Table 3.
Impact of baseline polymorphisms in NS3 and NS5A on treatment outcome in study GIFT‐II for Japanese GT2‐infected patients without cirrhosis
| SVR12 rate % (n/N) a | |||||||
|---|---|---|---|---|---|---|---|
| Treatment‐naive | Treatment‐experienced | Total | |||||
| GT | BP | With BP | Without BP | With BP | Without BP | With BP | Without BP |
| 12 weeks | |||||||
| GT2a b , NS5A | T24A/S | 100 (4/4) | 87 (20/23) | (0/1) | 90 (19/21) | 80 (4/5) | 89 (39/44) |
| F28L | 100 (1/1) | 88 (23/26) | ‐ | 86 (19/22) | 100 (1/1) | 88 (42/48) | |
| L31M | 88 (22/25) | 100 (2/2) | 86 (19/22) | ‐ | 87 (41/47) | 100 (2/2) | |
| P58S | 100 (1/1) | 88 (23/26) | 100 (1/1) | 86 (18/21) | 100 (2/2) | 87 (41/47) | |
| C92S | ‐ | 89 (24/27) | 50 (1/2) | 90 (18/20) | 50 (1/2) | 89 (42/47) | |
| GT2b, NS3 | Y56F/H | 100 (1/1) | 65 (11/17) | (0/1) | 25 (2/8) | 50 (1/2) | 52 (13/25) |
| GT2b, NS5A | L28F | 67 (2/3) | 67 (10/15) | 50 (1/2) | 14 (1/7) | 60 (3/5) | 50 (11/22) |
| K30R | 100 (1/1) | 65 (11/17) | ‐ | 22 (2/9) | 100 (1/1) | 50 (13/26) | |
| M31L | 83 (5/6) | 58 (7/12) | (0/1) | 25 (2/8) | 71 (5/7) | 45 (9/20) | |
| P58S | 100 (1/1) | 65 (11/17) | ‐ | 22 (2/9) | 100 (1/1) | 50 (13/26) | |
| C92S | 67 (2/3) | 67 (10/15) | ‐ | 22 (2/9) | 67 (2/3) | 50 (12/24) | |
| 16 weeks | |||||||
| GT2a, NS3 | Y56F | ‐ | 94 (30/32) | (0/1) | 100 (15/15) | (0/1) | 96 (45/47) |
| D168E | ‐ | 94 (30/32) | 100 (1/1) | 93 (14/15) | 100 (1/1) | 94 (44/47) | |
| GT2a, NS5A | T24A/S | 100 (5/5) | 93 (26/28) | 100 (1/1) | 93 (14/15) | 100 (6/6) | 93 (40/43) |
| F28C/L | 100 (2/2) | 94 (29/31) | ‐ | 94 (15/16) | 100 (2/2) | 94 (44/47) | |
| K30R | 100 (1/1) | 94 (30/32) | ‐ | 94 (15/16) | 100 (1/1) | 94 (45/48) | |
| L31I | ‐ | 94 (31/33) | 100 (1/1) | 93 (14/15) | 100 (1/1) | 94 (45/48) | |
| L31M | 93 (28/30) | 100 (3/3) | 93 (13/14) | 100 (2/2) | 93 (41/44) | 100 (5/5) | |
| P58H | 100 (1/1) | 94 (30/32) | ‐ | 94 (15/16) | 100 (1/1) | 94 (45/48) | |
| GT2b, NS3 | Y56F | ‐ | 86 (12/14) | (0/1) | 69 (9/13) | (0/1) | 78 (21/27) |
| GT2b, NS5A | L28F | 100 (1/1) | 83 (10/12) | (0/1) | 64 (9/14) | 50 (1/2) | 73 (19/26) |
| K30R | ‐ | 85 (11/13) | 100 (1/1) | 57 (8/14) | 100 (1/1) | 70 (19/27) | |
| M31I | 100 (1/1) | 83 (10/12) | ‐ | 60 (9/15) | 100 (1/1) | 70 (19/27) | |
| M31L | 100 (2/2) | 82 (9/11) | ‐ | 60 (9/15) | 100 (2/2) | 69 (18/26) | |
| P58S/T | 50 (1/2) | 91 (10/11) | ‐ | 60 (9/15) | 50 (1/2) | 73 (19/26) | |
GT, genotype; BP, baseline polymorphism; TN, treatment‐naïve; TE, treatment‐experienced to an IFN‐containing regimen (IFN alpha, beta, or pegIFN) with or without RBV.
a
% of patients achieving SVR12 with or without the polymorphism at the corresponding amino acid position, n = number of patients with baseline polymorphism, N = total number of samples sequenced. Patients with compensated cirrhosis and patients not achieving SVR12 for reasons other than VF were excluded from this analysis.
b
Baseline polymorphisms were not detected in NS3.