Pretreatment Assessment of Psychosocial Readiness Is Not Associated with Improved Treatment Outcomes in a Safety-Net HCV Treatment Clinic.

OBJECTIVES: Hepatitis C virus (HCV) is highly curable with antiviral therapy, and traditionally, treatment adherence has been critical for treatment success. We sought to determine whether assessing HCV treatment readiness with a structured treatment readiness tool was associated with increased rates of adherence and cure among patients at a safety-net HCV clinic. METHODS: We administered the Psychosocial Readiness Evaluation and Preparation for HCV Treatment (PREP-C) tool to 50 patients and compared them with 50 patients who received the usual care. The outcome measures included achievement of treatment milestones (eg, adherence to treatment, clinic visit attendance) and sustained virologic response (cure). RESULTS: We found no association between receiving the PREP-C assessment and outcomes, including referral to or starting HCV treatment, adherence to treatment, and HCV cure. CONCLUSIONS: We found that receiving the PREP-C assessment did not improve treatment outcomes, suggesting that targeted pretreatment assessment is unnecessary even in a medically and psychosocially complex population.

[QOL Assessment in Chronic Hepatitis C Patients Receiving Ledipasvir/ Sofosbuvir or Simeprevir/Peginterferon/Ribavirin in Clinical Practice].

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.

HCV and HBV prevalence based on home blood self-sampling and screening history in the general population in 2016: contribution to the new French screening strategy.

BACKGROUND: The advent of effective direct-acting antivirals (DAAs), has prompted an assessment of the French Hepatitis C virus (HCV) screening strategy, which historically targeted high-risk groups. One of the options put forward is the implementation of combined (i.e., simultaneous) HCV, Hepatitis B virus (HBV) and HIV screening for all adults at least once during their lifetime ("universal combined screening"). However, recent national survey-based data are lacking to guide decision-making regarding which new strategy to implement. Accordingly, we aimed to provide updated data for both chronic hepatitis C (CHC) and B (CHB) prevalence and for HCV and HBV screening history, using data from the BaroTest and 2016 Health Barometer (2016-HB) studies, respectively. METHODS: 2016-HB was a national cross-sectional phone based health survey conducted in 2016 among 20,032 randomly selected individuals from the general population in mainland France. BaroTest was a virological sub-study nested in 2016-HB. Data collected for BaroTest were based on home blood self-sampling on dried blood spots (DBS). RESULTS: From 6945 analyzed DBS, chronic hepatitis C (CHC) and B (CHB) prevalence was estimated at 0.30% (95% Confidence Interval (CI): 0.13-0.70) and 0.30% (95% CI: 0.13-0.70), respectively. The proportion of individuals aware of their status was estimated at 80.6% (95% CI: 44.2-95.6) for CHC and 17.5% (95% CI: 4.9-46.4) for CHB. Universal combined screening would involve testing between 32.6 and 85.3% of 15-75 year olds according to whether we consider only individuals not previously tested for any of the three viruses, or also those already tested for one or two of the viruses. CONCLUSIONS: Our data are essential to guide decision-making regarding which new HCV screening recommendation to implement in France. They also highlight that efforts are still needed to achieve the WHO's targets for eliminating these diseases. Home blood self-sampling may prove to be a useful tool for screening and epidemiological studies.

Barriers to treatment of chronic hepatitis C with direct acting antivirals in an urban clinic.

INTRODUCTION AND AIM: Direct-acting antiviral (DAA) agents are highly effective for treatment of chronic hepatitis C virus (HCV) yet access to treatment remains a serious challenge. The aim of this study was to identify barriers to treatment initiation with DAA-containing regimens in an urban clinic setting. MATERIALS AND METHODS: A retrospective cohort of all chronic HCV patients seen in an urban academic practice in Jacksonville, FL, USA from 1/2014 to 1/2017 was analyzed. Baseline characteristics were recorded and a review of medical records was performed to identify barriers to treatment initiation and overall success rates. RESULTS: Two-hundred and forty patients with chronic HCV were analyzed. Fifty-six percent of patients were African-American and 63% were insured through Medicaid/county programs or uninsured. Sixty-nine percent had barriers to initiating antiviral therapy categorized as psychosocial (n=112), provider (n=26), medical (n=20), and insurance-related factors (n=7). The most commonly encountered psychosocial barriers included failure to keep appointments (79/240, 33%), active substance abuse (18/240, 8%), and failure to obtain laboratory testing (11/240, 5%). Overall, only 27% of patients evaluated were initiated on DAA-containing regimens with 18% reaching SVR12 within the 36-month study period. CONCLUSION: In conclusion, only 27% of patients who presented to an urban academic practice with chronic HCV received DAA-containing regimens over a 36-month period. Psychosocial issues were the major barriers to antiviral therapy. These findings illustrate the need for an integrated approach that addresses psychosocial factors as well as comorbidities and adherence to care in order to increase rates of HCV treatment in at risk patients.

Determinants of Hepatitis C Treatment Adherence and Treatment Completion Among Veterans in the Direct Acting Antiviral Era.

BACKGROUND: Despite the availability of direct acting antiviral medications (DAAs), there are ongoing concerns about adherence to hepatitis C virus (HCV) treatment. We sought to understand the barriers to and facilitators of DAA adherence in the Veteran population. METHODS: Patients completed semi-structured interviews focused on barriers to and facilitators of HCV treatment adherence both pre- and post-DAA treatment. Adherence was assessed via provider pill count and self-report. Thematic analyses were conducted in the qualitative software program Atlas.ti in order to understand anticipated barriers to and facilitators of treatment adherence and completion. Charts were reviewed for clinical data and sustained virologic response (SVR12). RESULTS: Of 40 patients, 15 had cirrhosis and 10 had prior interferon-based treatment. Pre-treatment interviews revealed anticipated barriers to adherence such as side effects (n = 21) and forgetting pills (n = 11). Most patients (n = 27) reported following provider advice, and others had unique reasons not to (e.g., feeling like a "guinea pig"). Post-treatment interviews uncovered facilitators of treatment including wanting to cure HCV (n = 17), positive results (n = 18), and minimal side effects (n = 15). Three patients (8%) did not complete therapy (whom we further elaborate on) and 6 (15%) missed doses but completed treatment. SVR12 was achieved by all participants who completed therapy (93%). Patients who did not complete therapy or missed doses were all treatment naïve, mostly non-cirrhotic (8 of 9), and often anticipated concerns with forgetting their medications. CONCLUSIONS: This qualitative study uncovered several unanticipated determinants of HCV treatment completion and provides rationale for several targeted interventions such as incorporating structured positive reinforcement.

Burden of disease in patients with chronic hepatitis C in the Austrian REAL study.

BACKGROUND: The direct-acting antiviral regimen of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) ± dasabuvir (DSV) ± ribavirin (RBV) is approved to treat patients with chronic hepatitis C (CHC) infection genotypes 1 or 4, including compensated cirrhosis. The aim of the prospective, multicenter, observational REAL study was to provide evidence of the effectiveness of this regimen in an Austrian real-world setting and to determine the impact on patient-reported outcomes (PROs). METHODS: Effectiveness was defined as sustained virologic response 12 weeks after the end of treatment (SVR12). EuroQol 5 Dimension 5 Level (EQ-5D-5L) and Work Productivity and Activity Impairment HepC v2.0 (WPAI) questionnaires were used to assess PROs. RESULTS: A total of 173 patients were enrolled. The SVR12 was 95.9% (140/146) in the core population with sufficient follow-up (i. e. patients without SVR12 data not due to efficacy/safety reasons, such as lost to follow-up, were excluded) and 84.8% (140/165) in the core population (CP). Data at all timepoints for the EQ-5D-5L index score and visual analog scale and the total activity impairment score of the WPAI were available for 88, 95 and 72 patients, respectively. All PROs remained generally unaltered during treatment with OBV/PTV/r ± DSV ± RBV but showed a statistically significant (p < 0.01) improvement 12 weeks after the end of treatment versus baseline. CONCLUSIONS: These are the first data on PROs in a real-world setting with OBV/PTV/r ± DSV ± RBV treatment; this study demonstrated that treatment did not negatively impact quality of life. Results from the Austrian REAL study support the effectiveness of OBV/PTV/r ± DSV ± RBV in patients with CHC genotype 1 and 4 in everyday clinical practice.

Barriers and facilitators to hepatitis C (HCV) screening and treatment-a description of prisoners' perspective.

BACKGROUND: Hepatitis C virus (HCV) infection is a global epidemic with an estimated 71 million people infected worldwide. People who inject drugs (PWID) are overrepresented in prison populations globally and have higher levels of HCV infection than the general population. Despite increased access to primary health care while in prison, many HCV infected prisoners do not engage with screening or treatment. With recent advances in treatment regimes, HCV in now a curable and preventable disease and prisons provide an ideal opportunity to engage this hard to reach population. AIM: To identify barriers and enablers to HCV screening and treatment in prisons. METHODS: A qualitative study of four prisoner focus groups (n = 46) conducted at two prison settings in Dublin, Ireland. RESULTS: The following barriers to HCV screening and treatment were identified: lack of knowledge, concerns regarding confidentiality and stigma experienced and inconsistent and delayed access to prison health services. Enablers identified included; access to health care, opt-out screening at committal, peer support, and stability of prison life which removed many of the competing priorities associated with life on the outside. Unique blocks and enablers to HCV treatment reported were fear of treatment and having a liver biopsy, the requirement to go to hospital and in-reach hepatology services and fibroscanning. CONCLUSION: The many barriers and enablers to HCV screening and treatment reported by Irish prisoners will inform both national and international public health HCV elimination strategies. Incarceration provides a unique opportunity to upscale HCV treatment and linkage to the community would support effectiveness.

A cross-sectional assessment of health-related quality of life in Chinese patients with chronic hepatitis c virus infection with EQ-5D.

BACKGROUND: Hepatitis C virus (HCV) infection is one of the most common liver infections, with a decrement in HRQoL of HCV patients. This study aims to assess Health-related quality of life (HRQoL) in Chinese patients with chronic HCV infection, and to identify significant predictors of the HRQoL in these patients of China. METHODS: In this cross-sectional observational study, treatment-naïve Han ethnic adults with chronic HCV infection were enrolled. Adopting European Quality of Life scale (EQ-5D) and EuroQOL visual analogue scale (EQ-VAS) were used to qualify HRQoL. Results were reported in descriptive analyses to describe sociodemographic and clinical characteristics. Multiple linear regression analysis was applied to investigate the associations of these variables with HRQoL. Binary logistic regression analysis was performed to identify associations of these variables with HRQoL by dimensions of EQ-5D. RESULTS: Nine hundred ninety-seven patients were enrolled in the study [median age 46.0 (37.0, 56.0) years; male 54.8%]. Mean EQ-5D index and EQ-VAS score were 0.780 ± 0.083 and 77.2 ± 14.8. Multiple Linear regression analysis showed that income (< 2000 RMB, ß = - 0.134; 2000-4999 RMB, ß = - 0.085), moderate or severe symptoms of discomfort (more than one symptoms, ß = - 0.090), disease profile (cirrhosis, ß = - 0.114), hyperlipidemia (ß = - 0.065) and depression (ß = - 0.065) were independently associated with EQ-5D index. Residence (the west, ß = 0.087), income (< 2000 RMB, ß = - 0.129; 2000-4999 RMB, ß = - 0.052), moderate or severe symptoms of discomfort (more than one symptoms, ß = - 0.091), disease profile and depression (ß = - 0.316) were the influencing factors on EQ-VAS. Binary logistic regression indicated that disease profile and clinical depression were the major influencing factors on all five dimensions of EQ-5D. CONCLUSIONS: In this cross-sectional assessment of HCV patients in China, we indicated HRQoL of Chinese HCV patients. Significant negative associations between HRQoL and sociodemographic and clinical factors such as moderate or severe symptoms of discomfort, disease profile and depression emerged. We have to focus on optimally managing care of HCV patients and improving their HRQoL. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01293279. Date of registration: February 10, 2011.

Prediction of Health Utility Scores in Patients with Chronic Hepatitis C Using the Chronic Liver Disease Questionnaire-Hepatitis C Version (CLDQ-HCV).

BACKGROUND: Preference-based health utilities are used in economic analyses of disease burden and health care interventions. When specifically designed instruments cannot be applied, mapping algorithms for non-preference-based instruments can be used for prediction of health utility scores. OBJECTIVES: To develop a mapping algorithm for the Chronic Liver Disease Questionnaire-Hepatitis C Version (CLDQ-HCV), the hepatitis C virus-specific quality-of-life instrument. METHODS: We used a sample of patients with HCV who completed the short form 36 health survey and the CLDQ-HCV in clinical trials; six-dimensional health state short form (SF-6D) utilities were derived from the 36-item short form health survey. Regression models with components of the CLDQ-HCV being predictors and SF-6D being the outcome were developed and tested in an independent testing set and in clinically significant subpopulations. RESULTS: The sample of 34,822 records was split (4:1) into training and testing set. Simple mixed models had a root mean square error up to 0.088; predicted and observed utilities were highly correlated (Pearson correlation 0.81-0.82) although predicted utilities were underestimated in the range closest to perfect scores. Generalized linear models had better average accuracy (root mean square error up to 0.0839; correlations up to 0.844) and significantly better accuracy in the highest values (median error up to 0.065). Accuracy in the independent testing set was nearly identical, and so was accuracy in patients with compensated and decompensated cirrhosis; the errors of group means were less than 0.015. CONCLUSIONS: A number of linear models for mapping domains or items of CLDQ-HCV to SF-6D health utilities have been developed. The models have excellent accuracy at the group level. Predicted health utility scores can be used in further economic analyses involving patients with HCV.

The impact of nutrition on quality of life of patients with hepatitis C.

PURPOSE OF REVIEW: The aim of this study was to review the most recent aspects of nutrition and its impact on health-related quality of life (HRQOL) in patients with chronic hepatitis C (CHC). RECENT FINDINGS: Low HRQOL scores have been found in all stages of hepatitis C virus (HCV) infection. Of the factors linked to HRQOL, three aspects should be emphasized, nutritional status, physical activity and mental health status. Regarding the nutrition and metabolic conditions, a broad spectrum of nutritional disorders may impact on HRQOL of patients with CHC. SUMMARY: Malnutrition, which is a significant comorbidity in end-stage of all chronic liver diseases, has been recognized as a significant factor related to poor HRQOL. Of note, in individuals chronically infected with HCV, low muscle skeletal mass, an early indicator of undernourishment, precedes the development of cirrhosis. Because of the strict linkage between HRQOL, nutrition and physical activity, the assessment of the musculoskeletal system abnormalities in every patient with CHC, independently of the stage of the liver disease, is of utmost relevance. Maintenance of healthy skeletal muscle is essential to reduce the negative effects of sarcopenia on HRQOL. Otherwise, overweight/obesity and chronic HCV infection can cause insulin resistance, which has been associated with HRQOL impairment.

Chronic hepatitis C and individuals with a history of injecting drugs in Spain: population assessment, challenges for successful treatment.

In Spain, there is a need to improve chronic hepatitis C care among people who inject drugs (PWID). Injecting drug use is an important risk behaviour for hepatitis C virus (HCV) infection. Review of 28 sources of the relevant published literature mapped the size of the addiction-HCV population in Spain. Experts in opioid use disorder (OUD) treatment in Spain completed a consensus to define the population size, HCV prevalence and access or barriers to hepatitis C treatment for PWID populations. In Spain, over 300 000 individuals have a lifetime history of injecting drugs. Currently, 150 000 individuals in Spain have OUD; many have injected drugs. Each year, 80 000 individuals engage with treatment services for OUD. A proportion of this group continues to inject drugs. There is a high HCV prevalence in PWID - estimates of 60-80% in Spain. Uptake of hepatitis C therapy in PWID in Spain is limited; barriers include awareness of treatment pathways, advocacy for regular screening and effective joint care. There is an urgent need to address barriers to effective hepatitis C care for PWID in Spain. Practical and specific strategies including peer-led solutions, patient buddy systems and joint working models at the local level can make important short-term differences.

[Study of disease burden of chronic hepatitis B and C patients in Shanghai based on Bronfenbrenner' s ecological systems theory: a community-based survey].

Objective: To systemically analyze family burden, quality of life of chronic hepatitis B and C patients in Shanghai and related influencing factors. Methods: A representative sample of chronic hepatitis patients (n=1 478) and their family members (n=1 478) was randomly selected through a multi-stage cluster sampling from 30 communities in 10 districts of Shanghai. One patient and one family member of each family were interviewed using different questionnaires to collect related information. Based on Bronfenbrenner' s ecological systems, psychological measurement, two-level random intercept model and multivariable structural equation model were applied to determine the effects and directions of the factors between life quality of chronic hepatitis patients and family burden. Results: The mean score of quality of life of chronic hepatitis patients in Shanghai was 78.70 ± 13.25, the score of " specific module" was highest and the score of " social function" was lowest. Additionally, the mean score of burden reported by the family members was 12.62±10.74, the score of " financial burden" was highest, and the score of " effect on family member' s health" was lowest. Multivariable structural equation model indicated that eight factors were related with life quality and family burden of patients with chronic hepatitis. Among them, HCV infection, elevated serum alanine aminotransferase level, average monthly cost for patient >3 000 yuan (RMB) and poor health of family members were the direct risk factors for the life quality of the patients as well as family burden. The factor of drinking more than once a week influenced the patients' life quality directly and family burden indirectly. On the contrary, the factors of local household registration, hospitalization and family member's indifferent attitude to hepatitis B vaccination influenced the family burden of the chronic hepatitis patients directly and the life quality of the patients indirectly. Conclusion: The findings could be used in the development of community based management and intervention of chronic hepatitis patients in Shanghai.

Hepatitis C in Intravenous Drug Users: Study of Obstacles and Facilitators to Access to Health Care and Services / Hépatite C chez les usagers de drogues par voie veineuse : exploration des barrières et des facilitants pour l'accès aux soins et services.

Objective: The study was designed to document the experiences of people affected by hepatitis C with respect to prevention, screening and treatment to more clearly understand the determinants of health trajectories and access to the health system.Methods: Based on an evaluative research, we conducted a thematic qualitative analysis of four focus group interviews with people affected by hepatitis C. Two interviews (n = 3) consisted of people at risk of contracting hepatitis C, the third interview (n = 6) concerned people diagnosed HCV positive but not treated and the fourth interview (n = 6) targeted people who had access to treatment (n = 6).Results: We identified the drivers, barriers and facilitating factors, trajectories of health and care of people affected by hepatitis C in two periods of life: from the injection to HCV screening and from HCV diagnosis to treatment. Life trajectories in relation to hepatitis C are the product of many influences: the personal life experience, the attitude of healthcare staff, the organization of the health system and contingent factors.Conclusion: Understanding the life experience of people affected by hepatitis C is essential to identify potential levers of change and new ways to organize the health system in order to more effectively reach these people.

Assessment of health-related quality of life and related factors in patients with chronic liver disease

ABSTRACT BACKGROUND AND OBJECTIVES: Assessing health-related quality of life is an important aspect of clinical practice. Thus, the present study attempts to assess the health-related quality of life of patients with chronic liver disease. METHODS: A cross-sectional survey was conducted on 133 chronic liver disease patients, using three instruments: a demographic questionnaire, the Chronic Liver Disease Questionnaire, and Model for End-Stage Liver Disease index. Variables were expressed as frequencies, percentages, means, and standard deviations. The statistical analysis included Pearson's correlation, Student's t-test, and analysis of variance (p < 0.05 was considered significant). RESULTS: The mean age of included subjects was 50.5 ± 13.3 years. The majority were male (66.2%), Caucasian (70.7%), and had a family income of US$329-US$658.2. Over half of the patients (56.4%) were infected by hepatitis C virus and 93.2% had low Model for End-Stage Liver Disease scores. Model for End-Stage Liver Disease score was related to age (r = 0.185;p = 0.033). Higher mean Chronic Liver Disease Questionnaire scores were obtained for emotional function (39.70/SD ± 12.98) and while lower scores were obtained for abdominal symptoms (16.00/SD ± 6.25). Fifty-two patients (39.1%) presented overall low (<5) Chronic Liver Disease Questionnaire scores. Furthermore, Chronic Liver Disease Questionnaire score was related to family income (r = 0.187, p = 0.031). CONCLUSION: Most individuals presented high mean Chronic Liver Disease Questionnaire scores, indicating low health-related quality of life, especially individuals with low family income.

Assessment of health-related quality of life and related factors in patients with chronic liver disease.

BACKGROUND AND OBJECTIVES: Assessing health-related quality of life is an important aspect of clinical practice. Thus, the present study attempts to assess the health-related quality of life of patients with chronic liver disease. METHODS: A cross-sectional survey was conducted on 133 chronic liver disease patients, using three instruments: a demographic questionnaire, the Chronic Liver Disease Questionnaire, and Model for End-Stage Liver Disease index. Variables were expressed as frequencies, percentages, means, and standard deviations. The statistical analysis included Pearson's correlation, Student's t-test, and analysis of variance (p<0.05 was considered significant). RESULTS: The mean age of included subjects was 50.5±13.3 years. The majority were male (66.2%), Caucasian (70.7%), and had a family income of US$329-US$658.2. Over half of the patients (56.4%) were infected by hepatitis C virus and 93.2% had low Model for End-Stage Liver Disease scores. Model for End-Stage Liver Disease score was related to age (r=0.185; p=0.033). Higher mean Chronic Liver Disease Questionnaire scores were obtained for emotional function (39.70/SD±12.98) and while lower scores were obtained for abdominal symptoms (16.00/SD±6.25). Fifty-two patients (39.1%) presented overall low (<5) Chronic Liver Disease Questionnaire scores. Furthermore, Chronic Liver Disease Questionnaire score was related to family income (r=0.187, p=0.031). CONCLUSION: Most individuals presented high mean Chronic Liver Disease Questionnaire scores, indicating low health-related quality of life, especially individuals with low family income.

Evidence-based interventions to enhance assessment, treatment, and adherence in the chronic Hepatitis C care continuum.

BACKGROUND: With the explosion of newly available direct acting antiviral (DAA) Hepatitis C virus (HCV) treatments that demonstrate 95% sustained virologic response (SVR) rates, evidence-based strategies are urgently needed to achieve real-world effectiveness in challenging patient populations. While HIV is incurable, lessons from over 30 years of experience overcoming obstacles to the HIV treatment cascade could be applied to the HCV context. METHODS: Using Institute of Medicine guidelines, we conducted a systematic review of published interventions from PubMed, Medline, GoogleScholar, EmBASE, and PsychInfo bibliographic databases and citation indices. Abstracts were first screened by three independent reviewers and studies were included if they involved original research, described a specific intervention, were published in English in a peer-reviewed journal between 2001 and 2014, and had full text available. RESULTS: Evidence-based interventions to enhance HCV assessment, treatment, and adherence generally fell into one of 4 categories, including those involving: (1) diagnosis or case-finding; (2) linkage to HCV care; (3) pre-therapeutic evaluation or treatment initiation; or (4) treatment adherence. While most available eligible studies described interventions using non-contemporary interferon-based HCV treatments, future research will need to address how these interventions apply to the context of well-tolerated, simple, oral treatment regimens. In some cases, we explored how HIV-specific interventions might be modified to fit the HCV spectrum of care engagement. CONCLUSIONS: Evidence-based interventions should be strategically incorporated into HCV treatment implementation efforts to most effectively deliver treatment and maximize treatment outcomes.

Achieving sustained virologic response in hepatitis C: a systematic review of the clinical, economic and quality of life benefits.

BACKGROUND: The goal of chronic hepatitis C treatment is to remove the virus to avoid progression of HCV-related disease. Sustained virologic response (SVR) is the most widely used efficacy endpoint in clinical studies of hepatitis C, and represents the eradication of HCV from the body. The aim of the current review was to examine the long-term clinical, economic and quality of life benefits associated with achieving SVR. METHODS: A systematic literature review was performed using the PubMed, EMBASE and Cochrane library databases to identify articles examining the clinical, economic and quality of life benefits associated with SVR, published in English language from 2002-2013. For inclusion studies were required to enroll ≥100 patients and to report clinical endpoints including hepatocellular carcinoma, overall- or liver-related mortality, or progression of disease/complications (e.g. portal hypertension, esophageal varices). Review of economic studies on cost/cost-effectiveness of achieving SVR were focused on studies assessing boceprevir/telaprevir plus pegIFN and ribavirin as this represents the current standard of care in several jurisdictions worldwide. Quality of life evidence was required to use validated quality of life instruments and provide a quantitative analysis of the impact of SVR versus no treatment or treatment failure. RESULTS: SVR is durable with late relapse rates over 4-5 year periods being in the range of 1-2%. Patients who achieve SVR frequently demonstrate some regression of fibrosis/cirrhosis and have a substantially reduced risk for hepatocellular carcinoma (relative risk [RR] 0.1-0.25), liver-related mortality (RR 0.03-0.2) and overall mortality (RR 0.1-0.3) in comparison with no treatment or treatment failure. In the 5 years post-treatment, medical costs for patients achieving SVR are 13-fold lower than patients not achieving SVR. Patients who achieve SVR also have health state utility values that are 0.05 to 0.31 higher than non-responders to treatment. CONCLUSIONS: SVR represents the fundamental goal of antiviral treatment for patients infected with chronic HCV, so as to reduce risk of liver disease progression. Achievement of SVR has implications beyond those of clearing viral infection; it is associated with improved long-term clinical outcomes, economic benefits and improved health-related quality of life.

Assessment of the Reliability of the Serbian Version of the Sickness Impact Profile Questionnaire in Patients with Chronic Viral Hepatitis.

INTRODUCTION: Health-related quality of life (HRQL) of chronic patients has been researched as the ultimate goal of modern treatment of chronic diseases to improve patients'quality of life. OBJECTIVE: The objective was to assess the reliability of the Serbian version of the Sickness Impact Profile (SIP) questionnaire on the sample of patients with chronic viral hepatitis. METHODS: The research covered 102 patients with chronic hepatitis (47 type B and 55 type C). The assessment of the reliability of the SIP questionnaire was performed by testing the internal consistency of the questions by calculating the Cronbach's alpha coefficient. The factor analysis was used to assess whether the grouping of the questions within dimensions matches the distribution of the questions in the original English version of the questionnaire administered to U.S. patient population. RESULTS: The Cronbach's alpha coefficient for the entire questionnaire is 0.925, 0.869 for the physical dimension, and 0.857 for the psychosocial dimension. After running a factor analysis of the psychosocial dimension, "emotional instability" was extracted as the key factor, confirming the results of previous research. Compared with the English version of the questionnaire, the Cronbach's alpha coefficient of the Serbian version does not diverge significantly, whereas the factor analysis confirms the classification of the questionnaire into two dimensions. CONCLUSION: Our study has shown that the Serbian version of the SIP questionnaire is a reliable tool for assessing the HRQL of patients with chronic hepatitis B and C before starting treatment.

Self-efficacy and adherence to antiviral treatment for chronic hepatitis C.

GOALS: To investigate the role of self-efficacy (SE) during hepatitis C virus (HCV) treatment. BACKGROUND: Adherence to chronic HCV treatment is critical. SE is an important predictor of medication adherence in a number of chronic disease populations and medication regimens, but its role during HCV treatment remains unknown. STUDY: Data from the prospective Virahep-C study were analyzed to examine relationships between SE and patient-driven deviations (ie, missed doses measured using electronic pill caps, and nonpersistence) from adherence to HCV antiviral treatment. SE was measured using the 17-item HCV Treatment Self-Efficacy scale. This measure provides a global estimate of a patient's confidence to undergo and adhere to HCV treatment, and can estimate SE in 4 underlying domains: communication SE (ie, confidence to communicate with health care provider), physical coping SE (ie, confidence to cope with physical side effects), psychological coping SE (ie, confidence to cope with psychiatric side effects), and treatment adherence SE (ie, confidence to take all medications as prescribed and attend doctor visits). Generalized estimating equations and Cox proportional hazards models were used to assess associations between SE and missed doses and nonpersistence, respectively. RESULTS: SE was associated with being in a relationship, educated, privately insured, and less depressed. Higher communication SE at TW24 reduced the risk of missed doses between TW24 and TW48. Higher baseline treatment adherence SE reduced the likelihood of nonpersistence between baseline and TW24. CONCLUSIONS: SE's relationship to HCV treatment adherence has promising clinical and research implications.

Psychometric evaluation of the hepatitis C virus patient-reported outcomes (HCV-PRO) instrument: validity, responsiveness, and identification of the minimally important difference in a phase 2 clinical trial.

PURPOSE: To describe the psychometric properties and identify the minimally important difference (MID) of the hepatitis C virus patient-reported outcomes (HCV-PRO) instrument. Chronic HCV infection and associated treatments negatively affect PROs of function and well-being. METHODS: In a phase 2 trial, HCV-infected patients received direct-acting antivirals (DAAs) for 12 weeks with peg-interferon/ribavirin (peg-IFN/RBV) for 48 weeks, or placebo plus peg-IFN/RBV. The HCV-PRO total score, SF-36 PCS and MCS scores, EQ-5D-3L, and EQ VAS were measured at baseline, week 8, end of DAA treatment (EODT), end of peg-IFN/RBV treatment (EOT), and posttreatment week 24 (SVR24). Convergent validity of the HCV-PRO was assessed by Pearson's correlation coefficients. Discriminant validity was assessed by analyzing mean HCV-PRO total scores by EQ-5D anxiety/depression and pain/discomfort domain scores (none vs. some) and presence/absence of depression or fatigue adverse events. MID was identified through effect size (ES) and receiver-operating characteristic (ROC) curve analyses (HCV-PRO response vs. SF-36 PCS/MCS and EQ VAS MID thresholds). RESULTS: In 74 patients (22 % female; 81 % White; 51 % ≥50 years), correlations (0.64-0.96) between HCV-PRO total scores, SF-36 PCS/MCS scores, and EQ VAS scores at all time points supported convergent validity. HCV-PRO total scores were reduced to 10-30 points in patients impaired by depression, pain, or fatigue symptoms. Impact of peg-IFN/RBV regimen on HCV-PRO ES increased over time (EODT -0.76; EOT -0.93). ES and ROC curve analyses indicated an MID of -10 points. CONCLUSION: The HCV-PRO was valid and responsive in the population studied. An MID of -10 points represented a threshold of clinical significance for the HCV-PRO.