LEDIPASVIR/SOFOSBUVIR+/ RIBAVIRIN IN PATIENTS CO-INFECTED WITH HCVAND HIV: REAL-WORLD HETEROGENEOUS POPULATION FROM THE TRIO NETWORK
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1 LEDIPASVIR/SOFOSBUVIR+/ RIBAVIRIN IN PATIENTS CO-INFECTED WITH HCVAND HIV: REAL-WORLD HETEROGENEOUS POPULATION FROM THE TRIO NETWORK Douglas T. Dieterich, Bruce Bacon, Michael Curry, Steven L. Flamm, Lauren Guest, Kris Kowdley, Yoori Lee, Zobair Younossi, Naoky Tsai, and Nezam Afdhal Abstract SAT-34 Patient Disposition LDV-SOF±RBV (n=5) 8 Weeks (n=8) 2 Weeks (n=2) 24 Weeks (n=3) (n=) (n=) (n=) (n=) (n=) (n=) (n=) (n= (n=) (n=8) (n=) (n=) (n=) (n=29) (n=) % 97% Dieterich D, et al. 5st EASL; Barcelona, Spain; April 3-7, 26. Abst. SAT-34.
2 Baseline Demographics Group - no. (%) LDV-SOF +/- RBV n =5 8 Week Regimen - no. (%) 8 (5%) 2 Week Regimen - no. (%) 2 (75%) 24 Week Regimen - no. (%) 3 (2%) Academic Practice no. (%) 68 (45%) Age - mean (range) 56 (36-84) Male - no. (%) 5 (7%) Patient Ethnicity - no. (%) Non Black 9 (73%) Black 32 (2%) Unknown 9 (6%) Baseline Labs ALT - mean (s.d.) 67 (5), n=99 AST - mean (s.d.) 66 (55), n= Hb - mean (s.d.) 4 (3), n=99 Platelets < K/ml - no. (%) 5 (%) Platelets K/ml - no. (%) 83 (55%) Fibrosis - no. (%) - No Fibrosis 6 (4%) - Mild 7 (%) 2 - Moderate 9 (3%) 3 - Severe 28 (9%) 4 - Cirrhosis 53 (35%) No Cirrhosis - Score Unknown 27 (8%) Dieterich D, et al. 5st EASL; Barcelona, Spain; April 3-7, 26. Abst. SAT-34. Baseline Demographics cont. Group - no. (%) LDV-SOF +/- RBV n =5 Genotype - no. (%) a 2 (8%) b 28 (9%) Unknown 2 (%) Initial Viral Load - no. (%) <8K IU/ml 5 (34%) 8K<2MM IU/ml 35 (23%) 2MM<6MM IU/ml 33 (22%) 6MM+ IU/ml 32 (2%) Prior Treatment - no. (%) PEG + RBV 9 (26%) BOC + PEG + RBV (%) TVR + +PEG + RBV 6 (9%) SMV + SOF +/- RBV 2 (3%) SOF + RBV (%) Prior Regimen Unknown 43 (6%) Prior Response - no. (%) Discontinued 2 (3%) Null Responder 2 (7%) Responder (5%) Unknown 47 (65%) Dieterich D, et al. 5st EASL; Barcelona, Spain; April 3-7, 26. Abst. SAT-34.
3 SVR2 Rates by Duration- ITT % 97% 8/8 /2 29/3 8 Weeks 2 Weeks 24 Weeks Dieterich D, et al. 5st EASL; Barcelona, Spain; April 3-7, 26. Abst. SAT-34. SVR2 Rates by Cirrhosis & Prior Treatment Experience - PP % % TE TN % 24/24 28/28 47/48 48/48 Cirrhotic Non-Cirrhotic Dieterich D, et al. 5st EASL; Barcelona, Spain; April 3-7, 26. Abst. SAT-34.
4 SVR2 Rates by PPI Use - PP % 99% 23/23 PPI 8/9 No PPI Dieterich D, et al. 5st EASL; Barcelona, Spain; April 3-7, 26. Abst. SAT-34. SVR2 Rates by Ethnicity - PP 97% % 3/3 African American 8/8 Non African American Dieterich D, et al. 5st EASL; Barcelona, Spain; April 3-7, 26. Abst. SAT-34.
5 LEDIPASVIR/SOFOSBUVIR ± RIBAVIRIN IN HCV POST-TRANSPLANT PATIENTS: REAL-WORLD HETEROGENEOUS POPULATION FROM THE TRIO NETWORK Steven L. Flamm, Bruce Bacon, Michael Curry, Douglas T. Dieterich, Lauren Guest, Kris Kowdley, Yoori Lee, Naoky Tsai, Zobair Younossi, and, Nezam Afdhal Abstract SAT-269 Patient Disposition LDV-SOF+/-RBV (n=67) 8 Weeks (n=2) 2 Weeks (n=54) 24 Weeks (n=) (n=) (n=) (n=) (n=) (n=) (n=) (n=) (n=) (n=) (n=2) (n=) (n=53) (n=) (n=9) (n=) % 82% Flamm S, et al. 5st EASL; Barcelona, Spain; April 3-7, 26. Abst. SAT-269.
6 Baseline Demographics Group - no. (%) LDV-SOF +/- RBV n= 67 8 Week Regimen - no. (%) 2 (3%) 2 Week Regimen - no. (%) 54 (8%) 24 Week Regimen - no. (%) (6%) Academic Practice no. (%) 53 (79%) Age - mean (range) 6 (36-78) Male - no. (%) 5 (76%) Patient Ethnicity - no. (%) Non Black 52 (78%) Black (5%) Unknown 5 (7%) Baseline Labs ALT - mean (s.d.) 67 (49), n=64 AST - mean (s.d.) 65 (49), n=64 Hb - mean (s.d.) 4 (2), n=67 Platelets < K/ml - no. (%) (5%) Platelets K/ml - no. (%) 54 (8%) Fibrosis - no. (%) - No Fibrosis 6 (9%) - Mild 6 (24%) 2 - Moderate 9 (28%) 3 - Severe 2 (3%) 4 - Cirrhosis 2 (3%) No Cirrhosis - Score Unknown 3 (5%) Flamm S, et al. 5st EASL; Barcelona, Spain; April 3-7, 26. Abst. SAT-269. Baseline Demographics (cont d) Group - no. (%) LDV-SOF +/- RBV n= 67 Genotype - no. (%) a 44 (66%) b 8 (28%) Unknown 4 (6%) Initial Viral Load - no. (%) <8K IU/ml 4 (2%) 8K<2MM IU/ml 4 (2%) 2MM<6MM IU/ml 2 (3%) 6MM+ IU/ml 9 (28%) Prior Treatment - no. (%) PEG + RBV 22 (59%) BOC + PEG + RBV 3 (8%) TVR + +PEG + RBV (3%) SMV + SOF +/- RBV (3%) SOF + RBV (3%) Prior Regimen Unknown 9 (24%) Prior Response - no. (%) Discontinued 4 (38%) Null Responder (27%) Responder 3 (35%) Unknown 44 (66%) Flamm S, et al. 5st EASL; Barcelona, Spain; April 3-7, 26. Abst. SAT-269.
7 SVR2 Rates by Duration % 82% 2/2 53/54 9/ 8 Weeks 2 Weeks 24 Weeks Flamm S, et al. 5st EASL; Barcelona, Spain; April 3-7, 26. Abst. SAT-269. SVR2 Rates by Cirrhosis and Prior Treatment Experience - PP % % TE TN 96% % / 8/8 23/24 22/22 Cirrhotic Non-Cirrhotic Flamm S, et al. 5st EASL; Barcelona, Spain; April 3-7, 26. Abst. SAT-269.
8 SVR2 Rates by Ethnicity- PP % % / African American 5/5 Non African American Flamm S, et al. 5st EASL; Barcelona, Spain; April 3-7, 26. Abst. SAT-269. Predictors of Response All Treatment Regimens - PP n = 65 p=.533 p=.58 p=. p=.44 p=. p=.57 p=.678 p=.57 p=.35 p=.6 8% 85% 9% 95% % Age <65 Age 65+ Female Male Non African American African American Academic Site Community Site GTa GTb Baseline VL <6MM IU/ml Baseline VL 6MM+ IU/ml Platelets < k/ml Platelets k+ Cirrhotic Non Cirrhotic TE TN 8 Weeks 2 Weeks 24 Weeks Flamm S, et al. 5st EASL; Barcelona, Spain; April 3-7, 26. Abst. SAT-269. *Closed circles = proportions; whiskers = 95% confidence interval; dotted lines = overall SVR2; 2-side asympt. p-value via Pearson χ 2.
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