Molnupiravir When Used Alone Seems to Be Safe and Effective as Outpatient COVID-19 Therapy for Hemodialyzed Patients and Kidney Transplant Recipients

Abstract

Background: Molnupiravir demonstrated an in vitro antiviral activity against positive-sense RNA viruses, including SARS-CoV-2. The study aimed to present the results of outpatient molnupiravir use in kidney transplant recipients and hemodialysis patients during the first months of 2022 in Poland. Methods: The retrospective observational cohort study at one kidney transplant center included 36 patients diagnosed with COVID-19 with an automated nucleic acid amplification test on nasopharyngeal swab specimens. All patients received molnupiravir for home-based therapy at a dose of 800 mg every 12 h orally for 5 days. Both kidney transplant recipients (n = 16) and hemodialysis patients (n = 20) presented a lot of comorbidities with a Charlson comorbidity index of 4.1 and 5.1, respectively. Results: Patients presented with fever, cough, and weakness followed by muscle and joint pain. Five kidney transplant recipients experienced acute kidney injury with a rise in serum creatinine level from 0.4 to 1.9 mg/dL. No serious side effects of molnupiravir therapy or interactions with immunosuppressive medications were observed. Symptoms of COVID-19 improved rapidly or resolved within 24–48 h of starting treatment. Conclusion: The study suggests the safety and efficacy of molnupiravir therapy alone early after the onset of SARS-CoV-2 infection, but further investigations should be performed to confirm our preliminary results. To the best of the authors’ knowledge, it is the first published report on molnupiravir use in end-stage kidney disease (ESKD) patients on hemodialysis and the third concerning kidney transplant recipients.

Real-World Effectiveness of SARS-CoV-2 Vaccine Booster in Hemodialysis Patients with COVID-19 Receiving Molnupiravir

“…However, most existing studies have focused on the immunogenicity of booster vaccination, and its real-world benefits on the clinical outcomes of COVID-19 have less been investigated in the HD population, particularly in those receiving oral antiviral agents. In addition, although the combination of SARS-CoV-2 vaccines and antiviral treatments is considered beneficial for patients with COVID-19 who are at high risk of disease progression, current reports have yielded mixed results on this issue, and the integrated effects of vaccination and oral antiviral agents have yet to be characterized in HD patients [ 34 , 35 , 49 , 50 ]. A previous study utilizing an agent-based mathematical model suggested that combining SARS-CoV-2 vaccines and antiviral treatments could synergistically reduce COVID-19-related hospitalization and mortality in the overall population [ 49 ].…”

“…A previous study utilizing an agent-based mathematical model suggested that combining SARS-CoV-2 vaccines and antiviral treatments could synergistically reduce COVID-19-related hospitalization and mortality in the overall population [ 49 ]. Two observational studies in Poland and Japan suggested that combining booster vaccination and molnupiravir treatment was associated with a shorter illness duration and fewer medical requirements in HD patients with COVID-19, although the sample sizes were both small [ 34 , 35 ]. In contrast, another open-label trial addressing the effects of molnupiravir in a highly vaccinated population in the UK (3-dose vaccination, 94%) indicated that hospitalization and mortality might be primarily avoided via extensive vaccination rather than antiviral agents.…”

“…Among the available therapeutics, molnupiravir is a feasible option for HD patients with non-severe COVID-19, which decreases the risk of hospitalization or mortality and can be prescribed without dose adjustment in patients with severe renal impairment [ 31 , 32 , 33 ]. In recent real-world studies, molnupiravir was well-tolerated and accelerated clinical improvement in non-hospitalized HD patients with COVID-19, thereby highlighting its therapeutic role in this population [ 34 , 35 ]. Since HD patients are considered particularly susceptible to COVID-19, it is important to integrate booster vaccination and effective medical management in this population.…”

COVID-19 in Elderly Patients Receiving Haemodialysis: A Current Review

“…There are few studies which investigated the efficacy of molnupiravir in the context of the dialysis population. Poznansk and colleagues presented a retrospective cohort study reporting on the use of molnupiravir in 20 dialysis patients with positive COVID-19 test results [ 99 ]. These patients received a regimen of 800 mg of molnupiravir twice daily for 5 days.…”

Coronavirus Disease 2019 Management Strategies in Solid Organ Transplant Recipients

“…None of the patients suffered adverse effects attributed to molnupiravir‚ and no adjustment of tacrolimus dose was needed 56 . Another retrospective cohort study of 16 kidney transplant patients showed that molnupiravir resulted in improvement of clinical symptoms and no serious side effects were reported, but then, this was not compared to any control 57 . Therefore, given the NIH recommendation as well as the lack of data to support its use in the transplant population, molnupiravir should be used only when the first-line options of remdesivir or nirmatrelvir-ritonavir are not available.…”