Dysphagia as an Initial Presentation of Acute Myeloid Leukemia: A Rare Presentation of Myeloid Sarcoma.

Myeloid sarcoma (MS) represents a unique clinical presentation of acute myeloid leukemia (AML). This report describes a case of MS in a 66-year-old man who presented with dysphagia, nausea, vomiting, anorexia, and fatigue. Generalized lymphadenopathy was noted on physical exam and confirmed by CT scans which also showed diffuse esophageal wall thickening. Axillary lymph node biopsy was positive for MS. Bone marrow biopsy confirmed AML with 88% blasts. The patient received induction chemotherapy with decitabine and venetoclax and was planned for four cycles of treatment over three months while monitoring the response.

Blood donation practices, processing and utilisation of blood components in government tertiary hospitals in Nigeria: a multicentre cooperative study.

BACKGROUND: Timely access to safe blood and blood components is still a challenge in Nigeria. This study aimed to determine blood donation practices, processing and utilization of blood components across government tertiary hospitals (THs) in Nigeria. METHODS: This was a descriptive cross-sectional study done in Nigeria in June-July 2020. Data were analysed with SPSS version 21.0. RESULTS: Data were collected from 50 THs. The majority (68%) of the THs lack facilities for blood component preparation and only 18% and 32% provide cryoprecipitate and platelet concentrate, respectively. Whole blood was most commonly requested (57.04%). All facilities tested blood for HIV, HBV and HCV, but the majority (23 [46%]) employed rapid screening tests alone and nucleic acid testing was not available in any hospitals. The manual method was the most common method of compatibility testing in 90% (45/50) and none of the THs routinely perform extended red cell typing. The average time to process routine, emergency and uncross-matched requests were a mean of 109.58±79.76 min (range 45.00-360.00), 41.62±25.23 (10.00-240.00) and 11.09±4.92 (2.00-20.00), respectively. CONCLUSION: Facilities for blood component preparation were not widely available. Concerned government authorities should provide facilities for blood component preparation.

Treatment patterns and economic burden among newly diagnosed cervical and endometrial cancer patients.

Aim: This study evaluated treatment patterns, healthcare resource use and healthcare costs among newly diagnosed US patients with cervical or endometrial cancer. Materials & methods: The authors identified patients diagnosed between 2015 and 2018, described them by line of therapy (LOT), then summarized all-cause per patient per month healthcare resource use and healthcare costs per LOT. Results: Among 1004 patients with cervical cancer and 2006 patients with endometrial cancer, 65.2 and 71.4%, respectively, received at least LOT1. Common treatment modalities in LOT1 were surgery (cervical, 58.0%; endometrial, 92.6%), radiation therapy (cervical, 49.8%; 24.7%) and systemic therapy (cervical, 53.3%; endometrial, 26.1%). Mean per patient per month costs per LOT were pre-treatment (cervical, US$17,210; endometrial, US$14,601), LOT1 (cervical, US$10,929; endometrial, US$6859), LOT2 (cervical, US$15,183; endometrial, US$10,649) and LOT3+ (cervical, US$19,681; endometrial, US$9206). Conclusion: Overall, newly diagnosed patients with cervical or endometrial cancer received guideline-recommended treatment. Outpatient visits mainly drove healthcare costs across LOTs.

Treatment patterns and economic burden among cervical and endometrial cancer patients newly initiating systemic therapy.

Aim: To evaluate treatment patterns, healthcare resource use (HCRU) and all-cause healthcare costs among patients with cervical or endometrial cancer newly initiating systemic therapy. Methods: We identified patients with cervical or endometrial cancer newly initiating systemic therapy - a claims-based proxy for advanced disease - between 2014 and 2019, described them by line of therapy (LOT), and summarized the per patient per month (PPPM) HCRU and healthcare costs per LOT. Results: Among 1229 patients with cervical cancer and 2659 patients with endometrial cancer, LOT1 therapies included systemic only (cervical, 50.1%; endometrial, 83.2%) and systemic with radiation therapy (cervical, 49.9%; endometrial, 16.8%). Mean PPPM total costs were: LOT1 (cervical, US$15,892; endometrial, US$11,363), LOT2 (US$20,193; US$14,019) and LOT3+ (US$16,576; US$14,645). Conclusions: Overall, patients received guideline-concordant care and experienced significant economic burden, which increased with LOT.

Phase-specific and lifetime economic burden of cervical cancer and endometrial cancer in a commercially insured United States population.

AIM: To estimate the incremental phase-specific and lifetime economic burden among newly diagnosed cervical and endometrial cancer patients vs. non-cancer controls. METHODS: Cervical and endometrial cancer patients newly diagnosed between January 2015 and June 2018 were identified in the Optum Clinformatics DataMart database. The index date was the date of the first diagnosis for cancer cases and the first claim date after 12 months of continuous enrollment for non-cancer controls. Patients were followed until death/loss of enrollment/end of data availability. Per patient per month (PPPM) costs attributable to cancer were calculated for four phases: pre-diagnosis (3 months before diagnosis), initial (6 months post-diagnosis), terminal (6 months pre-death), and continuation (remaining time between initial and terminal phases). Survival data were obtained to determine the monthly proportion of patients in each phase. Total survival adjusted monthly costs were obtained by multiplying the proportion of patients in each phase by the total cost incurred during that month. Phase-specific and lifetime incremental costs of cervical and endometrial cancer were obtained using generalized linear models. RESULTS: The analytic cohort included 1,002 cervical cancer patients and 4,005 matched non-cancer controls and 5,003 endometrial cancer patients matched with 19,999 non-cancer controls. Mean adjusted incremental PPPM lifetime costs (95% CI) for cervical cancer and endometrial cancer cases were $5,910 ($5,373-$6,446) and $3,475 ($3,259-$3,691), respectively. Incremental total PPPM phase-specific costs attributable to cervical and endometrial cancer were pre-diagnosis (cervical: $1,057; endometrial: $3,315), initial ($12,084; $8,618), continuation ($2,732; $1,147), and terminal ($2,702; $5,442). Incremental costs were significantly higher for cancer patients vs. non-cancer controls across patient lifetime and all phases of care (except terminal phase costs for cervical cancer). Outpatient costs were the major driver of costs across all post-diagnosis phases. CONCLUSION: This study highlights the cost burden associated with cervical/endometrial cancer and cost variation by phases of care.

Corrigendum: Economic Value of Lost Productivity Attributable to Human Papillomavirus Cancer Mortality in the United States.

[This corrects the article DOI: 10.3389/fpubh.2020.624092.].

Cost-effectiveness of pembrolizumab compared with chemotherapy in the US for women with previously treated deficient mismatch repair or high microsatellite instability unresectable or metastatic endometrial cancer.

AIMS: There is limited published evidence for the cost-effectiveness of treatments for unresectable or metastatic endometrial cancer (mEC). The objective of this analysis was to assess the cost-effectiveness of pembrolizumab versus chemotherapy for previously treated unresectable or mEC, in women whose tumors have deficient mismatch repair (dMMR) or high microsatellite instability (MSI-H). The analysis was carried out from a US healthcare payer perspective. MATERIALS AND METHODS: A lifetime partitioned survival model comprising three health states (progression-free, progressed disease and death) was constructed. Chemotherapy was represented by single-agent paclitaxel or doxorubicin. Overall survival, progression-free survival and time on treatment data for pembrolizumab were obtained from a Phase II clinical study that included women with previously treated dMMR/MSI-H unresectable or mEC (KEYNOTE-158, NCT02628067). Survival data for chemotherapy were obtained from a published Phase III study for previously treated advanced endometrial cancer. Costs included were drug acquisition and administration, health-state, end-of-life, and adverse event management. Costs were presented in 2019 US$. Outcomes were calculated as quality-adjusted life-years (QALYs), using EQ-5D data from KEYNOTE-158. Model results were tested extensively in deterministic and probabilistic sensitivity analyses. RESULTS: Results demonstrated that pembrolizumab is a highly cost-effective treatment option when compared with chemotherapy, with estimated deterministic and probabilistic incremental cost-effectiveness ratios (ICERs) of $58,165 and $57,668 per QALY gained, respectively. Pembrolizumab was associated with a large QALY and life-year gain per person versus chemotherapy over the model time horizon (deterministic 4.68 life year gain, 3.80 QALYs), with the majority of QALYs accrued in the progression-free health state. LIMITATIONS: The key limitation of the analysis was the lack of comparative effectiveness data for pembrolizumab versus chemotherapy. CONCLUSIONS: Pembrolizumab is a highly cost-effective treatment option when compared with chemotherapy for women with previously treated dMMR/MSI-H unresectable or mEC. Results were robust to the changes in parameters and assumptions explored.

Economic and Humanistic Burden of Cervical Cancer in the United States: Results from a Nationally Representative Survey.

Objective: To measure the economic and humanistic burden of cervical cancer in the United States. Materials and Methods: This was a retrospective analysis of Medical Expenditure Panel Survey data (2006-2015). Cervical cancer cases were identified using International Classification of Diseases, Ninth Revision, Clinical Modification code "180" or clinical classification software code "26". The control group included women without any cancer diagnosis. Study outcomes included health care resource use (institutional inpatient and outpatient, emergency room, and physician office visits), costs, limitations in activities of daily living, and quality of life (general health status, 12-Item Short Form Health Survey [SF-12] physical and mental component summary [MCS], EuroQol-5D and Short-Form Six-Dimension health utility, and Patient Health Questionnaire-2 depression severity). Generalized linear models, controlling for sociodemographic and clinical covariates, were conducted to compare outcomes between cases and controls. Results: The analytic cohort included 275,246 cervical cancer cases and 146,061,609 noncancer controls. Cases were significantly older (mean age [years]: 42.03 vs. 36.98) and had a higher Charlson comorbidity burden (mean score: 1.06 vs. 0.46) versus controls. Multivariate analyses suggested that compared to controls, cancer cases had significantly higher costs: institutional outpatient ($1,610 vs. $502), physician visit ($2,422 vs. $1,321), and total health care ($10,031 vs. $4,913). Cases were 1.99 (odds ratio [OR]: 1.991; 95% confidence interval [CI]: 1.23-3.22) and 2.56 (OR: 2.562; 95% CI: 1.78-3.68) times as likely to report activity limitations and poor general health versus controls. Cervical cancer patients had significantly lower SF-12 physical and MCS score, health utility, and higher depression severity. Conclusions: Cervical cancer is associated with significant economic burden, activity limitations, and quality of life impairment among ambulatory women in the United States.

Economic Value of Lost Productivity Attributable to Human Papillomavirus Cancer Mortality in the United States.

Objectives: To estimate years of potential life lost (YPLL) and present value of future lost productivity (PVFLP) associated with premature mortality due to HPV-attributable cancers, specifically those targeted by nonavalent HPV (9vHPV) vaccination, in the United States (US) before vaccine use. Methods: YPLL was estimated from the reported number of deaths in 2017 due to HPV-related cancers, the proportion attributable to 9vHPV-targeted types, and age- and sex-specific US life expectancy. PVFLP was estimated as the product of YPLL by age- and sex-specific probability of labor force participation, annual wage, value of non-market labor, and fringe benefits markup factor. Results: An estimated 7,085 HPV-attributable cancer deaths occurred in 2017 accounting for 154,954 YPLL, with 5,450 deaths (77%) and 121,226 YPLL (78%) attributable to 9vHPV-targeted types. The estimated PVFLP was $3.3 billion for cancer deaths attributable to 9vHPV-targeted types (86% from women). The highest productivity burden was associated with cervical cancer in women and anal and oropharyngeal cancers in men. Conclusions: HPV-attributable cancer deaths are associated with a substantial economic burden in the US, much of which could be vaccine preventable.

Perceived barriers related to testing, management and treatment of HCV infection among physicians prescribing opioid agonist therapy: The C-SCOPE Study.

The aim of this analysis was to evaluate perceived barriers related to HCV testing, management and treatment among physicians practicing in clinics offering opioid agonist treatment (OAT). C-SCOPE was a study consisting of a self-administered survey among physicians practicing at clinics providing OAT in Australia, Canada, Europe and the United States between April and May 2017. A 5-point Likert scale (1 = not a barrier, 3 = moderate barrier, 5 = extreme barrier) was used to measure responses to perceived barriers for HCV testing, evaluation and treatment across the domains of the health system, clinic and patient. Among the 203 physicians enrolled (40% USA, 45% Europe, 14% Australia/Canada), 21% were addiction medicine specialists, 29% psychiatrists and 69% were metro/urban. OAT physicians in this study reported poor access to on-site venepuncture (35%), point-of-care HCV testing (16%), and noninvasive liver disease assessment (25%). Only 30% of OAT physicians reported personally treating HCV infection. Major perceived health system barriers to HCV management included the lack of funding for noninvasive liver disease testing, long wait times to see an HCV specialist, lack of funding for new HCV therapies, and reimbursement restrictions based on drug/alcohol use. Major perceived clinic barriers included the lack of peer support programmes and/or HCV case managers to facilitate linkage to care, the need to refer people off-site for noninvasive liver disease staging, the lack of support for on-site phlebotomy and the lack of on-site delivery of HCV therapy. This study highlights several important modifiable barriers to enhance HCV testing, evaluation and treatment among PWID attending OAT clinics.

Lost Annual Productivity Costs Due to Uterine Cancer Deaths in the United States in 2014.

Background: An estimated 11,350 uterine cancer deaths are projected to occur in the United States in 2018. We constructed an economic model to estimate the annual productivity costs associated with uterine cancer death, for the year 2014. Materials and Methods: The model calculated the number of women who would be alive in 2014 if they had not died of uterine cancer, and the lost earnings resulting from early mortality. The age-stratified number of deaths from uterine cancer per year (1935-2014) was obtained from the National Center for Health Statistics. Life expectancy by birth year was used to determine the probability of survival to the age the patient would have been in 2014, had she not died of uterine cancer. The proportion of patients employed and median annual wage and fringe benefits per year were obtained from the Bureau of Labor Statistics. The primary model outcome was the total annual productivity costs attributable to uterine cancer deaths in 2014. Results: A total of 558,717 women in the United States died of uterine cancer between 1935 and 2014. The model estimated that 110,792 of these women would be alive in 2014 had they not died of uterine cancer; of these, 24,758 would have been part of the work force based on age and labor participation rate. The total productivity loss in 2014 due to uterine cancer was estimated at $1.35 billion. Conclusion: Uterine cancer deaths in the United States are associated with substantial indirect costs owing to lost earnings. Total productivity losses are more than half of the estimated annual direct costs of uterine cancer care.

Prevalence, incidence, and risk factors for hepatitis C virus infection in hemodialysis patients.

Hepatitis C virus (HCV) infection is common in dialysis patients and is associated with increased morbidity and mortality. We used the Dialysis Outcomes and Practice Patterns Study (DOPPS, 1996-2015) to assess trends in the prevalence, incidence, and risk factors for HCV infection as defined by a documented diagnosis or antibody positivity. Among prevalent hemodialysis patients, HCV prevalence was nearly 10% in 2012-2015. Prevalence ranged from 4% in Belgium to as high as 20% in the Middle East, with intermediate prevalence in China, Japan, Italy, Spain, and Russia. HCV prevalence decreased over time in most countries participating in more than one phase of DOPPS, and prevalence was around 5% among patients who had recently (<4 months) initiated dialysis. The incidence of HCV infection decreased from 2.9 to 1.2 per 100 patient-years in countries participating in the initial phase of DOPPS. Although most units reported no seroconversions, 10% of units experienced 3 or more cases over a median of 1.1 years. High HCV prevalence in the hemodialysis unit was a powerful facility-level risk factor for seroconversion, but the use of isolation stations for HCV-positive patients was not associated with significantly lower seroconversion rates. Overall, despite a trend toward lower HCV prevalence among hemodialysis patients, the prevalence of HCV infection remains higher than in the general population. Combined with a high prevalence of HCV infection among patients with Stage 5 CKD, high rates of HCV seroconversion in a subset of hemodialysis units may contribute to this disparity.

Projected impact of elbasvir/grazoprevir in patients with hepatitis C virus genotype 1 and chronic kidney disease in Vietnam.

BACKGROUND: Hepatitis C virus (HCV) infection is an important cause of morbidity and mortality in patients with chronic kidney disease (CKD). The objective of this study was to predict the impact of EBR/GZR on the incidence of liver and kidney related complications compared with no treatment (NoTx) and pegylated interferon plus ribavirin (pegIFN/RBV) in patients with CKD stage 4/5 in Vietnam. METHODS: We developed a mathematical model of the natural history of chronic HCV, CKD, and liver disease. Efficacy of EBR/GZR and pegIFN/RBV were derived from the C-SURFER trial and a meta-analysis, respectively. We calculated lifetime cumulative morbidity and mortality rates, including incidence of decompensated cirrhosis (DC), hepatocellular carcinoma (HCC), and life expectancy. RESULTS: Estimated lifetime incidence of DC was significantly reduced in patients receiving EBR/GZR (3.47%) compared to NoTx (18.14%) and pegIFN/RBV (9.01%). Estimated incidence of HCC was 1.02%, 21.64%, and 8.90%, and 1.02% in patients receiving EBR/GZR, NoTx, and pegIFN/RBV. EBR/GZR was estimated to extend life expectancy by 4.2 and 2.0 years compared with NoTx and pegIFN/RBV. CONCLUSIONS: Our model predicted that EBR/GZR will significantly reduce the incidence of liver-related complications and prolong life in patients with chronic HCV GT1 infection and CKD compared with NoTx or pegIFN/RBV.

Perceptions and self-reported competency related to testing, management and treatment of hepatitis C virus infection among physicians prescribing opioid agonist treatment: The C-SCOPE study.

BACKGROUND: This study evaluated competency related to HCV testing, management and treatment among physicians practicing in clinics offering opioid agonist treatment (OAT). METHODS: C-SCOPE is a study consisting of a self-administered survey among physicians practicing at clinics providing OAT in Australia, Canada, Europe and USA between April-May 2017. A 7-point scale was used to measure < average competence (score >4 of 7) related to HCV testing, management and treatment. RESULTS: Among 203 physicians (40% USA, 45% Europe, 14% Australia/Canada) 21% were addiction medicine specialists, 29% psychiatrists, and 70% were metro/urban [mean PWID managed, 51; years of experience, 11]. The majority perceived HCV testing (82%) and treatment (85%) among PWID as important. The minority reported < average competence with respect to regular screening (12%) and interpretation of HCV test results (14%), while greater proportions reported < average competence in advising patients about new HCV therapies (28%), knowledge of new treatments (37%), and treatment/management of HCV (40%). In adjusted analysis, factors independently associated with < average self-reported competency related to the ability to treat HCV and manage side effects included fewer years in medical practice, fewer numbers of patients treated for HCV infection in the past six months, not having obtained information on screening, diagnosing or treatment of HCV, not having attended any training on HCV in the past year, and not having read or consulted AASLD/IDSA, EASL or other guidelines for HCV. CONCLUSION: Physicians treating HCV infection among PWID attending OAT clinics recognized the importance of HCV testing and treatment. However, self-perceived competency related to HCV management and treatment was low, highlighting the importance of improved HCV education and training among physicians practicing in clinics offering OAT.

Patient-reported outcomes in individuals with hepatitis C virus infection treated with elbasvir/grazoprevir.

PURPOSE: People chronically infected with hepatitis C virus (HCV) have diminished patient-reported outcomes (PROs). This study aimed to compare the impact of elbasvir/grazoprevir (EBR/GZR) treatment versus sofosbuvir with pegylated interferon and ribavirin (SOF/PR) on changes in PROs: 1) during the treatment period and 2) at posttreatment follow-up. PATIENTS AND METHODS: PRO data collected during the Phase III C-EDGE Head-2-Head (H2H) open-label study was analyzed. In this trial, patients infected with HCV were randomized 1:1 to receive either EBR/GZR or SOF/PR for 12 weeks. Patients self-administered the Short Form-36 version 2 (SF-36v2®) Health Survey Acute (1-week recall) Form and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale at baseline, during treatment, and posttreatment. Between-group differences in mean change of PRO scores from baseline were estimated during the treatment period and also at the posttreatment follow-up. Effect sizes were calculated to evaluate if the detected change in mean PRO scores is clinically meaningful between groups. RESULTS: There were 255 patients (99.2% White, 54.1% female, 74.9% treatment naïve) included in the analysis. During the treatment period, significant declines in SF-36v2 scores were observed across all domains for the SOF/PR group. Compared to the SOF/PR group, the EBR/GZR group reported more improvement in scores across all SF-36v2 domain scores at the end of the treatment period. At treatment week 12, the between-group differences for 6 out of the 8 domain scores for these patients reflected at least moderate effects (effect sizes >0.5). No significant between-group differences in change in SF-36v2 scores from baseline were detected posttreatment. The decline in SF-36v2 scores observed during the treatment period for the SOF/PR group returned to near baseline scores or above posttreatment. Treatment with EBR/GZR did not impact fatigue scores, but treatment with SOF/PR led to increased fatigue scores during treatment which resolved by posttreatment follow-up week 12. CONCLUSION: This study demonstrated that HCV treatment with EBR/GZR resulted in a significantly better PRO profile as compared to SOF/PR. PROs are an important consideration as worsening PROs experienced during treatment may negatively influence adherence and ultimately contribute to an unfavorable clinical outcome. CLINICALTRIALSGOV IDENTIFIER: NCT02358044.

Chronic Exposure to Solvents Among Construction Painters: Reductions in Exposure and Neurobehavioral Health Effects.

OBJECTIVE: The aim of this study was to assess the neurobehavioral effects of lifetime solvent exposure by comparing the performance of painters and demographically comparable controls. METHODS: Performance of exposed painters (N = 133) was compared with unexposed tapers, glaziers, or carpenters (N = 78) on the following domains: motor/perceptual speed, visual contrast, attention, working memory/planning, and visual and verbal memory. Lifetime exposure was estimated with questionnaires, field measurements, and paint composition. RESULTS: After controlling for confounders, lifetime solvent exposure did not predict reduction in performance for overall domains of function. Lifetime solvent exposures predicted subtle alterations for individual tests of verbal learning, motor coordination, and visuospatial accuracy. CONCLUSION: Concentrations of solvents in paints have steadily declined during the working lifetime of subjects in this study. Although reduced performance was observed on individual tests, these alterations were not consistent across tests and unlikely to be of clinical significance.

Cost-effectiveness analysis of elbasvir-grazoprevir regimen for treating hepatitis C virus genotype 1 infection in stage 4-5 chronic kidney disease patients in France.

OBJECTIVE: To assess the cost-effectiveness of the elbasvir/grazoprevir (EBR/GZR) regimen in patients with genotype 1 chronic hepatitis C virus (HCV) infection with severe and end-stage renal disease compared to no treatment. DESIGN: This study uses a health economic model to estimate the cost-effectiveness of treating previously untreated and treatment experienced chronic hepatitis C patients who have severe and end stage renal disease with the elbasvir-grazoprevir regimen versus no treatment in the French context. The lifetime homogeneous markovian model comprises of forty combined health states including hepatitis C virus and chronic kidney disease. The model parameters were from a multicentre randomized controlled trial, ANRS CO22 HEPATHER French cohort and literature. 1000 Monte Carlo simulations of patient health states for each treatment strategy are used for probabilistic sensitivity analysis and 95% confidence intervals calculations. The results were expressed in cost per quality-adjusted life year (QALY) gained. PATIENTS: The mean age of patients in the HEPATHER French cohort was 59.6 years and 56% of them were men. 22.3% of patients had a F0 fibrosis stage (no fibrosis), 24.1% a F1 stage (portal fibrosis without septa), 7.1% a F2 stage (portal fibrosis with few septa), 21.4% a F3 stage (numerous septa without fibrosis) and 25% a F4 fibrosis stage (compensated cirrhosis). Among these HCV genotype 1 patients, 30% had severe renal impairment stage 4, 33% had a severe renal insufficiency stage 5 and 37% had terminal severe renal impairment stage 5 treated by dialysis. INTERVENTION: Fixed-dose combination of direct-acting antiviral agents elbasvir and grazoprevir compared to no-treatment. RESULTS: EBR/GZR increased the number of life years (6.3 years) compared to no treatment (5.1 years) on a lifetime horizon. The total number of QALYs was higher for the new treatment because of better utility on health conditions (6.2 versus 3.7 QALYs). The incremental cost-utility ratio (ICUR) was of €15,212 per QALY gained for the base case analysis. CONCLUSIONS: This cost-utility model is an innovative approach that simultaneously looks at the disease evolution of chronic hepatitis C and chronic kidney disease. EBR/GZR without interferon and ribavirin, produced the greatest benefit in terms of life expectancy and quality-adjusted life years (QALY) in treatment-naïve or experienced patients with chronic hepatitis C genotype 1 and stage 4-5 chronic kidney disease including dialysis patients. Based on shape of the acceptability curve, EBR/GZR can be considered cost-effective at a willingness to pay of €20,000 /QALY for patients with renal insufficiency with severe and end-stage renal disease compared to no treatment.

Cost-Utility of Elbasvir/Grazoprevir in Patients with Chronic Hepatitis C Genotype 1 Infection.

OBJECTIVE: To evaluate the cost-utility of treatment with elbasvir/grazoprevir (EBR/GZR) regimens compared with ledipasvir/sofosbuvir (LDV/SOF), ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin (3D ± RBV), and sofosbuvir/velpatasvir (SOF/VEL) in patients with chronic hepatitis C genotype (GT) 1 infection. METHODS: A Markov cohort state-transition model was constructed to evaluate the cost-utility of EBR/GZR ± RBV over a lifetime time horizon from the payer perspective. The target population was patients infected with chronic hepatitis C GT1 subtypes a or b (GT1a or GT1b), stratified by treatment history (treatment-naive [TN] or treatment-experienced), presence of cirrhosis, baseline hepatitis C virus RNA (< or ≥6 million IU/mL), and presence of NS5A resistance-associated variants. The primary outcome was incremental cost-utility ratio for EBR/GZR ± RBV versus available oral direct-acting antiviral agents. One-way and probabilistic sensitivity analyses were performed to test the robustness of the model. RESULTS: EBR/GZR ± RBV was economically dominant versus LDV/SOF in all patient populations. EBR/GZR ± RBV was also less costly than SOF/VEL and 3D ± RBV, but produced fewer quality-adjusted life-years in select populations. In the remaining populations, EBR/GZR ± RBV was economically dominant. One-way sensitivity analyses showed varying sustained virologic response rates across EBR/GZR ± RBV regimens, commonly impacted model conclusions when lower bound values were inserted, and at the upper bound resulted in dominance over SOF/VEL in GT1a cirrhotic and GT1b TN noncirrhotic patients. Results of the probabilistic sensitivity analysis showed that EBR/GZR ± RBV was cost-effective in more than 99% of iterations in GT1a and GT1b noncirrhotic patients and more than 69% of iterations in GT1b cirrhotic patients. CONCLUSIONS: Compared with other oral direct-acting antiviral agents, EBR/GZR ± RBV was the economically dominant regimen for treating GT1a noncirrhotic and GT1b TN cirrhotic patients, and was cost saving in all other populations.

Confluence of Epidemics of Hepatitis C, Diabetes, Obesity, and Chronic Kidney Disease in the United States Population.

BACKGROUND & AIMS: Obesity, kidney disease, and diabetes are common conditions that can affect outcomes of patients with chronic hepatitis C. The authors aimed to quantify the burden of these comorbid conditions among adults with chronic hepatitis C in the United States and to estimate the risk of death among people with chronic hepatitis C and comorbidities. METHODS: The authors conducted cross-sectional and prospective analyses of 13,726 participants in the third National Health and Nutrition Examination Survey (NHANES III) and 23,691 participants of NHANES 1999-2012. Serum samples were analyzed for the presence of antibodies to hepatitis C virus (anti-HCV); in samples found to be positive for anti-HCV, the authors quantified HCV RNA (viral load). Individuals with anti-HCV and detectable HCV RNA were considered to have chronic hepatitis C. Comorbidities were defined using self-reported, physical examination, and laboratory data, as available. The authors used logistic models and predictive margins to estimate the adjusted prevalence of comorbidities in patients with chronic hepatitis C. The authors used Poisson regression models to estimate adjusted mortality rates based on chronic hepatitis C status, with or without comorbidities. Cox proportional hazards regression models to estimate adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) of all-cause, cardiovascular, and cancer mortality according to chronic hepatitis C status, with and without comorbidities. RESULTS: Among persons with chronic hepatitis C, the demographic-adjusted prevalence estimate of diabetes was 17.9% (95% CI, 11.2%-27.5%) and of obesity was 20.9% (95% CI, 12.4%-29.5%). Overall, 69.6% of persons with chronic hepatitis C had at least 1 major cardiometabolic comorbidity (95% CI, 62.1%-76.2%). Only 38% of adults with chronic hepatitis C reported a diagnosis of liver disease. Chronic hepatitis C was associated with a substantially increased risk of death (HR, 2.45), especially in the presence of diabetes (HR, 3.24) or chronic kidney disease (HR, 4.39). CONCLUSION: In an analysis of NHANES data, the authors found that individuals with chronic hepatitis C have a high burden of major cardiometabolic comorbidities. Diabetes and chronic kidney disease, in particular, are associated with substantial excess mortality in persons with chronic hepatitis C.