Epclusa (Sofosbuvir/Velpatasvir) for HIV/HCV
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1 Mountain West AIDS Education and Training Center Epclusa (Sofosbuvir/Velpatasvir) for HIV/HCV John Scott, MD, MSc Associate Professor University of Washington Jul 28, 2016 This presentation is intended for educational use only, and does not in any way constitute medical consultation or advice related to any specific patient.
2 Disclosures In the past year, I have served on the DSMB for Tacere Therapeutics. My institution has received research funding from Merck for a study on which I m the principal investigator.
3 Objectives Review the prescribing information for velpatasvir/sofosbuvir, including efficacy, side effects, and drug interactions
4 Epclusa Fixed-dose combination of sofosbuvir (NS5B inhibitor) and velpatasvir (NS5A inhibitor) Approved June 28, 2016 for chronic HCV genotypes 1, 2, 3, 4, 5, or 6 Treatment naïve Treatment experienced (Peg-IFN/RBV with or without PI) HIV+ not specifically called out Epclusa [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2016.
5 Dosage and Administration Patients Recommended Treatment Regimen Patients without cirrhosis and patients with compensated cirrhosis (Child- Pugh class A) Patients with decompensated cirrhosis (Child-Pugh class B or C) Epclusa x 12 weeks Epclusa + ribavirin x 12 weeks 1 table once per day with or without food No dosage recommendations in severe renal impairment and end stage renal disease (in general, don t use with CrCl <60 ml/min Epclusa [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2016
6 SVR12 (%) Feld, AASLD, 2015, LB-2. Feld JJ, et al. N Engl J Med DOI: /NEJMoa SVR12 by Cirrhosis Status or Treatment History ASTRAL-1: SOF/VEL STR for 12 Weeks in GT 1, 2, 4, 5, 6 HCV-Infected Patients / / / /423 Total Non-Cirrhotic Cirrhotic Treatment- Naïve Error bars represent 95% confidence intervals. 200/201 Treatment- Experienced
7 SVR12 (%) Mangia, AASLD, 2015, 249. Foster GR, et al. New Engl J Med DOI: /NEJMoa SVR12 ASTRAL-3: SOF/VEL STR for 12 Weeks Compared to SOF+RBV for 24 Weeks in GT 3 HCV-Infected Patients P< relapse 2 other 38 relapse 1 BT 15 other / /275 0 SOF/VEL SOF + RBV BT=breakthrough
8 SVR12 per negative baseline predictor SVR% (n/n) Patients, n(%) GT1 n=328 GT2 n=238 GT3 n=277 GT4 n=116 GT5 n=35 GT6 n=41 Total n=1035 Cirrhosis Platelets Albumin FibroScan Yes 99 (72/73) 100 (29/29) 91 (73/80) 100 (27/27) 100 (5/5) 100 (6/6) 96 (212/220) No 98 (251/255) 99 (207/208) 97 (191/197) 100 (89/89) 97 (28/29) 100 (35/35) 99 (801/813) <100 x 10 3 /μl 95 (20/21) 100 (4/4) 88 (22/25) 100 (8/8) 100 (1/1) 100 (3/3) 94 (58/62) 100 x 10 3 /μl 99 (303/307) 99 (233/234) 96 (242/252) 100 (108/108) 97 (33/34) 100 (38/38) 98 (957/973) <3.5 mg/dl 100 (6/6) 100 (1/1) 88 (7/8) 100 (6/6) (20/21) 3.5 mg/dl 98 (317/322) 99 (236/237) 96 (257/269) 100 (110/110) 97 (34/35) 100 (41/41) 98 (995/1014) 15 kpa 100 (30/30) 100 (9/9) 90 (36/40) 100 (17/17) 100 (4/4) 100 (5/5) 96 (101/105) <15 kpa 98 (154/158) 99 (118/119) 97 (152/156) 100 (74/74) 95 (19/20) 100 (22/22) 98 (539/549) Treatment experienced NS5A RAVs (15% cut off) Experienced 99 (109/110) 100 (44/44) 90 (64/71) 100 (52/52) 100 (11/11) 100 (3/3) 97 (283/291) Naïve 98 (214/218) 99 (193/194) 97 (200/206) 100 (64/64) 96 (23/24) 100 (38/38) 98 (732/744) With RAVs 96 (48/50) 100 (146/146) 87 (27/31) 100 (69/69) 100 (3/3) 100 (19/19) 98 (312/318) Without RAVs 99 (275/278) 99 (89/90) 96 (236/245) 100 (46/46) 97 (31/32) 100 (21/21) 98 (698/712) Agarwal, EASL Poster #SAT-195
9 Integrated Efficacy: SVR12 by Number of Negative Predictive Factors Patients, n/n (%) GT1 n=328 GT2 n=238 GT3 n=277 GT4 n=116 GT5 n=35 GT6 n=41 Total N=1035 Overall 323/32 8 (98) 237/23 8 (99) 264/27 7 (95) 116/ /35 (97) 41/ /103 5 (98) 0 factor 33/33 13/13 53/53 11/11 3/4 (75) 5/5 118/119 (99) 1 factor 148/15 1 (98) 80/81 (99) 108/11 1 (97) 31/31 21/21 17/17 405/412 (98) 2 factors 96/97 (99) 111/111 74/78 (95) 40/40 6/6 15/15 342/347 (99) 3 factors 44/45 (98) 30/30 29/34 (85) 25/25 4/4 4/4 136/142 (96) 4 factors 2/2 3/3 0/1 (0) 9/ /15 (93) Baseline factors analyzed included presence of NS5A RAVs, presence of cirrhosis, baseline HCV RNA 800 IU/mL, and prior HCV treatment. Agarwal, EASL 2016, Poster SAT-195
10 SVR12 (%) SOF+GS-5816±RBV for 12 Weeks in TE HCV GT3: Efficacy Results Treatment-Experienced GT 3 With Cirrhosis GS-5816, mg RBV 25 Pianko, AASLD, 2014, Oral # Error bars represent 95% confidence intervals
11 Sofosbuvir/velpatasvir in HCV/HIV Coinfected Patients: ASTRAL 5
12 SVR 12 Results by Genotype in ASTRAL 5 Wyles D, et al. EASL 2016; PS 104.
13 Wyles D, et al. EASL 2016; PS 104. SVR12 Results in ASTRAL 5
14 Adverse Effects and Laboratory Abnormalities Most common in clinical trials: Headache (22%) Fatigue (15%) Nausea (9%) Asthenia (5%) Insomnia (5%) Adverse effects occurred at similar frequency or more frequently with placebo Exception asthenia (3% in placebo vs. 5% with Epclusa) Irritability also observed in >5% of patients in ASTRAL-3 study (genotype 3 clinical trial) Laboratory abnormalities infrequent Asymptomatic lipase elevations Asymptomatic creatine kinase elevations Elevated indirect bilirubin among HIV/HCV coinfected patients on atazanvir/ritonavir Epclusa package insert
15 Drug Interactions: Acid Suppressive Therapy Concomitant Drug Class: Drug Name Effect on Concentration Recommendation Antacids Velpatasvir Avoid co-administration Separate antacid and Epclusa by 4 hours H2-Antagonists: (e.g. famotidine, ranitidine) Proton Pump Inhibitors: (e.g. omeprazole) Velpatasvir Velpatasvir Velpatasvir requires acidic environment for absorption Give at same time or 12 hours apart Do not co-administer If medically necessary: take Epclusa with food 4 hours before omeprazole 20 mg (max dose; no data with other PPIs)
16 Drug Interactions Concomitant Drug Class: Drug Name Antiarrhythmic: Amiodarone Antiarrhythmic: Digoxin Anticancer: Topotecan Antimycobacterials: Rifabutin Rifampin Rifapentine Herbal Supplements: St. John s Wort Effect on Concentration Unknown Digoxin Topotecan Sofosbuvir Velpatasvir Sofosbuvir Velpatasvir Recommendation Avoid- may cause serious symptomatic bradycardia Monitor digoxin levels and adjust digoxin levels if indicated Avoid co-administration Avoid co-administration Avoid co-administration Epclusa package insert
17 Drug Interactions Concomitant Drug Class: Drug Name HIV Antiretrovirals: Efavirenz HIV Antiretrovirals: Tenovir DF containing regimens HIV Antiretrovirals: Tipranavir/ritonavir HMG-CoA Reductase Inhibitors: Rosuvastatin HMG-CoA Reductase Inhibitors: Atorvastatin Effect on Concentration Velpatasvir Tenofovir Sofosbuvir Velpatasvir Rosuvastatin Atorvastatin Recommendation Avoid co-administration Monitor for tenofovir associated adverse effects; renal monitoring Avoid co-administration Risk of myopathy- maximum dose 10 mg rosuvastatin; monitor Risk of myopathy; monitor
18 Key Points: Epclusa Epclusa (velpatasvir/sofosbuvir) approved for genotypes 1, 2, 3, 4, 5, and 6 - For non-cirrhotic and patients with CTP class A cirrhosis: Epclusa x 12 weeks - For patients with decompensated cirrhosis including CTP class B and C: Eplusa and ribavirin x 12 weeks Headache and fatigue most commonly reported AEs Laboratory monitoring minimal Drug interactions include acid suppressive therapy and major drug interaction concerns previously identified for sofosbuvir
19 Questions?
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