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1.
BMC Infect Dis ; 19(1): 1019, 2019 Dec 02.
Artículo en Inglés | MEDLINE | ID: mdl-31791253

RESUMEN

BACKGROUND: Chronic hepatitis C is a major public health burden. With new interferon-free direct-acting agents (showing sustained viral response rates of more than 98%), elimination of HCV seems feasible for the first time. However, as HCV infection often remains undiagnosed, screening is crucial for improving health outcomes of HCV-patients. Our aim was to assess the long-term cost-effectiveness of a nationwide screening strategy in Germany. METHODS: We used a Markov cohort model to simulate disease progression and examine long-term population outcomes, HCV associated costs and cost-effectiveness of HCV screening. The model divides the total population into three subpopulations: general population (GEP), people who inject drugs (PWID) and HIV-infected men who have sex with men (MSM), with total infection numbers being highest in GEP, but new infections occurring only in PWIDs and MSM. The model compares four alternative screening strategies (no/basic/advanced/total screening) differing in participation and treatment rates. RESULTS: Total number of HCV-infected patients declined from 275,000 in 2015 to between 125,000 (no screening) and 14,000 (total screening) in 2040. Similarly, lost quality adjusted life years (QALYs) were 320,000 QALYs lower, while costs were 2.4 billion EUR higher in total screening compared to no screening. While incremental cost-effectiveness ratio (ICER) increased sharply in GEP and MSM with more comprehensive strategies (30,000 EUR per QALY for total vs. advanced screening), ICER decreased in PWIDs (30 EUR per QALY for total vs. advanced screening). CONCLUSIONS: Screening is key to have an efficient decline of the HCV-infected population in Germany. Recommendation for an overall population screening is to screen the total PWID subpopulation, and to apply less comprehensive advanced screening for MSM and GEP.


Asunto(s)
Erradicación de la Enfermedad , Hepatitis C/prevención & control , Tamizaje Masivo/economía , Tamizaje Masivo/métodos , Adulto , Antivirales/economía , Antivirales/uso terapéutico , Estudios de Cohortes , Análisis Costo-Beneficio , Pruebas Diagnósticas de Rutina/economía , Pruebas Diagnósticas de Rutina/estadística & datos numéricos , Erradicación de la Enfermedad/economía , Erradicación de la Enfermedad/métodos , Erradicación de la Enfermedad/estadística & datos numéricos , Consumidores de Drogas/estadística & datos numéricos , Femenino , Alemania/epidemiología , Infecciones por VIH/diagnóstico , Infecciones por VIH/economía , Infecciones por VIH/epidemiología , Costos de la Atención en Salud , Hepacivirus/genética , Hepacivirus/aislamiento & purificación , Hepatitis C/diagnóstico , Hepatitis C/economía , Hepatitis C/epidemiología , Hepatitis C Crónica/diagnóstico , Hepatitis C Crónica/economía , Hepatitis C Crónica/epidemiología , Hepatitis C Crónica/prevención & control , Homosexualidad Masculina/estadística & datos numéricos , Humanos , Masculino , Tamizaje Masivo/estadística & datos numéricos , Persona de Mediana Edad , Vigilancia de la Población/métodos , Años de Vida Ajustados por Calidad de Vida , Minorías Sexuales y de Género/estadística & datos numéricos
2.
Pharmacol Res Perspect ; 7(6): e00552, 2019 12.
Artículo en Inglés | MEDLINE | ID: mdl-31857910

RESUMEN

The high cost of drugs for hepatitis C limits access and adherence to treatment. In 2017, the Colombian health care system decided to design a strategy. It consisted of centralized purchasing, regulations, clinical practice guidelines, and direct observation of the treatment and follow-up of patients. The main objective of this study was to assess the centralized purchasing strategy in Colombia. The study design was a policy implementation assessment. We analyzed the change in prices, the clinical outcomes, and the opinions of stakeholders using data from the Ministry of Health. Additional information about effectiveness came from the Colombian Fund for High-Cost Diseases and semi-structured interviews of the stakeholders. The follow-up was from October, 2017 to October, 2018. The total number of patients reported in the cohort period was 1069. The number that finished 12 weeks of treatment, completed the follow-up for the case closure, and were considered cured through the end of October, 2018 was 563 (53%). The remainder, 506 patients (47%), are currently in treatment. A total of 543 of these treated patients (96%) were cured. After implementing this strategy, the drug prices decreased by more than 90% overall. Before implementation, the total direct cost was $100 102 171.75 dollars. Afterward, the cost was $8 378 747 dollars.


Asunto(s)
Antivirales/economía , Prestación de Atención de Salud/organización & administración , Costos de los Medicamentos/legislación & jurisprudencia , Implementación de Plan de Salud , Hepatitis C/tratamiento farmacológico , Antivirales/uso terapéutico , Colombia/epidemiología , Ahorro de Costo/economía , Ahorro de Costo/estadística & datos numéricos , Análisis Costo-Beneficio , Prestación de Atención de Salud/economía , Prestación de Atención de Salud/legislación & jurisprudencia , Prestación de Atención de Salud/normas , Costos de los Medicamentos/estadística & datos numéricos , Industria Farmacéutica/economía , Industria Farmacéutica/estadística & datos numéricos , Femenino , Adquisición en Grupo/economía , Adquisición en Grupo/legislación & jurisprudencia , Adquisición en Grupo/organización & administración , Adquisición en Grupo/normas , Hepacivirus/aislamiento & purificación , Hepatitis C/epidemiología , Hepatitis C/virología , Humanos , Masculino , Persona de Mediana Edad , Negociación , Políticas , Guías de Práctica Clínica como Asunto , Evaluación de Programas y Proyectos de Salud , Participación de los Interesados , Resultado del Tratamiento
4.
Medicine (Baltimore) ; 98(51): e18458, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31861022

RESUMEN

BACKGROUND: Chronic viral hepatitis b and its related complications have caused serious harm to human health and become a worldwide public health problem. Hepatitis b cirrhosis is one of the most common complications in Asia. Traditional Chinese medicine combined with antiviral therapy has become the first choice for clinical treatment of hepatitis b Cirrhosis. Biejia Pill is an effective prescription of traditional Chinese medicine in treating Compensatory period of cirrhosis, and there are more and more clinical reports about its validity in treating Compensatory period of cirrhosis. Therefore, we designed this study protocol to evaluate the adjuvant role of Biejia Pill in the treatment of Compensatory period of cirrhosis. METHOD: Electronic Databases, PubMed, EMBASE database, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wan Fang, Chinese Scientific Journals Database (VIP) and China Biology Medicine disc, (CBM), will be systematically searched from inception to July 2019. Randomized controlled trials (RCTs) on Biejiajian Pill combined with Entecavir and Entecavir alone against Compensatory period of hepatitis b cirrhosis will be included; inclusion and exclusion criteria will be used to screen the trials. liver fibrosis biomarkers including ECM or its metabolites (serum hyaluronic acid (HA), laminin (LN), procollagen type III (PC-III), and type IV collagen (IV-C)) will be measured as primary outcomes. Liver function, including alanine aminotransferase (ALT) and aspartarte aminotransferase (AST), and improvement of related clinical symptoms will be measured as secondary outcomes. RevMan5 software will be used for literature quality evaluation and data synthesis and analysis. RESULT: To evaluate the efficacy and safety of Biejiajian Pill in combination therapy by observing the outcomes of serum liver fibrosis markers, adverse reactions and liver function. CONCLUSION: This study protocol will be used to evaluate the efficacy and safety of Biejia Pill in combination with entecavir in the treatment of Compensatory period of hepatitis b cirrhosis, as well as the adjuvant treatment of Biejia Pill in combination.PROSPERO registration number: CRD42019135402.


Asunto(s)
Antivirales/uso terapéutico , Medicamentos Herbarios Chinos/uso terapéutico , Guanina/análogos & derivados , Hepatitis B/complicaciones , Cirrosis Hepática/tratamiento farmacológico , Biomarcadores/sangre , Quimioterapia Combinada , Guanina/uso terapéutico , Humanos , Cirrosis Hepática/sangre , Cirrosis Hepática/etiología , Cirrosis Hepática/virología , Revisiones Sistemáticas como Asunto
5.
Int J Drug Policy ; : 102634, 2019 Dec 24.
Artículo en Inglés | MEDLINE | ID: mdl-31882272

RESUMEN

BACKGROUND: Hepatitis C (HCV) elimination strategies are required for low and middle-income countries (LMICs), because although treatment access is currently limited, this is unlikely to remain the case forever. We estimate and compare the impact, cost and cost-effectiveness of a variety of prevent, test and treat strategies for HCV in Dar es Salaam, Tanzania. METHODS: A mathematical model. RESULTS: Without intervention, the HCV epidemic in Dar es Salaam was estimated to result in US$29.1 million in disease costs between 2018 and 2030. Maintaining existing harm reduction coverage (4% needle and syringe program, 42% opioid substitution therapy) over this period was estimated to prevent 22% of injecting drug use-acquired HCV infections compared to a zero coverage scenario. Implementing antibody/RNA, serum-based HCV core antigen (HCVcAg) and dry blood spot (DBS) HCVcAg test/treat programs among PWID increased the total cost by US$0.7 million, US$3.1 million and US$6.5 million respectively by 2030; however this expenditure led to 57%, 61% and 73% reductions in annual incidence among PWID, 25%, 27% and 33% reductions overall annual incidence (PWID+non-PWID), and reduced HCV prevalence among PWID from 27% to 9%, 8% and 5%, respectively. The Ab/RNA, serum-based and DBS HCVcAg test/treat programs cost US$689, US$2857 and US$5400 per disability-adjusted life year averted, respectively, compared to no test/treat program. CONCLUSION: Primary prevention among PWID can provide important reductions in HCV transmission in the absence of treatment availability. HCV Ab/RNA or serum-based HCVcAg test/treat programs among PWID are likely to be cost-effective in Dar es Salaam, with serum-based HCVcAg test/treat achieving greater impact due to a simpler diagnostic process and better retention in care. If used for regular testing of PWID, the additional coverage benefits of non-laboratory-based DBS HCVcAg tests in LMICs would outweigh their reduced sensitivity.

6.
J Antimicrob Chemother ; 74(Suppl 5): v5-v16, 2019 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-31782503

RESUMEN

BACKGROUND: HCV disproportionately affects marginalized communities such as homeless populations and people who inject drugs (PWID), posing a challenge to traditional health services. The HepFriend initiative in London is a model of care utilizing HCV outreach screening and peer support to link vulnerable individuals to HCV treatment in secondary care. OBJECTIVES: To assess the cost-effectiveness of the HepFriend initiative from a healthcare provider perspective, compared with standard-of-care pathways (consisting of testing in primary care and other static locations, including drug treatment centres, and linkage to secondary care). METHODS: Cost-effectiveness analysis using a dynamic HCV transmission and disease progression model among PWID and those who have ceased injecting, including housing status and drug treatment service contact. The model was parameterized using London-specific surveillance and survey data, and primary intervention cost and effectiveness data (September 2015 to June 2018). Out of 461 individuals screened, 197 were identified as HCV RNA positive, 180 attended secondary care and 89 have commenced treatment to date. The incremental cost-effectiveness ratio (ICER) was determined using a 50 year time horizon. RESULTS: For a willingness-to-pay threshold of £20000 per QALY gained, the HepFriend initiative is cost-effective, with a mean ICER of £9408/QALY, and would become cost saving at 27% (£10525 per treatment) of the current drug list price. Results are robust to variations in intervention costs and model assumptions, and if treatment rates are doubled the intervention becomes more cost-effective (£8853/QALY). CONCLUSIONS: New models of care that undertake active case-finding with enhanced peer support to improve testing and treatment uptake amongst marginalized and vulnerable groups could be highly cost-effective and possibly cost saving.

7.
EBioMedicine ; 49: 247-257, 2019 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-31680000

RESUMEN

BACKGROUND: Chronic Hepatitis B (CHB) remains a major problem for global public health. Viral persistence and immune defects are the two major reasons for CHB, and it was hypothesized that based on a transient clearance of serum viral DNA and HBsAg "window stage", active immunization against hepatitis B virus (HBV) might initiate effective host immune responses versus HBV to achieve functional cure of CHB. METHODS: Two experimental mouse models that mice hydrodynamic injected HBV DNA or infected with recombinant AAV/HBV were used. The "sandwich" therapeutic effect by using a potent human anti-HBsAg neutralizing monoclonal antibody (G12) in combination with antiviral drug tenofovir disoproxil fumarate (TDF), followed by active immunization with HBsAg-HBsAb (mYIC) was evaluated. FINDINGS: A single G12 injection rapidly cleared serum HBsAg in HDI-HBV carrier mice, with a synergistic effect in decreasing viral DNA load when TDF was given orally. When both serum viral DNA and HBsAg load became low or undetectable, mYIC was administered. A more effective clearance of viral DNA and HBsAg was observed and serum HBsAb was developed only in these "sandwich"-treated mice. Efficient intrahepatic anti-HBV immune responses were also observed in these mice, including the formation of aggregates of myeloid cells with CD8+T cells and increased TNF-α, granzyme B production. INTERPRETATION: The "sandwich" combination therapy not only efficiently decreased HBsAg and HBV DNA levels but also induced effective cellular and humoral immunity, which may result in functional cure of CHB.


Asunto(s)
Antivirales/uso terapéutico , Hepatitis B Crónica/tratamiento farmacológico , Hepatitis B Crónica/inmunología , Inmunización Pasiva , Vacunación , Animales , Anticuerpos Monoclonales/farmacocinética , Anticuerpos Monoclonales/uso terapéutico , Antivirales/farmacología , Modelos Animales de Enfermedad , Quimioterapia Combinada , Antígenos de Superficie de la Hepatitis B/inmunología , Humanos , Hidrodinámica , Inmunidad Celular/efectos de los fármacos , Inmunidad Humoral/efectos de los fármacos , Inyecciones , Hígado/efectos de los fármacos , Hígado/inmunología , Hígado/patología , Ratones Endogámicos C57BL
8.
BMC Infect Dis ; 19(1): 943, 2019 Nov 08.
Artículo en Inglés | MEDLINE | ID: mdl-31703669

RESUMEN

BACKGROUND: A large proportion of people who inject drugs (PWID) living with hepatitis C virus (HCV) infection have not been treated. It is unknown whether inclusion of HCV diagnostics and treatment into integrated substance use disorder treatment and care clinics will improve uptake and outcome of HCV treatment in PWID. The aim is to assess the efficacy of integrating HCV treatment to PWID and this paper will present the protocol for an ongoing trial. METHODS: INTRO-HCV is a multicentre, randomised controlled clinical trial that will compare the efficacy of integrated treatment of HCV in PWID with the current standard treatment. Integrated treatment includes testing for HCV, assessing liver fibrosis with transient elastography, counselling, treatment delivery, follow-up and evaluation provided by integrated substance use disorder treatment and care clinics. Most of these clinics for PWID provide opioid agonist therapy while some clinics provide low-threshold care without opioid agonist therapy. Standard care involves referral to further diagnostics, treatment and treatment follow-up given in a hospital outpatient clinic with equivalent medications. The differences between the delivery platforms in the two trial arms involve use of a drop-in approach rather than specific appointment times, no need for additional travelling, less blood samples taken during treatment, and treatment given from already known clinicians. The trial will recruit approximately 200 HCV infected individuals in Bergen and Stavanger, Norway. The primary outcomes are time to treatment initiation and sustained virologic response, defined as undetectable HCV RNA 12 weeks after end of treatment. Secondary outcomes are cost-effectiveness, treatment adherence, changes in quality of life, fatigue and psychological well-being, changes in drug use, infection related risk behaviour, and risk of reinfection. The target group is PWID with HCV diagnosed receiving treatment and care within clinics for PWID. DISCUSSION: This study will inform on the effects of an integrated treatment program for HCV in clinics for PWID compared to standard care aiming to increase access to treatment and improving treatment adherence. If the integrated treatment model is found to be safe and efficacious, it can be considered for further scale-up. TRIAL REGISTRATION: ClinicalTrials.gov.no. NCT03155906.


Asunto(s)
Antivirales/uso terapéutico , Prestación Integrada de Atención de Salud/métodos , Hepacivirus/genética , Hepatitis C/tratamiento farmacológico , Tratamiento de Sustitución de Opiáceos , Abuso de Sustancias por Vía Intravenosa/tratamiento farmacológico , Cuidados Posteriores , Análisis Costo-Beneficio , Consejo , Femenino , Hepatitis C/etiología , Humanos , Masculino , Noruega , Reacción en Cadena de la Polimerasa , Calidad de Vida , Recurrencia , Abuso de Sustancias por Vía Intravenosa/complicaciones , Respuesta Virológica Sostenida , Cumplimiento y Adherencia al Tratamiento
9.
Arq Gastroenterol ; 56(4): 440-446, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31721974

RESUMEN

BACKGROUND: Although liver transplantation is considered to be a high-risk procedure, it is well-established as a treatment option for the cure and quality of life enhancement for individuals who suffer from diseases. Preventing an infection by hepatitis B virus through immunization schedules has been the most effective way to reduce complications, since it decreases the number of people who suffer from chronic hepatitis caused by the hepatitis B virus and eradicates its transmission. OBJECTIVE: 1. Analyzing evidence in the literature on various schedules employed for immunization against hepatitis B in patients who have received a liver transplantation. 2. Suggesting potential immunization schedules against hepatitis B in patients who suffer from liver cirrhosis, without previous verifying documentation, using the Child-Turcotte Pugh score, according to evidences found in the literature. METHODS: Systematic review of the literature, conducted on the data bases MedLine, PubMed, and Lilacs, between September, 2017 and January, 2018, by using the following keywords: "Liver Transplantation, "Immunization Schedule", "Hepatitis B Vaccines". In order to analyze the articles, a summary figure was especially designed and both the results and discussion were presented in a descriptive way. RESULTS: We included 24 studies; among them, eight had accelerated immunization schedules, 13 followed the conventional schedules, and three had super accelerated schedules. Regarding immunization, 21 studies were conducted with patients in the pre-transplant period, one with a transplanted patient, one with a pre-transplant group, and one with a post-transplant group. Found articles suggest that, disregarding the chosen immunization schedule, seroconversion rates tended to be lower as the liver disease advanced, compared to the healthy population. CONCLUSION: The studies did not find seroconversion superiority between the different immunization schedules (conventional and unconventional). However, since candidates to liver transplantation are usually very vulnerable, results show that super accelerated immunization schedules are possibly recommended for such group of patients; serologic test results will be higher when the immunization schedule is completed in the pre-transplant period.


Asunto(s)
Vacunas contra Hepatitis B/administración & dosificación , Hepatitis B/prevención & control , Esquemas de Inmunización , Trasplante de Hígado , Vacunas contra Hepatitis B/inmunología , Humanos
10.
Value Health ; 22(11): 1248-1256, 2019 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-31708061

RESUMEN

BACKGROUND AND OBJECTIVES: Birth cohort screening for the hepatitis C virus (HCV) has been implemented in the US, but there is little evidence of its cost-effectiveness in England. We aim to evaluate the cost-effectiveness of one-time HCV screening for individuals born between 1950 and 1979 as part of the National Health Service health check in England, a health check for adults aged 40 to 74 years in primary care. METHODS: A Markov model was developed to analyze add-on HCV testing to the National Health Service health check for individuals in birth cohorts between 1950 and 1979, versus current background HCV testing only, over a lifetime horizon. The model used data from a back-calculation model of the burden of HCV in England, sentinel surveillance of HCV testing, and published literature. Results are presented from a health service perspective in pounds in 2017, as incremental cost-effectiveness ratios per quality-adjusted life years gained. RESULTS: The base-case incremental cost-effectiveness ratios ranged from £7648 to £24 434, and £18 681 to £46 024, across birth cohorts when considering 2 sources of HCV transition probabilities. The intervention is most likely to be cost-effective for those born in the 1970s, and potentially cost-effective for those born from 1955 to 1969. The model results were most sensitive to the source of HCV transition probabilities, the probability of referral and receiving treatment, and the HCV prevalence among testers. The maximum value of future research across all birth cohorts was £11.3 million at £20 000 per quality-adjusted life years gained. CONCLUSION: Birth cohort screening is likely to be cost-effective for younger birth cohorts, although considerable uncertainty exists for other birth cohorts. Further studies are warranted to reduce uncertainty in cost-effectiveness and consider the acceptability of the intervention.

11.
Infect Agent Cancer ; 14: 33, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31709005

RESUMEN

Background and aim: Hepatitis B caused by HBV is a serious public health hazard prevalent worldwide including Bangladesh. Few scattered molecular studies of HBV have been reported in Bangladesh. This study aimed to analyze the genetic variability of RT/HBsAg overlapping region of HBV isolates of Bangladesh and determination of correlation among the genotype/serotype and HBsAg escape and/or drug-resistant mutations. Methods: A total of 97 complete HBsAg sequences of Bangladeshi HBV isolates from 2005 to 2017 from NCBI GenBank were extracted and analyzed using several HBV bioinformatics tools such as Geno2pheno-HBV, HBV Serotyper, HIV-Grade:HBV-Tool, and CLC sequence viewer. Results: The prevalence of genotypes A, C, and D are 18, 46 and 35% which correspond to serotype adw, adr, and ayw, respectively. The prevalence of HBsAg escape mutations is 51% and most of which (62%) are found in the genotype D followed by 32% in genotype C and 6% in genotype A. Interestingly most (24/36) of the sequences of HBsAg escape mutations contained 128 V mutant which all belongs to only serotype ayw3 (Genotype D). Prevalence of drug-resistant mutations is ~ 11%, most of which are from genotype C (63.64%) and D (36.36%). Lamivudine resistant mutations were found in ~ 11% of sequences followed by Telbivudine 10% and Adefovir 3% where Tenofovir showed susceptibility to all 97 sequences. Moreover, 7 among of 97 sequences showed both HBsAg and drugs resistant mutations and none of them are found due to the same nucleotide substitutions. Conclusion: There is a strong correlation among the genotype/serotype and HBsAg escape and/or drug-resistant mutations. This meta-analytical review will be helpful for genotype-serotype prediction by PCR-based diagnosis and development of vaccine and/or diagnostic kits, and the treatment against HBV infection in the future.

12.
Sci Rep ; 9(1): 16849, 2019 11 14.
Artículo en Inglés | MEDLINE | ID: mdl-31727921

RESUMEN

Hepatitis C virus (HCV) is 15 times more prevalent among persons in Spain's prisons than in the community. Recently, Spain initiated a pilot program, JAILFREE-C, to treat HCV in prisons using direct-acting antivirals (DAAs). Our aim was to identify a cost-effective strategy to scale-up HCV treatment in all prisons. Using a validated agent-based model, we simulated the HCV landscape in Spain's prisons considering disease transmission, screening, treatment, and prison-community dynamics. Costs and disease outcomes under status quo were compared with strategies to scale-up treatment in prisons considering prioritization (HCV fibrosis stage vs. HCV prevalence of prisons), treatment capacity (2,000/year vs. unlimited) and treatment initiation based on sentence lengths (>6 months vs. any). Scaling-up treatment by treating all incarcerated persons irrespective of their sentence length provided maximum health benefits-preventing 10,200 new cases of HCV, and 8,300 HCV-related deaths between 2019-2050; 90% deaths prevented would have occurred in the community. Compared with status quo, this strategy increased quality-adjusted life year (QALYs) by 69,700 and costs by €670 million, yielding an incremental cost-effectiveness ratio of €9,600/QALY. Scaling-up HCV treatment with DAAs for the entire Spanish prison population, irrespective of sentence length, is cost-effective and would reduce HCV burden.

13.
Aust Health Rev ; 2019 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-31671288

RESUMEN

ObjectiveAlthough community-based models for treating hepatitis C virus (HCV) are widely recognised for reaching more people who require treatment, little is known about their organisational and operational elements. This study aimed to address this gap and develop a framework for designing, implementing and evaluating community-based models for treating HCV.MethodsThis study was a systematic review in which 17 databases were searched for published and unpublished studies. The final search of databases was performed in September 2017. A qualitative inductive thematic approach was used to extract and categorise organisational and operational elements of community-based models for treating HCV.ResultsData analysis yielded 13 organisational and operational elements that were categorised into three domains: support for patients, support for healthcare providers and service delivery facilitation. In the support for patients domain, support was categorised into four elements: peer support, psychological assessment and support, social assessment and support and adherence support. In the support for healthcare providers domain, the elements included the provision of educational opportunities for HCV care providers, specialist mentoring, decision making support and rewarding and recognition for HCV care providers. Finally, the service delivery facilitation domain included seven elements that target service-level enablers for community-based HCV treatment, including essential infrastructure, policy implementation and collocation and collaboration with other related services.ConclusionThis framework for understanding the components of models of community-based HCV treatment may be used as a guide for designing, implementing and evaluating models of care in support of HCV elimination. HCV care providers and patients need to be supported to improve their engagement with the provision of community-based treatment. In addition, evidence-based strategies to facilitate service delivery need to be included.What is known about the topic?Community-based models for treating HCV are widely recognised as having the advantage of reaching more people who require treatment. These types of models aim to remove barriers related to accessibility and acceptability associated with tertiary centre-based HCV treatment.What does this paper add?Community-based models for treating HCV use various organisational and operational elements to improve the accessibility, effectiveness and acceptability of these services. The elements we identified target three main domains: support for patients with HCV, support for HCV care providers and service delivery facilitation. The importance of these organisational and operational elements designed to improve health and health services outcomes of community-based models for treating HCV is strongly influenced by context, and dependent on both the setting and target population.What are the implications for practitioners?Health policy makers and practitioners need to consider a patient's psychosocial and economic status and provide support when needed. To successfully deliver HCV treatment in community settings, HCV care providers need to be trained and supported, and need to establish linkages, collaborations or colocations with other related services.

14.
Yakugaku Zasshi ; 139(11): 1427-1434, 2019.
Artículo en Japonés | MEDLINE | ID: mdl-31685739

RESUMEN

Recently, a clinical study using a Chronic Liver Disease Questionnaire (CLDQ) showed that ledipasvir/sofosbuvir (LDV/SOF)-treated patients' QOL was more favorable than that of IFN/ribavirin (RBV)-treated patients. However, no study has reported QOL assessment in clinical practice. In this study, we compared the QOL between patients treated with LDV/SOF and those treated with simeprevir (SMV)/peginterferon (Peg-IFN)/RBV to provide QOL information in clinical practice. The subjects were 169 patients with type I chronic hepatitis C or compensated cirrhosis C (Child-Pugh Grade A) who were treated with SMV/Peg-IFN/RBV or LDV/SOF in Hitachi General Hospital. The QOL was assessed ≥2 weeks after the start of administration using the Japanese version of the CLDQ (Kida et al., 2008 version). The total CLDQ score in the LDV/SOF group was significantly higher than in the SMV/Peg-IFN/RBV group (6.59 vs. 6.38, respectively, p=0.007). In particular, the scores for 4 domains (abdominal symptoms, systemic symptoms, activity, and emotional function) in the former were significantly higher than in the latter (p<0.05). Furthermore, the rates of patients scoring 7 (no symptom) on 8 items in the former were significantly higher than in the latter (p<0.05). In clinical practice, LDV/SOF-treated patients' QOL was more favorable than that of those receiving conventional treatment with IFN and RBV. This study may make it possible for health care professionals to provide clinical QOL information on LDV/SOF therapy to patients. Furthermore, QOL information may promote decision-making for treatment, leading to effective treatment.


Asunto(s)
Antivirales/administración & dosificación , Bencimidazoles/administración & dosificación , Fluorenos/administración & dosificación , Hepatitis C Crónica/tratamiento farmacológico , Hepatitis C Crónica/psicología , Interferón-alfa/administración & dosificación , Polietilenglicoles/administración & dosificación , Calidad de Vida , Ribavirina/administración & dosificación , Simeprevir/administración & dosificación , Sofosbuvir/administración & dosificación , Encuestas y Cuestionarios , Adulto , Anciano , Anciano de 80 o más Años , Quimioterapia Combinada , Femenino , Humanos , Masculino , Persona de Mediana Edad , Proteínas Recombinantes/administración & dosificación
15.
Cochrane Database Syst Rev ; 2019(11)2019 11 07.
Artículo en Inglés | MEDLINE | ID: mdl-31697415

RESUMEN

BACKGROUND: Chronic hepatitis B is associated with high morbidity and mortality. Chronic hepatitis B requires long-term management aiming at reduction of the risks of hepatocellular inflammatory necrosis, liver fibrosis, decompensated liver cirrhosis, liver failure, and liver cancer, and improving health-related quality of life. The Chinese herbal medicine formula Xiao Chai Hu Tang has been used to decrease discomfort and replication of the virus in people with chronic hepatitis B. However, the benefits and harms of Xiao Chai Hu Tang formula have never been established with rigorous review methodology. OBJECTIVES: To assess the benefits and harms of Xiao Chai Hu Tang formula versus placebo or no intervention in people with chronic hepatitis B. SEARCH METHODS: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, and seven other databases to 1 March 2019. We also searched the World Health Organization International Clinical Trials Registry Platform (www.who.int/ictrp), ClinicalTrials.gov (www.clinicaltrials.gov/), and the Chinese Clinical Trial Registry for ongoing or unpublished trials to 1 March 2019. SELECTION CRITERIA: We included randomised clinical trials, irrespective of publication status, language, and blinding, comparing Xiao Chai Hu Tang formula versus no intervention or placebo in people with chronic hepatitis B. We included participants of any sex and age, diagnosed with chronic hepatitis B according to guidelines or as defined by the trialists. We allowed co-interventions when the co-interventions were administered equally to all the intervention groups. DATA COLLECTION AND ANALYSIS: Review authors independently retrieved data from reports and after correspondence with investigators. Our primary outcomes were all-cause mortality, serious adverse events, and health-related quality of life. Our secondary outcomes were hepatitis B-related mortality, hepatitis B-related morbidity, and adverse events considered 'not to be serious'. We presented the meta-analysed results as risk ratios (RR) with 95% confidence intervals (CI). We assessed the risks of bias using risk of bias domains with predefined definitions. We used GRADE methodology to evaluate our certainty in the evidence. MAIN RESULTS: We included 10 randomised clinical trials with 934 participants, but only five trials with 490 participants provided data for analysis. All the trials compared Xiao Chai Hu Tang formula with no intervention. All trials appeared to have been conducted and published only in China. The included trials assessed heterogeneous forms of Xiao Chai Hu Tang formula, administered for three to eight months. One trial included participants with hepatitis B and comorbid tuberculosis, and one trial included participants with hepatitis B and liver cirrhosis. The remaining trials included participants with hepatitis B only. All the trials were at high risk of bias, and the certainty of evidence for all outcomes that provided data for analyses was very low. We downgraded the evidence by one or two levels because of outcome risk of bias, inconsistency or heterogeneity of results (opposite direction of effect), indirectness of evidence (use of surrogate outcomes instead of clinically relevant outcomes), imprecision of results (the CIs were wide), and publication bias (small sample size of the trials). Additionally, 47 trials lacked the necessary methodological information needed to ensure the inclusion of these trials in our review. None of the included trials aimed to assess clinically relevant outcomes such as all-cause mortality, serious adverse events, health-related quality of life, hepatitis B-related mortality, or hepatitis B-related morbidity. The effects of Xiao Chai Hu Tang formula on the proportion of participants with adverse events considered 'not to be serious' is uncertain (RR 0.43, 95% CI 0.02 to 11.98; I2 = 69%; very low-certainty evidence). Only three trials with 222 participants reported the proportion of people with detectable hepatitis B virus DNA (HBV-DNA), but the evidence that Xiao Chai Hu Tang formula reduces the presence of HBV-DNA in the blood (a surrogate outcome) is uncertain (RR 0.62, 95% CI 0.45 to 0.85; I2 = 0%; very low-certainty evidence). Only two trials with 160 participants reported the proportion of people with detectable hepatitis B virus e-antigen (HBeAg; a surrogate outcome) (RR 0.72, 95% CI 0.50 to 1.02; I2 = 38%; very low-certainty evidence) and the evidence is uncertain. The evidence is also uncertain for separately reported adverse events considered 'not to be serious'. FUNDING: two of the 10 included trials received academic funding from government or hospital. None of the remaining eight trials reported information on funding. AUTHORS' CONCLUSIONS: The clinical effects of Xiao Chai Hu Tang formula for chronic hepatitis B remain unclear. The included trials were small and of low methodological quality. Despite the wide use of Xiao Chai Hu Tang formula, we lack data on all-cause mortality, serious adverse events, health-related quality of life, hepatitis B-related mortality, and hepatitis B-related morbidity. The evidence in this systematic review comes from data obtained from a maximum three trials. We graded the certainty of evidence as very low for adverse events considered not to be serious and the surrogate outcomes HBeAg and HBV-DNA. We found a large number of trials which lacked clear description of their design and conduct, and hence, these trials are not included in the present review. As all identified trials were conducted in China, there might be a concern about the applicability of this review outside China. Large-sized, high-quality randomised sham-controlled trials with homogeneous groups of participants and transparent funding are lacking.


Asunto(s)
Medicamentos Herbarios Chinos/uso terapéutico , Hepatitis B Crónica/tratamiento farmacológico , Medicina de Hierbas , Humanos , Fitoterapia , Ensayos Clínicos Controlados Aleatorios como Asunto
16.
BMC Health Serv Res ; 19(1): 765, 2019 Oct 28.
Artículo en Inglés | MEDLINE | ID: mdl-31660966

RESUMEN

BACKGROUND: Direct Acting Antiviral (DAAs) drugs have a much lower burden of treatment and monitoring requirements than regimens containing interferon and ribavirin, and a much higher efficacy in treating hepatitis C (HCV). These characteristics mean that initiating treatment and obtaining a virological cure (Sustained Viral response, SVR) on completion of treatment, in non-specialist environments should be feasible. We investigated the English-language literature evaluating community and primary care-based pathways using DAAs to treat HCV infection. METHODS: Databases (Cinahl; Embase; Medline; PsycINFO; PubMed) were searched for studies of treatment with DAAs in non-specialist settings to achieve SVR. Relevant studies were identified including those containing a comparison between a community and specialist services where available. A narrative synthesis and linked meta-analysis were performed on suitable studies with a strength of evidence assessment (GRADE). RESULTS: Seventeen studies fulfilled the inclusion criteria: five from Australia; two from Canada; two from UK and eight from USA. Seven studies demonstrated use of DAAs in primary care environments; four studies evaluated integrated systems linking specialists with primary care providers; three studies evaluated services in locations providing care to people who inject drugs; two studies evaluated delivery in pharmacies; and one evaluated delivery through telemedicine. Sixteen studies recorded treatment uptake. Patient numbers varied from around 60 participants with pathway studies to several thousand in two large database studies. Most studies recruited less than 500 patients. Five studies reported reduced SVR rates from an intention-to-treat analysis perspective because of loss to follow-up before the final confirmatory SVR test. GRADE assessments were made for uptake of HCV treatment (medium); completion of HCV treatment (low) and achievement of SVR at 12 weeks (medium). CONCLUSION: Services sited in community settings are feasible and can deliver increased uptake of treatment. Such clinics are able to demonstrate similar SVR rates to published studies and real-world clinics in secondary care. Stronger study designs are needed to confirm the precision of effect size seen in current studies. Prospero: CRD42017069873.


Asunto(s)
Antivirales/uso terapéutico , Servicios de Salud Comunitaria/estadística & datos numéricos , Hepatitis C/diagnóstico , Hepatitis C/tratamiento farmacológico , Tamizaje Masivo/estadística & datos numéricos , Atención Primaria de Salud/estadística & datos numéricos , Investigación sobre Servicios de Salud , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto
17.
JAAPA ; 32(11): 15-20, 2019 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-31592934

RESUMEN

Viral hepatitis remains a significant public health problem in the United States, despite advances in antiviral therapy and effective vaccines. According to the CDC, about 20,000 deaths each year are attributed to viral hepatitis, and 5 million people are chronically infected and at risk for serious liver disease and hepatocellular cancer. This article reviews the three most common causes of viral hepatitis, screening guidelines, clinical features, medical management, approaches for primary prevention, and the natural history of untreated disease.


Asunto(s)
Antivirales/uso terapéutico , Hepatitis Viral Humana , Tamizaje Masivo/métodos , Humanos , Estados Unidos
18.
J Infect ; 79(6): 503-512, 2019 12.
Artículo en Inglés | MEDLINE | ID: mdl-31629015

RESUMEN

The treatment of hepatitis C virus (HCV) infection has been revolutionised by the advent of oral, well-tolerated, direct acting antiviral therapies (DAA), with high cure rates. However, in some scenarios, HCV resistance to antiviral therapies may have an impact on treatment success. Public Health England's HCV Resistance Group was established to support clinicians treating people with HCV, where the issue of resistance may be a factor in clinical decision-making, and this review includes the Group's current recommendations on the use of HCV resistance testing. The authors describe the principles behind and approach to HCV resistance testing and consider evidence from in vitro studies, clinical trials and real world cohorts on the impact of HCV resistance on treatment outcomes for particular DAA regimens. Five scenarios are identified in the UK and similar settings, where, in the Group's opinion, resistance testing should be performed.

19.
Vnitr Lek ; 65(9): 546-551, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31635465

RESUMEN

Hepatitis B virus (HBV) infection remains a global public health problem with changing epidemiology due to several factors predominantly vaccination policy and migration. Chronic hepatitis B means the duration of HBV infection for more than 6 months. It is a dynamic process reflecting the interaction between HBV replication and the host immune response and not all patients with chronic HBV infection have chronic hepatitis B. All patients with chronic HBV infection are in increased risk of progression to liver cirrhosis and hepatocellular carcinoma. The long-term administration of potent nucleos(t)ide analogue with high barrier of resistance (tenofovir, entecavir) represents the treatment of choice. Pegylated interferon-α can also be considered in mid to moderate chronic hepatitis B patients.


Asunto(s)
Antivirales , Hepatitis B Crónica , Antivirales/uso terapéutico , Virus de la Hepatitis B , Hepatitis B Crónica/complicaciones , Hepatitis B Crónica/diagnóstico , Hepatitis B Crónica/tratamiento farmacológico , Humanos
20.
Int J Health Care Qual Assur ; 32(8): 1175-1199, 2019 Oct 14.
Artículo en Inglés | MEDLINE | ID: mdl-31566514

RESUMEN

PURPOSE: Hepatitis A is a prevalent disease that is largely preventable by vaccine usage. The vaccine for this illness is highly underused in most regions. In an attempt to find the strategies that are most beneficial in regard to quality-adjusted life years (QALYs) and cost in current environments, the purpose of this paper is to conduct cost-effectiveness analyses to investigate vaccination strategies in a more economically developed country (MEDC), generally known as a "developed" area: the USA, and a less economically developed country (LEDC), generally known as a "developing" area: the state of Rio de Janeiro, Brazil. DESIGN/METHODOLOGY/APPROACH: This study used a dynamic transmission model for comparative effectiveness analyses. The model ran two different scenarios. The two regions studied have different policies and strategies for Hepatitis A vaccination currently, and also used different strategies in 2009. In the USA, a universal vaccination policy was modeled, along with a scenario in which it was removed. In Rio de Janeiro, a no vaccination policy was modeled, along with a scenario in which a universal vaccination policy was effected. FINDINGS: The comparison of resulting incremental cost-effectiveness ratio values to accepted threshold values showed universal vaccination to be cost-effective in both the USA and Rio de Janeiro as compared to no vaccination. When episode and vaccination costs and vaccination efficacy were varied, this still remained true. Universal vaccination was found to result in lower incidence of Hepatitis A in both the USA and Rio de Janeiro. Over the twenty-year time horizon, universal vaccination is projected to prevent 506,945 cases of symptomatic Hepatitis A in the USA and 42,318 cases of Hepatitis A in Rio de Janeiro. Other benefits include a projected increase in cumulative QALYs through the use of universal vaccination. ORIGINALITY/VALUE: This analysis showed universal vaccination to be cost-effective as compared to no vaccination, and portions of the study's approach had not previously been applied in tandem to investigate Hepatitis A interventions. The results may help foster higher compliance rates for Hepatitis A vaccination and even greater per-person economic benefits of universal vaccination, particularly in the USA. The purpose of this study is also to encourage elevated levels of surveillance on age of infection in developing regions and consistent reevaluation utilizing dynamic transmission models in both the USA and Brazil, as well as other rapidly developing regions, in order to prevent future epidemics and costs associated with the disease.


Asunto(s)
Análisis Costo-Beneficio , Países en Desarrollo , Hepatitis A/prevención & control , Vacunación/economía , Vacunación/tendencias , Adolescente , Adulto , Brasil/epidemiología , Niño , Preescolar , Hepatitis A/epidemiología , Humanos , Lactante , Persona de Mediana Edad , Años de Vida Ajustados por Calidad de Vida , Adulto Joven
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