Use of remdesivir for COVID-19 pneumonia in patients with advanced kidney disease: A retrospective multicenter study

Stancampiano, Fernando; Jhawar, Nikita; Alsafi, W.; Valery, Jose; Harris, Donna S.; Kempaiah, Prakasha; Shah, Sadia Z.; Heckman, Michael G.; Siddiqui, H.; Libertin, Claudia R.

doi:10.1016/j.clinpr.2022.100207

Cited by 8 publications

(9 citation statements)

References 29 publications

(34 reference statements)

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“…These SBECD doses are higher than those of IV perampanel at maximum daily dose (6000 mg as SBECD; 100 mg/kg in adults weighting 60 kg). Furthermore, there is also evidence that SBECD did not lead to worsening renal function in subjects who administered remdesivir including SBECD, and a systematic review by Turner et al concluded that there is no strong evidence indicating that SBECD increased the risk of worsening renal function 19,23 . Our results indicated that there were no clinically relevant changes in renal function markers leading to renal dysfunction following short‐term IV perampanel in both studies.…”

Section: Discussionmentioning

confidence: 45%

“…Furthermore, there is also evidence that SBECD did not lead to worsening renal function in subjects who administered remdesivir including SBECD, and a systematic review by Turner et al concluded that there is no strong evidence indicating that SBECD increased the risk of worsening renal function. 19,23 Our results indicated that there were no clinically relevant changes in renal function markers leading to renal dysfunction following short-term IV perampanel in both studies. Given the small sample size in these studies, interpretation of the effect of IV perampanel on renal function may be limited; hence, renal function should be carefully monitored during and after IV infusions, particularly in patients with renal dysfunction, and further investigation to establish the evidence for an association between SBECD and worsening renal function is needed.…”

Section: Discussionmentioning

confidence: 59%

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Intravenous perampanel as an alternative to the oral formulations in Japanese patients with epilepsy

Hanaya,

Kubota,

Mizobuchi

et al. 2023

Epilepsia Open

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ObjectivePerampanel is an oral anti‐seizure medication, which is approved in Japan for focal‐onset seizures, with/without focal to bilateral tonic‐clonic seizures, as monotherapy/adjunctive therapy in patients aged 4 years and older. Treatment for generalized tonic‐clonic seizures as adjunctive therapy in patients aged 12 years and older is approved as well. We evaluated the feasibility of intravenous (IV) administration of perampanel as an alternative to oral administration.MethodsStudy 240 (NCT03754582) was an uncontrolled, open‐label study of IV perampanel, conducted in 21 Japanese patients with epilepsy who received a stable dose of 8 to 12 mg/day of oral perampanel. Patients received 30‐minute IV infusions at equivalent daily doses of oral perampanel for 4 days, then were switched back to oral perampanel. Safety, tolerability, plasma concentration, and maintenance of efficacy throughout the transition between IV and oral dosing of perampanel were assessed. As supportive data, a subgroup analysis was also conducted using data from healthy Japanese subjects (n=18) who were enrolled in Study 050 (NCT03376997) investigating the pharmacokinetics and safety of IV perampanel in healthy subjects who received an IV infusion (30‐, 60‐, or 90‐minute) of perampanel 12 mg and a single oral administration of perampanel 12‐mg tablet.ResultsIn Study 240, the transition between 30‐minute IV and oral perampanel dosing was associated with a ≤1.4‐fold increase in the mean change in maximum observed concentration of perampanel. Seizure outcomes demonstrated no considerable changes in efficacy before, during, or after 30‐minute IV dosing of perampanel. The safety profiles were similar between IV and oral formulations. In Study 050, the pharmacokinetics of 30‐ or 60‐minute IV infusion of perampanel further support the interchangeability between oral and IV formulations in the Japanese subjects.SignificanceThese results support that 30‐minute IV perampanel may be a potential short‐term alternative to oral formulations for patients with epilepsy.

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Section: Discussionmentioning

confidence: 45%

Section: Discussionmentioning

confidence: 59%

Intravenous perampanel as an alternative to the oral formulations in Japanese patients with epilepsy

Hanaya,

Kubota,

Mizobuchi

et al. 2023

Epilepsia Open

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show abstract

“…There exists a contraindication to using remdesivir in patients under renal replacement therapy due to the accumulation of cyclodextrin. Experience with voriconazole and also several published studies have shown that the brief exposure of 5 days does not warrant these concerns and that remdesivir is safe to use in end-stage renal disease [ 128 , 129 ]. Finally, pertinent to people receiving ART, a recent publication by Shytaz et al examined the effect of cobicistat on remdesivir treatment and found that cobicistat not only has a moderate antiviral effect on its own, but it can also synergize and enhance remdesivir in an animal model of COVID-19 infection [ 130 ].…”

Section: Management Of Covid-19 In Pwhmentioning

confidence: 99%

HIV and COVID-19 Co-Infection: Epidemiology, Clinical Characteristics, and Treatment

Basoulis

Mastrogianni

Voutsinas

et al. 2023

Viruses

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The COVID-19 pandemic has been a global medical emergency with a significant socio-economic impact. People with HIV (PWH), due to the underlying immunosuppression and the particularities of HIV stigma, are considered a vulnerable population at high risk. In this review, we report what is currently known in the available literature with regards to the clinical implications of the overlap of the two epidemics. PWH share the same risk factors for severe COVID-19 as the general population (age, comorbidities), but virological and immunological status also plays an important role. Clinical presentation does not differ significantly, but there are some opportunistic infections that can mimic or co-exist with COVID-19. PWH should be prime candidates for preventative COVID-19 treatments when they are available, but in the setting of resistant strains, this might be not easy. When considering small-molecule medications, physicians need to always remember to address potential interactions with ART, and when considering immunosuppressants, they need to be aware of potential risks for opportunistic infections. COVID-19 shares similarities with HIV in how the public perceives patients—with fear of the unknown and prejudice. There are opportunities for HIV treatment hidden in COVID-19 research with the leaps gained in both monoclonal antibody and vaccine development.

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“…Even though the respective toxic doses were 3.5 times higher than those used in treatment, RDV use in individuals with impaired renal function is a safety concern. A high number of studies assessed the efficacy and safety of RDV in patients with chronic kidney disease, patients on dialysis, and kidney transplant recipients [ 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 ]. RDV was well tolerated in patients with acute kidney injury or chronic kidney disease [ 63 ] while reducing the risk of mortality in patients on dialysis [ 64 ].…”

Section: Special Populationsmentioning

confidence: 99%

Remdesivir Use in the Real-World Setting: An Overview of Available Evidence

Akinosoglou,

Rigopoulos,

Schinas

et al. 2023

Viruses

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In the years of Coronavirus Disease 2019 (COVID-19), various treatment options have been utilized. COVID-19 continues to circulate in the global population, and the evolution of the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus has posed significant challenges to the treatment and prevention of infection. Remdesivir (RDV), an anti-viral agent with in vitro efficacy against coronaviruses, is a potent and safe treatment as suggested by a plethora of in vitro and in vivo studies and clinical trials. Emerging real-world data have confirmed its effectiveness, and there are currently datasets evaluating its efficacy and safety against SARS-CoV-2 infections in various clinical scenarios, including some that are not in the SmPC recommendations according for COVID-19 pharmacotherapy. Remdesivir increases the chance of recovery, reduces progression to severe disease, lowers mortality rates, and exhibits beneficial post-hospitalization outcomes, especially when used early in the course of the disease. Strong evidence suggests the expansion of remdesivir use in special populations (e.g., pregnancy, immunosuppression, renal impairment, transplantation, elderly and co-medicated patients) where the benefits of treatment outweigh the risk of adverse effects. In this article, we attempt to overview the available real-world data of remdesivir pharmacotherapy. With the unpredictable course of COVID-19, we need to utilize all available knowledge to bridge the gap between clinical research and clinical practice and be sufficiently prepared for the future.

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Use of remdesivir for COVID-19 pneumonia in patients with advanced kidney disease: A retrospective multicenter study

Cited by 8 publications

References 29 publications

Intravenous perampanel as an alternative to the oral formulations in Japanese patients with epilepsy

Intravenous perampanel as an alternative to the oral formulations in Japanese patients with epilepsy

HIV and COVID-19 Co-Infection: Epidemiology, Clinical Characteristics, and Treatment

Remdesivir Use in the Real-World Setting: An Overview of Available Evidence

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