Clinical efficacy and safety of molnupiravir for nonhospitalized and hospitalized patients with COVID‐19: A systematic review and meta‐analysis of randomized control trials

Abstract

The efficacy of molnupiravir in treating patients with coronavirus disease 2019 (COVID‐19) has been inconsistent across randomized controlled trials (RCTs). Thus, this meta‐analysis was conducted to clarify the literature. A literature search of electronic databases—PubMed, Embase, and Cochrane Library—was performed to identify relevant articles published up to December 31, 2022. Only RCTs that investigated the clinical efficacy and safety of molnupiravir for patients with COVID‐19 were included. The primary outcome was all‐cause mortality at 28–30 days. This pooled analysis of nine RCTs did not reveal a significant difference in all‐cause mortality between molnupiravir and control groups (risk ratio [RR], 0.43; 95% confidence interval [CI], 0.10–1.77) for overall patients. However, the risks of mortality and hospitalization were lower in the molnupiravir group than in the control group (mortality: RR, 0.28; 95% CI, 0.10–0.79; hospitalization: RR, 0.67; 95% CI, 0.45–0.99) among nonhospitalized patients. In addition, molnupiravir use was associated with a borderline higher virological eradication rate relative to the control (RR, 1.05; 95% CI, 1.00–1.11). Finally, no significant difference in adverse event risk was discovered between the groups (RR, 0.98; 95% CI, 0.89–1.08). The findings reveal the clinical benefits of molnupiravir for nonhospitalized patients with COVID‐19. However, molnupiravir may not improve the clinical outcomes of hospitalized patients. These findings support the recommended use of molnupiravir for treating nonhospitalized patients with COVID‐19 but not for hospitalized patients.

Clinical efficacy of nirmatrelvir and ritonavir combination for treating diabetic patients with COVID‐19

“…The TriNetX platform enables the establishment of cohorts by developing inclusion and exclusion criteria, which can be matched to control for confounding variables, and outcomes of interest can be analyzed over specific timeframes. The data source is well‐established and has been used to study medical topics of global relevance, including the COVID‐19 pandemic 25–30 . As aggregated deidentified data were used, written informed consent was not required.…”

Comparison of effectiveness and safety of molnupiravir versus sotrovimab for COVID‐19: A systematic review and meta‐analysis

“…The incidence of adverse events was significantly higher in patients receiving molnupiravir compared to those receiving sotrovimab. Recently published meta‐analyses revealed that there was no significant difference in the incidence of adverse events between the molnupiravir and control groups 21,44,46 . Additionally, our previous research revealed no significant difference in the incidence of adverse events between different doses of molnupiravir (200, 400, and 800 mg) and placebo in COVID‐19 patients 48 .…”

“…Recently published metaanalyses revealed that there was no significant difference in the incidence of adverse events between the molnupiravir and control groups. 21,44,46 Additionally, our previous research revealed no significant difference in the incidence of adverse events between different doses of molnupiravir (200, 400, and 800 mg) and placebo in COVID-19 patients. 48 This discrepancy can be attributed to the type of control groups in the meta-analyses.…”

“…However, the FDA has suspended its use in regions with a high proportion of the Omicron BA.2 subvariant, 16 despite real‐world studies demonstrating its effectiveness in patients infected with this subvariant 17–19 . Recent systematic reviews and meta‐analyses have indicated that both molnupiravir and sotrovimab treatments improve clinical outcomes in patients with mild to moderate COVID‐19 20,21 . Real‐world evidence has revealed diverse findings when comparing the effectiveness of molnupiravir and sotrovimab.…”

Response to the letter to the editor on “Clinical efficacy and safety of molnupiravir for nonhospitalized and hospitalized patients with COVID‐19: A systematic review and meta‐analysis of randomized control trials”

“…To the Editor, Huang et al 1 raised several concerns about our recent metaanalysis. 1 First, he thought that Caraco et al's study 2 was the interim analysis of the full MOVe-out study, 3 so it should not include interim and entire studies at the same time. In fact, MOVe-OUT was a phase 2/3 double-blind, parallel-group, randomized placebo-controlled trial.…”