Hepatitis C Virus Treatment Outcomes Research Articles

Medicaid Policy and Hepatitis C Treatment Among Rural People Who Use Drugs

Background: Restrictive Medicaid policies regarding hepatitis C virus (HCV) treatment may exacerbate rural health care disparities for people who use drugs (PWUD). We assessed associations between Medicaid restrictions and HCV treatment among rural PWUD. Methods: We compiled state-specific Medicaid treatment policies across 8 US rural sites in 10 states and merged these with participant survey data. We hypothesized that local restrictions regarding prescriber type, sobriety, and fibrosis estimates were associated with HCV treatment outcomes. We conducted a cross-sectional, ecological analysis of treatment restrictions and HCV treatment outcomes using bivariate analyses to characterize differences between PWUD who initiated HCV treatment and unadjusted logistic regressions to assess associations between restrictions and treatment. Results: Among 944 participants, 111 (12%) reported receiving HCV treatment. Participants receiving treatment were older [median age (interquartile range): 42 (34–53) vs. 35 (29–42), P<0.001], more likely to receive disability support (32% vs. 20%, P=0.002), and less likely to be Medicaid-insured (57% vs. 71%, P < 0.001). More PWUD in states without any restrictions reported receiving treatment (17% vs. 11%, P=0.08) and achieving HCV cure/clearance (42% vs. 30%, P=0.01) than in states with restrictions. Restrictions were associated with lower odds of receiving HCV treatment (odds ratio=0.61, 95% CI: 0.35–1.06, P=0.08). Sensitivity analyses showed a similar association with HCV cure/clearance (odds ratio=0.60, 95% CI: 0.40–0.91, P=0.02). Conclusions: We identified significant unadjusted associations between Medicaid restrictions and receipt of HCV treatment and cure, which has substantial implications for health outcomes among rural PWUD. Lifting remaining Medicaid restrictions will be critical to achieving HCV elimination.

A precision randomized trial to evaluate the impact of tailored hepatitis C treatment adherence support on HCV treatment outcomes among people who inject drugs in India: Design and Baseline Characteristics of the STOP-C Trial.

Efforts to eliminate hepatitis C virus (HCV) as a public health problem must include people who inject drugs (PWID). We describe the design and baseline characteristics of the Supporting Treatment Outcomes among PWID (STOP-C) trial which evaluates whether HCV treatment outcomes in PWID can be optimized by tailoring treatment support in 7 PWID-focused integrated HIV/HCV prevention/treatment centers. The design is a 3-arm, individual-level precision-randomized trial. Leveraging empirical data, a prediction model assigned participants as minimal or elevated risk for failure. Minimal risk participants were randomized 1:2:3 to low- (basic services), medium- (patient navigation), and high-intensity (patient navigation + directly observed therapy) support, respectively. Elevated risk participants were randomized 3:2:1 to high, medium, and low-intensity support respectively. All received 12 weeks of oral direct-acting antiviral therapy. The primary outcome is sustained virologic response (SVR) 12 weeks after treatment completion in an intention-to-treat analysis. Three thousand participants were randomized (2048 [68%] minimal risk, 952 [32%] elevated risk of failure). This approach will allow for the estimation of efficacy within treatment failure risk strata while preserving the ability to estimate the average treatment effect and has particular relevance with increasing emphasis of precision medicine in health care delivery.

Outcomes of early vs late treatment initiation in solid organ transplantation from hepatitis C virus nucleic acid test-positive donors to hepatitis C virus-uninfected recipients: Results from the HCV-TARGET study

Curative hepatitis C virus (HCV) therapy has increased transplantation from HCV-infected nucleic acid test-positive donors to HCV-uninfected recipients (D+/R-). We evaluated outcomes of early and late HCV treatment among D+/R- nonliver organ transplants. Patients received HCV regimens per local standard (n = 10 sites). Outcomes were compared between early and late treatments. Early treatment regimens (ETR) (n = 56) were initiated pretransplantation to day 7 posttransplant. Late treatment regimens (LTRs) (n = 102) began median 31 (range, 8-114) days posttransplant. There were 79 kidney, 50 lung, 23 heart, and 6 mixed transplants, similar between groups. HCV RNA was quantifiable in 98% of LTR versus 44.6% of ETR recipients (P < .001). Mean (range) days on treatment were 28 (7-93) ETR and 81 (51-111) LTR (P < .0001). There were no virological failures with ETR, but relapse (n = 3) and nonresponse (n = 2) in LTR (P = .16), including fibrosing cholestatic hepatitis postrelapse (n = 1). Sustained virological response was 100% (95% confidence interval, 93.4-100.0) in ETR (n = 54) and 94.9% (95% confidence interval, 88.5-98.3) in LTR (n = 98). Acute rejection occurred in 11 (19.6%) ETR and 25 (24.5%) LTR. In total, 11 HCV-unrelated deaths occurred: 8 ETR and 3 LTR. Organ transplantation from HCV-infected nucleic acid test-positive donors to HCV-uninfected recipients was safe. ETR led to fewer virological failures with shorter treatment duration, supporting recommendations to initiate treatment promptly posttransplant.

Reduction in Depressive Symptoms in People who Inject Drugs who Are Cured of Hepatitis C Virus Infection: The HERO Study.

Depressive symptoms are prevalent among people who inject drugs (PWID) and people with hepatitis C virus (HCV). We examined changes in depressive symptoms among HCV-infected PWID following direct-acting antiviral treatments to evaluate whether these changes differed by history of depressive symptoms, substance use, or HCV treatment outcome. We conducted a secondary analysis of the HERO Study (NCT02824640), a pragmatic randomized clinical trial among PWID, to test the effectiveness of HCV care models. Depressive symptoms (primary outcome) were measured using the Patient Health Questionnaire (PHQ-9) at baseline, end of treatment (EOT), and at follow-up 12 and 24 weeks after EOT. Sustained virologic response (SVR) was defined as undetectable HCV RNA at ≥12 weeks following EOT. Baseline drug use was defined as having a positive urine screening test for amphetamine, methamphetamine, benzodiazepine, cocaine, cannabis, opiate, or oxycodone. The sample (n = 498) was 72.3% male, 64.2% White, and on average 43.9 years old. In patients who achieved SVR (F(3432) = 4.58; P = .004) and those with drug use at baseline (F(3478) = 5.11; P < .01), PHQ-9 scores significantly declined over time, with scores lower at EOT and both follow-ups as compared with baseline. Mean PHQ-9 scores at EOT and follow-ups were significantly lower than at baseline, except for those with no depression or mild depression at baseline. This study showed that HCV treatment in PWID is associated with sustained declines in depression up to 24 weeks post-treatment among those who achieve SVR and that drug use does not interfere with improvement in depressive symptoms.

Cytokine polymorphisms and genotypic susceptibility of HCV infection in ribavirin response to peg interferon.

Immune responses are largely regulated by cytokines. Genetic polymorphisms of the regulatory coding regions are recognized to impact the expression of cytokines. The abnormal cytokine levels in hepatitis C virus (HCV) infection seems to be involved in disease progression, viral survival, and therapeutic response. The current study assesses the polymorphisms associated with IL-6, IL-10, IL28B, IFN-γ, TGF-β, and TNF-α on the genotypic susceptibility to HCV infection and Ribavirin response to Peg interferon. Droplet digital polymerase chain reaction (PCR) was used to assess the gene polymorphisms associated with IL-6 A/G (rs2069837), IL-10-1082 G/A (rs1800896)], IL28B C/T (rs12979860), IFN-γ +874 A/T (rs2430561), TGF-β 1-509 C/T (rs1800469) and TNF-α-308 G/A promoter (rs1800629) from stored samples of 200 healthy individuals and 300 HCV infected patients. There was a significant association of AG and AA genotypes of IL28B, IFN-γ, TGF-β1, and TNF-α over HCV susceptibility and treatment outcome. However, no association between IL-6 and IL-10 gene polymorphism to HCV susceptibility response to the treatment. The observations indicate IL28B CT, TGF-β1 CT, TT and TNF- AG with AA genotypes influence the cytokine expression, which is related to susceptibility and resistance to HCV infection and combined antiviral therapy.

Impact of an interdisciplinary patient care model and routine screening on clinical outcomes in patients with hepatitis C.

Testing for hepatitis C in hospital emergency departments (ED) and linkage to care to clinics have been reported to provide the most opportunity for screening patients and facilitating continuum of care. Treatment model initiatives have expanded to include telehealth services and open treatment capacity to non-physician providers, such as pharmacists. This study's objective was to assess the impact of implementing automated routine screening for hepatitis C virus (HCV) and a clinical pharmacist into the interdisciplinary care model on HCV diagnosis and treatment outcomes. This retrospective cohort study compared outcomes in a pre-intervention and post-intervention group. Patients were screened and diagnosed with HCV at Jersey City Medical Center (JCMC) and completed linkage to care at JCMC Center for Comprehensive Care. Interventions were the implementation of automated routine HCV screening in the ED and addition of a clinical pharmacist to the interdisciplinary patient care model. Primary endpoints analyzed the number of patients who have achieved sustained virologic response after 12 weeks of treatment (SVR12) and patients who have completed treatment with no reported record of SVR12. Secondary endpoints analyzed the number of patients lost to follow-up, appointment type, time spent in appointments, and clinical pharmacist specialist interventions. Data was collected as categorical variables and chi-squared tests assessed if there were differences between the two samples. Data was collected from 46 patients in the pre-intervention group and 37 patients in the post-intervention group. Patients consisted of mostly males. Ages ranged from 27 to 83 years old. Race included Black, White, Asian, and Other. This study's results showed the positive impact on implementation of routine screening, telehealth services, and an interdisciplinary team approach to HCV diagnosis and management. Given the timeframe, it also showed the potential positive impact on these interventions during a global pandemic.

Prevalence, risk factors, treatment uptake and treatment outcome of hepatitis C virus in people who inject drugs at the needle and syringe program in Uppsala, Sweden

BackgroundThe World Health Organization has set a goal to reach world elimination of hepatitis C virus (HCV) by 2030. Needle and syringe programs (NSP) for people who inject drugs (PWID) are crucial to achieve this goal. The NSP in Uppsala, Sweden, was opened in 2016 and has since 2018 provided HCV treatment for PWID. The aim of this study was to investigate HCV prevalence, risk factors and treatment uptake and outcome in NSP participants.MethodsData from 450 PWID registered at the Uppsala NSP between 2016-11-01 and 2021-12-31 were collected from the national quality registry InfCare NSP. Data from the 101 PWID treated for HCV at the Uppsala NSP were collected through patient journal review. Descriptive and inferential analysis was performed. Ethical approval was obtained from the Ethical Review Board in Uppsala (dnr 2019/00215).ResultsThe mean age was 35 years. 75% were males (336/450), and 25% were females (114/450). The overall HCV prevalence was 48% (215/450) with a declining trend over time. Factors associated with a higher risk of HCV were older age at registration (OR 1.025, 95% CI 1.004–1.046), lower age at injection drug debut (OR 0.963, 95% CI 0.932–0.996), lower education level (OR 1.829, 95% CI 1.185–2.821) and higher number of total visits at the NSP (OR 1.005, 95% CI 1.001–1.009). The overall HCV treatment uptake was 47% (101/215), of which 77% (78/101) completed HCV treatment. The HCV treatment compliance was 88% (78/89). 99% (77/78) were cured with a sustained virologic response 12 weeks after completed treatment. The reinfection rate over the study period was 9/77 (11.7%); all were male with mean age of 36.ConclusionsHCV prevalence, treatment uptake and treatment outcome have improved since the opening of the Uppsala NSP. However, further measures are needed to reach the HCV elimination goal. Outreach HCV treatment programs for PWID should be explored and evaluated in combination with further implementation of low-threshold programs.

HCV prevalence and treatment outcomes among drug users in an outpatient center for drug addiction in Northern Italy.

We aimed at evaluating hepatitis C virus (HCV) prevalence and treatment referral outcomes in a large population of drug users in Northern Italy. Each participant underwent a quick capillary blood test. Positive participants underwent HCV RNA quantification. HCV RNA positive subjects were referred to treatment and evaluated immediately at the end of treatment and at 3 and 6 months after treatment. Of the 636 participants tested, 244 were positive. Intravenous drug use was more frequent among subjects who tested positive for HCV antibodies (99%). Among subjects who tested positive, 68% were HCV-RNA positive while 32% were negative. Among people referred to treatment, nearly 30% did not show up while 70% completed the treatment with success. Over 99% of people who started direct-acting antiviral agent (DAA) have a sustained response. We observed a significant higher prevalence of HCV positive subjects among people who inject drugs (99%) and we observed a high success rate for HCV treatment engagement. Rapid testing for HCV represents a potential tool for HCV screening among high-risk groups.

Effectiveness of direct-acting antiviral therapy among Aboriginal and Torres Strait Islander peoples with HCV infection in Australia: A national real-world cohort (REACH-C).

Aboriginal and Torres Strait Islander peoples experience a disproportionate burden of hepatitis C virus (HCV) infection. This study assessed the effectiveness of direct-acting antiviral (DAA) therapy among Aboriginal peoples in the three years following universal access in Australia. REACH-C, a national multicentre prospective cohort study, evaluated HCV treatment outcomes from sequential DAA initiations across 33 health services between March 2016 and June 2019. DAA effectiveness was assessed by sustained virological response (SVR) in the total (full analysis set) and effectiveness (modified analysis set excluding those lost to follow-up) populations. Overall, 915 (10%) Aboriginal and 8095 (90%) non-Indigenous people commenced DAA therapy, of whom 30% and 16% reported current injecting drug use and 73% and 42% were treated in primary care, respectively. SVR in the total and effectiveness populations was 74% and 94% among Aboriginal people and 82% and 94% among non-Indigenous people, with loss to follow-up contributing to lower SVR in the total population analysis (22% Aboriginal, 13% non-Indigenous). Among Aboriginal people, returning for follow-up was positively associated with older age (aOR 1.20; 95% CI 1.04, 1.39) and SVR was negatively associated with cirrhosis (aOR 0.39; 95% CI 0.19, 0.80) and prior DAA treatment (aOR 0.14; 95% CI 0.04, 0.49). Factors reflecting higher vulnerability or inequity were not associated with returning for testing or SVR. DAA therapy was highly effective among Aboriginal peoples with HCV treated through primary and tertiary services. Tailored community-led interventions are necessary to optimize follow-up and engagement. Sustained DAA uptake and equitable access to care, treatment and prevention are required for HCV elimination.

Hepatitis C Core Protein Induces a Genotype-Specific Susceptibility of Hepatocytes to TNF-Induced Death In Vitro and In Vivo.

Hepatitis C virus (HCV) core protein is a multifunctional protein that is involved in the proliferation, inflammation, and apoptosis mechanism of hepatocytes. HCV core protein genetic variability has been implicated in various outcomes of HCV pathology and treatment. In the present study, we aimed to analyze the role of the HCV core protein in tumor necrosis factor α (TNFα)-induced death under the viewpoint of HCV genetic variability. Immortalized hepatocytes (IHH), and not the Huh 7.5 hepatoma cell line, stably expressing HCV subtype 4a and HCV subtype 4f core proteins showed that only the HCV 4a core protein could increase sensitivity to TNFα-induced death. Development of two transgenic mice expressing the two different core proteins under the liver-specific promoter of transthyretin (TTR) allowed for the in vivo assessment of the role of the core in TNFα-induced death. Using the TNFα-dependent model of lipopolysaccharide/D-galactosamine (LPS/Dgal), we were able to recapitulate the in vitro results in IHH cells in vivo. Transgenic mice expressing the HCV 4a core protein were more susceptible to the LPS/Dgal model, while mice expressing the HCV 4f core protein had the same susceptibility as their littermate controls. Transcriptome analysis in liver biopsies from these transgenic mice gave insights into HCV core molecular pathogenesis while linking HCV core protein genetic variability to differential pathology in vivo.

Factors Associated with Sustained Virologic Response to Hepatitis C Treatment in a Homeless-Experienced Cohort in Boston, 2014-2020.

Engaging people experiencing homelessness or unstable housing in hepatitis C virus (HCV) treatment is critical to achieving HCV elimination. To describe HCV treatment outcomes, including factors associated with retention through the treatment cascade, for a cohort of individuals treated in a homeless health center in Boston. Retrospective cohort study. All individuals who initiated HCV treatment with Boston Health Care for the Homeless Program's HCV treatment program between January 2014 and March 2020 (N = 867). The primary outcome was sustained virologic response (SVR), defined as an HCV ribonucleic acid (RNA) level ≤ 15 IU/mL at least 12 weeks after treatment completion. We used multivariable logistic regression to examine the association between baseline variables and SVR. Process-oriented outcomes included treatment completion, assessment for SVR, and achievement of SVR. Of 867 individuals who started HCV treatment, 796 (91.8%) completed treatment, 678 (78.2%) were assessed for SVR, and 607 (70.0%) achieved SVR. In adjusted analysis, residing in stable housing (OR 3.83, 95% CI 1.85-7.90) and age > 45 years old (OR 1.53, 95% CI 1.04-2.26) were associated with a greater likelihood of achieving SVR. Recent drug use (OR 0.63, 95% CI 0.41-0.95) was associated with a lower likelihood of SVR. Age, housing status, and drug use status impacted retention at every step in the treatment cascade. A large proportion of homeless-experienced individuals engaging in HCV treatment in a homeless health center achieved SVR, but enhanced approaches are needed to engage and retain younger individuals, those with recent or ongoing substance use, or those experiencing homelessness or unstable housing. Efforts to achieve HCV elimination in this population should consider the complex and overlapping challenges experienced by this population and aim to address the fundamental harm of homelessness itself.

Real-world experience for the outcomes and costs of treating hepatitis C patients: Results from the German Hepatitis C-Registry (DHC-R).

With long-term consequences like the development of liver cirrhosis and hepatocellular carcinoma, chronic hepatitis C virus (HCV) infection is associated with a significant health burden. Information on HCV treatment outcomes and costs in routine care is still rare, especially for subgroups. The aim of this study was to analyse the treatment outcomes and costs of subgroups in routine care and to compare them over time with previous analyses. Data were derived from a noninterventional study including a subset of 10298 patients receiving DAAs with genotypes 1 and 3. Sociodemographic, clinical parameters and costs were collected using a web-based data recording system. The total sample was subdivided according to treatment regimen, cirrhosis status as well as present HIV infection and opioid substitution treatment (OST). 95% of all patients achieved SVR. Currently used DAA showed higher SVR-rates and less adverse events (AE) compared to former treatments. Concerning subgroups, cirrhotic patients, HIV-coinfected patients and OST patients showed lower but still high SVR-rates. In comparison, cirrhotic had considerably longer treatment duration and more frequent (serious) AE. Overall, average treatment costs were €48470 and costs per SVR were €51129; for currently used DAAs costs amounted to €30330 and costs per SVR to €31692. After the end of treatment, physical health is similar to the general population in all patients except cirrhotic. Mental health remains far behind in all subgroups, even for currently used DAA. Over time, some relevant factors developed positively (SVR-rates, costs, treatment duration, adverse events, health-related quality of life (HRQoL)). Further research on HRQoL, especially on mental health, is necessary to evaluate the differences between subgroups and HRQoL over time and to identify influencing factors.

Impact of the COVID-19 pandemic on hepatitis C outcomes at a health-system specialty pharmacy.

BACKGROUND: The goal of hepatitis C virus (HCV) treatment is to cure the patient of the infection, defined as a nondetectable HCV RNA at least 12 weeks after treatment completion, or sustained virologic response (SVR). The COVID-19 pandemic has presented new barriers to care in the treatment of patients with HCV that resulted in a transition to tele-health services at many health systems to overcome these barriers. OBJECTIVE: To assess the real-world impact of the COVID-19 pandemic and the subsequent shift to a telehealth model on collection of SVR data and other HCV treatment outcomes in a health-system setting. METHODS: Subjects who received a referral for an HCV direct-acting antiviral agent between January 1, 2018, and November 30, 2020, and were aged 18 years or older at time of enrollment were placed in either "pre-COVID-19" or "COVID-19" cohorts based on enrollment date. The primary endpoint of this study evaluated confirmed SVR to treatment determined by the absence of HCV RNA by polymerase chain reaction testing at least 12 weeks after completion of drug therapy. Secondary endpoints evaluated completion of medication therapy and adherence to laboratory appointments. RESULTS: 1,504 patients met study inclusion criteria (pre-COVID-19 cohort, n = 1,230; COVID-19 cohort, n = 274). The COVID-19 cohort demonstrated significantly lower therapy completion rates (P = 0.001), were less likely to obtain SVR laboratory tests (P < 0.001), and had a significantly lower confirmed SVR rate (P < 0.001) compared with the pre-COVID-19 cohort. In a subset of patients who completed therapy and had SVR laboratory tests collected, there were no significant differences observed in the rate of patients who achieved SVR (P = 0.959). CONCLUSIONS: During the COVID-19 pandemic, patients with HCV were significantly less likely to complete therapy or participate in SVR laboratory work. Further studies are needed to determine if offering a telehealth option for our patients in a post-COVID-19 environment would offer any additional advantage in increasing access to care for patients with HCV. DISCLOSURES: No outside funding supported this study. Dr Cooper is an employee of the University of Kentucky whose position was partially funded by Gilead Sciences, Inc.

Gaps in hepatitis C virus prevention and care for HIV-hepatitis C virus co-infected people who inject drugs in Canada.

People who inject drugs (PWID) living with HIV are a priority population for eliminating hepatitis C virus (HCV) as a public health threat. Maximizing access to HCV prevention and treatment strategies are key steps towards elimination. We aimed to evaluate engagement in harm reduction programs and HCV treatment, and to describe injection practices among HIV-HCV co-infected PWID in Canada from 2003 to 2019. We included Canadian Coinfection Cohort study participants who reported injecting drugs between 2003 and 2019 in Quebec, Ontario, Saskatchewan, and British Columbia, Canada. We investigated temporal trends in HCV treatment uptake, efficacy, and effectiveness; injection practices; and engagement in harm reduction programs in three time periods based on HCV treatment availability: 1) interferon/ribavirin (2003-2010); 2) first-generation direct acting antivirals (DAAs) (2011-2013); 3) second-generation DAAs (2014-2019). Harm reduction services assessed included needle and syringe programs (NSP), opioid agonist therapy (OAT), and supervised injection sites (SIS). Median age of participants (N=1,077) at cohort entry was 44 years; 69% were males. Province-specific HCV treatment rates increased among HCV RNA-positive PWID, reaching 16 to 31 per 100 person-years in 2014-2019. Treatment efficacy improved from a 50 to 70% range in 2003-2010 to >90% across provinces in 2014-2019. Drug injecting patterns among active PWID varied by province, with an overall decrease in cocaine injection frequency and increasing opioid injections. In the most recent time period (2014-2019), needle/syringe sharing was reported at 8-22% of visits. Gaps remained in engagement in harm reduction programs: NSP use decreased (58-70% of visits), OAT engagement among opioid users was low (8-26% of visits), and participants rarely used SIS (1-15% of visits). HCV treatment uptake and outcomes have improved among HIV-HCV coinfected PWID. Yet, this population remains exposed to drug-related harms, highlighting the need to tie HCV elimination strategies with enhanced harm reduction programs to improve overall health for this population.

Impact of successful HCV treatment using direct acting antivirals on recurrence of well ablated hepatocellular carcinoma

ABSTRACT Background There are many contradictory studies that dealt with hepatocellular carcinoma (HCC) recurrence rate of well ablated hepatitis C virus (HCV) related HCC. We aim to assess the recurrence rate of previously ablated HCC in patients who received direct acting antiviral (DAA) for their HCV. Research design and methods This is a retrospective data analysis of 523 HCV patients who have a history of successfully ablated HCC and eligible for HCV treatment. Retrieval was done to demographic/clinical data, HCV pretreatment investigations, HCV treatment outcome. Follow up for survival and HCC recurrence was done every 3 months using abdominal ultrasound and alfa-fetoprotein. Results Mean age was 53.83 years. Sofosbuvir/daclatasvir/ribavirin was the most used regimen (35.4%) with 438 patients (83.7%) achieved sustained virologic response (SVR). The median duration for surveillance was 159 weeks. Hundred and five patients developed recurrent HCC, with a crude recurrence rate of 20.1%. There was no difference between HCV responders and non-responders in crude recurrence rate (p = 0.94) but HCC developed earlier in non-responders (p = <0.01). Conclusion Recurrence of HCC remains a threat in HCV patients even after achieving an SVR. Implementation of long-term surveillance programs is highly recommended.

PMU15 A Budget Impact Analysis of Universal Hepatitis C Virus (HCV) Testing for Patients with Substance Use Disorders

To estimate the budget impact of providing universal hepatitis C virus (HCV) testing and treatment in patients with substance use disorders (SUD) in the United States. We developed an interactive ten-year (2020-2029) budget impact model (BIM) to project the health and economic outcomes associated with HCV testing among patients with SUD from a payer perspective. We compared two strategies in terms of costs related to HCV testing, treatment, and liver-related outcomes: 1) current HCV testing rate (i.e., a testing rate of 18%) in the baseline year and followed by direct-acting antivirals (DAA) treatment; and 2) universal HCV testing rate (i.e., a testing rate of 100%) in the baseline year then followed by DAA treatment. DAA treatment receipt following a positive HCV test was stratified by baseline cirrhosis status. We explored sensitivity analyses around values for the BIM time horizon (5∼20 years), and proportion of patients with cirrhosis at baseline (5%∼20%). By 2029, universal HCV testing would save $30 billion ($183 per person) to the health care budget compared to the current scenario. In our twenty-year BIM, cost-savings from prevented liver-related complications ($17,977) would outweigh HCV testing and treatment costs ($12,369) by $5,608 per person for all populations with SUD. However, the five-year BIM would not achieve the cost-savings, adding $4,189 per person. Increases in the proportion of patients with cirrhosis from 5% to 20% would result in saving ranging from $606 to -$662 per person, indicating that screening patients with SUD for HCV earlier without cirrhosis saves more budget. Increasing HCV testing reduces liver-related costs, which outweighs the cost of HCV testing and treatment within a 10-year time horizon. Policymakers should consider the economic value in providing HCV testing and treatment early before patients with SUD and HCV developing costly advanced liver disease.

Impact of Behavioral Health Consultation on Hepatitis C Treatment Outcomes at a Federally Qualified Health Center; Philadelphia, PA.

Hepatitis C virus (HCV) infection is a public health issue that claims the lives of 350,000 individuals globally every year. Primary care providers are increasingly prescribing HCV medications with more modern, simplified administrations. Individuals with HCV are disproportionately affected by behavioral health challenges and substance use disorders. Integrated behavioral health providers can work in concert with their patients' primary care teams to provide innovative treatment programs to help support the needs of HCV care. We used simple and multivariable logistic regression to determine the association between receipt of behavioral health consultation and two outcomes on the care continuum: insurance approval for treatment and initiated HCV treatment regimen. These models were fitted using theoretically hypothesized variables and multivariable regression models included age, sex, and race/ethnicity as potential confounders. From January 2015 to May 2017, 189 patients at health centers were referred for onsite HCV primary care treatment. Of these, 142 were approved for participation, and 132 started treatment. Simple regression revealed a significant association between behavioral health consultation and treatment approval; however, behavioral health consultation was non-significant in the multivariable model for treatment approval. For initiating HCV treatment, onsite behavioral health consultation was significantly associated in both the unadjusted and adjusted regression models. Integrating behavioral health services for patients seeking HCV treatment may improve movement across the care continuum, optimizing patient's HCV health outcomes. Behavioral health consultation in primary care settings should be studied further to improve HCV treatment outcomes for patients with behavioral health and substance use disorders.

Relationship between Hepatic Steatosis and Outcome of Viral Hepatitis C Treatment

Background: Hepatitis C virus (HCV) infection is an important cause of liver disease. The correlation between hepatic steatosis and HCV treatment results is unclear. Majority of studies showed that hepatic steatosis decreases efficacy of treatment while some showed no correlation. Noninvasive modalities (transient elastrography; TE) have recently largely supplanted liver biopsy, which may limit recognition of steatosis. The controlled attenuation parameter (CAP) from TE is a parameter to identify hepatic steatosis. Objective: To determine the correlation between hepatic steatosis and sustained virological response (SVR). Materials and Methods: The retrospective study analyzed data from HCV infected patients in the hepatitis clinic of Hatyai Hospital between 2014 and 2017. All patients were measured for CAP before treatment. The correlation between hepatic steatosis and SVR was analyzed. Results: Seventy four HCV infected patients participated in the present study. Twenty five percent of participants were hepatic steatosis (n = 15). SVR was 80% in hepatic steatosis group and 71.2% in group without hepatic steatosis (p = 0.50). Other factors showed no significant except significant fibrosis. Conclusion: There was no relationship between hepatic steatosis and HCV treatment outcome. Keywords: Controlled attenuation parameter, CAP, Hepatic steatosis, Outcome, Viral hepatitis C, Treatment

Factors and HCV treatment outcomes associated with smoking among people who inject drugs on opioid agonist treatment: secondary analysis of the PREVAIL randomized clinical trial

BackgroundCigarette smoking has emerged as a leading cause of mortality among people with hepatitis C virus (HCV). People who inject drugs (PWID) represent the largest group of adults infected with HCV in the US. However, cigarette smoking remains virtually unexplored among this population. This study aimed at (1) determining prevalence and correlates of cigarette smoking among HCV-infected PWID enrolled in opiate agonist treatment programs; (2) exploring the association of smoking with HCV treatment outcomes including adherence, treatment completion and sustained virologic response (SVR); and 3) exploring whether cigarette smoking decreased after HCV treatment.MethodsParticipants were 150 HCV-infected PWID enrolled in a randomized clinical trial primarily designed to test three intensive models of HCV care. Assessments included sociodemographics, presence of chronic health and psychiatric comorbidities, prior and current drug use, quality of life, and HCV treatment outcomes.ResultsThe majority of the patients (84%) were current cigarette smokers at baseline. There was a high prevalence of psychiatric and medical comorbidities in the overall sample of PWID. Alcohol and cocaine use were identified as correlates of cigarette smoking. Smoking status did not influence HCV treatment outcomes including adherence, treatment completion and SVR. HCV treatment was not associated with decreased cigarette smoking.ConclusionsThe present study showed high prevalence of cigarette smoking among this population as well as identified correlates of smoking, namely alcohol and cocaine use. Cigarette smoking was not associated with HCV treatment outcomes. Given the detrimental effects that cigarette smoking and other co-occurring, substance use behaviors have on HCV-infected individuals’ health, it is imperative that clinicians treating HCV also target smoking, especially among PWID. The high prevalence of cigarette smoking among PWID will contribute to growing morbidity and mortality among this population even if cured of HCV. Tailored smoking cessation interventions for PWID along with HCV treatment may need to be put into clinical practice.Trial registrationNCT01857245. Registered May 20, 2013.

Towards HCV elimination among people who inject drugs in Hai Phong, Vietnam: study protocol for an effectiveness-implementation trial evaluating an integrated model of HCV care (DRIVE-C: DRug use & Infections in ViEtnam–hepatitis C)

IntroductionIn Vietnam, people who inject drugs (PWID), who are the major population infected by hepatitis C virus (HCV), remain largely undiagnosed and unlinked to HCV prevention and care despite recommended...