- Email: [email protected]
Daclatasvir with or without Beclabuvir for Treatment of HCV Genotype 1 in Patients Co-Infected with HIV
POSTER PRESENTATIONS undetectable at week 4) was not associated with SVR12 (RVR 94.2% [81/86] and non-RVR 85.7% [18/21]). Ribavirin dosage reduction was required for 13.3% of the patients due to anemia, especially for patients aged ≥70 (24.2%), however, this did not result in treatment failure. Only three patients (0.9%) discontinued treatment due to adverse effects. The most common adverse effect (13.2%) was anemia (hemoglobin <10.0 g/dL), but the rate of severe anemia (<8.5 g/dL) was only 1.9%. Conclusions: Sofosbuvir and ribavirin for HCV genotype 2 was effective and well tolerated by patients aged ≥70. The data of all 338 patients and a multivariable regression analysis for predictors of SVR12 will be available for presentation at the congress. SAT-141 COST-EFFECTIVENESS OF ELBASVIR (EBR, MK-8742)/GRAZOPREVIR (GZR, MK-5172) USE IN TREATMENT-NAIVE AND TREATMENTEXPERIENCED PATIENTS WITH HEPATITIS C VIRUS (HCV) GENOTYPE 1 INFECTION AND CHRONIC KIDNEY DISEASE (CKD) IN THE UNITED STATES E. Elbasha1, W. Greaves1, C. Nwankwo1. 1Merck, Kenilworth, United States E-mail: [email protected] Background and Aims: HCV infection is an important cause of morbidity, end-stage liver disease (ESLD) mortality from decompensated cirrhosis (DC) and hepatocellular carcinoma (HCC), cardiovascular and end-stage renal disease (ESRD) mortality, and costs in CKD patients in the United States. We evaluated the costeffectiveness of EBR/GZR in CKD patients compared with no treatment (NoTX) and pegylated interferon plus ribavirin ( peg-IFN/ RBV).
Methods: A computer-based model of the natural history of chronic HCV genotype 1 infection, CKD, and liver disease was developed to project lifetime cumulative incidence of DC, HCC, liver-transplant (LT), kidney transplant (KT), ESLD mortality, ESRD mortality, and associated lifetime costs and quality-adjusted life years (QALY). Efficacy of EBR/GZR of 0.99 (0.95–1.00) was obtained from C-SURFER, a phase 2/3 double-blind, placebo-control trial in HCV genotype 1S760
infected patients with CKD4/5. Based on a meta-analysis, we assumed an efficacy of 0.60 (0.47–0.71) for peg-IFN/RBV. Data on baseline characteristics of the simulated patients were obtained from NHANES. Other model’s inputs were estimated from published studies. Cost of treatment with EBR/GZR was assumed to be similar to that of recently launched directly-acting agents. We conducted Monte Carlo simulations to estimate mean and 95% uncertainty intervals (UI) of outcomes. Results: Compared with NoTx, use of EBR/GZR was projected to reduce the lifetime cumulative incidence of HCC from an average of 19.96% (UI: 7.25–37.23) to an average of 0.89% (UI: 0.04–3.63) (Table 1). EBR/GZR-based regimens reduced lifetime cumulative incidence of DC from 8.80% (UI: 3.06–16.97) when peg-IFN/RBV was used to 3.19% (UI: 0.16–11.35). Use of EBR/GZR reduced ESLD mortality to 0.23% (UI: 0.00–0.99) from 10.60% (UI: 3.71–21.31) with peg-INF/RBV and 26.56% (UI: 14.23–41.08) with NoTx. Compared with NoTx, use of EBR/GZR lowered ESRD mortality from 12.70% (UI: 8.41–18.02) to 11.88% (UI: 10.34–13.46). EBR/GZR-based regimens resulted in higher average remaining QALYs and higher costs, and were cost-effective at a threshold of $100,000/QALY in 99.8% of the simulations. Conclusions: Use of EBR/GZR was projected to substantially reduce the incidence of liver- and CKD-related complications and mortality in treatment-naïve and treatment-experienced patients with hepatitis C virus genotype 1 infection and chronic kidney disease. In addition, EBR/GZR is cost-effective in the United States at commonly cited thresholds. SAT-142 VIROLOGIC RESPONSE FOLLOWING ASUNAPREVIR/DACLATASVIR WITH OR WITHOUT BECLABUVIR FOR TREATMENT OF HCV GENOTYPE 1 IN PATIENTS CO-INFECTED WITH HIV E.S. Rosenthal, M.D.1,2, L. Howard, B.A.3, J. Purdy, MSN, CRNP1, M. McLaughlin, RN, BSN3, S. Kattakuzhy, M.D.1,4, A. Kohli, M.D.1,5, E. Wilson, M.D.1,4, H. Masur, M.D.1, S. Kottilil, M.D., Ph.D.6. 1Critical Care Medicine Department, National Institutes of Health, Bethesda, MD; 2 Clinical Monitoring Research Program, Leidos Biomedical, Frederick, MD; 3NIAID, National Institutes of Health, Bethesda, MD; 4Institute of Human Virology, University of Maryland, Baltimore, MD; 5Department of Hepatology, St. Joseph’s Hospital, Phoenix, AZ; 6Institute of Human Virology, University of Maryland, Bethesda, MD, United States E-mail: [email protected] Background and Aims: Direct acting antivirals have revolutionized the treatment of HCV. Treatment of HCV in the setting of HIV coinfection has shown similar efficacy to HCV monoinfected patients, but therapeutic options are limited by drug interactions. In this study, we evaluated the safety and efficacy of asunaprevir (ASV, an NS3 protease inhibitor), daclatasvir (DCV, a pan-genotypic NS5A inhibitor), and beclabuvir (BCV, a nonnucleoside NS5B inhibitor) in HIV/HCV co-infected individuals. Methods: The CONQUER study (NCT02124044) is a prospective, single center, phase II, open label study conducted at the NIH Clinical Center to assess the safety, tolerability and efficacy of two regimens for the treatment of HCV genotype 1 in HIV co-infected patients. HIV/ HCV individuals with HCV genotype 1b (N = 10) were treated with ASV 100 mg twice daily and DCV 60 mg daily for 24 weeks and patients with HCV genotype 1a or 1b (N = 20) were treated with ASV 200 mg, DCV 30 mg, and BCV 75 mg in fixed dose combination twice daily for 12 weeks. Subjects (F0-F4) were treatment-naïve or treatment-experienced with an interferon-based regimen and were on approved antiretrovirals with CD4 >100 cells/mL and HIV RNA <50 copies/mL. The primary outcome was the proportion of patients with sustained viral response ( plasma HCV RNA level <12 IU/mL) 12 weeks after end of treatment (EOT), SVR12. Results: Demographic characteristics are shown in Table 1. In the ASV/DCV arm, 8/10 patients (80%) achieved SVR12; one patient had
Journal of Hepatology 2016 vol. 64 | S631–S832
POSTER PRESENTATIONS non-response, and one patient relapsed 4 weeks after EOT. There was one grade 4 lipase elevation which resolved. There were no discontinuations or serious adverse events attributable to study drug. In the ASV/DCV/BCV arm, 14/16 (87.5%) patients have achieved SVR12. Four additional patients will complete end point by March 2016. There were three patients who had grade 3 hypophosphatemia. One patient discontinued drug at week 8 due to paranoid delusions possibly attributable to the study drug.
Conclusions: In this open-label study, a high rate of sustained viral response was achieved in HCV genotype 1 patients co-infected with HIV, who received ASV/DCV for 24 weeks or ASV/DCV/BCV for 12 weeks allowing more therapeutic options for HIV/HCV coinfected subjects. Complete data on sustained viral response will be available at the time of the conference. SAT-143 PREVALENCE AND MANAGEMENT OF DRUG-DRUG INTERACTIONS (DDIS) WITH OMBITASVIR (OBV), PARITAPREVIR/R (PRV/R) ± DASABUVIR (DBV) ± RIBAVIRIN (RBV) IN PACIENTS WITH CHRONIC HEPATITIS C IN REAL-LIFE CLINICAL PRACTICE E. González-Colominas1, M.-C. Londoño2, R.M. Morillas3, X. Torras4, S. Mojal5, S. Lens2, D. López3, A. Gallego4, Z. Mariño2, M. Ardèvol6, N. Pagès7, R. Solà8, J.A. Carrión8. 1Pharmacy Department, Hospital del Mar, Parc de Salut Mar; 2Liver Unit, Institut de Malalties Digestives i Metabòliques, Hospital Clínic de Barcelona, CIBERehd, IDIBAPS, Barcelona; 3Hepatology Department, Hospital Germans Trias i Pujol, CIBERehd, Badalona; 4Gastroenterology Department, Hospital de la Santa Creu i Sant Pau, CIBERehd; 5Biomedical Research Methods Consultant, (IMIM) Hospital del Mar Medical Research Institute, Barcelona; 6Pharmacy Department, Hospital Germans Trias i Pujol, Badalona; 7Pharmacy Department, Hospital de la Santa Creu i Sant Pau, CIBERehd; 8Liver Section, Gastroenterology Department, Hospital del Mar, Parc de Salut Mar, Universitat Autònoma de Barcelona (UAB), IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain E-mail: [email protected] Background and Aims: Evaluation and management of drug-drug interactions (DDIs) using direct acting antivirals (DAAs) in patients with chronic hepatitis C (CHC) can avoid adverse effects and decrease the efficacy. The studies evaluating DDIs with OBV + PRV/r ± DSV ±
RBV have not been analyzed on clinical practice. The aim of our study was to evaluate the prevalence and management of DDIs with OBV + PRV/r ± DSV ± RBV on clinical practice. Methods: Retrospective analysis of data prospectively collected from CHC patients infected by genotype 1 or 4 treated with OBV + PRV/r ± DSV ± RBV in 4 Spanish Hospitals. Patients were classified according to the most serious DDIs using the database of the University of Liverpool in: “Category 0” (no drugs), “Category 1” (without DDIs), “Category 2” (DDIs manageable = surveillance/dosing adjustment), “Category 3” (contraindicated association) and according to the medical action in: “non-action/monitoring” or “treatment modification”. Results: We included 177 patients with a mean (±SD) age of 61 (±12), 49% were male, 98 (53.4%) with cirrhosis, 153 (86.4%) with genotype 1b and 94 (53%) naïve. Out of 126 (71.2%) patients with concomitant therapy, 56 (44.4%) received ≥3 drugs. We found DDIs in 111 (62.7%) patients, being Amlodipine the most common drug (n = 15; 11.9%) (Category 2). According to the DDIs, patients were classified in “Category 0” (n = 51; 28.8%), “Category 1” (n = 15; 8.5%), “Category 2” (n = 100; 56.5%) and “Category 3” (n = 11; 6.2%). The medical action was “non-action/ monitoring” in 123 (69.5%) patients and “treatment modification” in 54 (30.5%). Patients with a glomerular filtration rate (GFR) <60 mL/min/1.73 had higher rates of “treatment modification” by DDIs (67% vs 27%)(p < 0.001). None of the patients whose “surveillance” of DDIs was performed (32.8%, n = 58) required “treatment modification” during therapy with OBV + PRV/r ± DSV ± RBV. Conclusions: Although 71% of CHC patients treated with OBV + PRV/r ± DSV ± RBV received concomitant drugs; only 6% had DDIs with contraindicated association. Moreover, in 70% of cases, the usual therapy was not modified at baseline or during the antiviral treatment. SAT-144 HIGH SVR RATES WITH SMV + SOF IN HCV GT1 AND GT4 PATIENTS WITH CIRRHOSIS OR ADVANCED FIBROSIS: A REAL PRACTICE ANALYSIS FROM A LARGE REGIONAL DATABASE IN TUSCANY, ITALY E. Salomoni1, E. Gianni2, L. Gragnani3, F. Oliveri4, M.R. Brunetto4, S. Luchi5, D. Bartolozzi1, P. Forte2, S. Sani6, P. Blanc7, R. Sacco8, A.L. Zignego3, A. De Luca9, D. Tacconi10, D. Aquilini11, F. Menichetti12, C. Catalani13, C. Nencioni14, P. Carrai15, S. Chigiotti14, P. Colombatto4, on behalf of Epatologi Toscani and SIMIT Toscana. 1Malattie Infettive e Tropicali; 2Gastroenterologia 2; 3Centro MASVE Medicina Sperimentale e Clinica, Azienda Ospedaliera Universitaria Careggi, Florence; 4Epatologia, Azienda Ospedaliera Universitaria Pisana, Pisa; 5Malattie Infettive e Epatologia, Ospedale San Luca, Lucca; 6 Malattie Infettive, Spedali Riuniti di Livorno, Livorno; 7Malattie Infettive e Tropicali, Ospedale Santa Maria Annunziata, Florence; 8 Gastroenterologia e Malattie del Ricambio, Azienda Ospedaliera Universitaria Pisana, Pisa; 9Malattie Infettive Universitarie, Azienda Ospedaliera Universitaria Senese, Siena; 10Malattie Infettive, Ospedale S. Donato, Arezzo; 11Malattie Infettive, Ospedale di Prato, Prato; 12 Malattie Infettive, Azienda Ospedaliera Universitaria Pisana, Pisa; 13 Malattie Infettive, Ospedale del Ceppo, Pistoia; 14Malattie Infettive, Ospedale Misericordia, Grosseto; 15Chirurgia Epatica e del Trapianto di Fegato, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy E-mail: [email protected] Background and Aims: Combined simeprevir (SMV) and sofosbuvir (SOF) with or without ribavirin (RBV) is a current treatment option in Italy for patients ( pts) with hepatitis C genotype 1 and 4 (HCV GT1,4). The aim of this study was to investigate the performance of this therapy in the real practice. Methods: From February 2015 a total of 370 pts (age 58.6 ± 10.4 yrs, 66.5% males) were treated for 12 weeks with SMV + SOF (54.1%) or SMV + SOF + RBV (45.9%) in 15 referral centres covering the whole region of Tuscany. The stage of fibrosis was assessed by histology
Journal of Hepatology 2016 vol. 64 | S631–S832
S761
Methods: A computer-based model of the natural history of chronic HCV genotype 1 infection, CKD, and liver disease was developed to project lifetime cumulative incidence of DC, HCC, liver-transplant (LT), kidney transplant (KT), ESLD mortality, ESRD mortality, and associated lifetime costs and quality-adjusted life years (QALY). Efficacy of EBR/GZR of 0.99 (0.95–1.00) was obtained from C-SURFER, a phase 2/3 double-blind, placebo-control trial in HCV genotype 1S760
infected patients with CKD4/5. Based on a meta-analysis, we assumed an efficacy of 0.60 (0.47–0.71) for peg-IFN/RBV. Data on baseline characteristics of the simulated patients were obtained from NHANES. Other model’s inputs were estimated from published studies. Cost of treatment with EBR/GZR was assumed to be similar to that of recently launched directly-acting agents. We conducted Monte Carlo simulations to estimate mean and 95% uncertainty intervals (UI) of outcomes. Results: Compared with NoTx, use of EBR/GZR was projected to reduce the lifetime cumulative incidence of HCC from an average of 19.96% (UI: 7.25–37.23) to an average of 0.89% (UI: 0.04–3.63) (Table 1). EBR/GZR-based regimens reduced lifetime cumulative incidence of DC from 8.80% (UI: 3.06–16.97) when peg-IFN/RBV was used to 3.19% (UI: 0.16–11.35). Use of EBR/GZR reduced ESLD mortality to 0.23% (UI: 0.00–0.99) from 10.60% (UI: 3.71–21.31) with peg-INF/RBV and 26.56% (UI: 14.23–41.08) with NoTx. Compared with NoTx, use of EBR/GZR lowered ESRD mortality from 12.70% (UI: 8.41–18.02) to 11.88% (UI: 10.34–13.46). EBR/GZR-based regimens resulted in higher average remaining QALYs and higher costs, and were cost-effective at a threshold of $100,000/QALY in 99.8% of the simulations. Conclusions: Use of EBR/GZR was projected to substantially reduce the incidence of liver- and CKD-related complications and mortality in treatment-naïve and treatment-experienced patients with hepatitis C virus genotype 1 infection and chronic kidney disease. In addition, EBR/GZR is cost-effective in the United States at commonly cited thresholds. SAT-142 VIROLOGIC RESPONSE FOLLOWING ASUNAPREVIR/DACLATASVIR WITH OR WITHOUT BECLABUVIR FOR TREATMENT OF HCV GENOTYPE 1 IN PATIENTS CO-INFECTED WITH HIV E.S. Rosenthal, M.D.1,2, L. Howard, B.A.3, J. Purdy, MSN, CRNP1, M. McLaughlin, RN, BSN3, S. Kattakuzhy, M.D.1,4, A. Kohli, M.D.1,5, E. Wilson, M.D.1,4, H. Masur, M.D.1, S. Kottilil, M.D., Ph.D.6. 1Critical Care Medicine Department, National Institutes of Health, Bethesda, MD; 2 Clinical Monitoring Research Program, Leidos Biomedical, Frederick, MD; 3NIAID, National Institutes of Health, Bethesda, MD; 4Institute of Human Virology, University of Maryland, Baltimore, MD; 5Department of Hepatology, St. Joseph’s Hospital, Phoenix, AZ; 6Institute of Human Virology, University of Maryland, Bethesda, MD, United States E-mail: [email protected] Background and Aims: Direct acting antivirals have revolutionized the treatment of HCV. Treatment of HCV in the setting of HIV coinfection has shown similar efficacy to HCV monoinfected patients, but therapeutic options are limited by drug interactions. In this study, we evaluated the safety and efficacy of asunaprevir (ASV, an NS3 protease inhibitor), daclatasvir (DCV, a pan-genotypic NS5A inhibitor), and beclabuvir (BCV, a nonnucleoside NS5B inhibitor) in HIV/HCV co-infected individuals. Methods: The CONQUER study (NCT02124044) is a prospective, single center, phase II, open label study conducted at the NIH Clinical Center to assess the safety, tolerability and efficacy of two regimens for the treatment of HCV genotype 1 in HIV co-infected patients. HIV/ HCV individuals with HCV genotype 1b (N = 10) were treated with ASV 100 mg twice daily and DCV 60 mg daily for 24 weeks and patients with HCV genotype 1a or 1b (N = 20) were treated with ASV 200 mg, DCV 30 mg, and BCV 75 mg in fixed dose combination twice daily for 12 weeks. Subjects (F0-F4) were treatment-naïve or treatment-experienced with an interferon-based regimen and were on approved antiretrovirals with CD4 >100 cells/mL and HIV RNA <50 copies/mL. The primary outcome was the proportion of patients with sustained viral response ( plasma HCV RNA level <12 IU/mL) 12 weeks after end of treatment (EOT), SVR12. Results: Demographic characteristics are shown in Table 1. In the ASV/DCV arm, 8/10 patients (80%) achieved SVR12; one patient had
Journal of Hepatology 2016 vol. 64 | S631–S832
POSTER PRESENTATIONS non-response, and one patient relapsed 4 weeks after EOT. There was one grade 4 lipase elevation which resolved. There were no discontinuations or serious adverse events attributable to study drug. In the ASV/DCV/BCV arm, 14/16 (87.5%) patients have achieved SVR12. Four additional patients will complete end point by March 2016. There were three patients who had grade 3 hypophosphatemia. One patient discontinued drug at week 8 due to paranoid delusions possibly attributable to the study drug.
Conclusions: In this open-label study, a high rate of sustained viral response was achieved in HCV genotype 1 patients co-infected with HIV, who received ASV/DCV for 24 weeks or ASV/DCV/BCV for 12 weeks allowing more therapeutic options for HIV/HCV coinfected subjects. Complete data on sustained viral response will be available at the time of the conference. SAT-143 PREVALENCE AND MANAGEMENT OF DRUG-DRUG INTERACTIONS (DDIS) WITH OMBITASVIR (OBV), PARITAPREVIR/R (PRV/R) ± DASABUVIR (DBV) ± RIBAVIRIN (RBV) IN PACIENTS WITH CHRONIC HEPATITIS C IN REAL-LIFE CLINICAL PRACTICE E. González-Colominas1, M.-C. Londoño2, R.M. Morillas3, X. Torras4, S. Mojal5, S. Lens2, D. López3, A. Gallego4, Z. Mariño2, M. Ardèvol6, N. Pagès7, R. Solà8, J.A. Carrión8. 1Pharmacy Department, Hospital del Mar, Parc de Salut Mar; 2Liver Unit, Institut de Malalties Digestives i Metabòliques, Hospital Clínic de Barcelona, CIBERehd, IDIBAPS, Barcelona; 3Hepatology Department, Hospital Germans Trias i Pujol, CIBERehd, Badalona; 4Gastroenterology Department, Hospital de la Santa Creu i Sant Pau, CIBERehd; 5Biomedical Research Methods Consultant, (IMIM) Hospital del Mar Medical Research Institute, Barcelona; 6Pharmacy Department, Hospital Germans Trias i Pujol, Badalona; 7Pharmacy Department, Hospital de la Santa Creu i Sant Pau, CIBERehd; 8Liver Section, Gastroenterology Department, Hospital del Mar, Parc de Salut Mar, Universitat Autònoma de Barcelona (UAB), IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain E-mail: [email protected] Background and Aims: Evaluation and management of drug-drug interactions (DDIs) using direct acting antivirals (DAAs) in patients with chronic hepatitis C (CHC) can avoid adverse effects and decrease the efficacy. The studies evaluating DDIs with OBV + PRV/r ± DSV ±
RBV have not been analyzed on clinical practice. The aim of our study was to evaluate the prevalence and management of DDIs with OBV + PRV/r ± DSV ± RBV on clinical practice. Methods: Retrospective analysis of data prospectively collected from CHC patients infected by genotype 1 or 4 treated with OBV + PRV/r ± DSV ± RBV in 4 Spanish Hospitals. Patients were classified according to the most serious DDIs using the database of the University of Liverpool in: “Category 0” (no drugs), “Category 1” (without DDIs), “Category 2” (DDIs manageable = surveillance/dosing adjustment), “Category 3” (contraindicated association) and according to the medical action in: “non-action/monitoring” or “treatment modification”. Results: We included 177 patients with a mean (±SD) age of 61 (±12), 49% were male, 98 (53.4%) with cirrhosis, 153 (86.4%) with genotype 1b and 94 (53%) naïve. Out of 126 (71.2%) patients with concomitant therapy, 56 (44.4%) received ≥3 drugs. We found DDIs in 111 (62.7%) patients, being Amlodipine the most common drug (n = 15; 11.9%) (Category 2). According to the DDIs, patients were classified in “Category 0” (n = 51; 28.8%), “Category 1” (n = 15; 8.5%), “Category 2” (n = 100; 56.5%) and “Category 3” (n = 11; 6.2%). The medical action was “non-action/ monitoring” in 123 (69.5%) patients and “treatment modification” in 54 (30.5%). Patients with a glomerular filtration rate (GFR) <60 mL/min/1.73 had higher rates of “treatment modification” by DDIs (67% vs 27%)(p < 0.001). None of the patients whose “surveillance” of DDIs was performed (32.8%, n = 58) required “treatment modification” during therapy with OBV + PRV/r ± DSV ± RBV. Conclusions: Although 71% of CHC patients treated with OBV + PRV/r ± DSV ± RBV received concomitant drugs; only 6% had DDIs with contraindicated association. Moreover, in 70% of cases, the usual therapy was not modified at baseline or during the antiviral treatment. SAT-144 HIGH SVR RATES WITH SMV + SOF IN HCV GT1 AND GT4 PATIENTS WITH CIRRHOSIS OR ADVANCED FIBROSIS: A REAL PRACTICE ANALYSIS FROM A LARGE REGIONAL DATABASE IN TUSCANY, ITALY E. Salomoni1, E. Gianni2, L. Gragnani3, F. Oliveri4, M.R. Brunetto4, S. Luchi5, D. Bartolozzi1, P. Forte2, S. Sani6, P. Blanc7, R. Sacco8, A.L. Zignego3, A. De Luca9, D. Tacconi10, D. Aquilini11, F. Menichetti12, C. Catalani13, C. Nencioni14, P. Carrai15, S. Chigiotti14, P. Colombatto4, on behalf of Epatologi Toscani and SIMIT Toscana. 1Malattie Infettive e Tropicali; 2Gastroenterologia 2; 3Centro MASVE Medicina Sperimentale e Clinica, Azienda Ospedaliera Universitaria Careggi, Florence; 4Epatologia, Azienda Ospedaliera Universitaria Pisana, Pisa; 5Malattie Infettive e Epatologia, Ospedale San Luca, Lucca; 6 Malattie Infettive, Spedali Riuniti di Livorno, Livorno; 7Malattie Infettive e Tropicali, Ospedale Santa Maria Annunziata, Florence; 8 Gastroenterologia e Malattie del Ricambio, Azienda Ospedaliera Universitaria Pisana, Pisa; 9Malattie Infettive Universitarie, Azienda Ospedaliera Universitaria Senese, Siena; 10Malattie Infettive, Ospedale S. Donato, Arezzo; 11Malattie Infettive, Ospedale di Prato, Prato; 12 Malattie Infettive, Azienda Ospedaliera Universitaria Pisana, Pisa; 13 Malattie Infettive, Ospedale del Ceppo, Pistoia; 14Malattie Infettive, Ospedale Misericordia, Grosseto; 15Chirurgia Epatica e del Trapianto di Fegato, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy E-mail: [email protected] Background and Aims: Combined simeprevir (SMV) and sofosbuvir (SOF) with or without ribavirin (RBV) is a current treatment option in Italy for patients ( pts) with hepatitis C genotype 1 and 4 (HCV GT1,4). The aim of this study was to investigate the performance of this therapy in the real practice. Methods: From February 2015 a total of 370 pts (age 58.6 ± 10.4 yrs, 66.5% males) were treated for 12 weeks with SMV + SOF (54.1%) or SMV + SOF + RBV (45.9%) in 15 referral centres covering the whole region of Tuscany. The stage of fibrosis was assessed by histology
Journal of Hepatology 2016 vol. 64 | S631–S832
S761