HCV co-infected as compared with HCV mono-infected patients: meaning and correlates

POSTER PRESENTATIONS protocol, patients achieving a RVR (<50 iu/ml at Wk4) continued treatment for 16 weeks (baseline viral load <800,000 iu/ml) or 24 weeks (>800,000 iu/ml). Non RVR patients had SOF added for a further 8 weeks. Baseline factors (Age, Gender, LSM, viral load), RVR rates, intented treament duration, premature discontinuation, and SVR rates were collected. Results: 60 patients (38 (63%) male, mean age 42 ( ± 8.9), median LSM 6.1 (IQR:4.3–7.6), median viral load 5.78 (IQR:4.53–6.3) log iu/ml) commenced treatment. 10 (16.7%) patients not achieving RVR had SOF added for a further 8 weeks of combination therapy. 28 (46.7%) with low baseline viral load continued IFN/RBV for 16 weeks total, the remainder (22 (36.7%)) for 24 weeks. To date all but 2 patients have completed treatment, 8 (13.3%) prematurely (6 due to treatment related adverse event (AEs), 2 non treatment related). 34/37 (91.9%) attending for post treatment bloods have achieved SVR12, including 2 premature discontinuers. 6/6 (100%) of non RVR (SOF/IFN/RBV) patients have achieved SVR, 16/17 (94.1%) of 16 week treated patients (16/16 (100%) per protocol), and 13/15 (86.7%) (11/12 (91.6% per protocol) 24 week patients. Full SVR rates will be presented. Conclusions: Response guided addition of Sofosbuvir to IFN/RBV produces a high SVR rate amongst GT3 patients without advanced fibrosis. Premature discontinuation rates are higher than for IFN free regimens, however early SVR rates suggest a high cure rate despite this. Such an approach may be considered in resource limited settings with experience of interferon based regimens. FRI-227 Lower proportion of sustained virologic response and higher residual HCV viremia at the end of direct-acting antivirals treatment in HIV/HCV co-infected as compared with HCV monoinfected patients: meaning and correlates I. Mastrorosa1, U.V. Comandini1, A. Ammassari1, G. Fabbri1, A.R. Garbuglia2, M.R. Capobianchi2, G. D’Offizi1, R. Lionetti1, A. Vergori1, A. Giannetti1, A. Antinori1, M. Zaccarelli1. 1Clinical Department; 2Laboratory of Virology, National Institute for Infectious Diseases, I.R.C.C.S., L. Spallanzani, Rome, Italy E-mail: [email protected] Background and Aims: Direct-acting antivirals (DAA) achieve high rates of sustained virologic response (SVR) in both HIV/ HCVcoinfected (HIV/HCV) and HCVmonoinfected (HCVmono) patients ( pts). Only a little subset of pts experiences treatment failure, but factors associated with response to DAA are not yet established in real life settings. Aim was to analyze variables correlated to HCV residual viremia (RV) below the limit of quantification (<12 UI/ml) at end of treatment (EOT) and to identify predictors of failure in HIV/HCV compared with HCVmono pts. Methods: Observational, retrospective, mono-centre study. HIV/HCV and HCVmono pts treated with DAA and with an available HCVRNA at DAA starting date (baseline BL) and EOT, were enrolled. Plasma Samples with HCV RV < 12 IU/ml with Abbott Real-Time kit at EOT were retested for RV by Ultrasensitive (US) HCV RNA assay. Two adjusted logistic regression models were built in order to identify factors correlated to HCV RV < 12 IU/ml at EOT and to treatment failure at week 12 after EOT. Results: Overall, 448 pts were included: 145 (32.4%) HIV/HCV and 303 (67.6%) HCVmono. Main characteristics were similar between groups: male gender 73.9%, median age 56 years (IQR: 52–61), cirrhosis 62.5%. Distribution of HCV was: G1a 34.9%, G1b 26.6%, G3 9.1%, G4 11.7%, G2 7.0%; higher proportions of G1a and G3 were found in HIV/HCV compared to HCVmono pts. DAA regimens: 86.4% SOFbased and 13.6% nonSOF-based. Rates of pts treated for 12 and 24 weeks were 60.5% and 39.5%, respectively. At EOT, 49 pts had HCV RV < 12 UI/ml: 12.4% among HIV/HCV and 10.7% among HCVmono. At adjusted logistic regression, higher BL HCVRNA was associated with higher risk and treatment of 24 weeks with lower risk of HCV RV < 12 UI/ml at EOT. HIV/HCV (vs. HCVmono) was not associated (Table). S510

At week 12 after EOT, HCVRNA was available for 398 pts, 24 failures were observed: 10.5% in HIV/HCV and 4.6% in HCVmono pts. Adjusting for possible cofactors, HIV/HCV coinfection and HCV RV < 12 UI/ml at EOT were both associated with higher risk of DAA failure. Thirtytwo samples with HCV RV < 12 IU/ml at EOT were retested with US HCVRNA assay (cutoff <4 IU/ml). No correlation was found between detectable HCVRNA (>4 IU/ml) and treatment failure. Table: Factors Associated with Risk of HCV-RNA Residual Viremia (RV) Below the Limit of Quantification (<12 IU/ml) at the End of DAA Treatment and with Risk of DAA Treatment Failure (Adjusted Logistic Regression). Adjusted Risk of HCV-RNA RV <12 IU/ml at DAA End of Treatment* OR

95% CI

Log10 HCV-RNA (each log) 1.95 1.18–2.23 24 weeks of therapy 0.15 0.05–0.44 (vs. 12 weeks) Adjusted Risk of failing to achieve SVR12 after DAA** HIV/HCV coinfection 2.80 1.00–7.85 HCV-RNA RV <12 IU/ml at the 9.58 3.04–30.21 end of DAA treatment

p value 0.009 0.001

0.05 <0.001

*Other factors considered in the adjusted analysis that were not significantly associated with detectable HCV-RNA were: age, gender, HIV/HCV coinfection, HCV genotype, cirrhosis, type of DAA treatment. **Other factors considered in the adjusted analysis that were not associated with DAA treatment failure were: age, gender, HCV genotype, cirrhosis, type of DAA treatment, BL HCV-RNA, length of treatment.

Conclusions: HCVRNA RV < 12 UI/ml at EOT was not different between HIV/HCV and HCVmono pts. The meaning of HCVRNA RV at EOT is still unclear. Our data showed that it is correlated to higher BL HCVRNA and shorter DAA treatment and that it may have an impact on DAA failure in particular in HIV/HCV pts. FRI-228 Efficacy of oral Direct Acting Antivirals for the treatment of chronic hepatitis/cirhhosis due to hepatitis C virus infection: the real-life experience of the Sicily Registry I. Cacciola1, S. Petta1, M. Di Stefano1, M.R. Cannavò1, A. Davì1, S. Madonia1, V. Calvaruso1, L.L. Rocca1, F. Di Lorenzo1, A. Digiacomo1, G. Bertino1, A. Licata1, F. Benanti1, R. Volpes1, L. Guarneri1, A. Averna1, I. Scalisi1, C. Iacobello1, P. Colletti1, F. Cartabellotta1, V. Portelli1, M. Russello1, G. Scifo1, G. Squadrito1, G. Raimondo1, A. Craxì1, V. Di Marco1. 1RESIST-HCV (Rete Sicilia Selezione Terapia – HCV), Palermo, Italy E-mail: [email protected] Background and Aims: We reported real-life data on the effectiveness of Direct Acting Antivirals (DAAs) in patients with chronic hepatitis/cirrhosis due to hepatitis C virus (HCV) infection. Methods: The RESIST-HCV (Rete Sicilia Selezione Terapia – HCV) is a network that collected data of patients with HCV infection evaluated for DAA therapy. We analyzed data of 5,100 patients treated with DAA regimens available in Italy between March 2015 and October 2016 according to current guidelines. Available regimens were Sofosbuvir plus Simeprevir (SOF + SIM) ± Ribavirin (RBV); Sofosbuvir plus Daclatasvir (SOF + DCL) ± RBV; Sofosbuvir plus Ledipasvir (SOF + LDV) ± RBV; Ombitasvir/Paritaprevir/Ritonavir (OBV/PTV/r) ± Dasabuvir (DSV) ± RBV. Effectiveness was assessed in 2106 patients who reached post-treatment week 12. A rate of sustained virological response at week 12 of follow-up (SVR12) by intention-to-treat analysis higher than 90% was defined as optimal. Results: SOF + LDV was optimal in G1b Child A cirrhotic patients treated for 24 weeks (208/230, 92%) or for 12 weeks plus RBV (100/ 107, 93.4%), while suboptimal in G1b Fibrosis 3 (F3) (41/46, 89.1%) and Child A cirrhotic patients (33/42, 78.5%) underwent 12 weeks of therapy without RBV. OBV/PTV/r/DSV for 12 weeks was optimal in G1b F3 patients (105/109, 96.4%), as well as in G1b Child A cirrhotic

Journal of Hepatology 2017 vol. 66 | S333–S542