Cumulative incidence of post-infection asthma or wheezing among young children clinically diagnosed with respiratory syncytial virus infection in the United States: A retrospective database analysis.

BACKGROUND: Respiratory syncytial virus (RSV) infection is implicated in subsequent development of asthma/wheezing (AW) among term and pre-term infants. We describe the cumulative incidence of AW among hospitalized and ambulatory neonates/infants/toddlers following RSV infection diagnosis over three independent follow-up periods. METHODS: Between January 1, 2007 and March 31, 2016, patients aged 0-2 years old with first clinical diagnosis of RSV infection were identified using the Optum® integrated electronic health records and claims database. Patients diagnosed with AW ≤ 30 days post-RSV diagnosis were excluded. Three cohorts with 1, 3, and 5 years of follow-up were stratified by presence or absence of specific RSV high-risk factors, including pre-term birth and pre-defined, pre-existing comorbidities. Descriptive statistics and logistic regression results were reported. RESULTS: Overall, 9811, 4524, and 1788 RSV-infected high-risk factor negative patients were included in 1, 3, and 5-year independent cohorts, respectively. Of these, 6.5%, 6.9%, and 5.8%, respectively had RSV-related hospitalization. By the end of follow-up, 14.9%, 28.2%, and 36.3% had AW events. Overall, 3030, 1378, and 552 RSV-infected high-risk factor positive patients were included in the respective cohorts. Of these, 11.4%, 11.1%, and 11.6%, respectively were hospitalized with initial RSV infection and 18.1%, 32.9%, and 37.9% had subsequent AW events within the follow-up period. Logistic regression confirmed RSV-related hospitalization significantly increased the likelihood of developing AW (P < .05) in high-risk factor positive and negative patients. CONCLUSIONS: In infants diagnosed with RSV infection, RSV-related hospitalization was associated with a significantly increased likelihood of AW development for at least 5 years, compared with non-hospitalized patients.

A Real-World Analysis of Patient Characteristics and Predictors of Hospitalization Among US Medicare Beneficiaries with Respiratory Syncytial Virus Infection.

INTRODUCTION: Little has been published on respiratory syncytial virus (RSV) among Medicare patients at high risk (HR) of RSV complications due to age or comorbidity. METHODS: Adult patients (at least 18 years of age) with at least 1 diagnostic code for RSV were identified using the 5% US Medicare database from 2011 through 2015. Patients were required to have continuous health plan enrollment for 180 days pre- and 180 days post-RSV diagnosis (baseline and follow-up periods, respectively). HR was defined as diagnosis of chronic lung disease, congestive heart failure, or weakened immune system for 180 days during the baseline period. Patients were categorized as initially hospitalized if hospitalized within 1 day of RSV diagnosis. Logistic regression models were developed to determine predictors of initial hospitalization. Healthcare utilization and costs for 180 days pre- and post-RSV diagnosis were compared. RESULTS: The study included 756 HR patients who were initially hospitalized with RSV diagnoses. Among these, 61.7% were diagnosed in the emergency department vs 15.3% in a physician's office, with hypertension (76.3%), chronic obstructive pulmonary disease (COPD) (53.7%), and high cholesterol (52.0%) observed as the most prevalent comorbidities. Of these, COPD, congestive heart failure, chronic kidney disease, and previous evidence of pneumonia were significant predictors of hospitalization. Other significant predictors of hospitalization included older age, hematological malignancies, stroke, and baseline healthcare resource use. Among both HR and non-HR hospitalized patients, there was a significant increase in healthcare resource utilization following hospitalization, including the number of inpatient admissions and longer hospital stays post-RSV diagnosis. The total mean all-cause healthcare costs among HR hospitalized patients increased by $9210 per patient (p < 0.0001) post-RSV diagnosis. CONCLUSION: Hospitalized Medicare beneficiaries with RSV infections pose a significant healthcare burden as compared with non-hospitalized patients, mainly driven by higher comorbidity, higher likelihood of multiple inpatient admissions, and costly medical interventions.

Cost-effectiveness of telaprevir in combination with pegylated interferon alpha and ribavirin in previously untreated chronic hepatitis C genotype 1 patients.

BACKGROUND: Telaprevir (T, TVR) is a direct-acting antiviral (DAA) used for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection. The sustained virological response (SVR) rates, i.e., undetectable HCV RNA levels 24 weeks after the end of treatment, is what differentiate treatments. This analysis evaluated the cost-effectiveness of TVR combined with pegylated interferon (Peg-IFN) alfa-2a plus ribavirin (RBV), with Peg-IFN and RBV (PR) alone or with boceprevir (B, BOC) plus Peg-IFN alfa-2b and RBV, in naïve patients. METHODS: A Markov cohort model of chronic HCV disease progression reflected the pathway of naïve patients initiating anti-HCV therapy. SVR rates were derived from a mixed-treatment comparison including results from Phase II and III trials of TVR and BOC, and trials comparing both PR regimens. SVR has significant impact on survival, quality-of-life, and costs. Incremental cost per life year (LY) gained and quality-adjusted-life-year (QALY) gained were computed at lifetime, adopting the (National Health Service) NHS perspective. Cost and health outcomes were discounted at 3.5%. Uncertainty was assessed using deterministic and probabilistic sensitivity analyses. Sub-group analyses were also performed by interleukin (IL)-28B genotype and fibrosis stage. RESULTS: Higher costs and improved outcomes were associated with T/PR relative to PR alone, resulting in an ICER of £12,733 per QALY gained. T/PR retained a significant SVR advantage over PR alone and was cost-effective regardless of IL-28B genotype and fibrosis stages. T/PR regimen 'dominated' B/PR, generating 0.2 additional QALYs and reducing lifetime cost by £2758. Sensitivity analyses consistently resulted in ICERs less than £30,000/QALY for the T/PR regimen over PR alone. LIMITATIONS: No head-to-head trial provides direct evidence of better efficacy of T/PR vs B/PR. CONCLUSION: The introduction of TVR-based therapy for genotype 1 HCV patients is cost-effective for naïve patients at the £30,000 willingness-to-pay threshold, regardless of IL-28B genotype or fibrosis stage.

Cost-effectiveness of telaprevir in combination with pegylated interferon alpha and ribavirin in treatment-experienced chronic hepatitis C genotype 1 patients.

BACKGROUND: Telaprevir (TVR,T) and boceprevir (BOC,B) are direct-acting antivirals (DAAs) used for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection. This analysis evaluated the cost-effectiveness of TVR combined with pegylated interferon (Peg-IFN) alfa-2a plus ribavirin (RBV) compared with Peg-IFN alfa-2a and RBV (PR) alone or BOC plus Peg-IFN alfa-2b and RBV in treatment-experienced patients. METHODS: A Markov cohort model of chronic genotype 1 HCV disease progression reflected the pathway of experienced patients retreated with DAA therapy. The population was stratified by previous response to treatment (i.e., previous relapsers, partial responders, and null responders). Sustained virologic response (SVR) rates were derived from a mixed-treatment comparison that included results from separate Phase III trials of TVR and BOC. Incremental cost per life year (LY) gained and quality-adjusted-life-year (QALY) gained were computed at lifetime, adopting the NHS perspective. Costs and health outcomes were discounted at 3.5%. Uncertainty was assessed using deterministic and probabilistic sensitivity analyses. Sub-group analyses were carried out by interleukin (IL)-28B genotype. RESULTS: Higher costs and improved outcomes were associated with T/PR relative to PR alone for all experienced patients (ICER of £6079). T/PR was cost-effective for each sub-group population with high SVR advantage in relapsers (ICER of £2658 vs £7593 and £20,875 for partial and null responders). T/PR remained cost-effective regardless of IL-28B sub-type. Compared to B/PR, T/PR prolonged QALYs by 0.57 and reduced lifetime costs by £13,960 for relapsers. For partial responders T/PR was less costly but less efficacious than B/PR, equating to an ICER of £128,117 per QALY gained. LIMITATIONS: No head-to-head trial provides direct evidence of better efficacy of T/PR vs B/PR. CONCLUSION: T/PR is cost-effective compared with PR alone in experienced patients regardless of treatment history and IL-28B genotype. Compared to B/PR, T/PR is always cost-saving but only more effective in relapsers.

Treatment-seeking behavior of erectile dysfunction patients in Europe: Results of the Erectile Dysfunction Observational Study.

INTRODUCTION: The Erectile Dysfunction Observational Study (EDOS) is a 6-month, pan-European prospective, observational study of health outcomes designed to assess patients' profiles and characteristics and the effectiveness of erectile dysfunction (ED) treatment in routine clinical practice. AIM: To present baseline characteristics and treatment-seeking behavior of a large sample of ED patients recruited in real-life clinical settings. METHODS: Men aged 18 years and older who visited a physician to initiate or change any ED treatment were enrolled in EDOS. They were assessed at baseline, 3 months, and 6 months as part of their normal course of care in nine European countries. MAIN OUTCOME MEASURES: Sexual health outcomes using the short form of the Psychological and Interpersonal Relationship Scales. Treatment effectiveness and satisfaction were assessed using the International Index of Erectile Function questionnaire, Global Assessment Questions, and further single-item questions. RESULTS: Of the 8,186 patients enrolled by 904 investigators (69% general practitioners [GPs]) across nine European countries, 8,055 patients were eligible for analysis at baseline; 63.9% were ED treatment-naive. Of the total patient population, mean age was 56.5 years, mean body mass index (BMI) was 27.2 kg/m2, 18.3% were obese (BMI > 30 kg/m2), 42.5% had severe ED, and there was a high frequency of comorbidities and concomitant medication use. A similar proportion of the treatment-naive patients were seen by GPs (62.9%) and specialists (65.8%). In the treatment-naive group, there was a higher frequency of severe ED among ex-smokers, obese patients, and in those who drank no alcohol or excessive amounts of alcohol. CONCLUSIONS: Unmet need of treatment in ED is high; 66% of patients had experienced ED symptoms for 1 year or longer when they were looking for treatment. Severity seems to be related to treatment seeking.