Post-Exposure Prophylaxis with Favipiravir among Household Close Contacts to Confirmed COVID-19 Cases: A Cluster-Randomized Trial (PEPfavi)
et al., Journal of Infection and Public Health, doi:10.1016/j.jiph.2026.103150, PEPfavi, TCTR20210909002, Jan 2026
RCT 168 household close contacts showing no significant difference in SARS-CoV-2 infection with favipiravir post-exposure prophylaxis. The primary endpoint of laboratory-confirmed infection by day 14 occurred in 7.3% of the favipiravir group versus 14.5% of usual care (p=0.147).
Potential risks of favipiravir include kidney injury1-3, liver injury2-5, cardiovascular events5, and mutagenicity, carcinogenicity, teratogenicity, embryotoxicity, and the creation of dangerous variants6-12.
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risk of symptomatic case, 50.0% lower, RR 0.50, p = 0.37, treatment 4 of 84 (4.8%), control 8 of 84 (9.5%), NNT 21, day 14.
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risk of case, 36.4% lower, RR 0.64, p = 0.46, treatment 7 of 84 (8.3%), control 11 of 84 (13.1%), NNT 21, day 28.
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risk of case, 45.5% lower, RR 0.55, p = 0.31, treatment 6 of 84 (7.1%), control 11 of 84 (13.1%), NNT 17, day 14, primary outcome.
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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
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Waters et al., Human genetic risk of treatment with antiviral nucleoside analog drugs that induce lethal mutagenesis: the special case of molnupiravir, Environmental and Molecular Mutagenesis, doi:10.1002/em.22471.
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Hadj Hassine et al., Lethal Mutagenesis of RNA Viruses and Approved Drugs with Antiviral Mutagenic Activity, Viruses, doi:10.3390/v14040841.
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Shum, C., An investigational study into the drug-associated mutational signature in SARS-CoV-2 viruses, The University of Hong Kong, PhD Thesis, hub.hku.hk/handle/10722/344396.
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Siripongboonsitti et al., 14 Jan 2026, Randomized Controlled Trial, Thailand, peer-reviewed, median age 41.0, mean age 44.0, 11 authors, study period 17 October, 2021 - 5 May, 2022, trial TCTR20210909002 (PEPfavi).
Contact: taweegrit.sir@cra.ac.th.
Post-Exposure Prophylaxis with Favipiravir among Household Close Contacts to Confirmed COVID-19 Cases: A Cluster-Randomized Trial (PEPfavi)
Journal of Infection and Public Health, doi:10.1016/j.jiph.2026.103150
limited evidence supporting the efficacy of antiviral post-exposure prophylaxis (PEP) in this context.
Methods: The phase 2/3, open-label, (1:1) cluster-randomized controlled trial in Thailand, 168 household close contacts from 76 index cases were enrolled to receive either favipiravir-PEP (FPV-PEP) (1600-2000 mg/day for 7 days) or usual care. The efficacy of FPV-PEP was investigated in preventing SARS-CoV-2 infection after contact with index cases.
Results: The incidence of confirmed SARS-CoV-2 infection was lower in the FPV-PEP group than in the usual care group (7.32% vs. 14.47%), although the difference was not statistically significant. A trend toward fewer early positive rapid diagnostic test results on day 3 was observed in the FPV-PEP group. Symptom development was less frequent among FPV-PEP recipients, with fewer cases of fever, rhinorrhea, and myalgia. A significantly higher probability of remaining asymptomatic and delayed symptom onset was observed in the FPV-PEP group. No participants developed severe COVID-19 or required hospitalization.
Conclusion: FPV-PEP was associated with a lower incidence of fever, rhinorrhea, and myalgia among household contacts. While a reduction in secondary transmission was observed, it did not reach statistical significance. Further large-scale studies are warranted to clarify its role in preventing household transmission. Trial Registration: Thai clinical trials registry (TCTR) no.20210909002
Competing interests All authors do not have an association that might pose a conflict of interest.
Authors' Contributions T.S. had full access to all data in this study and was responsible for the data's integrity and accuracy. T.S., first authors and corresponding authors, Concept and design-T.S., T.U., N.M.; Investigation-T.S., T.U., K.T., K.N., K.C., W.S., N.W., M.M., S.W., K.S., N.M.; The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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