Evidence map›Paper›PMID 21811554›Full record

SynthesisPloS one2011

Effectiveness of protease inhibitor monotherapy versus combination antiretroviral maintenance therapy: a meta-analysis.

Sandra Mathis, Bettina Khanlari, Federico Pulido, Mauro Schechter, Eugenia Negredo, Mark Nelson, Pietro Vernazza, Pedro Cahn, Jean-Luc Meynard, Jose Arribas and 1 more

Registry-linked trialAbstract readComparative StudyMeta-AnalysisReview
In one paragraph

Synthesis in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01905059 (Multicenter, International, Prospective, Phase III, Randomized, Superiority Trial Comparing Two Maintenance Strategies With Mono or Bi-therapy of Protease Inhibitors With or Without Lamivudine in Virologically Suppressed HIV Patients on Second Line Antiretroviral Treatment Over a Period of 96 Weeks in Africa), which is not on this map. Cited by 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT01905059 phase3completednot on this mapstarted 2014, after this paper: background citation

Multicenter, International, Prospective, Phase III, Randomized, Superiority Trial Comparing Two Maintenance Strategies With Mono or Bi-therapy of Protease Inhibitors With or Without Lamivudine in Virologically Suppressed HIV Patients on Second Line Antiretroviral Treatment Over a Period of 96 Weeks in Africa (Dakar, Bobo Dioulasso, Yaounde)

TypeinterventionalSponsorANRS, Emerging Infectious DiseasesRan2014 to 2017Enrolled265ConditionsHIV InfectionArmsmonoPI - boosted lopinavir or boosted darunavir, bi therapy - (boosted lopinavir or boosted darunavir) + lamivudine
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  8. Past and future of HIV infection. A document based on expert opinion.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2022
    Review
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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

11 authors.

Sandra MathisBasel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland.
Bettina Khanlari
Federico Pulido
Mauro Schechter
Eugenia Negredo
Mark Nelson
Pietro Vernazza
Pedro Cahn
Jean-Luc Meynard
Jose Arribas
Heiner C Bucher

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe unparalleled success of combination antiretroviral therapy (cART) is based on the combination of three drugs from two classes. There is insufficient evidence whether simplification to ritonavir boosted protease inhibitor (PI/r) monotherapy in virologically suppressed HIV-infected patients is effective and safe to reduce cART side effects and costs.

methodsWe systematically searched Medline, Embase, the Cochrane Library, conference proceedings and trial registries to identify all randomised controlled trials comparing PI/r monotherapy to cART in suppressed patients. We calculated in an intention to treat (loss-of follow-up, discontinuation of assigned drugs equals failure) and per-protocol analysis (exclusion of protocol violators following randomisation) and based on three different definitions for virological failure pooled risk ratios for remaining virologically suppressed.

findingsWe identified 10 trials comparing 3 different PIs with cART based on a PI/r plus 2 reverse transcriptase inhibitors in 1189 patients. With the most conservative approach (viral load <50 copies/ml on two consecutive measurements), the risk ratios for viral suppression at 48 weeks of PI/r monotherapy compared to cART were in the ITT analysis 0.94 8 (95% CI 0.89 to 1.00) p = 0.06; risk difference -0.06 (95%CI -0.11 to 0) p = 0.05, p for heterogeneity  = 0.08, I(2) = 43.1%) and in the PP analysis 0.93 ((95%CI 0.90 to 0.97) p<0.001; risk difference -0.07 (95%CI -0.10 to -0.03) p<0.001, p for heterogeneity  = 0.44, I(2) = 0%). Reintroduction of cART in 44 patients with virological failure led in 93% to de-novo viral suppression.

interpretationVirologically well suppressed HIV-infected patients have a lower chance to maintain viral suppression when switching from cART to PI/r monotherapy. Failing patients achieve high rates of de-novo viral suppression following reintroduction of reverse transcriptase inhibitors.

Indexed as

Clinical Trials as TopicDrug Therapy, CombinationFollow-Up StudiesHIV InfectionsHIV Protease InhibitorsHumansIntention to Treat AnalysisMaintenance ChemotherapyRisk FactorsTreatment OutcomeHIV Protease Inhibitors

Identifiers

PMID21811554
PMCPMC3139616

What OpenQuestion holds

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Registered trials

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.