New Therapies, Evidence, and Guidance in Hepatitis C Management: Expert Practices and Insights from an Educational Symposium at the AMCP 27th Annual Meeting Expo.

BACKGROUND: The 2013-2014 approvals of new direct-acting antiviral (DAA) therapies for hepatitis C virus (HCV) infection have engendered a paradigm shift in HCV treatment and management, offering the potential for a cure at a population level. The availability of the highly effective and relatively safe DAAs prompted revisions to guidance recommendations based on new clinical trial evidence. In the context of this paradigm shift and considerations of the costs associated with the new DAAs, managed care professionals face new questions and challenges regarding HCV treatment and management approaches. To address the continuing education needs of this group, PRIME Education, Inc. (PRIME) conducted a symposium on HCV at the 27th Annual Meeting Expo of the Academy of Managed Care Pharmacy. Moderated by Michael R. Stinchon, Jr., RPh, the program panel featured 2 internationally recognized leaders in hepatitis C treatment and research: Norah Terrault, MD, MPH, and Alex Monto, MD.  OBJECTIVE: To summarize the educational symposium presentations and discussions. METHODS: This article is organized by key questions that the panelists and attendees raised for discussion during the 2-hour symposium. The questions addressed methods for assessing liver fibrosis; comprehensive patient assessment to inform treatment decisions; the influence of viral load on decisions about treatment duration; the role of ribavirin in optimizing treatment efficacy; unmet treatment needs for patients with HCV genotype 3 or advanced liver disease; and managed care strategies for patient education, adherence promotion, and care coordination. In answering attendee questions on these issues, the expert panelists presented established evidence, and recognizing limitations to current evidence and guidance recommendations, they discussed applications of clinical judgment and offered their views and practices regarding individualized care for patients with HCV.  SUMMARY: In response to questions about the utility of noninvasive methods for assessing liver fibrosis, the expert panel presented a comparative overview of the methodology, accuracy, risks, limitations, and costs of noninvasive tests and liver biopsy. Discussion highlighted the strengths of noninvasive methods for diagnosing advanced disease and cirrhosis and the methods' limitations that pose barriers to ensuring that patients receive necessary antiviral therapy. Based on guidance recommendations, treatment should be prioritized in patients with advanced fibrosis or cirrhosis (Metavir score F3 to F4). While acknowledging the importance of this recommendation, the symposium panelists also argued that making effective decisions about whom, and when, to treat requires a more comprehensive clinical approach to patient assessment and adjusting recommended priorities according to individual patient considerations. This approach involves evaluating outcomes such as extrahepatic complications, including those affecting quality of life, functional status, and work productivity. In response to questions regarding decisions about DAA therapy duration based on viral load, the panel engaged the audience in thinking critically about evidence-based cutoff values and natural fluctuations of HCV RNA concentrations. Discussions centered on the importance of clinical judgment to ensure that the treatment duration promotes the highest efficacy and avoids risks of relapse. The panel responded to several audience questions about the role of ribavirin in new DAA regimens. Evidence-based presentations and discussions focused on patient-specific factors that must be considered to inform effective decisions about adding ribavirin. The panel took a similar approach to answering questions about emerging challenges and the difficult-to-treat populations of patients with HCV genotype 3 or advanced liver disease. The symposium concluded with presentation of, and discussion on, managed care strategies for educating patients about appropriate HCV medication use, improving adherence, and coordinating care provided by the interprofessional team.  CONCLUSIONS: The availability of new DAAs for HCV raises new questions and challenges for managed care professionals, especially regarding prioritizing patients for immediate therapy as well as treatment and management approaches that account for the needs of individual patients and subpopulations. The educational symposium summarized in this article directly addressed key questions and challenges through presentations of evidence, guidance recommendations, and interactive discussions on the views and practices of international leaders in HCV treatment and research.

Influence of Continuing Medical Education on Rheumatologists' Performance on National Quality Measures for Rheumatoid Arthritis.

INTRODUCTION: In recent years researchers have reported deficits in the quality of care provided to patients with rheumatoid arthritis (RA), including low rates of performance on quality measures. We sought to determine the influence of a quality improvement (QI) continuing education program on rheumatologists' performance on national quality measures for RA, along with other measures aligned with National Quality Strategy priorities. Performance was assessed through baseline and post-education chart audits. METHODS: Twenty community-based rheumatologists across the United States were recruited to participate in the QI education program and chart audits. Charts were retrospectively audited before (n = 160 charts) and after (n = 160 charts) the rheumatologists participated in a series of accredited QI-focused educational activities that included private audit feedback, small-group webinars, and online- and mobile-accessible print and video activities. The charts were audited for patient demographics and the rheumatologists' documented performance on the 6 quality measures for RA included in the Physician Quality Reporting System (PQRS). In addition, charts were abstracted for documentation of patient counseling about medication benefits/risks and adherence, lifestyle modifications, and quality of life; assessment of RA medication side effects; and assessment of RA medication adherence. RESULTS: Mean rates of documented performance on 4 of the 6 PQRS measures for RA were significantly higher in the post-education versus baseline charts (absolute increases ranged from 9 to 24% of patient charts). In addition, after the intervention, significantly higher mean rates were observed for patient counseling about medications and quality of life, and for assessments of medication side effects and adherence (absolute increases ranged from 9 to 40% of patient charts). CONCLUSION: This pragmatic study provides preliminary evidence for the positive influence of QI-focused education in helping rheumatologists improve performance on national quality measures for RA.

An Evidence-Based Systematic Review of Goji (Lycium spp.) by the Natural Standard Research Collaboration.

An evidence-based systematic review of goji (Lycium spp.) by the Natural Standard Research Collaboration consolidates the safety and efficacy data available in the scientific literature using a validated, reproducible grading rationale. This article includes written and statistical analysis of clinical trials, plus a compilation of expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.

An evidence-based systematic review of kudzu (Pueraria lobata) by the Natural Standard Research Collaboration.

An evidence-based systematic review of kudzu (Pueraria lobata) by the Natural Standard Research Collaboration consolidates the safety and efficacy data available in the scientific literature using a validated, reproducible grading rationale. This article includes written and statistical analysis of clinical trials, plus a compilation of expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.

An evidence-based systematic review of bitter orange (Citrus aurantium) by the Natural Standard Research Collaboration.

An evidence-based systematic review of bitter orange (Citrus aurantium) by the Natural Standard Research Collaboration consolidates the safety and efficacy data available in the scientific literature using a validated, reproducible grading rationale. This article includes written and statistical analysis of clinical trials, plus a compilation of expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.

NSAIDs for musculoskeletal pain management:current perspectives and novel strategies to improve safety.

BACKGROUND: Musculoskeletal disorders are a growing burden on the health care system in the United States. Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used to assist in the management of mild-to moderate musculoskeletal pain. After the withdrawal of rofecoxib because of cardiovascular toxicity, the safety of these agents became a topic of controversy and confusion. Recent evidence is facilitating a better understanding of the risks and mechanisms by which NSAIDs cause injury. In an effort to raise awareness, this review addresses the current challenges, recent progress, and novel strategies for improving tolerability. With new data to help guide decision making and the anticipated increase in pharmacological options for managing musculoskeletal pain, the role of the managed care professional is particularly important in this evolving field. OBJECTIVES: To review recommendations for the appropriate use of NSAIDs, incorporate risk/benefit analysis into decision making, and evaluate the efficacy and safety of recently approved and emerging NSAID formulations. SUMMARY: Musculoskeletal-related conditions are a major public health burden. NSAIDs are among the most commonly used medications for musculoskeletal conditions. Since the introduction of selective cyclooxygenease-2 (COX-2) inhibitors (or coxibs), there has been ongoing discussion and debate about the safety of all NSAIDs. Current available evidence suggests both traditional NSAIDs and coxibs increase the risk of gastrointestinal and cardiovascular toxicity; however, with proper risk assessment, these dangers can be limited. Moreover, new and emerging NSAID formulations and delivery systems aim to enhance the effectiveness and reduce the toxicity associated with these anti-inflammatory agents.

An evidence-based systematic review of active hexose correlated compound (AHCC) by the Natural Standard Research Collaboration.

An evidence-based systematic review of active hexose correlated compound (AHCC) by the Natural Standard Research Collaboration consolidates the safety and efficacy data available in the scientific literature using a validated, reproducible grading rationale. This article includes written and statistical analysis of clinical trials, plus a compilation of expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.

An evidence-based systematic review of tongkat ali (Eurycoma longifolia) by the Natural Standard Research Collaboration.

An evidence-based systematic review of tongkat ali (Eurycoma longifolia) by the Natural Standard Research Collaboration consolidates the safety and efficacy data available in the scientific literature using a validated, reproducible grading rationale. This article includes written and statistical analysis of clinical trials, plus a compilation of expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.

An evidence-based systematic review of vitamin A by the natural standard research collaboration.

An evidence-based systematic review of vitamin A by the Natural Standard Research Collaboration consolidates the safety and efficacy data available in the scientific literature using a validated and reproducible grading rationale. This paper includes written and statistical analysis of clinical trials, plus a compilation of expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.

An evidence-based systematic review of vanadium by the Natural Standard Research Collaboration.

An evidence-based systematic review of vanadium by the Natural Standard Research Collaboration consolidates the safety and efficacy data available in the scientific literature using a validated, reproducible grading rationale. This article includes written and statistical analysis of clinical trials, plus a compilation of expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.

An evidence-based systematic review of senna (Cassia senna) by the Natural Standard Research Collaboration.

An evidence-based systematic review, including written and statistical analysis of scientific literature, expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.

An evidence-based systematic review of gymnema (Gymnema sylvestre R. Br.) by the Natural Standard Research Collaboration.

An evidence-based systematic review of gymnema (Gymnema sylvestre R. Br.), including written and statistical analysis of scientific literature, expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.

An evidence-based systematic review of stevia by the Natural Standard Research Collaboration.

The objective of this study was to evaluate the scientific evidence on stevia, including expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing. This review serves as a clinical support tool. Electronic searches were conducted in 10 databases, 20 additional journals (not indexed in common databases), and bibliographies from 50 selected secondary references. No restrictions were placed on the language or quality of the publications. All literature collected pertained to efficacy in humans, dosing, precautions, adverse effects, use in pregnancy and lactation, interactions, alteration of laboratory assays, and mechanisms of action. Standardized inclusion and exclusion criteria were used for selection. Grades were assigned using an evidence-based grading rationale. Based on the availability of scientific data, two indications are discussed in this review: hypertension and hyperglycemia. Evaluation of two long-term studies (1 and 2 years in length, respectively) indicates that stevia may be effective in lowering blood pressure in hypertensive patients, although data from shorter studies (1-3 months) did not support these findings. A pair of small studies also report positive results with respect to glucose tolerance and response, although the relatively low methodological rigor of these experiments limits the strength of these findings. Further investigation is warranted in both indications.

An evidence-based systematic review of umckaloabo (Pelargonium sidoides) by the Natural Standard Research Collaboration.

An evidence-based systematic review, including written and statistical analysis of scientific literature, expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.

An evidence-based systematic review of rosemary (Rosmarinus officinalis) by the Natural Standard Research Collaboration.

An evidence-based systematic review of rosemary (Rosmarinus officinalis), including written and statistical analysis of scientific literature, expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.

Chia (Salvia hispanica): a systematic review by the natural standard research collaboration.

OBJECTIVE: To evaluate the scientific evidence on chia (Salvia hispanica) including history, folkloric precedent, expert opinion, pharmacology, dosing, interactions, adverse effects, and toxicology. This review serves as a clinical support tool. METHODS: Electronic searches were conducted in ten databases, 20 additional journals (not indexed in common databases), and bibliographies from 50 selected secondary references. No restrictions were placed on language or quality of publications. All literature collected pertained to efficacy in humans, dosing, precautions, adverse effects, use in pregnancy/lactation, interactions, alteration of laboratory assays, and mechanisms of action. Standardized inclusion/exclusion criteria are utilized for selection. Grades were assigned using an evidence-based grading rationale. RESULTS: The available human and non-human studies show possible effectiveness for allergies, angina, athletic performance enhancement, cancer, coronary heart disease (CHD), heart attack, hormonal/endocrine disorders, hyperlipidemia, hypertension, stroke, and vasodilatation. Some evidence also suggests possible anticoagulant, antioxidant, and antiviral effects of Salvia hispanica. CONCLUSION: There is limited evidence supporting the efficacy of Salvia hispanica for any indication; thus far, only two clinical studies have examined the effects of Salvia hispanica on cardiovascular disease (CVD) risk factors (including body weight). One study showed some effects on some CVD risk factors, while the other did not. Neither study showed any effects of Salvia hispanica on weight loss. However, the historical use of Salvia hispanica suggests that it is safe for consumption by nonallergic individuals. Further rigorous examination is warranted pertaining to the use of Salvia hispanica as a dietary supplement, as well as in the treatment or prevention of human disease.