Copyright
©The Author(s) 2016.
World J Hepatol. Feb 28, 2016; 8(6): 331-339
Published online Feb 28, 2016. doi: 10.4254/wjh.v8.i6.331
Published online Feb 28, 2016. doi: 10.4254/wjh.v8.i6.331
Table 1 Patient demographics n (%)
| Boceprevir plus PR (n = 159) | PR (n = 78) | |
| Sex | ||
| Male | 94 (59.1) | 45 (57.7) |
| Female | 65 (40.9) | 33 (42.3) |
| Age (yr), mean (SD) | 38.6 (9.8) | 38.1 (10.0) |
| Race | ||
| White | 158 (99.4) | 77 (98.7) |
| Asian | 1 (0.6) | 1 (1.3) |
| Ethnicity | ||
| Not Hispanic or Latino | 159 (100) | 78 (100) |
| Weight (kg), mean (SD) | 78.1 (16.6) | 78.5 (16.8) |
| BMI (kg/m2), mean (SD) | 25.9 (4.2) | 26.0 (4.4) |
| Previous treatment | ||
| Naive | 97 (61.0) | 48 (61.5) |
| Experienced | 62 (39.0) | 30 (38.5) |
| IL28B genotype | ||
| CC allele | 22 (13.8) | 11 (14.1) |
| Non-CC allele | 137 (86.2) | 67 (85.9) |
| HCV genotype | ||
| GT1a | 4 (2.5) | 0 (0) |
| GT1b | 155 (97.5) | 78 (100) |
| Baseline HCV RNA | ||
| ≤ 800000 IU/mL | 89 (56.0) | 53 (67.9) |
| > 800000 IU/mL | 70 (44.0) | 25 (32.1) |
| Hemoglobin (g/dL), mean (SD) | 15.0 (1.5) | 14.9 (1.5) |
| Liver histology | ||
| Cirrhosis | 7 (4.4) | 2 (2.6) |
| No cirrhosis | 152 (95.6) | 76 (97.4) |
Table 2 Sustained virologic response by previous treatment, interleukin-28B genotype, and on-treatment virologic response n (%)
| Boceprevir plus PR (n = 159) | PR (n = 78) | |
| Treatment naive | 76/97 (78.4) | 27/48 (56.3) |
| Treatment experienced | 43/62 (69.4) | 9/30 (30.0) |
| Null responder | 8/17 (47.1) | 1/6 (16.7) |
| Partial responder | 5/8 (62.5) | 1/4 (25.0) |
| Relapser | 30/37 (81.1) | 7/20 (35.0) |
| Treatment naive | ||
| IL28B CC genotype | 19/20 (95.0) | 11/11 (100.0) |
| IL28B non-CC genotype | 57/77 (74.0) | 16/37 (43.2) |
| Treatment experienced | ||
| IL28B CC genotype | 2/2 (100.0) | 0/0 |
| IL28B non-CC genotype | 41/60 (68.3) | 9/30 (30.0) |
| SVR according to baseline HCV RNA | ||
| All patients | ||
| ≤ 800000 IU/mL | 71/89 (79.8) | 25/53 (47.2) |
| > 800000 IU/mL | 48/70 (68.8) | 11/25 (44.0) |
| Treatment naive | ||
| ≤ 800000 IU/mL | 45/52 (86.5) | 16/27 (59.3) |
| > 800000 IU/mL | 31/45 (68.9) | 11/21 (52.4) |
| Treatment experienced | ||
| ≤ 800000 IU/mL | 26/37 (70.3) | 9/26 (34.6) |
| > 800000 IU/mL | 17/25 (68.0) | 0/4 (0) |
| SVR according to TW4 response | ||
| TW4 < 1 log drop | 20/43 (46.5) | 0/22 (0) |
| TW4 ≥ 1 log drop | 75/90 (83.3) | 26/45 (57.8) |
| TW4 undetectable | 23/23 (100) | 10/10 (100) |
| Missing | 1/3 | 0/1 |
| SVR according to TW8 response | ||
| TW8 undetectable | 115/139 (82.7) | 29/33 (87.9) |
| TW8 detectable | 4/16 (25) | 7/44 (15.9) |
| Missing | 0/4 | 0/1 |
| SVR according to presence of anemia | ||
| Yes | 47/66 (71.2) | 6/11 (54.5) |
| No | 72/93 (77.4) | 30/67 (44.8) |
| SVR according to EPO use | ||
| Yes | 10/15 (66.7) | 3/3 (100) |
| No | 109/144 (75.7) | 33/75 (44) |
| SVR according to ribavirin dose reduction | ||
| Yes | 46/67 (68.7) | 12/17 (70.6) |
| No | 73/92 (79.4) | 24/61 (39.3) |
Table 3 Sustained virologic response at follow-up week 24 in the crossover group n (%)
| SVR | |
| Total | 19/27 (70.4) |
| TN TW12 failure (< 2 log decline HCV RNA) | 8/11 (72.7) |
| TE TW12 failure (detectable HCV RNA) | 11/16 (68.8) |
| TN TW24 failure (detectable HCV RNA) | 0/0 |
Table 4 Adverse events (≥ 20% in any treatment arm) n (%)
| Boceprevir plus PR (n = 159) | PR (n = 78) | |
| Any AE | 155 (97.5) | 71 (91.0) |
| Neutropenia | 84 (52.8) | 31 (41.0) |
| Pyrexia | 77 (48.4) | 36 (46.2) |
| Anemia | 75 (47.2) | 19 (24.4) |
| Leukopenia | 62 (39.0) | 25 (32.1) |
| Dysgeusia | 59 (37.1) | 3 (3.8) |
| Asthenia | 44 (27.7) | 23 (29.5) |
| Headache | 43 (27.0) | 25 (32.1) |
| Influenza-like illness | 39 (24.5) | 14 (17.9) |
| Nausea | 39 (24.5) | 9 (11.5) |
| Anemia | ||
| 8.5-10 g/dL | 56 (35.2) | 9 (11.5) |
| < 8.5 g/dL | 10 (6.3) | 2 (2.6) |
| Ribavirin dose reduction | 65 (40.9) | 14 (17.9) |
| EPO use | 15 (9.4) | 3 (3.8) |
| Serious AE | 17 (10.7) | 9 (11.5) |
| Discontinued because of an AE | 7 (4.4) | 2 (2.6) |
| Dose modification due to an AE | 89 (56.0) | 26 (33.3) |
Table 5 Comparison of virologic response rates between Russian patients and western patients receiving boceprevir-based triple therapy in the serine protease inhibitor therapy 2 and retreatment with hepatitis C virus serine protease inhibitor boceprevir and pegIntron/rebetol 2 studies n (%)
| Russian patients | SPRINT-2 | RESPOND-2 | ||||
| RGT of BOC | PR | RGT of BOC | PR | RGT of BOC | PR | |
| TN | ||||||
| EOT | 89/97 (91.8) | 33/48 (68.8) | 277/366 (76) | 191/363 (53) | - | - |
| SVR | 76/97 (78.4) | 27/48 (56.3) | 242/366 (66) | 137/363 (38) | - | - |
| Relapse | 13/89 (14.6) | 6/33 (18.2) | 24/265 (9) | 39/176 (22) | - | - |
| TE | ||||||
| EOT | 50/62 (80.6) | 13/30 (43.3) | - | - | 114/162 (70.4) | 25/80 (31) |
| SVR | 43/62 (69.4) | 9/30 (30) | - | - | 107/161 (66) | 17/80 (21) |
| Relapse | 7/48 (14.6) | 3/12 (25.0) | - | - | 14/121 (12) | 8/25 (32) |
- Citation: Isakov V, Nikitin I, Chulanov V, Ogurtsov P, Lukyanova E, Long J, Wahl J, Helmond FA, The P08160 Trial Investigators. Boceprevir plus peginterferon/ribavirin for treatment of chronic hepatitis C in Russia. World J Hepatol 2016; 8(6): 331-339
- URL: https://www.wjgnet.com/1948-5182/full/v8/i6/331.htm
- DOI: https://dx.doi.org/10.4254/wjh.v8.i6.331