Treatment outcomes of patients with chronic hepatitis C receiving sofosbuvir-based combination therapy within national hepatitis C elimination program in the country of Georgia

POSTER PRESENTATIONS SAT-284 Treatment outcomes of patients with chronic hepatitis C receiving sofosbuvir-based combination therapy within national hepatitis C elimination program in the country of Georgia T. Tsertsvadze1,2, A. Gamkrelidze3, M. Nasrullah4, L. Sharvadze2,5, J. Morgan6, L. Gvinjilia7, G. Kamkamidze8, D. Metreveli9, V. Kerashvili1, M. Butsashvili8, J. Zarkua9, N. Chkhartishvili1, A. Abutidze1, D. Baliashvili3, V. Kvaratskhelia10, F. Averhoff4. 1Infectious Diseases, AIDS and Clinical Immunology Research Center, Tbilisi, Georgia; 2Ivane Javakhishvili Tbilisi State University, Tbilisi, Georgia; 3National Center for Disease control and Public Health, Tbilisi, Georgia; 4Centers for Disease Control and Prevention, Atlanta, United States; 5Georgian-French Hepatology clinic HEPA, Tbilisi, Georgia; 6South Caucasus CDC Office, Tbilisi, Georgia; 7CDC Foundation, Tbilisi, Georgia; 8Clinic NeoLab, Tbilisi, Georgia; 9Clinic Mrcheveli, Tbilisi, Georgia; 10Ministry of Labor, Health and Social Affairs, Tbilisi, Georgia E-mail: [email protected] Background and Aims: Georgia has one of the highest HCV prevalence rates in the world. In partnership with the US CDC, and commitment from Gilead Sciences to donate direct acting antivirals (DAAs), initially sofosbuvir (SOF), the country embarked on the world’s first hepatitis C elimination program in April, 2015. A key strategy of this program is to eliminate HCV in the country through identifying and treating all HCV infected persons. We report on the results of the first 18 months of the program. Methods: A national treatment database was established, which collected data for each patient enrolled in the program. Treatmentnaive and experienced patients with cirrhosis and advanced liver fibrosis were prioritized for enrollment in the treatment program beginning 28 April 2015. Initial treatment consisted of SOF plus ribavirin (RBV) with or without pegylated interferon (INF). Sustained virologic response (SVR) was defined as undetectable HCV RNA at least 12 weeks after the end of treatment. Results for patients who completed treatment and tested for SVR through 30 September 2016 were analyzed. Results: Of the 7,072 patients who initiated treatment with SOFbased regimens during the study period, 3,966 (56%) patients were tested for SVR. HCV RNA was undetectable in 3,147 (79%) cases. The lowest response rate was observed among genotype 1 patients (1,070/ 1,566; 68%), intermediate response rate was achieved in genotype 2 patients (695/865; 80%), while the highest response rate was among genotype 3 patients (1,379/1,531; 90%). There were only 4 patients with genotype 4 of which 3 were cured. Among cirrhotic patients, 75% (2,154/2,857) achieved SVR vs. 90% (993/1,109) of patients without cirrhosis. Overall, SOF/RBV regimens achieved lower response rates (68%) than SOF/RBV/INF regimens (90%). Among patients who began treatment, 5% (364/7,072) did not complete the treatment course; death (241/364; 66%) was the most common cause for not completing therapy, and most patients who died, 228/241 (95%) had cirrhosis. Conclusions: The program achieved high overall response rates although most patients had cirrhosis/advanced liver disease. Lower efficacy of treatment in genotype 2 patients may have been associated with a reported high prevalence of HCV recombinant form 2 k/1 b, which requires additional treatment regimens to achieve higher cure rate in these patients. With the introduction of additional DAAs, improved response rates are expected, paving the way for Georgia to achieve the goal of HCV elimination. SAT-285 Feasibility of anti-HCV direct acting anti-viral agents in French prison settings M. Bouteille-Gaillet1, A. Dulioust1, M. Bocquentin1, M.G. Tateo2,3,4,5, D. Samuel2,3,4,5, J.C. Duclos-Vallée2,3,4,5, T. Antonini2,3,4,5. 1Service de médecine, EPSNF, Fresnes; 2Centre Hépato-Biliaire, APHP Hopital Paul Brousse; 3INSERM U1193, Univ Paris-Sud, Université Paris-Saclay; 4 INSERM U1193, Inserm; 5DHU Hepatinov, Villejuif, France E-mail: [email protected]

Background and Aims: To asses feasibility of anti-HCV direct acting anti-virals in French prison. Methods: Retrospective consecutive cohort of 185 patients in prison affected by HCV hepatitis from July 2014 to May 2016 in Paris region. After an initial screening in penitentiary centers, patients had an assessment in a specialized center. Cases eligibles for treatment were discussed in multidisciplinary team prior to initiation of treatment in custody. Results: The majority were men (92.3%), mean age was 42.7 years [24–59]. One hundred and thirty-seven patients (74%) had a history of incarceration and 87.6% drug abuse. The fibrosis score was F0F2, F3 and F4 for 59.4%, 17.6% and 23% of patients, respectively. Twenty four (13.0%) patients had HIV co-infections (13.0%), 2 had cryoglobulinemia and 1 had an indolent lymphoma. Three patients (1.6%) were excluded because HCV viral load was negative. HCV genotype was 1, 2, 3 and 4 in 51.6%, 9.1%, 24.4% and 8.9% of patients, respectively. Eighty-six patients (46.5%) had treatment criteria. Of these, 29 (33.7%) patients weren’t treated for social reasons (sentence length too short to achieve assessment or treatment) and 2 patients refused treatment. Anti HCV treatment was: sofosbuvir/NS5A ± ribavirin, sofosbuvir/simeprevir and sofosbuvir/ribavirin ± pegylated interferon in 11 (20%)/33 (60%), 4 (7.3%) and 2 (3.6%)/5 (9%) patients respectively. Fifty-five patients (64%) were treated, 29 (53%) patients achieved SVR, 13 treatments are in progress (24%), 11 patients were released/transferred after starting (20%). We note 2 failures (no response: 1, suicide before SVR12: 1). Conclusions: Use of new anti HCV direct-acting antiviral agents in prison is possible, effective and safe. One third of the patients could not be treated due to the impossibility of follow-up of social care to the release. SAT-286 Outcome of liver transplantation in HCV infected patients – implications for antiviral treatment decisions T. Greuter1, H. Seidl2, P. Dutkowsky3, B. Müllhaupt1, T. Kuntzen1. 1 Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland; 2Gastroenterology, Isar Klinikum, Munich, Germany; 3 Visceral and Transplant Surgery, University Hospital Zurich, Zurich, Switzerland E-mail: [email protected] Background and Aims: The indication and optimal time point for anti-HCV treatment before and after orthotopic liver transplantation (OLT) continues to be a matter of debate in the era of directly acting antivirals (DAA) due to side effects and cost considerations still requiring individualized treatment decisions, for which this study aims to contribute to a better basis of knowledge. Methods: In 448 patients who underwent liver transplantation at the University Hospital Zurich between 1995 and 2013 we retrospectively studied fibrosis progression as well as patient and graft survival in HCV infected patients with and without antiviral treatment before and after liver transplantation compared to patients transplanted for other disease entities. Results: In eighteen patients interferon-based antiviral therapy – in two cases including first generation DAAs – was carried out on the transplant waiting list. Cure was achieved in 14 (78%) patients, notably in 13/14 (93%) who achieved at least 27 days of pre-OLT aviremia. After transplantation, 124/159 patients with a history of HCV infection experienced HCV recurrence, which was treated in 67 cases up to three times, eventually achieving SVR in 26/67 (39%) patients. Data on fibrosis progression was available in 94, 79, 54 and 36 patients at years one, 2–3, 4–5 and 6–9 after OLT. Here, the proportion of liver fibrosis ≥ Metavir F2 rose from 27% (25/94) in the first year to 75% (27/36) in years 6–9. Likewise, cirrhosis developed in 2.1% (2/94) by year 1 and in 41.7% (15/36) of patients by years 6–9. Graft survival was reduced compared to HCV negative patients at 1 year (85% versus 92%) and 5 years (76% versus 87%) after OLT mainly due to HCV induced graft failure (17/159, 11%). Upon antiviral treatment liver fibrosis remained unchanged (mean Metavir fibrosis

Journal of Hepatology 2017 vol. 66 | S543–S750

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