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Su1443 The Impact of Antiviral (HCV) Therapy on Kidney Function in Liver Transplant Recipient
Ledipasvir-Sovaldi Therapy for Hepatitis C Has High Rate of Viral Eradication in a Diverse Urban Population Omar Sadiq, Alexander Weick, Adrienne Lenhart, Wiliam Kane, Khalid George, Dilip Moonka, Syed-Mohammed Jafri Objectives: Evaluate outcomes of ledipasvir-sofosbuvir based hepatitis C (HCV) therapy in patients at a single center clinical setting. Methods: All patients without history of transplant treated with ledipasvir-sofosbuvir therapy between January 1st, 2015 and October 1st, 2015 were evaluated for efficacy of therapy at a single center. Detailed demographic and laboratory evaluation was reviewed for all patients. Patients reaching 12 weeks post-therapy were included. Sustained viral response (SVR) was evaluated at weeks 4 (SVR4) and 12 (SVR12) after treatment. Results: 506 patients were started on treatment, 121 completed therapy and were at least 12 weeks out from treatment. 61% were male, mean age was 61 (range 3386) and mean BMI was 29.0 (range 15.4-41.7). 46% were African American and 41% white. 56% had genotype 1a, 37% genotype 1b. 13% of patients were treated appropriately for 8 weeks, 74% for 12 weeks and the 12% for 24 weeks. 11% were treated with 12 weeks of therapy in combination with ribavirin. 41 patients (34%) had cirrhosis. 115 patients (95%) achieved SVR12. 40 (98%) of patients with cirrhosis achieved SVR12. Six patients failed therapy. 4 were on 12 weeks of ledipasvir-sofosbuvir alone, one had addition of ribavirin and one had 24 weeks therapy. No patients treated for 8 weeks due to treatment naïve with viral load <6 million failed therapy. 43 (36%) patients were previous treated, of which 7 were previously treated with boceprevir and 3 with telaprevir. 42 (98%) of previously treated patients achieved SVR12. 19 (100%) previously treated cirrhotics achieved SVR12. One patient with prior treatment failure on boceprevir failed ledipasvir-sofosbuvir therapy. Two (1.7%) patients did not complete therapy. One patient treated with ribavirin was unable to complete therapy because of a rash and another was noncompliant with 12-week therapy. Two patients (2%) not on ribavirin developed hyperbilirubinemia (total bilirubin ‡2.5) during therapy. One patient's hyperbilirubinemia resolved and patient achieved SVR12 without any other significant side effects. The second patient's hyperbilirubinemia workup revealed diffuse hepatocellular carcinoma. Average reduction in hemoglobin without ribaviran was 1.0g/dL. Average reduction in hemoglobin on ribavirin was 2.2g/dL. Discussion: In our initial experience, combination therapy of ledipasvir-sofosbuvir is well tolerated in the management of HCV. Therapy achieved high rates of SVR with low rates of complication with or without ribavirin. This regimen was 95% effective at achieving SVR12 in our population.
Su1443 The Impact of Antiviral (HCV) Therapy on Kidney Function in Liver Transplant Recipient Kirbylee K. Nelson, Michael T. Caire, Ambuj Kumar, Jamie Morano, Nyingi Kemmer Introduction: Hepatitis C virus (HCV) infection is currently the leading cause of liver transplantation (LT) in the United States. Advances in treatment, including antiviral drugs such as Sofosbuvir (SOF), have led to increased cure rates. The burden of chronic kidney disease (CKD) in patients with HCV post-LT is significant. Currently, the impact of CKD with an estimated glomerular filtration rate (eGFR) >30 mL/min on treatment with a SOF based regimen is not well understood, and no dosage recommendation can be given for patients with severe renal impairment. We sought to quantify the incidence of CKD in patients post-LT with HCV and to determine the effect of SOF based regimen on CKD stage. Methods: We performed a retrospective cohort study of all LT patients receiving SOF based regimen treatment for HCV at our center from June 2013 to October 2015. Our primary endpoint was incidence of CKD (eGFR <60) pre-treatment. CKD stage was classified as CKD 1 (>90), CKD 2 (60-89), CKD 3 (30-59), CKD 4 (15-29), and CKD 5 (<15). The secondary outcome was change in eGFR values from baseline to post treatment and at follow-up of 12 weeks. Difference in eGFR values from baseline to post treatment and 12 weeks follow up was assessed using the paired samples t test. Continuous data were summarized as mean difference (MD) along with 95% confidence intervals (CI). The statistical significance for all assessments was set at 5%. Results: In our post-LT population, 57 patients received HCV therapy. Prior to HCV treatment, 30/57 (52.6%) had CKD stages 1 or 2, 26/57 (45.8%) had CKD stage 3, and 1/57 (1.7%) had CKD stage 4. The mean eGFR was 55.1 (SD±15.1) at baseline, 56.4 (SD±14.9) at post treatment, and 53.2 (SD±16.9) at 12 weeks follow up. The change in eGFR values from baseline to post treatment (MD=-1.481; 95% CI -5.361 to 2.398; p=0.440), baseline to 12 weeks follow-up (MD=-2.174; 95% CI -3.421 to 7.469; p=0.429) and post treatment to 12 weeks follow up (MD=4.130; 95% CI -0.661 to 8.922; p=0.088) was not statistically significant. Sustained virologic response was 100%. No patient progressed to renal failure or required hemodialysis during therapy. Discussion: CKD is of significant burden in the post-LT HCV treatment population. Although no dosage recommendation has been given for patient's with eGFR <30, in our center we observed that SOF based therapy was safe and effective in the treatment of HCV in post-LT patients with eGFR >30. Future studies to evaluate the long-term impact of antiviral therapy on renal function in LT recipients are warranted.
with a mixed urban population. Methods: We conducted a retrospective analysis of 219 outpatients receiving treatment with various DAA regimens (88.6% with ledipasvir/sofosbuvir) for chronic HCV between August 2014 and July 2015 at a single center (Boston Medical Center). We used means and proportions to describe the study sample and treatment outcomes. The primary outcome was the percentage of patients attaining sustained virologic response (SVR), defined as an undetectable HCV RNA level at 12 weeks post-treatment completion. Treatment completion, indicative of adherence and tolerability, was a secondary outcome. Results: A total of 219 patients with HCV (29.7% women, mean age 55.8 years) were treated in the 11 month study period. 91.7% of patients had genotype 1 infection and 66.8% were treatment naïve. The majority of patients were non-white (44.6% African American, 16.6% Hispanic, and 4.3% Asian). A minority of patients had private insurance (31.2%), while the remainder had Medicaid (39.0%), Medicare (13.7%), or a combination of Medicare and Medicaid (16.1%). Over half of patients (52.5%) had cirrhosis with a mean MELD 7.9 +/- 2.4 and 29.7% of cirrhotic patients had some form of decompensation. Overall, 87.8% of patients achieved an SVR and 91.3% of patients completed treatment. Of the 19 patients who did not complete therapy, 5 (26.3%) discontinued therapy because of adverse side effects while the remaining patients were largely lost to follow-up before the week 4 viral load visit. Conclusions: Overall, of the 219 chronic HCV patients treated at a single safety-net hospital, ultimately 87.8% achieved a SVR after treatment with DAAs. While this SVR rate is lower than has been reported in clinical trials, this study demonstrates the efficacy of treatment in an urban, underserved population in real world practice. As numerous viral-, patient-, and treatment-related factors are known to affect viral response and treatment adherence, future studies should continue to examine the interplay of these variables in the setting of newer DAA regimen use.
Su1445 Ombitasvir (ABT 267), Ritanavir Boost With Dastasbuvir (ABT 333) and Prataspravir (ABT 450) With or Without Ribavirin (RBV) in G1 Special Population in Hemodialysis (HD) in Chronic Hepatitis C (HCV) Patients. Drop C Trial: An Open Label Prospective Clinical Pilot Study Patrick Basu, Niraj J. Shah, Sakina Farhat, Nimy John, L Kavali, Mark Aloysius Introduction: Chronic Hepatitis C (CHC) is global epidemic in USA with a prevalence of 2.8% with an incidence of 3.3% in end-stage renal disease (ESRD) in hemodialysis (HD) population. CHC in ERSD with HD has significant higher fibrotic state and accelerated cirrhosis with decompensation and higher rate of hepatocellular carcinoma (HCC). The mortality and hazard ratio of chronic hepatitis C in ESRD on HD with relative risk of death is 1.79% and post renal transplant graft failure is1. 56%. Prior DAA's with Interferon and Ribavirin achieved 63% SVR in 48 weeks. Aim: Primary Objective: To show the efficacy of the triple regimen (Paritaprevir, Ritonavir and Ombitasvir) by obtaining SVR12 Secondary Objectives: Safety, tolerability Methods: Thirty Six (36) patients (18 cirrhotics and 18 noncirrhotics) were recruited from 4 dialysis centers across Brooklyn; in patients undergoing hemodialysis with chronic hepatitis C; genotype 1. The patients were divided into two groups: group A (n=18) with cirrhosis and group B (n=18) with no cirrhosis. Group A: Ombitasvir (Abt 267) + Ritanavir + Dastasbuvir (Abt 333) + Prataspravir (Abt 450); with 200 mg daily of RBV Group B: Ombitasvir (Abt 267) + Ritanavir + Dastasbuvir (Abt 333) + Prataspravir (Abt 450); without RBV Patient characteristics: to follow in the poster/oral presentation Results: Table 1 Conclusion: This study demonstrates a high SVR with a very short course DAA's in HCV in patients on HD Both the groups achieved overall 94.4 % SVR 12 Both groups had one patient with virological failure (5.5 %) A total of 3/36 (8.3%) patients relapsed; 2/18 (11.1%) in group A versus 1/18 (5.5%) in group B Role of DAA's in ESRD patients on HD in CHILD A cirrhotics have encouraging SVR rates; though carries a risk of higher relapse rate despite daily modified doses of RBV Overall the drugs were well tolerated with minimal side events and without treatment failure Triple therapy with RBV is a viable option and larger clinical trials will validate the efficacy and short treatment paradigm. Results: table 1
Su1444 Effectiveness of Hepatitis C Treatment With Direct Acting Antiviral Agents in a Safety-Net Hospital Rishabh Sachdev, Ashley N. Tran, Michael Leber, Toni Zahorian, Bhavesh Shah, David Nunes, Michelle T. Long Background: An estimated 3.2 million people are chronically infected with Hepatitis C (HCV) in the United States. In treating HCV and obtaining viral suppression, the ultimate goal is to reduce the risk of progression of chronic liver disease. Over the last several years, HCV treatment has shifted largely to interferon-free, oral direct acting antiviral (DAA) regimens. Such regimens have demonstrated 95% SVR rates in clinical trials. The real world efficacy of these agents is not known. The objective of this study was to assess the reproducibility of the clinical trial outcomes in actual clinical practice in a safety-net hospital
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Su1443 The Impact of Antiviral (HCV) Therapy on Kidney Function in Liver Transplant Recipient Kirbylee K. Nelson, Michael T. Caire, Ambuj Kumar, Jamie Morano, Nyingi Kemmer Introduction: Hepatitis C virus (HCV) infection is currently the leading cause of liver transplantation (LT) in the United States. Advances in treatment, including antiviral drugs such as Sofosbuvir (SOF), have led to increased cure rates. The burden of chronic kidney disease (CKD) in patients with HCV post-LT is significant. Currently, the impact of CKD with an estimated glomerular filtration rate (eGFR) >30 mL/min on treatment with a SOF based regimen is not well understood, and no dosage recommendation can be given for patients with severe renal impairment. We sought to quantify the incidence of CKD in patients post-LT with HCV and to determine the effect of SOF based regimen on CKD stage. Methods: We performed a retrospective cohort study of all LT patients receiving SOF based regimen treatment for HCV at our center from June 2013 to October 2015. Our primary endpoint was incidence of CKD (eGFR <60) pre-treatment. CKD stage was classified as CKD 1 (>90), CKD 2 (60-89), CKD 3 (30-59), CKD 4 (15-29), and CKD 5 (<15). The secondary outcome was change in eGFR values from baseline to post treatment and at follow-up of 12 weeks. Difference in eGFR values from baseline to post treatment and 12 weeks follow up was assessed using the paired samples t test. Continuous data were summarized as mean difference (MD) along with 95% confidence intervals (CI). The statistical significance for all assessments was set at 5%. Results: In our post-LT population, 57 patients received HCV therapy. Prior to HCV treatment, 30/57 (52.6%) had CKD stages 1 or 2, 26/57 (45.8%) had CKD stage 3, and 1/57 (1.7%) had CKD stage 4. The mean eGFR was 55.1 (SD±15.1) at baseline, 56.4 (SD±14.9) at post treatment, and 53.2 (SD±16.9) at 12 weeks follow up. The change in eGFR values from baseline to post treatment (MD=-1.481; 95% CI -5.361 to 2.398; p=0.440), baseline to 12 weeks follow-up (MD=-2.174; 95% CI -3.421 to 7.469; p=0.429) and post treatment to 12 weeks follow up (MD=4.130; 95% CI -0.661 to 8.922; p=0.088) was not statistically significant. Sustained virologic response was 100%. No patient progressed to renal failure or required hemodialysis during therapy. Discussion: CKD is of significant burden in the post-LT HCV treatment population. Although no dosage recommendation has been given for patient's with eGFR <30, in our center we observed that SOF based therapy was safe and effective in the treatment of HCV in post-LT patients with eGFR >30. Future studies to evaluate the long-term impact of antiviral therapy on renal function in LT recipients are warranted.
with a mixed urban population. Methods: We conducted a retrospective analysis of 219 outpatients receiving treatment with various DAA regimens (88.6% with ledipasvir/sofosbuvir) for chronic HCV between August 2014 and July 2015 at a single center (Boston Medical Center). We used means and proportions to describe the study sample and treatment outcomes. The primary outcome was the percentage of patients attaining sustained virologic response (SVR), defined as an undetectable HCV RNA level at 12 weeks post-treatment completion. Treatment completion, indicative of adherence and tolerability, was a secondary outcome. Results: A total of 219 patients with HCV (29.7% women, mean age 55.8 years) were treated in the 11 month study period. 91.7% of patients had genotype 1 infection and 66.8% were treatment naïve. The majority of patients were non-white (44.6% African American, 16.6% Hispanic, and 4.3% Asian). A minority of patients had private insurance (31.2%), while the remainder had Medicaid (39.0%), Medicare (13.7%), or a combination of Medicare and Medicaid (16.1%). Over half of patients (52.5%) had cirrhosis with a mean MELD 7.9 +/- 2.4 and 29.7% of cirrhotic patients had some form of decompensation. Overall, 87.8% of patients achieved an SVR and 91.3% of patients completed treatment. Of the 19 patients who did not complete therapy, 5 (26.3%) discontinued therapy because of adverse side effects while the remaining patients were largely lost to follow-up before the week 4 viral load visit. Conclusions: Overall, of the 219 chronic HCV patients treated at a single safety-net hospital, ultimately 87.8% achieved a SVR after treatment with DAAs. While this SVR rate is lower than has been reported in clinical trials, this study demonstrates the efficacy of treatment in an urban, underserved population in real world practice. As numerous viral-, patient-, and treatment-related factors are known to affect viral response and treatment adherence, future studies should continue to examine the interplay of these variables in the setting of newer DAA regimen use.
Su1445 Ombitasvir (ABT 267), Ritanavir Boost With Dastasbuvir (ABT 333) and Prataspravir (ABT 450) With or Without Ribavirin (RBV) in G1 Special Population in Hemodialysis (HD) in Chronic Hepatitis C (HCV) Patients. Drop C Trial: An Open Label Prospective Clinical Pilot Study Patrick Basu, Niraj J. Shah, Sakina Farhat, Nimy John, L Kavali, Mark Aloysius Introduction: Chronic Hepatitis C (CHC) is global epidemic in USA with a prevalence of 2.8% with an incidence of 3.3% in end-stage renal disease (ESRD) in hemodialysis (HD) population. CHC in ERSD with HD has significant higher fibrotic state and accelerated cirrhosis with decompensation and higher rate of hepatocellular carcinoma (HCC). The mortality and hazard ratio of chronic hepatitis C in ESRD on HD with relative risk of death is 1.79% and post renal transplant graft failure is1. 56%. Prior DAA's with Interferon and Ribavirin achieved 63% SVR in 48 weeks. Aim: Primary Objective: To show the efficacy of the triple regimen (Paritaprevir, Ritonavir and Ombitasvir) by obtaining SVR12 Secondary Objectives: Safety, tolerability Methods: Thirty Six (36) patients (18 cirrhotics and 18 noncirrhotics) were recruited from 4 dialysis centers across Brooklyn; in patients undergoing hemodialysis with chronic hepatitis C; genotype 1. The patients were divided into two groups: group A (n=18) with cirrhosis and group B (n=18) with no cirrhosis. Group A: Ombitasvir (Abt 267) + Ritanavir + Dastasbuvir (Abt 333) + Prataspravir (Abt 450); with 200 mg daily of RBV Group B: Ombitasvir (Abt 267) + Ritanavir + Dastasbuvir (Abt 333) + Prataspravir (Abt 450); without RBV Patient characteristics: to follow in the poster/oral presentation Results: Table 1 Conclusion: This study demonstrates a high SVR with a very short course DAA's in HCV in patients on HD Both the groups achieved overall 94.4 % SVR 12 Both groups had one patient with virological failure (5.5 %) A total of 3/36 (8.3%) patients relapsed; 2/18 (11.1%) in group A versus 1/18 (5.5%) in group B Role of DAA's in ESRD patients on HD in CHILD A cirrhotics have encouraging SVR rates; though carries a risk of higher relapse rate despite daily modified doses of RBV Overall the drugs were well tolerated with minimal side events and without treatment failure Triple therapy with RBV is a viable option and larger clinical trials will validate the efficacy and short treatment paradigm. Results: table 1
Su1444 Effectiveness of Hepatitis C Treatment With Direct Acting Antiviral Agents in a Safety-Net Hospital Rishabh Sachdev, Ashley N. Tran, Michael Leber, Toni Zahorian, Bhavesh Shah, David Nunes, Michelle T. Long Background: An estimated 3.2 million people are chronically infected with Hepatitis C (HCV) in the United States. In treating HCV and obtaining viral suppression, the ultimate goal is to reduce the risk of progression of chronic liver disease. Over the last several years, HCV treatment has shifted largely to interferon-free, oral direct acting antiviral (DAA) regimens. Such regimens have demonstrated 95% SVR rates in clinical trials. The real world efficacy of these agents is not known. The objective of this study was to assess the reproducibility of the clinical trial outcomes in actual clinical practice in a safety-net hospital
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