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Article ; Online: Editorial: risk of hepatocellular carcinoma with tenofovir vs entecavir-A "knock-out" is yet to be delivered-Authors' reply.

Kim, W Ray / Telep, Laura E / Chokkalingam, Anand P

2022 Volume 55, Issue 10, Page(s) 1344–1345

MeSH term(s)	Carcinoma, Hepatocellular/drug therapy ; Carcinoma, Hepatocellular/genetics ; Guanine/analogs & derivatives ; Guanine/therapeutic use ; Humans ; Liver Neoplasms/drug therapy ; Liver Neoplasms/genetics ; Tenofovir/therapeutic use
Chemical Substances	entecavir (5968Y6H45M) ; Guanine (5Z93L87A1R) ; Tenofovir (99YXE507IL)
Language	English
Publishing date	2022-04-26
Publishing country	England
Document type	Editorial ; Comment
ZDB-ID	639012-2
ISSN	1365-2036 ; 0269-2813 ; 0953-0673
ISSN (online)	1365-2036
ISSN	0269-2813 ; 0953-0673
DOI	10.1111/apt.16920
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Article ; Online: Risk of hepatocellular carcinoma in treatment-naïve chronic hepatitis B patients receiving tenofovir disoproxil fumarate versus entecavir in the United States.

Kim, W Ray / Telep, Laura E / Jump, Belinda / Lu, Mei / Ramroth, Heribert / Flaherty, John / Gaggar, Anuj / Chokkalingam, Anand P / Gordon, Stuart C

Alimentary pharmacology & therapeutics

2022 Volume 55, Issue 7, Page(s) 828–835

Abstract: Background: Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are the first-line treatment agents for chronic hepatitis B virus (HBV). Recently, whether the degree to which the risk of hepatocellular carcinoma (HCC) may be reduced by ETV vs TDF ... ...

Abstract	Background: Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are the first-line treatment agents for chronic hepatitis B virus (HBV). Recently, whether the degree to which the risk of hepatocellular carcinoma (HCC) may be reduced by ETV vs TDF has been debated. We compared the incidence of HCC among treatment-naïve patients receiving TDF vs ETV in the United States. Methods: From a large administrative medical claims database of commercially insured patients, we identified 166,933 adults with a diagnosis of chronic hepatitis B and a minimum of 12 months of prior enrolment, of whom 3934 and 6127 initiated ETV and TDF respectively. Fine-Gray hazard regression models incorporating treatment propensity scores (PS) were used to estimate the risk of HCC incidence associated with TDF vs ETV; variables considered for adjustment included demographic characteristics, concomitant medication use and baseline comorbidities, as well as competing events including liver transplantation and medication changes. Results: After PS weighting, the TDF and ETV groups were well-matched. During the follow-up, 90 patients developed HCC, including 50 receiving ETV and 40 receiving TDF, giving rise to crude incidence rates of 0.62 per 100 person-years (PY) and 0.30 per 100 PY respectively. In PS-weighted, multivariable analysis, TDF was associated with a subdistribution hazard ratio for HCC of 0.58 (95% confidence interval [CI]: 0.38-0.89) compared to ETV. Results were similar when patients ≥40 years and men and women were analysed separately. Conclusion: Among commercially insured, treatment-naïve patients with chronic hepatitis B in the United States, treatment with TDF was associated with significantly lower risk of HCC than ETV.
MeSH term(s)	Adult ; Antiviral Agents/adverse effects ; Carcinoma, Hepatocellular/chemically induced ; Carcinoma, Hepatocellular/drug therapy ; Carcinoma, Hepatocellular/epidemiology ; Female ; Guanine/analogs & derivatives ; Hepatitis B virus ; Hepatitis B, Chronic/complications ; Humans ; Liver Neoplasms/chemically induced ; Liver Neoplasms/drug therapy ; Liver Neoplasms/epidemiology ; Male ; Retrospective Studies ; Tenofovir/adverse effects ; Treatment Outcome ; United States/epidemiology
Chemical Substances	Antiviral Agents ; entecavir (5968Y6H45M) ; Guanine (5Z93L87A1R) ; Tenofovir (99YXE507IL)
Language	English
Publishing date	2022-02-08
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	639012-2
ISSN	1365-2036 ; 0269-2813 ; 0953-0673
ISSN (online)	1365-2036
ISSN	0269-2813 ; 0953-0673
DOI	10.1111/apt.16786
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Article ; Online: Sofosbuvir and risk of estimated glomerular filtration rate decline or end-stage renal disease in patients with renal impairment.

Sulkowski, Mark / Telep, Laura E / Colombo, Massimo / Durand, Francois / Reddy, K Rajender / Lawitz, Eric / Bourlière, Marc / Cheinquer, Nelson / Scherbakovsky, Stacey / Ni, Liyun / Force, Lindsey / Ramroth, Heribert / Gaggar, Anuj / Chokkalingam, Anand P / Sise, Meghan E

Alimentary pharmacology & therapeutics

2022 Volume 55, Issue 9, Page(s) 1169–1178

Abstract: Background: Sofosbuvir, a prodrug nucleoside inhibitor of hepatitis C virus, has a predominant circulating metabolite that is renally eliminated. Whether sofosbuvir is associated with chronic kidney disease (CKD) progression is not well understood.: ... ...

Abstract	Background: Sofosbuvir, a prodrug nucleoside inhibitor of hepatitis C virus, has a predominant circulating metabolite that is renally eliminated. Whether sofosbuvir is associated with chronic kidney disease (CKD) progression is not well understood. Methods: We performed a retrospective analysis of patients with estimated glomerular filtration rate (eGFR) 30-89 mL/min/1.73 m Results: Among 4642 trial participants with baseline stage 2 CKD (eGFR 60-89 ml/min/1.73 m Conclusions: Clinical trial participants with CKD did not experience worsening eGFR during sofosbuvir-based treatment, and sofosbuvir was not associated with an increased risk of ESRD in patients with CKD in a nationally-representative administrative claims database.
MeSH term(s)	Antiviral Agents/adverse effects ; Disease Progression ; Female ; Glomerular Filtration Rate ; Humans ; Kidney Failure, Chronic/complications ; Male ; Renal Insufficiency/chemically induced ; Renal Insufficiency, Chronic/complications ; Renal Insufficiency, Chronic/diagnosis ; Renal Insufficiency, Chronic/drug therapy ; Retrospective Studies ; Sofosbuvir/adverse effects
Chemical Substances	Antiviral Agents ; Sofosbuvir (WJ6CA3ZU8B)
Language	English
Publishing date	2022-03-02
Publishing country	England
Document type	Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	639012-2
ISSN	1365-2036 ; 0269-2813 ; 0953-0673
ISSN (online)	1365-2036
ISSN	0269-2813 ; 0953-0673
DOI	10.1111/apt.16830
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Article ; Online: Compassionate Use of Remdesivir in Children With Severe COVID-19.

Pediatrics

2021 Volume 147, Issue 5

Abstract: Objectives: Remdesivir shortens time to recovery in adults with severe coronavirus disease 2019 (COVID-19), but its efficacy and safety in children are unknown. We describe outcomes in children with severe COVID-19 treated with remdesivir.: Methods: ... ...

Abstract	Objectives: Remdesivir shortens time to recovery in adults with severe coronavirus disease 2019 (COVID-19), but its efficacy and safety in children are unknown. We describe outcomes in children with severe COVID-19 treated with remdesivir. Methods: Seventy-seven hospitalized patients <18 years old with confirmed severe acute respiratory syndrome coronavirus 2 infection received remdesivir through a compassionate-use program between March 21 and April 22, 2020. The intended remdesivir treatment course was 10 days (200 mg on day 1 and 100 mg daily subsequently for children ≥40 kg and 5 mg/kg on day 1 and 2.5 mg/kg daily subsequently for children <40 kg, given intravenously). Clinical data through 28 days of follow-up were collected. Results: Median age was 14 years (interquartile range 7-16, range <2 months to 17 years). Seventy-nine percent of patients had ≥1 comorbid condition. At baseline, 90% of children required supplemental oxygen and 51% required invasive ventilation. By day 28 of follow-up, 88% of patients had a decreased oxygen-support requirement, 83% recovered, and 73% were discharged. Among children requiring invasive ventilation at baseline, 90% were extubated, 80% recovered, and 67% were discharged. There were 4 deaths, of which 3 were attributed to COVID-19. Remdesivir was well tolerated, with a low incidence of serious adverse events (16%). Most adverse events were related to COVID-19 or comorbid conditions. Laboratory abnormalities, including elevations in transaminase levels, were common; 61% were grades 1 or 2. Conclusions: Among 77 children treated with remdesivir for severe COVID-19, most recovered and the rate of serious adverse events was low.
MeSH term(s)	Adenosine Monophosphate/adverse effects ; Adenosine Monophosphate/analogs & derivatives ; Adenosine Monophosphate/therapeutic use ; Adolescent ; Alanine/adverse effects ; Alanine/analogs & derivatives ; Alanine/therapeutic use ; Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use ; COVID-19/diagnosis ; COVID-19/drug therapy ; Child ; Child, Preschool ; Compassionate Use Trials ; Drug Therapy, Combination ; Female ; Hospitalization ; Humans ; Infant ; Male ; Oxygen Inhalation Therapy ; Respiration, Artificial ; SARS-CoV-2 ; Severity of Illness Index ; Treatment Outcome
Chemical Substances	Antiviral Agents ; remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX)
Language	English
Publishing date	2021-06-24
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	207677-9
ISSN	1098-4275 ; 0031-4005
ISSN (online)	1098-4275
ISSN	0031-4005
DOI	10.1542/peds.2020-047803
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Um IV Zs.131: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
Zs.MO 357: Show issues

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Article ; Online: Compassionate Use of Remdesivir in Pregnant Women With Severe Coronavirus Disease 2019.

Burwick, Richard M / Yawetz, Sigal / Stephenson, Kathryn E / Collier, Ai-Ris Y / Sen, Pritha / Blackburn, Brian G / Kojic, E Milunka / Hirshberg, Adi / Suarez, Jose F / Sobieszczyk, Magdalena E / Marks, Kristen M / Mazur, Shawn / Big, Cecilia / Manuel, Oriol / Morlin, Gregory / Rose, Suzanne J / Naqvi, Mariam / Goldfarb, Ilona T / DeZure, Adam /

Telep, Laura / Tan, Susanna K / Zhao, Yang / Hahambis, Tom / Hindman, Jason / Chokkalingam, Anand P / Carter, Christoph / Das, Moupali / Osinusi, Anu O / Brainard, Diana M / Varughese, Tilly A / Kovalenko, Olga / Sims, Matthew D / Desai, Samit / Swamy, Geeta / Sheffield, Jeanne S / Zash, Rebecca / Short, William R

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2020 Volume 73, Issue 11, Page(s) e3996–e4004

Abstract: Background: Remdesivir is efficacious for severe coronavirus disease 2019 (COVID-19) in adults, but data in pregnant women are limited. We describe outcomes in the first 86 pregnant women with severe COVID-19 who were treated with remdesivir.: Methods! ...

Abstract	Background: Remdesivir is efficacious for severe coronavirus disease 2019 (COVID-19) in adults, but data in pregnant women are limited. We describe outcomes in the first 86 pregnant women with severe COVID-19 who were treated with remdesivir. Methods: The reported data span 21 March to 16 June 2020 for hospitalized pregnant women with polymerase chain reaction-confirmed severe acute respiratory syndrome coronavirus 2 infection and room air oxygen saturation ≤94% whose clinicians requested remdesivir through the compassionate use program. The intended remdesivir treatment course was 10 days (200 mg on day 1, followed by 100 mg for days 2-10, given intravenously). Results: Nineteen of 86 women delivered before their first dose and were reclassified as immediate "postpartum" (median postpartum day 1 [range, 0-3]). At baseline, 40% of pregnant women (median gestational age, 28 weeks) required invasive ventilation, in contrast to 95% of postpartum women (median gestational age at delivery 30 weeks). By day 28 of follow-up, the level of oxygen requirement decreased in 96% and 89% of pregnant and postpartum women, respectively. Among pregnant women, 93% of those on mechanical ventilation were extubated, 93% recovered, and 90% were discharged. Among postpartum women, 89% were extubated, 89% recovered, and 84% were discharged. Remdesivir was well tolerated, with a low incidence of serious adverse events (AEs) (16%). Most AEs were related to pregnancy and underlying disease; most laboratory abnormalities were grade 1 or 2. There was 1 maternal death attributed to underlying disease and no neonatal deaths. Conclusions: Among 86 pregnant and postpartum women with severe COVID-19 who received compassionate-use remdesivir, recovery rates were high, with a low rate of serious AEs.
MeSH term(s)	Adenosine Monophosphate/analogs & derivatives ; Adult ; Alanine/analogs & derivatives ; COVID-19/drug therapy ; Compassionate Use Trials ; Female ; Humans ; Infant ; Oxygen Saturation ; Pregnancy ; Pregnancy Complications, Infectious/drug therapy ; Pregnant Women ; SARS-CoV-2
Chemical Substances	remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX)
Keywords	covid19
Language	English
Publishing date	2020-10-08
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciaa1466
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Zs.MO 480: Show issues

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Article ; Online: Compassionate Use of Remdesivir for Patients with Severe Covid-19.

Grein, Jonathan / Ohmagari, Norio / Shin, Daniel / Diaz, George / Asperges, Erika / Castagna, Antonella / Feldt, Torsten / Green, Gary / Green, Margaret L / Lescure, François-Xavier / Nicastri, Emanuele / Oda, Rentaro / Yo, Kikuo / Quiros-Roldan, Eugenia / Studemeister, Alex / Redinski, John / Ahmed, Seema / Bernett, Jorge / Chelliah, Daniel /

Chen, Danny / Chihara, Shingo / Cohen, Stuart H / Cunningham, Jennifer / D'Arminio Monforte, Antonella / Ismail, Saad / Kato, Hideaki / Lapadula, Giuseppe / L'Her, Erwan / Maeno, Toshitaka / Majumder, Sumit / Massari, Marco / Mora-Rillo, Marta / Mutoh, Yoshikazu / Nguyen, Duc / Verweij, Ewa / Zoufaly, Alexander / Osinusi, Anu O / DeZure, Adam / Zhao, Yang / Zhong, Lijie / Chokkalingam, Anand / Elboudwarej, Emon / Telep, Laura / Timbs, Leighann / Henne, Ilana / Sellers, Scott / Cao, Huyen / Tan, Susanna K / Winterbourne, Lucinda / Desai, Polly / Mera, Robertino / Gaggar, Anuj / Myers, Robert P / Brainard, Diana M / Childs, Richard / Flanigan, Timothy

The New England journal of medicine

2020 Volume 382, Issue 24, Page(s) 2327–2336

Abstract: Background: Remdesivir, a nucleotide analogue prodrug that inhibits viral RNA polymerases, has shown in vitro activity against SARS-CoV-2.: Methods: We provided remdesivir on a compassionate-use basis to patients hospitalized with Covid-19, the ... ...

Abstract	Background: Remdesivir, a nucleotide analogue prodrug that inhibits viral RNA polymerases, has shown in vitro activity against SARS-CoV-2. Methods: We provided remdesivir on a compassionate-use basis to patients hospitalized with Covid-19, the illness caused by infection with SARS-CoV-2. Patients were those with confirmed SARS-CoV-2 infection who had an oxygen saturation of 94% or less while they were breathing ambient air or who were receiving oxygen support. Patients received a 10-day course of remdesivir, consisting of 200 mg administered intravenously on day 1, followed by 100 mg daily for the remaining 9 days of treatment. This report is based on data from patients who received remdesivir during the period from January 25, 2020, through March 7, 2020, and have clinical data for at least 1 subsequent day. Results: Of the 61 patients who received at least one dose of remdesivir, data from 8 could not be analyzed (including 7 patients with no post-treatment data and 1 with a dosing error). Of the 53 patients whose data were analyzed, 22 were in the United States, 22 in Europe or Canada, and 9 in Japan. At baseline, 30 patients (57%) were receiving mechanical ventilation and 4 (8%) were receiving extracorporeal membrane oxygenation. During a median follow-up of 18 days, 36 patients (68%) had an improvement in oxygen-support class, including 17 of 30 patients (57%) receiving mechanical ventilation who were extubated. A total of 25 patients (47%) were discharged, and 7 patients (13%) died; mortality was 18% (6 of 34) among patients receiving invasive ventilation and 5% (1 of 19) among those not receiving invasive ventilation. Conclusions: In this cohort of patients hospitalized for severe Covid-19 who were treated with compassionate-use remdesivir, clinical improvement was observed in 36 of 53 patients (68%). Measurement of efficacy will require ongoing randomized, placebo-controlled trials of remdesivir therapy. (Funded by Gilead Sciences.).
MeSH term(s)	Adenosine Monophosphate/adverse effects ; Adenosine Monophosphate/analogs & derivatives ; Adenosine Monophosphate/therapeutic use ; Administration, Intravenous ; Adult ; Aged ; Aged, 80 and over ; Alanine/adverse effects ; Alanine/analogs & derivatives ; Alanine/therapeutic use ; Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use ; Betacoronavirus ; COVID-19 ; Canada ; Compassionate Use Trials ; Coronavirus Infections/drug therapy ; Coronavirus Infections/mortality ; Europe ; Female ; Humans ; Japan ; Male ; Middle Aged ; Pandemics ; Pneumonia, Viral/drug therapy ; Pneumonia, Viral/mortality ; Respiration, Artificial ; SARS-CoV-2 ; United States ; Young Adult ; COVID-19 Drug Treatment
Chemical Substances	Antiviral Agents ; remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX)
Keywords	covid19
Language	English
Publishing date	2020-04-10
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa2007016
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Article: Compassionate Use of Remdesivir in Pregnant Women with Severe Covid-19

Clin. infect. dis

Abstract: BACKGROUND: Remdesivir is efficacious for severe COVID-19 in adults, but data in pregnant women are limited. We describe outcomes in the first 86 pregnant women with severe COVID-19 who were treated with remdesivir. METHODS: Reported data span March 21 ... ...

Abstract	BACKGROUND: Remdesivir is efficacious for severe COVID-19 in adults, but data in pregnant women are limited. We describe outcomes in the first 86 pregnant women with severe COVID-19 who were treated with remdesivir. METHODS: Reported data span March 21 to June 16, 2020 for hospitalized pregnant women with PCR-confirmed SARS-CoV-2 infection and room air oxygen saturation ≤94% whose clinicians requested remdesivir through the compassionate use program. The intended remdesivir treatment course was 10 days (200mg on Day 1, followed by 100mg for Days 2-10, given intravenously). RESULTS: Nineteen of 86 women delivered before their first dose and were reclassified as immediate "postpartum" (median postpartum day=1; range 0-3). At baseline, 40% of pregnant women (median gestational age 28 weeks) required invasive ventilation, in contrast to 95% of postpartum women (median gestational age at delivery 30 weeks). By Day 28 of follow-up, the level of oxygen requirement decreased in 96% and 89% of pregnant and postpartum women, respectively. Among pregnant women, 93% of those on mechanical ventilation were extubated, 93% recovered, and 90% were discharged. Among postpartum women, 89% were extubated, 89% recovered, and 84% were discharged. Remdesivir was well tolerated, with a low incidence of serious adverse events (16%). Most adverse events were related to pregnancy and underlying disease; most laboratory abnormalities were Grades 1 or 2. There was one maternal death attributed to underlying disease and no neonatal deaths. CONCLUSIONS: Among 86 pregnant and postpartum women with severe COVID-19 who received compassionate use remdesivir, recovery rates were high, with a low rate of serious adverse events.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #837143
Database	COVID19

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Article: Compassionate Use of Remdesivir for Patients with Severe Covid-19

Chen, Danny / Chihara, Shingo / Cohen, Stuart H / Cunningham, Jennifer / D039, / Arminio Monforte, Antonella / Ismail, Saad / Kato, Hideaki / Lapadula, Giuseppe / L039, / Her, Erwan / Maeno, Toshitaka / Majumder, Sumit / Massari, Marco / Mora-Rillo, Marta / Mutoh, Yoshikazu / Nguyen, Duc / Verweij, Ewa / Zoufaly, Alexander / Osinusi, Anu O / DeZure, Adam / Zhao, Yang / Zhong, Lijie / Chokkalingam, Anand / Elboudwarej, Emon / Telep, Laura / Timbs, Leighann / Henne, Ilana / Sellers, Scott / Cao, Huyen / Tan, Susanna K / Winterbourne, Lucinda / Desai, Polly

N Engl J Med

Abstract: BACKGROUND: Remdesivir, a nucleotide analogue prodrug that inhibits viral RNA polymerases, has shown in vitro activity against SARS-CoV-2. METHODS: We provided remdesivir on a compassionate-use basis to patients hospitalized with Covid-19, the illness ... ...

Abstract	BACKGROUND: Remdesivir, a nucleotide analogue prodrug that inhibits viral RNA polymerases, has shown in vitro activity against SARS-CoV-2. METHODS: We provided remdesivir on a compassionate-use basis to patients hospitalized with Covid-19, the illness caused by infection with SARS-CoV-2. Patients were those with confirmed SARS-CoV-2 infection who had an oxygen saturation of 94% or less while they were breathing ambient air or who were receiving oxygen support. Patients received a 10-day course of remdesivir, consisting of 200 mg administered intravenously on day 1, followed by 100 mg daily for the remaining 9 days of treatment. This report is based on data from patients who received remdesivir during the period from January 25, 2020, through March 7, 2020, and have clinical data for at least 1 subsequent day. RESULTS: Of the 61 patients who received at least one dose of remdesivir, data from 8 could not be analyzed (including 7 patients with no post-treatment data and 1 with a dosing error). Of the 53 patients whose data were analyzed, 22 were in the United States, 22 in Europe or Canada, and 9 in Japan. At baseline, 30 patients (57%) were receiving mechanical ventilation and 4 (8%) were receiving extracorporeal membrane oxygenation. During a median follow-up of 18 days, 36 patients (68%) had an improvement in oxygen-support class, including 17 of 30 patients (57%) receiving mechanical ventilation who were extubated. A total of 25 patients (47%) were discharged, and 7 patients (13%) died; mortality was 18% (6 of 34) among patients receiving invasive ventilation and 5% (1 of 19) among those not receiving invasive ventilation. CONCLUSIONS: In this cohort of patients hospitalized for severe Covid-19 who were treated with compassionate-use remdesivir, clinical improvement was observed in 36 of 53 patients (68%). Measurement of efficacy will require ongoing randomized, placebo-controlled trials of remdesivir therapy. (Funded by Gilead Sciences.).
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #47286
Database	COVID19

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Article ; Online: Compassionate Use of Remdesivir in Pregnant Women With Severe Coronavirus Disease 2019

Clinical Infectious Diseases ; ISSN 1058-4838 1537-6591

2020

Abstract: Abstract Background Remdesivir is efficacious for severe coronavirus disease 2019 (COVID-19) in adults, but data in pregnant women are limited. We describe outcomes in the first 86 pregnant women with severe COVID-19 who were treated with remdesivir. ... ...

Abstract	Abstract Background Remdesivir is efficacious for severe coronavirus disease 2019 (COVID-19) in adults, but data in pregnant women are limited. We describe outcomes in the first 86 pregnant women with severe COVID-19 who were treated with remdesivir. Methods The reported data span 21 March to 16 June 2020 for hospitalized pregnant women with polymerase chain reaction–confirmed severe acute respiratory syndrome coronavirus 2 infection and room air oxygen saturation ≤94% whose clinicians requested remdesivir through the compassionate use program. The intended remdesivir treatment course was 10 days (200 mg on day 1, followed by 100 mg for days 2–10, given intravenously). Results Nineteen of 86 women delivered before their first dose and were reclassified as immediate “postpartum” (median postpartum day 1 [range, 0–3]). At baseline, 40% of pregnant women (median gestational age, 28 weeks) required invasive ventilation, in contrast to 95% of postpartum women (median gestational age at delivery 30 weeks). By day 28 of follow-up, the level of oxygen requirement decreased in 96% and 89% of pregnant and postpartum women, respectively. Among pregnant women, 93% of those on mechanical ventilation were extubated, 93% recovered, and 90% were discharged. Among postpartum women, 89% were extubated, 89% recovered, and 84% were discharged. Remdesivir was well tolerated, with a low incidence of serious adverse events (AEs) (16%). Most AEs were related to pregnancy and underlying disease; most laboratory abnormalities were grade 1 or 2. There was 1 maternal death attributed to underlying disease and no neonatal deaths. Conclusions Among 86 pregnant and postpartum women with severe COVID-19 who received compassionate-use remdesivir, recovery rates were high, with a low rate of serious AEs.
Keywords	Microbiology (medical) ; Infectious Diseases ; covid19
Language	English
Publisher	Oxford University Press (OUP)
Publishing country	uk
Document type	Article ; Online
DOI	10.1093/cid/ciaa1466
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Book ; Online: Compassionate Use of Remdesivir for Patients with Severe Covid-19.

Articles, Abstracts, and Reports

2020

Abstract	BACKGROUND: Remdesivir, a nucleotide analogue prodrug that inhibits viral RNA polymerases, has shown in vitro activity against SARS-CoV-2. METHODS: We provided remdesivir on a compassionate-use basis to patients hospitalized with Covid-19, the illness caused by infection with SARS-CoV-2. Patients were those with confirmed SARS-CoV-2 infection who had an oxygen saturation of 94% or less while they were breathing ambient air or who were receiving oxygen support. Patients received a 10-day course of remdesivir, consisting of 200 mg administered intravenously on day 1, followed by 100 mg daily for the remaining 9 days of treatment. This report is based on data from patients who received remdesivir during the period from January 25, 2020, through March 7, 2020, and have clinical data for at least 1 subsequent day. RESULTS: Of the 61 patients who received at least one dose of remdesivir, data from 8 could not be analyzed (including 7 patients with no post-treatment data and 1 with a dosing error). Of the 53 patients whose data were analyzed, 22 were in the United States, 22 in Europe or Canada, and 9 in Japan. At baseline, 30 patients (57%) were receiving mechanical ventilation and 4 (8%) were receiving extracorporeal membrane oxygenation. During a median follow-up of 18 days, 36 patients (68%) had an improvement in oxygen-support class, including 17 of 30 patients (57%) receiving mechanical ventilation who were extubated. A total of 25 patients (47%) were discharged, and 7 patients (13%) died; mortality was 18% (6 of 34) among patients receiving invasive ventilation and 5% (1 of 19) among those not receiving invasive ventilation. CONCLUSIONS: In this cohort of patients hospitalized for severe Covid-19 who were treated with compassionate-use remdesivir, clinical improvement was observed in 36 of 53 patients (68%). Measurement of efficacy will require ongoing randomized, placebo-controlled trials of remdesivir therapy. (Funded by Gilead Sciences.).
Keywords	2019-nCoV ; Infectious Disease ; Pharmacy and Pharmaceutical Sciences ; covid19
Subject code	610 ; 616
Publishing date	2020-04-10T07:00:00Z
Publisher	Providence St. Joseph Health Digital Commons
Publishing country	us
Document type	Book ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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