- Email: [email protected]
Sofosbuvir 8 Weeks Chronic Hepatitis C Treatment
POSTER PRESENTATIONS SAT-243 REAL-WORLD EFFECTIVENESS OF LEDIPASVIR/SOFOSBUVIR 8 WEEKS CHRONIC HEPATITIS C TREATMENT P. Buggisch1, K. Wursthorn1, A. Stoehr1, A. Gauthier2, P.K. Atanasov2, J. Petersen1. 1IFI Institut für Interdisziplinäre Medizin, Asklepios Klinik St. Georg, Hamburg, Germany; 2Amaris, London, United Kingdom E-mail: [email protected] Background and Aims: Ledipasvir/Sofosbuvir (LDV/SOF) single tablet regimen (STR) is approved in Europe for the treatment of chronic hepatitis C (CHC) patients with genotypes (GT) 1, 3 and 4. The ION-3 study showed 8 weeks (8w) of LDV/SOF treatment was noninferior to 12 weeks in previously untreated GT1 patients without cirrhosis with no benefit for the addition of ribavirin. According to the SmPC 8w may be considered in this population. The aim of the present analysis is to characterise the population receiving 8w LDV/SOF and to describe outcomes in clinical practice in Germany. Methods: The first CHC patients treated with 8w LDV/SOF in a single centre (with SVR after 12 weeks of follow-up (SVR12) available in April 2016) were included in the analysis. Baseline characteristics, prior treatment history, safety and effectiveness were investigated using descriptive statistics. Results: 110 patients met the inclusion criteria for this analysis. Patients initiated 8w LDV/SOF treatment between 21/11/2014 and 01/06/2015. No patient had ribavirin added to the STR. The mean (SD) age was 49.8 (11.7) years; 42.7% were males. The genotype distribution was 49%, 49% and 2% for 1a, 1b and 4. No patient had cirrhosis. The METAVIR stage distribution of non-cirrhotic patients at baseline was 53.6%, 24.6%, 17.3% and 4.5% for F0, F1, F2 and F3. Median (range) HCV RNA at baseline was 0.89 (Q1–Q3 0.20–2.24; Min–Max 0.00–18.62) million IU/mL, 4 patients had HCV RNA ≥ 6 million IU/mL (7.1, 11.5, 13.8 and 18.6 million IU/mL; METAVIR stages F2, F0, F0 and F0). 3.6% (0%) of patients were HIV (HBV) coinfected. 97% of the patients were treatment-naïve. One patient had relapsed after IFN/RBV therapy and two patients had null response to IFN monotherapy. 93% of patients reported comorbidities; depression (16%) and arterial hypertension (10%) were common. To date, no discontinuations have been observed; 1.9% of patients experienced grade 3 or 4 adverse events, one was possibly related to LDV/SOF. 103 (94%) of patients had SVR12 available and all were undetectable. 100% (103/103) of patients achieved SVR12. Full SVR12 information will be available at the conference. Conclusions: 8w LDV/SOF is predominantly prescribed according to the SPC for treatment-naïve non-cirrhotic CHC patients with HCV RNA <6 million IU/mL at baseline. The preliminary results of this real world study indicate that in line with clinical trials, an 8w regimen of LDV/SOF, is a highly effective and well tolerated if used in patients according to the EMA label. SAT-244 INCARCERATION OF PEOPLE WHO INJECT DRUGS – MODELLING ITS ROLE IN HCV TRANSMISSION AND THE IMPACT OF SCALED-UP HCV TREATMENT IN PRISONS J. Stone1, N.K. Martin1,2, M. Hickman1, S. Hutchinson3,4, E. Aspinall3,4, A. Taylor5, A. Munro5, K. Dunleavy5, E. Peters6, P. Bramley7, P. Hayes8, D. Goldberg3,4, P. Vickerman1. 1School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom; 2Division of Global Public Health, University of California San Diego, San Diego, United States; 3School of Health and Life Sciences, Glasgow Caledonian University; 4Health Protection Scotland, Glasgow; 5School of Social Sciences, University of the West of Scotland, Paisley; 6Gartnavel General Hospital, Glasgow; 7NHS Forth Valley, Stirling; 8Division of Health Sciences, University of Edinburgh, Edinburgh, United Kingdom E-mail: [email protected] Background and Aims: People who inject drugs (PWID) experience high rates of incarceration, and history of incarceration is
associated with elevated HCV transmission risk. We assess the impact of incarceration on HCV transmission amongst PWID in Scotland and project the impact of scaling-up interferon-free direct-acting antiviral treatments (IFN-free DAAs) amongst incarcerated PWID. Methods: We developed a dynamic model of incarceration and HCV transmission amongst PWID in Scotland. Based on national data, the model assumed a lower HCV incidence of exposure amongst incarcerated PWID (4.3 per 100 person years ( py) amongst incarcerated PWID in 2010) than community PWID (16.8 and 6.9 per 100py in 2008 for recent (<5 years injecting)/non-recent (>5 years) community PWID respectively) and a 2.5-fold elevated transmission risk amongst recently released PWID. The model projected the contribution of incarceration to the Scottish HCV epidemic, and the impact of current prison opiate substitution therapy (OST; 57% coverage amongst PWID), removing the elevated acquisition risk amongst recently released PWID, and/or scaling-up HCV IFN-free DAAs (90% SVR; 12 wks) in prison (current treatment rate: 17 incarcerated PWID a year; an average 11 per 1,000 incarcerated PWID per year). Treatment was restricted to PWID with sentences >16 wks (42% of incarcerated PWID). Results: The current chronic HCV incidence in Scotland (10.9 per 100 py) is 30% relatively higher than if incarceration did not affect HCV transmission. Without prison OST, HCV chronic incidence would have been greater by 10%, whilst removing the elevated risk amongst recently released PWID could reduce incidence by 39%. Continuing HCV treatment levels amongst incarcerated PWID could reduce the overall chronic prevalence amongst PWID by 10% over 2015–2030, whilst tripling these rates could reduce prevalence by 16%. Annually treating 90% of chronic PWID prison entrants with sufficient sentence lengths reduces prevalence by 49% by 2030. Conclusions: This is the first study to model the role of incarceration on overall HCV transmission, and suggests that linking released PWID to services should be prioritized, whilst scaling-up OST and HCV treatment in prison could also provide important prevention benefits. SAT-245 LONG-TERM IMPACT OF RESPONSE TO INTERFERON-BASED THERAPY IN PATIENTS WITH CHRONIC HEPATITIS C VIRUS IN RELATION TO LIVER FUNCTION, SURVIVAL AND CAUSE OF DEATH P. Johnson1,2, E. de Groot3, S. Berhane1, T. Tada4, T. Kumada4, H. Toyoda4. 1Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool; 2The Clatterbridge Cancer Centre NHS Foundation Trust, Wirral; 3University of St Andrews, Fife, United Kingdom; 4Department of Gastroenterology and Hepatology, Ogaki Municipal Hospital, Ogaki, Japan E-mail: [email protected] Background and Aims: Although it is widely acknowledged that achievement of Sustained Virologic Response (SVR) in patients with chronic HCV infection is beneficial to outcome, there is little information on that benefit in terms of liver function particularly in comparison to those patients who do not respond (NR) or relapse after initial response (REL). Here we assess liver function by the recently devised ALBI score (a statistical model developed for assessment of liver function in hepatocellular carcinoma (HCC) but also validated on patients with chronic liver disease without HCC).1 Methods: We had access to detailed serial data on a cohort of 1,118 patients followed-up for up to 26 years (median follow-up of 8.9 years, 95% CI 8.5–9.2) and who were classified as achieving SVR (59%), relapse (24%) or no response (17%) having received interferon based therapy. In each of these categories we calculated the ALBI score at all available time points (20–60) per patient and, using a novel irregular time series statistical approach, we aggregated the changes over the 20 year period. As supporting data we also assessed overall survival in
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associated with elevated HCV transmission risk. We assess the impact of incarceration on HCV transmission amongst PWID in Scotland and project the impact of scaling-up interferon-free direct-acting antiviral treatments (IFN-free DAAs) amongst incarcerated PWID. Methods: We developed a dynamic model of incarceration and HCV transmission amongst PWID in Scotland. Based on national data, the model assumed a lower HCV incidence of exposure amongst incarcerated PWID (4.3 per 100 person years ( py) amongst incarcerated PWID in 2010) than community PWID (16.8 and 6.9 per 100py in 2008 for recent (<5 years injecting)/non-recent (>5 years) community PWID respectively) and a 2.5-fold elevated transmission risk amongst recently released PWID. The model projected the contribution of incarceration to the Scottish HCV epidemic, and the impact of current prison opiate substitution therapy (OST; 57% coverage amongst PWID), removing the elevated acquisition risk amongst recently released PWID, and/or scaling-up HCV IFN-free DAAs (90% SVR; 12 wks) in prison (current treatment rate: 17 incarcerated PWID a year; an average 11 per 1,000 incarcerated PWID per year). Treatment was restricted to PWID with sentences >16 wks (42% of incarcerated PWID). Results: The current chronic HCV incidence in Scotland (10.9 per 100 py) is 30% relatively higher than if incarceration did not affect HCV transmission. Without prison OST, HCV chronic incidence would have been greater by 10%, whilst removing the elevated risk amongst recently released PWID could reduce incidence by 39%. Continuing HCV treatment levels amongst incarcerated PWID could reduce the overall chronic prevalence amongst PWID by 10% over 2015–2030, whilst tripling these rates could reduce prevalence by 16%. Annually treating 90% of chronic PWID prison entrants with sufficient sentence lengths reduces prevalence by 49% by 2030. Conclusions: This is the first study to model the role of incarceration on overall HCV transmission, and suggests that linking released PWID to services should be prioritized, whilst scaling-up OST and HCV treatment in prison could also provide important prevention benefits. SAT-245 LONG-TERM IMPACT OF RESPONSE TO INTERFERON-BASED THERAPY IN PATIENTS WITH CHRONIC HEPATITIS C VIRUS IN RELATION TO LIVER FUNCTION, SURVIVAL AND CAUSE OF DEATH P. Johnson1,2, E. de Groot3, S. Berhane1, T. Tada4, T. Kumada4, H. Toyoda4. 1Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool; 2The Clatterbridge Cancer Centre NHS Foundation Trust, Wirral; 3University of St Andrews, Fife, United Kingdom; 4Department of Gastroenterology and Hepatology, Ogaki Municipal Hospital, Ogaki, Japan E-mail: [email protected] Background and Aims: Although it is widely acknowledged that achievement of Sustained Virologic Response (SVR) in patients with chronic HCV infection is beneficial to outcome, there is little information on that benefit in terms of liver function particularly in comparison to those patients who do not respond (NR) or relapse after initial response (REL). Here we assess liver function by the recently devised ALBI score (a statistical model developed for assessment of liver function in hepatocellular carcinoma (HCC) but also validated on patients with chronic liver disease without HCC).1 Methods: We had access to detailed serial data on a cohort of 1,118 patients followed-up for up to 26 years (median follow-up of 8.9 years, 95% CI 8.5–9.2) and who were classified as achieving SVR (59%), relapse (24%) or no response (17%) having received interferon based therapy. In each of these categories we calculated the ALBI score at all available time points (20–60) per patient and, using a novel irregular time series statistical approach, we aggregated the changes over the 20 year period. As supporting data we also assessed overall survival in
Journal of Hepatology 2016 vol. 64 | S631–S832
S811