Performance of the validated EGCRISC screening tool in chronic hepatitis C infection detection after application in the Egyptian setting

POSTER PRESENTATIONS model were used to assess the impact of clinical and virological variables on the outcome. Results: Seventy-eight HIV patients with AHC were included. Most of them were males [n = 75 (96%)], median age was 38 (35–43) years old with 7 (3–12) years of HIV infection. Men-who-have-sex-with-men (MSM) were 65 (83%). Ten (13%) had a previous AIDS diagnosis. HCV genotype 1 was the most common [58 (83%)]. One-year cumulative probability of HCV clearance was 20% (95% CI 12–31%), but reached 24% (15–37%) and 29% (19–44%) after 2 and 3 years, respectively. By HCV genotype (1 vs non-1), the cumulative probability of clearance was 12% (5–24%) vs 28% (9–65%) and 15% (7–30%) vs 42% (17–79%) at 1 and 2 years, respectively ( p = 0.163 at log-rank test). Patients not achieving HCV clearance were more frequently ART-naive [14 (24%) vs 0; p = 0.017)] and had a higher plasma HCVRNA [5.9 (5.1–6.6) vs 4.4 (2.4–5.5) Log IU/mL; p = 0.005]. In multivariate analysis, HCV genotype non-1 and CD8 count were found to be independently associated with the risk of HCV clearance (Table 1). Table 1: (number events = 65/78), AIC = 92.71

Characteristic HCV genotype 1 vs non-1 Calendar year of AHC (per more recent year) ART exposure (per 5-years longer) Total lymphocytes (per 109/L higher) Total bilirubin (per 1-mg/dL higher) CD4+ (per 100-cells/mm3 higher) CD8 (per 100-cells/mm3 higher) HIV-RNA (per log10 copies/mL higher) HCV-RNA (per log10 copies/mL higher) Total cholesterol (per 50-mg/dL higher) Triglycerides (per 50-mg/dL higher) FIB-4 Index (per 1-point higher)

Adjusted Hazard ratio (95% confidence interval)

p-value

0.04 (0.01–0.45) 1.11 (0.80–1.56)

0.010 0.528

1.03 (0.48–2.21) 0.70 (0.18–2.69) 1.33 (0.93–1.91) 1.29 (0.90–1.84) 1.31 (1.04–1.65) 0.34 (0.07–1.65) 0.84 (0.57–1.24) 2.97 (0.87–10.07) 1.30 (0.68–2.51) 0.96 (0.86–1.07)

0.948 0.609 0.117 0.170 0.023 0.181 0.370 0.081 0.429 0.418

Conclusions: In this cohort of HIV patients HCV spontaneous clearance after AHC was 20%, 24% and 29% after one year, 2 and 3 years respectively, higher than previously reported. Genotype non-1 and a higher CD8 count were found to favorably impact the chance of clearance. THU-207 Characterization of liver fibrosis stage and regression in chronic hepatitis C infected patients after achieving sustained virologic response using direct-acting antivirals as demonstrated by elastography E. Thomas1, M. Yoneda2, S. Alawad3, E. Schiff2. 1University of Miami Miller School of Medicine, Miami, United States; 2Schiff Center for Liver Diseases; 3Schiff Center for Liver Disease, University of Miami Miller School of Medicine, Miami, United States E-mail: [email protected] Background and Aims: Cirrhosis due to HCV infection has been associated with increased risk for hepatocellular carcinoma. The aim of our study was to assess changes in liver transient elastography (TE) and fibrosis-4 (FIB-4) score in patients with chronic hepatitis C (CHC) in a large cohort of patients and in a subcohort who achieved sustained viral response (SVR). Methods: Our cohort included approximately 1,200 patients with chronic liver disease. In our cohort, approximately 500 had liver biopsies. Retrospective prospective study included 60 patients with CHC and a baseline liver biopsy who achieved SVR after treatment with DAA regimens and had a pretreatment TE study and at least one follow up TE measurement at 24 weeks or later post end of treatment response (EOTR). The estimated stage of liver fibrosis based on TE was

categorized as F0-F2 (<9.4 kpa), or F3 (9.5–12.4 Kpa), or F4/cirrhotics (TE ≥ 12.5 kpa). Results: Approximetly 1,200 patients were successfully assessed by fibroscan and comparisons made with clinical parameters of liver disease. The median baseline TE for the entire cohort was 11.9 Kpa (range 3.8–65.2) and at follow up, TE decreased to 7.35 Kpa (range 2.9–34.8) with a median change in TE of −3.4 Kpa (range −35.3 to +1, p = 7.355e−11). Follow up median TE done in the cirrhotic population after median time of 39 weeks post EOTR decreased to 11.7 Kpa and FIB4 was 2.3. The median change of TE in cirrhotic patients was −6.5 kpa (range −35.3 to +1, p = 1.043e−7) and for FIB4 was −1.97 (range −17.47 to −0.33, p = 1.49e−8). Non-cirrhotic patients (TE ≤ 12.4) comprised 55% of the entire cohort and their median change of TE was −2.4 Kpa (range −6.4 to 0.7, p = 1.539e−6) and FIB4 was −0.68 (range −2.8 to 0.41, p = 2.987e−6). 48% of the entire cohort downstaged their liver fibrosis as determined by TE. In a multiple logistic regression analysis for factors associated with down-staging in liver fibrosis, we found that patients who were treatment naïve were more likely to improve their fibrosis stage (OR 5.73, p = 0.033). Conclusions: Liver fibrosis stage, as determined by TE, improved after achieving SVR with DAA treatments in most patients. The significant drop in TE measurement post SVR was also correlated with a significant drop in FIB4. Although cirrhotic patients had a more significant drop in their median TE when compared to non-cirrhotic patients, they had a lower probability of improving their fibrosis stage. THU-208 Performance of the validated EGCRISC screening tool in chronic hepatitis C infection detection after application in the Egyptian setting E.M. El-Ghitany1, A. Farghaly1, S. Farag2. 1Tropical Health; 2Biostatistics, High Institute of Public Health, Alexandria University, Alexandria, Egypt E-mail: [email protected] Background and Aims: Hepatitis C virus infection is a major health problem in Egypt. The government has been offering a powerful regularly updated treatment protocol for chronically infected individuals for years. Nevertheless, there are evidences of ongoing transmission. Efforts on the primary prevention level including awareness and robust screening strategy have to be strengthened. We previously developed an Egyptian HCV risk screening tool (EGCRISC) (J. Med. Virol. 88:1767–1775, 2016) based on exhaustive analysis of risk factors in four groups (males and females less and more than 45 years old). The tool is available in Arabic through our website “www.virus-c.com”. This study aims to test the performance of EGCRISC on a large sample simulating the Egyptian setting. Methods: Through a nation-wide survey, we tested 5934 randomly selected individuals from governorates representing the five major provinces in Egypt according to their population density where urban and rural areas were proportionally allocated (Greater Cairo; 1027, Alexandria; 1210, Delta; 1222, Canal; 780, Upper Egypt; 1695). The participant underwent an interview to fill the tailored EGCRISC tool and at the same time, a blood sample was collected for ELISA screening and PCR testing of positive cases. Results: The study comprised of Male < 45; 1767, Male 45+; 1060, Female < 45; 1997, Female 45+; 1110. Rural residence participants represented 69.4%. In general, all the individual risk factors were significantly associated with HCV infection ( p < 0.05) namely; (rural residence, histories of blood contaminated piercing, blood transfusion, jaundice, Schistosomiasis, Parental antischistosomal treatment, fatigue, shared sharp objects, hospitalization, invasive procedures, contact with jaundiced patient, blood sampling, dental visits and home delivery. HCV antibody prevalence among those who didn’t know their status and those denied having the infection was 16.7% and 10.7% respectively. The EGCRISC showed good significant performance in all groups. The degree of agreement and Kappa values were 72.3% & 0.53, 55.6% & 0.43, 36% & 0.15 and 72.9% & 0.69 in

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POSTER PRESENTATIONS Males <45 years, Males >45 years, Females <45 years, Females >45 years respectively.

Conclusions: EGCRISC has a good considerable performance allover Egypt and is recommended to be integrated in the primary care practice for early detection of HCV infection. The study was sponsored by Science and Technology Development Fund (STDF), Egypt; Project No. 3469.

Viral hepatitis: Hepatitis C – Clinical (therapy) THU-209 In hepatitis C virus-related advanced fibrosis and cirrhosis, early decline of liver stiffness following antiviral therapy with DAAs is related to decline in liver inflammation A. Winters1, S. Luedtke1,2, A. Moreland3, P. Jangouk4,5, G. Weng6, M. Silveira3,7, P. Davitkov3,7, A. Duarte-Rojo8, R. Cheung9,10, G. Garcia-Tsao8,11, Y. Falck-Ytter3,7,12, A. Branch1, N. Bräu1,2. 1Medicine, Mount Sinai School of Medicine, New York, NY; 2James J. Peters VA Medical Center, Bronx, NY; 3Louis Stokes VA Medical Center, Cleveland, OH; 4VA Connecticut Health Care System, West Haven, CT; 5Medicine, Yale University, New Haven, CT; 6University of Arkansas for Medical Sciences, Little Rock, AR; 7Case Western Reserve University, Cleveland, OH; 8Yale University, New Haven, CT; 9VA Palo Alto Health Care System, Palo Alto, CA; 10Stanford University, Stanford, CA; 11VA Connecticut Health Care System, New Haven, CT; 12University Hospital, Cleveland, OH, United States E-mail: [email protected] Background and Aims: Decline in liver stiffness (LS) as measured by transient elastography (TE) has been described in most patients following HCV therapy with direct-acting antiviral agents (DAAs). In patients with advanced fibrosis or cirrhosis (METAVIR F3-F4), substantial early post-treatment declines in LS have been observed at a time point when a significant regression of fibrosis is not yet expected. This study examines the influence of pre-treatment liver inflammation and its decline post-treatment on the early decline of LS following DAA therapy. Methods: In six centers, HCV patients who received their first all-oral DAA therapy and had at least one LS measure pre- and post-treatment were retrospectively identified and included if pre-treatment LS ≥ 9.5 kPa. Patients with ascites or liver cancer were excluded. ALT levels were used as a surrogate of liver inflammation. Results: Among 185 eligible patients, 60 (32%) were classified based on pre-treatment baseline (BL) LS as F3 (LS = 9.5–12.4 kPa), and 125 (68%) as F4 cirrhosis (LS ≥ 12.5 kPa), among whom 64 (35%) had low LS (12.5–19.9 kPa, F4a), 36 (20%) had intermediate LS (20.0–29.9 kPa, F4b), and 25 (13%) had high LS (≥30.0 kPa, F4c). With each increasing S280

LS category (F3-F4a-F4b-F4c), there was a significant increase in BL esophageal varices (0-3-36-56%, respectively) and BL thrombocytopenia <100,000/mm3 (5-9-33-40%). Median time between BL and post-treatment (PT) LS measures was 10.3 months (IQR, 7.7–14.4 months). Mean absolute decline of PT vs. BL LS increased with each LS category (2.9-4.6-7.7-11.8 kPa, p < 0.001), but the mean percent decline was not different (17-29-31-26%, p = 0.89). There was a significant correlation between the log10 decline of PT/BL ALT level and log10 decline of PT/BL LS: R = 0.21, p = 0.005. The rate of patients with a decline to PT LS < 9.5 kPa was 73-47-11-0% ( p < 0.001) with a rate of 27% (34/125) among F4 patients. In these F4 patients, LS decline to <9.5 kPa was associated with absence of BL esophageal varices (0% vs. 32% in patients with PT LS ≥ 9.5 kPa, p = 0.001), lower rate of BL thrombocytopenia <100,000/mm3 (3% vs. 30%, p = 0.001), and of BL APRI < 1.0 (60% vs. 26%, p = 0.001). Conclusions: In HCV patients with F3-F4 fibrosis, PT decline of LS is correlated to PT decline in ALT level. Over 25% of F4 patients had PT LS < 9.5 kPa. These patients may not have had BL cirrhosis with a significant proportion of their BL LS stemming from liver inflammation, or PT LS may need to be redefined to account for resolved inflammation. THU-210 Factors that influence the improvement of serum albumin during interferon-free sofosbuvir/ledipasvir therapy for Japanese patients with chronic hepatitis C virus infection A. Kawano1, E. Ogawa2, N. Furusyo2, H. Nomura3, K. Dohmen4, N. Higashi5, K. Takahashi6, K. Azuma7, T. Satoh8, M. Nakamuta9, T. Koyanagi10, S. Shimoda11, M. Kato12, E. Kajiwara13, J. Hayashi14 and The Kyushu University Liver Disease Study (KULDS) Group. 1 Department of Medicine, Kitakyushu Municipal Medical Center, Kitakyushu; 2Department of General Internal Medicine, Kyushu University Hospital, Fukuoka; 3The Center for Liver Disease, Shin-Kokura Hospital, Kitakyushu; 4Department of Internal Medicine, Chihaya Hospital, Fukuoka; 5Department of Hepatology, Steel Memorial Yawata Hospital, Kitakyushu; 6Department of Medicine, Hamanomachi Hospital; 7Department of Medicine, Kyushu Central Hospital, Fukuoka; 8 Center for Liver Disease, Kokura Medical Center, National Hospital Organization, Kitakyushu; 9Department of Gastroenterology, Kyushu Medical Center, National Hospital Organization; 10Department of Medicine, Fukuoka City Hospital; 11Department of Medicine and Biosystemic Science; 12Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka; 13Kajiwara Clinic, Kitakyushu; 14Kyushu General Internal Medicine Center, Haradoi Hospital, Fukuoka, Japan E-mail: [email protected] Background and Aims: Interferon (IFN)-free regimens of directacting antiviral agents have improved the treatment response for chronic hepatitis C virus (HCV) infection and the improvement of serum albumin during interferon-free antiviral therapy has been reported. The aim of this study was to identify the factors that influence the improvement of serum albumin in the patients receiving interferon-free antiviral therapy. Methods: This prospective, multicenter study consisted of 767 Japanese patients with chronic HCV genotype 1b infectionwho completed sofosbuvir (SOF)/ledipasvir (LDV) therapy for 12 weeks. Decompensated cirrhosis was excluded. We evaluated the changes of serum albumin between the baseline and the end of treatment (EOT) (Δ Alb). The area under the receiver operating characteristic curve (AUROC) analysis was performed to evaluate the relationship between serum albumin and Δ Alb. Multivariate logistic regression analysis was done to identify the independent factors that influence Δ Alb. Results: HCV RNA negativity at EOT was 100% (767/767). For the entire cohort, median serum albumin significantly increased from 40 to 41 g/L ( p < 0.001). The AUROC for predicting Δ Alb ≥ 3.0, 5.0 and 7.0 g/L were 0.80, 0.84 and 0.86, respectively. In order to predict Δ Alb ≥ 7.0 g/L, the cutoff value for serum albumin at baseline

Journal of Hepatology 2017 vol. 66 | S95–S332