La Paz
-
- Castagna, Antonella (författare)
- Vita-Salute San Raffaele University
-
- Girard, Pierre-Marie (författare)
- Hospital Saint-Antoine
-
- Chene, Genevieve (författare)
- University of Bordeaux
-
- Raffi, Francois (författare)
- College of Professors of Infectious and Tropical Diseases
-
- Arribas, Jose R (författare)
- University Hospital La Paz
-
- Odermarsky, Michal (författare)
- Lund University,Lunds universitet,Pediatrik, Lund,Sektion V,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Paediatrics (Lund),Section V,Department of Clinical Sciences, Lund,Faculty of Medicine
-
visa färre...
-
(creator_code:org_t)
-
- 2015
- 2015
- Engelska.
-
Ingår i: The Lancet. - 1474-547X .- 2352-3018. ; 2:11, s. 73-464
- Relaterad länk:
-
http://dx.doi.org/10...
-
visa fler...
-
https://lup.lub.lu.s...
-
https://doi.org/10.1...
-
http://kipublication...
-
visa färre...
Abstract
Ämnesord
Stäng
- BACKGROUND: Osteopenia, osteoporosis, and low bone mineral density are frequent in patients with HIV. We assessed the 96 week loss of bone mineral density associated with a nucleoside or nucleotide reverse transcriptase inhibitor (NtRTI)-sparing regimen.METHODS: Antiretroviral-naive adults with HIV were enrolled in 78 clinical sites in 15 European countries into a randomised (1:1), open-label, non-inferiority trial (NEAT001/ANRS143) assessing the efficacy and safety of darunavir (800 mg once per day) and ritonavir (100 mg once per day) plus either raltegravir (400 mg twice per day; NtRTI-sparing regimen) or tenofovir (245 mg once per day) and emtricitabine (200 mg once per day; standard regimen). For this bone-health substudy, 20 of the original sites in six countries participated, and any patient enrolled at one of these sites who met the following criteria was eligible: plasma viral loads greater than 1000 HIV RNA copies per mL and CD4 cell counts of fewer than 500 cells per μL, except in those with symptomatic HIV infection. Exclusion criteria included treatment for malignant disease, testing positive for hepatitis B virus surface antigen, pregnancy, creatinine clearance less than 60 mL per min, treatment for osteoporosis, systemic steroids, or oestrogen-replacement therapy. The two primary endpoints were the mean percentage changes in lumbar spine and total hip bone mineral density at week 48, assessed by dual energy x-ray absorptiometry (DXA) scans. We did the analysis with an intention-to-treat-exposed approach with antiretroviral modifications ignored. The parent trial is registered with ClinicalTrials.gov, number NCT01066962, and is closed to new participants.FINDINGS: Between Aug 2, 2010, and April 18, 2011, we recruited 146 patients to the substudy, 70 assigned to the NtRTI-sparing regimen and 76 to the standard regimen. DXA data were available for 129, 121 and 107 patients at baseline, 48 and 96 weeks respectively. At week 48, the mean percentage loss in bone mineral density in the lumbar spine was greater in the standard group than in the NtRTI-sparing group (mean percentage change -2.49% vs -1.00%, mean percentage difference -1.49, 95% CI -2.94 to -0.04; p=0.046). Total hip bone mineral density loss was similarly greater at week 48 in the standard group than in the NtRTI-sparing group (mean percentage change -3.30% vs -0.73%; mean percentage difference -2.57, 95% CI -3.75 to -1.35; p<0.0001). Seven new fractures occurred during the trial (two in the NtRTI-sparing group and five in the standard group).INTERPRETATION: A raltegravir-based regimen was associated with significantly less loss of bone mineral density than a standard regimen containing tenofovir disoproxil fumarate, and might be a treatment option for patients at high risk of osteopenia or osteoporosis who are not suitable for NtRTIs such as abacavir or tenofovir alafenamide.FUNDING: The European Union Sixth Framework Programme, Inserm-ANRS, Ministerio de Sanidad y Asuntos Sociales de España, Gilead Sciences, Janssen Pharmaceuticals, and Merck Laboratories.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
Nyckelord
- Absorptiometry, Photon
- Adult
- Anti-HIV Agents
- Biomarkers
- Bone Density
- Bone Diseases, Metabolic
- CD4 Lymphocyte Count
- Comorbidity
- Darunavir
- Drug Therapy, Combination
- Emtricitabine
- Europe
- Female
- HIV Infections
- Humans
- Inflammation
- Male
- Middle Aged
- Osteopetrosis
- Raltegravir Potassium
- Ritonavir
- Tenofovir
- Viral Load
- Journal Article
- Multicenter Study
- Randomized Controlled Trial
- Research Support, Non-U.S. Gov't
Publikations- och innehållstyp
- art (ämneskategori)
- ref (ämneskategori)
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
-
Bernardino, Jose ...
-
Mocroft, Amanda
-
Mallon, Patrick ...
-
Wallet, Cedrick
-
Gerstoft, Jan
-
Russell, Charlot ...
-
visa fler...
-
Reiss, Peter
-
Katlama, Christi ...
-
De Wit, Stephane
-
Richert, Laura
-
Babiker, Abdel G ...
-
Buño, Antonio
-
Castagna, Antone ...
-
Girard, Pierre-M ...
-
Chene, Genevieve
-
Raffi, Francois
-
Arribas, Jose R
-
Odermarsky, Mich ...
-
visa färre...
- Om ämnet
-
- MEDICIN OCH HÄLSOVETENSKAP
-
MEDICIN OCH HÄLS ...
-
och Klinisk medicin
-
och Infektionsmedici ...
- Artiklar i publikationen
-
The Lancet
- Av lärosätet
-
Lunds universitet
-
Karolinska Institutet