Comparison of 48‐week efficacies of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide and nucleoside/nucleotide reverse transcriptase inhibitor‐sparing regimens: a systematic review and network meta‐analysis

Gallien, Sébastien; Massetti, Massimo; Flandre, Philippe; Leleu, Henri; Descamps, Diane; Lazaro, Estibaliz

doi:10.1111/hiv.12643

Cited by 3 publications

(4 citation statements)

References 45 publications

(41 reference statements)

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“…EVG is a second generation INSTI, co-formulated with the booster Cobicistat (EVG/c), with very limited data from human studies in pregnancy. A recent systematic review 15 suggests that EVG/c/Emtricitabine/Tenofovir Alafenamide is a more effective option than NRTI-sparing regimens for treatment-naïve non-pregnant patients.…”

Section: A C C E P T E Dmentioning

confidence: 99%

Brief Report: Surveillance of Congenital Anomalies After Exposure to Raltegravir or Elvitegravir During Pregnancy in the United Kingdom and Ireland, 2008–2018

Rasi

Cortina‐Borja

Peters

et al. 2019

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Background: The indisputable benefits of antiretroviral therapy (ART) in the reduction of mother-to-child-transmission of HIV (MTCT) have to be carefully balanced with the risks of embryo-foetal toxicities due to foetal exposure to maternal ART. The recent report of a potential safety signal with Dolutegravir use in pregnancy and potential increased rate of neural tube defects (NTDs), has raised the question of a potential class effect for Integrase Strand Inhibitors. To contribute real-world evidence we evaluated data on pregnant women receiving Raltegravir (RAL) or Elvitegravir (EVG) in the UK and Ireland. Methods: The National Study of HIV in Pregnancy and Childhood (NSHPC) is a comprehensive population-based surveillance study collecting data on all HIV-positive pregnant women and their children. We collected data on all pregnancies exposed to an ART regimen containing RAL or EVG resulting in livebirth, stillbirth and induced abortion with an expected date of delivery between September 2008 and April 2018. Pregnancies were stratified into three groups of earliest exposure. Results: A total of 908 pregnancies were exposed to a RAL or EVG-based regimen (875 to RAL and 33 to EVG). There were 886 live-born infants exposed to RAL, eight pregnancies ended in stillbirth and nine in induced abortions. Among the 886 live-born infants there were 23 (2.59% 95% CI 1.65, 3.86) reported congenital anomalies, two nervous system defects but no reported NTDs. Of the 33 pregnancies exposed to EVG, 31 resulted in live-born infants with no congenital anomaly and the remaining two pregnancies ended in induced abortion. Conclusions: The prevalence of congenital anomalies is consistent with national population estimates for 2008-2016 in the UK. More data are needed on safety of RAL and EVG in pregnancy.

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Section: A C C E P T E Dmentioning

confidence: 99%

Brief Report: Surveillance of Congenital Anomalies After Exposure to Raltegravir or Elvitegravir During Pregnancy in the United Kingdom and Ireland, 2008–2018

Rasi

Cortina‐Borja

Peters

et al. 2019

JAIDS Journal of Acquired Immune Deficiency Syndromes

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“…A previous NMA comparing the efficacy and safety of EVG/c+TAF+FTC with other regimens at 48 weeks demonstrated that EFV+ABC+3TC was inferior to EVG/c+TAF+FTC in terms of virologic suppression, and the current NMA also confirmed it ( Patel et al, 2014 ). In addition, unlike previous NMAs that compared treatments only at 48 weeks ( Patel et al, 2014 ; Gallien et al, 2018 ; Radford et al, 2019 ; Snedecor et al, 2019 ), the present study also synthesized data from 96-weeks studies, and three-drug regimens containing INI showed good efficacy and safety at 96 weeks.…”

Section: Discussionmentioning

confidence: 94%

“…Additionally, those with HIV-1 often need to take ART for the rest of their lives, so the effectiveness (e.g., virologic suppression) and toxicity [e.g., adverse events (AEs)] of drugs are of concern. Many previous NMAs were of great significance in clinical practice, and the most commonly selected time point in those studies was 48 weeks ( Patel et al, 2014 ; Gallien et al, 2018 ; Radford et al, 2019 ; Snedecor et al, 2019 ). This NMA compared triple-drug regimens containing INI with those containing RPV or EFV for their efficacy and safety at 48 and 96 weeks, respectively, in treatment-naive HIV-1 adults.…”

Section: Introductionmentioning

confidence: 99%

Three-Drug Regimens Containing Integrase Inhibitor Show Good Efficacy and Safety in Treatment-Naive Patients With HIV-1: A Bayesian Analysis

Zhang

Liu

et al. 2021

Front. Pharmacol.

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Introduction: The extensive utilisation of antiretroviral therapy has greatly improved the survival rates of those infected with human immunodeficiency virus (HIV). The objective of this study was to compare 3-drug regimens containing non-nucleoside reverse transcriptase inhibitor with 3-drug regimens containing integrase inhibitor (INI) regarding efficacy and safety in treatment-naive HIV-1-infected adults at 48 and 96 weeks, respectively.Methods: This study was a network meta-analysis using a Bayesian methodology. On January 8, 2020, we searched databases and other sources for randomized controlled trials conducted in treatment-naive HIV-1 adults and compared multiple 3-drug antiretroviral regimens containing INI, efavirenz (EFV), or rilpivirine (RPV). We extracted data on the following outcomes: virologic suppression, CD4+ cell recovery, discontinuations, deaths, adverse events, serious adverse events, deaths related to study drugs, and drug-related adverse events. We conducted calculations within a Bayesian framework using R software.Results: The network contained 15 randomized controlled trials including 9,745 patients. For efficacy outcomes, regimens containing INI, especially dolutegravir (DTG), were generally superior to other regimens. For virologic suppression at 48 weeks, odds ratios (95% credible intervals) were 0.6 (0.43, 0.82) for EFV+ tenofovir disoproxil fumarate (TDF)+emtricitabine (FTC) versus DTG+ abacavir+ lamivudine (3TC) and 0.52 (0.36, 0.75) for EFV+TDF+FTC vs. DTG+TDF+FTC/3TC. For safety outcomes, regimens containing INI tended to be safer relative to regimens without INI. Outcomes associated with death were unsuitable for network meta-analysis due to low event rates.Conclusion: 3-drug regimens containing INI demonstrate better efficacy and safety than those containing RPV or EFV.

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“…Past studies used third core drugs as network nodes for analysis when comparing the effectiveness and safety of ARTs in treatment-naive HIV patients ( Kanters et al, 2016 ; Gallien et al, 2018 ). Considering that the backbone of the DOR + TDF+3TC/FTC we wanted to compare is defined, we used a complete treatment regimen as network node.…”

Section: Methodsmentioning

confidence: 99%

Comparison of the Efficacy and Safety of a Doravirine-Based, Three-Drug Regimen in Treatment-Naïve HIV-1 Positive Adults: A Bayesian Network Meta-Analysis

Zhang

Zhou

et al. 2022

Front. Pharmacol.

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Introduction: Extensive use of antiretroviral therapy has remarkably improved the survival rates of people living with HIV. Doravirine (DOR) is a newly-approved antiretroviral belonging to the class of non-nucleoside reverse transcriptase inhibitors. Here, we compared the efficacy and safety of DOR + tenofovir dipivoxil fumarate (TDF)+Lamivudine (3TC)/Emtritabine (FTC) with traditional triple therapies in treatment-naïve HIV-1-positive adults.Methods: Randomized controlled trials involving treatment-naïve HIV-1-positive adults that met inclusion criteria were systematically retrieved and data on the following outcomes extracted: virological suppression, adverse events, severe adverse events, and drug-related adverse events. A Bayesian network meta-analysis was then performed on the data.Results: This study included a total of 39 randomized controlled trials involving 26 antiretroviral therapies and 21,110 HIV1-positive patients. At week 48, relative to the other 25 regimens included in the network of virological suppression, DOR + TDF+3TC/FTC exhibited superiority to some efavirenz, nevirapine, atazanavir, or lopinavir-based regimens, including efavirenz + abacavir+3TC [Odd Ratio (OR) = 0.52, 95% confidence interval (CrI) = 0.35–0.77]. At week 48, the performance of DOR + TDF+3TC/FTC was relatively similar to all other analyzed regimens in terms of adverse events. The DOR + TDF+3TC/FTC regimen performed better in terms of severe adverse events and drug-related adverse events.Conclusion: The network meta-analysis showed that DOR + TDF+3TC/FTC has good efficacy and safety at 48 weeks.Systematic Review Registration: Open Science Framework, https://osf.io/6ybp7.

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Comparison of 48‐week efficacies of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide and nucleoside/nucleotide reverse transcriptase inhibitor‐sparing regimens: a systematic review and network meta‐analysis

Cited by 3 publications

References 45 publications

Brief Report: Surveillance of Congenital Anomalies After Exposure to Raltegravir or Elvitegravir During Pregnancy in the United Kingdom and Ireland, 2008–2018

Brief Report: Surveillance of Congenital Anomalies After Exposure to Raltegravir or Elvitegravir During Pregnancy in the United Kingdom and Ireland, 2008–2018

Three-Drug Regimens Containing Integrase Inhibitor Show Good Efficacy and Safety in Treatment-Naive Patients With HIV-1: A Bayesian Analysis

Comparison of the Efficacy and Safety of a Doravirine-Based, Three-Drug Regimen in Treatment-Naïve HIV-1 Positive Adults: A Bayesian Network Meta-Analysis

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