A Population Approach to Disease Management: Hepatitis C Direct-Acting Antiviral Use in a Large Health Care System

Belperio, Pamela S.; Backus, Lisa I.; Neuhauser, Melinda M.; Molé, L

doi:10.18553/jmcp.2014.20.6.533

Cited by 17 publications

(19 citation statements)

References 14 publications

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“…It is encouraging that our findings are similar to these studies, as our cohort reflects a different population (regularly insured, nonveterans, and a higher proportion of women) than the other large observational treatment cohorts. Of note, while our observed rates of ribavirin dose reduction were similar to those reported in a large VA population taking TVR or BOC, our rates of erythropoietin use were much higher than the less 26% found in that population[27]. Nevertheless, our SVR rate was lower than those reported in the clinical trials.…”

Section: Discussionsupporting

confidence: 82%

Effectiveness of Telaprevir and Boceprevir Triple Therapy for Patients with Hepatitis C Virus Infection in a Large Integrated Care Setting

et al. 2014

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Background In 2011, the FDA approved telaprevir (TVR) and boceprevir (BOC) for use with pegylated-interferon and ribavirin to treat hepatitis C virus (HCV) genotype 1. We aimed to evaluate the real-world application, tolerability, and effectiveness of TVR and BOC-based HCV treatment in a large integrated care setting. Methods We utilized Northern California Kaiser Permanente Medical Care Program (KPNC) electronic databases and medical records to study the experience of all KPNC patients who initiated TVR or BOC from June 2011-March 2012. Results Compared to the pool of 5,194 treatment-eligible patients, the 352 treatment initiators were more likely to be cirrhotic (24% vs 10%, p<0.001) and treatment-experienced (44% vs 22%, p<0.001). Among the treatment initiators, 211 received TVR and 141 BOC. Overall, 31% discontinued treatment prematurely; 16% of patients stopped treatment early because of side effects. One patient with cirrhosis died of sepsis during treatment. Premature discontinuation was highest among TVR-treated cirrhotic patients (58%). Sustained virologic response (SVR) was achieved in 55% overall and was similar comparing the TVR- (56%) and BOC- (53%) treated groups. The only independent predictors of treatment failure were cirrhosis at baseline [odds ratio (OR) for SVR 0.44, p=0.004] and prior partial or null response (OR for SVR 0.57, p=0.02). Conclusions In the initial application of TVR and BOC, patients with cirrhosis and prior treatment failure were prioritized for treatment. In this real-world experience, most patients successfully completed a full treatment course. However, side effect-related premature discontinuations were common, and SVR rates were lower than reported in clinical trials.

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Section: Discussionsupporting

confidence: 82%

Effectiveness of Telaprevir and Boceprevir Triple Therapy for Patients with Hepatitis C Virus Infection in a Large Integrated Care Setting

et al. 2014

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“…In addition to the direct impact on PRO impairment during treatment, the side effect profile of IFN‐based regimens (flu‐like symptoms, fatigue, rash and depression) excluded many patients from receiving treatment leaving only a small number of HCV patients eligible for anti‐HCV treatment . In addition, the presence of certain comorbid conditions (anaemia, autoimmune disorder, renal dysfunction, cardiovascular disease, psychiatric issues including severe depression, psychosis/bipolar disease, severe lung disease and substance abuse) contraindicated the use of IFN, RBV and first generation DAAs further decreasing the pool of eligible candidates for treatment . The lack of insurance coverage created another important barrier to receive treatment.…”

Section: Application Of Pro Assessment In Ch‐cmentioning

confidence: 99%

Systematic review: patient-reported outcomes in chronic hepatitis C - the impact of liver disease and new treatment regimens

Younossi

Henry

2015

Aliment Pharmacol Ther

164

189

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Summary Background Treatment for chronic hepatitis C (CH‐C) is rapidly changing and moving away from an interferon and ribavirin‐based therapy to interferon‐free ribavirin‐free all oral regimens. These regimens are simpler and shorter to administer with very high efficacy rates and better side effect profiles. As advances in the treatment of CH‐C occur, it is imperative to capture both clinical outcomes (efficacy and safety) as well as patient‐reported outcomes (PROs). In fact, PROs assesses and quantifies the impact of these regimens on patient experience. PROs assess patients' health‐related quality of life (HRQOL) especially in the realms of fatigue and neuropsychiatric issues such as depression which can affect treatment adherence and work productivity. Aim To review the literature related to PRO's in HCV patients and summarise the impact of CH‐C and its treatment on PROs. Methods Databases Ovid MEDLINE and PubMed were searched from 1990 to October 2014 using a combination of MEsh, thesaurus terms and relevant text words: hepatitis C, CH‐C, treatment, quality of life, health‐related quality of life, fatigue, work productivity, adherence, patient‐reported outcomes, direct acting anti‐viral agents and second generation direct acting anti‐viral agents. Each manuscript was assessed for pertinence to the issue of PROs in CH‐C as well as the quality of study design and publications. Results From the literature, it is evident that CH‐C patients have baseline PRO impairment. Furthermore, treatment with interferon with or without ribavirin and first generation DAAs causes additional PRO burden which can negatively impact treatment adherence and indirectly, treatment efficacy and work productivity. The new treatment regimens with interferon‐ and ribavirin‐free regimens not only have very high efficacy, but also result in the improvement of PRO scores as early as 2 weeks into treatment as well as possibly better adherence to treatment regimens. Conclusions CH‐C and its treatment have been associated with patient‐reported outcome impairment. The new IF‐free and RBV‐free regimens are associated with high efficacy and substantial improvement of patient‐reported outcomes in clinical trial setting. Although very encouraging, more data are needed to assess patient‐reported outcomes, adherence and work productivity of CH‐C patients in the real world setting of clinical practice.

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“…We evaluated HCC screening in two subgroups: (1) patients with cirrhosis and (2) high-risk carriers (defined by age 40 and at least one of the following: HBV DNA >2000 IU/mL, ALT 2 upper limit of normal [ULN]). (5,24) In these two subgroups, we calculated the proportion of total follow-up time during which patients were adherent to annual or biannual screening intervals with appropriate liver imaging (ultrasound, contrast-enhanced computed tomography, or magnetic resonance imaging) using a similar method to Goldberg et al in which adherence is measured as a continuous variable. (25) A grace period of 30 days was accounted for in adherence calculations.…”

Section: Process Outcomesmentioning

confidence: 99%

Care delivery and outcomes among US veterans with hepatitis B: A national cohort study

et al. 2016

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Previous studies have identified gaps in hepatitis B care. The objectives of this study were to evaluate the delivery of care among a national cohort of US veterans with chronic hepatitis B infection and examine risk factors for adverse clinical outcomes. We conducted a retrospective cohort study using the Veterans Health Administration Corporate Data Warehouse from 1999 to 2013 to evaluate (1) care delivery and (2) clinical outcomes such as hepatocellular carcinoma, hepatic decompensation, and mortality among US veterans with hepatitis B. Incidence rates with 95% confidence intervals were calculated and Cox regression models were used to evaluate clinical outcomes. We identified 21,419 veterans with a positive hepatitis B surface antigen, and 97% of patients had alanine aminotransferase and 44% had hepatitis B virus DNA testing; hepatitis B e antigen and hepatitis B e antibody were tested <50% of the time. Patients receiving specialty care had a higher prevalence of recommended laboratory testing. Patients with elevated alanine aminotransferase in specialty care were more likely to receive antiviral therapy (50% versus 24% for specialty care versus no specialty care, P < 0.001). Among patients with cirrhosis, 69% received one-time liver imaging. The proportion of follow-up time adherent to annual imaging was 0.39 (standard deviation 5 0.42), and the proportion was 0.28 (standard deviation 5 0.33) for biannual imaging; both proportions were higher in the specialty care group (all P < 0.05). Antiviral therapy (hazard ratio 5 0.85, 95% confidence interval 0.76-0.95, P 5 0.005) and liver imaging (hazard ratio 5 0.84, 95% confidence interval 0.76-0.91, P < 0.001) were independently associated with decreased mortality in adjusted analyses. Conclusion: We observed a low prevalence of recommended laboratory testing, antiviral therapy initiation, and liver imaging among a national cohort of veterans with hepatitis B infection; antiviral therapy and liver imaging were independently associated with decreased mortality. (HEPATOLOGY 2016;63:1774-1782 SEE EDITORIAL ON PAGE 1755A pproximately 350 million people worldwide are chronically infected with hepatitis B virus (HBV). In the United States, the prevalence of chronic hepatitis B remains incompletely quantified, with estimates ranging from approximately 800,000 individuals to as high as 2.2 million when including foreign-born Americans. (1,2) Chronic HBV infection is a significant cause of morbidity and mortality, leading to liver failure, cirrhosis, and hepatocellular carcinoma (HCC) in 25%-40% of infected persons. (3) Specifically, in the United States, hepatitis B is the underlying cause of an estimated 1800-4000 deaths each year. (2,4) Despite the significant burden of disease and existence of management guidelines for the evaluation and treatment of chronic HBV, (5) studies have shown variable adherence to recommended HBV care, including low rates of alanine aminotransferase (ALT) and HBV DNA level monitoring and infrequent HCC surveillance. (6,7) Significant gaps i...

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A Population Approach to Disease Management: Hepatitis C Direct-Acting Antiviral Use in a Large Health Care System

Cited by 17 publications

References 14 publications

Effectiveness of Telaprevir and Boceprevir Triple Therapy for Patients with Hepatitis C Virus Infection in a Large Integrated Care Setting

Effectiveness of Telaprevir and Boceprevir Triple Therapy for Patients with Hepatitis C Virus Infection in a Large Integrated Care Setting

Systematic review: patient-reported outcomes in chronic hepatitis C - the impact of liver disease and new treatment regimens

Care delivery and outcomes among US veterans with hepatitis B: A national cohort study

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