Trial Outcomes & Findings for Boceprevir Treatment in Participants With Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin (P05514) (NCT NCT00910624)

Last Updated: 2021-02-08

Results Overview

SVR24 was defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) at Follow-up Week (FW) 24. SVR rates were evaluated by the prior interferon response (e.g., log drop from baseline at TW 4 or TW 12) in the previous studies.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

168 participants

Primary outcome timeframe

From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through Follow-Up Week (FW) 24 (up to 68 weeks)

Results posted on

2021-02-08

Participant Flow

168 participants enrolled and received at least one dose of study medication. Participants were categorized by prior treatment response on the referring study: prior null response, prior partial response, prior relapse, or other.

Participant milestones

Participant milestones
Measure	BOC + PEG/RBV: Prior Null Responders Participants who achieved "null" response (defined as \<2-log10 decrease and detectable HCV RNA at Treatment Week (TW) 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.	BOC + PEG/RBV: Prior Partial Responders Participants who achieved "partial" response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.	BOC + PEG/RBV: Prior Relapsers Participants who achieved "prior relapse" (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.	BOC + PEG/RBV: Other Participants who were characterized as "Other" (not in the categories of prior treatment failure as defined by this protocol), after completing treatment on the PEG/RBV control arm on a previous SPRI study, received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
Treatment Phase STARTED	52	85	29	2
Treatment Phase COMPLETED	22	64	20	2
Treatment Phase NOT COMPLETED	30	21	9	0
Follow-Up Phase STARTED	48	80	29	2
Follow-Up Phase COMPLETED	42	76	25	2
Follow-Up Phase NOT COMPLETED	6	4	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	BOC + PEG/RBV: Prior Null Responders Participants who achieved "null" response (defined as \<2-log10 decrease and detectable HCV RNA at Treatment Week (TW) 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.	BOC + PEG/RBV: Prior Partial Responders Participants who achieved "partial" response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.	BOC + PEG/RBV: Prior Relapsers Participants who achieved "prior relapse" (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
Treatment Phase Adverse Event	2	6	6
Treatment Phase Treatment Failure	23	10	0
Treatment Phase Lost to Follow-up	0	0	1
Treatment Phase Reasons Unrelated To Assigned Treatment	3	3	1
Treatment Phase Withdrawal by Subject	2	1	0
Treatment Phase Non-Compliance With Protocol	0	1	1
Follow-Up Phase Adverse Event	0	0	1
Follow-Up Phase Lost to Follow-up	3	1	2
Follow-Up Phase Reasons Unrelated To Assigned Treatment	1	2	0
Follow-Up Phase Withdrawal by Subject	1	0	0
Follow-Up Phase Withdrew Due To Retreatment Opportunity	1	0	0
Follow-Up Phase Administrative	0	1	1

Baseline Characteristics

Boceprevir Treatment in Participants With Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin (P05514)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BOC + PEG/RBV: Prior Null Responders n=52 Participants Participants who achieved "null" response (defined as \<2-log10 decrease and detectable HCV RNA at TW 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.	BOC + PEG/RBV: Prior Partial Responders n=85 Participants Participants who achieved "partial" response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.	BOC + PEG/RBV: Prior Relapsers n=29 Participants Participants who achieved "prior relapse" (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.	BOC + PEG/RBV: Other n=2 Participants Participants who were characterized as "Other" (not in the categories of prior treatment failure as defined by this protocol), after completing treatment on the PEG/RBV control arm on a previous SPRI study, received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.	Total n=168 Participants Total of all reporting groups
Age, Continuous	51.3 years STANDARD_DEVIATION 7.7 • n=5 Participants	52.6 years STANDARD_DEVIATION 8.4 • n=7 Participants	53.6 years STANDARD_DEVIATION 6.4 • n=5 Participants	52.0 years STANDARD_DEVIATION 1.4 • n=4 Participants	52.3 years STANDARD_DEVIATION 7.8 • n=21 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	25 Participants n=7 Participants	10 Participants n=5 Participants	1 Participants n=4 Participants	55 Participants n=21 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	60 Participants n=7 Participants	19 Participants n=5 Participants	1 Participants n=4 Participants	113 Participants n=21 Participants

PRIMARY outcome

Timeframe: From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through Follow-Up Week (FW) 24 (up to 68 weeks)

Population: All BOC-Treated Participants: All enrolled participants who received at least 1 dose of BOC. Data for 2 "Other" participants were included in the calculations for "BOC + PEG/RBV: All " (n=164). 4 discontinued during the 4-week PEG/RBV lead-in and did not receive BOC and thus were excluded from analysis.

Outcome measures

Outcome measures
Measure	BOC + PEG/RBV: Prior Null Responders n=49 Participants Participants who achieved "null" response (defined as \<2-log10 decrease and detectable HCV RNA at TW 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.	BOC + PEG/RBV: Prior Partial Responders n=85 Participants Participants who achieved "partial" response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.	BOC + PEG/RBV: Prior Relapsers n=28 Participants Participants who achieved "prior relapse" (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.	BOC + PEG/RBV: All n=164 Participants Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24);	41 percentage of participants	67 percentage of participants	96 percentage of participants	65 percentage of participants

PRIMARY outcome

Timeframe: From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks)

Population: All Treated Participants: All enrolled participants who received at least one dose of treatment.

AE= any untoward medical occurrence in a participant administered a pharmaceutical product/biologic (at any dose), whether or not considered related to the use of that product. Included the onset of new illness and the exacerbation of pre-existing conditions. Clinically significant laboratory abnormalities that required intervention/additional therapy, required a dose modification, or were associated with a clinical manifestation were considered AEs. SAE= any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, or was a congenital anomaly or birth defect.

Outcome measures

Outcome measures
Measure	BOC + PEG/RBV: Prior Null Responders n=168 Participants Participants who achieved "null" response (defined as \<2-log10 decrease and detectable HCV RNA at TW 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.	BOC + PEG/RBV: Prior Partial Responders Participants who achieved "partial" response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.	BOC + PEG/RBV: Prior Relapsers Participants who achieved "prior relapse" (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.	BOC + PEG/RBV: All Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
Percentage of Participants With Adverse Events (AEs) Leading to Dose Modification (DM) or Discontinuation (DC), Treatment-Related Serious AEs (SAEs), Neutrophil Count <0.75 × 10^9/L, or Hemoglobin (Hgb) <10 g/dL AEs Leading to DC	8 percentage of participants	—	—	—
Percentage of Participants With Adverse Events (AEs) Leading to Dose Modification (DM) or Discontinuation (DC), Treatment-Related Serious AEs (SAEs), Neutrophil Count <0.75 × 10^9/L, or Hemoglobin (Hgb) <10 g/dL AEs Leading to DM	35 percentage of participants	—	—	—
Percentage of Participants With Adverse Events (AEs) Leading to Dose Modification (DM) or Discontinuation (DC), Treatment-Related Serious AEs (SAEs), Neutrophil Count <0.75 × 10^9/L, or Hemoglobin (Hgb) <10 g/dL All Treatment-Related SAEs	7 percentage of participants	—	—	—
Percentage of Participants With Adverse Events (AEs) Leading to Dose Modification (DM) or Discontinuation (DC), Treatment-Related Serious AEs (SAEs), Neutrophil Count <0.75 × 10^9/L, or Hemoglobin (Hgb) <10 g/dL SAEs Related to BOC+PEG or BOC+P/R	4 percentage of participants	—	—	—
Percentage of Participants With Adverse Events (AEs) Leading to Dose Modification (DM) or Discontinuation (DC), Treatment-Related Serious AEs (SAEs), Neutrophil Count <0.75 × 10^9/L, or Hemoglobin (Hgb) <10 g/dL Neutrophil Count <0.75 × 10^9/L	25 percentage of participants	—	—	—
Percentage of Participants With Adverse Events (AEs) Leading to Dose Modification (DM) or Discontinuation (DC), Treatment-Related Serious AEs (SAEs), Neutrophil Count <0.75 × 10^9/L, or Hemoglobin (Hgb) <10 g/dL Hgb <10 g/dL	53 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: From TW 1 to TW 12

EVR was defined as undetectable HCV-RNA at TW 12 of BOC + PEG/RBV. EVR rates were evaluated by the prior interferon response (e.g., log drop from baseline at TW 4 or TW 12) in the previous studies.

Outcome measures

Outcome measures
Measure	BOC + PEG/RBV: Prior Null Responders n=49 Participants Participants who achieved "null" response (defined as \<2-log10 decrease and detectable HCV RNA at TW 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.	BOC + PEG/RBV: Prior Partial Responders n=85 Participants Participants who achieved "partial" response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.	BOC + PEG/RBV: Prior Relapsers n=28 Participants Participants who achieved "prior relapse" (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.	BOC + PEG/RBV: All n=164 Participants Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
Percentage of Participants With Early Virologic Response (EVR)	49 percentage of participants	76 percentage of participants	100 percentage of participants	73 percentage of participants

Adverse Events

All Treated Participants

Serious events: 18 serious events

Other events: 161 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Treated Participants n=168 participants at risk Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
Gastrointestinal disorders Abdominal pain	0.60% 1/168 • Number of events 1 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Gastrointestinal disorders Diarrhoea	1.2% 2/168 • Number of events 2 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
General disorders Chest pain	1.2% 2/168 • Number of events 2 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
General disorders Oedema peripheral	0.60% 1/168 • Number of events 1 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Hepatobiliary disorders Hepatic cirrhosis	0.60% 1/168 • Number of events 1 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Immune system disorders Sarcoidosis	0.60% 1/168 • Number of events 1 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Infections and infestations Appendicitis	0.60% 1/168 • Number of events 1 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Infections and infestations Cellulitis	0.60% 1/168 • Number of events 1 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Infections and infestations Injection site abscess	0.60% 1/168 • Number of events 1 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Infections and infestations Lobar pneumonia	0.60% 1/168 • Number of events 1 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Infections and infestations Staphylococcal infection	0.60% 1/168 • Number of events 1 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Injury, poisoning and procedural complications Joint injury	0.60% 1/168 • Number of events 1 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Metabolism and nutrition disorders Dehydration	0.60% 1/168 • Number of events 1 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Metabolism and nutrition disorders Hyponatraemia	0.60% 1/168 • Number of events 1 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Musculoskeletal and connective tissue disorders Muscular weakness	0.60% 1/168 • Number of events 1 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland neoplasm	0.60% 1/168 • Number of events 1 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Psychiatric disorders Acute psychosis	0.60% 1/168 • Number of events 1 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Psychiatric disorders Mood swings	0.60% 1/168 • Number of events 1 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Vascular disorders Arterial occlusive disease	0.60% 1/168 • Number of events 1 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Vascular disorders Femoral artery occlusion	0.60% 1/168 • Number of events 1 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.

Other adverse events

Other adverse events
Measure	All Treated Participants n=168 participants at risk Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
Blood and lymphatic system disorders Anaemia	49.4% 83/168 • Number of events 141 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Blood and lymphatic system disorders Leukopenia	8.9% 15/168 • Number of events 19 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Blood and lymphatic system disorders Neutropenia	22.6% 38/168 • Number of events 53 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Blood and lymphatic system disorders Thrombocytopenia	6.0% 10/168 • Number of events 15 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Gastrointestinal disorders Abdominal pain	7.1% 12/168 • Number of events 16 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Gastrointestinal disorders Abdominal pain upper	6.0% 10/168 • Number of events 10 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Gastrointestinal disorders Constipation	5.4% 9/168 • Number of events 11 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Gastrointestinal disorders Diarrhoea	22.0% 37/168 • Number of events 49 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Gastrointestinal disorders Dry mouth	6.0% 10/168 • Number of events 11 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Gastrointestinal disorders Dysgeusia	35.1% 59/168 • Number of events 64 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Gastrointestinal disorders Dyspepsia	7.1% 12/168 • Number of events 12 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.0% 10/168 • Number of events 13 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Gastrointestinal disorders Nausea	31.0% 52/168 • Number of events 59 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Gastrointestinal disorders Vomiting	8.3% 14/168 • Number of events 16 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
General disorders Asthenia	13.7% 23/168 • Number of events 27 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
General disorders Chills	16.1% 27/168 • Number of events 28 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
General disorders Fatigue	48.2% 81/168 • Number of events 104 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
General disorders Influenza like illness	20.8% 35/168 • Number of events 37 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
General disorders Injection site reaction	9.5% 16/168 • Number of events 16 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
General disorders Irritability	14.9% 25/168 • Number of events 32 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
General disorders Pain	6.0% 10/168 • Number of events 12 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
General disorders Pyrexia	13.1% 22/168 • Number of events 27 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Investigations Weight decreased	8.9% 15/168 • Number of events 18 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Metabolism and nutrition disorders Decreased appetite	20.8% 35/168 • Number of events 40 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Musculoskeletal and connective tissue disorders Arthralgia	9.5% 16/168 • Number of events 16 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Musculoskeletal and connective tissue disorders Back pain	5.4% 9/168 • Number of events 15 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Musculoskeletal and connective tissue disorders Myalgia	9.5% 16/168 • Number of events 18 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Nervous system disorders Disturbance in attention	6.5% 11/168 • Number of events 11 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Nervous system disorders Dizziness	16.1% 27/168 • Number of events 32 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Nervous system disorders Headache	26.8% 45/168 • Number of events 50 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Psychiatric disorders Depression	13.1% 22/168 • Number of events 25 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Psychiatric disorders Insomnia	23.8% 40/168 • Number of events 52 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Respiratory, thoracic and mediastinal disorders Cough	14.9% 25/168 • Number of events 30 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	18.5% 31/168 • Number of events 35 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Skin and subcutaneous tissue disorders Alopecia	15.5% 26/168 • Number of events 29 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Skin and subcutaneous tissue disorders Dry skin	16.7% 28/168 • Number of events 31 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Skin and subcutaneous tissue disorders Pruritus	14.9% 25/168 • Number of events 25 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
Skin and subcutaneous tissue disorders Rash	14.3% 24/168 • Number of events 29 • From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator agrees not to publish or publicly present any interim results of the study without the prior written consent of the sponsor, and further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study.
Publication restrictions are in place

Restriction type: OTHER