- Email: [email protected]
Daclatasvir plus Sofosbuvir plus Ribavirin for 12 or 16 Weeks in Treatment-Experienced Patients with HCV Genotype 3 Infection and Advanced Fibrosis or Cirrhosis
POSTER PRESENTATIONS Background and Aims: The second generation DAA, Sofosbuvir (SOF), Simeprevir (SMP), Daclatasvir (DAC), Ledipasvir (LED), and the “3D”-regimen (Paritaprevir/r, Ombitasvir, Dasabuvir) were approved by the authorities. This single center retrospective interim-analysis was conducted to assess the efficacy and safety of 2nd generation DAA treatment in HCV patients. Methods: 207 consecutive patients infected with HCV were treated with (i) SOF, Ribavirin (RBV) +/− PEG-IFN (n = 59), (ii) SOF, DAC +/− RBV (n = 78), (iii) SOF, SMP +/− RBV (n = 30), (iv) SOF, LED (n = 40). 115 patients were treatment experienced. Distribution of HCV genotypes (GT): GT 1a: 28%, GT 1b: 42%, GT 1x: 3% GT 2: 3%, GT 3: 20%, GT 4: 5%, GT 6: 1%. Median baseline viral load was 1.17 Mio. IU/mL HCV RNA. 37% had liver cirrhosis. 16 patients were treated after liver transplantation. 1 patient was treated post-kidney transplantation. Results: Efficacy: At end of treatment (EOT), 98% (197/202) were HCV negative, while 93% (182/196) reached SVR 12. Subgroup analysis for SVR 12: SOF/RBV +/− PEG-IFN: 93% (53/57); SOF, DAC +/− RBV 93% (67/76); SOF, SMP +/− RBV 90% (27/30); SOF, LED +/− RBV (35/37). SVR 12 in patients with cirrhosis: 87% (61/70; p < 0.03), SVR 12 in pretreated patients: 92% (100/109), SVR 12 in patients after liver transplantation 87% (13/15). SVR 12 in patients with platelets <100/nL at baseline: 84% (38/45; p < 0.03). 5 patients discontinued prematurely (4 patients died during treatment, 1 patient had a virological relapse afterwards), 9 patients had a virological relapse after EOT. No virological breakthrough occurred. Safety1 patient with relapse after SOF/RBV/PEG-IFN had liver cirrhosis and developed liver failure after relapse, but could be retreated with SOF-DAC, and reached SVR 12. Altogether 4 patients died during treatment, all of those with advanced liver cirrhosis. Conclusions: New DAA are impressively effective with respect to SVR 12. At least in our interim analysis, new DAA are less active in patients with liver cirrhosis, and especially in those with portal hypertension ( platelet count <100/nL) in comparison with other subgroups ( p < 0.03). The safety of DAA combinations in special subgroups of patients, foremost in those with advanced cirrhosis, needs further investigation. Additionally, at the ILC 2016, SVR 12 data of our patients treated with “3D” regimen will be available. SAT-128 C-EDGE IBLD: EFFICACY AND SAFETY OF ELBASVIR/GRAZOPREVIR (EBR/GZR) IN SUBJECTS WITH CHRONIC HEPATITIS C VIRUS INFECTION AND INHERITED BLOOD DISORDERS C. Hezode1, M. Colombo2, U. Spengler3, Z. Ben-Ari4,5, S. Strasser6, W.M. Lee7, L. Morgan8, J. Qiu8, P. Hwang8, M. Robertson8, B.-Y. Nguyen8, E. Barr8, J. Wahl8, B. Haber8, R. Talwani8, V. Di Marco9. 1 Henri Mondor Hospital, Creteil, France; 2Università degli Studi di Milano, Milan, Italy; 3University of Bonn, Bonn, Germany; 4Sheba Medical Center, Ramat Gan; 5Sackler School of Medicine, Tel Aviv, Israel; 6 AW Morrow Gastroenterology and Liver Centre, Sydney, Australia; 7UT Southwestern Medical Center, Dallas; 8Merck & Co., Inc., Kenilworth, United States; 9University of Palermo, Palermo, Italy E-mail: [email protected] Background and Aims: Complications from chronic hepatitis C virus (HCV) infection remain a major cause of morbidity and mortality among individuals with inherited blood disorders (IBLD), including those with haemophilia (HEM), beta thalassemia (BTHAL), von Willebrand disease (VWD) and sickle cell anaemia (SCA). Inability to tolerate ribavirin and frequent comorbidities have limited HCV treatment options in these patients. The efficacy and safety of a oncedaily, fixed-dose combination of EBR 50 mg (NS5A inhibitor) and GZR 100 mg (NS3/4A protease inhibitor) has been demonstrated in a broad population of HCV-infected patients and supported evaluation in the IBLD population. Methods: C-EDGE-IBLD is a double-blind, placebo-controlled study that randomized treatment-naïve (TN) and peg-IFN/RBV treatment-
experienced (TE) HCV genotype (GT)1, 4 or 6-infected patients in a 2:1 ratio to either an immediate treatment group (ITG; 12 weeks of EBR/GZR) or deferred treatment group (DTG; 12 weeks of placebo, followed by EBR/GZR). Randomization was stratified according to cirrhosis status and IBLD group, defined as 1) HEM (A or B) or VWD, 2) BTHAL and 3) SCA. The primary endpoints for this study are proportion of patients in the ITG who achieved an SVR12 (HCV RNA <15 IU/mL 12 weeks after study treatment completion) and a comparison of the safety and tolerability of EBR/GZR in the ITG relative to placebo treatment in the DTG. Results: 158 of 159 randomized patients have unblinded treatment allocation (106, ITG; 52, DTG); treatment arm is still blinded for 1 patient. Mean age was 44 years; 75% male; 18% black; 40% GT1a; 44% GT1b; 11% GT4; 26% cirrhotic; 50% TE; 6% HIV/HCV co-infected; 43% HEM/VWD; 38% BTHAL; 18% SCA). All 106 patients in the ITG and 50 of 52 patients in the DTG completed 12 weeks of treatment. Available HCV RNA results at follow-up week 4 (SVR4) for patients in the ITG (n = 105) are summarized in Table 1. There were 3 (2.9%) patients with serious adverse events (SAEs) (1 drug-related, 2 related to IBLD) in the ITG. In the DTG, 1 patient discontinued due to AE, and 1 withdrew consent; 6/52 (11.5%) had SAEs (1 drug-related, 3 related to IBLD). No patient in either arm prematurely discontinued from the trial due to worsening of underlying IBLD. There was 1 hepatic event of clinical interest (ALT >3× baseline and >100 U/L) in each arm. SVR12 results will be presented.
Conclusions: Preliminary data indicate that EBR/GZR is well tolerated and effective in patients with HCV GT1, 4 or 6 with and without cirrhosis with IBLD. SAT-129 DACLATASVIR PLUS SOFOSBUVIR PLUS RIBAVIRIN FOR 12 OR 16 WEEKS IN TREATMENT-EXPERIENCED PATIENTS WITH HCV GENOTYPE 3 INFECTION AND ADVANCED FIBROSIS OR CIRRHOSIS C. Hezode1, G. Dore2, S. Pianko3, S. Pol4, K. Stuart5, A. Thompson6, E. Tse7, R. Bhore8, M.J. Jimenez-Exposito8. 1Hépato-gastro-entérologie, CHU Henri-Mondor, Créteil, France; 2St. Vincent’s Hospital and Kirby Institute, Sydney; 3Monash Medical Centre, Clayton, Australia; 4Hôpital Cochin, Paris, France; 5Gallipoli Medical Research Foundation, Greenslopes; 6St. Vincent’s Hospital and the University of Melbourne, Melbourne; 7Royal Adelaide Hospital, Adelaide, Australia; 8Research and Development, Bristol-Myers Squibb, Princeton, United States E-mail: [email protected] Background and Aims: Patients with HCV genotype 3 infection are a challenging population in urgent need of optimally effective therapies. The phase 3 ALLY-3+ study evaluated 12 and 16 weeks of daclatasvir + sofosbuvir + ribavirin in patients with HCV GT 3 infection and advanced fibrosis or cirrhosis. Sustained virologic response at posttreatment Week 12 (SVR12) was achieved by 100% of patients with advanced fibrosis and 86% of patients with cirrhosis. Here, we present the results of the treatment-experienced population.
Journal of Hepatology 2016 vol. 64 | S631–S832
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POSTER PRESENTATIONS Methods: Treatment-experienced patients (N = 37) received openlabel daclatasvir 60 mg + sofosbuvir 400 mg (both once daily) + weight-based ribavirin (1,200 or 1,000 mg/day) for 12 (n = 18) or 16 (n = 19) weeks. Advanced fibrosis or cirrhosis was determined by liver biopsy, FibroScan (advanced fibrosis: ≥9.6 – <14.6 kPa; cirrhosis: ≥14.6 kPa), or FibroTest + aspartate aminotransferase platelet ratio index >2. This subanalysis provides further details of efficacy and safety outcomes in these patients. Results: Treatment-experienced patients were predominantly male (78%), white (97%) and cirrhotic (81%); 60% had baseline HCV RNA ≥6,000,000 IU/mL and 59% had non-CC IL28B genotypes. Patients had previously received interferon- (n = 31; 15 had prior relapse) or sofosbuvir-based (+ribavirin, n = 5; + interferon + ribavirin, n = 1; all had prior relapse) regimens. SVR12 was achieved by 89% of patients overall (12-week arm: 89%; 16-week arm: 90%), 100% of patients with advanced fibrosis (n = 7/7) and 87% of patients with cirrhosis (n = 26/30). SVR12 was also achieved by 96% of patients with baseline HCV RNA ≥6,000,000 IU/mL (n = 21/22) and 100% of patients with baseline NS5A (A30, L31 and Y93) polymorphisms (n = 5/5). Four patients failed treatment (relapse, n = 3; unrelated death, n = 1). There were no adverse events leading to study discontinuation. Serious and grade 3/4 adverse events each occurred in 11% of patients overall. Grade 3/4 laboratory abnormalities were uncommon (haemoglobin, n = 1; total bilirubin, n = 2). The most frequent adverse events overall (any grade) were insomnia (27%), fatigue (27%) and headache (24%). Conclusions: Daclatasvir + sofosbuvir + ribavirin for 12 or 16 weeks is highly efficacious in patients with HCV GT 3 infection and advanced fibrosis (SVR12, 100%) or cirrhosis (SVR12, 87%) who have failed previous interferon- or sofosbuvir-based therapies. This regimen is also safe and well tolerated. SAT-130 EFFICACY AND TOLERABILITY OF SIMEPREVIR AND DACLATASVIR FOR 12 OR 24 WEEKS IN HCV GENOTYPE 1B-INFECTED TREATMENT-NAÏVE PATIENTS WITH ADVANCED FIBROSIS OR COMPENSATED CIRRHOSIS C. Hezode1, P. Almasio2, S. Bourgeois3, P. Buggisch4, A. Brown5, M. Diago6, Y. Horsmans7, L. Serfaty8, F. Szalay9, G.B. Gaeta10, R. Planas11, M. Schlag12, I. Lonjon-Domanec13, L. Gilles14, R. DeMasi15, S. Zeuzem16. 1Department of Hepatology and Gastroenterology, Hôpital Henri Mondor, Université Paris-Est, Paris, France; 2Gastroenterology & Hepatology Unit, Di.Bi.MI.S. University of Palermo, Palermo, Italy; 3 Department of Gastroenterology and Hepatology, ZNA Campus Stuivenberg, Antwerp, Belgium; 4Institute for Interdisciplinary Medicine, Asklepios Klinik St. Georg, Hamburg, Germany; 5Department of Hepatology, St Mary’s Hospital, Imperial College Healthcare NHS Trust, London, United Kingdom; 6Hospital General Universitario Valencia, Valencia, Spain; 7Cliniques Universitaires Saint-Luc (U.C.L.), Brussels, Belgium; 8Department of Hepatology, Hôpital Saint-Antoine, Paris, France; 91st Department of Internal Medicine, Semmelweis University, Budapest, Hungary; 10Department of Internal and Specialized Medicine, Second University of Naples, Caserta CE, Italy; 11Hepatology Unit, Hospital Germans Trias i Pujol & ciberehd, Badalona, Barcelona, Spain; 12 Janssen-Cilag, Vienna, Austria; 13Janssen Pharmaceuticals, Paris, France; 14Janssen Infectious Diseases BVBA, Beerse, Belgium; 15Janssen Research & Development, Titusville, NJ, United States; 16Department of Gastroenterology and Hepatology, J. W. Goethe University, Frankfurt, Germany E-mail: [email protected] Background and Aims: Simeprevir (SMV) and daclatasvir (DCV) are approved, widely available direct-acting antivirals (DAAs). This combination of therapies warrants further investigation in HCV GT1b, as does the effect of baseline NS5A RAVs. We describe interim data from an ongoing Phase 2 study investigating the efficacy and safety of SMV + DCV in HCV GT1b.
S754
Methods: The open-label COMMIT study included patients with chronic HCV GT1b infection (≥18 years; treatment-naïve; G1b; advanced fibrosis or compensated cirrhosis [METAVIR F3/4]; no restriction on age or body mass index [BMI]). Patients harboring NS5A-Y93H and/or L31M/V RAVs at screening ( population sequencing) were excluded. SMV (150 mg) + DCV (60 mg) once daily was administered for 12 weeks; patients could extend treatment to 24 weeks at investigator discretion. The primary efficacy endpoint is sustained virologic response after 12 weeks (SVR12). This interim analysis was conducted when all patients had reached study Week 16. HCV RNA was quantified with the Roche Ampliprep assay (LLOQ = 15 IU/mL; LOD = 15 IU/mL). Results: Of 151 patients screened, 23 (15%) were excluded due to NS5A variants (Y93H or L31M/V) and 106 (70%) were treated (for demographics, see Table). 42/106 (40%) patients received 12 weeks of treatment; 64/106 (60%) extended treatment to 24 weeks. Amongst patients receiving 12 weeks’ treatment (ITT), 37/ 42 (88%) achieved SVR4; of those who did not achieve SVR4, four experienced viral breakthrough (VBT) and one withdrew consent. In the 24-week group, three patients experienced virologic failure, all due to VBT. Characteristics of patients (n = 7) experiencing VBT included male gender (n = 2/7), baseline HCV RNA ≥6,000,000 IU/mL (n = 3/7); IL28B CT¦TT genotype (n = 4¦3/7); METAVIR F4 (n = 4/7), IFN-ineligibility (n = 2/7). VBT occurred at Week 4 (n = 3), Week 8 (n = 1), Week 12 (n = 2) and Week 16 (n = 1).
Two (2%) patients discontinued treatment due to AEs that were not deemed related to SMV + DCV; 74 (70%) experienced any AE; 6 (6%) ≥1 SAE (of which 1 was considered possibly related to SMV + DCV); 7 (7%) ≥1 Grade 3/4 AE (of which 3 were considered related to SMV + DCV). Conclusions: SMV + DCV demonstrated strong antiviral activity: among patients treated for 12 weeks, 88% achieved SVR4. However, VBT occurred in four patients in the 12-week group and three patients in the 24-week group. SMV + DCV was well tolerated in this patient population with advanced liver disease. Full SVR12 and resistance analysis will be presented.
Journal of Hepatology 2016 vol. 64 | S631–S832
experienced (TE) HCV genotype (GT)1, 4 or 6-infected patients in a 2:1 ratio to either an immediate treatment group (ITG; 12 weeks of EBR/GZR) or deferred treatment group (DTG; 12 weeks of placebo, followed by EBR/GZR). Randomization was stratified according to cirrhosis status and IBLD group, defined as 1) HEM (A or B) or VWD, 2) BTHAL and 3) SCA. The primary endpoints for this study are proportion of patients in the ITG who achieved an SVR12 (HCV RNA <15 IU/mL 12 weeks after study treatment completion) and a comparison of the safety and tolerability of EBR/GZR in the ITG relative to placebo treatment in the DTG. Results: 158 of 159 randomized patients have unblinded treatment allocation (106, ITG; 52, DTG); treatment arm is still blinded for 1 patient. Mean age was 44 years; 75% male; 18% black; 40% GT1a; 44% GT1b; 11% GT4; 26% cirrhotic; 50% TE; 6% HIV/HCV co-infected; 43% HEM/VWD; 38% BTHAL; 18% SCA). All 106 patients in the ITG and 50 of 52 patients in the DTG completed 12 weeks of treatment. Available HCV RNA results at follow-up week 4 (SVR4) for patients in the ITG (n = 105) are summarized in Table 1. There were 3 (2.9%) patients with serious adverse events (SAEs) (1 drug-related, 2 related to IBLD) in the ITG. In the DTG, 1 patient discontinued due to AE, and 1 withdrew consent; 6/52 (11.5%) had SAEs (1 drug-related, 3 related to IBLD). No patient in either arm prematurely discontinued from the trial due to worsening of underlying IBLD. There was 1 hepatic event of clinical interest (ALT >3× baseline and >100 U/L) in each arm. SVR12 results will be presented.
Conclusions: Preliminary data indicate that EBR/GZR is well tolerated and effective in patients with HCV GT1, 4 or 6 with and without cirrhosis with IBLD. SAT-129 DACLATASVIR PLUS SOFOSBUVIR PLUS RIBAVIRIN FOR 12 OR 16 WEEKS IN TREATMENT-EXPERIENCED PATIENTS WITH HCV GENOTYPE 3 INFECTION AND ADVANCED FIBROSIS OR CIRRHOSIS C. Hezode1, G. Dore2, S. Pianko3, S. Pol4, K. Stuart5, A. Thompson6, E. Tse7, R. Bhore8, M.J. Jimenez-Exposito8. 1Hépato-gastro-entérologie, CHU Henri-Mondor, Créteil, France; 2St. Vincent’s Hospital and Kirby Institute, Sydney; 3Monash Medical Centre, Clayton, Australia; 4Hôpital Cochin, Paris, France; 5Gallipoli Medical Research Foundation, Greenslopes; 6St. Vincent’s Hospital and the University of Melbourne, Melbourne; 7Royal Adelaide Hospital, Adelaide, Australia; 8Research and Development, Bristol-Myers Squibb, Princeton, United States E-mail: [email protected] Background and Aims: Patients with HCV genotype 3 infection are a challenging population in urgent need of optimally effective therapies. The phase 3 ALLY-3+ study evaluated 12 and 16 weeks of daclatasvir + sofosbuvir + ribavirin in patients with HCV GT 3 infection and advanced fibrosis or cirrhosis. Sustained virologic response at posttreatment Week 12 (SVR12) was achieved by 100% of patients with advanced fibrosis and 86% of patients with cirrhosis. Here, we present the results of the treatment-experienced population.
Journal of Hepatology 2016 vol. 64 | S631–S832
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POSTER PRESENTATIONS Methods: Treatment-experienced patients (N = 37) received openlabel daclatasvir 60 mg + sofosbuvir 400 mg (both once daily) + weight-based ribavirin (1,200 or 1,000 mg/day) for 12 (n = 18) or 16 (n = 19) weeks. Advanced fibrosis or cirrhosis was determined by liver biopsy, FibroScan (advanced fibrosis: ≥9.6 – <14.6 kPa; cirrhosis: ≥14.6 kPa), or FibroTest + aspartate aminotransferase platelet ratio index >2. This subanalysis provides further details of efficacy and safety outcomes in these patients. Results: Treatment-experienced patients were predominantly male (78%), white (97%) and cirrhotic (81%); 60% had baseline HCV RNA ≥6,000,000 IU/mL and 59% had non-CC IL28B genotypes. Patients had previously received interferon- (n = 31; 15 had prior relapse) or sofosbuvir-based (+ribavirin, n = 5; + interferon + ribavirin, n = 1; all had prior relapse) regimens. SVR12 was achieved by 89% of patients overall (12-week arm: 89%; 16-week arm: 90%), 100% of patients with advanced fibrosis (n = 7/7) and 87% of patients with cirrhosis (n = 26/30). SVR12 was also achieved by 96% of patients with baseline HCV RNA ≥6,000,000 IU/mL (n = 21/22) and 100% of patients with baseline NS5A (A30, L31 and Y93) polymorphisms (n = 5/5). Four patients failed treatment (relapse, n = 3; unrelated death, n = 1). There were no adverse events leading to study discontinuation. Serious and grade 3/4 adverse events each occurred in 11% of patients overall. Grade 3/4 laboratory abnormalities were uncommon (haemoglobin, n = 1; total bilirubin, n = 2). The most frequent adverse events overall (any grade) were insomnia (27%), fatigue (27%) and headache (24%). Conclusions: Daclatasvir + sofosbuvir + ribavirin for 12 or 16 weeks is highly efficacious in patients with HCV GT 3 infection and advanced fibrosis (SVR12, 100%) or cirrhosis (SVR12, 87%) who have failed previous interferon- or sofosbuvir-based therapies. This regimen is also safe and well tolerated. SAT-130 EFFICACY AND TOLERABILITY OF SIMEPREVIR AND DACLATASVIR FOR 12 OR 24 WEEKS IN HCV GENOTYPE 1B-INFECTED TREATMENT-NAÏVE PATIENTS WITH ADVANCED FIBROSIS OR COMPENSATED CIRRHOSIS C. Hezode1, P. Almasio2, S. Bourgeois3, P. Buggisch4, A. Brown5, M. Diago6, Y. Horsmans7, L. Serfaty8, F. Szalay9, G.B. Gaeta10, R. Planas11, M. Schlag12, I. Lonjon-Domanec13, L. Gilles14, R. DeMasi15, S. Zeuzem16. 1Department of Hepatology and Gastroenterology, Hôpital Henri Mondor, Université Paris-Est, Paris, France; 2Gastroenterology & Hepatology Unit, Di.Bi.MI.S. University of Palermo, Palermo, Italy; 3 Department of Gastroenterology and Hepatology, ZNA Campus Stuivenberg, Antwerp, Belgium; 4Institute for Interdisciplinary Medicine, Asklepios Klinik St. Georg, Hamburg, Germany; 5Department of Hepatology, St Mary’s Hospital, Imperial College Healthcare NHS Trust, London, United Kingdom; 6Hospital General Universitario Valencia, Valencia, Spain; 7Cliniques Universitaires Saint-Luc (U.C.L.), Brussels, Belgium; 8Department of Hepatology, Hôpital Saint-Antoine, Paris, France; 91st Department of Internal Medicine, Semmelweis University, Budapest, Hungary; 10Department of Internal and Specialized Medicine, Second University of Naples, Caserta CE, Italy; 11Hepatology Unit, Hospital Germans Trias i Pujol & ciberehd, Badalona, Barcelona, Spain; 12 Janssen-Cilag, Vienna, Austria; 13Janssen Pharmaceuticals, Paris, France; 14Janssen Infectious Diseases BVBA, Beerse, Belgium; 15Janssen Research & Development, Titusville, NJ, United States; 16Department of Gastroenterology and Hepatology, J. W. Goethe University, Frankfurt, Germany E-mail: [email protected] Background and Aims: Simeprevir (SMV) and daclatasvir (DCV) are approved, widely available direct-acting antivirals (DAAs). This combination of therapies warrants further investigation in HCV GT1b, as does the effect of baseline NS5A RAVs. We describe interim data from an ongoing Phase 2 study investigating the efficacy and safety of SMV + DCV in HCV GT1b.
S754
Methods: The open-label COMMIT study included patients with chronic HCV GT1b infection (≥18 years; treatment-naïve; G1b; advanced fibrosis or compensated cirrhosis [METAVIR F3/4]; no restriction on age or body mass index [BMI]). Patients harboring NS5A-Y93H and/or L31M/V RAVs at screening ( population sequencing) were excluded. SMV (150 mg) + DCV (60 mg) once daily was administered for 12 weeks; patients could extend treatment to 24 weeks at investigator discretion. The primary efficacy endpoint is sustained virologic response after 12 weeks (SVR12). This interim analysis was conducted when all patients had reached study Week 16. HCV RNA was quantified with the Roche Ampliprep assay (LLOQ = 15 IU/mL; LOD = 15 IU/mL). Results: Of 151 patients screened, 23 (15%) were excluded due to NS5A variants (Y93H or L31M/V) and 106 (70%) were treated (for demographics, see Table). 42/106 (40%) patients received 12 weeks of treatment; 64/106 (60%) extended treatment to 24 weeks. Amongst patients receiving 12 weeks’ treatment (ITT), 37/ 42 (88%) achieved SVR4; of those who did not achieve SVR4, four experienced viral breakthrough (VBT) and one withdrew consent. In the 24-week group, three patients experienced virologic failure, all due to VBT. Characteristics of patients (n = 7) experiencing VBT included male gender (n = 2/7), baseline HCV RNA ≥6,000,000 IU/mL (n = 3/7); IL28B CT¦TT genotype (n = 4¦3/7); METAVIR F4 (n = 4/7), IFN-ineligibility (n = 2/7). VBT occurred at Week 4 (n = 3), Week 8 (n = 1), Week 12 (n = 2) and Week 16 (n = 1).
Two (2%) patients discontinued treatment due to AEs that were not deemed related to SMV + DCV; 74 (70%) experienced any AE; 6 (6%) ≥1 SAE (of which 1 was considered possibly related to SMV + DCV); 7 (7%) ≥1 Grade 3/4 AE (of which 3 were considered related to SMV + DCV). Conclusions: SMV + DCV demonstrated strong antiviral activity: among patients treated for 12 weeks, 88% achieved SVR4. However, VBT occurred in four patients in the 12-week group and three patients in the 24-week group. SMV + DCV was well tolerated in this patient population with advanced liver disease. Full SVR12 and resistance analysis will be presented.
Journal of Hepatology 2016 vol. 64 | S631–S832