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Objectives CDC reported that 45% of Hepatitis C (HCV) infected people denied known risk factors. Electronic health record RF-based, non-Birth Cohort (born outside of years 1945-1965) screening is challenging as risk factors are often input as nonsearchable data. Testing non-Birth Cohort patients solely based on risk factors has the potential to miss a substantial number of HCV infected patients. The aim was to determine the HCV antibody positive prevalence who would have been missed had providers only followed risk factor based screening recommendations. Methods A 1:3 case-control retrospective nested chart review was conducted. HCV risk factors and opioid prescriptions were manually abstracted from the Electronic Health Record; other variables were collected using Explorys. In July 2015 HCV screening data was collected on non-Birth Cohort patients who were HCV tested across MedStar Health, as a presumptive marker for high risk. Univariate and multivariate logistic regression models were utilized to determine HCV antibody positive predictors. Results Eighteen (23%) HCV antibody positive and 123 (49%) HCV antibody negative had no identified risk factors; 6 (33%) HCV antibody positive reported risk factors only after a positive test result. There was a significant interaction between age over 40 and opioid prescription use; these groups were 11× more likely to be HCV antibody positive (CI95 1.6-74.8). Conclusions HCV testing solely based on presence of risk factors in non-Birth Cohort patients has the potential to miss a significant number of HCV antibody positive patients. Given patient- and provider-level barriers in elucidating risk factors, universal HCV antibody screening may be warranted.

Background The opioid epidemic across the U.S. poses an array of public health concerns, especially HCV transmission. HCV is now widely curable, yet incident rates are increasing due to the opioid epidemic. Despite the established trajectory from oral prescription opioids (OPOs) to opioid use disorder (OUD), OUD to injection drug use (IDU), and IDU to hepatitis C virus (HCV), OPOs are not a defined risk factor (RF) for HCV infection. The objective of this study was to observe rates of HCV testing and Ab reactivity (HCVAb+) in patients receiving OPOs to substantiate them as a RF, ultimately contributing to HCV elimination. Methods Data from MedStar Health patients receiving OPOs from 1/2017 to 12/2018 were collected and analyzed using chi-squared or student t-tests and logistic regression for uni- or multi-variable analyses, respectively. Statistical significance was defined as P Results There were 115 415 individuals prescribed OPOs over the study period. In this population, 8.6% (932) were HCVAb+ when tested and not previously diagnosed (10 900); 3.4% (3893) had an OUD diagnosis, 20.6% (803) of whom were HCV tested; 25.4% (361) of all HCVAb+ (1421) had an OUD diagnosis. OUD (ORadj 8.53 [7.22-10.07]) was an independent predictor of HCVAb+ in this population. Conclusions (1) In a large population prescribed oral opioids, HCVAb+ was 8.6%, higher than our previously published data (2.5%) and the US rate (1.7%); (2) only 20% of patients diagnosed with OUD were tested; and (3) only 25% of HCVAb+ patients were classified with OUD; this suggests underreporting of OUD in this population. Primary Care and Community Health Recommendations: (1) Re-testing for HCV in patients taking OPOs; (2) increased HCV testing among OUD patients; and (3) improved surveillance and reporting of OUD.

Background There are approximately 300,000 people in the United States who are co-infected with HIV and HCV. Several organizations recommend that individuals who are HCV infected, as well as persons over the age of 13, should be HIV tested. Comorbidities associated with HCV can be reduced with early identification of HIV. Our objective was to determine whether providers routinely followed HIV testing guidelines for patients who tested HCV positive (HCV+). Methods A retrospective chart review was conducted of all patients in primary care at an academic health system from 7/2015–3/2017 who tested HCV+. As part of a primary database, HCV testing data was collected; HIV testing data was abstracted manually. We collected and described the intervals between HCV and HIV tests. To determine associations with HIV testing univariable and multivariable analyses were performed. Results We identified 445 patients who tested HCV+: 56.6% were tested for HIV, the mean age was 57 ± 10.9 years, 77% were from the Birth Cohort born 1945–1965 (BC); 61% were male; and 51% were Black/AA. Patients in the BC were more likely to be HIV tested if they were: male (p = 0.019), Black/AA (p Conclusion As demonstrated, providers did not routinely follow CDC recommendations as almost half of the HCV+ patients were not correctly tested for HIV. It is important to emphasize that six persons were tested HIV positive simultaneously with their HCV+ diagnosis. If providers did not follow the CDC guidelines, then these patients may not have been identified. Improvements in EHR clinical decision support tools and provider education can help improve the HIV testing rate among individuals who are HCV+.

Background Improved hepatitis C virus (HCV) clearance due to directly acting antiviral agents has led to remarkably improved outcomes of indolent HCV-associated non-Hodgkin lymphoma (NHL). The impact of directly acting antivirals on the outcomes of aggressive NHL is still under investigation. Characteristics of HCV-associated NHL in black patients are not well characterized. We report outcomes of HCV-associated NHL compared to their HCV-negative counterparts in a predominantly black population. Patients and Methods Patients with lymphoma between January 2007 and December 2017 were retrospectively studied. Depending on presence or absence of HCV RNA, patients were grouped into HCV positive (HCV+) and HCV negative (HCV−) cohorts. Depending on virologic clearance (VC), HCV+ were classified into HCV+ with VC and HCV+ without VC. Overall response rate (ORR), complete response, overall survival (OS), and progression-free survival (PFS) of HCV+ patients with and without VC were compared to HCV− patients. Results Of 397 patients with lymphoma, 40 had HCV. Black comprised 90% of HCV+ patients. Diffuse large B-cell lymphoma was most frequent (47%) in the HCV+ group. HCV+ patients without VC had significantly worse OS and PFS compared to HCV− patients. There were no differences in ORR, complete response, PFS, and OS of HCV+ patients with VC and HCV− patients. These results were consistent in subgroups of diffuse large B-cell lymphoma and aggressive lymphoma. Conclusion HCV clearance is positively associated with lymphoma outcomes in black patients. Patients who clear HCV have noninferior outcomes to HCV− patients, while those who fail to clear HCV have significantly worse outcomes.

Hepatitis C viral infection is recognized worldwide as a leading cause of cirrhosis and hepatocellular carcinoma. The goal of hepatitis C viral antiviral therapy is the permanent eradication of hepatitis C viral RNA, commonly referred to as a sustained virologic response – defined as “undetectable” RNA at 12 weeks following the completion of therapy. Hepatitis C viral treatment has dramatically advanced with the FDA approval of several new agents known as direct-acting antivirals. These drugs target specific nonstructural proteins of the virus, which disrupt viral replication, and therefore halt infection. However, recently, there has been a concern for increased risk of recurrence of treated hepatocellular carcinoma or denovo occurrence of hepatocellular carcinoma after treatment with direct-acting antivirals. We are now reporting three cases of intrahepatic cholangiocarcinoma that developed after sustained virologic response following hepatitis C viral treatment with direct-acting antivirals.

Highly efficacious and tolerable treatments that cure hepatitis C viral (HCV) infection exist today, increasing the feasibility of disease elimination. However, large healthcare systems may not be fully prepared for supporting recommended actions due to knowledge gaps, inadequate infrastructure and uninformed policy direction. Additionally, the HCV cascade of care is complex, with many embedded barriers, and a significant number of patients do not progress through the cascade and are thus not cured. The aim of this retrospective cohort study was to evaluate a large healthcare system’s HCV screening rates, linkage to care efficiency, and provider testing preferences. Patients born during 1945–1965, not previously HCV positive or tested from within the Electronic Health Record (EHR), were identified given that three-quarters of HCV-infected persons in the United States are from this Birth Cohort (BC). In building this HCV testing EHR prompt, non-Birth Cohort patients were excluded as HCV-specific risk factors identifying this population were not usually captured in searchable, structured data fields. Once completed, the BC prompt was released to primary care locations. From July 2015 through December 2016, 11.5% of eligible patients (n = 9,304/80,556) were HCV antibody tested (anti-HCV), 3.8% (353/9,304) anti-HCV positive, 98.1% (n = 311/317) HCV RNA tested, 59.8% (n = 186/311) HCV RNA positive, 86.6% (161/186) referred and 76.4% (n = 123/161) seen by a specialist, and 34.1% (n = 42/123) cured of their HCV. Results from the middle stages of the cascade in this large healthcare system are encouraging; however, entry into the cascade–HCV testing–was performed for only 11% of the birth cohort, and the endpoint–HCV cure–accounted for only 22% of all infected. Action is needed to align current practice with recommendations for HCV testing and treatment given that these are significant barriers toward elimination.

Objective. CDC recommends that all people born between 1945 and 1965 be tested for hepatitis C virus (HCV). We hypothesized that HCV testing in a large, urban primary care clinic would reveal higher rates of HCV infection than previously published. Methods. Through the Hepatitis Testing and Linkage to Care initiative, the primary care clinic at MedStar Washington Hospital Center in Washington, DC, provided HCV antibody (anti-HCV) testing and linkage to care from October 2012 through September 2013 for patients born between 1945 and 1965 without previously noted risk factors. We collected data on age, race/ethnicity, sex, anti-HCV and HCV ribonucleic acid (RNA) results, risk factors in those who tested anti-HCV positive, and health insurance type and made comparisons using χ2 and Student's t-tests. Results. Of 1,123 patients tested, the mean age was 57 years, 742 (66.1%) were women, 969 (86.3%) were black/African American, and 654 (58.2%) had public health insurance. Of the 99 (8.8%) patients who tested anti-HCV positive, the mean age was 58 years, 54 were men, and 93 were black/African American; 41 of 74 anti-HCV-positive patients were intravenous drug users. Of 82 anti-HCV-positive patients, 51 were HCV RNA positive. Of the black/African American patients tested, 49 of 317 men (15.5%) and 44 of 652 women (6.7%) were anti-HCV positive ( pConclusion. Testing initiatives in primary care settings need to be more rigorously upheld, and internal champions are needed to advocate for increased screening to ensure linkage to care and engagement in the HCV care cascade.

Background: Association of hepatitis C virus (HCV) infection and B-cell non-Hodgkin Lymphoma (B-NHL) is well-established. Directly-acting antiviral HCV therapy (DAA) results in very high rates of sustained viral response (SVR) and HCV cure. Studies of the impact of successful antiviral therapy on lymphoma outcomes in HCV-infected patients can have important implications for patient management and for understanding of the biology of different lymphomas. The strongest evidence of positive impact of HCV antiviral therapy on lymphoma regression is available for indolent lymphomas, especially marginal zone lymphoma. Impact of antiviral therapy on HCV-associated aggressive B-NHL is still under investigation. Furthermore, there is no data on outcomes for HCV-associated B-NHL in African-American (AA) patients. The aim of this study was to evaluate lymphoma characteristics and outcomes in HCV-associated B-NHL, in a predominantly AA population. Methods: All consecutive patients with lymphoma and reactive HCV Antibody (HCV Ab+) diagnosed and treated at our center between January 2003 and December 2017 were studied. Patients with HCV-associated mixed cryoglobulinemia without any overt lymphoma, HCV-associated paraproteinemia and patients who did not have antiviral treatment history available were excluded. All information was obtained by review of electronic medical records. Baseline patient characteristics including age, sex, race, comorbidity including HIV infection, lymphoma stage, histology, prognostic score and baseline lactate dehydrogenase (LDH) were recorded. Lymphomas were classified according to the 2016 WHO classification. Prognostic score was calculated using International Prognostic Index (IPI) for aggressive lymphomas, Follicular Lymphoma International Prognostic Index (FLIPI) for indolent lymphomas other than chronic lymphocytic leukemia (CLL) and CLL-IPI for CLL. Details of lymphoma treatment and antiviral therapy were recorded. Virologic clearance (VC) was used to collectively describe both SVR (undetectable HCV RNA 12 weeks after completion of antiviral treatment) and spontaneous clearance of HCV without treatment. Study outcomes were overall response rate (ORR), complete response rate (CR), overall survival (OS) and progression free survival (PFS). Results: We found 397 patients with lymphoma at our institution, of which, 40 patients had HCV. Thirty-eight patients had complete lymphoma and antiviral treatment history available and were included in the analysis. Median age was 58 years, 90% were AA; 68% were men. Diffuse large B-cell lymphoma (DLBCL) was the predominant histology (50%). Advanced stage (64%), aggressive lymphoma (60%), good prognostic score (74%) and elevated LDH (66%) were common. A total of 21 patients were treated, 18 with DAA and 3 with interferon-based therapy. Twenty-two patients had VC, either spontaneous or with antiviral therapy. Patients with VC, had significantly higher ORR (95% vs 69%, RR 2.4, CI95 1.3-4.4, p Conclusions: Hepatitis C VC is associated with improved CR and OS in predominantly AA lymphoma patients including patients with aggressive B-NHL. The precise role and timing of HCV antiviral therapy in HCV-associated aggressive B-NHL should be assessed in large prospective studies that include AA patients. Disclosures No relevant conflicts of interest to declare.

BACKGROUND The combination of daclatasvir, a hepatitis C virus (HCV) NS5A inhibitor, and the NS5B inhibitor sofosbuvir has shown efficacy in patients with HCV monoinfection. Data are lacking on the efficacy and safety of this combination in patients coinfected with human immunodeficiency virus type 1 (HIV-1). METHODS This was an open-label study involving 151 patients who had not received HCV treatment and 52 previously treated patients, all of whom were coinfected with HIV-1. Previously untreated patients were randomly assigned in a 2:1 ratio to receive either 12 weeks or 8 weeks of daclatasvir at a standard dose of 60 mg daily (with dose adjustment for concomitant antiretroviral medications) plus 400 mg of sofosbuvir daily. Previously treated patients were assigned to undergo 12 weeks of therapy at the same doses. The primary end point was a sustained virologic response at week 12 after the end of therapy among previously untreated patients with HCV genotype 1 who were treated for 12 weeks. RESULTS Patients had HCV genotypes 1 through 4 (83% with genotype 1), and 14% had compensated cirrhosis; 98% were receiving antiretroviral therapy. Among patients with genotype 1, a sustained virologic response was reported in 96.4% (95% confidence interval [CI], 89.8 to 99.2) who were treated for 12 weeks and in 75.6% (95% CI, 59.7 to 87.6) who were treated for 8 weeks among previously untreated patients and in 97.7% (95% CI, 88.0 to 99.9) who were treated for 12 weeks among previously treated patients. Rates of sustained virologic response across all genotypes were 97.0% (95% CI, 91.6 to 99.4), 76.0% (95% CI, 61.8 to 86.9), and 98.1% (95% CI, 89.7 to 100), respectively. The most common adverse events were fatigue, nausea, and headache. There were no study-drug discontinuations because of adverse events. HIV-1 suppression was not compromised. CONCLUSIONS Among previously untreated HIV–HCV coinfected patients receiving daclatasvir plus sofosbuvir for HCV infection, the rate of sustained virologic response across all genotypes was 97.0% after 12 weeks of treatment and 76.0% after 8 weeks. (Funded by Bristol-Myers Squibb; ALLY-2 ClinicalTrials.gov number, NCT02032888.)

Background Prevalence of HCV in pregnancy is 0.1–3.6%. AASLD and IDSA now recommend HCV screening in pregnancy although CDC, USPSTF, or ACOG still do not—though HCV can be perinatally transmitted and carries associated complications for the mother and fetus. Our study objectives were to analyze prenatal HCV screening practices at a large regional healthcare system and the prevalence of HCV-associated maternal and fetal/neonatal outcomes. Methods We performed a nested propensity score (PS) case–control study of pregnant women who tested HCV Ab+ in a cross-sectional study of women presenting for prenatal care at a large regional healthcare system from January 17 to December 18. We collected retrospective EHR data, including state of residency, HCV Ab, RNA, care engagement, HCV risk factors, comorbidities, maternal and fetal/neonatal morbidity, and neonatal HCV testing (when available). Mixed and generalized linear models were used to examine differences in continuous and categorical variables, respectively, between cases and controls Results 14,363 women were seen for prenatal care; 4,891 (34%) were HCV tested, 75 (1.5%) tested HCV Ab+. Demographic and comorbidity data are shown in Table 1. HCV Ab+ cases had more co-morbidities, including obesity, heart disease, opioid use, and behavioral health issues compared with the controls. HCV risk factors included IVDU (64%) and tattoos (24%) (Figure 1). Neither past/current pregnancy-related complications nor fetal or neonatal adverse events (Figure 2) were statistically significantly different except for cholestasis in HCV Ab+ cases (5.3 vs. 0%, P = 0.04). Conclusion Our study showed only one-third of pregnant women are currently HCV screened in our health system. Universal screening would likely increase the number of HCV-infected women identified. Early HCV detection, repeated testing, and behavioral health intervention of those at high-risk may decrease further horizontal and vertical transmission of HCV in pregnancy. Disclosures All authors: No reported disclosures.

The efficacy of directly acting antiviral agents in interferon-free regimens for the treatment of chronic hepatitis C infections needs to be evaluated in different populations.To determine the efficacy and safety of sofosbuvir with weight-based or low-dose ribavirin among a population with unfavorable treatment characteristics.Single-center, randomized, 2-part, open-label phase 2 study involving 60 treatment-naive patients with hepatitis C virus (HCV) genotype 1 enrolled at the National Institutes of Health (October 2011-April 2012).In the study's first part, 10 participants with early to moderate liver fibrosis were treated with 400 mg/d of sofosbuvir and weight-based ribavirin for 24 weeks. In the second part, 50 participants with all stages of liver fibrosis were randomized 1:1 to receive 400 mg of sofosbuvir with either weight-based or low-dose 600 mg/d of ribavirin for 24 weeks.The primary study end point was the proportion of participants with undetectable HCV viral load 24 weeks after treatment completion (sustained virologic response of 24 weeks [SVR24]).In the first part of the study, 9 participants (90%; 95% CI, 55%-100%) achieved SVR24. In the second part, 7 participants (28%) in the weight-based group and 10 (40%) in the low-dose group relapsed after treatment completion leading to SVR24 rates of 68% (95% CI, 46%-85%) in the weight-based group and 48% (95% CI, 28%-69%; P = .20) in the low-dose group. Twenty individuals participated in a pharmacokinetic-viral kinetic substudy, which demonstrated a slower loss rate of infectious virus in relapsers than in participants who achieved SVR (clearance, 3.57/d vs 5.60/d; P = .009). The most frequent adverse events were headache, anemia, fatigue, and nausea. There were 7 grade 3 events including anemia, neutropenia, nausea, hypophosphatemia, and cholelithiasis or pancreatitis. No one discontinued treatment due to adverse events.In a population of patients with a high prevalence of unfavorable traditional predictors of treatment response, a 24-week regimen of sofosbuvir and weight-based or low-dose ribavirin resulted in SVR24 rates of 68% and 48%, respectively.clinicaltrials.gov Identifier: NCT01441180.