BackgroundA network meta-analysis can provide estimates of relative efficacy for treatments not directly studied in head-to-head randomized controlled trials. We estimated the relative efficacy and safety of dolutegravir (DTG) versus third agents currently recommended by guidelines, including ritonavir-boosted atazanavir (ATV/r), ritonavir-boosted darunavir (DRV/r), efavirenz (EFV), cobicistat-boosted elvitegravir (EVG/c), ritonavir-boosted lopinavir (LPV/r), raltegravir (RAL), and rilpivirine (RPV), in treatment-naive HIV-1–infected patients.MethodsA systematic review of published literature was conducted to identify phase 3/4 randomized controlled clinical trials (up to August 2013) including at least one third agent of interest in combination with a backbone nucleoside reverse transcriptase inhibitor (NRTI) regimen. Bayesian fixed-effect network meta-analysis models adjusting for the type of nucleoside reverse transcriptase inhibitor backbone (tenofovir disoproxil fumarate/emtricitabine [TDF/FTC] or abacavir/lamivudine [ABC/3TC]) were used to evaluate week 48 efficacy (HIV-RNA suppression to <50 copies/mL and change in CD4+ cells/µL) and safety (lipid changes, adverse events, and discontinuations due to adverse events) of DTG relative to all other treatments. Sensitivity analyses assessing the impact of NRTI treatment adjustment and random-effects models were performed.ResultsThirty-one studies including 17,000 patients were combined in the analysis. Adjusting for the effect of NRTI backbone, treatment with DTG resulted in significantly higher odds of virologic suppression (HIV RNA<50 copies/mL) and increase in CD4+ cells/µL versus ATV/r, DRV/r, EFV, LPV/r, and RPV. Dolutegravir had better or equivalent changes in total cholesterol, LDL, triglycerides, and lower odds of adverse events and discontinuation due to adverse events compared to all treatments. Random-effects and unadjusted models resulted in similar conclusions.ConclusionThree clinical trials of DTG have demonstrated comparable or superior efficacy and safety to DRV, RAL, and EFV in HIV-1–infected treatment-naive patients. This network meta-analysis suggests DTG is also favorable or comparable to other commonly used third agents (ATV/r, LPV/r, RPV, and EVG/c).

Introduction Prior epidemiology studies on erectile dysfunction (ED) have varied in geography/place, time period, and methodology. Due to this variability, comparisons of data across studies are greatly limited. Additionally, little is known about the rates of comorbid ED and benign prostatic hyperplasia (BPH). Aim To update the prevalence of ED and patient characteristics using a single methodology in 8 countries: Brazil, China, France, Germany, Italy, Spain, the United Kingdom, and the United States. Methods This retrospective cross-sectional study included men (≥18 years) who self-reported experiencing difficulty in achieving or maintaing an erection in the past 6 months in the 2015 and 2016 National Health and Wellness Surveys (N = 97,159). Pairwise comparisons between the United States and each of the other countries were performed among respondents with ED and no BPH, aged ≥18 years, and within the subset of men aged 40–70 years. Main Outcome Measures ED prevalence (with BPH, with no BPH, and overall), health characteristics, and ED risk factors were assessed. Results ED with BPH was found to be &lt; 6.0% in all countries. ED prevalence overall varied from 37.2% (Brazil) to 48.6% (Italy). Similar patterns were observed for the subset of men aged 40−70 years. Patients in Brazil were younger (aged ≥18: 43.85 vs. 52.35; aged 40−70: 52.94 vs. 56.76 years; for both, P &lt; .05) than those in the United States. ED-related comorbidities were more common in European countries, comparatively. Conclusion This study provides an important update and outlook to ED epidemiology in Brazil, China, France, Germany, Italy, Spain, the United Kingdom, and the United States. Overall, ED prevalence is high, relative to some previous estimates. Findings from this study highlight the continued burden ED plays in the lives of men in these countries.

Aim:To evaluate the association of erectile dysfunction (ED) with work productivity loss, activity impairment and health-related quality of life (HRQoL) across Brazil, China, France, Germany, Italy, Spain, the UK and the US. Methods:This cross-sectional observational study used data from adult men (40-70 years old; N = 52 697) from the 2015 and 2016 National Health and Wellness Surveys. ED assessment was based on self-reported difficulty in achieving or maintaining an erection in the past 6 months. Impairment to work and non-work activities and HRQoL were assessed for each country and compared against the US. Multivariable models tested interactions between ED status and country for each outcome. Results:Overall ED prevalence was reported as 49.7%, with Italy reporting the highest rate (54.7%). Men with ED reported significantly higher absenteeism (7.1% vs 3.2%), presenteeism (22.5% vs 10.1%), overall work productivity impairment (24.8% vs 11.2%), activity impairment (28.6% vs 14.5%) and significantly lower Mental Component Summary scores (MCS; 46.7 vs 51.2), Physical Component Summary scores (PCS; 48.3 vs 53.0), and health state utilities (SF-6D: 0.693 vs 0.778; all, P < 0.001) than men with no ED. After adjusting for covariates, compared with the US, the association of ED status with overall work productivity impairment was greatest in the UK (26% higher; P < 0.05), and with MCS, PCS and SF-6D scores was greatest in China (−2.67, −1.58, and −0.043 points, respectively; all, P < 0.001). Greater ED severity was significantly associated with higher impairment to work and non-work activities and lower HRQoL, with China reporting the highest burden, compared with the US (most P < 0.05).Conclusion: ED poses a significant burden with respect to work productivity and HRQoL, with greater severity associated with worse outcomes. Better management and earlier detection may help reduce this burden, especially in countries reporting a strong association between ED and poor economic and health outcomes. | INTRODUC TI ONErectile dysfunction (ED) is defined as the persistent inability to achieve and/or maintain penile erection sufficient for performing sexual intercourse. 1 ED can be caused by endocrine (reduced serum testosterone levels), non-endocrine (arterial inflow disorders and abnormalities of venous outflow), neurogenic (affecting innervation and nervous function) and iatrogenic (relating to a medical or surgical treatment) factors. 2 An extrapolation of the Massachusetts Male Aging Study, whichreported an ED prevalence of 52% in men aged 40-70 years, suggested that global ED prevalence will increase from 152 million

Biopharmaceuticals (biologics) represent one of the fastest growing sectors of cancer treatment. They are recommended for treating underlying cancer and as supportive care for management of treatment side effects. Given the high costs of cancer care and the need to balance health care provision and associated budgets, patient access and value are the subject of discussion and debate in the USA and globally. As the costs of biologics are high, biosimilars offer the potential of greater choice and value, increased patient access to treatment, and the potential for improved outcomes. Value-based care aims to improve the quality of care, while containing costs. The Centers for Medicare & Medicaid Services (CMS) has developed value-based care programs as alternatives to fee-for-service reimbursement, including in oncology, that reward health care providers with incentive payments for improving the quality of care they provide. It is anticipated that CMS payments in oncology care will be increasingly tied to measured performance. This review provides an overview of value-based care models in oncology with a focus on CMS programs and discusses the contribution of biosimilars to CMS value-based care objectives. Biosimilars may provide an important tool for providers participating in value-based care initiatives, resulting in cost savings and efficiencies in the delivery of high-value care through expanded use of biologic treatment and supportive care agents during episodes of cancer care.

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