Phase 4
N=4,766
A Study on the Correlation Between Interleukin 28B Genotypes With Clinical and Demographic Characteristics in Treatment-Naïve and Treatment-Experienced Patients With Chronic Hepatitis C
Hepatitis C, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT01675427 ↗Enrolled (actual)
4,766
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Number of Participants With Interleukin 28B (IL28B) Genotype rs12979860 by Cirrhosis Status and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Genotype: Treatment-Naive — 111; 255; 87; 388 participants — p=0.0018
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Interleukin 28B testing (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Interleukin 28B (IL28B) Genotype rs12979860 by Cirrhosis Status and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Genotype: Treatment-Naive |
111; 255; 87; 388; 673; 182 | 0.0018 sig |
| PRIMARY Number of Participants With IL28B Genotype rs12979860 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced |
93; 208; 67; 188; 445; 159 | 0.4133 |
| PRIMARY Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Naive |
200; 217; 36; 635; 528; 80 | 0.0126 sig |
| PRIMARY Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced |
158; 179; 31; 370; 360; 62 | 0.2693 |
| PRIMARY Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive |
10; 17; 14; 28; 40; 17 | 0.1981 |
| PRIMARY Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced |
20; 41; 10; 35; 86; 26 | 0.0911 |
| PRIMARY Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive |
20; 16; 5; 44; 34; 7 | 0.8686 |
| PRIMARY Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced |
34; 32; 5; 58; 74; 15 | 0.3709 |
| PRIMARY Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive |
6; 20; 5; 33; 63; 16 | 0.5348 |
| PRIMARY Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced |
7; 20; 8; 28; 61; 15 | 0.2510 |
| PRIMARY Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive |
13; 16; 2; 59; 45; 8 | 0.9887 |
| PRIMARY Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced |
14; 18; 3; 46; 50; 8 | 0.8622 |
| PRIMARY Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive |
9.61; 10.2; 12.6; 11.1; 7.69; 7.15 | 0.0605 |
| PRIMARY Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced |
11.7; 13.2; 13.5; 13.3; 5.11; 8.17 | 0.7454 |
| PRIMARY Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive |
9.46; 10.9; 13.7; 9.44; 7.95; 8.76 | 0.0017 sig |
| PRIMARY Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced |
12.7; 13.7; 10.2; 10.5; 5.21; NA | 0.4207 |
| SECONDARY Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive |
1; 4; 2; 38; 54; 24 | 0.9859 |
| SECONDARY Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced |
3; 5; 2; 33; 79; 19 | 0.5216 |
| SECONDARY Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive |
1; 4; 2; 63; 45; 8 | 0.8537 |
| SECONDARY Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced |
4; 5; 1; 52; 70; 9 | 0.2416 |
| SECONDARY Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Naive |
582; 802; 224; 396; 716; 196 | 0.0049 sig |
| SECONDARY Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Experienced |
287; 509; 169; 203; 405; 127 | 0.5651 |
| SECONDARY Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Naive |
910; 608; 90; 688; 539; 81 | 0.0420 sig |
| SECONDARY Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Experienced |
489; 412; 64; 362; 318; 55 | 0.4545 |
| SECONDARY Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Naive |
860; 1349; 373; 5; 24; 19 | < 0.0001 sig |
| SECONDARY Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Experienced |
314; 807; 259; 3; 20; 15 | < 0.0001 sig |
| SECONDARY Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Naive |
1402; 1030; 150; 34; 12; 2 | < 0.0001 sig |
| SECONDARY Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Experienced |
628; 651; 101; 31; 6; 1 | < 0.0001 sig |
| SECONDARY Mean Body Weight by IL28B Genotype rs12979860: Treatment-Naive |
74.6; 74.4; 74.2 | 0.5468 |
| SECONDARY Mean Body Weight by IL28B Genotype rs12979860: Treatment-Experienced |
72.7; 75.0; 75.1 | 0.0020 sig |
| SECONDARY Mean Body Weight by IL28B Genotype rs8099917: Treatment-Naive |
74.8; 74.2; 72.8 | 0.1623 |
| SECONDARY Mean Body Weight by IL28B Genotype rs8099917: Treatment-Experienced |
73.7; 75.2; 73.8 | 0.0663 |
| SECONDARY Mean Body Mass Index (BMI) by IL28B Genotype rs12979860: Treatment-Naive |
25.8; 26.0; 26.0 | 0.2617 |
| SECONDARY BMI by IL28B Genotype rs12979860: Treatment-Experienced |
25.8; 26.4; 26.3 | 0.0526 |
| SECONDARY BMI by IL28B Genotype rs8099917: Treatment-Naive |
26.0; 26.0; 25.4 | 0.7918 |
| SECONDARY BMI by IL28B Genotype rs8099917: Treatment-Experienced |
26.0; 26.4; 26.4 | 0.0842 |
| SECONDARY Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Naive |
500; 930; 272; 126; 160; 37 | < 0.0001 sig |
| SECONDARY Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Experienced |
295; 703; 239; 92; 38; 11 | < 0.0001 sig |
| SECONDARY Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Naive |
837; 747; 118; 198; 113; 12 | < 0.0001 sig |
| SECONDARY Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Experienced |
563; 574; 100; 107; 27; 7 | < 0.0001 sig |
| SECONDARY Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive |
5.96; 5.89; 5.72; 5.95; 5.76; 5.92 | < 0.0001 sig |
| SECONDARY Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced |
6.06; 5.98; 5.84; 5.39; 6.07; 5.64 | < 0.0001 sig |
| SECONDARY Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive |
5.99; 5.82; 5.61; 5.90; 5.74; 6.20 | < 0.0001 sig |
| SECONDARY Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced |
6.04; 5.92; 5.85; 5.52; 5.97; 5.49 | < 0.0001 sig |
| SECONDARY Mean Alanine Aminotransferase (ALT) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive |
2.09; 1.77; 1.63; 2.42; 1.96; 1.21 | 0.0007 sig |
| SECONDARY Mean ALT Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced |
3.00; 2.14; 2.00; 3.45; 1.84; 2.02 | < 0.0001 sig |
| SECONDARY Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive |
2.02; 1.67; 1.67; 2.09; 2.06; 1.31 | 0.0098 sig |
| SECONDARY Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced |
2.60; 2.11; 2.00; 3.26; 1.79; 2.04 | 0.0007 sig |
| SECONDARY Mean Aspartate Aminotransferase (AST) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive |
1.62; 1.59; 1.46; 1.93; 1.63; 1.06 | 0.1894 |
| SECONDARY Mean AST Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced |
2.27; 1.78; 1.65; 2.49; 1.33; 1.58 | 0.0002 sig |
| SECONDARY Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive |
1.65; 1.51; 1.49; 1.71; 1.66; 1.37 | 0.0688 |
| SECONDARY Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced |
2.01; 1.78; 1.66; 2.34; 1.36; 1.61 | 0.0247 sig |
| SECONDARY Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive |
200; 204; 201; 190; 212; 203 | 0.3609 |
| SECONDARY Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced |
180; 196; 197; 166; 181; 165 | 0.0002 sig |
| SECONDARY Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive |
200; 205; 203; 199; 209; 194 | 0.0671 |
| SECONDARY Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced |
186; 199; 190; 167; 184; 162 | 0.0059 sig |
| SECONDARY Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Naive |
16; 9; 0; 388; 680; 183 | < 0.0001 sig |
| SECONDARY Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Experienced |
83; 13; 0; 174; 534; 186 | < 0.0001 sig |
| SECONDARY Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Naive |
19; 6; 0; 632; 543; 76 | < 0.0001 sig |
| SECONDARY Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Experienced |
87; 9; 0; 378; 442; 74 | < 0.0001 sig |
| SECONDARY Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3]) |
5; 7; 4; 15; 41; 13 | 0.0103 sig |
| SECONDARY Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total]) |
1; 3; 0; 1; 8; 4 | 0.0637 |
| SECONDARY Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3]) |
4; 9; 0; 14; 37; 9 | < 0.0001 sig |
| SECONDARY Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total]) |
0; 1; 0; 1; 4; 6 | 0.5117 |
| SECONDARY Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3]) |
7; 7; 2; 32; 32; 5 | 0.0381 sig |
| SECONDARY Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total]) |
2; 2; 0; 9; 4; 0 | 0.2611 |
| SECONDARY Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3]) |
6; 7; 0; 28; 27; 5 | < 0.0001 sig |
| SECONDARY Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total]) |
1; 0; 0; 10; 1; 0 | 0.3465 |
| SECONDARY Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Naive |
974; 550; 74; 4; 965; 178 | < 0.0001 sig |
| SECONDARY Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Experienced |
489; 314; 48; 1; 597; 132 | < 0.0001 sig |
| SECONDARY Number of Participants With Inosine Triphosphatase (ITPA) Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Naive |
0; 0; 11; 0; 34; 343 | < 0.0001 sig |
| SECONDARY Number of Participants With ITPA Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Experienced |
0; 0; 15; 0; 23; 211 | 0.0066 sig |
| SECONDARY Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Naive |
0; 8; 17; 7; 167; 1077 | 0.0018 sig |
| SECONDARY Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Experienced |
2; 27; 67; 8; 117; 768 | 0.0003 sig |
| SECONDARY Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Naive |
0; 0; 25; 14; 230; 1007 | 0.1834 |
| SECONDARY Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Experienced |
0; 0; 96; 13; 175; 706 | < 0.0001 sig |
| SECONDARY Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3]) |
0; 0; 16; 0; 12; 57 | < 0.0001 sig |
| SECONDARY Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total]) |
0; 0; 4; 0; 1; 12 | 0.1158 |
| SECONDARY Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3]) |
0; 1; 12; 0; 8; 52 | 0.1236 |
| SECONDARY Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total]) |
0; 0; 1; 0; 1; 10 | 0.9734 |
| SECONDARY Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3]) |
0; 4; 12; 0; 10; 59 | 0.0065 sig |
| SECONDARY Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total]) |
0; 1; 3; 0; 1; 12 | 0.2564 |
| SECONDARY Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3]) |
0; 6; 7; 0; 6; 54 | 0.0097 sig |
| SECONDARY Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total]) |
0; 0; 1; 0; 3; 8 | 0.0151 sig |
| SECONDARY Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype |
41; 37; 13; 117; 199; 44 | < 0.0001 sig |
| SECONDARY Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype |
59; 23; 9; 205; 140; 15 | < 0.0001 sig |
| SECONDARY Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response at End of Treatment and HCV RNA Genotype |
194; 297; 79; 62; 313; 125 | < 0.0001 sig |
| SECONDARY Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response at End of Treatment and HCV RNA Genotype |
326; 222; 22; 161; 279; 60 | < 0.0001 sig |
| SECONDARY Number of Participants With IL28B Genotype rs12979860 by Overall Virological Response Type and HCV RNA Genotype |
99; 72; 14; 95; 221; 63 | < 0.0001 sig |
| SECONDARY Number of Participants With IL28B Genotype rs8099917 by Overall Virological Response Type and HCV RNA Genotype |
133; 46; 6; 194; 168; 17 | < 0.0001 sig |
| SECONDARY Number of Participants With ITPA Genotype rs1127354 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype |
2; 35; 322; 7; 98; 488 | 0.0021 sig |
| SECONDARY Number of Participants With ITPA Genotype rs7270101 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype |
1; 49; 309; 9; 110; 474 | 0.0081 sig |
| SECONDARY Number of Participants With ITPA Genotype rs1127354 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype |
1; 8; 103; 9; 154; 913 | 0.0634 |
| SECONDARY Number of Participants With ITPA Genotype rs7270101 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype |
2; 19; 91; 12; 187; 878 | 0.8234 |
Summary
This multicenter study will evaluate the correlation of interleukin 28B (IL28B) genotypes with disease characteristics and demographics in treatment-naïve and treatment-experienced chronic hepatitis C patients, including patients with HIV co-infection. There will be a single study visit for testing.
Eligibility Criteria
Inclusion Criteria
- Adult (according to local legislation) male or female patient
- Chronic hepatitis C (CHC)
- Patients naïve to CHC treatment or patients who received prior interferon-based therapy for CHC for whom data on treatment received and treatment outcome is available; information on fibrosis stage prior to previous treatment is also required
Exclusion Criteria
- Co-infection with hepatitis B
- History or evidence of decompensated liver disease
- History of major organ transplantation with an existing functional graft (including liver transplantation)
- End stage renal disease
Data sourced from ClinicalTrials.gov (NCT01675427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.