Sofosbuvir-Velpatasvir (Epclusa)
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1 HEPATITIS WEB STUDY HEPATITIS C ONLINE Sofosbuvir-Velpatasvir (Epclusa) Prepared by: H. Nina Kim, MD MSc and David Spach, MD Last Updated: July 8, 216
2 SOFOSBUVIR-VELPATASVIR (EPCLUSA) Background and Dosing
3 Sofosbuvir-Velpatasvir (Epclusa) Approval Status - Approval by United States FDA on June 28, 216 Indications and Usage Indicated for the treatment of chronic HCV genotypes 1-6 in adults: - without cirrhosis or with compensated cirrhosis (Child-Pugh A) - with decompensated cirrhosis (Child-Pugh B and C) combined with ribavirin Class and Mechanism - Sofosbuvir: HCV NS5B polymerase inhibitor - Velpatasvir: HCV NS5A inhibitor Preparation: Sofosbuvir-Velpatasvir (fixed dose 4 mg/1 mg) Dosing: One tablet orally once daily, with or without food Adverse Effects (AE): Headache and fatigue Source: Epclusa Prescribing Information, Gilead Sciences.
4 Sofosbuvir-Velpatasvir (Epclusa) Indications and Usage Sofosbuvir-Velpatasvir* for HCV Treatment in Patients with Genotype 1-6 Patient Population Treatment Duration Patients without cirrhosis and patients with compensated cirrhosis (Child-Pugh A) Sofosbuvir-Velpatasvir 12 weeks Patients with decompensated cirrhosis (Child-Pugh B and C) Sofosbuvir-Velpatasvir + Ribavirin^ 12 weeks A dosage recommendation cannot be made for patients with severe renal impairment or end stage renal disease. ^The recommended dosage of ribavirin is based on weight (administered with food): 1 mg per day for patients less than 75 kg and 12 mg for those weighing at least 75 kg, divided and administered twice daily. The starting dosage and on-treatment dosage of ribavirin can be decreased based on hemoglobin and creatinine clearance. For ribavirin dosage modifications, refer to the ribavirin prescribing information. Source: Epclusa Prescribing Information, Gilead Sciences.
5 Sofosbuvir-Velpatasvir (Epclusa) Estimated Cost of Therapy Estimated Cost of Sofosbuvir-Velpatasvir Based on Treatment Duration Duration of Treatment Estimated Cost* 12 Weeks $74,76 *Estimated cost based on Wholesaler Acquisition Cost in United States of $89 per pill Source: Gilead Sciences
6 Phase 3 Treatment Naïve & Experienced Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6 ASTRAL-1 Feld JJ, et al. N Engl J Med. 215;373:
7 Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6 ASTRAL-1: Study Features ASTRAL-1 Trial Design: Randomized, placebo-controlled, phase 3 trial using a fixed-dose combination of sofosbuvir-velpatasvir for 12 weeks in treatment-naïve and treatment-experienced patients with GT 1, 2, 4, 5, or 6 chronic HCV Setting: 81 sites in United States, Europe, & Hong Kong Entry Criteria - Chronic HCV GT 1, 2, 4, 5, 6 - HCV RNA 1, IU/mL at screening - Prior treatment failure with interferon allowed (but no prior NS5A or NS5B) - Patients with compensated cirrhosis allowed Primary End-Point: SVR12 Source: Feld JJ, et al. N Engl J Med. 215;373:
8 Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6 ASTRAL-1: Study Design Week Treatment-naïve or experienced GT 1, 2, 4, 5* or 6 (N=74) N=624 N=116 Sofosbuvir-Velpatasvir Placebo SVR12 SVR12 Randomized 5:1 ratio for treatment to placebo. Stratified by cirrhosis and HCV genotype. *Genotype 5 patients (n=6) were assigned to active arm (and not randomized) Placebo recipients were eligible for deferred treatment with sofosbuvir-velpatasvir Drug Dosing Sofosbuvir-Velpatasvir (4/1 mg): fixed dose combination; one pill once daily Source: Feld JJ, et al. N Engl J Med. 215;373:
9 Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6 ASTRAL-1: Baseline Characteristics Baseline Characteristic Sofosbuvir-Velpatasvir (N=624) Placebo (N=113) Age, mean (range) 54 (18-82) 53 (25-74) Male, n (%) 374 (6) 68 (59) Race, n (%) White Black Asian HCV genotype, % 1a 1b (79) 52 (8) 62 (1) 21 (34) 118 (19) 14 (17) 116 (19) 35 (6) 41 (7) 9 (78) 11 (9) 11 (9) 46 (4) 19 (16) 21 (18) 22 (19) 8 (7) Body mass index, mean (range) 27 (17-57) 26 (18-4) HCV RNA 8, IU/mL, n (%) 461 (74) 87 (75) IL28B non-cc, n (%) 433 (69) 79 (68) Source: Feld JJ, et al. N Engl J Med. 215;373:
10 Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6 ASTRAL-1: Baseline Characteristics Baseline Characteristic Sofosbuvir-Velpatasvir (N=624) Placebo (N=113) Cirrhosis, n (%) 121 (19) 21 (18) Treatment experienced, n (%) 21 (32) 33 (28) Prior therapy, n (%) Peginterferon + Ribavirin Peginterferon + Ribavirin + Protease Inhibitor Standard Interferon +/- Ribavirin 122 (61) 56 (28) 23 (11) 24 (73) 6 (18) 3 (9) Source: Feld JJ, et al. N Engl J Med. 215;373:
11 Patients with SVR12 (%) Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6 ASTRAL-1: Results ASTRAL-1: SVR12 Results by Genotype /624 26/21 117/118 14/14 116/116 34/35 41/41 All 1a 1b Genotype Source: Feld JJ, et al. N Engl J Med. 215;373:
12 Patients with SVR12 (%) Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6 ASTRAL-1: Results ASTRAL-1: SVR12 Results by Genotype Relapse 2 Lost to follow-up 1 Withdrew consent 2 1 Relapse 1 Death 618/624 26/21 117/118 14/14 116/116 34/35 41/41 All 1a 1b Genotype Source: Feld JJ, et al. N Engl J Med. 215;373:
13 Patients with SVR12 (%) Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6 ASTRAL-1: Results ASTRAL-1: SVR12 Results by Cirrhosis & Treatment Experience / /51 12/ /423 2/21 All Non-Cirrhotic Cirrhotic Treatment Naïve Treatment Experienced Source: Feld JJ, et al. N Engl J Med. 215;373:
14 SVR12 (%) Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6 ASTRAL-1: Resistance Baseline NS5A Resistance-Associated Variants and SVR12 Total, n= % SVR12 99% SVR % No NS5A RAVs N=359 42% NS5A RAVs N= / /257 83/86 58/65 24/25 14/14 Source: Feld JJ, et al. N Engl J Med. 215;373:
15 Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6 ASTRAL-1: Adverse Events Adverse Event (AE), n (%) SOF-VEL (n=624) Placebo (n=116) Discontinuation due to AE 1 (<1) 2 (2) Serious AEs 15 (2) Deaths 1 (<1) Any AE in 1% of patients Headache Fatigue Nasopharyngitis Nausea Laboratory AEs Hemoglobin <1 g/dl Lymphocyte count 35 to <5/mm 3 Neutrophil count 5 to <75/mm 3 Platelet count 25K to <5K/mm 3 Death was not considered to be study-related. 182 (29) 126 (2) 79 (13) 75 (12) 2 (<1) 3 (<1) 4 (1) 1 (<1) 33 (28) 23 (2) 12 (1) 13 (11) Source: Feld JJ, et al. N Engl J Med. 215;373:
16 Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6 ASTRAL-1: Conclusion Conclusions: Once-daily sofosbuvir velpatasvir for 12 weeks provided high rates of sustained virologic response among both previously treated and untreated patients infected with HCV genotype 1, 2, 4, 5, or 6, including those with compensated cirrhosis. Source: Feld JJ, et al. N Engl J Med. 215;373:
17 Phase 3 Treatment Naïve & Experienced Sofosbuvir-Velpatasvir in Genotype 2 ASTRAL-2* *Published in tandem with ASTRAL-3 Trial Foster GR, et al. N Engl J Med. 215;373:
18 Sofosbuvir-Velpatasvir in HCV Genotype 2 ASTRAL-2: Study Features ASTRAL-2 Trial Design: Randomized, placebo-controlled, phase 3 trial using a fixed-dose combination of sofosbuvir-velpatasvir for 12 weeks compared with sofosbuvir plus ribavirin in treatment-naïve and treatment-experienced patients with GT 2 chronic HCV Setting: 51 sites in United States Entry Criteria - Chronic HCV GT 2 - HCV RNA 1, IU/mL at screening - Prior treatment failure with interferon allowed (but no prior NS5A or NS5B) - Patients with compensated cirrhosis allowed Primary End-Point: SVR12 Source: Foster GR, et al. N Engl J Med. 215;373:
19 Sofosbuvir-Velpatasvir in HCV Genotype 2 ASTRAL-2: Study Design Week Treatment-naïve or experienced GT 2 (N=266) N=134 N=132 Sofosbuvir-Velpatasvir Sofosbuvir + Ribavirin SVR12 SVR12 *Randomization stratified by treatment experience and cirrhosis status. Abbreviations: SOF-VEL = sofosbuvir-velpatasvir; RBV = ribavirin Drug Dosing Sofosbuvir-velpatasvir (4/1 mg): fixed-dose combination; one pill once daily Sofosbuvir: 4 mg once daily Ribavirin (weight-based and divided bid): 1 mg/day if < 75 kg or 12 mg/day if 75 kg Source: Foster GR, et al. N Engl J Med. 215;373:
20 Sofosbuvir-Velpatasvir in HCV Genotype 2 ASTRAL-2: Baseline Characteristics Baseline Characteristic Sofosbuvir-Velpatasvir (N=134) Sofosbuvir + Ribavirin (N=132) Age, mean (range) 57 (26-81) 57 (23-76) Male, n (%) 86 (64) 72 (55) Race, n (%) White Black Asian 124 (93) 6 (4) 1 (1) 111 (84) 12 (9) 5 (4) Body mass index, mean (range) 28 (17-45) 29 (19-61) HCV RNA 8, IU/mL, n (%) 111 (83) 11 (77) IL28B non-cc, n (%) 79 (59) 86 (65) Cirrhosis, n (%) 19 (14) 19 (14) Treatment-experienced, n (%) 19 (14) 2 (15) Prior response, no./total (%) Non-response Relapse or breakthrough 3/19 (16) 16/19 (84) 3/2 (15) 17/2 (85) Source: Foster GR, et al. N Engl J Med. 215;373:
21 Patients with SVR12 (%) Sofosbuvir-Velpatasvir in HCV Genotype 2 ASTRAL-2: Results 1 8 ASTRAL-2: SVR12 Results / /132 Sofosbuvir-Velpatasvir Sofosbuvir + Ribavirin P=.18 for superiority of Sofosbuvir-Velpatasvir compared with Sofosbuvir + Ribavirin Source: Foster GR, et al. N Engl J Med. 215;373:
22 Patients (%) with SVR 12 Sofosbuvir-Velpatasvir in HCV Genotype 2 ASTRAL-2: Results ASTRAL-2: SVR12 Results by Cirrhosis & Treatment Experience 1 8 Sofosbuvir-Velpatasvir Sofosbuvir + Ribavirin /1 92/96 15/15 14/15 15/15 13/16 4/4 4/4 Non-Cirrhotic Cirrhotic Non-Cirrhotic Cirrhotic Treatment Naïve Treatment-Experienced Source: Foster GR, et al. N Engl J Med. 215;373:
23 Sofosbuvir-Velpatasvir in HCV Genotype 2 ASTRAL-2: Adverse Events Adverse Event (AE), n (%) Sofosbuvir-Velpatasvir (n=134) Sofosbuvir + Ribavirin (n=132) Discontinuation due to AE 1 (1) Serious AEs 2 (1) 2 (2) Deaths 2 (1) Any AE in 1% of patients Fatigue Headache Nausea Insomnia Laboratory AEs Hemoglobin <1 g/dl Total bilirubin >2.5 to 3 mg/dl Platelet count 25K to <5K/mm 3 2 (15) 24 (18) 14 (1) 6 (4) 47 (36) 29 (22) 19 (14) 18 (14) 6 (5) 3 (2) Deaths were not considered to be study-related. Source: Foster GR, et al. N Engl J Med. 215;373:
24 Sofosbuvir-Velpatasvir in HCV Genotype 2 ASTRAL-2: Conclusions Conclusions: Among patients with HCV genotype 2 [or 3] with or without previous treatment, including those with compensated cirrhosis, 12 weeks of treatment with sofosbuvir-velpatasvir resulted in rates of sustained virologic response that were superior to those with standard treatment with sofosbuvir-ribavirin. Source: Foster GR, et al. N Engl J Med. 215;373:
25 Phase 3 Treatment Naïve & Experienced Sofosbuvir-Velpatasvir in Genotype 3 ASTRAL-3 *Published in tandem with ASTRAL-2 Trial Foster GR, et al. N Engl J Med. 215;373:
26 Sofosbuvir-Velpatasvir in HCV Genotype 3 ASTRAL-3: Study Features ASTRAL-3 Trial Design: Randomized, placebo-controlled, phase 3 trial using a fixed-dose combination of sofosbuvir-velpatasvir for 12 weeks (compared with sofosbuvir + ribavirin) in treatment-naïve and treatment-experienced patients with GT 3 chronic HCV Setting: 76 sites in US, Canada, Europe, Australia, New Zealand Entry Criteria - Chronic HCV GT 3 - HCV RNA 1, IU/mL at screening - Prior treatment failure with interferon allowed (but no prior NS5A or NS5B) - Patients with compensated cirrhosis allowed Primary End-Point: SVR12 Source: Foster GR, et al. N Engl J Med. 215;373:
27 Sofosbuvir-Velpatasvir in HCV Genotype 3 ASTRAL-3: Study Design Week Treatment-naïve or experienced GT 3 (N=552) N=277 N=275 SOF-VEL SOF + RBV SVR12 SVR12 *Randomization stratified by treatment experience and cirrhosis status. Abbreviations: SOF-VEL = sofosbuvir-velpatasvir; RBV = ribavirin Drug Dosing Sofosbuvir-velpatasvir (4/1 mg): fixed-dose combination; one pill once daily Sofosbuvir: 4 mg once daily Ribavirin (weight-based and divided bid): 1 mg/day if < 75 kg or 12 mg/day if 75 kg Source: Foster GR, et al. N Engl J Med. 215;373:
28 Sofosbuvir-Velpatasvir in HCV Genotype 3 ASTRAL-3: Baseline Characteristics Baseline Characteristic Sofosbuvir-Velpatasvir (N=277) Sofosbuvir + Ribavirin (N=275) Age, mean (range) 49 (21-76) 5 (19-74) Male, n (%) 17 (61) 174 (63) Race, n (%) White Black Asian 25 (9) 3 (1) 23 (8) 239 (87) 1 (<1) 29 (11) Body mass index, mean (range) 26 (17-48) 27 (17-56) HCV RNA 8, IU/mL, n (%) 191 (69) 194 (71) IL28B non-cc, n (%) 172 (62) 164 (6) Cirrhosis, n (%) 8 (29) 83 (3) Treatment-experienced, n (%) 71 (26) 71 (26) Prior response, no./total (%) Non-response Relapse or breakthrough 2/71 (28) 51/71 (72) 24/71 (34) 47/71 (66) Source: Foster GR, et al. N Engl J Med. 215;373:
29 Patients with SVR12 (%) Sofosbuvir-Velpatasvir in HCV Genotype 3 ASTRAL-3: Results ASTRAL-3: SVR12 Results / / / /275 Sofosbuvir-Velpatasvir Sofosbuvir + Ribavirin P<.1 for superiority of Sofosbuvir-Velpatasvir compared with Sofosbuvir + Ribavirin Source: Foster GR, et al. N Engl J Med. 215;373:
30 Patients (%) with SVR 12 Sofosbuvir-Velpatasvir in HCV Genotype 3 ASTRAL-3: Results ASTRAL-3: SVR12 Results by Cirrhosis & Treatment Experience Sofosbuvir-Velpatasvir Sofosbuvir + Ribavirin / /156 4/43 33/45 31/34 22/31 33/37 22/38 Non-Cirrhotic Cirrhotic Non-Cirrhotic Cirrhotic Treatment Naïve Treatment-Experienced Source: Foster GR, et al. N Engl J Med. 215;373:
31 SVR12 (%) Sofosbuvir-Velpatasvir in HCV Genotype 3 ASTRAL-3: Resistance Baseline NS5A Resistance-Associated Variants and SVR12 Total, n= % SVR12 84% No BL NS5A RAVs N=231 16% BL NS5A RAVs N=43 88% SVR /231 38/43 SVR12 was 84% (21/25) in patients with Y93H Source: Foster GR, et al. N Engl J Med. 215;373:
32 Sofosbuvir-Velpatasvir in HCV Genotype 3 ASTRAL-3: Adverse Events Adverse Event (AE), n (%) Sofosbuvir-Velpatasvir (n=277) Sofosbuvir + Ribavirin (n=275) Discontinuation due to AE 9 (3) Serious AEs 6 (2) 15 (5) Deaths 3 (1) Any AE in 1% of patients Fatigue Headache Nausea Insomnia Laboratory AEs Hemoglobin <1 g/dl Total bilirubin >2.5 to 3 mg/dl Platelet count 25K to <5K/mm 3 71 (26) 9 (32) 46 (17) 31 (11) 1 (<1) 15 (38) 89 (32) 58 (21) 74 (27) 1 (4) 2 (1) 1 (<1) Source: Foster GR, et al. N Engl J Med. 215;373:
33 Sofosbuvir-Velpatasvir in HCV Genotype 3 ASTRAL-3: Conclusions Conclusions: Among patients with HCV genotype [2 or] 3 with or without previous treatment, including those with compensated cirrhosis, 12 weeks of treatment with sofosbuvir-velpatasvir resulted in rates of sustained virologic response that were superior to those with standard treatment with sofosbuvir-ribavirin. Source: Foster GR, et al. N Engl J Med. 215;373:
34 Phase 3 Treatment Naïve & Experienced Sofosbuvir-Velpatasvir in Decompensated HCV Cirrhosis ASTRAL-4 Curry MP, et al. N Engl J Med. 215;373:
35 Sofosbuvir-Velpatasvir in Decompensated HCV Cirrhosis ASTRAL-4: Study Features ASTRAL-4 Trial Design: Randomized, phase 3 trial to examine the safety and efficacy of a fixed-dose combination of sofosbuvir-velpatasvir for 12 weeks +/- ribavirin or for 24 weeks in patients with GT 1-6 chronic HCV with decompensated cirrhosis Setting: 47 sites in United States Entry Criteria - Chronic HCV GT 1, 2, 3, 4, 6 - Child-Pugh-Turcotte class B - Prior treatment failure (except for prior NS5A or NS5B) allowed Exclusion Criteria - Prior or impending (within 12 weeks of study entry) liver transplantation - Platelet count <3, or CrCl <5 ml/min Primary End-Point: SVR12 Source: Curry MP, et al. N Engl J Med. 215;373:
36 Sofosbuvir-Velpatasvir in Decompensated HCV Cirrhosis ASTRAL-4: Study Design Week N=9 SOF-VEL SVR12 Treatment-naïve & experienced GT 1, 2, 3, 4, 6 CTP Class B N=87 SOF-VEL + RBV SVR12 SOF-VEL N=9 SVR12 Abbreviations: SOF-VEL = sofosbuvir-velpatasvir; RBV = ribavirin Drug Dosing Sofosbuvir-velpatasvir (4/1 mg): fixed-dose combination; one pill once daily Sofosbuvir: 4 mg once daily Ribavirin (weight-based and divided bid): 1 mg/day if < 75 kg or 12 mg/day if 75 kg Source: Curry MP, et al. N Engl J Med. 215;373:
37 Sofosbuvir-Velpatasvir in Decompensated HCV Cirrhosis ASTRAL-4: Participants Baseline Characteristic SOF-VEL 12 weeks n=9 SOF-VEL + RBV 12 weeks n=87 SOF-VEL 24 weeks n=9 Mean age, years (range) 58 (42-73) 58 (4-71) 58 (46-72) Male sex, % Race, % White Black Asian HCV Genotype, % 1a 1b HCV RNA 8, IU/mL, % IL28B genotype, non-cc, % Mean egfr, ml/min (range) 89 (15-169) 9 (5-167) 9 (43-198) Source: Curry MP, et al. N Engl J Med. 215;373:
38 Sofosbuvir-Velpatasvir in Decompensated HCV Cirrhosis ASTRAL-4: Participants Baseline Characteristic SOF-VEL 12 weeks n=9 SOF-VEL + RBV 12 weeks n=87 SOF-VEL 24 weeks n=9 CPT score, % MELD score, % < Ascites, % None Mild or moderate Severe Prior HCV treatment, % No Yes Protease inhibitor regimen Peginterferon + Ribavirin Source: Curry MP, et al. N Engl J Med. 215;373:
39 SVR12 (%) Sofosbuvir-Velpatasvir in Decompensated HCV Cirrhosis ASTRAL-4: Results ASTRAL-4: SVR12 Results by Genotype SOF/VEL 12 wk SOF/VEL+RBV 12 wk SOF/VEL 24 wk /9 82/87 77/9 6/68 65/68 65/71 7/14 11/13 6/12 8/8 6/6 6/7 Overall GT 1 GT 3 GT 2, 4, and 6 Source: Curry MP, et al. N Engl J Med. 215;373:
40 Patients (%) Patients (%) Sofosbuvir-Velpatasvir in Decompensated HCV Cirrhosis ASTRAL-4: Change in MELD Scores on Treatment Baseline MELD <15 n=28 Change in MELD n= % Improved 27% Worsened <1 < % Improved 8% Worsened 27 Baseline MELD >15 n= n= 4 4 Source: Curry MP, et al. N Engl J Med. 215;373: Change in MELD
41 Sofosbuvir-Velpatasvir in Decompensated HCV Cirrhosis ASTRAL-4: Adverse Events Adverse Event (AE), % SOF-VEL 12 weeks (n=9) Source: Curry MP, et al. N Engl J Med. 215;373: SOF-VEL + RBV 12 weeks (n=87) SOF-VEL 24 weeks (n=9) Discontinuation due to AE Serious AEs Deaths Any AE in 1% of patients Fatigue Nausea Headache Anemia Diarrhea Insomnia Pruritus Muscle spasm Dyspnea Hemoglobin <1 g/dl
42 Sofosbuvir-Velpatasvir in Decompensated HCV Cirrhosis ASTRAL-4: Conclusions Conclusions: Treatment with sofosbuvir velpatasvir with or without ribavirin for 12 weeks and with sofosbuvir velpatasvir for 24 weeks resulted in high rates of sustained virologic response in patients with HCV infection and decompensated cirrhosis. Source: Curry MP, et al. N Engl J Med. 215;373:
43 Phase 3 Treatment Naïve & Experienced Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5 Wyles D, et al. EASL 216, Abstract PS14.
44 Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5: Study Features ASTRAL-5 Trial Design: Single-arm, open-label, multicenter phase 3 trial of sofosbuvirvelpatasvir in HIV-HCV coinfected patients with genotypes 1-6 HCV Setting: Multiple sites in US Entry Criteria - Chronic HCV GT HIV coinfection; CD4 count 1 cells/mm 3, HIV RNA 5 copies/ml - On stable ART for 8 weeks - Prior treatment failure allowed (but no prior NS5A or NS5B) - Patients with compensated cirrhosis allowed Primary End-Point: SVR12 Source: Wyles D, et al. EASL 216, Abstract PS14.
45 Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5: Study Design Week HIV-HCV Coinfected Treatment-naïve & experienced GT 1, 2, 3, 4, or 6 N=16 Sofosbuvir-Velpatasvir SVR12 Drug Dosing: Sofosbuvir-velpatasvir (4/1 mg): fixed-dose combination; one pill once daily Source: Wyles D, et al. EASL 216, Abstract PS14.
46 Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5: Participants Baseline Characteristic Sofosbuvir-Velpatasvir (N=16) Age, mean, years (range) 54 (25-72) Male, n (%) 91 (86) Black race, n (%) 48 (45) HCV genotype, n (%) 1a 1b (62) 12 (11) 11 (1) 12 (11) 5 (5) IL28B non-cc, n (%) 82 (77) Mean HCV RNA, log 1 IU/ml (range) 6.3 (5.-7.4) Cirrhosis, n (%) 19 (18) Treatment experienced, n (%) 31 (29) Source: Wyles D, et al. EASL 216, Abstract PS14.
47 Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5: Participants HIV Baseline Characteristics Sofosbuvir-Velpatasvir (N=16) Mean CD4 cell count, (range) 598 ( ) Nucleos(t)ide pair TDF with boosted agent (RTV or Cobi) TDF without boosted agent Abacavir/lamivudine Other antiretroviral agent(s) PI (DRV, LPV or ATV) NNRTI (RPV) Integrase inhibitor (RAL or EVG) Other (>1 of above classes) 56 (53) 35 (33) 15 (14) 5 (47) 13 (12) 36 (34) 7 (7) Abbreviations: TDF = Tenofovir disoproxil fumarate; RTV = ritonavir; Cobi = cobicistat; PI = HIV protease inhibitor; DRV = darunavir; LPV = lopinavir; ATV = atazanavir; PRV = rilpivirine; RAL = raltegravir; EVG = elvitegravir Source: Wyles D, et al. EASL 216, Abstract PS14.
48 Patients with SVR12 (%) Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5: Results ASTRAL-5: SVR12 Results by Genotype /14 62/65 11/12 11/11 11/12 4/4 Overall 1a 1b HCV Genotype Source: Wyles D, et al. EASL 216, Abstract PS14.
49 Patients with SVR12 (%) Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5: Results ASTRAL-5: SVR12 Results by Genotype Relapses 1 LTFU 1 LTFU 1 Withdrew Consent 2 99/14 62/65 11/12 11/11 11/12 4/4 21/ /144 42/44 27/28 Overall 1a 1b HCV Genotype LTFU=lost to follow-up Source: Wyles D, et al. EASL 216, Abstract PS14.
50 Patients with SVR12 (%) Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5: Results ASTRAL-5: SVR12 Results by Cirrhosis & Treatment Experience /14 71/75 28/29 8/85 19/19 21/ /144 42/44 27/28 All Naive Experienced No cirrhosis Cirrhosis Treatment Experience Cirrhosis Status Source: Wyles D, et al. EASL 216, Abstract PS14.
51 SVR12 (%) Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5: Resistance Baseline NS5A Resistance-Associated Variants and SVR12 Total, n= % SVR12 1% SVR % No NS5A RAVs 89/11 12% NS5A RAVs 12/ /89 12/12 83/86 58/65 24/25 14/14 Source: Wyles D, et al. EASL 216, Abstract PS14. 5
52 Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5: Adverse Events Adverse Event (AE), n (%) Sofosbuvir-Velpatasvir (N=16) Discontinuation due to AE 2 (2) Serious AEs 2 (2) Deaths Any AE in >5% of patients Fatigue Headache Arthralgia Upper respiratory tract infection Diarrhea Insomnia Nausea 26 (25) 14 (13) 9 (8) 9 (8) 9 (8) 7 (7) 7 (7) The majority of AEs were mild in severity (grade 1 or 2). No patient with confirmed on-treatment HIV virologic breakthrough. Source: Wyles D, et al. EASL 216, Abstract PS14.
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