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Saeed YA, Mitsakakis N, Feld JJ, Krahn MD, Kwong JC, Wong WWL. Health Utilities in People with Hepatitis C Virus Infection: A Study Using Real-World Population-Level Data. Med Decis Making 2025; 45:332-343. [PMID: 39985398 PMCID: PMC11894892 DOI: 10.1177/0272989x251319342] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/17/2024] [Accepted: 01/02/2025] [Indexed: 02/24/2025]
Abstract
BackgroundHepatitis C virus (HCV) infection is associated with reduced quality of life and health utility. It is unclear whether this is primarily due to HCV infection itself or commonly co-occurring patient characteristics such as low income and mental health issues. This study aims to estimate and separate the effects of HCV infection on health utility from the effects of clinical and sociodemographic factors using real-world population-level data.MethodsWe conducted a cross-sectional retrospective cohort study to estimate health utilities in people with and without HCV infection in Ontario, Canada, from 2000 to 2014 using linked survey data from the Canadian Community Health Survey and health administrative data. Utilities were derived from the Health Utilities Index Mark 3 instrument. We used propensity score matching and multivariable linear regression to examine the impact of HCV infection on utility scores while adjusting for clinical and sociodemographic factors.ResultsThere were 7,102 individuals with hepatitis C status and health utility data available (506 HCV-positive, 6,596 HCV-negative). Factors associated with marginalization were more prevalent in the HCV-positive cohort (e.g., household income <$20,000: 36% versus 15%). Propensity score matching resulted in 454 matched pairs of HCV-positive and HCV-negative individuals. HCV-positive individuals had substantially lower unadjusted utilities than HCV-negative individuals did (mean ± standard error: 0.662 ± 0.016 versus 0.734 ± 0.015). The regression model showed that HCV positivity (coefficient: -0.066), age, comorbidity, mental health history, and household income had large impacts on health utility.ConclusionsHCV infection is associated with low health utility even after controlling for clinical and sociodemographic variables. Individuals with HCV infection may benefit from additional social services and supports alongside antiviral therapy to improve their quality of life.HighlightsHepatitis C virus (HCV) infection is associated with reduced quality of life and health utility. There is debate in the literature on whether this is primarily due to HCV infection itself or commonly co-occurring patient characteristics such as low income and mental health issues.We showed that individuals with HCV infection have substantially lower health utilities than uninfected individuals do even after controlling for clinical and sociodemographic variables, based on a large, real-world population-level dataset. Socioeconomically marginalized individuals with HCV infection had particularly low health utilities.In addition to improving access to HCV testing and treatment, it may be beneficial to provide social services such as mental health and financial supports to improve the quality of life and health utility of people living with HCV.
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Affiliation(s)
- Yasmin A. Saeed
- Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada
- Toronto Health Economics and Technology Assessment (THETA) Collaborative, University Health Network, Toronto, ON, Canada
- ICES, Toronto, ON, Canada
- School of Pharmacy, University of Waterloo, Kitchener, Ontario, Canada
| | - Nicholas Mitsakakis
- Children’s Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada
| | - Jordan J. Feld
- Toronto Centre for Liver Disease, University Health Network, Toronto, ON, Canada
| | - Murray D. Krahn
- Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada
- Toronto Health Economics and Technology Assessment (THETA) Collaborative, University Health Network, Toronto, ON, Canada
- ICES, Toronto, ON, Canada
| | - Jeffrey C. Kwong
- ICES, Toronto, ON, Canada
- Public Health Ontario, Toronto, ON, Canada
- Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada
- Centre for Vaccine Preventable Diseases, University of Toronto, Toronto, ON, Canada
- Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada
- University Health Network, Toronto, ON, Canada
| | - William W. L. Wong
- Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada
- Toronto Health Economics and Technology Assessment (THETA) Collaborative, University Health Network, Toronto, ON, Canada
- ICES, Toronto, ON, Canada
- School of Pharmacy, University of Waterloo, Kitchener, Ontario, Canada
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Clinical and economic benefits of a new paradigm of HCV diagnosis and treatment. GLOBAL & REGIONAL HEALTH TECHNOLOGY ASSESSMENT 2021; 8:58-66. [PMID: 36627870 PMCID: PMC9616196 DOI: 10.33393/grhta.2021.2183] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/14/2020] [Accepted: 02/15/2021] [Indexed: 01/13/2023] Open
Abstract
Introduction The current paradigm (CP) of hepatitis C virus (HCV) diagnosis and treatment in Italy's National Health Service system has numerous steps. The European Association for the Study of the Liver recommends initiation of a pan-genotypic direct-acting antiviral regimen after a simple diagnostic process. The present study estimated the efficiency gains resulting from two simplified pathways from diagnosis to treatment of chronic hepatitis C patients in Italy over the next 5 years from a societal perspective. Methods The CP, a New Paradigm 1 (NP1), and a New Paradigm 2 (NP2) were evaluated in a Markov model. The NP1 model simplifies monitoring and laboratory test requirements in the diagnosis and treatment phases. The NP2 model also eliminates the primary care referral requirement. Results Treatment process time for non-cirrhotic patients was 48, 43, and 25 weeks in the CP, NP1, and NP2, respectively, and in cirrhotic patients was 49, 46, and 37 weeks. Under the CP, 19% of patients/year would be lost to follow-up, which decreases by 11% in NP1 and 100% in NP2. Compared with the CP, implementation of NP1 at 5 years would reduce compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, and liver-related deaths by 12.6%, 12.4%, 8.1%, and 8.8%, respectively; these cases would be reduced by 94.0%, 93.8%, 61.0%, and 58.4% in NP2. Total 5-year costs with the CP, NP1, and NP2 are estimated at 135.6€ million, 110.5€ million, and 80.5€ million, respectively. Conclusions Simplification of HCV diagnosis and monitoring requirements would allow Italy to move closer to international guidelines with significant health benefits and economic gains.
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Houri I, Horowitz N, Katchman H, Weksler Y, Miller O, Deutsch L, Shibolet O. Emergency department targeted screening for hepatitis C does not improve linkage to care. World J Gastroenterol 2020; 26:4878-4888. [PMID: 32921964 PMCID: PMC7459203 DOI: 10.3748/wjg.v26.i32.4878] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/20/2020] [Revised: 06/13/2020] [Accepted: 08/09/2020] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Hepatitis C virus (HCV) infection is a leading cause of chronic liver disease worldwide. New treatments for HCV revolutionized management and prompted the world health organization to set the goal of viral elimination by 2030. These developments strengthen the need for HCV screening in order to identify asymptomatic carriers prior to development of chronic liver disease and its complications. Different screening strategies have been attempted, most targeting high-risk populations. Previous studies focusing on patients arriving at emergency departments showed a higher prevalence of HCV compared to the general population.
AIM To identify previously undiagnosed HCV carriers among high risk emergency room attendees and link them to care for anti-viral treatment.
METHODS In this single center prospective study, persons visiting the emergency department in an urban hospital were screened by a risk factor-specific questionnaire. The risk factors screened for were exposure to blood products or organ transplantation before 1992; origins from countries with high prevalence of HCV; intravenous drug use; human immunodeficiency virus carriers; men who have sex with men; those born to HCV-infected mothers; prior prison time; and chronic kidney disease. Those with at least one risk factor were tested for HCV by serum for HCV antibodies, a novel oral test from saliva (OraQuick®) or both.
RESULTS Five hundred and forty-one participants had at least one risk factor and were tested for HCV. Eighty four percent of all study participants had only one risk factor. Eighty five percent of participants underwent OraQuick® testing, 34% were tested for serum anti-HCV antibodies, and 25% had both tests. 3.1% of patients (17/541) had a positive result, compared to local population incidence of 1.96%. Of these, 82% were people who inject drugs (current or former), and 64% served time in prison. One patient had a negative HCV-RNA, and two patients died from non-HCV related reasons. On review of past medical records, 12 patients were found to have been previously diagnosed with HCV but were unaware of their carrier state. At 1-year follow-up none of the remaining 14 patients had completed HCV-RNA testing, visited a hepatology clinic or received anti-viral treatment.
CONCLUSION Targeted high-risk screening in the emergency department identified undiagnosed and untreated HCV carriers, but did not improve treatment rates. Other strategies need to be developed to improve linkage to care in high risk populations.
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Affiliation(s)
- Inbal Houri
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 6997801, Israel
| | - Noya Horowitz
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
| | - Helena Katchman
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 6997801, Israel
| | - Yael Weksler
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 6997801, Israel
| | - Ofer Miller
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 6997801, Israel
| | - Liat Deutsch
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 6997801, Israel
| | - Oren Shibolet
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 6997801, Israel
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Mallolas J, Ahumada A, Ampuero J, Blanco JR, Hidalgo Á, Londoño MC, Molina E, Ruiz S. Quality of life in patients with hepatitis C. Importance of treatment. GASTROENTEROLOGIA Y HEPATOLOGIA 2020; 42 Suppl 1:20-25. [PMID: 32560769 DOI: 10.1016/s0210-5705(20)30184-9] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
Chronic hepatitis C virus infection is a systemic disease that impairs the quality of life of affected individuals. The impairment is not only due to physiological factors, such as the non-hepatic manifestations of the disease or certain symptoms such as fatigue, weakness and nausea, but is also due to the substantial psychological impact of the infection. Treatment with direct-acting antivirals (DAA) has been demonstrated to substantially improve patient's quality of life, starting in the initial phases. Supplement information: This article is part of a supplement entitled "The value of simplicity in hepatitis C treatment", which is sponsored by Gilead. © 2019 Elsevier España, S.L.U. All rights reserved.
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Affiliation(s)
- Josep Mallolas
- Servicio de Enfermedades Infecciosas, Hospital Clínic de Barcelona, Barcelona, España.
| | - Adriana Ahumada
- Servicio de Aparato Digestivo, Hospital General Universitario Gregorio Marañón, Madrid, España
| | - Javier Ampuero
- Servicio de Gastroenterología y Hepatología, Hospital Universitario Virgen del Rocío, Sevilla, España; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas; Instituto de Biomedicina de Sevilla, Sevilla, España; Universidad de Sevilla, Sevilla, España
| | - José Ramón Blanco
- Servicio de Enfermedades Infecciosas, Hospital San Pedro, Logroño, España
| | - Álvaro Hidalgo
- Economista de Salud, Universidad de Castilla-La Mancha, Ciudad Real, España
| | | | - Esther Molina
- Servicio de Aparato Digestivo, Hospital Clínico Universitario de Santiago, A Coruña, España
| | - Salvador Ruiz
- Psiquiatría de Urgencias, Hospital Universitario Príncipe de Asturias, Madrid, España
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Nguyen E, Trinh S, Trinh H, Nguyen H, Nguyen K, Do A, Levitt B, Do S, Nguyen M, Purohit T, Shieh E, Nguyen MH. Sustained virologic response rates in patients with chronic hepatitis C genotype 6 treated with ledipasvir+sofosbuvir or sofosbuvir+velpatasvir. Aliment Pharmacol Ther 2019; 49:99-106. [PMID: 30467877 DOI: 10.1111/apt.15043] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/19/2018] [Revised: 09/19/2018] [Accepted: 10/10/2018] [Indexed: 12/12/2022]
Abstract
BACKGROUND Hepatitis C virus (HCV) genotype 6 (GT 6) is the predominant genotype among certain Asian populations. The availability of newer DAA options is limited in many parts of Asia. AIM To compare sustained virologic response (SVR-12) rates between ledipasvir and sofosbuvir (LDV+SOF) and velpatasvir+SOF (SOF+VEL) for patients with HCVGT6 infection. METHOD Retrospective study of consecutive adult HCVGT6 patients identified via ICD 9 code: 070.5 from United States treatment centers. Treatment was LDV+SOF or SOF+VEL for 8-24 weeks. A 1:1 propensity score matching (PSM) on HCV RNA, cirrhosis, alanine aminotransferase, aspartate aminotransferase, platelets, and fibrosis score was conducted among the treatment-naïve HCVGT6 patients to balance groups and isolate treatment effects. RESULTS After exclusion criteria, 149 patients remained (n = 135 treatment-naïve; n = 14 treatment-experienced). The mean age was 63.8 ± 10.2 years, 66.9% male, and 93.9% Vietnamese. In treatment-naïve arm, 52.2% LDV+SOF cohort were cirrhotic compared to 11.6% SOF+VEL cohort (P < 0.0001). SVR-12 for LDV+SOF was 96.4% and 100% for the SOF+VEL cohort (P = 0.22). SVR-12 for cirrhotic patients was 95.4% (n = 41/43) for LDV+SOF and 100.0% (n = 5/5) for SOF+VEL (P = 0.62). After PSM (n = 33 per group), LDV+SOF SVR-12 rate was 97.0% compared to SOF+VEL SVR-12 of 100% (P = 0.31). The treatment-experienced group (n = 14), were all treated with LDV+SOF with an SVR-12 of 92.3%. CONCLUSION Whether treatment-naïve, treatment-experienced, or cirrhotic patients with HCV GT 6 residing in the US had excellent outcomes when treated with SOF+VEL or LDV+SOF. Since LDV+SOF is more readily available globally, our results may provide clinicians with a treatment option when cost and availability limit the treatment choice.
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Affiliation(s)
| | - Sam Trinh
- Division of Gastroenterology and Hepatology, Stanford University, Stanford, California
| | - Huy Trinh
- San Jose Gastroenterology, San Jose, California
| | - Huy Nguyen
- San Jose Gastroenterology, San Jose, California
| | | | - Aivien Do
- Digestive Health Associates of Texas, P.A., Richardson, Texas
| | | | - Son Do
- Digestive Health Associates of Texas, P.A., Richardson, Texas
| | - My Nguyen
- San Jose Gastroenterology, San Jose, California
| | | | | | - Mindie H Nguyen
- Division of Gastroenterology and Hepatology, Stanford University, Stanford, California
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Kracht PAM, Lieveld FI, Amelung LM, Verstraete CJR, Mauser-Bunschoten EP, de Bruijne J, Siersema PD, Hoepelman AIM, Arends JE, van Erpecum KJ. The Impact of Hepatitis C Virus Direct-Acting Antivirals on Patient-Reported Outcomes: A Dutch Prospective Cohort Study. Infect Dis Ther 2018; 7:373-385. [PMID: 30076582 PMCID: PMC6098748 DOI: 10.1007/s40121-018-0208-z] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/15/2018] [Indexed: 02/07/2023] Open
Abstract
INTRODUCTION Pegylated interferon-based therapy for hepatitis C virus (HCV) negatively impacts nutritional state and patient-reported outcomes (PROs) such as health-related quality of life (HRQL). Clinical trials with direct-acting antivirals (DAAs) report significant PRO improvement but real-world data are still scarce. METHODS Prospective cohort study recruiting HCV patients treated with DAAs in 2015-2016. Data at baseline, end of treatment (EOT) and 12 weeks thereafter (FU12) included: patient-reported medication adherence; SF-36; Karnofsky Performance Status; paid labour productivity; physical exercise level; nutritional state [by body mass index (BMI) and Jamar hand grip strength (HGS)] and Beliefs about Medicines Questionnaire. Potential factors predicting these PROs were evaluated with multiple regression analysis. RESULTS A total of 68 patients were enrolled: 85% male, median age 57 years, 80% genotype 1, 40% cirrhotics, 46% haemophilia. Both cure rate and patient-reported adherence were 97%. SF-36 Physical Component Summary did not change (43.2 ± 11.9, 44.9 ± 10.3 and 44.7 ± 10.9 at baseline, EOT and FU12, p = 0.71). In contrast, SF-36 mental component summary (MCS) decreased transiently during therapy (49.2 ± 11.9, 44.6 ± 10.3 and 49.9 ± 12.6 at baseline, EOT and FU12, p < 0.01). Concomitant ribavirin-use was the only independent predictor of decreased SF-36 MCS. BMI (25.7 ± 4.5 and 25.6 ± 4.4 at baseline and EOT, p = 0.8) and Jamar HGS (39.7 ± 13.0, 37.4 ± 11.9 and 37.9 ± 13.8 at baseline, EOT and FU12, p = 0.56) did not change. CONCLUSION Our study reveals concomitant ribavirin as the only independent predictor of transient decrease in SF-36 mental HRQL during DAA therapy. In contrast to interferon-based therapy, DAAs do not affect BMI or Jamar HGS.
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Affiliation(s)
- Patricia A M Kracht
- Department of Gastroenterology and Hepatology, University Medical Center Utrecht Affiliated to Utrecht University, Utrecht, The Netherlands
- Department of Internal Medicine and Infectious Diseases, University Medical Center Utrecht Affiliated to Utrecht University, Utrecht, The Netherlands
| | - Faydra I Lieveld
- Department of Gastroenterology and Hepatology, University Medical Center Utrecht Affiliated to Utrecht University, Utrecht, The Netherlands
- Department of Internal Medicine and Infectious Diseases, University Medical Center Utrecht Affiliated to Utrecht University, Utrecht, The Netherlands
| | - Linde M Amelung
- Department of Gastroenterology and Hepatology, University Medical Center Utrecht Affiliated to Utrecht University, Utrecht, The Netherlands
| | - Carina J R Verstraete
- Department of Gastroenterology and Hepatology, University Medical Center Utrecht Affiliated to Utrecht University, Utrecht, The Netherlands
| | - Eveline P Mauser-Bunschoten
- Department of Benign Haematology, Van Creveldkliniek, University Medical Center Utrecht Affiliated to Utrecht University, Utrecht, The Netherlands
| | - Joep de Bruijne
- Department of Gastroenterology and Hepatology, University Medical Center Utrecht Affiliated to Utrecht University, Utrecht, The Netherlands
| | - Peter D Siersema
- Department of Gastroenterology and Hepatology, Radboud University Medical Center Affiliated to Nijmegen University, Nijmegen, The Netherlands
| | - Andy I M Hoepelman
- Department of Internal Medicine and Infectious Diseases, University Medical Center Utrecht Affiliated to Utrecht University, Utrecht, The Netherlands
| | - Joop E Arends
- Department of Internal Medicine and Infectious Diseases, University Medical Center Utrecht Affiliated to Utrecht University, Utrecht, The Netherlands.
| | - Karel J van Erpecum
- Department of Gastroenterology and Hepatology, University Medical Center Utrecht Affiliated to Utrecht University, Utrecht, The Netherlands
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Boyd SD, Harrington P, Komatsu TE, Naeger LK, Chan-Tack K, Murray J, Birnkrant D, Struble K. HCV genotype 4, 5 and 6: Distribution of viral subtypes and sustained virologic response rates in clinical trials of approved direct-acting antiviral regimens. J Viral Hepat 2018; 25:969-975. [PMID: 29577495 DOI: 10.1111/jvh.12896] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/14/2017] [Accepted: 02/14/2018] [Indexed: 12/15/2022]
Abstract
Multiple direct-acting antiviral (DAA)-based regimens are now available for all hepatitis C virus (HCV) genotypes (GTs). Because HCV GT 4, 5 and 6 are less common in the United States (US) and worldwide, relatively small numbers of participants with these GTs were evaluated in individual clinical trials. To provide a comprehensive description of subtype diversity and treatment outcomes in clinical trials for these less common GTs, we analysed data from 744 participants with HCV GT4 (n = 573), GT5 (n = 81), or GT6 (n = 90) across 18 clinical trials of DAA regimens. These data are from US New Drug Applications submitted between 2014 and 2017, and our analyses included only approved regimens. Excluding unresolved or mixed subtypes, the distribution of reported GT4 subtypes was 49% 4a, 31% 4d and 16% for one of 14 other subtypes. The distribution of GT6 subtypes was 39% 6a, 27% 6e, 8% 6 L and 23% for one of 11 other subtypes. Across approved regimens, sustained virologic response rates 12 weeks post-treatment (SVR12) for GT 4, 5 and 6 ranged from 91% to 100%, 93% to 97% and 96% to 100%, respectively. SVR12 by GT4 subtype ranged from 96% to 100% for 4a and 81% to 100% for 4d. Virologic failures occurred in GT 4a, 4b, 4d and 4r. For GT6, SVR12 was 100% for all subtypes except 6 L, for which 1 of 7 participants experienced virologic failure. To our knowledge, this is the largest compilation of HCV GT 4, 5 or 6 clinical trial data. These analyses may be useful for clinicians treating HCV GT 4, 5 or 6.
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Affiliation(s)
- S D Boyd
- Center for Drug Evaluation and Research, Office of Antimicrobial Products, Division of Antiviral Products, Food and Drug Administration, Silver Spring, MD, USA
| | - P Harrington
- Center for Drug Evaluation and Research, Office of Antimicrobial Products, Division of Antiviral Products, Food and Drug Administration, Silver Spring, MD, USA
| | - T E Komatsu
- Center for Drug Evaluation and Research, Office of Antimicrobial Products, Division of Antiviral Products, Food and Drug Administration, Silver Spring, MD, USA
| | - L K Naeger
- Center for Drug Evaluation and Research, Office of Antimicrobial Products, Division of Antiviral Products, Food and Drug Administration, Silver Spring, MD, USA
| | - K Chan-Tack
- Center for Drug Evaluation and Research, Office of Antimicrobial Products, Division of Antiviral Products, Food and Drug Administration, Silver Spring, MD, USA
| | - J Murray
- Center for Drug Evaluation and Research, Office of Antimicrobial Products, Division of Antiviral Products, Food and Drug Administration, Silver Spring, MD, USA
| | - D Birnkrant
- Center for Drug Evaluation and Research, Office of Antimicrobial Products, Division of Antiviral Products, Food and Drug Administration, Silver Spring, MD, USA
| | - K Struble
- Center for Drug Evaluation and Research, Office of Antimicrobial Products, Division of Antiviral Products, Food and Drug Administration, Silver Spring, MD, USA
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Tsuji T, Matsudaira K, Sato H, Vietri J, Jaffe DH. Association between presenteeism and health-related quality of life among Japanese adults with chronic lower back pain: a retrospective observational study. BMJ Open 2018; 8:e021160. [PMID: 29950467 PMCID: PMC6042623 DOI: 10.1136/bmjopen-2017-021160] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/16/2017] [Revised: 03/14/2018] [Accepted: 04/13/2018] [Indexed: 12/29/2022] Open
Abstract
OBJECTIVES This study investigated the relationship between presenteeism and health-related quality of life (HRQoL) among Japanese adults with chronic lower back pain (CLBP). DESIGN This was a retrospective, cross-sectional study. SETTING Data were collected via a self-administered online survey of the Japanese adult general population. PARTICIPANTS The present study used 2014 Japan National Health and Wellness Survey (NHWS) data (n=30 000). Specifically, data were included from NHWS respondents who self-reported being employed in the past week and having experienced LBP in the past month, with these symptoms lasting for at least 3 months (n=239). 84 (35.1%) participants in this study were female. PRIMARY AND SECONDARY OUTCOME MEASURES Presenteeism and HRQoL were measured using the Work Productivity and Activity Impairment Questionnaire-General Health (categorical (none: 0%, low: 10%-20%, high: ≥30%) and continuous) and Medical Outcomes Study 36-Item Short Form Health Survey, respectively. Covariates included patient demographics, health characteristics, pain characteristics and depression severity (Patient Health Questionnaire). RESULTS Presenteeism was reported by 77.4% of respondents. High (vs no) presenteeism related to more severe pain in the prior week (4.9±2.2 vs 3.6±2.1, p=0.001) and currently (5.1±2.1 vs 3.9±3.9, p=0.007), more pain sites (1.9±1.6 vs 1.1±1.4, p=0.004) and greater depression severity (7.5±6.5 vs 3.6±3.6, p<0.001). Adjusting for covariates, high (vs no) presenteeism related to lower mental and physical HRQoL. For low versus no presenteeism, significant HRQoL differences were observed in general health (43.0, 95% CI 40.3 to 45.6 vs 46.9, 95% CI 43.9 to 49.8, p=0.015). CONCLUSIONS Most respondents experienced presenteeism. Those with high or low presenteeism had poorer HRQoL than respondents with no presenteeism. Monitoring presenteeism rates may help identify workers with an unmet need for better CLBP-related pain management.
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Affiliation(s)
- Toshinaga Tsuji
- Medical Affairs Department, Shionogi & Co., Ltd, Osaka, Japan
| | - Ko Matsudaira
- Department of Medical Research and Management for Musculoskeletal Pain, 22nd Century Medical and Research Center, The University of Tokyo, Tokyo, Japan
| | - Hiroki Sato
- Medical Affairs Department, Shionogi & Co., Ltd, Osaka, Japan
| | - Jeffrey Vietri
- Health Outcomes Practice, Kantar Health, Horsham, Pennsylvania, USA
| | - Dena H Jaffe
- Health Outcomes Practice, Kantar Health, Tel Aviv, Israel
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Kraus MR, Kleine H, Thönnes S, Pignot M, Sanchez Gonzalez Y. Clinical and Economic Burden of Hepatic and Extrahepatic Complications from Chronic Hepatitis C: A Retrospective Analysis of German Sickness Fund Data. Infect Dis Ther 2018; 7:327-338. [PMID: 29923033 PMCID: PMC6098751 DOI: 10.1007/s40121-018-0204-3] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/28/2018] [Indexed: 02/06/2023] Open
Abstract
Introduction German data regarding the burden of complications from chronic hepatitis C (CHC) virus infection are limited. To address this issue, this study evaluates the clinical and economic burden of hepatic and extrahepatic complications (EHCs) associated with CHC in Germany. Methods This retrospective, cross-sectional study used claims data from the Betriebskrankenkasse German sickness fund (2007–2014) to assess the risks and medical costs of hepatic complications and EHCs, including conditions that are prevalent and behavioral factors associated with CHC. Prevalence, incidence, and risks were calculated for 1:1 matched patients with and without CHC (n = 3994). All-cause cost, medical costs related to hepatic and EHCs, as well as CHC-related and non-CHC-related pharmacy costs (adjusted to the 2016 Euro rate), were calculated and compared between 1:5 matched patients with (n = 8425) and without CHC (n = 42,125). Results Patients with CHC had a 3-fold higher risk for any EHC (OR = 3.0; P < 0.05) and higher EHC-related medical costs (adjusted difference, €1606; P < 0.01) compared with patients without CHC. Total costs (€10,108 vs. €5430), hepatic complication-related medical costs (€1425 vs. €556), EHC-related costs (€3547 vs. €1921), CHC-related pharmacy costs (€577 vs. €116), and non-CHC-related pharmacy costs (€3719 vs. €1479) were all significantly greater for patients with CHC compared with patients without CHC. EHC-related medical costs were a major contributor to the higher all-cause medical (84.4%) and total (44.3%) cost differences between patients with CHC and the matched sample of patients without CHC. Conclusion CHC is associated with substantial clinical and economic burden in Germany, largely due to hepatic complications and EHCs. Funding Abbvie Inc.
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Affiliation(s)
- Michael R Kraus
- Department of Internal Medicine II, Academic Hospital Altötting-Burghausen, Burghausen, Germany
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10
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Struble K, Chan-Tack K, Qi K, Naeger LK, Birnkrant D. Benefit-risk assessment for sofosbuvir/velpatasvir/voxilaprevir based on patient population and hepatitis C virus genotype: U. S. Food and Drug Administration's evaluation. Hepatology 2018; 67:482-491. [PMID: 29059462 DOI: 10.1002/hep.29601] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/28/2017] [Revised: 10/05/2017] [Accepted: 10/16/2017] [Indexed: 12/12/2022]
Abstract
On July 18, 2017, the U.S. Food and Drug Administration (FDA) approved sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) (Vosevi) fixed-dose combination (FDC), an interferon-free, complete regimen for adult patients with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have: • genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing a nonstructural protein 5A (NS5A) inhibitor; and • genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor. Approval was based on an acceptable safety profile and high sustained virological response rates 12 weeks after the end of treatment (SVR12) in two phase 3 clinical trials in subjects previously treated with a direct-acting antiviral (DAA) regimen. In POLARIS-1, 96% of SOF/VEL/VOX-treated subjects achieved SVR12. In POLARIS-4, 98% of SOF/VEL/VOX-treated subjects achieved SVR12. A key and challenging question in evaluating the data was determining the contribution of VOX to SOF/VEL and how this differed depending on the genotype and patient population. In this article, we provide our perspective on the issues considered in making these determinations, especially regarding the POLARIS-4 data in subjects who have previously been treated with a chronic HCV regimen containing sofosbuvir without an NS5A inhibitor. Conclusion: We seek to provide context as to why a broad indication was given for NS5A inhibitor-experienced patients (HCV genotypes 1-6) while the indication for NS5A inhibitor- naïve patients was limited to HCV genotypes 1a and 3 only. (Hepatology 2018;67:482-491).
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Affiliation(s)
- Kimberly Struble
- Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD
| | - Kirk Chan-Tack
- Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD
| | - Karen Qi
- Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD
| | - Lisa K Naeger
- Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD
| | - Debra Birnkrant
- Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD
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11
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DiBonaventura MD, Meincke H, Le Lay A, Fournier J, Bakker E, Ehrenreich A. Obesity in Mexico: prevalence, comorbidities, associations with patient outcomes, and treatment experiences. Diabetes Metab Syndr Obes 2018; 11:1-10. [PMID: 29317841 PMCID: PMC5743111 DOI: 10.2147/dmso.s129247] [Citation(s) in RCA: 32] [Impact Index Per Article: 4.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022] Open
Abstract
OBJECTIVE The goal of this study is to investigate obesity and its concomitant effects including the prevalence of comorbidities, its association with patient-reported outcomes and costs, and weight loss strategies in a sample of Mexican adults. METHODS Mexican adults (N=2,511) were recruited from a combination of Internet panels and street intercepts using a random-stratified sampling framework, with strata defined by age and sex, so that they represent the population. Participants responded to a survey consisting of a range of topics including sociodemographics, health history, health-related quality of life (HRQoL), work productivity, health care resource use, and weight loss. RESULTS The sample consisted of 50.6% male with a mean age of 40.7 years (SD=14.5); 38.3% were overweight, and 24.4% were obese. Increasing body mass index (BMI) was associated with increased rates of type 2 diabetes, prediabetes, and hypertension, poorer HRQoL, and decreased work productivity. Of the total number of respondents, 62.2% reported taking steps to lose weight with 27.6% and 17.1% having used an over-the-counter/herbal product and a prescription medication, respectively. Treatment discontinuation rates were high. CONCLUSION Findings indicated that 62% of participants reported, at least, being overweight and that they were experiencing the deleterious effects associated with higher BMI despite the desire to lose weight. Given the rates of obesity, and its impact on humanistic and societal outcomes, improved education, prevention, and management could provide significant benefits.
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Affiliation(s)
| | - Henrik Meincke
- Novo Nordisk, Copenhagen, Denmark
- Correspondence: Henrik Meincke, Novo Nordisk A/S, Vandtårnsvej 114DK-2860 Søborg Denmark, Tel: +45 30798654, Email
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12
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Younossi ZM, Tanaka A, Eguchi Y, Lim YS, Yu ML, Kawada N, Dan YY, Brooks-Rooney C, Negro F, Mondelli MU. The impact of hepatitis C virus outside the liver: Evidence from Asia. Liver Int 2017; 37:159-172. [PMID: 27748564 DOI: 10.1111/liv.13272] [Citation(s) in RCA: 34] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/24/2016] [Accepted: 09/30/2016] [Indexed: 12/11/2022]
Abstract
Between 80 and 115 million people worldwide are chronically infected with hepatitis C virus, with 60%-90% of these being undiagnosed. Untreated chronic hepatitis C (CHC) is associated with progressive liver disease, cirrhosis, hepatocellular carcinoma and liver-related mortality. A number of extrahepatic manifestations are also reported in CHC patients, further adding to the burden of the disease. CHC also impacts patients in terms of lower health-related quality of life, higher levels of fatigue and reduced productivity. Furthermore, the later stages of disease are costly for both healthcare systems and society. Pegylated-interferon (PEG-IFN)+ribavirin (RBV), for many years the mainstay of treatment, leads to sustained virological response (SVR) in 40%-70% of patients. However, a substantial number of patients are ineligible for treatment, and many patients fail to achieve SVR with this regimen. Furthermore, PEG-IFN+RBV leads to impairment of patient-reported outcomes during treatment, and most patients suffer from adverse events, associated with poor adherence, treatment discontinuation and treatment failure. The approval of second-generation direct-acting antivirals (DAAs) has revolutionized the treatment of CHC patients. All-oral, PEG-IFN and RBV-free regimens have higher efficacy rates, shorter treatment durations, fewer adverse events, higher adherence rates and improvement in PROs from as early as Week 4, compared to PEG-IFN+RBV regimens. The aim of this article is to review the evidence for HCV infection as a systemic disease, summarizing the impact of hepatitis C and its treatments on clinical, patient and economic outcomes, with a focus on data from Asia and Japan specifically.
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Affiliation(s)
- Zobair M Younossi
- Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, USA
- Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, USA
| | - Atsushi Tanaka
- Department of Medicine, Teikyo University School of Medicine, Tokyo, Japan
| | - Yuichiro Eguchi
- Liver Center, Saga University Hospital, Saga University, Saga, Japan
| | - Young-Suk Lim
- Department of Gastroenterology, Liver Center, Asan Medical Center, Seoul, Korea
| | - Ming-Lung Yu
- Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
| | - Norifumi Kawada
- Department of Hepatology, Graduate School of Medicine, Osaka City University, Osaka, Japan
| | - Yock Young Dan
- Department of Medicine, National University of Singapore, Singapore
| | | | - Francesco Negro
- Division of Gastroenterology and Hepatology and Division of Clinical Pathology, University Hospital, Geneva, Switzerland
| | - Mario U Mondelli
- Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy
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13
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High prevalence of chronic hepatitis B and C virus infection in a population of a German metropolitan area: a prospective survey including 10 215 patients of an interdisciplinary emergency unit. Eur J Gastroenterol Hepatol 2016; 28:1246-52. [PMID: 27439034 DOI: 10.1097/meg.0000000000000702] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/28/2022]
Abstract
PURPOSE The prevalence of chronic hepatitis B virus- and hepatitis C virus-infections in the general German population has been estimated to be 0.6-0.7 and 0.3-0.4%, respectively. The population of Frankfurt/Main is multicultural and marked by different risks of chronic viral hepatitis. The aim of this prospective study was to define epidemiologic data for hepatitis B and C from consecutive patients of an interdisciplinary emergency unit in Frankfurt. PATIENTS AND METHODS Over a period of 12 months, 10 215 patients of an interdisciplinary emergency unit in Frankfurt/Main were screened for hepatitis B surface-antigen (HBsAg) and hepatitis C virus-antibodies (HCV-Ab). In case of positive HBsAg or HCV-Ab, a quantitative PCR analysis of virus was carried out. RESULTS The prevalence of HBsAg and HCV-Ab in the study population was 1.32% (n=135; group 1) and 2.70% (n=276; group 2), respectively, with a sex ratio close to 1. Quantitative PCR tests of virus load were performed in 72.59% (group 1) and in 82.61% (group 2), with confirmed viremia in 54.08% (group 1) and 41.67% (group 2), and correlated to elevated liver enzymes in 49.05% (group 1) and in 75.78% (group 2) of the cases. The ethnic distribution was 87.09% White (n=8897; group A) versus 12.90% other ethnic groups (n=1318; group B), with a prevalence of HBsAg-positive and HCV-Ab-positive cases of 1.08 and 2.76% (group A) and 2.96 and 2.28% (group B). CONCLUSION The results show that in multicultural areas, the prevalence of chronic viral hepatitis is increased. Because of the potential of progressive liver damage in viral hepatitis, field screening in specific populations at high risk for hepatitis should be performed.
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14
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Basnayake SK, Easterbrook PJ. Wide variation in estimates of global prevalence and burden of chronic hepatitis B and C infection cited in published literature. J Viral Hepat 2016; 23:545-59. [PMID: 27028545 DOI: 10.1111/jvh.12519] [Citation(s) in RCA: 41] [Impact Index Per Article: 4.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/30/2015] [Accepted: 01/14/2016] [Indexed: 12/15/2022]
Abstract
To evaluate the extent of heterogeneity in global estimates of chronic hepatitis B (HBV) and C (HCV) cited in the published literature, we undertook a systematic review of the published literature. We identified articles from 2010 to 2014 that had cited global estimates for at least one of ten indicators [prevalence and numbers infected with HBV, HCV, HIV-HBV or HIV-HCV co-infection, and mortality (number of deaths annually) for HBV and HCV]. Overall, 488 articles were retrieved: 239 articles cited a HBV-related global estimate [prevalence (n = 12), number infected (n = 193) and number of annual deaths (n = 82)]; 280 articles had HCV-related global estimates [prevalence (n = 86), number infected (n = 203) and number of annual deaths (n = 31)]; 31 had estimates on both HBV and HCV; 54 had HIV-HBV co-infection estimates [prevalence (n = 42) and number co-infected (n = 12)]; and 68 had estimates for HIV-HCV co-infection [prevalence (n = 40) and number co-infected (n = 28)]. There was considerable heterogeneity in the estimates cited and also a lack of consistency in the terminology used. Although 40% of 488 articles cited WHO as the source of the estimate, many of these were from outdated or secondary sources. Our findings highlight the importance of clear and consistent communication from WHO and other global health agencies on current consensus estimates of hepatitis B and C burden and prevalence, the need for standardisation in their citation, and for regular updates.
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Affiliation(s)
| | - P J Easterbrook
- Global Hepatitis Programme, HIV Department, World Health Organization, Geneva, Switzerland
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15
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Huisman EJ, van Meer S, van Hoek B, van Soest H, van Nieuwkerk KMJ, Arends JE, Siersema PD, van Erpecum KJ. Effects of preventive versus "on-demand" nutritional support on paid labour productivity, physical exercise and performance status during PEG-interferon-containing treatment for hepatitis C. Clin Res Hepatol Gastroenterol 2016; 40:221-9. [PMID: 26188490 DOI: 10.1016/j.clinre.2015.06.007] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/23/2015] [Revised: 05/31/2015] [Accepted: 06/08/2015] [Indexed: 02/04/2023]
Abstract
BACKGROUND AND OBJECTIVE Deterioration of nutritional status during PEG-interferon containing therapy for chronic hepatitis C can be ameliorated by preventive nutritional support. We aimed to explore whether such support also affects paid labour productivity, physical exercise and performance status. METHODS In this prospective randomized controlled trial (J Hepatol 2012;57:1069-75), 53 patients with chronic hepatitis C had been allocated to "on demand" support (n=26: nutritional intervention if weight loss>5%) or preventive support (n=27: regular dietary advice plus energy- and protein-rich evening snack) during PEG-interferon-containing therapy. Paid labour productivity, physical exercise and performance status were evaluated at baseline, after 24 and (if applicable) after 48 weeks of treatment. RESULTS At baseline, 46% of patients performed paid labour and 62% performed some kind of physical exercise. Furthermore, most patients were able to carry out normal activity with only minor symptoms of disease (mean Karnofsky performance score: 94). Decreases of paid labour productivity (-21% vs. -70%, P=0.003), physical exercise activity (-43% vs. -87%, P=0.005) and Karnofsky performance scores (-12% vs. -24%, P<0.001) were less in the preventive than in "on demand" group after 24 weeks of treatment. Effects of preventive nutritional support were even more pronounced after 48 weeks. CONCLUSIONS Preventive nutritional support markedly ameliorates decreases of paid labour productivity, physical exercise and performance status during PEG-interferon-containing treatment for chronic hepatitis C.
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Affiliation(s)
- Ellen J Huisman
- Department of Gastroenterology and Hepatology, University Medical Center, Utrecht, The Netherlands
| | - Suzanne van Meer
- Department of Gastroenterology and Hepatology, University Medical Center, Utrecht, The Netherlands
| | - Bart van Hoek
- Department of Gastroenterology and Hepatology, University Medical Center, Leiden, The Netherlands
| | - Hanneke van Soest
- Department of Gastroenterology and Hepatology, Medical Center Haaglanden, The Hague, The Netherlands
| | - Karin M J van Nieuwkerk
- Department of Gastroenterology and Hepatology, VU Medical Center, Amsterdam, The Netherlands
| | - Joop E Arends
- Department of Internal Medicine and Infectious Diseases, University Medical Center, Utrecht, The Netherlands
| | - Peter D Siersema
- Department of Gastroenterology and Hepatology, University Medical Center, Utrecht, The Netherlands
| | - Karel J van Erpecum
- Department of Gastroenterology and Hepatology, University Medical Center, Utrecht, The Netherlands.
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16
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Gupta S, Kwan P, Faught E, Tsong W, Forsythe A, Ryvlin P. Understanding the burden of idiopathic generalized epilepsy in the United States, Europe, and Brazil: An analysis from the National Health and Wellness Survey. Epilepsy Behav 2016; 55:146-56. [PMID: 26773686 DOI: 10.1016/j.yebeh.2015.12.018] [Citation(s) in RCA: 32] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/13/2015] [Revised: 12/01/2015] [Accepted: 12/10/2015] [Indexed: 09/30/2022]
Abstract
The aim of this study was to understand the current burden of primary generalized tonic-clonic seizures (PGTCS) associated with idiopathic generalized epilepsy (IGE) as a function of seizure frequency. We analyzed data for (IGE) as a proxy measure of PGTCS. Little is known about the quality of life (QoL), health utility, productivity, healthcare resource utilization (HRU), and cost burden of PGTCS or IGE. Patients were identified from the US (2011, 2012, & 2013), 5EU (2011 & 2013), and Brazil (2011 & 2012) National Health and Wellness Survey, a nationally representative, internet-based survey of adults (18+ years). Patients that self-reported a diagnosis of IGE were categorized into seizure frequencies of: ≥1 seizure per week, 1-3 seizures per month, 1-4 seizures per year, or <1 seizure per year. QoL was measured using the SF-36v2 Mental (MCS) and Physical Component Summary (PCS) scores, health utilities with the SF-6D, productivity with the Work Productivity and Activity Impairment (WPAI) questionnaire, and HRU as reported in the past six months. Unit costs were estimated from the literature and multiplied against HRU values to calculate direct costs and WPAI values to calculate indirect costs. Generalized linear regression was utilized to examine the relationship between seizure frequency and each measure of burden with adjustment for covariates. Out of the general population surveyed, IGE was self-reported in 782 of 176,093 (US), 172 of 30,000 (UK), 106 of 30,001 (Germany), 87 of 30,000 (France), 31 of 12,011 (Spain), 22 of 17,500 (Italy), and 34 of 24,000 (Brazil). Persistent seizures (≥1 per year) were reported in over 40% of patients with IGE (10-15% with ≥1 seizure per week, 10-15% with 1-3 seizures per month, 20-25% with 1-4 seizures per year). Over 75% were treated with antiepileptic drugs (AEDs). Compared with those having <1 seizure per year (reference group), patients in the two most frequent seizure categories reported worse MCS and PCS scores. Patients in the three highest seizure frequency groups consistently reported worse health utility scores, and greater presenteeism (attending work while not physically or mentally capable of working), overall work impairment, activity impairment, HRU, indirect costs, and direct costs than the reference group. Despite the availability of AEDs during the year surveyed, a substantial number of patients experienced persistent seizures. Increasing seizure frequency was clearly associated with worse outcomes. The burden of PGTCS and IGE may be proportionally reduced by newer AEDs which may increase the proportion of seizure-free patients or shift more patients into lower seizure frequency categories.
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Affiliation(s)
- Shaloo Gupta
- Kantar Health, 1 Independence Way, Suite 220, Princeton, NJ 08540, USA.
| | - Patrick Kwan
- The University of Melbourne and Royal Melbourne Hospital, Parkville, VIC 3050, Australia.
| | - Edward Faught
- Emory University School of Medicine, Emory Epilepsy Program, 12 Executive Park Drive NE, Atlanta, GA 30329, USA.
| | - Wan Tsong
- Eisai Inc., Global Value & Access, 155 Tice Blvd., Woodcliff Lake, NJ 07677, USA.
| | - Anna Forsythe
- Eisai Inc., Global Value & Access, 155 Tice Blvd., Woodcliff Lake, NJ 07677, USA.
| | - Phillipe Ryvlin
- Centre Hospitalier Universitaire Vaudois, Département des Neurosciences Cliniques, BH/10/137 Rue du Bugnon 46, CH-1011 Lausanne, Switzerland.
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Oliva-Moreno J, Peña-Longobardo LM, Alonso S, Fernández-Bolaños A, Gutiérrez ML, Hidalgo-Vega Á, de la Fuente E, Fernández-Rodríguez CM. Labour productivity losses caused by premature death associated with hepatitis C in Spain. Eur J Gastroenterol Hepatol 2015; 27:631-637. [PMID: 25853930 PMCID: PMC4415959 DOI: 10.1097/meg.0000000000000336] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/28/2014] [Accepted: 02/10/2015] [Indexed: 01/17/2023]
Abstract
BACKGROUND AND AIMS Hepatitis C virus (HCV) infection places a huge burden on healthcare systems. There is no study assessing the impact of HCV infection on premature deaths in Spain. The aim of this study was to estimate productivity losses because of premature deaths attributable to hepatitis C occurring in Spain during 2007-2011. MATERIALS AND METHODS We use data from several sources (Registry of Deaths, Labour Force Survey and Wage Structure Survey) to develop a simulation model based on the human capital approach and to estimate the flows in labour productivity losses in the period considered. The attributable fraction method was used to estimate the numbers of deaths associated with HCV infection. Two sensitivity analyses were developed to test the robustness of the results. RESULTS Our model shows total productivity losses attributable to HCV infection of 1054.7 million euros over the period analysed. The trend in productivity losses is decreasing over the period. This result is because of improvements in health outcomes, reflected in the reduction of the number of years of potential productive life lost. Of the total estimated losses, 18.6% were because of hepatitis C, 24.6% because of hepatocellular carcinoma, 30.1% because of cirrhosis, 15.9% because of other liver diseases and 10.7% because of HIV-HCV coinfection. CONCLUSION The results show that premature mortality attributable to hepatitis C involves significant productivity losses. This highlights the need to extend the analysis to consider other social costs and obtain a more complete picture of the actual economic impact of hepatitis C infection.
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Affiliation(s)
- Juan Oliva-Moreno
- University of Castille-La Mancha, Seminar of Research on Economy and Health
| | | | - Sonia Alonso
- Service of Gastroenterology, Fundacion Alcorcon University Hospital, University Rey Juan Carlos, Madrid, Spain
| | | | - María Luisa Gutiérrez
- Service of Gastroenterology, Fundacion Alcorcon University Hospital, University Rey Juan Carlos, Madrid, Spain
| | | | - Elsa de la Fuente
- Service of Gastroenterology, Fundacion Alcorcon University Hospital, University Rey Juan Carlos, Madrid, Spain
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Janardhan SV, Reau NS. Should NS5A inhibitors serve as the scaffold for all-oral anti-HCV combination therapies? ACTA ACUST UNITED AC 2015; 7:11-20. [PMID: 25926761 PMCID: PMC4403691 DOI: 10.2147/hmer.s79584] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
Abstract
Chronic hepatitis C virus (HCV) infection represents a global health problem that affects up to 130–150 million people worldwide. The HCV treatment landscape has been transformed recently by the introduction of direct-acting antiviral (DAA) agents that target viral proteins, including the NS3 protease, the NS5B polymerase, and the NS5A protein. Treatment with multiple DAAs in combination has been shown to result in high rates of sustained virologic response, without the need for pegylated interferon, and a shorter duration of therapy compared with interferon-based regimens; however, the optimal combination of DAAs has yet to be determined. The class of NS5A inhibitors has picomolar potency with pangenotypic activity, and recent clinical studies have shown these inhibitors to be an important component of DAA combination regimens. This review discusses the rational design of an optimal anti-HCV DAA cocktail, with a focus on the role of NS5A in the HCV life cycle, the attributes of the NS5A class of inhibitors, and the potential for NS5A inhibitors to act as a scaffold for DAA-only treatment regimens.
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Affiliation(s)
- Sujit V Janardhan
- Center for Liver Diseases, Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, University of Chicago, Chicago, IL, USA
| | - Nancy S Reau
- Center for Liver Diseases, Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, University of Chicago, Chicago, IL, USA
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Wang J, Chen R, Tang S, Lv X, Wu S, Zhang Y, Xia Y, Gao P, Tu D, Chen D, Zhan S. Analysis of IL-6, STAT3 and HSPA1L gene polymorphisms in anti-tuberculosis drug-induced hepatitis in a nested case-control study. PLoS One 2015; 10:e0118862. [PMID: 25789467 PMCID: PMC4366259 DOI: 10.1371/journal.pone.0118862] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/07/2014] [Accepted: 01/22/2015] [Indexed: 01/27/2023] Open
Abstract
OBJECTIVES To investigate the association of IL-6, STAT3 and HSPA1L polymorphisms with the risk of anti-tuberculosis drug-induced hepatitis (ATDH) in Chinese Han population. METHODS The study was designed as a nested case-control study within a prospective cohort. Each case was matched with four controls by sex, age at baseline (±5 years), treatment history, disease severity, drug dosage and place of sample collection. Genetic polymorphisms of IL-6, STAT3 and HSPA1L were determined blindly by TaqMan single-nucleotide polymorphism (SNP) genotyping assay. Odds ratio (OR) with 95% confidence intervals (CIs) was estimated by conditional logistic regression model to measure the association between selected SNPs and the risk of ATDH. RESULTS A total of 89 incident ATDH cases and 356 ATDH-free controls were genotyped for IL-6 (rs2066992, rs2069837, rs1524107), STAT3 (rs1053004, rs1053023, rs1053005) and HSPA1L (rs2227956). In genotype analysis, no significant difference was observed in genotypes frequencies of the seven selected SNPs between case and control group after Bonferroni correction. In haplotype analysis, carriers with STAT3 GAT and AGC (rs1053023-rs1053005-rs1053004) haplotypes had a significantly higher risk of ATDH compared with wild-type haplotype (P<0.0001). CONCLUSION This study suggested that genetic variants of STAT3 might contribute to ATDH susceptibility in Chinese Han population. Studies in larger, varied populations are required to confirm these findings.
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Affiliation(s)
- Jing Wang
- Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Centre, Beijing, China
| | - Ru Chen
- Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Centre, Beijing, China
| | - Shaowen Tang
- Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Centre, Beijing, China
- Department of Epidemiology and Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, China
| | - Xiaozhen Lv
- Clinical Research Division, Peking University Institute of Mental Health, and Key Laboratory for Mental Health, Ministry of Health, Beijing, China
| | - Shanshan Wu
- Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Centre, Beijing, China
| | - Yuan Zhang
- Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada
| | - Yinyin Xia
- Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China
| | - Pei Gao
- Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Centre, Beijing, China
| | - Dehua Tu
- Department of Tuberculosis Treatment, Beijing Institute for Tuberculosis Control, Beijing, China
| | - Dafang Chen
- Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Centre, Beijing, China
| | - Siyan Zhan
- Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Centre, Beijing, China
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20
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Mahmud HM, Siddiqui M, Bashir B, Ali SF, Baloch AA, Masroor M. Hemodialysis patients profile at Dow University of Health Sciences, Karachi. Pakistan. Pak J Med Sci 2015; 30:1327-30. [PMID: 25674133 PMCID: PMC4320725 DOI: 10.12669/pjms.306.5364] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/02/2014] [Revised: 09/10/2014] [Accepted: 09/15/2014] [Indexed: 11/15/2022] Open
Abstract
Objectives: To determine the frequency of diseases contributing to End Stage Renal Failure (ESRF) and to determine the frequency of seropositivity for hepatitis B and hepatitis C in our patients. Methods: This is an observational study of two years duration from January 2012 till December 2013, done at Dow university of Health Sciences. Sample size is 189 by convenient method. Data collection is retrospective. Inclusion criteria includes all patients ever hemodialysed at DIMC with age 14 or above. Exclusion criteria is age below 14. Data maintained and analyzed on SPSS version 16. All categorical data in percentages and numeric data is given in frequencies and mean with Standard deviation. Result: Total number of patients included in study were 189, Males were 94/189 (49.7%), females were 95/189 (50.3%), Male to female ratio was 0.98: 1.0. Mean age was 51.88+15.2, range was14-86 years. Patients started on Hemodialysis were found to have hypertension in 40.2%, both diabetes and hypertension was present in 42.8%, diabetes alone in 3.1% of patients as likely etiology of renal failure. Seropositivity for HBV was found 4/189(2.1%) and HCV in 31/189(16.4%) at initiation of Hemodialysis. Conclusion: Hypertension alone is an important disease found in patients with renal failure as likely cause followed by diabetes. Hepatitis C positivity at start of hemodialysis is 16%.
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Affiliation(s)
- Huma Mamun Mahmud
- Dr. Huma Mamun Mahmud, MBBS, FCPS, Consultant Nephrologist, In Charge Hemodialysis Unit, DIMC, Ojha Campus, Dow International Medical College (Ojha Campus), DUHS, Suparco Road, off Main University Road, Gulzar-e-Hijri, Scheme 33, Karachi, Pakistan
| | - Muneer Siddiqui
- Dr. Muneer Siddiqui, MBBS, FCPS, Dow International Medical College (Ojha Campus), DUHS, Suparco Road, off Main University Road, Gulzar-e-Hijri, Scheme 33, Karachi, Pakistan
| | - Babar Bashir
- Dr. Babar Bashir, MBBS, FCPS, Dow International Medical College (Ojha Campus), DUHS, Suparco Road, off Main University Road, Gulzar-e-Hijri, Scheme 33, Karachi, Pakistan
| | - Syed Farman Ali
- Dr. Syed Farman Ali, Dow International Medical College (Ojha Campus), DUHS, Suparco Road, off Main University Road, Gulzar-e-Hijri, Scheme 33, Karachi, Pakistan
| | - Akhter Ali Baloch
- Dr. Akhter Ali Baloch, Dow International Medical College (Ojha Campus), DUHS, Suparco Road, off Main University Road, Gulzar-e-Hijri, Scheme 33, Karachi, Pakistan
| | - Mohd Masroor
- Dr. Mohd Masroor, Dow International Medical College (Ojha Campus), DUHS, Suparco Road, off Main University Road, Gulzar-e-Hijri, Scheme 33, Karachi, Pakistan
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21
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Wang J, Chen R, Tang S, Lv X, Wu S, Zhang Y, Yang Z, Xia Y, Chen D, Zhan S. Interleukin-4 and interleukin-10 polymorphisms and antituberculosis drug-induced hepatotoxicity in Chinese population. J Clin Pharm Ther 2014; 40:186-91. [DOI: 10.1111/jcpt.12223] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/27/2014] [Accepted: 09/15/2014] [Indexed: 01/05/2023]
Affiliation(s)
- J. Wang
- Department of Epidemiology and Biostatistics; School of Public Health; Peking University Health Science Centre; Beijing China
| | - R. Chen
- Department of Epidemiology and Biostatistics; School of Public Health; Peking University Health Science Centre; Beijing China
| | - S. Tang
- Department of Epidemiology and Biostatistics; School of Public Health; Nanjing Medical University; Nanjing China
| | - X. Lv
- Clinical Research Division; Peking University Institute of Mental Health; Key Laboratory for Mental Health; Ministry of Health; Beijing China
| | - S. Wu
- Department of Epidemiology and Biostatistics; School of Public Health; Peking University Health Science Centre; Beijing China
| | - Y. Zhang
- Department of Clinical Epidemiology and Biostatistics; McMaster University; Hamilton ON Canada
| | - Z. Yang
- Department of Epidemiology and Biostatistics; School of Public Health; Peking University Health Science Centre; Beijing China
| | - Y. Xia
- Center for Tuberculosis Control and Prevention; Chinese Center for Disease Control and Prevention; Beijing China
| | - D. Chen
- Department of Epidemiology and Biostatistics; School of Public Health; Peking University Health Science Centre; Beijing China
| | - S. Zhan
- Department of Epidemiology and Biostatistics; School of Public Health; Peking University Health Science Centre; Beijing China
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22
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Unexpected structural features of the hepatitis C virus envelope protein 2 ectodomain. J Virol 2014; 88:10280-8. [PMID: 24991010 DOI: 10.1128/jvi.00874-14] [Citation(s) in RCA: 25] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022] Open
Abstract
Hepatitis C virus (HCV), a member of the family Flaviviridae, is a leading cause of chronic liver disease and cancer. Recent advances in HCV therapeutics have resulted in improved cure rates, but an HCV vaccine is not available and is urgently needed to control the global pandemic. Vaccine development has been hampered by the lack of high-resolution structural information for the two HCV envelope glycoproteins, E1 and E2. Recently, Kong and coworkers (Science 342:1090-1094, 2013, doi:10.1126/science.1243876) and Khan and coworkers (Nature 509[7500]:381-384, 2014, doi:10.1038/nature13117) independently determined the structure of the HCV E2 ectodomain core with some unexpected and informative results. The HCV E2 ectodomain core features a globular architecture with antiparallel β-sheets forming a central β sandwich. The residues comprising the epitopes of several neutralizing and nonneutralizing human monoclonal antibodies were also determined, which is an essential step toward obtaining a fine map of the human humoral response to HCV. Also clarified were the regions of E2 that directly bind CD81, an important HCV cellular receptor. While it has been widely assumed that HCV E2 is a class II viral fusion protein (VFP), the newly determined structure suggests that the HCV E2 ectodomain shares structural and functional similarities only with domain III of class II VFPs. The new structural determinations suggest that the HCV glycoproteins use a different mechanism than that used by class II fusion proteins for cell fusion.
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