Lack of effect of favipiravir, a novel antiviral agent, on QT interval in healthy Japanese adults

Kumagai, Yoshito; Murakawa, Yuji; Hasunuma, Tomoko; Aso, Masako; Yuji, Wakako; Sakurai, Tsutomu; Noto, Masahiko; Oe, Tetsuya; Kaneko, Akiko

doi:10.5414/cp202388

Cited by 48 publications

(45 citation statements)

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“…Significant QTc interval prolongation was not identified on ECG images, obtained three and six hours after the favipiravir was administered. [ 12 ] This study did not provide sufficient information about the effects of the treatment dose on the QTc interval and changes in the QTc interval in subsequent days since the loading dose was lower than that used for COVID-19 patients, and the ECG findings were obtained after three and six hours. In the current study, a significant change in the QTc(Bazett) and QTc(Fre) interval was not observed on the ECG images taken 48 h (median) after favipiravir treatment in Group 3 (respectively p = 0.247, p = 0,075).…”

Section: Discussionmentioning

confidence: 99%

“…[ 11 ] Favipiravir was not shown to have a detectable effect on QT intervals in a study performed by Kumagai et al on healthy adults that used moxifloxacin as a positive control to enable high-powered statistical analysis. [ 12 ] To the best of our knowledge, the effect of favipiravir on the QTc interval in COVID-19 patients has not been evaluated in any study to date. Thus, the current study objective was to investigate any change in the QTc interval in patients hospitalized due to COVID-19 receiving favipiravir therapy.…”

Section: Introductionmentioning

confidence: 99%

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The effect of favipiravir on QTc interval in patients hospitalized with coronavirus disease 2019

Çap

Bilge

Işık

et al. 2020

Journal of Electrocardiology

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Background The effect of favipiravir on the QTc interval during the treatment of Coronavirus Disease 2019 (COVID-19) patients is unclear. Thus, the current study objective was to evaluate any change in the QTc interval in patients who were hospitalized due to COVID-19 receiving favipiravir treatment. Method Patients hospitalized with COVID-19 were assessed in this single-center retrospective study. 189 patients, whose diagnosis was confirmed using real-time PCR, were included in the study. The patients were divided into three groups: those using hydroxychloroquine (Group 1, n = 66), hydroxychloroquine plus favipiravir (Group 2, n = 66), and favipiravir only (Group 3, n = 57). The QTc interval was measured before treatment (QTc-B) and 48 h after (i.e., the median) starting treatment (QTc-AT). Results The median age was 53 (39–66 IQR) and 97 (51%) of patients were female. The median QTc(Bazett)-change was 7 ms ( p = 0.028) and 12 ms ( p < 0.001) and in Group 1 and 2, respectively. In Group 3, the median QTc(Bazett)-change was observed as −3 ms and was not statistically significant ( p = 0.247). In multivariable analysis, while there was a significant relationship between QTc-AT(Bazett) and hydroxychloroquine (β coefficient = 2687, 95%CI 2599–16,976, p = 0,008), there was no significant relationship with favipiravir (β coefficient = 0,180, 95% CI -6435-7724, p = 0,858). Similarly, there was a significant relationship between the QTc-AT interval calculated using the Fredericia formula and hydroxychloroquine (β coefficient = 2120, 95% CI 0,514–14,398, p = 0,035), but not with favipiravir (β coefficient = 0,111, 95% CI -6450- 7221, p = 0,911). Conclusion In the ECG recordings received in the following days after the treatment was started in COVID-19 patients, there was a significant prolongation in the QTc interval with hydroxychloroquine, but there was no significant change with favipiravir.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The effect of favipiravir on QTc interval in patients hospitalized with coronavirus disease 2019

Çap

Bilge

Işık

et al. 2020

Journal of Electrocardiology

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“…Despite limited experience with favipiravir, we judged it to be the most appropriate agent in this scenario, given the lower risk for QT prolongation, no need for renal-dose adjustments, and no reported drug–drug interactions. Favipiravir was reported as not having caused QT prolongation after single oral doses of 1200 mg and 2400 mg [ 16 ]. However, in one case report in the treatment of Ebola virus, favipiravir prolonged the QT at higher doses [ 17 ].…”

Section: Discussionmentioning

confidence: 99%

Traveling for heart transplantation and returning with COVID-19: a logistical, clinical, and pharmacotherapeutic challenge from the Middle East

Atallah

Hamour

Mallah

et al. 2020

Drugs Ther Perspect

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Heart transplantation (HT) has become a standard option for patients with end-stage heart failure (HF). However, the scarcity of donor availability remains a major hurdle for receiving this novel therapy, especially in the context of the rapidly spreading severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; COVID-19) pandemic. We report the case of a patient in the United Arab Emirates (UAE) with advanced HF who was glucose-6-phosphate dehydrogenase deficient and had a history of type 2 diabetes mellitus with diabetic retinopathy and nephropathy, chronic kidney disease stage II, and hyperlipidemia. He was referred for HT abroad and was subsequently caught in the midst of the COVID-19 pandemic in New York, the US state most affected by the crisis at the time. Despite limited experience with favipiravir, we judged it to be the most appropriate agent with this patient’s complex history given the lower risk for QT prolongation, no need for renal-dose adjustment, and no reported drug–drug interactions. Given the limited clinical experience with this agent, particularly for our patient, we decided to adopt strategies to mitigate and monitor the potential for QT prolongation. We outline the logistical, clinical, and pharmacological challenges that the poly-morbid patient and our HT program in the Middle-East faced under those novel circumstances.

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“…It subsequently proved activity against several classes of viruses, including EBOV [ 8 ], and was used in both therapy and postexposure prophylaxis during the recent EBOV epidemic in West Africa [ 9 ]. In their recent work, Kumagai and colleagues [ 5 ] found no effect of favipiravir on the QT interval in healthy Japanese adults after administration of single oral doses of favipiravir 1,200 and 2,400 mg. To the best of our knowledge, there are no other studies assessing this issue [ 4 , 10 ]. Our patient was treated with favipiravir doses much higher than those reported by Kumagai and colleagues, i.e., 6 g on day 1 and 2.4 g on the following days, and this could explain a previously unreported effect on QTc interval prolongation.…”

Section: Case Discussionmentioning

confidence: 99%

“…Favipiravir has also been used in the recent epidemic of Ebolavirus (EBOV) in West Africa [ 4 ]. To date, no significant effects of favipiravir on the QT/QTc interval have been detected [ 5 ]. We report a case of QTc interval prolongation during favipiravir therapy in an EBOV-infected patient treated at our institution.…”

Section: Introductionmentioning

confidence: 99%

QTc interval prolongation during favipiravir therapy in an Ebolavirus-infected patient

et al. 2017

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Lack of effect of favipiravir, a novel antiviral agent, on QT interval in healthy Japanese adults

Abstract: It is possible to use a smaller number of subjects in thorough QT studies in Japan than in Europe and the US utilizing moxifloxacin as a positive control. There were no detectable effects of favipiravir on the QT/QTc interval.

Cited by 48 publications

References 0 publications

The effect of favipiravir on QTc interval in patients hospitalized with coronavirus disease 2019

The effect of favipiravir on QTc interval in patients hospitalized with coronavirus disease 2019

Traveling for heart transplantation and returning with COVID-19: a logistical, clinical, and pharmacotherapeutic challenge from the Middle East

QTc interval prolongation during favipiravir therapy in an Ebolavirus-infected patient

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