Evidence map›Paper›PMID 26355674›Full record

Trial reportAIDS (London, England)2015

Greater change in bone turnover markers for efavirenz/emtricitabine/tenofovir disoproxil fumarate versus dolutegravir + abacavir/lamivudine in antiretroviral therapy-naive adults over 144 weeks.

Pablo Tebas, Princy Kumar, Charles Hicks, Catherine Granier, Brian Wynne, Sherene Min, Keith Pappa

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in AIDS (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
3.5field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 34 citations in OpenAlex.

  1. Trial
  2. A Single-dose Zoledronic Acid Infusion Prevents Antiretroviral Therapy-induced Bone Loss in Treatment-naive HIV-infected Patients: A Phase IIb Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016
    Trial
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. People living with HIV and fracture risk.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2020
    Review
  10. Article
  11. Article
  12. Article
  13. Update on Adverse Effects of HIV Integrase Inhibitors.Current treatment options in infectious diseases · 2019
    Review
  14. Review
  15. Article
  16. Bone Mineral Density Declines Twice as Quickly Among HIV-Infected Women Compared With Men.Journal of acquired immune deficiency syndromes (1999) · 2018
    Article
  17. Article
  18. Tenofovir and bone health.Current opinion in HIV and AIDS · 2016
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 7 institutions in 2 countries.

Pablo TebasaUniversity of Pennsylvania, Philadelphia, Pennsylvania bGeorgetown University School of Medicine, Washington, District of Columbia cUniversity of California San Diego Owen Clinic, San Diego, California, USA dGlaxoSmithKline, London, UK eGlaxoSmithKline, Philadelphia, Pennsylvania fGlaxoSmithKline, Research Triangle Park, North Carolina gViiV Healthcare, Research Triangle Park, North Carolina, USA.
Princy Kumar
Charles Hicks
Catherine Granier
Brian Wynne
Sherene Min
Keith Pappa
Georgetown University · USGlaxoSmithKline (United Kingdom) · GBGlaxoSmithKline (United States) · USResearch Triangle Park Foundation · USUniversity of California, San Diego · USUniversity of Pennsylvania · USViiV Healthcare (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAntiretroviral therapy initiation has been linked to bone mineral density and bone biomarker changes. We assessed long-term bone turnover biomarker effects over 144 weeks in patients initiating dolutegravir (DTG) + abacavir/lamivudine (ABC/3TC) versus efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF).

methodsPatients randomized in SINGLE received DTG (50 mg once daily) + ABC/3TC or fixed-dose combination EFV/FTC/TDF. We evaluated vitamin D serum levels and bone turnover markers (BTMs), including type 1 collagen cross-linked C-telopeptide (CTx), osteocalcin, bone-specific alkaline phosphatase (BSAP), and procollagen type 1 N-terminal propeptide (P1NP), at baseline and weeks 48, 96, and 144.

resultsAmong the 833 enrolled patients (68% white, 85% men), baseline median age was 35 years (range 18-85), median CD4 was 338 cells/μl, and median BMI was 24 kg/m. Fifty-three percent of patients smoked, and 6% reported baseline vitamin D use, with no meaningful differences between groups. Relative to baseline, CTx, osteocalcin, BSAP, and P1NP increased; vitamin D decreased in both groups at weeks 48, 96, and 144. Changes from baseline typically peaked at weeks 48 or 96 and for the four analytes, excluding vitamin D, with the EFV/FTC/TDF group having significantly greater changes from baseline at all time points.

conclusionDTG + ABC/3TC in antiretroviral therapy-naive patients resulted in significantly lower increases in BTMs (CTx, osteocalcin, BSAP, P1NP) compared with EFV/FTC/TDF over 144 weeks. The observed changes are consistent with results from other smaller, randomized trials. These differences in BTMs likely correlate with changes in bone mineral density over time.

Indexed as

AdolescentAdultAgedAged, 80 and overAnti-Retroviral AgentsAntiretroviral Therapy, Highly ActiveBiomarkersBone RemodelingFemaleHIV InfectionsHumansMaleMiddle AgedSerumVitamin DYoung AdultAnti-Retroviral AgentsBiomarkersVitamin D

Identifiers

PMID26355674
PMCPMC4645955
OpenAlexW2419515216

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.