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Direct-acting antivirals for hepatitis C in patient in opioid substitution treatment and heroin assisted treatment: real-life data
POSTER PRESENTATIONS levels of anti-HBs and decrease less than <12 mIU/mL after treatment is significant risks of the reactivation. SAT-244 Utilization of DAA therapies ledipasvir/sofosbuvir and sofosbuvir/ velpatasvir in patients with genotype 1 HCV: real-world experience from the TRIO Network N. Tsai1, B. Bacon2, M. Curry3, D. Dieterich4, S. Flamm5, K. Kowdley6, S. Milligan7, Z. Younossi8, N. Afdhal3. 1Queens Medical Center, University of Hawaii, Honolulu; 2Saint Louis University School of Medicine, St. Louis; 3Beth Israel Deaconess Medical Center, Boston; 4 Icahn School of Medicine at Mount Sinai, New York; 5Northwestern University Feinberg School of Medicine, Chicago; 6Liver Care Network, Swedish Medical Center, Seattle; 7Trio Health Analytics, LaJolla; 8 Department of Medicine, Center for Liver Diseases, Inova Fairfax, Falls Church, United States E-mail: [email protected] Background and Aims: Real-world studies have reported intent to treat SVRs of >95% with ledipasvir/sofosbuvir (LDV/SOF) in genotype (GT) 1 HCV though results vary in patient subgroups where duration of treatment may be shortened (8 v. 12 weeks) or ribavirin (RBV) added (Hepatology 2015 62: 1046A and 1108A). Real-world effectiveness for sofosbuvir/velpatasvir (SOF/VEL) has not been determined as it was only recently approved for a 12 week treatment of GT1-6. The purpose of this study is to understand the real-world utilization of LDV/SOF and SOF/VEL in patients with genotype 1 chronic HCV. Methods: Data were collected from providers and specialty pharmacies through Trio Health’s Innervation Platform, a cloud-based disease management program. Patients with genotype 1 HCV who initiated 8 or 12 week LDV/SOF ± RBV (n = 1255) or 12 week SOF/VEL (n = 84) between July and October 2016 were included in the analyses.
July to October 2016 Age - mean (range) Male - no. (%) Baseline ALT - mean (SD) Baseline AST - mean (SD) Baseline Hb - mean (SD) Baseline Plt <100K/ml no. (%) Diabetes – no. (%) HIV Co-Infection - no. (%) HBV Co-Infection - no. (%) Fibrosis 3/4 – no. (%) GT1a - no. (%) GT1b - no (%) GT1x - no. (%) Baseline Viral >6MM IU/ml - no. (%) Treatment Naive (TN) no. (%) TN, non-cirrhotic, VL <6MM IU/ml – no (%)
8 week LDV/SOF n = 132
12 week LDV/SOF n = 1084
12 week LDV/SOF + RBV n = 39
12 week SOF/VEL n = 84
56 (25–81) n = 111 65/130 (50%) 55 (52) n = 89 42 (28) n = 90 14.3 (1.7) n = 87 2/87 (2%)
58 (20–87) n = 1005 623/1082 (58%) 75 (83) n = 836 66 (70) n = 822 14 (1.8) n = 760 59/754 (8%)
62 (47–88) n = 35 23/39 (59%) 70 (48) n = 33 88 (72) n = 34 13.8 (1.8) n = 30 10/32 (31%)
59 (26–85) n = 80 55/84 (65%) 83 (82) n = 62 75 (62) n = 60 14.2 (1.8) n = 58 11/55 (20%)
10/93 (11%) 4/132 (3%) 0/132 (0%) 10/87 (11%) 102 (77%) 24 (18%) 6 (5%) 1/97 (1%)
165/891 (19%) 129/1083 (12%) 7/1083 (1%) 383/825 (46%) 801 (74%) 239 (22%) 44 (4%) 165/949 (17%)
4/33 (12%) 6/39 (15%) 0/39 (0%) 29/33 (88%) 31 (79%) 8 (21%) (0%) 4/35 (11%)
16/69 (23%) 13/84 (15%) 1/84 (1%) 33/59 (56%) 62 (74%) 19 (23%) 3 (4%) 9/69 (13%)
91/93 (98%)
767/916 (84%)
11/28 (39%)
43/67 (64%)
90/93 (97%)
419/888 (47%)
1/27 (4%)
18/64 (28%)
Results: Clinical demographics are provided in the table. Differences between the groups initiating 12 week SOF/VEL v. 12 week LDV/SOF were <100 K/mL platelets at baseline (20% v. 8%, x^2 = 9.6, p = 0.002) and treatment naïve (TN) (64% v. 84%, x^2 = 16.5, p < 0.001). Differences between 12 week SOF/VEL v. 12 week LDV/SOF + RBV were Fibrosis 3/4 (56% v. 88%, z = −3.1, p = 0.002) and TN (64% v. 39%, x^2 = 5.0, p = 0.026). Differences between 12 week SOF/VEL v. 8 week LDV/SOF were male gender (65% v. 50%, x^2 = 5.0, p < 0.026), <100 K/ mL platelets at baseline (20% v. 2%, z = 3.6, p < 0.001), Diabetes (23% v. 11%, x^2 = 4.5, p = 0.033), HIV co-infection (15% v. 3%, z = 3.2, p = 0.001), Fibrosis 3/4 (56% v. 11%, x^2 = 33.4, p < 0.001), Baseline Viral load (VL) >6 MM IU/mL (13% v. 1%, z = 3.2, p = 0.001) and TN (67% v. 98%, z = −5.7, p < 0.001). 17% (90/528) of TN patients with baseline VL <6 MM IU/mL and non-cirrhotic disease eligible for 8 week LDV/SOF initiated 8 week LDV/SOF. The remaining patients with S726
TN, non-cirrhotic, baseline VL <6 MM IU/mL initiated 12 week LDV/ SOF (79%, 419/528), 12 week LDV/SOF + RBV (<1%, 1/528), or 12 week SOF/VEL (3%, 18/528). All patients in this study are either in therapy or pending SVR. Complete SVR data will be available at the meeting. Conclusions: LDV/SOF remains the dominant US regimen for genotype 1. Patients receiving 12 week SOF/VEL are more similar to those receiving 12 week LDV/SOF and 12 week LDV/SOF + RBV than those on 8 week LDV/SOF. 8 week LDV/SOF is still highly underutilized. SAT-245 Direct-acting antivirals for hepatitis C in patient in opioid substitution treatment and heroin assisted treatment: real-life data N. Scherz1, N. Brunner1, P. Bruggmann1. 1ARUD Centres for Addiction Medicine, Zürich, Switzerland E-mail: [email protected] Background and Aims: Most of the studies investigating treatment of chronic hepatitis C infection (HCV) with direct-acting antivirals (DAA) exclude people who use illicit drugs. Treating this population is crucial as it is at elevated risk for transmission of the virus and for progression of liver disease. This study provides real life data about HCV treatment with DAAs in an integrated care setting of a lowthreshold opioid substitution treatment (OST) and heroin assisted treatment (HAT) institution in Arud Centers for Addiction Medicine in Zurich, Switzerland. Methods: All HCV positive patients in OST or HAT in the Arud Centers were assessed for DAA treatment. The treatment decision and timing was based on international guidelines and reimbursement restrictions by the Swiss health authorities. We reported patient characteristics and 12-week sustained virological response (SVR12) for every patient treated between 10/2014 and 11/2016. Results: 50 patients (9 female, 41 male) were treated with DAA. Of those, 10 (20%) are in intravenous HAT and 6 (12%) reported ongoing illicit intravenous drug use. The genotype (GT) distribution was: 34% with 1a, 8% with 1b, 8% with GT1 and unknown subtype, 2% with 2, 36% with 3 and 12% with 4. Most of the patients (40, 80%) were treatment naïve. 29 patients (58%) had liver cirrhosis. Ledipasvir and Sofosbuvir (SOF) in combination were used for 21 patients (42%), Daclastavir and SOF in combination for 17 patients (34%), Elbasvir and Grazoprevir for 5 patients (10%). A combination of Ombitasvir, Paritaprevir, Ritonavir and Dasabuvir was used for 4 patients (8%). SOF plus Ribavirin (RBV) was used for 2 patients (4%), Simeprevir and SOF for one patient (2%). Weightbased RBV was added to DAAs in 23 patients (46%). 14 patients have not yet reached 12 weeks after treatment completion. Of the remaining 36 patients, 35 (97%) had SVR12. The patient failing treatment had a relapse after been treated 24 weeks with SOF plus RBV for GT3. He has cirrhosis and no ongoing drug use during treatment. Conclusions: DAA provided in an all-under-one-roof setting to patients in OST or HAT, including patient with ongoing illicit drug use is feasible and shows similar SVR12 rates to a selected abstinent population. HCV care integrated within OST or HAT allows successful treatment provision to this highly affected population. SAT-246 Are DAAs reducing barriers for HIV co-infected and people who inject drugs? A population based cohort study N. Janjua1,2, N. Islam1,2, J. Wong1,2, E.M. Yoshida2, A. Ramji2, H. Samji1, Z.A. Butt2, M. Chong1, D. Cook1, M. Alvarez1, M. Tyndall1,2, M. Krajden1,2 and The BC Hepatitis Testers. Cohort (BC-HTC). 1BC Centre for Disease Control; 2University of British Columbia, Vancouver, Canada E-mail: [email protected] Background and Aims: We evaluated the shift in the characteristics of people who received interferon-based Hepatitis C (HCV)
Journal of Hepatology 2017 vol. 66 | S543–S750
July to October 2016 Age - mean (range) Male - no. (%) Baseline ALT - mean (SD) Baseline AST - mean (SD) Baseline Hb - mean (SD) Baseline Plt <100K/ml no. (%) Diabetes – no. (%) HIV Co-Infection - no. (%) HBV Co-Infection - no. (%) Fibrosis 3/4 – no. (%) GT1a - no. (%) GT1b - no (%) GT1x - no. (%) Baseline Viral >6MM IU/ml - no. (%) Treatment Naive (TN) no. (%) TN, non-cirrhotic, VL <6MM IU/ml – no (%)
8 week LDV/SOF n = 132
12 week LDV/SOF n = 1084
12 week LDV/SOF + RBV n = 39
12 week SOF/VEL n = 84
56 (25–81) n = 111 65/130 (50%) 55 (52) n = 89 42 (28) n = 90 14.3 (1.7) n = 87 2/87 (2%)
58 (20–87) n = 1005 623/1082 (58%) 75 (83) n = 836 66 (70) n = 822 14 (1.8) n = 760 59/754 (8%)
62 (47–88) n = 35 23/39 (59%) 70 (48) n = 33 88 (72) n = 34 13.8 (1.8) n = 30 10/32 (31%)
59 (26–85) n = 80 55/84 (65%) 83 (82) n = 62 75 (62) n = 60 14.2 (1.8) n = 58 11/55 (20%)
10/93 (11%) 4/132 (3%) 0/132 (0%) 10/87 (11%) 102 (77%) 24 (18%) 6 (5%) 1/97 (1%)
165/891 (19%) 129/1083 (12%) 7/1083 (1%) 383/825 (46%) 801 (74%) 239 (22%) 44 (4%) 165/949 (17%)
4/33 (12%) 6/39 (15%) 0/39 (0%) 29/33 (88%) 31 (79%) 8 (21%) (0%) 4/35 (11%)
16/69 (23%) 13/84 (15%) 1/84 (1%) 33/59 (56%) 62 (74%) 19 (23%) 3 (4%) 9/69 (13%)
91/93 (98%)
767/916 (84%)
11/28 (39%)
43/67 (64%)
90/93 (97%)
419/888 (47%)
1/27 (4%)
18/64 (28%)
Results: Clinical demographics are provided in the table. Differences between the groups initiating 12 week SOF/VEL v. 12 week LDV/SOF were <100 K/mL platelets at baseline (20% v. 8%, x^2 = 9.6, p = 0.002) and treatment naïve (TN) (64% v. 84%, x^2 = 16.5, p < 0.001). Differences between 12 week SOF/VEL v. 12 week LDV/SOF + RBV were Fibrosis 3/4 (56% v. 88%, z = −3.1, p = 0.002) and TN (64% v. 39%, x^2 = 5.0, p = 0.026). Differences between 12 week SOF/VEL v. 8 week LDV/SOF were male gender (65% v. 50%, x^2 = 5.0, p < 0.026), <100 K/ mL platelets at baseline (20% v. 2%, z = 3.6, p < 0.001), Diabetes (23% v. 11%, x^2 = 4.5, p = 0.033), HIV co-infection (15% v. 3%, z = 3.2, p = 0.001), Fibrosis 3/4 (56% v. 11%, x^2 = 33.4, p < 0.001), Baseline Viral load (VL) >6 MM IU/mL (13% v. 1%, z = 3.2, p = 0.001) and TN (67% v. 98%, z = −5.7, p < 0.001). 17% (90/528) of TN patients with baseline VL <6 MM IU/mL and non-cirrhotic disease eligible for 8 week LDV/SOF initiated 8 week LDV/SOF. The remaining patients with S726
TN, non-cirrhotic, baseline VL <6 MM IU/mL initiated 12 week LDV/ SOF (79%, 419/528), 12 week LDV/SOF + RBV (<1%, 1/528), or 12 week SOF/VEL (3%, 18/528). All patients in this study are either in therapy or pending SVR. Complete SVR data will be available at the meeting. Conclusions: LDV/SOF remains the dominant US regimen for genotype 1. Patients receiving 12 week SOF/VEL are more similar to those receiving 12 week LDV/SOF and 12 week LDV/SOF + RBV than those on 8 week LDV/SOF. 8 week LDV/SOF is still highly underutilized. SAT-245 Direct-acting antivirals for hepatitis C in patient in opioid substitution treatment and heroin assisted treatment: real-life data N. Scherz1, N. Brunner1, P. Bruggmann1. 1ARUD Centres for Addiction Medicine, Zürich, Switzerland E-mail: [email protected] Background and Aims: Most of the studies investigating treatment of chronic hepatitis C infection (HCV) with direct-acting antivirals (DAA) exclude people who use illicit drugs. Treating this population is crucial as it is at elevated risk for transmission of the virus and for progression of liver disease. This study provides real life data about HCV treatment with DAAs in an integrated care setting of a lowthreshold opioid substitution treatment (OST) and heroin assisted treatment (HAT) institution in Arud Centers for Addiction Medicine in Zurich, Switzerland. Methods: All HCV positive patients in OST or HAT in the Arud Centers were assessed for DAA treatment. The treatment decision and timing was based on international guidelines and reimbursement restrictions by the Swiss health authorities. We reported patient characteristics and 12-week sustained virological response (SVR12) for every patient treated between 10/2014 and 11/2016. Results: 50 patients (9 female, 41 male) were treated with DAA. Of those, 10 (20%) are in intravenous HAT and 6 (12%) reported ongoing illicit intravenous drug use. The genotype (GT) distribution was: 34% with 1a, 8% with 1b, 8% with GT1 and unknown subtype, 2% with 2, 36% with 3 and 12% with 4. Most of the patients (40, 80%) were treatment naïve. 29 patients (58%) had liver cirrhosis. Ledipasvir and Sofosbuvir (SOF) in combination were used for 21 patients (42%), Daclastavir and SOF in combination for 17 patients (34%), Elbasvir and Grazoprevir for 5 patients (10%). A combination of Ombitasvir, Paritaprevir, Ritonavir and Dasabuvir was used for 4 patients (8%). SOF plus Ribavirin (RBV) was used for 2 patients (4%), Simeprevir and SOF for one patient (2%). Weightbased RBV was added to DAAs in 23 patients (46%). 14 patients have not yet reached 12 weeks after treatment completion. Of the remaining 36 patients, 35 (97%) had SVR12. The patient failing treatment had a relapse after been treated 24 weeks with SOF plus RBV for GT3. He has cirrhosis and no ongoing drug use during treatment. Conclusions: DAA provided in an all-under-one-roof setting to patients in OST or HAT, including patient with ongoing illicit drug use is feasible and shows similar SVR12 rates to a selected abstinent population. HCV care integrated within OST or HAT allows successful treatment provision to this highly affected population. SAT-246 Are DAAs reducing barriers for HIV co-infected and people who inject drugs? A population based cohort study N. Janjua1,2, N. Islam1,2, J. Wong1,2, E.M. Yoshida2, A. Ramji2, H. Samji1, Z.A. Butt2, M. Chong1, D. Cook1, M. Alvarez1, M. Tyndall1,2, M. Krajden1,2 and The BC Hepatitis Testers. Cohort (BC-HTC). 1BC Centre for Disease Control; 2University of British Columbia, Vancouver, Canada E-mail: [email protected] Background and Aims: We evaluated the shift in the characteristics of people who received interferon-based Hepatitis C (HCV)
Journal of Hepatology 2017 vol. 66 | S543–S750