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Article ; Online: Ivermectin for COVID-19: Promising but not yet conclusive.

Van Rensburg, R / Decloedt, E H / Reuter, H / Parker, A / Schrueder, N / Lahri, S

South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde

2021 Volume 111, Issue 3, Page(s) 13187

MeSH term(s)	COVID-19 ; Humans ; Ivermectin ; Pharmaceutical Preparations ; SARS-CoV-2 ; South Africa
Chemical Substances	Pharmaceutical Preparations ; Ivermectin (70288-86-7)
Language	English
Publishing date	2021-01-12
Publishing country	South Africa
Document type	Letter ; Comment
ZDB-ID	390968-2
ISSN	2078-5135 ; 0038-2469 ; 0256-9574
ISSN (online)	2078-5135
ISSN	0038-2469 ; 0256-9574
DOI	10.7196/SAMJ.2021.v111i3.15522
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Article ; Online: Current evidence for directed and supportive investigational therapies against COVID-19.

van Rensburg, R / Pillay-Fuentes Lorente, V / Decloedt, E H

African journal of thoracic and critical care medicine

2020 Volume 26, Issue 2

Abstract: Coronavirus disease 2019 (COVID-19) is a global health crisis. There is currently a great need for effective and safe therapies directed at the disease, but no drugs are presently registered for use in COVID-19. Several directed therapies have been ... ...

Abstract	Coronavirus disease 2019 (COVID-19) is a global health crisis. There is currently a great need for effective and safe therapies directed at the disease, but no drugs are presently registered for use in COVID-19. Several directed therapies have been proposed, and most are still in clinical trials. Currently available published, peer-reviewed results mostly involve small sample sizes with study limitations restricting the interpretation of the findings. Many trials currently published also do not have a control group, limiting the interpretation of the effect of the intervention. Investigational directed therapies as well as investigational supportive therapies against COVID-19 are reviewed here. Chloroquine and hydroxychloroquine show promise as directed therapies, but current trial results are conflicting. Lopinavir/ritonavir also shows potential, but was started late in the disease course in most trials. No randomised controlled evidence is currently available for remdesivir and favipiravir. Corticosteroid use is not recommended for directed therapy against COVID-19, and the role of tocilizumab is currently unclear, based on limited evidence. Early initiation of investigational directed therapies may provide benefit in selected patients. The results from larger randomised controlled trials will clarify the place of these therapies in COVID-19 treatment.
Language	English
Publishing date	2020-04-30
Publishing country	South Africa
Document type	Journal Article ; Review
ZDB-ID	2945902-3
ISSN	2617-0205 ; 2617-0191
ISSN (online)	2617-0205
ISSN	2617-0191
DOI	10.7196/AJTCCM.2020.v26i2.072
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Article ; Online: Blood and cerebrospinal fluid biomarker changes in patients with HIV-associated neurocognitive impairment treated with lithium: analysis from a randomised placebo-controlled trial.

Thela, Lindokuhle / Decloedt, Eric / Zetterberg, Henrik / Gisslén, Magnus / Lesosky, Maia / Gleich, Melanie / Koutsilieri, Eleni / Scheller, Carsten / Hye, Abdul / Joska, John

Journal of neurovirology

2023 Volume 29, Issue 2, Page(s) 156–166

Abstract: HIV-associated neurocognitive disorders (HAND) persist in the era of antiretroviral therapy (ART). Thus, ART does not completely halt or reverse the pathological processes behind HAND. Adjuvant mitigating treatments are, therefore, prudent. Lithium ... ...

Abstract	HIV-associated neurocognitive disorders (HAND) persist in the era of antiretroviral therapy (ART). Thus, ART does not completely halt or reverse the pathological processes behind HAND. Adjuvant mitigating treatments are, therefore, prudent. Lithium treatment is known to promote neuronal brain-derived neurotrophic factors (BDNF). Lithium is also an inhibitor of glycogen synthase kinase-3 beta (GSK-3-β). We analyzed biomarkers obtained from participants in a randomized placebo-controlled trial of lithium in ART-treated individuals with moderate or severe HAND. We assayed markers at baseline and 24 weeks across several pathways hypothesized to be affected by HIV, inflammation, or degeneration. Investigated biomarkers included dopamine, BDNF, neurofilament light chain, and CD8 + lymphocyte activation (CD38 + HLADR +). Alzheimer's Disease (AD) biomarkers included soluble amyloid precursor protein alpha and beta (sAPPα/β), Aβ38, 40, 42, and ten other biomarkers validated as predictors of mild cognitive impairment and progression in previous studies. These include apolipoprotein C3, pre-albumin, α1-acid glycoprotein, α1-antitrypsin, PEDF, CC4, ICAM-1, RANTES, clusterin, and cystatin c. We recruited 61 participants (placebo = 31; lithium = 30). The age baseline mean was 40 (± 8.35) years and the median CD4 + T-cell count was 498 (IQR: 389-651) cells/μL. Biomarker concentrations between groups did not differ at baseline. However, both groups' blood dopamine levels decreased significantly after 24 weeks (adj. p < 002). No other marker was significantly different between groups, and we concluded that lithium did not confer neuroprotection following 24 weeks of treatment. However, the study was limited in duration and sample size.
MeSH term(s)	Humans ; Adult ; Middle Aged ; HIV ; Lithium/therapeutic use ; Brain-Derived Neurotrophic Factor ; Dopamine ; Glycogen Synthase Kinase 3/therapeutic use ; HIV Infections/complications ; HIV Infections/drug therapy ; HIV Infections/psychology ; Biomarkers
Chemical Substances	Lithium (9FN79X2M3F) ; Brain-Derived Neurotrophic Factor ; Dopamine (VTD58H1Z2X) ; Glycogen Synthase Kinase 3 (EC 2.7.11.26) ; Biomarkers
Language	English
Publishing date	2023-02-15
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1283265-0
ISSN	1538-2443 ; 1355-0284
ISSN (online)	1538-2443
ISSN	1355-0284
DOI	10.1007/s13365-023-01116-4
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Article ; Online: Population pharmacokinetics of esomeprazole in patients with preterm preeclampsia.

Gebreyesus, Manna Semere / Decloedt, Eric H / Cluver, Catherine A / Hunfeld, Nicole G M / Helgadóttir, Hólmfríður / Björnsson, Einar S / Wasmann, Roeland E / Denti, Paolo

British journal of clinical pharmacology

2022 Volume 88, Issue 10, Page(s) 4639–4645

Abstract: Esomeprazole is a proton pump inhibitor being investigated for treatment of preeclampsia. Esomeprazole pharmacokinetics during pregnancy are unknown. We used data from 10 pregnant participants with preterm preeclampsia, and 49 non-pregnant participants ... ...

Abstract	Esomeprazole is a proton pump inhibitor being investigated for treatment of preeclampsia. Esomeprazole pharmacokinetics during pregnancy are unknown. We used data from 10 pregnant participants with preterm preeclampsia, and 49 non-pregnant participants to develop a population pharmacokinetic model of esomeprazole. A two-compartment model described the data well. In pregnant participants after single dose, clearance was 42.2% (14.9-61.6%) lower compared to non-pregnant, most likely due to inhibition of CYP2C19. In non-pregnant participants after repeated dosing, clearance was 54.9% (48.2-63.5%) lower in extensive metabolizers and bioavailability was 33% (10.0-52.0%) higher compared to single dosing, which could be due to autoinhibition of CYP2C19. During pregnancy, the CYP2C19 autoinhibition effect with repeated dosing is expected to lead to much lower increase in exposure compared to non-pregnant individuals, since CYP2C19 is already inhibited due to pregnancy.
MeSH term(s)	Cytochrome P-450 CYP2C19/genetics ; Esomeprazole ; Female ; Humans ; Infant, Newborn ; Pre-Eclampsia/drug therapy ; Pregnancy ; Proton Pump Inhibitors
Chemical Substances	Proton Pump Inhibitors ; Cytochrome P-450 CYP2C19 (EC 1.14.14.1) ; Esomeprazole (N3PA6559FT)
Language	English
Publishing date	2022-06-03
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.15416
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Article ; Online: Vasopressor therapy in atypical antipsychotic overdose.

Pillay-Fuentes Lorente, V / Van Rensburg, R / Cloete, D A / Lahri, S / Decloedt, E H

South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde

2020 Volume 110, Issue 10, Page(s) 1003–1005

Abstract: Hypotension is a common presentation following an overdose of quetiapine. Adrenaline is often used as the vasopressor of choice for hypotension not responding to intravenous fluids. We present a case of quetiapine overdose with hypotension unresponsive ... ...

Abstract	Hypotension is a common presentation following an overdose of quetiapine. Adrenaline is often used as the vasopressor of choice for hypotension not responding to intravenous fluids. We present a case of quetiapine overdose with hypotension unresponsive to high-dose adrenaline. The patient was commenced on noradrenaline and made a full recovery. We highlight learning points about vasopressor therapy for atypical antipsychotic overdose. Quetiapine-induced hypotension is thought to be mediated by α1-receptor antagonism. Adrenaline is unlikely to improve blood pressure, as it is an agonist at both α- and β-receptors. Alpha-2- and β2-agonism can reduce sympathetic outflow and cause vasodilation, respectively, further exacerbating the hypotension. Noradrenaline is the preferred vasopressor of choice for hypotension caused by quetiapine overdose, as it has less affinity for α2- and β2-receptors, but maintains α1-receptor agonism. Drugs with a similar mechanism of inducing hypotension should also be treated with noradrenaline as the vasopressor of choice.
MeSH term(s)	Antipsychotic Agents/poisoning ; Drug Overdose/drug therapy ; Epinephrine/pharmacology ; Epinephrine/therapeutic use ; Female ; Humans ; Hypotension/chemically induced ; Hypotension/drug therapy ; Norepinephrine/pharmacology ; Norepinephrine/therapeutic use ; Quetiapine Fumarate/poisoning ; Treatment Outcome ; Vasoconstrictor Agents/pharmacology ; Vasoconstrictor Agents/therapeutic use ; Young Adult
Chemical Substances	Antipsychotic Agents ; Vasoconstrictor Agents ; Quetiapine Fumarate (2S3PL1B6UJ) ; Norepinephrine (X4W3ENH1CV) ; Epinephrine (YKH834O4BH)
Language	English
Publishing date	2020-09-30
Publishing country	South Africa
Document type	Case Reports ; Journal Article
ZDB-ID	390968-2
ISSN	2078-5135 ; 0038-2469 ; 0256-9574
ISSN (online)	2078-5135
ISSN	0038-2469 ; 0256-9574
DOI	10.7196/SAMJ.2020.v110i10.14771
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Article ; Online: Ivermectin exposures reported to the Poisons Information Helpline in South Africa during the COVID-19 pandemic.

Pillay-Fuentes Lorente, V / Voigt, G / Du Plessis, C E / Balme, K / Marks, C J / Decloedt, E H / Stephen, C / Reuter, H / Van Rensburg, R

South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde

2022 Volume 112, Issue 8, Page(s) 522–525

Abstract: Background: Ivermectin is an antiparasitic drug that has shown in vitro activity against COVID‑19. Clinical studies supporting ivermectin for COVID‑19 prevention and treatment are conflicting, with important limitations. Public support for ivermectin is ...

Abstract	Background: Ivermectin is an antiparasitic drug that has shown in vitro activity against COVID‑19. Clinical studies supporting ivermectin for COVID‑19 prevention and treatment are conflicting, with important limitations. Public support for ivermectin is significant, with extensive off-label use despite the conflicting views on its efficacy. Ivermectin tablets and injectable formulations are not registered in South Africa for human use by the South African Health Products Regulatory Authority. The National Department of Health does not currently recommend the use of ivermectin for COVID‑19. Objectives: To describe cases of ivermectin exposure reported to the Poisons Information Helpline of the Western Cape (PIHWC) before and after publication of the drug's in vitro activity against SARS-CoV-2. Methods: In a retrospective review, ivermectin-related calls reported to the PIHWC from 1 June 2015 to 30 June 2020 (period 1) were compared with calls received from 1 July 2020 to 31 July 2021 (period 2), dichotomised according to the first publication indicating ivermectin activity against SARS-CoV-2. Results: Seventy-one cases were screened, and 65 were included for analysis; 19 cases were reported during period 1 and 46 during period 2. During period 2, 25 ivermectin cases (54.3%) were related to COVID‑19 use. Of these, 24 cases (52.2%) involved veterinary preparations, 3 (6.5%) human preparations and 19 (41.3%) unknown preparations. Fourteen cases (73.7%) during period 1 and 30 (65.2%) during period 2 were reported to be symptomatic. The most common organ systems involved were the central nervous (n=26 cases; 40.0%), gastrointestinal (n=18; 27.7%), ocular (n=9; 13.8%) and dermatological (n=5; 7.7%) systems. Conclusion: Ivermectin-related exposure calls increased during study period 2, probably as a result of ivermectin being used as preventive and definitive therapy for COVID‑19 in the absence of robust evidence on efficacy, dosing recommendations or appropriate formulations.
MeSH term(s)	Antiparasitic Agents/therapeutic use ; COVID-19 ; Humans ; Ivermectin/therapeutic use ; Pandemics/prevention & control ; Poisons ; SARS-CoV-2 ; South Africa/epidemiology
Chemical Substances	Antiparasitic Agents ; Poisons ; Ivermectin (70288-86-7)
Language	English
Publishing date	2022-08-02
Publishing country	South Africa
Document type	Journal Article
ZDB-ID	390968-2
ISSN	2078-5135 ; 0038-2469 ; 0256-9574
ISSN (online)	2078-5135
ISSN	0038-2469 ; 0256-9574
DOI	10.7196/SAMJ.2022.v112i8.16473
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Article ; Online: Current evidence for directed and supportive investigational therapies against COVID-19

Van Rensburg, R. / Pillay-Fuentes Lorente, V. / Decloedt, E. H.

2020

Abstract: CITATION: Van Rensburg, R., Pillay-Fuentes Lorente, V. & Decloedt, E. H. 2020. Current evidence ...

Abstract	CITATION: Van Rensburg, R., Pillay-Fuentes Lorente, V. & Decloedt, E. H. 2020. Current evidence for directed and supportive investigational therapies against COVID-19. African Journal of Thoracic and Critical Care Medicine, 26(2), doi:10.7196/AJTCCM.2020.v26i2.072. The original publication is available at http://www.ajtccm.org.za ENGLISH ABSTRACT: Coronavirus disease 2019 (COVID-19) is a global health crisis. There is currently a great need for effective and safe therapies directed at the disease, but no drugs are presently registered for use in COVID-19. Several directed therapies have been proposed, and most are still in clinical trials. Currently available published, peer-reviewed results mostly involve small sample sizes with study limitations restricting the interpretation of the findings. Many trials currently published also do not have a control group, limiting the interpretation of the effect of the intervention. Investigational directed therapies as well as investigational supportive therapies against COVID-19 are reviewed here. Chloroquine and hydroxychloroquine show promise as directed therapies, but current trial results are conflicting. Lopinavir/ritonavir also shows potential, but was started late in the disease course in most trials. No randomised controlled evidence is currently available for remdesivir and favipiravir. Corticosteroid use is not recommended for directed therapy against COVID-19, and the role of tocilizumab is currently unclear, based on limited evidence. Early initiation of investigational directed therapies may provide benefit in selected patients. The results from larger randomised controlled trials will clarify the place of these therapies in COVID-19 treatment. http://www.ajtccm.org.za/index.php/SARJ/article/view/275 Publisher's version
Keywords	COVID-19 (Disease) ; Clinical trials ; Drug -- Testing ; Vaccines ; SARS-CoV-2 disease ; covid19
Subject code	610
Language	English
Publishing date	2020-04-30
Publisher	Health & Medical Publishing Group
Publishing country	za
Document type	Article ; Online
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Article ; Online: Pediatric Antiretroviral Therapeutic Drug Monitoring: A Five and a Half Year Experience from a South African Tertiary Hospital.

Engelbrecht, Anton E / Wiesner, Lubbe / Norman, Jennifer / Rabie, Helena / Decloedt, Eric H

Journal of tropical pediatrics

2019 Volume 66, Issue 4, Page(s) 385–394

Abstract: Introduction: Antiretroviral therapeutic drug monitoring (TDM) is not routinely used in the management of human immunodeficiency virus, but may be useful in pediatric patients who are prone to altered pharmacokinetics. Data on the routine use of ... ...

Abstract	Introduction: Antiretroviral therapeutic drug monitoring (TDM) is not routinely used in the management of human immunodeficiency virus, but may be useful in pediatric patients who are prone to altered pharmacokinetics. Data on the routine use of antiretroviral TDM in pediatrics are sparse especially data from sub-Saharan Africa. Methods: We retrospectively reviewed the antiretroviral TDM indications at Tygerberg Children's Hospital, identified pediatric patients who had antiretroviral TDM requests from January 2012 until June 2017 and reviewed their clinical records. Results: Fifty-nine patients were identified who presented with 64 clinical problems for which TDM was requested. TDM was requested for lopinavir, efavirenz and nevirapine in 83% (53/64), 14% (9/64) and 3% (2/64) of clinical problems, respectively. Lopinavir was mostly requested in patients when adherence measures did not correlate with the clinical picture, suspected non-adherence, lopinavir-rifampicin interactions and for neonatal safety monitoring. Efavirenz was requested when toxicity was suspected and nevirapine in patients receiving rifampicin. Lopinavir TDM confirmed non-adherence in 25% (4/16) of cases when adherence measures did not correlate with the clinical picture and in 43% (3/7) of cases when non-adherence was suspected by the clinician. Efavirenz TDM confirmed toxicity in 100% (6/6) of patients. Conclusions: Lopinavir TDM was mostly requested when adherence measures did not correlate with the clinical picture, when rifampicin was co-administered and for perinatal safety monitoring. Lopinavir TDM excluded pharmacokinetic reasons for failure in patients failing treatment when lopinavir dosing was supervised. Efavirenz TDM was requested for suspected toxicity with a 100% positive predictive value.
MeSH term(s)	Adolescent ; Anti-HIV Agents/administration & dosage ; Anti-HIV Agents/therapeutic use ; Antiretroviral Therapy, Highly Active/methods ; Benzoxazines ; Child ; Child, Preschool ; Drug Interactions ; Drug Monitoring ; Drug Therapy, Combination ; Female ; HIV Infections/drug therapy ; HIV Infections/epidemiology ; HIV Infections/virology ; Humans ; Lopinavir/administration & dosage ; Lopinavir/therapeutic use ; Male ; Medication Adherence ; Nevirapine/administration & dosage ; Nevirapine/adverse effects ; Nevirapine/therapeutic use ; Pregnancy ; Retrospective Studies ; South Africa/epidemiology ; Tertiary Care Centers ; Treatment Outcome
Chemical Substances	Anti-HIV Agents ; Benzoxazines ; Lopinavir (2494G1JF75) ; Nevirapine (99DK7FVK1H) ; efavirenz (JE6H2O27P8)
Language	English
Publishing date	2019-11-18
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	800065-7
ISSN	1465-3664 ; 0449-3281 ; 0142-6338
ISSN (online)	1465-3664
ISSN	0449-3281 ; 0142-6338
DOI	10.1093/tropej/fmz077
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Article ; Online: Benefit v. risk when using chloroquine in patients with severe COVID-19 disease.

Decloedt, E H / Reuter, H / Allwood, B / Parker, A / Koegelenberg, C F N / Blockman, M / Taljaard, J

South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde

2020 Volume 110, Issue 5, Page(s) 12903

MeSH term(s)	Azithromycin ; Betacoronavirus ; Chloroquine ; Coronavirus Infections/drug therapy ; Humans ; Hydroxychloroquine ; Pandemics ; Pneumonia, Viral
Chemical Substances	Hydroxychloroquine (4QWG6N8QKH) ; Azithromycin (83905-01-5) ; Chloroquine (886U3H6UFF)
Keywords	covid19
Language	English
Publishing date	2020-04-02
Publishing country	South Africa
Document type	Letter ; Comment
ZDB-ID	390968-2
ISSN	2078-5135 ; 0038-2469 ; 0256-9574
ISSN (online)	2078-5135
ISSN	0038-2469 ; 0256-9574
DOI	10.7196/SAMJ.2020.v110i5.14761
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Article ; Online: Bleeding and thrombosis outcomes in hospitalised COVID-19 patients on low-molecular-weight heparin and antiplatelet therapy.

Pillay-Fuentes Lorente, V / Van Rensburg, R / Moolla, M S / McCaul, M / Parker, A / Taljaard, J / Reuter, H / Decloedt, E H

South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde

2022 Volume 112, Issue 7, Page(s) 472–477

Abstract: Background: An increased incidence of thromboembolic events in hospitalised COVID‑19 patients has been demonstrated despite the use of low-molecular-weight heparin (LMWH). Antiplatelet therapy prior to admission and early in the disease course has been ... ...

Abstract	Background: An increased incidence of thromboembolic events in hospitalised COVID‑19 patients has been demonstrated despite the use of low-molecular-weight heparin (LMWH). Antiplatelet therapy prior to admission and early in the disease course has been hypothesised to be protective against thrombosis. Objectives: To describe the bleeding and thrombosis outcomes in hospitalised patients with confirmed COVID‑19 receiving LMWH, with and without concomitant antiplatelet therapy. Secondary objectives were to explore predictors of bleeding and thrombosis outcomes, and dosing practices of antiplatelet therapy and LMWH. Methods: We conducted a descriptive, cross-sectional study of bleeding and thrombosis outcomes at Tygerberg Academic Hospital, Cape Town, South Africa, during the first COVID‑19 wave, in 808 hospitalised patients with confirmed COVID‑19 receiving LMWH with and without concomitant antiplatelet therapy. Multivariate logistic regression analysis was performed if predictors were deemed statistically and clinically significant. Results: Patients receiving both LMWH and antiplatelet therapy had similar bleeding outcomes compared with patients only receiving LMWH (odds ratio (OR) 1.5; 95% confidence interval (CI) 0.6 - 4.0). Patients receiving both LMWH and antiplatelet therapy had increased odds of developing thrombosis compared with patients only receiving LMWH (OR 4.8; 95% CI 2.1 - 10.7). Conclusion: The bleeding risk in COVID‑19 patients receiving both LMWH and antiplatelet therapy was not significantly increased. A potentially higher risk of thrombosis in patients receiving LMWH and antiplatelet therapy was observed. However, this could reflect confounding by indication. Randomised studies are required to further evaluate the use of antiplatelet therapy to treat hospitalised patients with COVID‑19.
MeSH term(s)	Anticoagulants/adverse effects ; COVID-19 ; Cross-Sectional Studies ; Heparin/adverse effects ; Heparin, Low-Molecular-Weight/adverse effects ; Humans ; South Africa/epidemiology ; Thrombosis/epidemiology ; Thrombosis/etiology ; Thrombosis/prevention & control
Chemical Substances	Anticoagulants ; Heparin, Low-Molecular-Weight ; Heparin (9005-49-6)
Language	English
Publishing date	2022-07-01
Publishing country	South Africa
Document type	Journal Article
ZDB-ID	390968-2
ISSN	2078-5135 ; 0038-2469 ; 0256-9574
ISSN (online)	2078-5135
ISSN	0038-2469 ; 0256-9574
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