Evidence map›Paper›PMID 18373851›Full record

ArticleAIDS research and therapy2008

Fosamprenavir or atazanavir once daily boosted with ritonavir 100 mg, plus tenofovir/emtricitabine, for the initial treatment of HIV infection: 48-week results of ALERT.

Kimberly Y Smith, Winkler G Weinberg, Edwin DeJesus, Margaret A Fischl, Qiming Liao, Lisa L Ross, Gary E Pakes, Keith A Pappa, C Tracey Lancaster, ALERT (COL103952) Study Team

Open access · goldAbstract read
In one paragraph

Article in AIDS research and therapy, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 3 pooled it
8.8field-weighted citation impact, top 2% 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

24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 100 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  4. Trial
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  7. Review
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  13. Protease Inhibitors for Patients With HIV-1 Infection: A Comparative Overview.P & T : a peer-reviewed journal for formulary management · 2011
    Article
  14. Article
  15. Article
  16. Challenges in initiating antiretroviral therapy in 2010.The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2010
    Article
  17. The nephrotoxic effects of HAART.Nature reviews. Nephrology · 2009
    Review
  18. Review
  19. Role of atazanavir in the treatment of HIV infection.Therapeutics and clinical risk management · 2009
    Article
  20. Article
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

10 authors at 6 institutions in 1 country.

Kimberly Y SmithSection of Infectious Diseases, Rush University Medical Center, Chicago, Illinois, USA.
Winkler G Weinberg *Infectious Diseases Service, Kaiser Permanente, Atlanta, Georgia, USA.
Edwin DeJesusOrlando Immunology Center Research Facility, Orlando Immunology Center, Orlando, Florida, USA.
Margaret A FischlAIDS Clinical Research Unit, University of Miami, Miami, Florida, USA.
Qiming LiaoInfectious Diseases, GlaxoSmithKline, Research Triangle Park, North Carolina, USA.
Lisa L RossInfectious Diseases, GlaxoSmithKline, Research Triangle Park, North Carolina, USA.
Gary E PakesInfectious Diseases, GlaxoSmithKline, Research Triangle Park, North Carolina, USA.
Keith A PappaInfectious Diseases, GlaxoSmithKline, Research Triangle Park, North Carolina, USA.
C Tracey LancasterInfectious Diseases, GlaxoSmithKline, Research Triangle Park, North Carolina, USA.
ALERT (COL103952) Study Team
Research Triangle Park Foundation · USGlaxoSmithKline (United States) · USKaiser Permanente · USOrlando Immunology Center · USRush University Medical Center · USUniversity of Miami · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOnce-daily (QD) ritonavir 100 mg-boosted fosamprenavir 1400 mg (FPV/r100) or atazanavir 300 mg (ATV/r100), plus tenofovir/emtricitabine (TDF/FTC) 300 mg/200 mg, have not been compared as initial antiretroviral treatment. To address this data gap, we conducted an open-label, multicenter 48-week study (ALERT) in 106 antiretroviral-naïve, HIV-infected patients (median HIV-1 RNA 4.9 log10 copies/mL; CD4+ count 191 cells/mm3) randomly assigned to the FPV/r100 or ATV/r100 regimens.

resultsAt baseline, the FPV/r100 or ATV/r100 arms were well-matched for HIV-1 RNA (median, 4.9 log10 copies/mL [both]), CD4+ count (mean, 176 vs 205 cells/mm3). At week 48, intent-to-treat: missing/discontinuation = failure analysis showed similar responses to FPV/r100 and ATV/r100 (HIV-1 RNA < 50 copies/mL: 75% (40/53) vs 83% (44/53), p = 0.34 [Cochran-Mantel-Haenszel test]); mean CD4+ count change-from-baseline: +170 vs +183 cells/mm3, p = 0.398 [Wilcoxon rank sum test]). Fasting total/LDL/HDL-cholesterol changes-from-baseline were also similar, although week 48 median fasting triglycerides were higher with FPV/r100 (150 vs 131 mg/dL). FPV/r100-treated patients experienced fewer treatment-related grade 2-4 adverse events (15% vs 57%), with differences driven by ATV-related hyperbilirubinemia. Three patients discontinued TDF/FTC because their GFR decreased to <50 mL/min.

conclusionThe all-QD regimens of FPV/r100 and ATV/r100, plus TDF/FTC, provided similar virologic, CD4+ response, and fasting total/LDL/HDL-cholesterol changes through 48 weeks. Fewer FPV/r100-treated patients experienced treatment-related grade 2-4 adverse events.

Identifiers

PMID18373851
PMCPMC2365957
OpenAlexW2066267771

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.