A Phase 2 interventional study of Boceprevir (BOC) and PegIntron (PEG) in Chronic Hepatitis C, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-10-14.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment
The primary objective of this study is to determine the safe and effective dose range of boceprevir (SCH 503034) in combination with PEG-Intron in adult subjects who have chronic hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy with peginterferon-alfa plus ribavirin. A secondary objective is to explore whether ribavirin provides an additional benefit when combined with PEG-Intron plus boceprevir.
1,090 studies on the registry are indexed under Hepatitis C, Chronic; 9 are open to participants now.
This study's enrollment of 357 is above the median of 90 across 789 interventional studies indexed under Hepatitis C, Chronic.
Browse Hepatitis C, Chronic studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.
Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key inclusion criteria:
Key exclusion criteria:
A single dose of PEG is given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA is undetected, PEG + RBV will continue for another 36 weeks.
Biological: PegIntron (PEG) · Drug: Ribavirin (RBV)
A single dose of PEG is given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA is detectable, BOC 400 mg TID will be added for 36 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Drug: Boceprevir (BOC) · Biological: PegIntron (PEG) · Drug: Ribavirin (RBV)
A single dose of PEG is given first, followed 1 week later by PEB + BOC 100 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Drug: Boceprevir (BOC) · Biological: PegIntron (PEG)
A single dose of PEG is given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Drug: Boceprevir (BOC) · Biological: PegIntron (PEG)
A single dose of PEG is given first, followed 1 week later by PEG + BOC 400 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Drug: Boceprevir (BOC) · Biological: PegIntron (PEG)
A single dose of PEG is given first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Drug: Boceprevir (BOC) · Biological: PegIntron (PEG) · Drug: Ribavirin (RBV)
A single dose of PEG is given first, followed 1 week later by PEG + BOC 400 for 24 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Drug: Boceprevir (BOC) · Biological: PegIntron (PEG)
By first protocol amendment to P03659, this non-randomized arm is added. A single dose of PEG is given first, followed 1 week later by PEG + BOC 800 for 24 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Drug: Boceprevir (BOC) · Biological: PegIntron (PEG)
By second protocol amendment to P03659, participants from all arms except Arm 1A will be rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
Drug: Boceprevir (BOC) · Biological: PegIntron (PEG) · Drug: Ribavirin (RBV)
100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID
Also known as: SCH 503034
1.5 mcg/kg weekly subcutaneously
200 mg capsules taken twice daily (BID) (total daily dose of 800-1400 mg/day, depending on weight \[weight-based dosing {WBD}\])
Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)
Sustained Viral Response (SVR) was defined as the percentage of participants with HCV-RNA undetectable at the follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC. Arm 1A was not analyzed.
Time frame: Baseline up to Week 49
Percent of Participants Who Achieved Sustained Virologic Response (SVR)
SVR was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) undetectable at the follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC. Arm 1A was not analyzed.
Time frame: Baseline up to Week 73 [24 weeks after end of treatment (EoT)]
Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA
Percentage of participants who became HCV-RNA undetectable within the first 13 weeks and subsequently became HCV-RNA positive were not considered negative for this analysis.
Time frame: Baseline up to Week 73 [24 weeks after EoT]
Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop
For each log drop category (\<0, 0 to 0.5, 0.5 to \<1, 1 to \<1.5, ≥1.5, and Missing), the percentage of participants receiving combination therapy who were HCV-RNA negative at EoT (Week 49) was calculated as follows: Number of participants in a log category who were HCV-RNA negative divided by the total number of participants in that log drop category (n). Percentages were NOT derived using treatment arm N values. The sum of the n values for all 6 log drop categories within a treatment arm equals the overall N for that treatment group.
Time frame: Week 1 and Week 49
Percent of Participants With Virologic Response Prior to Amendment 2
Virologic response was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) ≤10,000 IU/mL.
Time frame: Week 3, Week 5, Week 13
Peak Plasma Concentration of Boceprevir (BOC)
All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.
Time frame: All visits during treatment (baseline to Week 49) except Day 1 of Week 1
Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period
All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method. The dosing interval of 8 hours is represented as the hr in the unit of measure.
Time frame: All visits during treatment (baseline to Week 49) except Day 1 of Week 1
Trough Plasma Concentration Level
All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.
Time frame: All visits during treatment (baseline to Week 49) except Day 1 of Week 1
Change in Alanine Aminotransferase (ALT) Levels
Change in ALT levels during initial treatment regimen and after rolling into amendment 2 as compared to baseline.
Time frame: Baseline up to dosing change (> 25 weeks)
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])
Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).
Time frame: From dosing change to end of follow-up (Week 73)(up to 48 weeks)
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)
Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).
Time frame: From dosing change to end of follow-up (Week 73)(up to 48 weeks)
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)
Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).
Time frame: From dosing change to end of follow-up (Week 73) (up to 48 weeks)
| Milestone | Arm 1A: PEG + RBV | Arm 1B: PEG + RBV + BOC | Arm 2: PEG + BOC 100 (48 Weeks) | Arm 3: PEG + BOC 200 (48 Weeks) | Arm 5: PEG + RBV + BOC 400 | ARM 4+6: PEG + BOC 400 (24 + 48 Weeks) | Arm 7: PEG + BOC 800 | Arm 8: PEG + RBV + BOC 800 |
|---|---|---|---|---|---|---|---|---|
| Started | 15 | 34 | 48 | 49 | 49 | 97 | 65 | 0 |
| Completed | 6 | 28 | 4 | 9 | 21 | 14 | 61 | 0 |
| Not completed | 9 | 6 | 44 | 40 | 28 | 83 | 4 | 0 |
| Withdrew: Adverse event | 2 | 1 | 3 | 1 | 1 | 1 | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 4 | 37 | 35 | 24 | 55 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 3 | 1 | 3 | 4 | 2 | 3 | 3 | 0 |
| Withdrew: Noncompliance with protocol | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Completed treatment phase | 3 | 0 | 0 | 0 | 0 | 23 | 0 | 0 |
| Milestone | Arm 1A: PEG + RBV | Arm 1B: PEG + RBV + BOC | Arm 2: PEG + BOC 100 (48 Weeks) | Arm 3: PEG + BOC 200 (48 Weeks) | Arm 5: PEG + RBV + BOC 400 | ARM 4+6: PEG + BOC 400 (24 + 48 Weeks) | Arm 7: PEG + BOC 800 | Arm 8: PEG + RBV + BOC 800 |
|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 143 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 88 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 55 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 20 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 24 |
| Withdrew: Lost to follow-up/withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 11 |
Sustained Viral Response (SVR) was defined as the percentage of participants with HCV-RNA undetectable at the follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC. Arm 1A was not analyzed.
| Percent of participants | Arm 1B: PEG + RBV + BOC 400 | Arm 2: PEG + BOC 100 (48 Weeks) | Arm 3: PEG + BOC 200 (48 Weeks) | Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks) | Arm 5: PEG + RBV + BOC 400 | Arm 7: PEG + BOC 800 |
|---|---|---|---|---|---|---|
| Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT) | 35.0 | 6.3 | 16.3 | 13.4 | 20.4 | 21.5 |
Percentage of participants who became HCV-RNA undetectable within the first 13 weeks and subsequently became HCV-RNA positive were not considered negative for this analysis.
| Percent of participants | 0 to ≤ 4 Weeks to First Negative HCV-RNA Group | >4 to 8 Weeks to First Negative HCV-RNA Group | >8 to 12 Weeks to First Negative HCV-RNA Group | >12 to 36 Weeks to First Negative HCV-RNA Group |
|---|---|---|---|---|
| Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA | 58 | 33 | 33 | 0 |
For each log drop category (\<0, 0 to 0.5, 0.5 to \<1, 1 to \<1.5, ≥1.5, and Missing), the percentage of participants receiving combination therapy who were HCV-RNA negative at EoT (Week 49) was calculated as follows: Number of participants in a log category who were HCV-RNA negative divided by the total number of participants in that log drop category (n). Percentages were NOT derived using treatment arm N values. The sum of the n values for all 6 log drop categories within a treatment arm equals the overall N for that treatment group.
| Percent of participants | Arms 2, 3, 4, 6: PEG + BOC 100, 200, or 400 | Arm 5: PEG + RBV + BOC 400 | Arm 7: PEG + BOC 800 |
|---|---|---|---|
| Log drop <0 (Arm2-4,6 n=21/Arm5 n=6/Arm7 n=3) | 9.5 | 16.7 | 1 |
| Log drop 0-0.5 (Arm2-4,6 n=55/Arm5 n=17/Arm7 n=16) | 1.8 | 17.6 | 18.8 |
| Log drop 0.5to<1(Arm2-4,6 n=73/Arm5 n=11/Arm7 n=9) | 12.3 | 9.1 | 0 |
| Log drop 1to<1.5(Arm2-4,6 n=31/Arm5 n=9/Arm7 n=18) | 25.8 | 33.3 | 16.7 |
| Log drop ≥1.5 (Arm2-4,6 n=12/Arm5 n=4/Arm7 n=18) | 33.3 | 50.0 | 44.4 |
| Missing (Arm2-4,6 n=2/Arm5 n=2/Arm7 n=1) | 0 | 0 | 0 |
Virologic response was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) ≤10,000 IU/mL.
| Percent of participants | Arm 1A: PEG + RBV and Arm 1B: PEG + RBV + BOC 400 | Arm 2: PEG + BOC 100 (48 Weeks) | Arm 3: PEG + BOC 200 (48 Weeks) | Arm 5: PEG + RBV + BOC 400 | Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks) | Arm 7: PEG + BOC 800 |
|---|---|---|---|---|---|---|
| Week 3 | 4.1 | 0.0 | 0.0 | 0 | 5.2 | 4.6 |
| Week 5 | 4.1 | 0.0 | 8.2 | 12.2 | 9.3 | 15.4 |
| Week 13 | 6.1 | 2.1 | 14.3 | 30.6 | 13.4 | 0 |
All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.
| ng/mL | BOC 100 mg Dose | BOC 200 mg Dose | BOC 400 mg Dose | BOC 800 mg Dose |
|---|---|---|---|---|
| Peak Plasma Concentration of Boceprevir (BOC) | 203 ± 5 | 427 ± 18 | 704 ± 16 | 1312 ± 45 |
All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method. The dosing interval of 8 hours is represented as the hr in the unit of measure.
| ng*hr/mL | BOC 100 mg Dose | BOC 200 mg Dose | BOC 400 mg Dose | BOC 800 mg Dose |
|---|---|---|---|---|
| Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period | 1042 ± 25 | 2184 ± 181 | 3633 ± 88 | 6276 ± 337 |
All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.
| ng/mL | BOC 100 mg Dose | BOC 200 mg Dose | BOC 400 mg Dose | BOC 800 mg Dose |
|---|---|---|---|---|
| Trough Plasma Concentration Level | 56.7 ± 3 | 133.0 ± 27 | 214.0 ± 10 | 355 ± 42 |
Change in ALT levels during initial treatment regimen and after rolling into amendment 2 as compared to baseline.
| Participants | Arm 1A: PEG + RBV | Arm 1B: PEG + RBV + BOC 400 | Arm 2: PEG + BOC 100 (48 Weeks) | Arm 3: PEG + BOC 200 | Arm 5: PEG + RBV + BOC 400 | Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks) | Arm 7: PEG + BOC 800 | Arm 8: PEG + RBV + BOC 800 |
|---|---|---|---|---|---|---|---|---|
| <2.00 x baseline ALT value | 14 | 33 | 45 | 43 | 47 | 84 | 61 | 119 |
| 2.00-2.09 x baseline ALT value | 1 | 1 | 1 | 1 | 0 | 4 | 0 | 4 |
| 2.10-5.09 x baseline ALT value | 0 | 0 | 2 | 3 | 1 | 9 | 3 | 18 |
| 5.10-10.0 x baseline ALT value | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| >10.0 x baseline ALT value | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).
| Participants | Log Drop 0 to <1 | Log Drop 1 to <2 | Log Drop 2 to <3 | Log Drop 3 to <4 | Log Drop 4 to <5 | Log Drop ≥5 |
|---|---|---|---|---|---|---|
| Week 3 after dosing change | 0 | 0 | 0 | 4 | 11 | 2 |
| Week 6 after dosing change | 0 | 0 | 0 | 4 | 11 | 1 |
| Week 9 after dosing change | 0 | 0 | 0 | 4 | 9 | 1 |
| Week 12 after dosing change | 0 | 0 | 0 | 4 | 9 | 1 |
| Week 18 after dosing change | 1 | 0 | 1 | 4 | 11 | 1 |
| Week 24 after dosing change | 1 | 0 | 1 | 4 | 12 | 1 |
| End of treatment | 1 | 0 | 1 | 4 | 11 | 1 |
| Follow-up Week 4 after dosing change | 0 | 0 | 0 | 4 | 8 | 1 |
| Follow-up Week 8 after dosing change | 0 | 0 | 0 | 4 | 6 | 1 |
| Follow-up Week 12 after dosing change | 0 | 0 | 0 | 4 | 6 | 1 |
| Follow-up Week 24 after dosing change | 0 | 0 | 0 | 4 | 7 | 1 |
| End of follow-up after dosing change | 0 | 0 | 0 | 4 | 7 | 1 |
Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).
| Participants | Log Drop 1 to <2 | Log Drop 2 to <3 | Log Drop 3 to <4 | Log Drop 4 to <5 | Log Drop ≥5 |
|---|---|---|---|---|---|
| Week 3 after dosing change | 0 | 0 | 3 | 12 | 1 |
| Week 6 after dosing change | 0 | 0 | 3 | 10 | 0 |
| Week 9 after dosing change | 0 | 0 | 3 | 10 | 0 |
| Week 12 after dosing change | 0 | 0 | 3 | 9 | 0 |
| Week 18 after dosing change | 0 | 0 | 2 | 6 | 0 |
| Week 24 after dosing change | 0 | 0 | 3 | 5 | 0 |
| End of treatment | 0 | 0 | 3 | 7 | 0 |
| Follow-up Week 4 after dosing change | 0 | 0 | 3 | 6 | 0 |
| Follow-up Week 8 after dosing change | 0 | 0 | 3 | 4 | 0 |
| Follow-up Week 12 after dosing change | 0 | 0 | 2 | 5 | 0 |
| Follow-up Week 24 after dosing change | 0 | 0 | 3 | 4 | 0 |
| End of follow-up after dosing change | 0 | 0 | 3 | 4 | 0 |
Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).
| Participants | Log Drop <0 | Log Drop 0 to <1 | Log Drop 1 to <2 | Log Drop 2 to <3 | Log Drop 3 to <4 | Log Drop 4 to <5 | Log Drop ≥5 | Missing Data |
|---|---|---|---|---|---|---|---|---|
| Week 3 after dosing change | 0 | 0 | 0 | 0 | 5 | 7 | 4 | 3 |
| Week 6 after dosing change | 0 | 0 | 0 | 0 | 3 | 5 | 4 | 1 |
| Week 9 after dosing change | 0 | 0 | 0 | 0 | 5 | 7 | 3 | 1 |
| Week 12 after dosing change | 0 | 0 | 0 | 1 | 4 | 5 | 4 | 2 |
| Week 18 after dosing change | 0 | 0 | 0 | 1 | 5 | 3 | 4 | 2 |
| Week 24 after dosing change | 0 | 0 | 1 | 1 | 4 | 3 | 4 | 1 |
| End of treatment | 0 | 0 | 1 | 1 | 4 | 3 | 4 | 1 |
| Follow-up Week 4 after dosing change | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 0 |
| Follow-up Week 8 after dosing change | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Follow-up Week 12 after dosing change | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 |
| Follow-up Week 24 after dosing change | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 |
| End of follow-up after dosing change | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 |
SVR was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) undetectable at the follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC. Arm 1A was not analyzed.
| Percent of participants | Arm 1B: PEG + RBV + BOC 400 | Arm 2: PEG + BOC 100 (48 Weeks) | Arm 3: PEG + BOC 200 (48 Weeks) | Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks) | Arm 5: PEG + RBV + BOC 400 | Arm 7: PEG + BOC 800 |
|---|---|---|---|---|---|---|
| Percent of Participants Who Achieved Sustained Virologic Response (SVR) | 7.5 | 2.1 | 12.2 | 5.2 | 14.3 | 4.6 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PEG + RBV | — | 2/15 (13.3%) | 14/15 (93.3%) |
| PEG + RBV + BOC 400 (24 Weeks) | — | 1/34 (2.9%) | 33/34 (97.1%) |
| PEG + BOC 100 (48 Weeks) | — | 2/48 (4.2%) | 48/48 (100%) |
| PEG + BOC 200 (48 Weeks) | — | 4/49 (8.2%) | 48/49 (98%) |
| PEG + RBV + BOC 400 (48 Weeks) | — | 2/49 (4.1%) | 47/49 (95.9%) |
| PEG + BOC 400 (24 + 48 Weeks) | — | 4/97 (4.1%) | 96/97 (99%) |
| PEG + BOC 800 (24 Weeks) | — | 3/65 (4.6%) | 64/65 (98.5%) |
| PEG + RBV + BOC 800 | — | 12/143 (8.4%) | 136/143 (95.1%) |
| Event | PEG + RBV | PEG + RBV + BOC 400 (24 Weeks) | PEG + BOC 100 (48 Weeks) | PEG + BOC 200 (48 Weeks) | PEG + RBV + BOC 400 (48 Weeks) | PEG + BOC 400 (24 + 48 Weeks) | PEG + BOC 800 (24 Weeks) | PEG + RBV + BOC 800 |
|---|---|---|---|---|---|---|---|---|
| BLADDER NEOPLASMNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/15 | 0/34 | 0/48 | 0/49 | 0/49 | 0/97 | 0/65 | 0/143 |
| CONVULSIONNervous system disorders | 1/15 | 0/34 | 0/48 | 1/49 | 0/49 | 0/97 | 0/65 | 0/143 |
| HYPERTENSIVE CRISISVascular disorders | 1/15 | 0/34 | 0/48 | 0/49 | 0/49 | 0/97 | 0/65 | 0/143 |
| DIARRHOEAGastrointestinal disorders | 0/15 | 0/34 | 0/48 | 0/49 | 0/49 | 0/97 | 2/65 | 0/143 |
| ANAEMIABlood and lymphatic system disorders | 0/15 | 1/34 | 0/48 | 0/49 | 0/49 | 0/97 | 0/65 | 0/143 |
| CHEST PAINGeneral disorders | 0/15 | 0/34 | 0/48 | 1/49 | 0/49 | 0/97 | 0/65 | 3/143 |
| ABDOMINAL PAINGastrointestinal disorders | 0/15 | 0/34 | 1/48 | 0/49 | 0/49 | 0/97 | 0/65 | 0/143 |
| GASTROENTERITISInfections and infestations | 0/15 | 0/34 | 1/48 | 0/49 | 0/49 | 0/97 | 0/65 | 0/143 |
| PLEURISYRespiratory, thoracic and mediastinal disorders | 0/15 | 0/34 | 1/48 | 0/49 | 0/49 | 0/97 | 0/65 | 0/143 |
| ABDOMINAL PAIN UPPERGastrointestinal disorders | 0/15 | 0/34 | 0/48 | 1/49 | 0/49 | 0/97 | 0/65 | 0/143 |
| Event | PEG + RBV | PEG + RBV + BOC 400 (24 Weeks) | PEG + BOC 100 (48 Weeks) | PEG + BOC 200 (48 Weeks) | PEG + RBV + BOC 400 (48 Weeks) | PEG + BOC 400 (24 + 48 Weeks) | PEG + BOC 800 (24 Weeks) | PEG + RBV + BOC 800 |
|---|---|---|---|---|---|---|---|---|
| FATIGUEGeneral disorders | 10/15 | 14/34 | 25/48 | 31/49 | 24/49 | 45/97 | 40/65 | 38/143 |
| HEADACHENervous system disorders | 7/15 | 20/34 | 30/48 | 28/49 | 25/49 | 52/97 | 33/65 | 11/143 |
| MYALGIAMusculoskeletal and connective tissue disorders | 6/15 | 8/34 | 23/48 | 16/49 | 16/49 | 37/97 | 26/65 | 6/143 |
| DYSGEUSIANervous system disorders | 3/15 | 4/34 | 3/48 | 2/49 | 13/49 | 23/97 | 31/65 | 14/143 |
| NAUSEAGastrointestinal disorders | 6/15 | 9/34 | 15/48 | 13/49 | 22/49 | 32/97 | 23/65 | 22/143 |
| CHILLSGeneral disorders | 4/15 | 11/34 | 19/48 | 20/49 | 19/49 | 28/97 | 27/65 | 3/143 |
| PYREXIAGeneral disorders | 4/15 | 13/34 | 19/48 | 17/49 | 20/49 | 30/97 | 23/65 | 6/143 |
| DIARRHOEAGastrointestinal disorders | 6/15 | 7/34 | 11/48 | 11/49 | 10/49 | 29/97 | 21/65 | 13/143 |
| ANAEMIABlood and lymphatic system disorders | 1/15 | 4/34 | 1/48 | 0/49 | 8/49 | 1/97 | 2/65 | 54/143 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 5/15 | 5/34 | 17/48 | 15/49 | 17/49 | 35/97 | 15/65 | 8/143 |
| Age, Continuous(years) | Arm 1A: PEG + RBV OR Arm 1B: PEG + RBV + BOC 400 | Arm 2: PEG + BOC 100 (48 Weeks) | Arm 3: PEG + BOC 200 (48 Weeks) | Arm 5: PEG + RBV + BOC 400 | Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks) | Arm 7: PEG + BOC 800 | Total |
|---|---|---|---|---|---|---|---|
| Mean | 48.9 ± 9.7 | 51.6 ± 7.0 | 48.6 ± 9.4 | 48.2 ± 8.9 | 49.2 ± 8.7 | 50.4 ± 7.3 | 49.5 ± 8.6 |
| Sex: Female, Male(Participants) | Arm 1A: PEG + RBV OR Arm 1B: PEG + RBV + BOC 400 | Arm 2: PEG + BOC 100 (48 Weeks) | Arm 3: PEG + BOC 200 (48 Weeks) | Arm 5: PEG + RBV + BOC 400 | Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks) | Arm 7: PEG + BOC 800 | Total |
|---|---|---|---|---|---|---|---|
| Female | 17 | 21 | 14 | 21 | 37 | 24 | 134 |
| Male | 32 | 27 | 35 | 28 | 60 | 41 | 223 |
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Studies of the drugs tested here: Boceprevir · Ribavirin