- Email: [email protected]
1b with sofosbuvir based regimens in Georgia
POSTER PRESENTATIONS related to the modulation of serotonin metabolism in DAA-treated patients. THU-254 Potential effect of hepatitis C treatment on renal, cardiovascular and metabolic extrahepatic manifestations: results from clinical trials of ombitasvir/paritaprevir/ritonavir and dasabuvir ± ribavirin T. Tran1, D. Mehta2,3, A. Goldstein3, E. Cohen3, Y. Bao3, Y.S. Gonzalez3. 1 Cedars-Sinai Medical Center; 2Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles; 3Abbvie Inc., North Chicago, United States E-mail: [email protected] Background and Aims: Prior studies have shown patients with hepatitis C virus (HCV) infection are at higher odds for developing extrahepatic manifestations (EHMs), including renal (RNL), cardiovascular (CV) and metabolic (MET) disorders. As the effect of HCV treatment on EHM-related outcomes is not well-defined, we study the impact of HCV treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir ± ribavirin (3D ± RBV) on RNL, CV and MET EHMs. Methods: Estimated glomerular filtration rate (eGFR), fasting triglycerides (TGL) and glucose (GLc) values from 6 3D ± RBV phase3a trials were used to assess RNL, CV and MET EHMs. Using the SAPPHIRE I/II trials, proportion of patients maintaining or improving in these outcomes were compared between the 3D ± RBV and placebo (PB) arms over the 12-week double-blind (DB) period, and within the PB arm, between the DB and the open label (OL) periods when treatment was received. In addition, regression analyses were conducted to study effect of HCV treatment on each EHM adjusting for patient demographics and clinical characteristics. Clinically relevant threshold values for eGFR, TGL and GLc were used to define chronic kidney disease (CKD) stages, elevated TGL and presence of pre-diabetes/ diabetes. Regression analyses on the treated population from 6 trials were conducted to study the differential effect of HCV treatment on each EHM adjusting for aforementioned covariates.
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Results: A statistically significant higher proportion of treated patients maintained or improved in CV (55% vs. 44%; p = 0.02), MET (58% V. 48%; p = 0.04) and RNL (70% vs. 60%; p = 0.09) outcomes compared to PB patients during the 12-week DB period. Similarly, a higher proportion of patients in the PB arm maintained or improved during the OL period in CV (62% vs. 44%; p = 0.01); MET (57% V. 48%; p = 0.11); RNL (77% vs. 60%; p = 0.01) compared to DB period. This beneficial effect of treatment was supported across EHM by regression analysis on PB controlled SAPPHIRE population. Regression analysis on treated population showed patients with elevated TGL or with pre-diabetes/diabetes experienced a statistically significant decline in TGL and GLc during treatment. For eGFR, patients in stage-2 CKD or higher experienced a statistically significant improvement in eGFR compared to baseline. Conclusions: Treatment with 3D ± RBV improves CV, MET and RNL EHMs in patients with elevated TGL, pre-diabetes/diabetes and CKD stage 2 or higher. THU-255 Treatment outcomes of hepatitis C virus recombinant form 2k/1b with sofosbuvir based regimens in Georgia M. Zakalashvili1, J. Zarkua1, M. Weizenegger2, J. Bartel3, M. Raabe2, T. Telia1, M. Zhamutashvili1, S. Metreveli4, M. Barnova4, N. Abramishvili4, R. Gish5, I. Rtskhiladze4, D. Metreveli1. 1 Gastroenterology and Hepatology, Medical Center “MRCHEVELI”, Tbilisi, Georgia; 2Molecular Diagnostics; 3Clinical Pathology, MVZ Labor Dr. Limbach & Kollegen GbR, Heidelberg, Germany; 4Clinical Laboratory, Medical Center “MRCHEVELI”, Tbilisi, Georgia; 5Stanford University, La Jolla, CA, United States E-mail: [email protected] Background and Aims: The estimated prevalence of hepatitis C virus (HCV) infection in the Republic of Georgia is one of the highest in the world. Interestingly, last data suggest, that up to 20% of all genotypes (GT) in Georgia belong to the HCV intergenotypic recombinant form 2k/1b (RF_2k/1b), which appears to show the highest prevalence of this recombinant virus so far, reported worldwide. The aim of our study was to define optimal treatment regimen for RF_2k/1b within Georgian HCV Elimination Project. Methods: We retrospectively analyzed the data of GT2 patients identified by INNO-LiPAVERSANT HCV Genotype 2.0 in Medical Center Mrcheveli from May 2015 to May 2016. Partial genome sequencing of core and NS5B regions was performed for identification of RF_2k/1b variants before treatment. All interferon eligible recombinants were treated with Sofosbuvir (SOF) plus Pegilated Interferon (PegINF) plus Ribavirin (RBV) for 12 weeks and interferon ineligible patients with SOF/RBV 24 weeks. We compare SVR12 rates of RF_2k/1b to pure GT2 treated with SOF/RBV-12 or SOF/RBV-20 (depending on presence of cirrhosis). Also we performed regenotyping and partial sequencing of core and NS5B region in randomly selected 20 samples from 95 GT2 (by INNO-LiPA VERSANT) treatment failures from other medical centers treated with SOF/RBV 12 or SOF/RBV 20 weeks. Results: A total number of 67 HCV GT2 samples by INNO-LiPA were analyzed, in which 43 (64%) RF_2k/1b were identified. Antiviral therapy in 23 out of 24 GT2 patients with SOF/RBV for 12 or 20 weeks was initiated in 23 patients and SVR12 rates was achieved in 22/23 (96%) patients. 36 out of 43 RF_2k/1b patients (n = 24) were treated with either SOF/PegINF/RBV for 12 weeks (n = 24) or with SOF/RBV for 24 weeks (n = 12) depending on interferon eligibility criteria. 23/ 24 (96%) patients achieved SVR 12 rates in interferon-containing group and 9/12 (75%) patients in group without interferon. From unspecified GT2 patients (n = 446) who were treated with SOF/RBV for 12 or 20 weeks, 95/446 (21%) relapsed. Partial genome sequencing of core and NS5B regions of 20 randomly selected samples from 95 treatment failures was consistent with RF_2k/1b. Conclusions: Despite the small number of patients our findings suggest that treatment of RF_2k/1b patients with SOF/PegINF/RBV for 12 weeks was more effective than with SOF/RBV for 24 weeks
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POSTER PRESENTATIONS ( p = 0.061). Also we can conclude, that SVR12 rate was significantly higher in GT2 patients, confirmed by sequencing, treated with SOF/ RBV 12 or 20 weeks than in unspecified GT2, who were treated with the same regimen ( p < 0.05). THU-256 Hepatitis C: year 1 real life results from the All Wales hepatitis C roll out programme D. Samuel1, R. Alcolado2, M. Czajkowski1, N. Reeve3, I. Rees3, P. Hams2, G. Hardcastle1, K. Mitchell1, R. Gale4, A. Andrew2, B. Ball2, C.L. Ch’ng5, D. Tomkinson6, D. Blinston3, A. Davies4, H. Ryan7, T. Mathialahan7, S. Nicholas8, E. Alexander9, L. Mapp7, S. Walsh7, K. Rockey10, J. Rees3, W. Ahmed7, A. Thompson7, C. Sutton9, T. Grenier9, S. Kneath11, L. Johnson5, H. Edwards5, O. Sitta8, T. Jones12, B. Healy12 and All Wales Hepatitis C roll out group. 1Gastroenterology, Aneurin Bevan University Health Board, Newport; 2Gastroenterology, Cwm Taf University Health Board, Llantrisant; 3Gastroenterology, Hywel Dda University Health Board, Llanelli; 4Pharmacy, Cardiff and Vale University Health Board, Cardiff; 5Gastroenterology, Abertawe Bro Morgannwg University Health Board, Swansea; 6Gastroenterology, Cardiff and Vale University Health Board, Cardiff; 7Gastroenterology, Betsi Cadwaladr University Health Board, Wrexham; 8Microbiology, Cardiff and Vale University Health Board, Cardiff; 9Pharmacy, Betsi Cadwaladr University Health Board, Wrexham; 10Infectious Diseases, Cardiff and Vale University Health Board, Cardiff; 11Pharmacy, Abertawe Bro Morgannwg University Health Board, Swansea; 12Microbiology, Public Health Wales, Cardiff, United Kingdom E-mail: [email protected] Background and Aims: This study reports the outcomes of a real life cohort of patients treated during the first year of the All Wales Hepatitis C roll out programme (1/4/15–31/3/16). Methods: The All Wales Hepatitis C roll out programme is committed to delivering equitable and transparent access to the new all oral DAA medications to all patients in Wales. In year one treatment was prioritised according to clinical need in the following order (i) Cirrhosis (Biopsy, Fibroscan score or imaging) (ii) F3/F4 disease or (iii) F0-F2 disease but with another urgent reason to need treatment (virtual panel approval required). Data was collected prospectively on all patients. Individual Health Board teams were responsible for coordinating treatment in each locality. Results: 466 patients were treated between 1/10/15 and 31/3/16 using available funding. 42% of the patient had established cirrhosis, 31% had F3/F4 Fibroscan readings and 27% of patients were eligible for treatment based on other clinical needs. 267 genotype 1 patients were offered treatment and 97% completed their treatment, achieving a 96% Sustained viral response (SVR). 25 genotype 2 patients were offered treatment and 97% completed their treatment with a 96% SVR. 154 genotype 3 patients were offered treatment with 93% completing treatment and achieving an 87% SVR. 19 genotype 4 patients completed treatment with a 100% SVR. 1 genotype 6 patent was treated and achieved SVR. Our overall results for our 466 patients achieved a 95% SVR rate with 97% of patients completing their planned treatment regime. 1 death occurred in a patient with genotype 4 disease, co-infected with HIV as a result of a HIV related complication. Conclusions: A large “real life” cohort from Wales achieved similar successes and SVR comparable to large published trial data and other real life cohorts. Patients tolerated regimes well with low rates of early treatment cessation and low complication rates and mortality. Continued Welsh government support and funding, coupled with a relatively static populations provide a good starting point for achievement of WHO viral eradication targets.
THU-257 No impact of RASs on the high efficacy of SOF/VEL/VOX for 8 weeks in DAA-naïve patients: an integrated resistance analysis of the POLARIS-2 and POLARIS-3 studies D. Wyles1, A. Thompson2, E. Lawitz3, B. Willems4, E.J. Gane5, E. Svarovskaia6, H. Dvory-Sobol6, R. Martin6, G. Camus6, B.P. Doehle6, L.M. Stamm6, R.H. Hyland6, D.M. Brainard6, H.M. Mo6, T. Asselah7, I. Jacobson8, G.R. Foster9, S. Roberts10. 1University of California, San Diego, United States; 2Department of Gastroenterology, St. Vincent’s Hospital, Melbourne, Australia; 3Texas Liver Institute, University of Texas Health Science Center, San Antonio, United States; 4Centre Hospitalier de l’Université de Montréal, Québec, Canada; 5Auckland Clinical Studies, Auckland, New Zealand; 6Gilead, Foster City, United States; 7Université Paris Diderot, Clichy, France; 8Mount Sinai Beth Israel, New York, United States; 9Royal London Hospital, London, United Kingdom; 10Alfred Hospital, Melbourne, Australia E-mail: [email protected] Background and Aims: Treatment with the single tablet regimen of SOF/VEL/VOX for 8 weeks resulted in high SVR rates in genotype 1–6 DAA-naive patients with and without compensated cirrhosis. This analysis evaluated the impact of baseline resistance associated substitutions (RASs) on treatment outcome and emergence of RASs at relapse in HCV GT1-6 infected patients in the POLARIS-2 (GT1, 2, 4, 5, 6 with or without cirrhosis, GT3 without cirrhosis) and POLARIS-3 (GT3 with cirrhosis) studies. Methods: NS3, NS5A, and NS5B sequencing (15% cut off) was performed at baseline for all patients and at the time of relapse for patients with virologic failure. NS3 and NS5A class RASs as well as VOX or VEL-specific RASs that confer >2.5 –fold change in EC50 were evaluated. Results: In POLARIS-2, in the SOF/VEL/VOX 8 Week group, 50.3% (250/497) had NS3 and/or NS5A class RASs at baseline. The SVR12 rate was 94% (234 of 250 subjects) for subjects with baseline class RASs and 98% (223 of 228 subjects) for subjects without baseline class RASs. The SVR12 rates were similar in subjects with VOX or VELspecific RASs compared to subjects without VOX or VEL-specific RASs (Table 1). One of the 21 patients who relapsed had treatmentemergent NS5A class RASs Q30R and L31M. None of the remaining subjects who relapsed had detectable NS3, NS5A, or NS5B NI treatment-emergent RASs. In POLARIS-3, all patients with baseline NS3 and/or NS5A RASs, including patients with VOX or VEL-specific RASs, achieved SVR12 (Table 1). Two of 110 (1.8%) patients experienced virologic failure following treatment with SOF/VEL/ VOX for 8 Week. No NS3, NS5A, or NI NS5B RASs were detected in either of these patients at virologic failure.
SOF/VEL/VOX 8 Weeks POLARIS-2 (N = 497) No VOX and/or VEL RASs With VOX and/or VEL RASs NS3 VOX RASs R155any A156any D/Q168any NS5A VEL RASs Y93any
POLARIS-3 (N = 108)
385/404 (95%)
88/90 (98%)
73/74 (99 %)
15/15 (100%)
4/4 (100%) 1/1 (100%) – 15/16 (94%) 71/72 (99%) 10/10 (100%)
– – – 1/1 (100%) 15/15 (100%) 8/8 (100%)
Conclusions: SOF/VEL/VOX for 8 weeks resulted in high SVR12 in GT1-6 infected DAA-naïve patients irrespective of baseline NS3 and/or NS5A RASs. Virologic failure was not associated with emergence of resistance in the majority of patients treated with SOF/VEL/VOX.
Journal of Hepatology 2017 vol. 66 | S95–S332
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Results: A statistically significant higher proportion of treated patients maintained or improved in CV (55% vs. 44%; p = 0.02), MET (58% V. 48%; p = 0.04) and RNL (70% vs. 60%; p = 0.09) outcomes compared to PB patients during the 12-week DB period. Similarly, a higher proportion of patients in the PB arm maintained or improved during the OL period in CV (62% vs. 44%; p = 0.01); MET (57% V. 48%; p = 0.11); RNL (77% vs. 60%; p = 0.01) compared to DB period. This beneficial effect of treatment was supported across EHM by regression analysis on PB controlled SAPPHIRE population. Regression analysis on treated population showed patients with elevated TGL or with pre-diabetes/diabetes experienced a statistically significant decline in TGL and GLc during treatment. For eGFR, patients in stage-2 CKD or higher experienced a statistically significant improvement in eGFR compared to baseline. Conclusions: Treatment with 3D ± RBV improves CV, MET and RNL EHMs in patients with elevated TGL, pre-diabetes/diabetes and CKD stage 2 or higher. THU-255 Treatment outcomes of hepatitis C virus recombinant form 2k/1b with sofosbuvir based regimens in Georgia M. Zakalashvili1, J. Zarkua1, M. Weizenegger2, J. Bartel3, M. Raabe2, T. Telia1, M. Zhamutashvili1, S. Metreveli4, M. Barnova4, N. Abramishvili4, R. Gish5, I. Rtskhiladze4, D. Metreveli1. 1 Gastroenterology and Hepatology, Medical Center “MRCHEVELI”, Tbilisi, Georgia; 2Molecular Diagnostics; 3Clinical Pathology, MVZ Labor Dr. Limbach & Kollegen GbR, Heidelberg, Germany; 4Clinical Laboratory, Medical Center “MRCHEVELI”, Tbilisi, Georgia; 5Stanford University, La Jolla, CA, United States E-mail: [email protected] Background and Aims: The estimated prevalence of hepatitis C virus (HCV) infection in the Republic of Georgia is one of the highest in the world. Interestingly, last data suggest, that up to 20% of all genotypes (GT) in Georgia belong to the HCV intergenotypic recombinant form 2k/1b (RF_2k/1b), which appears to show the highest prevalence of this recombinant virus so far, reported worldwide. The aim of our study was to define optimal treatment regimen for RF_2k/1b within Georgian HCV Elimination Project. Methods: We retrospectively analyzed the data of GT2 patients identified by INNO-LiPAVERSANT HCV Genotype 2.0 in Medical Center Mrcheveli from May 2015 to May 2016. Partial genome sequencing of core and NS5B regions was performed for identification of RF_2k/1b variants before treatment. All interferon eligible recombinants were treated with Sofosbuvir (SOF) plus Pegilated Interferon (PegINF) plus Ribavirin (RBV) for 12 weeks and interferon ineligible patients with SOF/RBV 24 weeks. We compare SVR12 rates of RF_2k/1b to pure GT2 treated with SOF/RBV-12 or SOF/RBV-20 (depending on presence of cirrhosis). Also we performed regenotyping and partial sequencing of core and NS5B region in randomly selected 20 samples from 95 GT2 (by INNO-LiPA VERSANT) treatment failures from other medical centers treated with SOF/RBV 12 or SOF/RBV 20 weeks. Results: A total number of 67 HCV GT2 samples by INNO-LiPA were analyzed, in which 43 (64%) RF_2k/1b were identified. Antiviral therapy in 23 out of 24 GT2 patients with SOF/RBV for 12 or 20 weeks was initiated in 23 patients and SVR12 rates was achieved in 22/23 (96%) patients. 36 out of 43 RF_2k/1b patients (n = 24) were treated with either SOF/PegINF/RBV for 12 weeks (n = 24) or with SOF/RBV for 24 weeks (n = 12) depending on interferon eligibility criteria. 23/ 24 (96%) patients achieved SVR 12 rates in interferon-containing group and 9/12 (75%) patients in group without interferon. From unspecified GT2 patients (n = 446) who were treated with SOF/RBV for 12 or 20 weeks, 95/446 (21%) relapsed. Partial genome sequencing of core and NS5B regions of 20 randomly selected samples from 95 treatment failures was consistent with RF_2k/1b. Conclusions: Despite the small number of patients our findings suggest that treatment of RF_2k/1b patients with SOF/PegINF/RBV for 12 weeks was more effective than with SOF/RBV for 24 weeks
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POSTER PRESENTATIONS ( p = 0.061). Also we can conclude, that SVR12 rate was significantly higher in GT2 patients, confirmed by sequencing, treated with SOF/ RBV 12 or 20 weeks than in unspecified GT2, who were treated with the same regimen ( p < 0.05). THU-256 Hepatitis C: year 1 real life results from the All Wales hepatitis C roll out programme D. Samuel1, R. Alcolado2, M. Czajkowski1, N. Reeve3, I. Rees3, P. Hams2, G. Hardcastle1, K. Mitchell1, R. Gale4, A. Andrew2, B. Ball2, C.L. Ch’ng5, D. Tomkinson6, D. Blinston3, A. Davies4, H. Ryan7, T. Mathialahan7, S. Nicholas8, E. Alexander9, L. Mapp7, S. Walsh7, K. Rockey10, J. Rees3, W. Ahmed7, A. Thompson7, C. Sutton9, T. Grenier9, S. Kneath11, L. Johnson5, H. Edwards5, O. Sitta8, T. Jones12, B. Healy12 and All Wales Hepatitis C roll out group. 1Gastroenterology, Aneurin Bevan University Health Board, Newport; 2Gastroenterology, Cwm Taf University Health Board, Llantrisant; 3Gastroenterology, Hywel Dda University Health Board, Llanelli; 4Pharmacy, Cardiff and Vale University Health Board, Cardiff; 5Gastroenterology, Abertawe Bro Morgannwg University Health Board, Swansea; 6Gastroenterology, Cardiff and Vale University Health Board, Cardiff; 7Gastroenterology, Betsi Cadwaladr University Health Board, Wrexham; 8Microbiology, Cardiff and Vale University Health Board, Cardiff; 9Pharmacy, Betsi Cadwaladr University Health Board, Wrexham; 10Infectious Diseases, Cardiff and Vale University Health Board, Cardiff; 11Pharmacy, Abertawe Bro Morgannwg University Health Board, Swansea; 12Microbiology, Public Health Wales, Cardiff, United Kingdom E-mail: [email protected] Background and Aims: This study reports the outcomes of a real life cohort of patients treated during the first year of the All Wales Hepatitis C roll out programme (1/4/15–31/3/16). Methods: The All Wales Hepatitis C roll out programme is committed to delivering equitable and transparent access to the new all oral DAA medications to all patients in Wales. In year one treatment was prioritised according to clinical need in the following order (i) Cirrhosis (Biopsy, Fibroscan score or imaging) (ii) F3/F4 disease or (iii) F0-F2 disease but with another urgent reason to need treatment (virtual panel approval required). Data was collected prospectively on all patients. Individual Health Board teams were responsible for coordinating treatment in each locality. Results: 466 patients were treated between 1/10/15 and 31/3/16 using available funding. 42% of the patient had established cirrhosis, 31% had F3/F4 Fibroscan readings and 27% of patients were eligible for treatment based on other clinical needs. 267 genotype 1 patients were offered treatment and 97% completed their treatment, achieving a 96% Sustained viral response (SVR). 25 genotype 2 patients were offered treatment and 97% completed their treatment with a 96% SVR. 154 genotype 3 patients were offered treatment with 93% completing treatment and achieving an 87% SVR. 19 genotype 4 patients completed treatment with a 100% SVR. 1 genotype 6 patent was treated and achieved SVR. Our overall results for our 466 patients achieved a 95% SVR rate with 97% of patients completing their planned treatment regime. 1 death occurred in a patient with genotype 4 disease, co-infected with HIV as a result of a HIV related complication. Conclusions: A large “real life” cohort from Wales achieved similar successes and SVR comparable to large published trial data and other real life cohorts. Patients tolerated regimes well with low rates of early treatment cessation and low complication rates and mortality. Continued Welsh government support and funding, coupled with a relatively static populations provide a good starting point for achievement of WHO viral eradication targets.
THU-257 No impact of RASs on the high efficacy of SOF/VEL/VOX for 8 weeks in DAA-naïve patients: an integrated resistance analysis of the POLARIS-2 and POLARIS-3 studies D. Wyles1, A. Thompson2, E. Lawitz3, B. Willems4, E.J. Gane5, E. Svarovskaia6, H. Dvory-Sobol6, R. Martin6, G. Camus6, B.P. Doehle6, L.M. Stamm6, R.H. Hyland6, D.M. Brainard6, H.M. Mo6, T. Asselah7, I. Jacobson8, G.R. Foster9, S. Roberts10. 1University of California, San Diego, United States; 2Department of Gastroenterology, St. Vincent’s Hospital, Melbourne, Australia; 3Texas Liver Institute, University of Texas Health Science Center, San Antonio, United States; 4Centre Hospitalier de l’Université de Montréal, Québec, Canada; 5Auckland Clinical Studies, Auckland, New Zealand; 6Gilead, Foster City, United States; 7Université Paris Diderot, Clichy, France; 8Mount Sinai Beth Israel, New York, United States; 9Royal London Hospital, London, United Kingdom; 10Alfred Hospital, Melbourne, Australia E-mail: [email protected] Background and Aims: Treatment with the single tablet regimen of SOF/VEL/VOX for 8 weeks resulted in high SVR rates in genotype 1–6 DAA-naive patients with and without compensated cirrhosis. This analysis evaluated the impact of baseline resistance associated substitutions (RASs) on treatment outcome and emergence of RASs at relapse in HCV GT1-6 infected patients in the POLARIS-2 (GT1, 2, 4, 5, 6 with or without cirrhosis, GT3 without cirrhosis) and POLARIS-3 (GT3 with cirrhosis) studies. Methods: NS3, NS5A, and NS5B sequencing (15% cut off) was performed at baseline for all patients and at the time of relapse for patients with virologic failure. NS3 and NS5A class RASs as well as VOX or VEL-specific RASs that confer >2.5 –fold change in EC50 were evaluated. Results: In POLARIS-2, in the SOF/VEL/VOX 8 Week group, 50.3% (250/497) had NS3 and/or NS5A class RASs at baseline. The SVR12 rate was 94% (234 of 250 subjects) for subjects with baseline class RASs and 98% (223 of 228 subjects) for subjects without baseline class RASs. The SVR12 rates were similar in subjects with VOX or VELspecific RASs compared to subjects without VOX or VEL-specific RASs (Table 1). One of the 21 patients who relapsed had treatmentemergent NS5A class RASs Q30R and L31M. None of the remaining subjects who relapsed had detectable NS3, NS5A, or NS5B NI treatment-emergent RASs. In POLARIS-3, all patients with baseline NS3 and/or NS5A RASs, including patients with VOX or VEL-specific RASs, achieved SVR12 (Table 1). Two of 110 (1.8%) patients experienced virologic failure following treatment with SOF/VEL/ VOX for 8 Week. No NS3, NS5A, or NI NS5B RASs were detected in either of these patients at virologic failure.
SOF/VEL/VOX 8 Weeks POLARIS-2 (N = 497) No VOX and/or VEL RASs With VOX and/or VEL RASs NS3 VOX RASs R155any A156any D/Q168any NS5A VEL RASs Y93any
POLARIS-3 (N = 108)
385/404 (95%)
88/90 (98%)
73/74 (99 %)
15/15 (100%)
4/4 (100%) 1/1 (100%) – 15/16 (94%) 71/72 (99%) 10/10 (100%)
– – – 1/1 (100%) 15/15 (100%) 8/8 (100%)
Conclusions: SOF/VEL/VOX for 8 weeks resulted in high SVR12 in GT1-6 infected DAA-naïve patients irrespective of baseline NS3 and/or NS5A RASs. Virologic failure was not associated with emergence of resistance in the majority of patients treated with SOF/VEL/VOX.
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