Adverse reactions of drugs specifically used for treatment of SARS-CoV-2 infection

Regás, Valeria Herrera-Lasso; Culla, María Teresa Dordal; Bellfill, Ramón Lleonart

doi:10.1016/j.medcle.2020.06.026

Cited by 6 publications

(5 citation statements)

References 47 publications

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“…Several molecules are currently being administered for the treatment of SARS‐CoV‐2, many of which have unfavorable adverse reaction profiles. 30 , 31 The presence of preexisting comorbidities may exacerbate these effects and have the potential to render available treatment options unusable. The evaluation of treatment options for patients with COVID‐19 presenting with kidney injury and disease is urgent since many are at high risk of mortality, and existing treatment options, such as remdesivir, are contraindicated.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Safety, Tolerability, and Pharmacokinetics of Intravenous Doses of PF‐07304814, a Phosphate Prodrug Protease Inhibitor for the Treatment of SARS‐CoV‐2, in Healthy Adult Participants

Zhu

Pawlak

Toussi

et al. 2022

Clinical Pharm in Drug Dev

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Studies on targeted antivirals for treatment of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), the cause of the ongoing pandemic, are limited. PF‐07304814 (lufotrelvir) is the phosphate prodrug of PF‐00835231, a protease inhibitor targeting the 3C‐like protease of SARS‐CoV‐2. This phase 1 study evaluated the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous doses of lufotrelvir (continuous 24‐hour infusion of 50, 150, 500, or 700 mg) versus placebo in healthy volunteers (2 interleaving cohorts: 1, n = 8; 2, n = 7). Each dosing period was separated by a washout interval (≥5 days). Treatment‐emergent adverse events, PK, and biomarker concentrations were estimated from plasma/urine samples. Lufotrelvir was administered to 15 volunteers (mean [SD] age 39.7 [11.8] years). No serious adverse events, discontinuations, or deaths were reported. Mean maximum observed concentration of PF‐00835231 (active moiety; 97.0 ng/mL to 1288 ng/mL) were observed between median time to maximum concentration of 14 to 16 hours after the start of the lufotrelvir infusion. Near‐maximum plasma concentrations of PF‐00835231 were observed ≈6 hours after infusion start and sustained until infusion end. PF‐00835231 plasma concentrations declined rapidly after infusion end (mean terminal half‐life: 500 mg, 2.0 hours; 700 mg, 1.7 hours). Approximately 9%–11% of the dose was recovered in urine as PF‐00835231 across doses. A continuous, single‐dose, 24‐hour infusion of lufotrelvir (50–700 mg) was rapidly converted to PF‐00835231 (active moiety), with dose‐proportional PK exposures and no significant safety concerns. A daily, 24‐hour continuous infusion of 270 to 350 mg is expected to maintain PF‐00835231 concentration at steady state/above effective antiviral concentrations. Further studies exploring lufotrelvir efficacy in patients with coronavirus disease 2019 are ongoing.

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Section: Discussionmentioning

confidence: 99%

“…Several molecules are currently being administered for the treatment of SARS‐CoV‐2, many of which have unfavorable adverse reaction profiles 30,31 . The presence of preexisting comorbidities may exacerbate these effects and have the potential to render available treatment options unusable.…”

Section: Discussionmentioning

confidence: 99%

Safety, Tolerability, and Pharmacokinetics of Intravenous Doses of PF‐07304814, a Phosphate Prodrug Protease Inhibitor for the Treatment of SARS‐CoV‐2, in Healthy Adult Participants

Zhu

Pawlak

Toussi

et al. 2022

Clinical Pharm in Drug Dev

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“…The reported adverse effects of excessive use of ivermectin include nausea [ 20 ], acne [ 20 , 22 ], dizziness [ 22 ], abdominal pain [ 23 ], eosinophilia [ 23 , 24 ], neurotoxicity symptoms [ 23 ], diarrhea [ 24 ], and blurred vision [ 23 , 24 ]. High doses of ivermectin cross the blood-brain barrier, altering GABAergic communication, and consequently causing alterations in the central nervous system.…”

Section: Reviewmentioning

confidence: 99%

“…It is possible that ivermectin plays a role in inhibiting viral replication, which makes it a candidate for treating different viral diseases [ 6 , 22 ]. These effects have been demonstrated in vitro, making it necessary to complete large clinical studies to determine whether these effects translate to measurable clinical outcomes.…”

Section: Reviewmentioning

confidence: 99%

Use of Ivermectin and Chlorine Dioxide for COVID-19 Treatment and Prophylaxis in Peru: A Narrative Review

Farfán-Castillo¹,

Moreno-Núñez²,

Zárate-Yuyes³

et al. 2022

Cureus

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The spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, created a rapidly unfolding health crisis, especially in the initial phases of the pandemic. In the early stages of the pandemic, various strategies were proposed for COVID-19 prophylaxis and treatment with very little scientific evidence available. Among these proposed treatments were ivermectin and chlorine dioxide, which were both used widely in Peru for both disease prevention and treatment without considering their problematic side effects. For instance, ivermectin was part of an approved therapeutic scheme based on in vitro data, although its efficacy in humans was not demonstrated. In addition, chlorine dioxide was never shown to be effective but causes threatening side effects. In this article, we discuss current information regarding chlorine dioxide and ivermectin in the context of the COVID-19 pandemic, with a focus on experiences in Peru.

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“…Con la expansión de la enfermedad se fueron comunicando múltiples reacciones adversas a fármacos (RAF) en pacientes infectados por COVID-19, que se presentaron de forma concomitante o consecutiva a ella. Esto puede estar relacionado con el alto número de medicamentos a los que fueron expuestos los pacientes con enfermedad grave, ya que durante los primeros meses de la pandemia no existía un tratamiento estandarizado para las formas graves de la enfermedad [1][2][3] . Asimismo, se ha descripto que el SARS-CoV-2 estaría asociado con una mayor susceptibilidad de padecer reacciones adversas a fármacos debido a la desregulación del sistema inmunitario que ocasiona 1,2 .…”

Section: Introductionunclassified

Múltiples reacciones adversas graves a fármacos en un paciente luego de la infección por COVID-19. Informe de un caso

Daguer

Prinzio

Echeverría

et al. 2023

Rev. Hosp. Ital. B.Aires

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Durante la pandemia por COVID-19 se observaron diversas reacciones adversas a fármacos. Esto pudo haber estado relacionado con una mayor susceptibilidad inmunológica de los pacientes con SARS-CoV-2 a presentar este tipo de cuadros, así como también con la exposición a múltiples medicamentos utilizados en su tratamiento. Comunicamos el caso de un paciente con una infección respiratoria grave por COVID-19, que presentó 2 reacciones adversas graves a fármacos en un período corto de tiempo.

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Adverse reactions of drugs specifically used for treatment of SARS-CoV-2 infection

Cited by 6 publications

References 47 publications

Safety, Tolerability, and Pharmacokinetics of Intravenous Doses of PF‐07304814, a Phosphate Prodrug Protease Inhibitor for the Treatment of SARS‐CoV‐2, in Healthy Adult Participants

Safety, Tolerability, and Pharmacokinetics of Intravenous Doses of PF‐07304814, a Phosphate Prodrug Protease Inhibitor for the Treatment of SARS‐CoV‐2, in Healthy Adult Participants

Use of Ivermectin and Chlorine Dioxide for COVID-19 Treatment and Prophylaxis in Peru: A Narrative Review

Múltiples reacciones adversas graves a fármacos en un paciente luego de la infección por COVID-19. Informe de un caso

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