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Background Occult infection with hepatitis C virus (HCV) is defined as the presence of the HCV genome in either liver tissue or peripheral blood monocytes, despite constant negative results from tests for HCV RNA in serum. Objectives The aim of the study to detect the prevalence of occult hepatitis C Virus infection in patients who achieved a sustained virologic response (SVR) to direct-acting antiviral agents and to outline predictors of OCI. Patients and Methods This study included 100 patients with chronic HCV infection without liver cirrhosis attending to hepatitis C clinics at Ain Shams University Hospital, Ahmed Maher Teaching hospital and Elgomhorya Teaching Hospital.who received sofosbuvir (400mg) plus daclatasvir (60mg) daily for 12 weeks with or without ribavirin according to National committee to combat viral hepatitis (NCCVH) protocol. Results We tested peripheral blood for HCV RNA in PBMCs to detect OCI. Occult HCV was found positive in 12% of the studied cases. Occult HCV was positive more in male cases. Positive cases had significantly lower age, and higher total bilirubin, direct bilirubin, AST and ALT levels. Age had significant moderate diagnostic performance in predicting occult HCV, while direct bilirubin has significant low diagnostic performance in predicting occult HCV. Conclusion OCI following direct antiviral therapy may be present in some cases, and this may require further testing of patients with SVR particularly in younger male patients with persistantly high liver enzymes.

Background Hepatitis C Virus (HCV) infection is a global health problem. OCI is characterized by presence of HCV-RNA in the liver tissue only and/or Peripheral Blood Mononuclear Cells (PBMCs) with undetectable HCV-RNA or antibodies in the serum. Support for presence of this entity comes from the observation that HCV, even though a hepatotropic virus, can replicate as well at extrahepatic sites, including peripheral blood mononuclear cells. Objectives The current study evaluated the hidden infection of hepatitis C virus among patients on maintenance hemodialysis with negative ELISA and PCR by using PCR in mononuclear cells as a marker in these patients. Our study was done in Sharkia Governorate. Patients and Methods In our study, the 60 included subjects had an average age of 48.27 years with range from 19 to 77 years and included 33 males (55%) and 27 females (45%). The subjects had average dialysis duration of 6.51 ± 4.10years with range from 7 months to 19 years. Results Our study showed no statistically significant differences between occult HCV cases and negative cases in frequency of blood transfusion. There were no statistically significant differences between occult HCV cases and negative cases in splenomegaly, hepatomegaly or coarse liver but there was a statistically significant increase in frequency of severe ascites, moderate LL edema and jaundice among occult HCV cases compared to negative cases. There were no statistically significant differences between occult HCV cases and negative cases in urea, creatinine, ALT, AST or albumin. In our study total bilirubin>1.7 and direct bilirubin >0.4 were significant predictors for the presence of occult HCV in hemodialysis patients. Our study showed that there were no statistically significant correlation between viral load in PBMCs and laboratory findings among occult HCV cases. Conclusion Hemodialysis patients are liable for occult HCV infections with a considerable impact on their health. Total and direct bilirubin are predictors of presence of occult hepatitis C infection at cut-off values of 1.7 mg/dl and 0.4 mg/dl respectively.

Background Egypt has the highest prevalence rate of HCV in the world. About 14.7% of the Egyptian people have HCV antibodies and 9.8% have an active infection. The death rate due to liver disease about 40,000 each year (near10% of all deaths). It is the second after the cardiac diseases. Aim of Work to assess Doppler haemodynamic changes suggestive of portal hypertension in cirrhotic HCV Egyptian patients after sustained virological response to direct antiviral agents, and their correlation with liver stiffness measurements by Fibroscan. Patients and Methods This prospective cohort study was conducted at Viral Hepatitis Unit at Ain Shams University Hospital and Al-Agouza Police Hospital during the period from May 2018 to July 2019. The study included 50 Egyptian treatment-naïve chronic hepatitis C patients with cirrhosis on Sofosbuvir, Daclatasvir for 12 weeks. Patients were subjected to history and full physical examination, radiology assessment (Abdominal Ultrasound and color Doppler), Upper GI endoscopy and Fibroscan before treatment and 6 months after treatment. Followed up with CBC, AST, ALT, Total bilirubin, Albumin, creatinine and Coagulation profile before and after 12 weeks of treatment And HCV RNA by PCR and HCV CORE Antigen before and then after 12 weeks of treatment. Results Treatment with sofosbuvir plus Daclatasvir for 12weeks resulted in undetectable HCV RNA by PCR in 100% of the patients at the end of treatment. There was a significant improvement in portal hemodynamics 6 months after treatment as well as a significant correlation between Doppler indices and fibroscan. Conclusion: Doppler portal hypertensive parameters, as a marker of portal hypertension, were improved in parallel with the improvement in fibroscan values after viral clearance and its improvement in the current study mandate urgent treatment to avoid possible complications.

Objectives Hepatitis C virus (HCV) infection is a serious health problem in New York City. Although curative treatments are available, many people are out of care. The New York City Department of Health and Mental Hygiene (DOHMH) used surveillance data and various outreach methods to attempt to link to care people diagnosed with HCV infection from 2010 through 2015. Methods We randomly assigned people out of care (ie, no HCV test >6 months after first report) to 4 outreach groups: no outreach (control group); letter only; letter and telephone call; and letter, text message, and telephone call. Three months after outreach ended, we analyzed surveillance data to identify people with a subsequent HCV RNA or genotype test suggesting linkage to care. Results Of 2626 selected people, 199 (7.6%) had a subsequent HCV test. People in all 3 outreach groups had higher odds of a subsequent test than people in the control group (letter only: adjusted odds ratio [aOR] = 1.81 [95% CI, 1.18-2.91]; letter and telephone: aOR = 3.11 [95% CI, 1.67-5.79]; letter, text, and telephone: aOR = 3.17 [95% CI, 1.48-6.51]). People in the letter and telephone group had higher odds of a subsequent test than people in the letter-only group (aOR = 1.72; 95% CI, 1.04-2.74). Most people in the letter and telephone (136/200, 68.0%) and the letter, text, and telephone (71/99, 71.7%) groups could not be reached, primarily because telephone numbers were incorrect or out of service. Conclusion Reaching out to people soon after first report or prioritizing groups in which more recent contact information can be found might improve outcomes of future outreach.

The structure of electronic medical record data prevents easy population-level monitoring of hepatitis C virus (HCV) treatment uptake and cure. Using an HCV registry from a public hospital system in Atlanta, Georgia, we developed multiple algorithms that use serial HCV RNA test results as proxy measures for initiation of direct-acting antiviral (DAA) treatment and sustained virological response (SVR). We calculated sensitivity and positive predictive values (PPVs) by comparing the algorithms with the DAA initiation and SVR results from the registry. From December 2013 to August 2016, 1,807 persons actively infected with HCV were identified in the registry. Of those, 698 initiated DAA treatment on the basis of medical record abstraction; of 442 patients with treatment start and/or end dates, 314 had documented SVR. Treatment algorithm 2 (a detectable HCV RNA result followed by 2 sequential HCV RNA test results) and treatment algorithm 5 (a detectable HCV RNA result followed by 2 sequential HCV RNA test results >6 weeks apart) had the highest sensitivity (87% and 85%, respectively) and PPV (80% and 82%, respectively) combinations. Four SVR algorithms relied on fulfilling treatment algorithm definitions and having an undetectable HCV RNA test result ≥12 weeks after the last HCV RNA result; sensitivity for all 4 algorithms was 79%, and PPV was 92%-93%. Algorithms using serial quantitative HCV RNA results can serve as proxy measures for evaluating population-level DAA treatment and SVR outcomes.

BACKGROUND: Kidney transplantation from hepatitis C seropositive (HCV+) donors may benefit hepatitis C RNA-positive (RNA+) candidates, but it is unclear how the willingness to be listed for and accept such kidneys affects waitlist and transplant outcomes. METHODS: In a single-center retrospective analysis, HCV+ transplant candidates (N = 169) listed from March 2004 to February 2015 were evaluated. All RNA+ candidates were offered the option to be listed for HCV+ donors. RNA− candidates were listed only for HCV− donors. RESULTS: Fifty-seven patients (51% of all RNA+ transplant candidates) willing to accept HCV+ donors were listed for both HCV+ and HCV− donor kidneys. During 6-year follow up, 43 (75%) of 57 patients accepting HCV+ versus 19 (35%) of 55 patients not accepting HCV+ received a deceased donor kidney transplant (P < 0.0001). Multivariable analysis demonstrated that willingness to be listed for and accept HCV+ kidneys was associated with receiving deceased donor kidney transplant (P = 0.0016). Fewer patients accepting HCV+ donors (7 [12%] vs 16 [29%]) were removed from the list due to death or deteriorated medical condition (P = 0.0117). Posttransplant patient and graft survival rates were not significantly different. Overall patient survival since the listing (combined waitlist and posttransplant survival) was similar among the groups. CONCLUSIONS: HCV RNA+ candidates had better access to transplantation and similar overall survival before the era of widespread use of direct-acting anti-HCV agents.

The lack of hepatitis C virus (HCV) diagnostic tests designed for use in decentralized settings is a major obstacle for providing access to treatment and prevention services particularly in low and middle income countries. Here we describe the development and validation of two building blocks of the HCV Quant Assay, a test in development for point-of-care use: 1) an RT-qPCR assay with noncompetitive internal control that equivalently detects the 6 major HCV genotypes and 2) an automated sample prep method using immiscible phase filter technology. This novel assay has wide dynamic range of HCV quantification and a limit of detection of 30 IU/ml with 200 μl specimen volume. In a preliminary study of 61 clinical specimens, the HCV Quant Assay demonstrated 100% sensitivity and specificity and gave comparable viral load results across 4 logs of IU/ml when compared to the Abbott RealTime HCV Assay.

Background The Northern Alberta HIV Program (NAHP) provides care and support for about 2500 HIV positive individuals. Part of the program includes screening and therapy for co-morbidities such as hepatitis C virus (HCV) infection. This study aims to assess the occurrence of HCV co-infection among these patients, determine whether they had received treatment for HCV, and identify patients who are currently viremic so they can be linked to care. Methods NAHP patients from 2010 to 2019 were linked to their HCV antibody, RNA, and genotyping laboratory testing data from January 1, 2000 to December 31, 2019 as well as HCV medication dispensation data. Each patient’s current and previous state of HCV infection and treatment status was assessed. Chart reviews were conducted for patients presently HCV viremic to assess their HIV care and social determinants. Results Of the 2417 NAHP patients, 392 (16.2%) were identified as having been co-infected with HCV at some point between January 1, 2000 to December 31, 2019 and meeting the inclusion criteria. Overall, 198 (50.5%) of the HIV-HCV co-infected patients had received HCV treatment and 232 (59.2%) were no longer viremic at their most recent HCV RNA test. 99 (69.2%) of the 143 HCV viremic patients had a suppressed HIV infection suggesting they are active in their HIV care and good candidates for HCV treatment. Figure 1. 2417 patients in the Northern Alberta HIV Program were evaluated for the presence of an HIV- HCV co-infection. 404 patients were identified as having been HIV-HCV co-infected at some point between January 1, 2000 and December 31, 2019. Figure 2. 404 HIV-HCV co-infected patients from the Northern Alberta HIV Program were assessed for the occurrence of treatment as well as the current status of their HCV infection. 143 patients were found to currently have an active HIV-HCV co-infection. Table 2. Characteristics of HIV-HCV co-infected patients from the NAHP with an active HCV infection (n=143) Conclusion The NAHP has been successful in identifying and treating many of their HIV HCV co-infected patients, however, there remain patients with viremic HCV. Despite the availability of direct-acting antivirals (DAAs) in Alberta and many of these patients being successfully treated for HIV, a significant proportion of co-infected patients have not initiated HCV treatment The HIV treating physicians of these individuals will be notified and encouraged to assist in getting them linked to HCV care and treatment. Disclosures All Authors: No reported disclosures

[Objectives] To examine HCV prevalence and management among people who inject drugs (PWID) attending primary care and community-based health services at four European sites using baseline data from a multicentre feasibility study of a complex intervention (HepLink)., [Methods] Primary care and community-based health services in Dublin, London, Bucharest and Seville were recruited from the professional networks of the HepLink consortium. Patients were eligible to participate if aged ≥18 years, on opioid substitution treatment or at risk of HCV (i.e. injecting drug use, homeless or incarcerated), and attended the service. Data on patient demographics and prior HCV management were collected on participants at baseline., [Results] Twenty-nine primary care and community-based health services and 530 patients were recruited. Baseline data were collected on all participants. Participants’ mean age ranged from 35 (Bucharest) to 51 years (London), with 71%–89% male. Prior lifetime HCV antibody testing ranged from 65% (Bucharest) to 95% (Dublin) and HCV antibody positivity among those who had been tested ranged from 78% (Dublin) to 95% (Bucharest). Prior lifetime HCV RNA testing among HCV antibody-positive participants ranged from 17% (Bucharest) to 84% (London). Among HCV antibody- or RNA-positive participants, prior lifetime attendance at a hepatology/infectious disease service ranged from 6% (London) to 50% (Dublin) and prior lifetime HCV treatment initiation from 3% (London) to 33% (Seville)., [Conclusions] Baseline assessment of the HCV cascade of care among PWID attending primary care and community-based health services at four European sites identified key aspects of the care cascade at each site that need to be improved., This work is supported by the European Commission through its EU Third Health Programme (Grant Agreement Number 709844) and Ireland’s Health Services Executive.

Lung transplantation still remains the definitive treatment for patients with end-stage pulmonary disease. It provides health care providers the ability to not only prolong survival but improve quality of life for these patients. The success of this surgery is dependent on a number of variables such as the conduct of surgery. However, what is equally if not more important is the postoperative care that we tell patients will be continued for the rest of their lives. This care requires the use of immunosuppression to prevent immune graft injury as well as careful monitoring for opportunistic and chronic infections that may arise.

Background In Europe, increases in HCV infection have been observed over the last two decades in MSM, making them a key population for recently acquired HCV. Alternative combinations of direct-acting antiviral agents against early HCV infection need to be assessed. Patients and methods In this pilot trial, MSM with recently acquired genotype 1 or 4 HCV infection were prospectively included and received 8 weeks of oral grazoprevir 100 mg and elbasvir 50 mg in a fixed-dose combination administered once daily. The primary endpoint was sustained virological response evaluated 12 weeks after the end of treatment (EOT) (SVR12). Secondary endpoints were the virological characterization of failures, the quality of life before, during and after treatment and the rate of reinfection. Results In a 15 month period, 30 patients were enrolled, all of whom were MSM. Of the 29 patients completing follow-up, 28 (96%, 95% CI = 82%–99%) achieved SVR12. One patient interrupted follow-up (suicide) but had undetectable plasma HCV RNA at EOT. One patient with suboptimal adherence confirmed by plasma drug monitoring relapsed and developed NS3, NS5A and NS5B resistance-associated substitutions (V36M, M28V and S556G). The most common adverse events related to study drug were diarrhoea (n = 4, 13%), insomnia (n = 2, 7%) and fatigue (n = 2, 7%), although no patient discontinued treatment. No HIV RNA breakthrough was reported in the 28 patients with HIV coinfection. At Week 48, reinfection was diagnosed in three patients. Conclusions Our data support the use of grazoprevir/elbasvir for immediate treatment against HCV in order to reduce HCV transmission in MSM.

Objectives To assess progress in Australia toward the 2030 WHO hepatitis C elimination targets two years after the introduction of highly effective direct‐acting antiviral (DAA) treatments. Design Analysis of quarterly data on government‐subsidised hepatitis C RNA testing and hepatitis C treatment in Australia, January 2013 – June 2018. Changes in testing and treatment levels associated with DAA availability were assessed in an autoregressive integrated moving average (ARIMA) statistical model, and the impact by 2030 of different levels of testing and treatment were estimated using a mathematical model. Major outcome measures Hepatitis C prevalence among people who inject drugs; annual hepatitis C incidence relative to 2015 levels; projections for the hepatitis C care cascade in 2030. Results The mean annual number of treatments initiated for people with hepatitis C increased from 6747 during 2013–2015 (before the introduction of DAAs) to 28 022 during 2016–18; the mean annual number of diagnostic RNA tests increased from 17 385 to 23 819. If current trends in testing and treatment continue (ie, 2018 testing numbers are maintained but treatment numbers decline by 50%), it is projected that by 2030 only 72% of infected people would be treated (by 2025 all people diagnosed with hepatitis C would be treated). The incidence of hepatitis C in 2030 would be 59% lower than in 2015, well short of the WHO target of an 80% reduction. The identification and testing of people exposed to hepatitis C must be increased by at least 50% for Australia to reach the WHO elimination targets. Conclusion Hepatitis C elimination programs in Australia should focus on increasing testing rates and linkage with care to maintain adequate levels of treatment.

BACKGROUND: The fixed-dose combination of EBR 50 mg, an NS5A inhibitor, and GZR 100 mg, an NS3/4 protease inhibitor (EBR/GZR), is a highly effective and well-tolerated all-oral, once-daily regimen in diverse populations of hepatitis C virus (HCV) genotype (GT)1-, 4-, or 6-infected patients, including PWID on OAT. However, data on HCV reinfection rates after successful treatment are limited. AIMS: To determing the rate of reinfections following sucessful HCV therapy with EBR and GZR in PWID receiving OAT METHODS: The double-blind, placebo-controlled CO-STAR study evaluated the efficacy of EBR/GZR for 12 weeks in treatment-naïve HCV GT1-/4-/6-infected patients receiving OAT. Patients were randomized 2:1 to an immediate treatment group (ITG) or a deferred treatment group. HCV reinfection was evaluated among ITG patients with undetectable HCV RNA at end of treatment (EOT). In patients with recurrent viremia following EOT, population sequencing and phylogenetic analysis were performed on baseline and post-treatment samples to distinguish relapse from reinfection. RESULTS: Three hundred one patients were randomized, with 201 in the ITG (76% GT1a; 20% cirrhotic; 8% HIV+). Baseline OAT included methadone (81%) and buprenorphine (19%), and 46% had detectable illicit drugs, excluding marijuana. Post-treatment viremia was detected in 18 patients, with 12 virologic failures and 6 probable reinfections (5 through follow-up week (FW)12 and 1 at FW24). Three patients identified as reinfections had subsequent clearance of HCV RNA. Estimated reinfection incidence per 100 person-years from EOT through FW12 is 10.5 (95% CI: 3.42, 24.6), and from EOT through FW24 is 3.4 (95% CI: 1.3,7.5). Follow-up analysis to determine if any probable reinfections were due to relapse of nondominant baseline variants rather than reinfection will be presented. CONCLUSIONS: Several HCV reinfection cases were detected among PWID on OAT following successful EBR/GZR therapy. Further follow-up is required to determine the natural course of HCV reinfection in the setting of interferon-free HCV treatment and the impact of viral persistence following reinfection on long-term response rates in this population. FUNDING AGENCIES: Merck Pharmaceuticals

BACKGROUND: Potent direct-acting antivirals (DAAs) for treatment of chronic hepatitis C virus (HCV) infection have reduced the need for on-treatment monitoring. Currently, on-treatment response and outcome are determined by HCV RNA testing. A less expensive alternative to verify viral replication is HCV core antigen (HCV Ag). AIMS: The aim of this study was to determine if HCV Ag can be used for initial confirmation of viremia, on-treatment monitoring and determination of SVR in patients with chronic HCV infection receiving DAA treatment. METHODS: To evaluate the role of HCV Ag in confirming SVR, patients treated with DAAs ±Peg-interferon (IFN)/RBV were included, for the purpose of assessing HCV Ag to determine relapse, patients treated with any regimen (including Peg-IFN/RBV) were included. Serum HCV RNA and HCV Ag levels were assessed at baseline (BL), on-treatment (OT), end of treatment (EOT) and week 12 and/or 24 of follow up (FU). HCV RNA was considered the gold standard. RESULTS: In total, 181 patients were included, 112 (62%) of whom achieved SVR. Mean age was 54 years (19–79), 115 (64%) patients were male. The majority of patients was infected with genotype 1 (68%) and treated with a sofosbuvir-based regimen (58%). Median HCV RNA level at BL was 6.1 Log10 IU/mL (2.7–7.4) and HCV Ag level was 2409 fmol/L (0.85-20000). At BL, 165 out of 167 (98.8%) viremic patients tested positive for HCV Ag. Of the two patients who tested HCV Ag negative, one patient had a low RNA level (2.67 log10 IU/mL), whereas in the second patient HCV RNA level was high (6.38 log10 IU/mL). Baseline HCV Ag and HCV RNA levels were significantly correlated (R=0.87, p

Background There are scant data regarding hepatitis C (HCV) virologic response to directly acting antiviral agents (DAAs) in chronic hepatitis B (HBV) and HCV coinfected persons. HCV treatment response in those with spontaneously cleared HBV infection is unknown. Methods All HCV-infected persons treated with a DAA regimen in ERCHIVES were identified and categorized into HBV/HCV-coinfected (HBsAg, HBV DNA or both positive), HCV-monoinfected, and resolved HBV (isolated HBcAb+). SVR rates were determined and compared for all groups. A logistic regression model was used to determine factors associated with SVR. Results Among 115 HCV/HBV-coinfected, 38,570 HCV-monoinfected persons, and 13,096 persons with resolved HBV, 31.6% of HCV/HBV-coinfected, 24.6% of HCV-monoinfected and 26.4% with resolved HBV had cirrhosis at baseline. SVR was achieved in 90.4% of HCV/HBV-coinfected, 83.4% of HCV-monoinfected and 84.5% of those with resolved HBV infection (P = 0.04 HCV/HBV vs. HCV monoinfected). In a logistic regression model, those with HCV/HBV were more likely to achieve SVR compared with HCV monoinfected (OR 2.25, 95% CI 1.17, 4.31). For HCV/HBV coinfected, the SVR rates dropped numerically with increasing severity of liver fibrosis (P-value non-significant). Factors associated with a lower likelihood of attaining SVR included cirrhosis at baseline (OR 0.85, 95% CI 0.80, 0.92), diabetes (OR 0.93, 95% CI 0.87, 0.99) and higher pretreatment HCV RNA (OR 0.86, 95% CI 0.84, 0.87). Conclusion HBV/HCV-coinfected persons have higher overall SVR rates with newer DAA regimens. The virologic response is graded, with decreasing SVR rates with increasing degree of liver fibrosis as determined by the FIB-4 scores. Disclosures All authors: No reported disclosures.

Background Despite hepatitis C virus (HCV) age cohort and risk factor screening recommendations, many at-risk individuals remain undiagnosed. Current screening practices may not adequately capture those at high risk for infection, especially in regions with increasing injection drug use (IDU). Universal HCV screening in a Tennessee tertiary care emergency department (ED) was introduced to help define regional epidemiology and to improve diagnosis and linkage to care. Methods This screening program was implemented in the Vanderbilt University Medical Center ED. Adult patients who underwent phlebotomy for clinical purposes were offered HCV screening. Samples were initially tested for HCV antibodies; if positive, samples were reflexed for HCV RNA testing. Patients with positive HCV RNA tests (i.e., active HCV infection) were notified, counseled, and offered linkage to care. Results A total of 11,637 screening tests were performed between April 1, 2017 and March 31, 2018, with 1,008 (8.7%) HCV antibody positive and 488 (4.2%) RNA positive. Of note, 81 (0.7%) were HCV antibody positive but RNA testing could not be performed due to insufficient sample volume. Several notable populations had high rates of HCV (Table 1). Importantly, 3.9% of people not born between 1945 and 1965 were HCV RNA positive, and they were the majority (63.5%) of patients with active HCV (Table 2). A minority (31.6%) of those with active HCV had a known history of IDU (Table 2). Conclusion HCV is common among patients presenting for emergency care at a Tennessee tertiary care ED. Universal screening identified many infections that would have been missed using age cohort and risk factors alone. ED HCV screening may be a useful method to augment guideline-based testing and intervene among populations not consistently screened. Disclosures C. A. Chastain, Gilead Sciences, Inc.: Grant Investigator and Research Contractor, Grant recipient and Research support. J. Johnson, Gilead Sciences, Inc.: Grant Investigator, Grant recipient. K. Miller, Gilead Sciences, Inc.: Grant Investigator, Grant recipient. J. H. Han, Gilead Sciences, Inc.: Grant Investigator, Grant recipient. W. H. Self, Gilead Sciences, Inc.: Grant Investigator, Grant recipient.

Background To achieve hepatitis C elimination, treatment programs need to be developed to engage, treat, and cure people who are actively injecting drugs. Methods We present preliminary data from the first 65 participants in the Accessible Care intervention for engaging people who inject illicit drugs (PWID) in hepatitis C (HCV) care. The randomized clinical trial compares the effectiveness of Accessible Care (low-threshold care in a syringe service program located in New York City) with Usual Care (referral to existing services) in facilitating linkage, engagement, and retention in HCV care. Eligible participants were HCV RNA positive and had injected drugs in the past 90 days. We compared the percentage of participants in each arm linked to HCV care (defined as one visit with HCV treatment provider), and initiated direct-acting antiviral (DAA) treatment within 6 months of enrollment. Results Among the 65 participants, the mean age is 41.2 years; 28% are females; 73% homeless; 6% black, 51% Latina/o and 39% white. 82% of participants had injected drugs in the last 30 days, with an average of 13.2 injections/month (median 10). Nearly all participants had health insurance, 88% public insurance, 6% uninsured. Thirty-two participants were randomized to the Accessible Care arm. Within 6 months of enrollment 79% of the Accessible Care arm and 25% of the Usual Care arm had linked to HCV care, and 69% and 13% had been started on DAA therapy, respectively. Of the 26 participants in the Accessible Care arm started on DAA therapy, the median time from enrollment to treatment initiation was 87.5 days [range 22–180]. Conclusion Among HCV-infected PWID enrolled at a syringe service program, higher rates of linkage to care and treatment initiation were seen in the Accessible Care arm where stigma- and shame-free treatment was located within a community-based location. Disclosures All authors: No reported disclosures.

Approval of Ledipasvir/Sofosbuvir for the treatment of chronic hepatitis C (HCV) includes the truncation of therapy from 12 to 8 weeks in treatment naïve, non-cirrhotic patients with baseline HCV RNA levels

Background Newer directing antiviral agents against HCV (DAAs) are safe and efficacious in persons with chronic kidney disease (CKD). Whether availability of these newer DAAs has resulted in more persons with CKD initiating HCV treatment remains unknown. Methods We identified HCV+ persons in ERCHIVES. We excluded HIV+ and HBsAg+ and those with missing HCV RNA and eGFR data. We determined the CKD stage according to National Kidney Foundation criteria. We determined the number of persons initiated on any of the approved DAA-regimen (defined as >14 days of DAA prescription). Logistic regression analyses was used to determine factors associated with treatment initiation. Results Among 76,513 evaluable persons, 21.1% initiated DAA treatment. Initiation rates differed significantly by CKD stage: 21.1% (15,136/68,469) for eGFR>90mL/minute/1.73m2 and CKD stage-2; 14.0% 9853/6,086) for CKD stage 3; and 7.6% (148/1,958) for CKD stage-4/5. Those with CKD stage-3 were 35% less likely and those with CKD stage-4/5 were 65% less likely to initiate treatment with a DAA compared with those with baseline eGFR>90mL/minute/1.73m2. Those with Body Mass Index (BMI)>30 were more likely to initiate treatment (OR 1.24, 95% CI 1.19,1.29). Treatment initiation was less likely in HCV genotype 2 or 3 and those with diabetes (OR 0.82, 95% CI 0.78,0.86), cardiovascular disease (OR 0.73, 95% CI 0.68,0.78), alcohol abuse or dependence (OR 0.75, 95% CI 0.72,0.78) or cirrhosis (OR 0.85, 95% CI 0.80,0.89) at baseline. Conclusion Persons with more advanced CKD are less likely to receive treatment for HCV. Strategies are needed to improve treatment rates in the HCV/CKD population. Disclosures A. Butt, Merck: Investigator, Grant recipient. A. Puenpatom, Merck: Employee, Salary. J. M. Arduino, Merck: Employee, Salary. R. Kumar, Merck: Employee, Salary

Background Hepatitis C Virus (HCV) infection is a significant public health problem associated with a high morbidity and mortality. HCV recurrence is a particular concern in patients with ongoing high-risk behaviors. Previous studies have shown a wide variation in HCV reinfection rates, but have considered small selected populations. The aim of our study was to estimate the HCV reinfection rates in a representative real-world cohort of HCV/HIV co-infected patients in Houston, Texas and to compare it with published data. Methods Retrospective cohort study of HCV/HIV co-infected patients treated between January 2004 to July 2016 at a freestanding HIV clinic that serves indigent and minority patients. HCV reinfection was defined as a single detectable HCV RNA level after achieving SVR 12. We reviewed demographic data, risk behaviors, laboratory tests and treatment outcomes. Cox proportional hazards regression was used to estimate reinfection rates. A meta-analysis was performed to calculate the reinfection rates reported in the literature in different patient populations. Results Of 288 patients treated, 187 (65%) achieved SVR12 by the end of the study. Follow-up data were available in 151 (81%) patients. Median follow-up time after SVR12 was 1.26 (0.66, 2.13) years. After achieving SVR12, two patients became reinfected, with a reinfection rate of 10.8 (1.3–39.1) per 1,000 PYFU. Our meta analysis demonstrated higher reinfection rates in different populations (87.8 (60.9–127) per 1,000 PYFU in MSM; 65.6 (34.1–126) per 1,000 PYFU in IVDU and 13.5 (10.4–17.5) per 1,000 PYFU in non-IVDU). In our patient population, the mean time from SVR12 to reinfection was 52.5 weeks, and reinfection was with the same HCV genotype. Both patients were MSM and reported high-risk sexual behavior; one patient also developed syphilis. Both patients have been retreated. One has achieved SVR12 and the other has successfully completed treatment and is awaiting SVR12 check-up in the following weeks. Conclusion The reinfection rate in our diverse cohort of HIV/HCV treated patients is very low compared with others studies. Efforts to reduce risk behaviors are important if HCV elimination is to be achieved. Disclosures All authors: No reported disclosures.

Background Many children born to HCV-infected mothers in the U.S. never receive recommended anti-HCV antibody (Ab) screening at age ≥ 18 months. Earlier testing by HCV-RNA PCR might facilitate increased screening, though prior studies using older PCR assays reported unacceptably low sensitivity of one-time PCR testing in infants. We hypothesized that testing at age 2–6 months using modern blood HCV-RNA PCR platforms with enhanced analytical sensitivity and reliability will adequately detect infected infants. Methods Medical records of vertically exposed infants tested for HCV-RNA at age 2–6 months at Nationwide Children’s Hospital from January 1, 2008 to December 31, 2017 were reviewed. HCV-RNA tests included qualitative (in-house) and quantitative (ARUP reference lab) Cobas Taqman RT-PCR assays (Roche) with lower limits of detection of 1.2–1.9 log10 IU/mL. Diagnostic performance of early PCR screening was determined using a composite gold standard: (1) infected children had ≥ 2 positive PCRs or persistently positive Ab after age 24 months; (2) uninfected children lacked these criteria and required documentation of a negative Ab at a point after age 18 months. Results During the study period, 639 vertically exposed infants underwent HCV-RNA testing at age 2–6 months. Of these, 24 (3.8%) tested positive, consistent with prior estimates of the vertical transmission rate. Blood HCV-RNA levels were high at screening (median 6.7 log10 IU/mL, range 5.2–7.8 log10 IU/mL), and confirmatory PCR tests were positive in all who had repeat testing (n = 22). Among 615 infants with negative PCR screening, 444 had reached age ≥ 18 months, of whom 144 had undergone Ab testing. Ab tests were negative in 142, while two children had low positive Ab results at 18 months. In both cases, repeat PCR and repeat Ab after age 24 months were negative, suggesting waning maternal Ab rather than true infection. Using the composite gold standard there were 22 true positive, 0 false-positive, 144 true negative, and 0 false negative cases, yielding a sensitivity of 100% (95% CI: 85–100% [Wilson-Brown]). Conclusion These findings demonstrate that modern blood HCV-RNA PCR assays have excellent sensitivity for detecting vertically infected infants as early as 2–6 months of age and may improve HCV surveillance given the substantial number of children lost to follow-up prior to 18 months Ab screening. Disclosures All authors: No reported disclosures.

Background Huge efforts are being made to screen high-risk populations for Hepatitis C virus (HCV) infection, however linkage to care (LTC) rates remain low. The aim of this study was to assess the factors affecting LTC among HCV positives in a major tertiary academic medical center in eastern New York. Methods A retrospective chart review was performed on all patients with ICD-9 or 10 diagnostic codes for HCV positive antibody over a period of 2 years (2016–2017) at Stony Brook Medicine. Data were collected for HCV RNA, LTC, demographics, type of insurance, employment status, psychiatric diagnosis, comorbidities, HIV or HBV coinfections, substance use disorder, and level of fibrosis. Univariate and multivariate analyses were performed to find associated factors with LTC. Results A total of 600 cases (62.6% male; 74% White; median age: 59 years) had a positive HCV antibody, 264 (44.4%) had a positive follow-up HCV RNA test and 138 (52.2%) were LTC. The average time for LTC was 1.5 months (50 days; interquartile range 21–121). In the univariate analysis, the following factors were significantly associated with LTC: older age (OR 1.022), having medicaid (OR 0.421), people who inject drugs (PWID) (OR 0.216), cocaine and marijuana use (OR 0.457), polysubstance use (OR 0.311), having a primary care provider (OR 2.290) and being a baby boomer (OR 1.718). The vast majority of patients came from three zip codes within south central Suffolk County, coinciding with the highest prevalence of heroin use. Conclusion In this population insurance type, younger age and substance use (injection drugs, marijuana, cocaine, polysubstance) were associated with lower odds of LTC. Having a primary care provider and being a baby boomer were the only two independent risk factors associated with increased odds of LTC. Due to an increased number of HCV cases in younger populations, particularly PWID, further outreach efforts are urgently needed to spread HCV screening awareness and increase testing in high prevalence areas. Disclosures All authors: No reported disclosures.

Background While HIV and HCV testing targeted to high-risk groups results in substantially higher proportions of HIV diagnoses, universal HIV and HCV screening in emergency department (ED) settings is expected to reach populations who do not perceive themselves to be at risk or are otherwise less likely to participate in HIV and HCV testing. As a consequence the CDC recommends routine HIV screening for persons 13–64 years of age, and routine HCV screening for the birth cohort (born between 1945–1965). The objective of this analysis was to evaluate the yield of universal opt-out HIV and HCV screening in the two EDs at the University of California San Diego (UCSD). Methods In July 2017, electronic medical record (EMR) based universal opt-out HIV screening (Architect HIV antibody [Ab]/HIV p24 antigen detection) for persons aged 13–64 years (excluding persons known HIV+ or reporteing an HIV test within the last 12 months) was implemented in our EDs. The EMR algorithm also identified HIV+ individuals who had been out of care for >12 months. In March 2018, EMR based universal HCV screening for birth cohort was added in both EDs. Results Over a period of 9 months 7,303 HIV tests were conducted, resulting in 24 (0.3%) new HIV diagnoses, of which 21 were successfully linked to care. In five individuals without HIV infection Architect gave a false-positive result (specificity 99.93%). In addition, the EMR algorithm identified 38 out of care HIV+ individuals of which 21 were successfully relinked to care. During the 1-month HCV birth cohort screening 963 HCV Ab tests were conducted, of which 106 (11%) resulted positive. At the time being 78 of those seropositive individuals had HCV RNA testing, of which 36 (53%) resulted positive (3.7% of all participants). Conclusion In San Diego, a setting with a high density of free-of charge HIV screening programs, 1/300 HIV tests in the ED yielded a new HIV diagnosis and in total 21 newly diagnosed individuals were linked to care. Identification of HIV+ out of care individuals yielded in an equivalent number of individuals relinked to care. The rate of newly diagnosed HCV infections exceeded the rate of newly diagnosed HIV infections by >10-fold outlining the importance of screening for HCV in the ED. Disclosures All authors: No reported disclosures.

Background Approximately 1 in 5 and 1 in 2 of people infected with HIV and HCV respectively in the US are unaware of their infection. Risk based opt-in testing strategies result in missed or delayed diagnoses and may further stigmatize these illnesses. The use of routine opt-out testing increases test uptake and can identify patients with HIV or HCV early, resulting in improved outcomes and decreased transmission. This strategy has not yet been fully accepted or operationalized in many health care settings. Methods We implemented routine opt-out HIV and HCV testing for all inpatients using internal medicine resident and nurse driven screening models. Patients were eligible for each test if they had not been tested within 1 year and were not known to be infected. Residents were educated on rationale and protocols for routine opt out testing via one grand rounds lecture (January 2016) and one residency orientation lecture (August 2016). Between March and November 2016, residents were incentivized with gift cards awarded for most tests ordered. Nurses were educated through targeted forums. Instructions were distributed and placed in high traffic areas and HIV 1/2 fourth-generation Ag-Ab and HCV Ab orders were added to admission order sets. Patients were given a chance to decline after routine opt-out testing was offered and educational brochure provided, in accordance with Maryland law. Positive tests were confirmed using Western Blot initially, later changed to HIV 1/2 differentiation assay; HCV was confirmed with HCV RNA. Those with confirmed infection were linked to care. Results 71% of 3814 and 83% of 2219 eligible patients were tested for HIV and HCV; 54 (2%) and 390 (21%) were diagnosed with HIV and HCV respectively (Figure 1). Testing activity averaged 32 HIV and 28 HCV tests per month from January to March 2016 and increased after the noted interventions to an average of 300 HIV and 247 HCV tests per month from January to March 2017. Conclusion A high disease burden was found within the studied population, highlighting the benefit of routine opt out testing for HIV and HCV. Empowering residents and nurses to offer screening at time of admission is a viable strategy to scale up testing in the inpatient setting. Disclosures All authors: No reported disclosures.

Background Prevention of Hepatitis C virus (HCV) infection and its associated health complications are a national priority. To achieve optimal health outcomes, people with HCV must receive the diagnosis, link to and retain in care and receive treatment. Despite recent progress in increasing capacity and improving access to care for patients with HCV in the United States, there continues to be a need to improve Hepatitis C care especially in primary care settings. This study sought to assess HCV care in a resident-run primary care clinic of a community hospital. Methods Retrospective study of active patients ≥18 years with a diagnosis of Hepatitis C in the electronic medical records (EMR) at 2 outpatient medicine clinics at a community hospital in Rhode Island. Patients were identified by searching the following diagnoses in the EMR: “chronic hepatitis C”, “chronic hepatitis C without coma,” “chronic hepatitis C with coma,” “reactive HCV serology,” “hepatocellular carcinoma.” Patients with HIV coinfection were excluded as these patients are usually referred to a specialty clinic outside the hospital’s network. Results Of 12,482 outpatients, 306 had a diagnosis of Hepatitis C. One hundred and fifty-nine (54%) of these patients had HCV RNA detected indicating chronic infection, 51 (17%) patients had reactive HCV antibodies and undetected HCV RNA indicating past infection, and 84 (29%) patients had positive serology to HCV but lacked HCV RNA testing. Obesity was associated with not having HCV RNA checked (OR 2.9, 95% CI 1.66-5.24). No differences observed for other variables although patients with a history of alcohol use had a tendency towards lacking HCV RNA testing (P = 0.08). The prevalence of confirmed chronic hepatitis C was 1.6%. Twenty-three (21%) patients with chronic hepatitis C had cirrhosis and 5 had hepatocellular carcinoma however only a minority of them (11%) had received or were receiving direct acting antivirals. Hepatitis B vaccination in HCV infected patients was low (39%). Conclusion A significant proportion of patients with reactive serology to HCV in our primary care clinics miss the critical step of having HCV RNA checked. Other medical conditions such as obesity may take priority over HCV care. Implementation of HCV targeted interventions could improve HCV care in primary care. Disclosures All authors: No reported disclosures.

The prevalence of hepatitis C virus (HCV) infection in sub-Saharan Africa remains unclear. We tested 1000 individuals from Rakai, Uganda, with the Ortho version 3.0 HCV enzyme-linked immunosorbent assay. All serologically positive samples were tested for HCV RNA. Seventy-six of the 1000 (7.6%) participants were HCV antibody positive; none were confirmed by detection of HCV RNA.

Estimates of hepatitis C virus (HCV) clearance following acute infection range from 14 to 46%. This wide range is likely to be due to the characteristics of the populations studied and analysis methods. This paper examines how differing definitions of clearance parameters affect estimates of viral clearance in a cohort of 85 injecting drug users with newly acquired HCV infection. Kaplan–Meier estimates of time to HCV clearance were determined using varying definitions of eligible cohort, viral clearance, date of infection and date of clearance. Based on which combinations of definitions were used, the number of subjects eligible for analysis ranged from 27 to 75, clearance rate ranged from 14 to 68% and time to achieving 25% clearance ranged from approximately 5 months to 14 months. Standardized definitions and methodologies are required to enable valid comparisons of rates of clearance across newly acquired HCV infection natural history studies.

We evaluated the performance characteristics of the COBAS AMPLICOR Hepatitis C Virus (HCV) MONITOR Test, version 2.0. Dilution studies using patient specimens demonstrated a lower limit of detection of 1,000 copies per milliliter. The assay was linear from 1,000 to 1 million HCV RNA copies per milliliter. Within-run precision and between-run precision were acceptable (approximately 0.100 and 0.14 SD for log10 [copies per milliliter]). A comparison of this version of the test (y), with the manual AMPLICOR HCV MONITOR Test, version 1.0 (x), yielded the following Deming regression equation: y = 1.004(+/- 0.04)x + 0.654(+/- 0.22); Sy/x?D = 0.336; n = 92; r2 = 0.846; r = 0.920. Further comparison of the COBAS version 2.0 assay (x) with the QUANTIPLEX HCV bDNA Test (y) yielded the following Deming regression equation: y = 0.943 (+/- 0.130)x + 0.473 (+/- 0.717); Sy/x?D = 0.194; n = 26; r2 = 0.600; r = 0.774. Version 2.0 detected the spectrum of HCV genotypes better than version 1.0.