Publikasi Scopus 926 artikel (Per 14 Maret 2022)

Lazarus G., Wangsaputra V.K., Christianto, Louisa M., Soetikno V., Hamers R.L.
57214599425;57215576000;57223348000;41461551400;36769252100;23034345900;
Safety and Pharmacokinetic Profiles of Long-Acting Injectable Antiretroviral Drugs for HIV-1 Pre-Exposure Prophylaxis: A Systematic Review and Meta-analysis of Randomized Trials
2021
Frontiers in Pharmacology
12
664875
Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; Department of Pharmacology and Therapeutics, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; Eijkman-Oxford Clinical Research Unit, Jakarta, Indonesia; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom
Lazarus, G., Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; Wangsaputra, V.K., Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; Christianto, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; Louisa, M., Department of Pharmacology and Therapeutics, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; Soetikno, V., Department of Pharmacology and Therapeutics, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; Hamers, R.L., Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia, Eijkman-Oxford Clinical Research Unit, Jakarta, Indonesia, Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom
Objectives: To investigate the safety and pharmacokinetic profiles of long-acting injectable pre-exposure prophylaxis (LAI PrEP), notably cabotegravir (CAB-LA) and rilpivirine (RPV-LA), for the prevention of human immunodeficiency virus-1 (HIV-1) infection. Methods: Eligible randomized trials of LAI PrEP in HIV-uninfected and/or healthy patients were included and assessed with the Revised Cochrane risk-of-bias tool for randomized trials. Where feasible, a meta-analysis was performed for safety outcomes by using a random-effects model with risk ratios and their 95% confidence intervals as the common effect measure. The protocol was registered with PROSPERO CRD42020154772. Results: Eight studies cumulating a total of 666 participants were included in this systematic review, including five (362 intervention-arm volunteers) and four trials (194 intervention-arm volunteers) that investigated CAB-LA and RPV-LA, respectively. We found that both CAB-LA and RPV-LA were generally well-tolerated as their safety profiles were similar to placebo in terms of any adverse event (AE), serious AE, and AE-related withdrawals. Furthermore, pharmacokinetic analyses revealed favorable prospects in viral inhibitory activity of CAB-LA and RPV-LA. Intramuscular (IM) injection of CAB-LA 600 mg Q8W was superior to CAB-LA 800 mg Q12W in male participants, while the same was true for RPV-LA 1200 mg IM Q8W over other dosing regimens. Although these results are promising, further research is required to confirm the findings on RPV-LA as current evidence is limited. Conclusion: CAB-LA and RPV-LA have promising safety and pharmacokinetic profiles. The preventive efficacy of these agents is being evaluated in Phase 3 trials. © Copyright © 2021 Lazarus, Wangsaputra, Christianto, Louisa, Soetikno and Hamers.
cabotegravir; HIV-human immunodeficiency virus; long acting injectable (LAI); pre-exposure (PrEP) prophylaxis; rilpivirine
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