Effect of Oral Oseltamivir on Virological Outcomes in Low-risk Adults With Influenza: A Randomized Clinical Trial

Abstract

Background Duration of viral shedding is a determinant of infectivity and transmissibility, but few data exist about oseltamivir's ability to alter viral shedding. Methods From January 2012 through October 2017, a randomized, double-blinded multicenter clinical trial was conducted in adults aged 18–64 years at 42 sites in Thailand, the United States, and Argentina. Participants with influenza A or B and without risk factors for complications of influenza were screened for the study. Eligible participants were randomized to receive oseltamivir 75 mg or placebo twice daily for 5 days. The primary endpoint was the percentage of participants with virus detectable by polymerase chain reaction in nasopharyngeal swab at day 3. Results Of 716 adults screened for the study, 558 were randomized, and 501 were confirmed to have influenza. Forty-six participants in the pilot study were excluded, and 449 of the 455 participants in the population for the primary analysis had day 3 viral shedding results. Ninety-nine (45.0%) of 220 participants in the oseltamivir arm had virus detected at day 3 compared with 131 (57.2%) of 229 participants in the placebo arm (absolute difference of −12.2% [−21.4%, −3.0%], P =; .010). The median time to alleviation of symptoms was 79.0 hours for the oseltamivir arm and 84.0 hours for the placebo arm (P =; .34) in those with confirmed influenza infection. Conclusions Oseltamivir decreased viral shedding in this low-risk population. However, in the population enrolled in this study, it did not significantly decrease the time to resolution of clinical symptoms. Clinical Trials Registration NCT01314911.

Comparison of antiviral effect for mild-to-moderate COVID-19 cases between lopinavir/ritonavir versus hydroxychloroquine: A nationwide propensity score-matched cohort study

“…Antiviral agents are commonly used for improving clinical symptoms or ameliorating disease severity. Furthermore, they have an important clinical implication to suppress disease transmission by reducing the viral shedding duration, as shown from the effect of oseltamivir for influenza ( Beigel et al, 2020 , Meschi et al, 2011 ). Owing to the highly transmissible property of SARS-CoV-2, even asymptomatic and presymptomatic patients have transmitted the virus to their family members and colleagues ( Bai et al, 2020 , Gandhi et al, 2020 ).…”

Neuraminidase inhibitors are effective and safe in reducing influenza complications: meta-analysis of randomized controlled trials.

“…A total of 18 trials [20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37] was included in the study. Nine trials focused on oral oseltamivir therapy twice/daily for 5 days: four trials [20][21][22]24 administered 75mg; two trials 25,26 administered 2mg/kg; one trial 23 administered between 30-45mg depending on the weight; and two trials 27,28 administered 75 or 150 mg. Six trials focused on inhaled zanamivir therapy twice/daily for 5 days: five trials [29][30][31][32][33] administered 10mg; one trial 34 administered 10 mg plus zanamivir intranasal spray (6.4 mg) or plus placebo nasal spray. Three trials focused on intravenous peramivir once/daily for 5 days: one trial 35 administered 600mg; one trial 36 administered 150 or 300 mg; one trial 37 administered 300 or 600mg.…”

“…Baseline characteristics of the population included are described in table 2. Twelve trials 20,22,24,[27][28][29][31][32][33][34]36,37 involved patients aged less than or equal to 12 years only patients (≥12 year), whereas the remaining five trials 21,23,25,26,30 involved children (<12 years old) and one trial 35 involved adults (≥ 18 years), adolescents (11-12 years), or children (6-11 years) old. A total of 463 (5.1%) patients received any antibiotic treatment and 511 (5.6%) patients reported any complication at baseline.…”

Staying InformED: Top emergency Medicine pharmacotherapy articles of 2020

“… Effect of Oral Oseltamivir on Virological Outcomes in Low-risk Adults with Influenza: A Randomized Clinical Trial [ 35 ] [GRADE 1A]. …”

“…While the clinical efficacy of oseltamivir has previously been established in patients with influenza, data are limited on the virologic efficacy of oseltamivir. This study was a randomized, double-blind study conducted in Thailand, the United States, and Argentina including patients with influenza A or B without risk factors for complications of influenza [ 35 ]. Males and non-pregnant females aged 18–64 years with at least one respiratory symptom (cough, sore throat, or nasal symptoms) starting within 48 h before screening between 2012 and 2017 were randomized to receive oseltamivir 75 mg or placebo twice daily for five days.…”