Interprofessional team-based approach to patients with chronic hepatitis C and personality disorder: Three case studies.

Hepatitis C virus is a blood borne pathogen that infects 130 million people worldwide. After a prolonged period of slowly progressive liver injury, those infected are at risk of advancing to end stage liver disease, with its associated complications, and hepatocellular carcinoma. Rates of past and/or current substance use and behavioral comorbidities are higher among those infected with hepatitis C compared to the general population. A number of patient, provider and system barriers to care and treatment have led to low rates of treatment initiation in this population despite pharmacologic advances that have made hepatitis C a curable disease. Innovation in care delivery is considered a key strategy that will help reach more patients. We present three case studies of patients with chronic hepatitis C and multiple psychiatric comorbidities who were successfully engaged in care and treated for their chronic hepatitis C in our multidisciplinary primary care-based program.

Real-World Sustained Virologic Response Rates of Sofosbuvir-Containing Regimens in Patients Coinfected With Hepatitis C and HIV.

BACKGROUND: Patients with hepatitis C virus (HCV) with or without human immunodeficiency virus (HIV) achieve high sustained virological response (SVR) rates on sofosbuvir (SOF)-containing regimens in clinical trials. Real world data on patients coinfected with HCV and HIV treated with SOF-based regimens are lacking. METHODS: This observational cohort study included HIV/HCV-coinfected adults with genotype 1 HCV who initiated treatment with a SOF-containing regimen between December 2013 and December 2014 (n = 89) at the Mount Sinai Hospital or the Brooklyn Hospital Center. The primary outcome was SVR at 12 weeks after the end of treatment. The secondary outcomes were risk factors for treatment failure, serious adverse events, and side effects. A post hoc per protocol analysis of SVR was performed on patients who completed treatment and follow-up. RESULTS: In an intention-to-treat analysis, SVR rates were 76% (31/41) for simeprevir (SMV)/SOF, 94% (16/17) for SMV/SOF/ribavirin (RBV), and 52% (16/31) for SOF/RBV. The SVR rates of SMV/SOF/RBV and SMV/SOF did not differ significantly in this small study (P = .15). However the SVR rate of SMV/SOF/RBV was higher than that of SOF/RBV (P < .01). In a per protocol analysis, SMV/SOF/RBV had a higher SVR rate than SOF/RBV: 100% (16/16) vs 57% (16/28) (P < .01). The most commonly reported adverse effects were rash, pruritus, fatigue, and insomnia. One patient who had decompensated cirrhosis prior to treatment initiation died after receiving SMV/SOF. CONCLUSIONS: SMV/SOF ± RBV is an effective option with minimal adverse effects for most HIV-positive patients with genotype 1 HCV. SMV should be used with caution in patients with decompensated cirrhosis.

Costs of telaprevir-based triple therapy for hepatitis C: $189,000 per sustained virological response.

UNLABELLED: In registration trials, triple therapy with telaprevir (TVR), pegylated interferon (Peg-IFN), and ribavirin (RBV) achieved sustained virological response (SVR) rates between 64% and 75%, but the clinical effectiveness and economic burdens of this treatment in real-world practice remain to be determined. Records of 147 patients who initiated TVR-based triple therapy at the Mount Sinai Medical Center (May-December 2011) were reviewed. Direct medical costs for pretreatment, on-treatment, and posttreatment care were calculated using data from Medicare reimbursement databases, RED Book, and the Healthcare Cost and Utilization Project database. Costs are presented in 2012 U.S. dollars. SVR (undetectable hepatitis C virus [HCV] RNA 24 weeks after the end of treatment) was determined on an intention-to-treat basis. Cost per SVR was calculated by dividing the median cost by the SVR rate. Median age of the 147 patients was 56 years (interquartile range [IQR] = 51-61), 68% were male, 19% were black, 11% had human immunodeficiency virus/HCV coinfection, 36% had advanced fibrosis/cirrhosis (FIB-4 scores ≥3.25), and 44% achieved an SVR. The total cost of care was $11.56 million. Median cost of care was $83,721 per patient (IQR = $66,652-$98,102). The median cost per SVR was $189,338 (IQR = $150,735-$221,860). Total costs were TVR (61%), IFN (24%), RBV (4%), adverse event management (8%), professional fees (2%), and laboratory tests (1%). CONCLUSIONS: TVR and Peg-IFN accounted for 85% of costs. Pharmaceutical prices and the low (44%) SVR rate, in this real-world study, were major contributors to the high cost per SVR.

Hepatitis C treatment completion in individuals with psychiatric comorbidity and depression.

Hepatitis C virus is a common bloodborne pathogen. Patient, provider, and health care system factors combine to constrain access to treatment and have led to low rates of treatment initiation and continuation among medically eligible individuals. Behavioral health comorbidity, which is common in the patient population, has historically been an exclusion criterion and is one such barrier to care. We implemented an interdisciplinary nurse-managed primary care-based hepatitis C evaluation and treatment program to address behavioral health needs concurrently in an effort to increase treatment initiation and continuation rates among comorbid individuals. We found no association between having a psychiatric or substance use history and treatment discontinuation in our patient cohort. Likewise, there was no association in our cohort between becoming depressed or anxious while undergoing treatment and treatment discontinuation. The results of our study concur with others that have shown that addressing behavioral health comorbidities concurrently with hepatitis C evaluation and treatment may improve treatment continuation rates among comorbid patients, thereby helping to remove barriers to treatment of chronic hepatitis C.

Factors associated with success of telaprevir- and boceprevir-based triple therapy for hepatitis C virus infection.

AIM: To evaluate new therapies for hepatitis C virus (HCV), data about real-world outcomes are needed. METHODS: Outcomes of 223 patients with genotype 1 HCV who started telaprevir- or boceprevir-based triple therapy (May 2011-March 2012) at the Mount Sinai Medical Center were analyzed. Human immunodeficiency virus-positive patients and patients who received a liver transplant were excluded. Factors associated with sustained virological response (SVR24) and relapse were analyzed by univariable and multivariable logistic regression as well as classification and regression trees. Fast virological response (FVR) was defined as undetectable HCV RNA at week-4 (telaprevir) or week-8 (boceprevir). RESULTS: The median age was 57 years, 18% were black, 44% had advanced fibrosis/cirrhosis (FIB-4 ≥ 3.25). Only 42% (94/223) of patients achieved SVR24 on an intention-to-treat basis. In a model that included platelets, SVR24 was associated with white race [odds ratio (OR) = 5.92, 95% confidence interval (CI): 2.34-14.96], HCV sub-genotype 1b (OR = 2.81, 95%CI: 1.45-5.44), platelet count (OR = 1.10, per x 104 cells/µL, 95%CI: 1.05-1.16), and IL28B CC genotype (OR = 3.54, 95%CI: 1.19-10.53). Platelet counts > 135 x 103/µL were the strongest predictor of SVR by classification and regression tree. Relapse occurred in 25% (27/104) of patients with an end-of-treatment response and was associated with non-FVR (OR = 4.77, 95%CI: 1.68-13.56), HCV sub-genotype 1a (OR = 5.20; 95%CI: 1.40-18.97), and FIB-4 ≥ 3.25 (OR = 2.77; 95%CI: 1.07-7.22). CONCLUSION: The SVR rate was 42% with telaprevir- or boceprevir-based triple therapy in real-world practice. Low platelets and advanced fibrosis were associated with treatment failure and relapse.

Illness Perceptions, Medication Beliefs, and Adherence to Antiretrovirals and Medications for Comorbidities in Adults With HIV Infection and Hypertension or Chronic Kidney Disease.

BACKGROUND: Mortality in patients with HIV infection is increasingly due to comorbid medical conditions. Research on how adherence to medications for comorbidities relates to antiretroviral (ARV) medication adherence and how interrelations between illness perceptions and medication beliefs about HIV and comorbidities affect medication adherence is needed to inform adherence interventions. METHODS: HIV-infected adults with hypertension (HTN) (n = 151) or chronic kidney disease (CKD; n = 41) were recruited from ambulatory practices at an academic medical center. Illness perceptions and medication beliefs about HIV and HTN or CKD were assessed and adherence to one ARV medication and one medication for either HTN or CKD was electronically monitored for 10 weeks. RESULTS: Rates of taking, dosing, and timing adherence to ARV medication did not differ from adherence to medication for HTN or CKD, with the exception that patients were more adherent to the timing of their ARV (78%) than to the timing of their antihypertensive (68%; P = 0.01). Patients viewed HIV as better understood, more chronic, having more negative consequences, and eliciting more emotions, compared with HTN. Patients viewed ARVs as more necessary than medication for HTN or CKD. Having a realistic view of the efficacy of ARVs (r = -0.20; P < 0.05) and a high level of perceived HIV understanding (r = 0.21; P < 0.05) correlated with better ARV adherence. CONCLUSIONS: Patients with HIV showed similar rates of adherence to ARVs as to medications for comorbidities, despite perceiving HIV as more threatening and ARVs as more important. This can be used in adapting existing interventions for ARV adherence to encompass adherence to medications for comorbid conditions.

Hepatic decompensation/serious adverse events in post-liver transplantation recipients on sofosbuvir for recurrent hepatitis C virus.

AIM: To determine the safety profile of new hepatitis C virus (HCV) treatments in liver transplant (LT) recipients with recurrent HCV infection. METHODS: Forty-two patients were identified with recurrent HCV infection that underwent LT at least 12 mo prior to initiating treatment with a Sofosbuvir-based regimen during December 2013-June 2014. Cases were patients who experienced hepatic decompensation and/or serious adverse events (SAE) during or within one month of completing treatment. Controls had no evidence of hepatic decompensation and/or SAE. HIV-infected patients were excluded. Cumulative incidence of decompensation/SAE was calculated using the Kaplan Meier method. Exact logistic regression analysis was used to identify factors associated with the composite outcome. RESULTS: Median age of the 42 patients was 60 years [Interquartile Range (IQR): 56-65 years], 33% (14/42) were female, 21% (9/42) were Hispanic, and 9% (4/42) were Black. The median time from transplant to treatment initiation was 5.4 years (IQR: 2.1-8.8 years). Thirteen patients experienced one or more episodes of hepatic decompensation and/or SAE. Anemia requiring transfusion, the most common event, occurred in 62% (8/13) patients, while 54% (7/13) decompensated. The cumulative incidence of hepatic decompensation/SAE was 31% (95%CI: 16%-41%). Risk factors for decompensation/SAE included lower pre-treatment hemoglobin (OR = 0.61 per g/dL, 95%CI: 0.40-0.88, P < 0.01), estimated glomerular filtration rate (OR = 0.95 per mL/min per 1.73 m(2), 95%CI: 0.90-0.99, P = 0.01), and higher baseline serum total bilirubin (OR = 2.43 per mg/dL, 95%CI: 1.17-8.65, P < 0.01). The sustained virological response rate for the cohort of 42 patients was 45%, while it was 31% for cases. CONCLUSION: Sofosbuvir/ribavirin will continue to be used in the post-transplant population, including those with HCV genotypes 2 and 3. Management of anemia remains an important clinical challenge.

Primary Care-Based Hepatitis C Treatment Outcomes With First-Generation Direct-Acting Agents.

OBJECTIVES: Vulnerable, urban populations with a history of substance use disorders have a high prevalence of hepatitis C virus (HCV). Primary care-based treatment has been proposed to improve access to care. In this study, we present outcomes from our urban, primary care-based HCV treatment program in patients treated with telaprevir or boceprevir in combination with pegylated-interferon and ribavirin ("triple therapy"). METHODS: We collected data from 126 consecutive patients with genotype 1 HCV monoinfection seen in our treatment program (2011-2013). Among the 40 who initiated treatment, we analyzed factors associated with achieving a sustained viral response (SVR). RESULTS: During the study period, 40 patients initiated triple therapy (32%), 80% with recent or past substance use disorders. Patients initiating treatment were younger than untreated patients (P = 0.002), but otherwise did not differ demographically, or in the severity of their liver fibrosis (P > 0.05). An SVR was achieved in 18 patients (45%) and was less likely in patients with recent or past substance use disorders or psychiatric illness (both P < 0.01). CONCLUSIONS: Nearly one third of patients initiated triple therapy with SVR rates comparable to other HCV treatment settings, despite a significant burden of mental illness and substance dependence. Our experience demonstrates that a primary care-based practice can successfully deliver HCV care to a vulnerable population. Additional interventions may be needed to improve outcomes in patients with recent or past substance use disorders or psychiatric illness.

Social support and adherence: differences among clients in an AIDS day health care program.

Challenges in care management threaten health outcomes in persons living with HIV (PLWH), who also have other medical and psychiatric diagnoses, substance use problems, or adjustment issues (comorbid PLWH). Integrated primary care programs have been developed to address multiple care needs in comorbid PLWH. The effectiveness of these models has not been shown empirically, in part because of multidisciplinary approaches to care. Adherence and its relationship to social support are key factors in favorable outcomes in HIV. The authors measured social support and adherence among clients in AIDS day health care, an integrated primary care program for comorbid PLWH. The level of social support among AIDS day health care clients who were adherent to their antiretroviral therapy was reported to be significantly higher than social support among those who were nonadherent. Implications of the differences in social support and adherence in the population are explored and discussed. Implications for nursing practice and future research are also addressed.

Hepatitis C in an urban cohort: who's not being treated?

Hepatitis C virus (HCV) remains widely prevalent in the U.S. Treatment has improved, but rates of treatment initiation remain low. We sought to identify clinical and sociodemographic characteristics of patients that are associated with failure to initiate treatment of HCV infection. We conducted a retrospective cohort study in our primary care hepatitis C treatment clinic, affiliated with an urban academic hospital. Our population was multi-ethnic, HIV-, HCV+, treatment naïve patients. We measured rates of HCV treatment initiation and sociodemographic, viral, and patient-related variables associated with non-initiation of treatment. The total number of treatment-eligible patients was 168, of whom 41 began treatment and 127 did not. In multivariate analysis, individuals with HCV genotypes 1 and 4 were less likely than others to initiate treatment, as were patients with more medical comorbidities. Further research is needed to understand how factors around initiation interact and how interventions can overcome them.

Validation of a hepatitis C screening tool in primary care.

BACKGROUND: Although hepatitis C virus (HCV) has an estimated national prevalence of 1.8%, testing rates are lower than those recommended by guidelines, particularly in primary care. A critical step is the ability to identify patients at increased risk who should be screened. We sought to prospectively derive and validate a clinical predication tool to assist primary care providers in identifying patients who should be tested for HCV antibodies. METHODS: A total of 1000 randomly selected patients attending an inner-city primary care clinic filled out a 27-item questionnaire assessing 5 HCV risk factor domains: work, medical, exposure, personal care, and social history. Afterward, the patients underwent HCV antibody testing. Multivariable logistic regression analysis was performed to identify risk factors associated with HCV antibodies. RESULTS: There was an 8.3% (95% confidence interval, 6.7%-10.2%) prevalence of HCV antibodies. The patients who were HCV antibody positive were more likely to be male, older, and insured by Medicaid (P < or = .02). Those who had risk factors within the medical, exposure, and social history domains were more likely to be HCV antibody positive. The area under the receiver operating characteristic curve for the screening tool based on these 3 domains was 0.77. With an increasing number of positive domains, there was a higher likelihood of HCV antibody positivity. Only 2% of patients with 0 risk factors had HCV antibodies. CONCLUSIONS: A prediction tool can be used to accurately identify patients at high risk of HCV who may benefit from serologic screening. Future studies should assess whether wider use of this tool may lead to improved outcomes.

Medical/psychiatric comanagement by nurse practitioners in chronic hepatitis C treatment: a case study.

This article aims to increase access to care for patients with chronic hepatitis C who have medical and psychiatric comorbidities by reporting on a clinical advanced practice nursing comanagement model for evaluation, treatment, and follow-up care.

Treating chronic hepatitis C in the primary care setting.

The National Institutes of Health and other institutions have emphasized the need to expand access to treatment of chronic hepatitis C virus infection to a larger and more diverse patient population. To begin to address this need, the divisions of General Internal Medicine and Liver Diseases of the Mount Sinai Medical Center created a program to identify patients who might benefit from hepatitis C treatment, to treat uncomplicated patients in the primary care setting, and to refer appropriate patients to liver disease specialists. Preliminary data from this program suggest that primary care-based treatment of chronic hepatitis C may offer unique advantages. The primary care setting allows special needs to be addressed and allows comprehensive services to be provided. Patients are guided through the complex pretreatment evaluation process, and non-liver-related comorbidities are managed. Our program may provide a useful model for increasing hepatitis C literacy among primary care providers and for extending treatment to a broader population of patients with hepatitis C.