Treatment Of Influenza In Patients Research Articles

Cost-effectiveness of baloxavir marboxil compared with laninamivir for the treatment of influenza in patients at high risk for complications in Japan

Objective Baloxavir marboxil (baloxavir) is a single-dose antiviral which was previously found to be a cost-effective alternative to laninamivir in otherwise healthy adults in Japan. This study aimed at investigating the cost-effectiveness of baloxavir versus laninamivir in patients with influenza at high risk for complications. Methods A decision tree was utilized to estimate costs and health gains associated with the use of antivirals. A lifetime horizon was applied to capture the long-term impact of influenza complications, and other events with associated costs and health outcomes were accounted for one influenza season. The study population was stratified into three categories: adolescents and non-elderly adults with high-risk conditions (HRC), elderly without other HRC, and elderly with other HRC. The cost-effectiveness was assessed from a public healthcare payer’s perspective. The duration of influenza symptoms, probabilities of complications and probabilities of adverse events were obtained from a clinical trial and network meta-analysis. The costs of influenza and adverse events management were derived from the JammNet claims database. Utility values were informed by the clinical trial data and literature. Sensitivity analyses were also performed. Results The baloxavir strategy was associated with higher costs (+¥144) and higher quality-adjusted life-years (QALYs) in adults with HRC, elderly without HRC and elderly with HRC (+0.00078, +0.00183 and +0.00350 respectively). The overall incremental cost/QALY for baloxavir versus laninamivir was ¥68,855, which was below the willingness-to-pay threshold of ¥5 million/QALY gained. Key drivers of the model results were the probability of pneumonia and bronchitis. The probability of baloxavir being cost-effective was 72%. Conclusions This study suggests that influenza treatment with baloxavir is cost-effective compared with laninamivir in the adult high-risk population in Japan.

Outcomes of Influenza with Treatment in Patients with Diabetes: Subgroup Analysis of the Phase 3 CAPSTONE-2 Trial

Background: Patients with diabetes are at increased risk of developing complications from influenza infections, suggesting prompt antiviral treatment could be beneficial. Objective: This analysis explored the potential benefits of antiviral treatment of influenza in patients with diabetes. Methods: Patients with influenza at high risk of complications received single-dose baloxavir versus five days of oseltamivir versus placebo. A subgroup analysis was performed in patients with diabetes. Results: Overall, 329 of 1163 patients (28.3%) in the ITTI population (oseltamivir n=111, baloxavir n=103, placebo n=115) had diabetes. Baseline characteristics in patients with diabetes were balanced. Overall, the frequency of AEs was low and similar between arms; no safety signals were unique to patients with diabetes. Of patients with diabetes, median TTIIS was shorter for patients treated with baloxavir (73.2 h) than those treated with oseltamivir (95.7 h, p=0.572) or placebo (100.6 h; p=0.048). For influenza A infections, median TTIIS (baloxavir vs oseltamivir vs placebo) was 75.4 h vs 76.5 h vs 125.0 h, respectively and for influenza B infections, 70.7 h vs 109.9 h vs 82.6 h, respectively. Baloxavir- treated patients had significantly shorter median time-to-viral-clearance compared with oseltamivir- and placebo-treated patients (p<0.001) (48 h vs 96 h vs 96 h; both groups). Systemic antibiotic use for secondary infections was low across all arms (baloxavir 3.9% vs oseltamivir 4.5% vs placebo 7.0%). Conclusions: Clinical and virological efficacy was observed in baloxavir-treated diabetic outpatients with influenza in CAPSTONE-2 and no unique safety signals were identified.

Post-marketing safety evaluation of the intravenous anti-influenza neuraminidase inhibitor peramivir: A drug-use investigation in patients with high risk factors.

Peramivir, the only injectable anti-influenza neuraminidase inhibitor medically available in Japan at present, is considered first-line treatment in patients with high risk factors for influenza exacerbation. We conducted a drug-use investigation of peramivir in inpatients with high risk factors (old age, pregnancy, and underlying disease such as chronic respiratory disease) from January 2010 to March 2013. Data of 772 patients from 124 facilities across Japan were collected; peramivir's safety in 770 patients and effectiveness in 688 patients were examined. In total, 412 adverse events were observed in 219 patients (28.4%). Of these, 155 events were adverse drug reactions (ADRs) observed in 98 patients (12.7%). Major ADRs (≥2%) were increased aspartate aminotransferase (5.1%), increased alanine aminotransferase (3.8%) and decreased white blood cell count (2.5%). Fourteen serious ADRs were observed in 12 patients (1.6%). All serious ADRs were resolved or improved except for two events for which outcomes were unknown. Multivariate analyses revealed that ADR incidences were significantly associated with these four backgrounds of patients: medical history, no influenza vaccination, renal impairment and other infection(s). With regard to its effectiveness, the median time to alleviation of both influenza symptoms and fever was 3 days, including the first day of administration, which was the same as in other previous surveillance studies. This surveillance study indicated the safety of peramivir in the treatment of influenza inpatients with high risk factors under routine clinical settings.

The problem of antiviral therapy timely prescription in the patient with flu and chronic obstructive pulmonary disease

Purpose of the study: to conduct the study of the clinical efficacy of the use of antiviral rimantadine (Remavir) among influenza patients with chronic obstructive pulmonary disease, and the impact of treatment on the immune response, the incidence of complications.Materials and methods. There were examined 57 patients with influenza type A on the background of COPD, some of which received etiotropic treatment. The clinical, spirometric, immunological, virological and radiological examination.Results. Confirmed positive impact not only on Remavir for influenza, but also on the immune status of patients, the risk of complications and the need for antibiotics. Appointment causal treatment of influenza in patients with concomitant chronic obstructive pulmonary disease exhibits a pronounced therapeutic effect is subject to the timely use (1-2-day sickness). In the case of application of antiviral therapy 3-4th day flu, its effectiveness was significantly lower. Conclusion. High efficiency and good tolerability in patients with influenza Remavir with chronic obstructive pulmonary disease, and the impact of treatment on the immune response, the incidence of complications.

A randomized double-blind controlled study of laninamivir compared with oseltamivir for the treatment of influenza in patients with chronic respiratory diseases

Influenza infection tends to be severe in patients with chronic underlying diseases. This study evaluated the efficacy and safety of laninamivir octanoate, an inhaled neuraminidase inhibitor, for the treatment of influenza patients with chronic respiratory diseases; we conducted a double-blind, randomized controlled trial to compare the efficacy and safety of laninamivir octanoate and oseltamivir for the treatment of influenza in these patients. A total of 203 patients aged ≥20 years were randomized to receive either laninamivir octanoate or oseltamivir. The primary efficacy endpoint was the time to illness alleviation. This study is registered with JapicCTI; the registration number is JapicCTI-090940. The full analysis set (FAS) included a total of 201 patients (laninamivir group, n = 101; oseltamivir group, n = 100). Most patients had underlying bronchial asthma and 170 patients were infected with influenza A(H1N1)2009. The median time to illness alleviation was 64.7 h in the laninamivir group and 59.7 h in the oseltamivir group, with a difference of 5.0 h between the two groups (95 % confidence interval, -13.6 to 16.1 h). No adverse events specific to laninamivir octanoate were observed, and adverse events such as bronchospasm, which has been reported to be observed with other inhaled drugs related to laninamivir octanoate, did not occur. Laninamivir octanoate showed similar efficacy and safety to oseltamivir in the treatment of influenza, including that caused by influenza A(H1N1)2009, in patients with chronic respiratory diseases.

Efficacy and Safety of Inhaled Zanamivir for the Treatment of Influenza in Patients with Asthma or Chronic Obstructive Pulmonary Disease

Background: Influenza in patients with asthma can cause acute exacerbation and in patients with chronic obstructive pulmonary disease (COPD) it can lead to respiratory distress. Zanamivir is an effective treatment for both influenza A and B. However, controlled studies with zanamivir specifically in asthma or COPD patients with influenza illness are limited. Objective: To investigate the clinical efficacy and safety of inhaled zanamivir for the treatment of influenza in patients with asthma or COPD. Design and Setting: This randomised, double-blind, placebo-controlled, multi-centre study was conducted at 159 sites in 15 countries. Patients and Participants: 525 patients with asthma or COPD aged ≥12 years and with influenza-like illness were enrolled; 313 (60%) of these had laboratory-confirmed influenza virus infection and were included in the primary efficacy analysis. Methods: Patients were randomised to inhaled zanamivir 10mg or matching placebo via Diskhaler™ twice daily for 5 days. Patients recorded symptoms and pulmonary function twice daily in diary cards. The primary end-point in both patient groups was time to alleviation of symptoms of influenza. Results: Zanamivir significantly reduced the median time to alleviation of influenza symptoms compared with placebo (5.5 days vs 7.0 days; difference 1.5 days; 95% confidence interval 0.50 to 3.25 days; p = 0.009). Zanamivir significantly reduced the mean overall influenza assessment score compared with placebo (p = 0.004) over days 1 to 5. Patients recorded fewer nights of sleep disturbance with zanamivir compared with placebo (median 2 nights vs 3 nights; p = 0.042) during treatment. Zanamivir reduced the incidence of complications (requiring antibiotics and a change in respiratory medication) compared with placebo by 58% (p = 0.064). Zanamivir did not adversely affect pulmonary function, as determined by measurements of forced expiratory volume in 1 second and peak expiratory flow rate, compared with placebo. Zanamivir was well tolerated, with a safety profile similar to placebo. Compliance with treatment was high, with 495 (94%) patients successfully completing at least 4 days of treatment (8 doses). Furthermore, 90% of patients felt that the Diskhaler™ was easy or very easy to use. Conclusion: Zanamivir is an effective treatment for influenza in patients with asthma or COPD, and has a safety profile similar to that of placebo. Importantly, zanamivir does not adversely affect pulmonary function in this high-risk population.