IFN-free for Genotype 1 HCV: the current landscape. Prof. Graham R Foster
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1 IFN-free for Genotype 1 HCV: the current landscape Prof. Graham R Foster
2 Wonderful new drugs are coming Poordad F, et al. New Engl J Med 2014; online DOI: /NEJMoa
3 The New Drugs Two treatment strategies are emerging Protease inhibitor based Nucleotide based (At present these are restricted to Genotype 1 but G3 trials with both combinations are under way) 3
4 TREATMENT-NAIVE PATIENTS
5 SAPPHIRE-I: GT1 treatment-naive patients ABT-450/r/ABT-267 (ombitasvir) + ABT-333 (dasabuvir) + RBV HCV GT1, treatment-naive, non-cirrhotic (N=631) n=473 n=158 ABT-450/r/ombitasvir + dasabuvir + RBV Placebo ABT-450/r/ombitasvir + dasabuvir + RBV Study weeks ABT-450/r/ombitasvir = 150/100/25 mg QD co-formulated; dasabuvir = 250 mg BID; RBV = mg weight-based BID. Feld JJ, et al. EASL Abstract 60 [oral presentation]. 5
6 SAPPHIRE-I: GT1 treatment-naive patients SVR12 rates by HCV GT1 subtype SVR12 (%) Treatment-naive n N Error bars: 95% CI. Feld JJ, et al. EASL Abstract 60 [oral presentation]. 6
7 SAPPHIRE-I: GT1 treatment-naive patients adverse events occurring in 10% subjects Event, n (%) 3D + RBV (N=473) Placebo (N=158) D P Value Any AE 414 (87.5) 116 (73.4) 14.1 <0.05 Fatigue 164 (34.7) 45 (28.5) 6.2 NS Headache 156 (33.0) 42 (26.6) 6.4 NS Nausea 112 (23.7) 21 (13.3) 10.4 <0.05 Pruritus 80 (16.9) 6 (3.8) 13.1 <0.05 Insomnia 66 (14.0) 12 (7.6) 6.4 <0.05 Diarrhea 65 (13.7) 11 (7.0) 6.7 <0.05 Asthenia 57 (12.1) 6 (3.8) 8.3 <0.05 Rash 51 (10.8) 9 (5.7) 5.1 NS AEs were generally mild Low (0.6%) rate of discontinuation due to AEs in each treatment group Serious AEs occurred in 2.1% of 3D + RBV recipients. Feld JJ, et al. EASL Abstract 60 [oral presentation]. 7
8 PEARL-III: GT1b treatment-naive patients ABT-450/r/ABT-267 (ombitasvir) + ABT-333 (dasabuvir) +/- RBV HCV GT1, treatment-naive, non-cirrhotic (N=419) n=210 n=209 ABT-450/r/ABT-267 (ombitasvir) + ABT-333 (dasabuvir) + RBV ABT-450/r/ABT-267 (ombitasvir) + ABT-333 (dasabuvir) + Placebo for RBV Study weeks ABT-450/r/ombitasvir = 150/100/25 mg QD co-formulated; dasabuvir = 250 mg BID; RBV = mg weight-based BID. Ferenci P, et al. EASL Abstract 1299 [Latebreaker poster]. 8
9 PEARL-III: SVR rates with 3D ± RBV in GT1b treatmentnaive patients SVR12 (% patients) n N Error bars: 95% CI. Ferenci P, et al. EASL Abstract 1299 [Latebreaker poster]. 9
10 Laboratory Abnormalities of Note 3-DAA + RBV (N = 210) Decreased hemoglobin levels were infrequent in the absence of RBV 3-DAA (N = 209) P value Hemoglobin below LLN a 106 (51.2) 7 (3.4) <0.001 Hemoglobin 10 g/dl 19 (9.0) 0 (0) <0.001 Total bilirubin >3 x ULN 12 (5.7) 1 (0.5) Alanine aminotransferase >5 x ULN 2 (1.0) 0 (0) Aspartate aminotransferase >5 x ULN 0 (0) 0 (0) a Sample sizes were 207 and 205 for 3-DAA + RBV and 3-DAA, respectively, excluding patients below LLN at baseline. LLN, lower limit of normal; ULN, upper limit of normal. No patient discontinued study drug due to laboratory abnormalities RBV dose was reduced because of decreased hemoglobin in 19/210 (9%) patients All of these patients achieved SVR 12 10
11 CHC GT1 patients (N=865) ION-1: SOF/LDV ± RBV in GT1 treatment-naive patients SOF/LDV (n=214) SOF/LDV + RBV (n=217) SOF/LDV (n=217) SOF/LDV + RBV (n=217) Weeks Including 136 (15.7%) of patients with cirrhosis SOF = 400 mg/day; LDV = 90 mg/day; RBV = 1000 or 1200 mg/day. Afdhal N, et al. New Engl J Med 2014; online DOI: /NEJMoa
12 SVR12 (%) ION-1: SOF/LDV ± RBV in GT1 treatment-naive patients SVR12 rates in the ITT population (N=875) n N Afdhal N, et al. New Engl J Med 2014; online DOI: /NEJMoa
13 ION-1: SOF/LDV ± RBV in GT1 treatment-naive patients safety data Patients, n (%) SOF/LDV 12 weeks (N=214) SOF/LDV + RBV 12 weeks (N=217) LDV/SOF 24 weeks (N=217) LDV/SOF + RBV 24 weeks (N=217) Treatment discontinuations (2) 6 (3) Serious AEs 1 (<1) 7 (3) 18 (8) 7 (3) Any AE 169 (79) 185 (85) 178 (82) 200 (92) AEs in >15% of patients Fatigue 44 (21) 79 (36) 53 (24) 82 (38) Headache 53 (25) 49 (23) 54 (25) 65 (30) Insomnia 17 (8) 45 (21) 26 (12) 47 (22) Nausea 24 (11) 37 (17) 29 (13) 32 (15) Hemoglobin level <10 g/dl 0 20 (9) 0 16 (7) Afdhal N, et al. New Engl J Med 2014; online DOI: /NEJMoa
14 ION-3: Phase III SOF/LDV ± RBV in GT1 treatment-naive patients CHC GT1 patients (N=647) SOF/LDV (n=215) SOF/LDV + RBV (n=216) SOF/LDV (n=216) Weeks SOF = 400 mg/day; LDV = 90 mg/day; RBV = 1000 or 1200 mg/day. Kowdley, KV, et al. New Engl J Med 2014; online DOI: /NEJMoa
15 ION-3: Phase III SOF/LDV ± RBV in GT1 treatment-naive patients SVR12 data SVR12 (%) Overall GT1a GT1b n N * One patient achieved SVR12, but was not sub-genotyped; Error bars: 95% CI. Kowdley, KV, et al. New Engl J Med 2014; online DOI: /NEJMoa
16 Summary For treatment naïve patients with Genotype 1 we have fabulous treatment options:- We can use Protease + regimes OR Sofosbuvir + regimes Both regimes are very well tolerated and require no more than 3 months of therapy 16
17 TREATMENT- EXPERIENCED PATIENTS
18 SAPPHIRE-II: 3D + RBV in GT1 treatment-experienced patients ABT-450/r/ABT-267 (ombitasvir) + ABT-333 (dasabuvir) + RBV HCV GT1, treatmentexperienced, non-cirrhotic (N=394) n=297 n=97 ABT-450/r/ombitasvir + dasabuvir + RBV Placebo ABT-450/r/ombitasvir + dasabuvir + RBV Study weeks ABT-450/r/ombitasvir = 150/100/25 mg QD co-formulated; dasabuvir = 250 mg BID; RBV = mg weight-based BID. Zeuzem S, et al. EASL Abstract 1 [oral presentation]. 18
19 SAPPHIRE-II: GT1 treatment-experienced patients SVR12 rates by HCV GT1 subtype SVR12 (%) Treatment-experienced n N * One patient achieved SVR12, but was unable to be subgenotyped. Error bars: 95% CI. Zeuzem S, et al. EASL Abstract 1 [oral presentation]. 19
20 SAPPHIRE-II: GT1 treatment-experienced patients SVR12 rates by prior P/R response SVR12 (%) Treatment-experienced n N Error bars: 95% CI. Zeuzem S, et al. EASL Abstract 1 [oral presentation]. 20
21 SVR12 (%) PEARL-II: HCV GT1b treatment-experienced patients ABT-450/r/ABT-267 (ombitasvir) + ABT-333 (dasabuvir) ± RBV for 12 weeks GT1b Treatment-experienced n N ABT-450/r/ombitasvir = 150/100/25 mg QD co-formulated; dasabuvir = 250 mg BID; RBV = mg weight-based BID. AbbVie press release 2014 [Accessed ]. 21
22 CHC GT1 patients (N=440) ION-2: SOF/LDV ± RBV in GT1 treatment-experienced patients SOF/LDV (n=109) SOF/LDV + RBV (n=111) SOF/LDV (n=109) SOF/LDV + RBV (n=111) Study weeks Including 88 (20.0%) of patients with cirrhosis SOF = 400 mg/day; LDV = 90 mg/day; RBV = 1000 or 1200 mg/day. Afdhal N, et al. New Engl J Med 2014; online DOI: /NEJMoa
23 ION-2: SOF/LDV ± RBV in GT1 treatment-experienced patients SVR12 (%) Overall GT1a GT1b n N Error bars: 95% CI. Afdhal N, et al. New Engl J Med 2014; online DOI: /NEJMoa
24 Summary: data in non-cirrhotic patients SVR rates achieved in around 95% of GT1 patients with emerging IFN-free all-oral Phase III programmes Very low treatment discontinuation rates reflecting good safety and tolerability profile 24
25 CIRRHOTIC PATIENTS
26 TURQUOISE-II: GT1 treatment-naive and experienced cirrhotic patients ABT-450/r/ABT-267 (ombitasvir) + ABT-333 (dasabuvir) + RBV for 12 or 24 weeks HCV GT1, treatment-naive or -experienced, cirrhotic (N=380) n=208 n=172 ABT-450/r /ombitasvir + dasabuvir + RBV ABT-450/r /ombitasvir + dasabuvir + RBV Study weeks ABT-450/r/ombitasvir = 150/100 mg/25 mg QD co-formulated; dasabuvir = 250 mg BID; RBV = weight-based BID. Poordad F, et al. N Engl J Med Online DOI: /NEJMoa
27 SVR12, % Patients TURQUOISE-II: SVR12 rates in GT1 treatment-naive and experienced cirrhotic patients 91.8 P= Weeks 3D + RBV Weeks 3D + RBV Poordad F, et al. N Engl J Med Online DOI: /NEJMoa
28 SVR12, % Patients TURQUOISE-II: SVR12 rates in GT1 treatment-naive and experienced cirrhotic patients by HCV genotype D + RBV 12-week arm 24-week arm GT1a GT1b Poordad F, et al. N Engl J Med Online DOI: /NEJMoa
29 SVR12, % Patients TURQUOISE-II: SVR12 rates in GT1b treatment-naive and experienced cirrhotic patients by prior treatment response D + RBV 12-week arm 24-week arm Naive Prior Relapse Response Prior Partial Response HCV Subtype 1b Prior Null Response Poordad F, et al. N Engl J Med Online DOI: /NEJMoa
30 SVR12, % Patients TURQUOISE-II: SVR12 rates in GT1a treatment-naive and experienced cirrhotic patients by prior treatment response D + RBV 12-week arm 24-week arm Naive Prior Relapse Response Prior Partial Response HCV Subtype 1a Prior Null Response Poordad F, et al. N Engl J Med Online DOI: /NEJMoa
31 TURQUOISE-II: safety summary in GT1 treatment-naive and experienced cirrhotic patients Event, % 12-Week Arm (N=208) Hepatic decompensation events were rare (4 patients, 1.1%) None were considered related to study drug 3D + RBV 24-Week Arm (N=172) Any AE Severe AE Serious AE AE leading to drug discontinuation Death* 0 0 *1 patient with a non-treatment emergent death (occurring 80 days after last dose of study treatment), not attributed to 3D or RBV. Poordad F, et al. N Engl J Med Online DOI: /NEJMoa
32 TURQUOISE-II: safety summary in GT1 treatment-naive and experienced cirrhotic patients Event, % 12-Week Arm (N=208) 3D + RBV 24-Week Arm (N=172) P Value Fatigue <0.05 Headache NS Nausea NS Pruritus NS Insomnia NS Diarrhea NS Asthenia NS Rash NS Cough NS Irritability NS Anemia NS Dyspnea <0.05 Poordad F, et al. N Engl J Med Online DOI: /NEJMoa
33 TURQUOISE-II: laboratory assessments in GT1 treatment-naive and experienced cirrhotic patients 3D + RBV 12-Week Arm (N=208) 24-Week Arm (N=172) ALT >5x ULN (%) Total bilirubin >3x ULN (%) Hemoglobin (%) <10 g/dl <8.0 g/dl ALT elevation Asymptomatic, transient, and improved or resolved with ongoing study drug dosing Bilirubin elevation Transient, predominantly indirect, no discontinuations due to hyperbilirubinemia Hemoglobin decrease Managed with reduction of ribavirin dose in 34 patients (8.9%) Poordad F, et al. N Engl J Med Online DOI: /NEJMoa
34 ION-1: SOF + LDV ± RBV in GT1 treatment-naive cirrhotic patients (subgroup analysis) CHC GT1 patients (N=136) SOF/LDV (n=34) SOF/LDV + RBV (n=33) Overall study (N=865) 15.7% of patients were cirrhotic SOF/LDV (n=33) SOF/LDV + RBV (n=36) Weeks SOF = 400 mg/day; LDV = 90 mg/day; RBV = 1000 or 1200 mg/day. Afdhal N, et al. New Engl J Med 2014; online DOI: /NEJMoa
35 SVR12 (%) ION-1: SVR rates* in GT1 treatment-naive cirrhotic patients (subgroup analysis) SVR12 rates in the mitt population (N=852): subgroup results do not include patients who withdrew consent or who were lost to No cirrhosis Cirrhosis n N Afdhal N, et al. New Engl J Med 2014; online DOI: /NEJMoa
36 CHC GT1 patients (N=88) ION-2: SOF + LDV ± RBV in GT1 treatment-experienced cirrhotic patients (subgroup analysis) Overall study (N=440) 20.0% of patients were cirrhotic SOF/LDV (n=22) SOF/LDV + RBV (n=22) SOF/LDV (n=22) SOF/LDV + RBV (n=22) Study weeks SOF = 400 mg/day; LDV = 90 mg/day; RBV = 1000 or 1200 mg/day. Afdhal N, et al. New Engl J Med 2014; online DOI: /NEJMoa
37 ION-2: SVR rates in GT1 treatment-experienced cirrhotic patients (subgroup analysis) No cirrhosis Cirrhosis n N Afdhal N, et al. New Engl J Med 2014; online DOI: /NEJMoa
38 Summary slide In patients with cirrhosis across multiple regimens response rates of 84 97% are seen Therapy was well tolerated with very low treatment discontinuation rates Virologic characteristics may still play a role in selecting the optimal treatment regimen and duration 38
39 In summary Prof. Graham Foster
40 HCV Therapy today and tomorrow We have solved the HCV problem we now know how to kill this virus For Genotype 1 we have fabulous drugs today! 40
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