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499 Ribavirin-Free Regimen With Velpatasvir and Sofosbuvir is Associated With High Efficiency and Improvement of Patient-Reported Outcomes in Patients With Genotypes 2 and 3 Chronic Hepatitis C: Results From ASTRAL-2 and 3 Clinical Trials
without HAT. On multivariable (adjusted) analysis, PVT and high risk donors were the most statistically significant independent risk factors for HAT (OR 2.09 95% CI 1.41-3.07, p= 0.002) and this risk was 39% higher than in those recipients with PVT and a low risk donor (OR 1.80 95% CI 1.12-2.91, p=0.007). Recipients without PVT with a high risk donor did not have an increased risk of HAT. (OR 1.05 95% CI 0.82-1.35, p=0.169). Other significant covariates included male donors (OR 0.51 95% CI 0.41-0.62, p <0.001), hepatocellular carcinoma (OR 0.65 95% CI 0.48-0.90, p=0.008), heparin use at cross-clamp (OR 0.68, 95% CI 0.51-0.90, p=0.008), and international normalized ratio (INR) at transplantation (OR 0.86 95% CI 0.75-0.99, p=0.033). Conclusions: Candidates with pre-transplant PVT who receive an organ from a high-risk donor are at the highest risk for post-operative HAT independent of other measurable factors. Recipients with pre-transplant PVT would benefit from careful donor selection and possibly anticoagulation perioperatively.
430 How Much Radiation Is Too Much Radiation: A Descriptive Evaluation of Liver Transplant Patients Liz N. Toapanta-Yanchapaxi, Guillermo Hinojosa, Manuel Guerrero, Erwin Chiquete, Mario Vilatobá, Alan G. Contreras, Ignacio Garcia
AASLD Abstracts
Abstract Introduction and Aims. Over the years, imaging studies have become an important diagnostic complement. However, the advent of high definition imaging studies has resulted in an increase in radiation exposure (RE). Patients with liver disease require an extensive battery of studies for both, the diagnosis and management of complications, in the pretransplant period and follow-up after liver transplantation (LT). We aimed to evaluate the radiation exposure and associated factors in patients during evaluation for LT, in the waiting list and 6 months post-transplant period. Materials and Methods. This retrospective cohort study included patients with LT between February 2005 and March 2015. All patients were over 18 years-old, with a complete evaluation protocol before listing for LT and at least 6 months follow-up (after LT). Patient's records and imaging archives were reviewed. Clinical, demographic and listing data were also obtained. All studies that resulted in RE of the patients were included to determine the cumulative exposure dose (CED), reported in millisieverts (mSv). Non parametric tests, chi-squared analysis, log rank test, Kaplan Meier curves and Cox regression models were performed. A p-value of less than 0.05 was considered significant. Results. Among 128 patients evaluated, 100 (78%) patients met inclusion criteria. Mean age of patients was 46.79 ± 13.66 years, with 55% females. The overall observation period had a median of 513 (Interquartile range: 183 - 3,706 days). A total of 3,817 imaging evaluations were performed during the study time and 3,195 (83.4%) contributed to RE. Most of the studies performed were chest Rx 43% (n = 1645) and abdomen CT 13% (n = 493). In all, the patients received a mean of 30.42±16.41 imaging studies involving ionizing radiation per individual. Interventional radiology contributed with 84% of total amount of RE. Mean CED was 766.21±1,222.27 mSv, with 50% of patients achieving >150 mSv. Variables associated with the probability of attaining a CED >150 mSv were the waiting time for >6 months in the transplantation list and hepatocellular carcinoma as the cause for the transplantation. Conclusions. This study demonstrates that radiation exposure in liver transplant patients is thrice the maximum recommended occupational exposure dose and 50% higher than the dose associated with radiation-induced cancer risk. Patients at particular risk for medical imaging radiation are those waiting >6 months for the transplant and with hepatocellular carcinoma. This information must alert to clinicians involved in the care of liver transplant patients for a more judicious behavior when indicating diagnostic procedures posing risk to patients. Table. Comparative data for patients with hepatocellular carcinoma (HCC) and other indications for LT.
499 Ribavirin-Free Regimen With Velpatasvir and Sofosbuvir is Associated With High Efficiency and Improvement of Patient-Reported Outcomes in Patients With Genotypes 2 and 3 Chronic Hepatitis C: Results From ASTRAL-2 and 3 Clinical Trials Zobair M. Younossi, Maria Stepanova, Mark Sulkowski, Graham R. Foster, Nancy Reau, Alessandra Mangia, Keyur Patel, Norbert Brau, Stuart K. Roberts, Nezam H. Afdhal, Fatema Nader, Sharon Hunt BACKGROUND: The currently approved regimen for HCV genotype 2 and 3 is sofosbuvir (SOF) and ribavirin (RBV) with relatively good efficacy rates but also modest decrements in patient-reported outcomes (PROs) related to the side effects of RBV. The impact of RBVfree pan-genotypic regimen with SOF and velpatasvir (VEL/SOF) on PROs is not well understood. AIM: To compare PROs during treatment with VEL/SOF and SOF+RBV. METHODS: The PRO data were collected in two phase 3 trials (ASTRAL-2 and ASTRAL-3) of patients with HCV genotypes 2 and 3 who received VEL/SOF or SOF+RBV once daily for 12 or 24 weeks. The PROs were evaluated using four instruments (SF-36, FACIT-F, CLDQHCV, WPAI:SHP) at baseline, during treatment, and in follow-up (up to 24 weeks). RESULTS: A total of 818 patients were enrolled (52.2±10.6 years old, 61% male, 89% white, 78% treatment-naïve, 25% cirrhotic, 33% HCV genotype 2, 67% genotype 3). The SVR rates were 99.2% in VEL/SOF for 12 weeks in HCV genotype 2, 95.3% in genotype 3; 93.9% in SOF+RBV for 12 weeks in genotype 2; 80.4% in SOF+RBV for 24 weeks in genotype 3 (p<0.0001). All demographics and PROs were similar at baseline between the VEL/SOF and SOF+RBV treatment arms (p>0.05). By treatment week 4, 12 out of 23 PRO domains significantly improved in patients receiving VEL/SOF (up to +8.8 points on a 0100 scale). These improvements continued to increase during treatment (up to +11.6 by treatment week 8, p<0.05 for 15/23 PROs; up to +13.3 by treatment week 12, p<0.05 for all but 2 PROs). In contrast, in SOF+RBV group, there were some improvements in some PROs by the end of treatment (p<0.05 for 5/23 PROs), while decrements were noted in other PRO domains (p<0.05 for 5/23 PROs). Nevertheless, by post-treatment week 4, no residual PRO decrements were observed in SOF+RBV, and PRO improvements were similar regardless of the regimen. Patients with SVR-12 showed significant PRO improvements, also regardless of the regimens (up to +14.3, p<0.05 from baseline for 21/23 PROs). In multivariate analysis, after adjustment for clinico-demographic confounders, the use of VEL/SOF rather than SOF+RBV was independently associated with +3.3 to +10.3 points to the summary PROs at different time points during treatment. Longer treatment duration for SOF+RBV was not associated with treatment-emergent changes in PROs (all p>0.05). CONCLUSION: The use of an all-oral fixed-dose combination of velpatasvir and sofosbuvir in patients with HCV genotypes 2 and 3 is associated with improved patients' experience during treatment.
HCV: Hepatitis C virus, MELD: Model for end stage liver disease. IQR: Interquartile range
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430 How Much Radiation Is Too Much Radiation: A Descriptive Evaluation of Liver Transplant Patients Liz N. Toapanta-Yanchapaxi, Guillermo Hinojosa, Manuel Guerrero, Erwin Chiquete, Mario Vilatobá, Alan G. Contreras, Ignacio Garcia
AASLD Abstracts
Abstract Introduction and Aims. Over the years, imaging studies have become an important diagnostic complement. However, the advent of high definition imaging studies has resulted in an increase in radiation exposure (RE). Patients with liver disease require an extensive battery of studies for both, the diagnosis and management of complications, in the pretransplant period and follow-up after liver transplantation (LT). We aimed to evaluate the radiation exposure and associated factors in patients during evaluation for LT, in the waiting list and 6 months post-transplant period. Materials and Methods. This retrospective cohort study included patients with LT between February 2005 and March 2015. All patients were over 18 years-old, with a complete evaluation protocol before listing for LT and at least 6 months follow-up (after LT). Patient's records and imaging archives were reviewed. Clinical, demographic and listing data were also obtained. All studies that resulted in RE of the patients were included to determine the cumulative exposure dose (CED), reported in millisieverts (mSv). Non parametric tests, chi-squared analysis, log rank test, Kaplan Meier curves and Cox regression models were performed. A p-value of less than 0.05 was considered significant. Results. Among 128 patients evaluated, 100 (78%) patients met inclusion criteria. Mean age of patients was 46.79 ± 13.66 years, with 55% females. The overall observation period had a median of 513 (Interquartile range: 183 - 3,706 days). A total of 3,817 imaging evaluations were performed during the study time and 3,195 (83.4%) contributed to RE. Most of the studies performed were chest Rx 43% (n = 1645) and abdomen CT 13% (n = 493). In all, the patients received a mean of 30.42±16.41 imaging studies involving ionizing radiation per individual. Interventional radiology contributed with 84% of total amount of RE. Mean CED was 766.21±1,222.27 mSv, with 50% of patients achieving >150 mSv. Variables associated with the probability of attaining a CED >150 mSv were the waiting time for >6 months in the transplantation list and hepatocellular carcinoma as the cause for the transplantation. Conclusions. This study demonstrates that radiation exposure in liver transplant patients is thrice the maximum recommended occupational exposure dose and 50% higher than the dose associated with radiation-induced cancer risk. Patients at particular risk for medical imaging radiation are those waiting >6 months for the transplant and with hepatocellular carcinoma. This information must alert to clinicians involved in the care of liver transplant patients for a more judicious behavior when indicating diagnostic procedures posing risk to patients. Table. Comparative data for patients with hepatocellular carcinoma (HCC) and other indications for LT.
499 Ribavirin-Free Regimen With Velpatasvir and Sofosbuvir is Associated With High Efficiency and Improvement of Patient-Reported Outcomes in Patients With Genotypes 2 and 3 Chronic Hepatitis C: Results From ASTRAL-2 and 3 Clinical Trials Zobair M. Younossi, Maria Stepanova, Mark Sulkowski, Graham R. Foster, Nancy Reau, Alessandra Mangia, Keyur Patel, Norbert Brau, Stuart K. Roberts, Nezam H. Afdhal, Fatema Nader, Sharon Hunt BACKGROUND: The currently approved regimen for HCV genotype 2 and 3 is sofosbuvir (SOF) and ribavirin (RBV) with relatively good efficacy rates but also modest decrements in patient-reported outcomes (PROs) related to the side effects of RBV. The impact of RBVfree pan-genotypic regimen with SOF and velpatasvir (VEL/SOF) on PROs is not well understood. AIM: To compare PROs during treatment with VEL/SOF and SOF+RBV. METHODS: The PRO data were collected in two phase 3 trials (ASTRAL-2 and ASTRAL-3) of patients with HCV genotypes 2 and 3 who received VEL/SOF or SOF+RBV once daily for 12 or 24 weeks. The PROs were evaluated using four instruments (SF-36, FACIT-F, CLDQHCV, WPAI:SHP) at baseline, during treatment, and in follow-up (up to 24 weeks). RESULTS: A total of 818 patients were enrolled (52.2±10.6 years old, 61% male, 89% white, 78% treatment-naïve, 25% cirrhotic, 33% HCV genotype 2, 67% genotype 3). The SVR rates were 99.2% in VEL/SOF for 12 weeks in HCV genotype 2, 95.3% in genotype 3; 93.9% in SOF+RBV for 12 weeks in genotype 2; 80.4% in SOF+RBV for 24 weeks in genotype 3 (p<0.0001). All demographics and PROs were similar at baseline between the VEL/SOF and SOF+RBV treatment arms (p>0.05). By treatment week 4, 12 out of 23 PRO domains significantly improved in patients receiving VEL/SOF (up to +8.8 points on a 0100 scale). These improvements continued to increase during treatment (up to +11.6 by treatment week 8, p<0.05 for 15/23 PROs; up to +13.3 by treatment week 12, p<0.05 for all but 2 PROs). In contrast, in SOF+RBV group, there were some improvements in some PROs by the end of treatment (p<0.05 for 5/23 PROs), while decrements were noted in other PRO domains (p<0.05 for 5/23 PROs). Nevertheless, by post-treatment week 4, no residual PRO decrements were observed in SOF+RBV, and PRO improvements were similar regardless of the regimen. Patients with SVR-12 showed significant PRO improvements, also regardless of the regimens (up to +14.3, p<0.05 from baseline for 21/23 PROs). In multivariate analysis, after adjustment for clinico-demographic confounders, the use of VEL/SOF rather than SOF+RBV was independently associated with +3.3 to +10.3 points to the summary PROs at different time points during treatment. Longer treatment duration for SOF+RBV was not associated with treatment-emergent changes in PROs (all p>0.05). CONCLUSION: The use of an all-oral fixed-dose combination of velpatasvir and sofosbuvir in patients with HCV genotypes 2 and 3 is associated with improved patients' experience during treatment.
HCV: Hepatitis C virus, MELD: Model for end stage liver disease. IQR: Interquartile range
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