Drug-drug interaction between ensitrelvir and tacrolimus in a patient undergoing treatment for COVID-19: a case report

Journal of Pharmaceutical Health Care and Sciences, Journal Year: 2025, Volume and Issue: 11(1)

Published: Jan. 22, 2025

Abstract Background Ensitrelvir is a novel SARS-CoV-2 3-chymotrypsin-like protease inhibitor, similar to nirmatrelvir/ritonavir. Several case reports have demonstrated the efficacy of inhibitors in treating prolonged coronavirus disease 2019 (COVID-19) immunocompromised patients. Tacrolimus (TAC) widely used immunosuppressive agent whose blood level can increase significantly due inhibition cytochrome P450 3A (CYP3A) and P-glycoprotein by Since ensitrelvir also inhibits CYP3A P-gp, elevations TAC levels are expected. A prior report observed an trough with concurrent administration ensitrelvir. However, no studies quantitatively described changes clearances before after when was discontinued mitigate drug-drug interaction (DDI) risk; data on safe dosing protocols avoid DDI during co-administration remain lacking. Here, we which were successfully managed patient rheumatoid arthritis (RA) who received for persistent COVID-19 preemptive discontinuation close monitoring following administration. Case presentation An 81-year-old Japanese woman had been administered (1.5 mg once daily) RA two courses remdesivir moderate COVID-19. her viral load remained high respiratory status deteriorated. Considering COVID-19, initiated combination therapy (day 0). discontinued, decreased from 3.6 ng/mL 1.1 over five days. Subsequently, re-administered (0.2 mg), observing 1.0 day 7. The dose adjusted daily, 12 14 6.5 3.7 ng/mL, respectively. resumed 15. calculated t 1/2 33.7, 71.9, 114.6 h -1 0, 0 2, 2 5, extended 3.4-fold its original duration under treatment. Conclusions This half-life approximately 3.4-fold, effect that gradually diminished 7 10 When patients receiving treatment start therapy, reduction one-third one-fourth considered appropriate.

Language: Английский

---

The time to return-to-work in healthcare workers with COVID-19 treated with ensitrelvir, a novel oral inhibitor of 3C-like protease of SARS-CoV-2: An observational study utilizing pre-existing data from a single hospital

Journal of Infection and Chemotherapy, Journal Year: 2025, Volume and Issue: unknown, P. 102669 - 102669

Published: Feb. 1, 2025

Language: Английский

---

Ensitrelvir as a novel treatment option for mild-to-moderate COVID-19: a narrative literature review

Therapeutic Advances in Infectious Disease, Journal Year: 2025, Volume and Issue: 12

Published: March 1, 2025

To address the coronavirus disease 2019 (COVID-19) pandemic, several antiviral agents targeting severe acute respiratory syndrome 2 (SARS-CoV-2) have been developed for clinical use. However, antivirals that can be administered irrespective of risk factors were lacking until approval ensitrelvir fumaric acid (hereafter, ensitrelvir) in Japan, which took effect November 2022. Ensitrelvir is an oral SARS-CoV-2 3C-like protease inhibitor currently approved Japan and Singapore. This narrative review summarizes preclinical, trial, real-world data on ensitrelvir. The efficacy safety assessed a seamless, randomized, double-blind, placebo-controlled, phase II/III study conducted South Korea, Vietnam (Japan Registry Clinical Trials identifier, jRCT2031210350). enrolled patients with mild-to-moderate COVID-19 symptoms or asymptomatic individuals presence illness. Overall, demonstrated favorable symptom improvement, acceptable profile. In III part, time to resolution composite five typical showed difference between 125 mg placebo groups, median was approximately 1 day when randomized less than 72 h onset. one trials used patient as endpoint. Additional are underway investigate various populations. Moreover, published evidence generally supports effectiveness routine practice its activity against variants concern. Further research granted establish novel treatment. Royalty-free licensing agreements concluded drug manufacturers Medicines Patent Pool will facilitate access therapeutics, including ensitrelvir, low- middle-income countries.

Language: Английский

---

Effectiveness of ensitrelvir for cough caused by COVID-19 Omicron variant in patients with asthma

Microbiology Spectrum, Journal Year: 2025, Volume and Issue: unknown

Published: April 15, 2025

ABSTRACT In the post-acute coronavirus disease 2019 (COVID-19) period, patients with asthma had a significantly higher risk of cough than without history asthma. particular, cases persistent were increased during Omicron variant epidemic. this study, we evaluated efficacy ensitrelvir for treatment associated COVID-19 variants in This follows Strengthening Reporting Observational Studies Epidemiology statement. A total 223 registered study: 121 chose ensitrelvir, and 102 symptomatic treatment. Cough severity, frequency, cough-specific quality life using Japanese version Leicester Questionnaire (J-LCQ). J-LCQ documented at baseline on days 4, 7, 14 all showed steady improvement over time both groups. mixed model repeated measures model, which accounts measurements, change score from was 2.1 points group ( P <0.001). Additionally, who triple inhaled therapy 2.3-point Multiple regression analysis performed 14, as dependent variable. Ensitrelvir scores that 3.1 day 3.5 2.0 compared <0.001 all). conclusion, our results demonstrated early administration may be effective due to variant. IMPORTANCE We Our

Language: Английский

---

Cost-Effectiveness Analysis of Molnupiravir Versus Best Supportive Care for the Treatment of Outpatient COVID-19 in High-Risk Older Adults in Japan

PharmacoEconomics - Open, Journal Year: 2025, Volume and Issue: unknown

Published: April 23, 2025

This analysis aimed to evaluate the cost effectiveness of molnupiravir versus best supportive care for treatment older adult patients (aged ≥ 65 years) in Japan with mild moderate COVID-19 who are at risk disease progression leading hospitalization, predominantly using input data derived from Omicron era SARS-CoV2 pandemic. A decision-analytic model was developed, comprising a decision-tree acute phase (30 days), followed by lifetime Markov model. Inputs used parametrize were database study conducted and published systematic literature review real-world studies, ad-hoc searches other research (for progression, cost, utility estimates). modelled death averted due hospitalization as an indirect effect (through preventing hospitalization). Costs expressed 2022 Japanese yen (¥; JPY), perspective payers (the base case) or society (in scenario analysis). QALYs discounted 2% per year. Cost primarily compared willingness-to-pay (WTP) threshold ¥5,000,000 quality-adjusted life year (QALY) gained. Treatment is associated QALY gain 0.018 incremental ¥81,472 over effective (with cost-effectiveness ratio [ICER] ¥4,638,477) based on predefined WTP Molnupiravir leads reduction proportion die (0.09% vs 0.29% care). also lower costs hospitalizations (¥22,527 ¥27,472). In deterministic sensitivity analysis, top five most sensitive parameters baseline rate, mortality benefit molnupiravir, rate general ward, discount intensive unit. probabilistic gained, had 80% probability being care. cost-effective option outpatients (age symptomatic Japan, relative

Language: Английский

---

Detrimental Effects of Anti-Nucleocapsid Antibodies in SARS-CoV-2 Infection, Reinfection, and the Post-Acute Sequelae of COVID-19

Pathogens, Journal Year: 2024, Volume and Issue: 13(12), P. 1109 - 1109

Published: Dec. 15, 2024

Antibody-dependent enhancement (ADE) is a phenomenon in which antibodies enhance subsequent viral infections rather than preventing them. Sub-optimal levels of neutralizing individuals infected with dengue virus are known to be associated severe disease upon reinfection different serotype. For Severe Acute Respiratory Syndrome Coronavirus type-2 infection, three types ADE have been proposed: (1) Fc receptor-dependent infection cells expressing receptors, such as macrophages by anti-spike antibodies, (2) receptor-independent epithelial and (3) cytokine production anti-nucleocapsid antibodies. This review focuses on the induced examining its potential role COVID-19 during contribution post-acute sequelae COVID-19, i.e., prolonged symptoms lasting at least months after acute phase disease. We also discuss protective effects recently identified that neutralize Omicron variants.

Language: Английский

---

Ensitrelvir for the treatment of COVID-19: Final analysis of a post-marketing surveillance from Japan

Journal of Infection and Chemotherapy, Journal Year: 2024, Volume and Issue: unknown

Published: Dec. 1, 2024

Language: Английский

---

Advances and Challenges in Antiviral Development for Respiratory Viruses

Pathogens, Journal Year: 2024, Volume and Issue: 14(1), P. 20 - 20

Published: Dec. 31, 2024

The development of antivirals for respiratory viruses has advanced markedly in response to the growing threat pathogens such as Influenzavirus (IAV), syncytial virus (RSV), and SARS-CoV-2. This article reviews advances challenges this field, highlighting therapeutic strategies that target critical stages viral replication cycle, including inhibitors entry, replication, assembly. In addition, innovative approaches inhibiting host cellular proteins reduce resistance repurposing existing drugs are explored, using bioinformatics tools optimize identification antiviral candidates. analysis also covers emerging technologies nanomedicine CRISPR gene editing, which promise improve stability efficacy treatments. While current offer valuable options, they face evolution need accessible treatments vulnerable populations. underscores importance continued innovation biotechnology overcome these limitations provide safe effective Combining traditional developing is essential order address diseases affect global health.

Language: Английский

---

Letter to the Editor: “Real-World Effectiveness of Ensitrelvir in Reducing Severe Outcomes in Outpatients at High Risk for COVID-19”

Infectious Diseases and Therapy, Journal Year: 2024, Volume and Issue: unknown

Published: Sept. 24, 2024

Language: Английский

---

Letter to the Editor regarding Response to “Letter to Editor: “Real-World Effectiveness of Ensitrelvir in Reducing Severe Outcomes in Outpatients at High Risk for COVID-19”

Infectious Diseases and Therapy, Journal Year: 2024, Volume and Issue: 13(11), P. 2463 - 2467

Published: Sept. 27, 2024

Language: Английский

---