Pharmaceutical care recommendations for antiviral treatments in children with coronavirus disease 2019
Identifieur interne : 000357 ( Pmc/Corpus ); précédent : 000356; suivant : 000358Pharmaceutical care recommendations for antiviral treatments in children with coronavirus disease 2019
Auteurs : Yan Wang ; Li-Qin ZhuSource :
- World Journal of Pediatrics [ 1708-8569 ] ; 2020.
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DOI: 10.1007/s12519-020-00353-5
PubMed: NONE
PubMed Central: 7090514
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6814</institution-id><institution>Department of Pharmacy,</institution><institution>Tianjin First Central Hospital,</institution></institution-wrap>Tianjin 300192, China</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmc">7090514</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7090514</idno><idno type="RBID">PMC:7090514</idno><idno type="doi">10.1007/s12519-020-00353-5</idno><idno type="pmid">NONE</idno><date when="2020">2020</date><idno type="wicri:Area/Pmc/Corpus">000357</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000357</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Pharmaceutical care recommendations for antiviral treatments in children with coronavirus disease 2019</title><author><name sortKey="Wang, Yan" sort="Wang, Yan" uniqKey="Wang Y" first="Yan" last="Wang">Yan Wang</name><affiliation><nlm:aff 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<front><journal-meta><journal-id journal-id-type="nlm-ta">World J Pediatr</journal-id><journal-id journal-id-type="iso-abbrev">World J Pediatr</journal-id><journal-title-group><journal-title>World Journal of Pediatrics</journal-title></journal-title-group><issn pub-type="ppub">1708-8569</issn><issn pub-type="epub">1867-0687</issn><publisher><publisher-name>Springer Singapore</publisher-name><publisher-loc>Singapore</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmc">7090514</article-id><article-id pub-id-type="publisher-id">353</article-id><article-id pub-id-type="doi">10.1007/s12519-020-00353-5</article-id><article-categories><subj-group subj-group-type="heading"><subject>Viewpoint</subject></subj-group></article-categories><title-group><article-title>Pharmaceutical care recommendations for antiviral treatments in children with coronavirus disease 2019</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Wang</surname><given-names>Yan</given-names></name><xref ref-type="aff" rid="Aff1">1</xref></contrib><contrib contrib-type="author" corresp="yes"><name><surname>Zhu</surname><given-names>Li-Qin</given-names></name><address><email>zlq0713@aliyun.com</email></address><xref ref-type="aff" rid="Aff2">2</xref></contrib><aff id="Aff1"><label>1</label><institution-wrap><institution-id institution-id-type="GRID">grid.417022.2</institution-id><institution-id institution-id-type="ISNI">0000 0004 1772 3918</institution-id><institution>Department of Pharmacy,</institution><institution>Tianjin Children’s Hospital,</institution></institution-wrap>Tianjin 300134, China</aff><aff id="Aff2"><label>2</label><institution-wrap><institution-id institution-id-type="GRID">grid.417024.4</institution-id><institution-id institution-id-type="ISNI">0000 0004 0605 6814</institution-id><institution>Department of Pharmacy,</institution><institution>Tianjin First Central Hospital,</institution></institution-wrap>Tianjin 300192, China</aff></contrib-group><pub-date pub-type="epub"><day>12</day><month>3</month><year>2020</year></pub-date><fpage>1</fpage><lpage>4</lpage><history><date date-type="received"><day>20</day><month>2</month><year>2020</year></date><date date-type="accepted"><day>2</day><month>3</month><year>2020</year></date></history><permissions><copyright-statement>© Children's Hospital, Zhejiang University School of Medicine 2020</copyright-statement><license><license-p>This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.</license-p></license></permissions></article-meta></front><body><p id="Par1">Up to now, no antiviral therapeutic regimens with exact efficacy are recommended to be used in children with coronavirus disease 2019 (COVID-19). <italic>Interim Guidance for Diagnosis and Treatment (the sixth edition) of COVID-19</italic> [<xref ref-type="bibr" rid="CR1">1</xref>] only provided potential antiviral treatments in adults. According to the current guidelines for management in adults and children and available resources in antiviral drugs, we herein discussed the pharmaceutical care of the five antiviral treatments (IFN-α, lopinavir/ritonavir, ribavirin, chloroquine diphosphate and arbidol) in children with COVID-19 (Table <xref rid="Tab1" ref-type="table">1</xref>).<table-wrap id="Tab1"><label>Table 1</label><caption><p>Dosage regimen and precaution of antiviral drugs in children</p></caption><table frame="hsides" rules="groups"><thead><tr><th align="left">Drugs</th><th align="left">Age available</th><th align="left">Dosage regimen of COVID-19 in children</th><th align="left">Precaution/contraindication</th></tr></thead><tbody><tr><td align="left">IFN-α</td><td align="left">Nebulization: using with caution in neonates and infants younger than 2 months</td><td align="left"><p>Nebulization: 200,000–400,000 IU/kg or 2–4 μg/kg in 2 mL sterile water, twice daily for 5–7 days</p><p>Spray: 1–2 sprays on each nostril and 8–10 sprays on the oropharynx, once every 1–2 h, 8–10 sprays/day for 5–7 days</p></td><td align="left">Contraindication: CrCl < 50 mL/min; histories of mental illness, severe or unstable heart disease, or aplastic anemia</td></tr><tr><td align="left">LPVr</td><td align="left"><p>China: OS ≥ 6 months, T ≥ 2 years</p><p>USA: OS ≥ 14 days, T ≥ 6 months</p></td><td align="left"><p>Body weight (kg)</p><p> 7–15: 12 mg/3 mg/kg/time, twice daily for 1–2 weeks</p><p> 15–40: 10 mg/2.5 mg/kg/time, twice daily for 1–2 weeks</p><p> > 40: 400 mg/100 mg/time, twice daily for 1–2 weeks</p></td><td align="left"><p>Contraindication: patients with severe hepatic insufficiency</p><p>Not be recommended: children with jaundice</p></td></tr><tr><td align="left">Ribavirin</td><td align="left"><p>China: oral dosage forms ≥ 6 years</p><p>USA and Europe: oral dosage forms ≥ 3 years</p></td><td align="left">Intravenous infusion at a dose of 10 mg/kg every time (maximum 500 mg every time), 2–3 times daily</td><td align="left"><p>Not be recommended: CrCl < 50 mL/min</p><p>Should be discontinued: SCr > 2 mg/dL</p><p>Warning: hemolytic anemia</p></td></tr><tr><td align="left">CD</td><td align="left">Using with caution</td><td align="left">No recommendation</td><td align="left">Acute poisoning is usually fatal with a dose of 50 mg/kg</td></tr><tr><td align="left">Arbidol</td><td align="left">≥ 2 years for influenza in Russia</td><td align="left">No recommendation</td><td align="left">Using with caution in patients with liver dysfunction</td></tr></tbody></table><table-wrap-foot><p><italic>IFN-α</italic> interferon-α, <italic>LPVr</italic> lopinavir/ritonavir, <italic>CD</italic> chloroquine diphosphate, <italic>COVID-19</italic> coronavirus disease 2019, <italic>CrCl</italic> creatinine clearance, <italic>SCr</italic> serum creatinine, <italic>OS</italic> oral solutions, <italic>T</italic> tablets</p></table-wrap-foot></table-wrap></p><sec id="Sec2"><title>IFN-α</title><p id="Par2">IFN-α is a broad-spectrum antiviral drug, which could inhibit the synthesis of viral RNA and inhibit viral replication and spread. IFN-α, combined with ribavirin, which could reduce viral replication, moderated the host response and improved clinical outcome in MERS-CoV infected rhesus macaques [<xref ref-type="bibr" rid="CR2">2</xref>]. In China, IFN-α is available in injections, sprays, gels, etc. IFN-α nebulization or spray are commonly used in children for treating bronchiolitis [<xref ref-type="bibr" rid="CR3">3</xref>, <xref ref-type="bibr" rid="CR4">4</xref>], herpes angina [<xref ref-type="bibr" rid="CR5">5</xref>, <xref ref-type="bibr" rid="CR6">6</xref>], hand-foot-mouth disease [<xref ref-type="bibr" rid="CR7">7</xref>, <xref ref-type="bibr" rid="CR8">8</xref>], etc. In the experts' consensus statements, it could be also used for treatment of COVID-19 in children [<xref ref-type="bibr" rid="CR9">9</xref>], IFN-α is the only antiviral drug which is clearly recommended to be used in children with COVID-19.</p><p id="Par3">IFN-α nebulization can be given at a dosage of 200,000–400,000 IU/kg or 2–4 μg/kg (in 2 mL sterile water) two times daily for 5–7 days. IFN-α2b spray can be used for high-risk populations who have a close history of contact with suspected infected patients or those with only upper respiratory tract symptoms in the early phase. One to two sprays can be used on each nostril, and 8–10 sprays on the oropharynx. The dose of IFN-α2b injection is 8000 IU, once every 1–2 h, 8–10 sprays/day for 5–7 days. Intramuscular injection of high-dose IFN-α (> 2 μg/kg/time) could cause myelosuppression in children [<xref ref-type="bibr" rid="CR10">10</xref>]. Overdose of IFN-α also could cause liver enzyme abnormalities, renal failure, bleeding, etc. It should be cautious while prescribing for children.</p><p id="Par4">IFN-α is contraindicated in patients with abnormal liver function. In children with creatinine clearance (CrCl) below 50 mL/min, IFN-α is prohibited. IFN-α is also contraindicated in children with histories of mental illness, severe or unstable heart disease, or aplastic anemia. IFN-α nebulization should be used with caution in neonates and infants younger than 2 months [<xref ref-type="bibr" rid="CR10">10</xref>]. Adverse reactions of IFN-α mainly include low-grade fever and flu-like symptoms (both in children with intramuscularly injection) [<xref ref-type="bibr" rid="CR11">11</xref>]. Growth and development inhibition is more common when combining IFN-α with ribavirin. Suicidal ideation is more common in children (mainly adolescents) compared with adults (2.4% vs. 1%) [<xref ref-type="bibr" rid="CR12">12</xref>]. To our knowledge, IFN-α has few drug interactions. However, IFN-α should be used with caution while combining with sleeping pills and sedatives.</p></sec><sec id="Sec3"><title>Lopinavir/ritonavir (LPVr)</title><p id="Par5">LPVr is mainly used for treating HIV. Based on the clinical experiences in treating SARS [<xref ref-type="bibr" rid="CR13">13</xref>] and MERS [<xref ref-type="bibr" rid="CR14">14</xref>], LPVr is proposed to treat COVID-19. LPVr is available in oral tablets and solutions. LPVr oral solution is more suitable for children with a body surface area less than 0.6 m<sup>2</sup> or those who are unable to swallow tablets. LPVr oral solution contains approximately 42% (v/v) ethanol and 15% (w/v) propylene glycol, which is not recommended in premature infants within 42 weeks and neonates within 14 days based on drug instructions in the USA [<xref ref-type="bibr" rid="CR15">15</xref>]. In China, LPVr oral solution is suitable for children aged 6 months or older [<xref ref-type="bibr" rid="CR16">16</xref>]. Differences in age limitation maybe due to different excipients and the manufacture process used. The dosage regimen of LPVr was recommended as follows [<xref ref-type="bibr" rid="CR17">17</xref>]: LPVr tablets (200 mg/50 mg): 12 mg/3 mg/kg every time for the children with 7–15 kg body weight (BW); for those with BW of 15–40 kg, 10 mg/2.5 mg/kg every time; for those with BW of 40 kg or more, 400 mg/100 mg can be administrated every time. LPVr tablets are administered twice daily for 1–2 weeks.</p><p id="Par6">Lopinavir (LPV) is mainly metabolized by the liver, so LPVr should be used with caution in patients with mild to moderate hepatic insufficiency, and contraindicated in patients with severe hepatic insufficiency. In addition, LPVr could cause increased PR interval, second- or third-degree cardiac block [<xref ref-type="bibr" rid="CR18">18</xref>]. LPVr should be used with caution in children with congenital QT interval extension syndrome or hypokalemia. The most common adverse reactions of LPVr include diarrhea (adults 19.5%; children 12%), vomiting (adults 6.8%; children 21%), rash (adults 5%; children 12%), etc. [<xref ref-type="bibr" rid="CR19">19</xref>]. Children are more likely to present with adverse reactions such as rash and vomiting, these symptoms should be closely monitored in children. For LPVr, lopinavir is a substrate of CYP3A enzyme, and ritonavir is a strong inhibitor of CYP3A enzyme. LPVr should be cautiously used while combining with drugs metabolized by CYP3A enzyme or drugs affecting CYP3A enzyme activity. For children with jaundice, LPVr may increase free bilirubin and exacerbate jaundice. Therefore, LPVr should not be used in children with jaundice.</p></sec><sec id="Sec4"><title>Ribavirin</title><p id="Par7">Ribavirin is a broad-spectrum antiviral drug, which has inhibitory effects on RNA viruses and DNA viruses. Different dosage forms and age restrictions of ribavirin can be seen in China and other countries. In China, ribavirin is available in injections, oral dosage forms (capsules, granules, tablets), aerosols, etc. Clinical trials for oral dosage forms have not been carried out in children under 6 years in China, so oral ribavirin is not recommended to be used in children younger than 6 years in China. Ribavirin is available in oral dosage forms in USA and European countries and inhalation in USA. In these countries, the oral dosage forms are only recommended to be used in children aged 3 years or older. Intravenous infusion of ribavirin injections at a dose of 10 mg/kg every time (maximum 500 mg every time), 2–3 times daily was recommended for children with COVID-19 [<xref ref-type="bibr" rid="CR17">17</xref>].</p><p id="Par8">Ribavirin should be used with caution in patients with abnormal liver function. In patients with creatinine clearance (CrCl) below 50 mL/min, ribavirin is not recommended. In patients with serum creatinine (SCr) higher than 2 mg/dL, ribavirin should be discontinued. The most common adverse reactions of ribavirin in children include fever (80%), headache (62%), neutropenia (33%), fatigue (30%), etc. [<xref ref-type="bibr" rid="CR20">20</xref>]. Ribavirin should be noted to enter red blood cells and can be largely accumulated, which could lead to hemolytic anemia [<xref ref-type="bibr" rid="CR21">21</xref>, <xref ref-type="bibr" rid="CR22">22</xref>]. Large doses of ribavirin could cause decreased hemoglobin and serious heart damage. Children with heart diseases should be suggested to avoid using ribavirin. If necessary, ribavirin should not be given at a high dose and the hemoglobin and hematocrit should be closely monitored.</p></sec><sec id="Sec5"><title>Chloroquine diphosphate (CD)</title><p id="Par9">CD is an optimized drug based on the structure from a classic antimalarial drug named quinine which is mainly used for malaria, parenteral amoebiasis, etc. CD has shown apparent efficacy in treating COVID-19 in adult clinical trials [<xref ref-type="bibr" rid="CR23">23</xref>]. CD is available in oral tablets and injections. CD tablets were recommended for oral administration in 18–65 years of infected adults at a dose of 0.5 g every time, twice daily [<xref ref-type="bibr" rid="CR1">1</xref>], for 7 days. For BW ≤ 50 kg patients, CD dosage needs to be decreased to 0.5 g, once daily, during 3–7 days after administration in later released file [<xref ref-type="bibr" rid="CR24">24</xref>]. There is no dosage recommendation of CD in COVID-19 children so far. Acute poisoning of CD is usually fatal with a dose of 50 mg/kg according to the instruction. A report regarded chloroquine concentration > 25 μmol/L as a fatal predictor [<xref ref-type="bibr" rid="CR25">25</xref>]. Extreme caution should be followed while prescribing CD for children.</p><p id="Par10">CD should be used with caution in patients with heart diseases, liver or kidney dysfunction, hematoporphyria, mental illness. There are mild adverse reactions of CD in treating malaria, including dizziness, headache, loss of appetite, etc. [<xref ref-type="bibr" rid="CR26">26</xref>]. At higher doses of CD, the main adverse reaction is ocular toxicity, which could affect vision. If eye discomfort or visual abnormality occurs, CD should be discontinued. Other adverse reactions of CD include arrhythmia, drug-induced psychosis, leukopenia, etc. CD is mainly metabolized by liver and the burden of liver could be aggravated while combining with the other drugs (e.g., chlorpromazine) metabolized by liver. CD has a direct inhibitory effect on neuromuscular junctions, which could be aggravated while combining with drugs (e.g., clindamycin, streptomycin, gentamicin, etc.). Combination of CD with heparin could increase bleeding risk. For the patients with digitalization, CD could cause cardiac block. Other drug interactions (with indomethacin, thyroxine, isoniazid, etc.) also need to be noted.</p></sec><sec id="Sec6"><title>Arbidol</title><p id="Par11">Arbidol (umifenovir) is a broad-spectrum antiviral compound approved in Russia and China for prophylaxis and treatment of influenza. This compound shows activities against numerous DNA and RNA viruses [<xref ref-type="bibr" rid="CR27">27</xref>]. Arbidol was found to be effective to SARS-CoV-2 in vitro [<xref ref-type="bibr" rid="CR28">28</xref>]. Arbidol is available in oral dosage forms in China and Russia [<xref ref-type="bibr" rid="CR29">29</xref>]. The dosage regimen of arbidol (0.2 g every time, twice daily, not be given over 10 days) in adults with COVID-19 was recommended [<xref ref-type="bibr" rid="CR1">1</xref>]. There is no recommendation of dosage regimen of arbidol in children with COVID-19 so far.</p><p id="Par12">Arbidol is mainly metabolized by the liver, it should be used with caution in patients with liver dysfunction. Adverse reactions include nausea, diarrhea, dizziness, elevated serum aminotransferase, etc. The average plasma protein binding (PB) rate of arbidol is 89.2–91.6%. Arbidol could compete with drugs of higher PB rate for plasma protein, leading to increased concentration of combined drugs.</p><p id="Par13">In conclusion, all antiviral drugs are only tried to be used for treating COVID-19. Antiviral drugs should be used after weighing advantages and disadvantages with caution in children. For those with mild symptoms, low dosage of IFN-α nebulization can be used. In addition, LPVr is a choice for COVID-19 children. Ribavirin is usually used as a combined drug. The combination of three or more antiviral drugs at the same time is not recommended.</p></sec></body><back><fn-group><fn><p><bold>Publisher's Note</bold></p><p>Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.</p></fn></fn-group><notes notes-type="author-contribution"><title>Author contributions</title><p>YW and LQZ drafted, revised, reviewed, and approved the final manuscript.</p></notes><notes notes-type="funding-information"><title>Funding</title><p>There is no funding data for this article.</p></notes><notes notes-type="ethics"><title>Compliance with ethical standards</title><notes><title>Ethical approval</title><p id="Par15">This article does not contain any studies with human participants or animals performed by any of the authors.</p></notes><notes notes-type="COI-statement"><title>Conflict of interest</title><p id="Par14">Author declares no conflict of interests in the past 36 months.</p></notes></notes><ref-list id="Bib1"><title>References</title><ref id="CR1"><label>1.</label><mixed-citation publication-type="other">National Health Commission of the People's Republic of China. 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