Clinical effectiveness of oseltamivir for influenza A(H1N1) virus with H274Y neuraminidase mutation

Kawai, Naoki; Ikematsu, Hideyuki; Iwaki, Norio; Kondou, Kunio; Hirotsu, Nobuo; Kawashima, Takashi; Maeda, Tetsunari; Tanaka, Osame; Doniwa, Kenichi; Kashiwagi, Seizaburo

doi:10.1016/j.jinf.2009.07.002

Cited by 54 publications

(58 citation statements)

References 29 publications

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“…Trends suggestive of a shorter duration of clinical symptoms and viral shedding among the groups treated early with oseltamivir were found, but because of our small sample size, these findings may be explained by chance. In addition, these results are not consistent with a limited number of studies that have assessed the effectiveness of oseltamivir treatment in patients with oseltamivir‐resistant influenza A (H1N1) infection 5 , 6 , 7 . Our sample size was small because of the unplanned early study termination in the setting of antiviral resistance.…”

Section: Discussioncontrasting

confidence: 60%

Clinical and virologic outcomes in patients with oseltamivir‐resistant seasonal influenza A (H1N1) infections: results from a clinical trial

Dharan

Fry

Kieke

et al. 2011

Influenza Resp Viruses

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Please cite this paper as: Dharan et al. (2011) Clinical and virologic outcomes in patients with oseltamivir‐resistant seasonal influenza A (H1N1) infections: results from a clinical trial. Influenza and Other Respiratory Viruses 6(3), 153–158.Nineteen patients with oseltamivir‐resistant seasonal influenza A (H1N1) infections were randomized to receive oseltamivir or placebo. Nasopharyngeal swabs were obtained, and clinical and virologic outcomes were compared, stratified by early or late treatment. Neuraminidase inhibition assay and pyrosequencing for H275Y confirmed resistance. Twelve (63%) patients received oseltamivir; 8 (67%) received late treatment. Seven (37%) patients received placebo; 6 (86%) presented >48 hours after onset. Time to 50% decrease in symptom severity, complete symptom resolution, and first negative culture were shortest among the early treatment group. While sample size prohibits a strong conclusion, future studies should evaluate for similar trends.

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Section: Discussioncontrasting

confidence: 60%

Clinical and virologic outcomes in patients with oseltamivir‐resistant seasonal influenza A (H1N1) infections: results from a clinical trial

Dharan

Fry

Kieke

et al. 2011

Influenza Resp Viruses

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“…Accordingly, the differences in duration of illness between the laninamivir octanoate groups and oseltamivir group were marked in patients infected with influenza A (H1N1) virus; that is, both dose levels of laninamivir octanoate reduced the duration of illness by more than 60 h in comparison with oseltamivir. Thus, the results of this study demonstrated that laninamivir octanoate is fully effective against oseltamivir-resistant seasonal influenza A (H1N1) virus strains clinically, even though the effectiveness of oseltamivir against the H1N1 strain in children in the 2008 to 2009 season has been reported to be reduced (9).…”

Section: Discussionmentioning

confidence: 78%

Long-Acting Neuraminidase Inhibitor Laninamivir Octanoate (CS-8958) versus Oseltamivir as Treatment for Children with Influenza Virus Infection

Sugaya

Ohashi

2010

Antimicrob Agents Chemother

164

148

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We conducted a double-blind, randomized controlled trial to compare a long-acting neuraminidase inhibitor, laninamivir octanoate, with oseltamivir. Eligible patients were children 9 years of age and under who had febrile influenza symptoms of no more than 36-h duration. Patients were randomized to 1 of 3 treatment groups: a group given 40 mg laninamivir (40-mg group), a group given 20 mg laninamivir (20-mg group), and an oseltamivir group. Laninamivir octanoate was administered as a single inhalation. Oseltamivir (2 mg/kg of body weight) was administered orally twice daily for 5 days. The primary end point was the time to alleviation of influenza illness. The primary analysis included 184 patients (61, 61, and 62 in the 40-mg group, 20-mg group, and oseltamivir group, respectively). Laninamivir octanoate markedly reduced the median time to illness alleviation in comparison with oseltamivir in patients infected with oseltamivir-resistant influenza A (H1N1) virus, and the reductions were 60.9 h for the 40-mg group and 66.2 h for the 20-mg group. On the other hand, there were no significant differences in the times to alleviation of illness between the laninamivir groups and oseltamivir group for patients with influenza A (H3N2) or B virus infection. Laninamivir octanoate was well tolerated. The most common adverse events were gastrointestinal events. Laninamivir octanoate was an effective and well-tolerated treatment for children with oseltamivir-resistant influenza A (H1N1) virus infection. Further study will be needed to confirm clinical efficacy against influenza A (H3N2) or B virus infection.

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“…Given the possibility that oseltamivir may have been ineffective in the study population (approximately 50% of patients were infected with the less sensitive H274Y mutant of A/H1N1), the lack of a placebo group may have undermined the significance of the study. Kawai et al found that the clinical efficacy of oseltamivir against the H1N1 virus with H274Y was reduced, especially among children (10,11). In clinical trials with laninamivir (CS-8958) in the same season, this drug provided a shorter duration of influenza than did oseltamivir in the H1N1 subpopulation in a pediatric trial, but not in an adult trial (20,23).…”

Section: Discussionmentioning

confidence: 99%

Phase III Randomized, Double-Blind Study Comparing Single-Dose Intravenous Peramivir with Oral Oseltamivir in Patients with Seasonal Influenza Virus Infection

Kohno

Yen

Cheong

et al. 2011

Antimicrob Agents Chemother

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114

126

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Antiviral medications with activity against influenza viruses are important in controlling influenza. We compared intravenous peramivir, a potent neuraminidase inhibitor, with oseltamivir in patients with seasonal influenza virus infection. In a multinational, multicenter, double-blind, double-dummy randomized controlled study, patients aged >20 years with influenza A or B virus infection were randomly assigned to receive either a single intravenous infusion of peramivir (300 or 600 mg) or oral administration of oseltamivir (75 mg 5% CI, 0.814, 1.157), respectively. Both peramivir groups were noninferior to the oseltamivir group (97.5% CI, <1.170). The overall incidence of adverse drug reactions was significantly lower in the 300-mg-peramivir group, but the incidence of severe reactions in either peramivir group was not different from that in the oseltamivir group. Thus, a single intravenous dose of peramivir may be an alternative to a 5-day oral dose of oseltamivir for patients with seasonal influenza virus infection.

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Clinical effectiveness of oseltamivir for influenza A(H1N1) virus with H274Y neuraminidase mutation

Cited by 54 publications

References 29 publications

Clinical and virologic outcomes in patients with oseltamivir‐resistant seasonal influenza A (H1N1) infections: results from a clinical trial

Clinical and virologic outcomes in patients with oseltamivir‐resistant seasonal influenza A (H1N1) infections: results from a clinical trial

Long-Acting Neuraminidase Inhibitor Laninamivir Octanoate (CS-8958) versus Oseltamivir as Treatment for Children with Influenza Virus Infection

Phase III Randomized, Double-Blind Study Comparing Single-Dose Intravenous Peramivir with Oral Oseltamivir in Patients with Seasonal Influenza Virus Infection

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