Sustained Virologic Response Outcomes Research Articles

THU-212 - Sustained virologic response outcomes in patient with hemodialysis-hepatitis C receiving treatment with direct-acting antivirals agents

THU-212 - Sustained virologic response outcomes in patient with hemodialysis-hepatitis C receiving treatment with direct-acting antivirals agents

Direct-acting antiviral treatment uptake and sustained virological response outcomes are not affected by alcohol use: ACANUHCanalysis.

Alcohol use and hepatitis C virus (HCV) are two leading causes of liver disease. Alcohol use is prevalent among the HCV-infected population and accelerates the progression of HCV-related liver disease. Despite barriers to care faced by HCV-infected patients who use alcohol, few studies have analyzed uptake of direct-acting antiviral (DAA) treatment. We compared rates of treatment uptake and sustained virological response (SVR) between patients with and without alcohol use. Prospective data were obtained from the Canadian Network Undertaking against Hepatitis C (CANUHC) cohort. Consenting patients assessed for DAA treatment between January 2016 and December 2019 were included. Demographic and clinical characteristics were compared between patients with and without alcohol use by means of t-tests, χ2 tests, and Fisher's Exact Tests. Univariate and multivariate analyses were used to determine predictors of SVR and treatment initiation. Current alcohol use was reported for 217 of 725 (30%) patients. The proportion of patients initiating DAA treatment did not vary by alcohol use status (82% versus 83%; p= 0.99). SVR rate was similar between patients with alcohol use and patients without alcohol use (92% versus 94%; p= 0.45). Univariate and multivariate analysis found no association between alcohol use and SVR or treatment initiation. Patients engaged in HCV treatment have highly favourable treatment uptake and outcomes regardless of alcohol use. Public health interventions should be directed toward facilitating access to care for all patients irrespective of alcohol use. Research into high-level alcohol use and DAA outcomes is needed.

Treatment of HCV infection in liver transplant recipients with ledipasvir and sofosbuvir without ribavirin.

Ledipasvir and sofosbuvir is a well-tolerated regimen with high sustained virological response (SVR) rates in pre-liver transplant patients infected with chronic hepatitis C virus (HCV), but data in liver transplant recipients outside of clinical trials is limited. To address this knowledge gap and assess SVR rates without the use of ribavirin in liver transplant recipients METHODS: This is a retrospective study examining the treatment of 75 post-liver transplant recipients with ledipasvir and sofosbuvir without ribavirin. Differences between SVR cohorts and predictors of SVR were analysed in an intention-to-treat (ITT) fashion. A total of 408 genotype 1, HCV patients were treated with ledipasvir/sofosbuvir from October 2014 to August 2015 at our centre. Seventy-three patients were post-liver transplant and were treated with a median of 2.9years from transplant. Ledipasvir/sofosbuvir achieved an SVR12 of 95.9%. African Americans made up 28.8% of the cohort. Sixty-three per cent of patients were treated previously, including 13.7% of patients previously treated with direct-acting antivirals. Only 2.7% had recurrent allograft cirrhosis, and the majority (90.4%) was on calcineurin inhibitor based immunosuppressive therapy. Approximately 82% of patients had chronic kidney disease (CKD) stage 2 or 3. In univariate logistic regression, only detectable week 8 viral load was predictive of failure to achieve SVR. Our data confirm excellent SVR outcomes and favourable safety and tolerability profiles with ledipasvir/sofosbuvir without ribavirin in post-liver transplant recipients infected with HCV, despite treatment guidelines to use ribavirin.

Rapid virological response of telaprevir and boceprevir in a Brazilian cohort of HCV genotype 1 patients: a multicenter longitudinal study.

BackgroundChronic hepatitis C is a major public health issue, but there is a gap in the literature regarding the effectiveness and safety of direct-acting antiviral agents in the Brazilian population. The main aim of this study was to describe the effectiveness of boceprevir and telaprevir in patients treated at public health care institutions in Brazil.Materials and methodsA prospective longitudinal and multicenter study was conducted in five centers in the State of Paraná between September 2014 and June 2016. Data regarding effectiveness and safety were collected from medical records of patients treated with boceprevir or telaprevir. The effectiveness outcome comprised the rapid virological response (RVR). Multivariate analysis was performed to verify the influence of independent variables (ie, age, gender, baseline viral load) on RVR achievement.ResultsData were collected from 117 patients with chronic hepatitis C virus (HCV) genotype 1 infection. Fifteen patients received treatment with boceprevir and 102 received telaprevir. The mean age was 51.6 years, 64.1% were male, 44.4% were infected with HCV subtype 1a, 62.4% had a high baseline viral load (≥800,000 IU/mL) and 33% were cirrhotic. Furthermore, 79.5% of patients achieved RVR (26.7% in the boceprevir group and 87.3% in the telaprevir group). Multivariate analysis demonstrated that the type of protease inhibitor (boceprevir or telaprevir) and the baseline viral load had an influence on the RVR rate (odds ratio [OR] =0.011; 95% confidence interval [CI]: 0.001–0.119; P<0.001/OR =13.004; 95% CI: 1.522–111.115; P=0.019, respectively).ConclusionIn this longitudinal multicenter cohort study conducted from the Brazilian perspective, differences were found in the RVR rates, favoring telaprevir over boceprevir for genotype 1 HCV-infected patients. In addition, the baseline viral load was associated with RVR achievement in both evaluated groups. As RVR is also reported in the literature as a predictor of the sustained virological response (SVR), further analyses of RVR as predictor of SVR outcomes should be further evaluated in Brazil.

PTU-108 A UK single centre experience of management of hepatitis C virus genotype 4 infection with pegylated-interferon and ribavirin

<h3>Introduction</h3> New direct acting antiviral agents are revolutionising hepatitis C virus (HCV) treatment. However, to date published phase 3 clinical trial data in genotype 4 (GT4) HCV patients is limited. GT4 HCV is more common in Africa, the Middle East and Asia. In the UK, the mainstay of treatment has been pegylated interferon and ribavirin but limited data exists on outcomes in patients treated in Europe. We report the first “real-life’ sustained virological response (SVR) outcomes using pegylated interferon and ribavirin for HCV GT4 in the UK, and the largest European single centre cohort. <h3>Method</h3> HCV GT4 patients treated at a London, UK centre between 2002 and 2014 were assessed for SVR outcomes. Patient age, sex, region of origin, co-infection with HIV, pre-treatment liver biopsy histological assessment, genotype subtyping, treatment duration and dose reductions were compared against SVR outcomes on univariate analysis. Multivariate analysis was performed on results with P &lt; 0.1. <h3>Results</h3> During the study period 219 patients were diagnosed with HCV GT4. Of these 118 (54%) were treated with pegylated interferon and ribavirin and 57 achieved SVR (48%). The median age at the start of treatment was 48 years (range 6 to 66 years) and 72% were male. Six patients were intolerant, 25 were non responders, 3 developed breakthrough, 18 were relapsers, 3 are currently undergoing treatment and 6 lost to follow-up. Five out of 6 patients with acute HCV and HIV co-infection achieved SVR. Three HCV monoinfected patients were treated while on renal dialysis, with 2 achieving SVR. On univariate analysis age ≥ 45 (P &lt; 0.0001), high viral load (P &lt; 0.0001), Ishak staging 5–6 (P &lt; 0.0001) and non-Egyptian Africans (P = 0.0059) were all negatively associated with SVR. Eastern Europeans appeared to have higher rates of SVR (P &lt; 0.0001). Using multivariate correlation viral load (P = 0.0005); Ishak staging (P = 0.0031) and age (P = 0.0003) were associated with SVR but not country of origin (P = 0.0645). <h3>Conclusion</h3> Outcomes with pegylated interferon and ribavirin for HCV GT4 in this “real-life” setting were sub-optimal especially in the context of newer regimens. Patients with older age, high viral loads and advanced disease need prioritisation for alternative treatments. <h3>Disclosure of interest</h3> N. Selvapatt Conflict with: Gilead, BMS, M. Habibi: None Declared, A. Brown Speaker Bureau of: Abbvie, BMS, Gilead, Janssen, Merck.

A European single centre experience of management of hepatitis C virus genotype 4 infection with pegylated-interferon and ribavirin.

New direct acting antiviral agents are revolutionising hepatitis C virus (HCV) treatment. However, to date limited clinical trial data exists for outcomes in genotype 4 (GT4) HCV patients. GT4 HCV is more common in Africa, the Middle East, and Asia, and limited data exists to date for outcomes in Europe. We report the first "real-life" sustained virological response (SVR) outcomes using pegylated interferon and ribavirin for HCV GT4 in the UK, and the largest European single centre cohort. HCV GT4 patients treated at a London, UK centre between 2002 and 2014 were assessed for SVR outcomes. Patient age, sex, region of origin, co-infection with HIV, pre-treatment liver biopsy histological assessment, genotype subtyping, treatment duration, and dose reductions were compared against SVR outcomes on univariate analysis. Multivariate analysis was performed on results with P < 0.1. A total of 118 patients were treated with HCV GT4 during the study period, 57 achieved SVR (48%). On univariate analysis age ≥45 (P < 0.0001), high viral load (P < 0.0001), Ishak staging 5-6 (P < 0.0001), and non-Egyptian Africans (P = 0.0059) were all negatively associated with SVR. Eastern Europeans appeared to have higher SVR (P < 0.0001). Using multivariate correlation viral load (P = 0.0005); Ishak staging (P = 0.0031) and age (P = 0.0003) were associated with SVR but not country of origin (P = 0.0645). Outcomes with pegylated interferon and ribavirin for HCV GT4 in this "real-life" setting were sub-optimal especially in the context of newer regimens. Patients with older age, high viral loads, and advanced disease need prioritisation for alternative treatments.

Effects of Health Insurance Among Patients on Hepatitis C Treatment Along the Texas-Mexico Border

Introduction: The incidence of hepatitis C virus (HCV) infection is increasing along the U.S.-Mexico border and across the world. There are significant implications for patients who are non-funded and seeking treatment for hepatitis C that are faced by border communities. Having a disproportionate number of individuals without insurance and high rates of undocumented residents may influence treatment outcomes for HCV patients. The purpose of this project was to examine the effect of health insurance status and office visit compliance on sustained virologic response (SVR) in adult patients living along the Texas-Mexico border treated for HCV. Methods: We conducted a longitudinal retrospective chart review of patients who underwent treatment with dual and triple therapy in a border community in Texas. The sample included patients between the ages of 18 and 65, with a diagnosis of HCV, who underwent HCV treatment between January 01, 2010 and August 15, 2013, El Paso, Texas. Data were collected from the charts of patients who received HCV treatment with pegylated interferon, ribavirin, and a protease inhibitor. Results: A total of 76 charts were reviewed. Twenty patients met study criteria and were included in the data analysis. The other 56 (73%) patients did not complete treatment or did not return for SVR testing. Of the 20 patients who were included in the study, 19 (95%), were Hispanic, 12 (50%) were female, age included 11 (55%), age 20-29, 7 (35%), age 30-39, 2 (10%) age 40-49. Most patients were overweight with BMI 18-25 in 3 (15%), BMI 25-30 in 9 (45%), and BMI >30 in 8 (40%). Eleven patients were genotype 1, 4 were genotype 2, 5 were genotype 3. Of the 20 patients included in the study, 4 had insurance and 16 did not. Of the 16 patients who were non-funded, all 16 patients were on an indigent managed health care program. SVR was achieved in three-fourths (75%) of patients with insurance versus 12/16 (75%) without insurance (p=1.0). Gender, age, and HCV PCR baseline level did not show significant effects on SVR response using multiple logistic regression analysis. Conclusion: In conclusion, in this sample of HCV patients treated in a Texas-Mexico border community, insurance status did not affect SVR outcomes. Patients who did not have insurance, but were provided some type of assistance or managed care program, completed treatment and had high SVR rates. Disclosure - Roberta Romero DNP, RN, FNP-C has received honoraria from Genentech, Vertex, and Gilead Pharmaceuticals and is on the speaker’s bureau for Genentech and Gilead. Ogechika Alozie has received honoraria from Abbvie Pharmaceuticals and is on the speaker’s bureau for Abbvie and ViiV.