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Evaluating the Effectiveness of Boceprevir, Pegylated-Interferon Alfa 2b and Ribavirin in Treating Hepatitis C Virus (HCV) Infection in Adults With HIV and HCV Infection

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ClinicalTrials.gov Identifier: NCT01482767
Recruitment Status : Completed
First Posted : December 1, 2011
Results First Posted : May 10, 2016
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV Infections
Hepatitis C
Interventions Drug: Pegylated-Interferon Alfa 2b (PEG-IFN)
Drug: Ribavirin (RBV)
Drug: Boceprevir (BOC)
Enrollment 262

Recruitment Details Participants were enrolled from May 2012 to December 2013 at 42 U.S. sites.
Pre-assignment Details  
Arm/Group Title HCV Treatment-Naive (Group A) HCV Treatment-Experienced (Group B)
Hide Arm/Group Description Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV. Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Period Title: Overall Study
Started 135 127
Completed 81 78
Not Completed 54 49
Reason Not Completed
Death             1             1
Withdrawal by Subject             7             5
Lost to Follow-up             12             6
Adverse Event             0             3
Site closure             22             14
Non-adherence to study requirements             4             7
Alternate HCV treatment             7             8
Ineligible             0             5
Nurse error             1             0
Arm/Group Title HCV Treatment-Naive (Group A) HCV Treatment-Experienced (Group B) Total
Hide Arm/Group Description Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV. Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV. Total of all reporting groups
Overall Number of Baseline Participants 135 122 257
Hide Baseline Analysis Population Description
All eligible participants enrolled (Group B participants who were found ineligible after enrollment, n=5, were excluded).
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 135 participants 122 participants 257 participants
51
(44 to 57)
53
(49 to 57)
52
(47 to 57)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants 122 participants 257 participants
Female
25
  18.5%
29
  23.8%
54
  21.0%
Male
110
  81.5%
93
  76.2%
203
  79.0%
[1]
Measure Description: Sex at birth.
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants 122 participants 257 participants
Hispanic or Latino
17
  12.6%
28
  23.0%
45
  17.5%
Not Hispanic or Latino
117
  86.7%
93
  76.2%
210
  81.7%
Unknown or Not Reported
1
   0.7%
1
   0.8%
2
   0.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants 122 participants 257 participants
American Indian or Alaska Native
0
   0.0%
2
   1.6%
2
   0.8%
Asian
2
   1.5%
2
   1.6%
4
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
73
  54.1%
53
  43.4%
126
  49.0%
White
57
  42.2%
58
  47.5%
115
  44.7%
More than one race
2
   1.5%
2
   1.6%
4
   1.6%
Unknown or Not Reported
1
   0.7%
5
   4.1%
6
   2.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 135 participants 122 participants 257 participants
135 122 257
Intravenous Drug Use History  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 135 participants 122 participants 257 participants
Never 71 70 141
Previously 64 52 116
Cirrhosis Status at Screening   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 135 participants 122 participants 257 participants
Cirrhotic 18 38 56
Non-cirrhotic 117 84 201
[1]
Measure Description: Liver cirrhosis was defined as cirrhosis identified by screening liver biopsy or screening FibroSure score greater than 0.74.
HCV RNA at Entry   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Log10 IU/mL
Number Analyzed 135 participants 122 participants 257 participants
6.7
(6.2 to 7.1)
6.9
(6.5 to 7.3)
6.8
(6.4 to 7.2)
[1]
Measure Description: Group A: Among n=134 participants with samples collected.
ART Regimen at Entry  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 135 participants 122 participants 257 participants
EFV + 2 NRTIs 58 51 109
RAL + 2 NRTIs 47 45 92
LPV/RTV + 2 NRTIs 4 4 8
ATV/RTV + 2 NRTIs 18 10 28
DRV/RTV + 2 NRTIs 6 6 12
Not on ART 2 6 8
CD4 Cell Count at Entry   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 135 participants 122 participants 257 participants
646
(462 to 818)
622
(489 to 859)
625
(473 to 835)
[1]
Measure Description: Among n=133 Group A and n=120 Group B participants who had results available.
HIV-1 RNA Quantitation at Entry   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 135 participants 122 participants 257 participants
Unquantifiable 133 113 246
Quantifiable 0 9 9
Unknown 2 0 2
[1]
Measure Description: Unquantifiable HIV-1 RNA was defined as below the lower limit of the assay (LLOQ). Abbott RealTime HIV-1 assay (LLOQ=40 copies/ml) or Roche COBAS Ampliprep/Taqman HIV-1 assay (LLOQ=20 copies/ml) was used.
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response at 24 Weeks After Treatment Discontinuation (SVR24)
Hide Description SVR24 was defined as undetectable HCV RNA (below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0) at 24 weeks after treatment discontinuation. Participants without HCV RNA for SVR24 determination were considered not to have achieved SVR24.
Time Frame 24 weeks after treatment discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants enrolled (Group B participants who were found ineligible after enrollment, n=5, were excluded).
Arm/Group Title HCV Treatment-Naive (Group A) HCV Treatment-Experienced (Group B)
Hide Arm/Group Description:
Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Overall Number of Participants Analyzed 135 122
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
34.8
(27.3 to 43.2)
25.4
(18.5 to 33.8)
2.Secondary Outcome
Title Percentage of Participants With Grade 3 or Higher Adverse Events (AEs)
Hide Description Number of participants who experienced an AE (sign or symptom or laboratory abnormality) of Grade 3 or higher at any time after baseline while on study. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening.
Time Frame From study treatment dispensation to Week 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants enrolled (Group B participants who were found ineligible after enrollment, n=5, were excluded).
Arm/Group Title HCV Treatment-Naive (Group A) HCV Treatment-Experienced (Group B)
Hide Arm/Group Description:
Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Overall Number of Participants Analyzed 135 122
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
74.1
(66.1 to 80.7)
73.8
(65.3 to 80.8)
3.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response at 12 Weeks After Treatment Discontinuation (SVR12)
Hide Description SVR12 was defined as undetectable HCV RNA (below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0) at 12 weeks after treatment discontinuation. Participants without HCV RNA for SVR12 determination were considered not to have achieved SVR12.
Time Frame 12 weeks after treatment discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants enrolled (Group B participants who were found ineligible after enrollment, n=5, were excluded).
Arm/Group Title HCV Treatment-Naive (Group A) HCV Treatment-Experienced (Group B)
Hide Arm/Group Description:
Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Overall Number of Participants Analyzed 135 122
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
35.6
(28.0 to 43.9)
30.3
(22.9 to 39.0)
4.Secondary Outcome
Title Percentage of Participants With HIV-1 Viral Load <50 Copies/mL
Hide Description HIV-1 RNA testing was performed with Abbott RealTime HIV-1 assay (LLOQ=40 copies/mL) or with Roche COBAS AmpliPrep/Taqman HIV-1 assay (LLOQ=20 copies/mL).
Time Frame Entry and weeks (W) 4, 8, 12, 24, 28, 40, 48, 52, 60, 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants with HIV-1 RNA result available at the respective visit (numbers of participants in Category Titles below; n). Participants who discontinued treatment early due to HCV virologic failure, safety or any other reason started following a separate visit schedule and are not included here.
Arm/Group Title HCV Treatment-Naive (Group A) HCV Treatment-Experienced (Group B)
Hide Arm/Group Description:
Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Overall Number of Participants Analyzed 135 122
Measure Type: Number
Unit of Measure: percentage of participants
W0 HIV-1 RNA (A: n=133, B: n=122) 100.0 92.6
W4 HIV-1 RNA (A: n=123, B: n=114) 98.4 96.5
W8 HIV-1 RNA (A: n=117, B: n=104) 100.0 96.2
W12 HIV-1 RNA (A: n=108, B: n=99) 98.1 98.0
W24 HIV-1 RNA (A: n=62, B: n=52) 100.0 100.0
W28 HIV-1 RNA: (A: n=54, B: n=45) 98.1 100.0
W40 HIV-1 RNA (A: n=52, B: n=38) 92.3 100.0
W48 HIV-1 RNA (A: n=23, B: n=33) 100.0 100.0
W52 HIV-1 RNA (A: n=24, B: n=0) 100.0 NA [1] 
W60 HIV-1 RNA (A: n=40, B: n=36) 100.0 97.2
W72 HIV-1 RNA (A: n=34, B: n=27) 97.1 100.0
[1]
Group B participants did not have a study visit at Week 52.
5.Secondary Outcome
Title CD4+ T-Cell Count (CD4) Change From Baseline
Hide Description Change in CD4 T-cell count was calculated as value at the post entry visit minus the value at entry.
Time Frame Entry and weeks (W) 8, 12, 24, 28, 40, 48, 52, 60, 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants enrolled with CD4 result available from entry and the respective post-entry visit (numbers of participants in Category Titles below; n). Participants who discontinued treatment early due to HCV virologic failure, safety or any other reason started following a separate visit schedule and are not included here.
Arm/Group Title HCV Treatment-Naive (Group A) HCV Treatment-Experienced (Group B)
Hide Arm/Group Description:
Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Overall Number of Participants Analyzed 135 122
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
W8 CD4 change (A: n=115, B: n=101)
-174
(-285 to -77)
-170
(-290 to -83)
W12 CD4 change (A: n=106, B: n=95)
-194
(-342 to -101)
-202
(-331 to -90)
W24 CD4 change (A: n=61, B: n=52)
-277
(-402 to -143)
-263
(-418 to -184)
W28 CD4 change (A: n=53, B: n=44)
-304
(-441 to -157)
-284
(-412 to -227)
W40 CD4 change (A: n=50, B: n=37)
-128
(-234 to -47)
-276
(-368 to -180)
W48 CD4 change (A: n=22, B: n=35)
-220
(-420 to -77)
-237
(-352 to -147)
W52 CD4 change (A: n=23, B: n=0)
-24
(-174 to 75)
NA [1] 
(NA to NA)
W60 CD4 change (A: n=39, B: n=36)
-34
(-210 to 107)
-79
(-146 to 40)
W72 CD4 change (A: n=33, B: n=27)
8
(-123 to 77)
-15
(-129 to 124)
[1]
Group B participants did not have a study visit at Week 52.
6.Secondary Outcome
Title Number of Participants With Undetectable HCV RNA at Week 4, 8 and 12 Study Visits
Hide Description Undetectable HCV RNA was defined as below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0.
Time Frame Weeks (W) 4, 8, 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants with HCV RNA result available at the respective visit (numbers of participants in Category Titles below; n). Participants who discontinued treatment early due to HCV virologic failure, safety or any other reason started following a separate visit schedule and are not included here.
Arm/Group Title HCV Treatment-Naive (Group A) HCV Treatment-Experienced (Group B)
Hide Arm/Group Description:
Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Overall Number of Participants Analyzed 135 122
Measure Type: Number
Unit of Measure: participants
W4 HCV RNA (A: n=122, B: n=116) 9 3
W8 HCV RNA (A: n=117, B: n=104) 48 28
W12 HCV RNA (A: n=109, B: n=99) 68 43
7.Secondary Outcome
Title Number of Participants With Undetectable HCV RNA at Week 16, 20, 24 and 28 Study Visits
Hide Description Undetectable HCV RNA was defined as below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0. This outcome measure was intended for a potential interim analysis when study data up to Week 28 were complete. However, this interim analysis was not conducted.
Time Frame Weeks (W) 16, 20, 24, and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was intended for a potential interim analysis which was not conducted.
Arm/Group Title HCV Treatment-Naive (Group A) HCV Treatment-Experienced (Group B)
Hide Arm/Group Description:
Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Participants With Grade 2 or Higher Signs and Symptoms and Laboratory Abnormalities and Other Serious AEs
Hide Description This outcome measure was intended for a potential interim analysis when study data up to Week 28 were complete. However, this interim analysis was not conducted. Refer to Outcome Measure 2 above for the safety outcome that includes the whole study duration from entry to week 72.
Time Frame From study treatment dispensation to Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was intended for a potential interim analysis which was not conducted.
Arm/Group Title HCV Treatment-Naive (Group A) HCV Treatment-Experienced (Group B)
Hide Arm/Group Description:
Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From study treatment dispensation to Week 72.
Adverse Event Reporting Description The protocol required reporting of signs/symptoms >=Grade 2, laboratory results >=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
 
Arm/Group Title HCV Treatment-Naive (Group A) HCV Treatment-Experienced (Group B)
Hide Arm/Group Description Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV. Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
All-Cause Mortality
HCV Treatment-Naive (Group A) HCV Treatment-Experienced (Group B)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HCV Treatment-Naive (Group A) HCV Treatment-Experienced (Group B)
Affected / at Risk (%) Affected / at Risk (%)
Total   32/135 (23.70%)   31/122 (25.41%) 
Blood and lymphatic system disorders     
Anaemia  1  1/135 (0.74%)  4/122 (3.28%) 
Leukopenia  1  0/135 (0.00%)  1/122 (0.82%) 
Lymphadenitis  1  1/135 (0.74%)  0/122 (0.00%) 
Lymphopenia  1  0/135 (0.00%)  1/122 (0.82%) 
Neutropenia  1  4/135 (2.96%)  9/122 (7.38%) 
Pancytopenia  1  1/135 (0.74%)  0/122 (0.00%) 
Thrombocytopenia  1  0/135 (0.00%)  1/122 (0.82%) 
Cardiac disorders     
Cardiac failure congestive  1  0/135 (0.00%)  1/122 (0.82%) 
Gastrointestinal disorders     
Diarrhoea  1  0/135 (0.00%)  1/122 (0.82%) 
Gastrointestinal haemorrhage  1  0/135 (0.00%)  1/122 (0.82%) 
Pancreatitis acute  1  1/135 (0.74%)  0/122 (0.00%) 
General disorders     
Asthenia  1  0/135 (0.00%)  2/122 (1.64%) 
Chest pain  1  2/135 (1.48%)  0/122 (0.00%) 
Injection site mass  1  1/135 (0.74%)  0/122 (0.00%) 
Non-cardiac chest pain  1  1/135 (0.74%)  0/122 (0.00%) 
Pyrexia  1  2/135 (1.48%)  1/122 (0.82%) 
Hepatobiliary disorders     
Cholecystitis acute  1  1/135 (0.74%)  0/122 (0.00%) 
Hyperbilirubinaemia  1  0/135 (0.00%)  2/122 (1.64%) 
Liver disorder  1  0/135 (0.00%)  1/122 (0.82%) 
Infections and infestations     
Abscess  1  0/135 (0.00%)  1/122 (0.82%) 
Cellulitis  1  0/135 (0.00%)  2/122 (1.64%) 
Injection site cellulitis  1  0/135 (0.00%)  1/122 (0.82%) 
Lobar pneumonia  1  0/135 (0.00%)  1/122 (0.82%) 
Perinephric abscess  1  0/135 (0.00%)  1/122 (0.82%) 
Pneumonia  1  0/135 (0.00%)  1/122 (0.82%) 
Pneumonia bacterial  1  1/135 (0.74%)  0/122 (0.00%) 
Pyelonephritis  1  1/135 (0.74%)  0/122 (0.00%) 
Sepsis syndrome  1  1/135 (0.74%)  0/122 (0.00%) 
Septic shock  1  1/135 (0.74%)  0/122 (0.00%) 
Subcutaneous abscess  1  1/135 (0.74%)  0/122 (0.00%) 
Toxoplasmosis  1  0/135 (0.00%)  1/122 (0.82%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  0/135 (0.00%)  1/122 (0.82%) 
Heat illness  1  1/135 (0.74%)  0/122 (0.00%) 
Lumbar vertebral fracture  1  1/135 (0.74%)  0/122 (0.00%) 
Overdose  1  3/135 (2.22%)  0/122 (0.00%) 
Investigations     
Haemoglobin decreased  1  1/135 (0.74%)  1/122 (0.82%) 
Lipase increased  1  0/135 (0.00%)  2/122 (1.64%) 
Neutrophil count decreased  1  0/135 (0.00%)  1/122 (0.82%) 
Metabolism and nutrition disorders     
Hypertriglyceridaemia  1  1/135 (0.74%)  1/122 (0.82%) 
Hypophosphataemia  1  1/135 (0.74%)  0/122 (0.00%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  0/135 (0.00%)  1/122 (0.82%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung adenocarcinoma metastatic  1  0/135 (0.00%)  1/122 (0.82%) 
Metastatic malignant melanoma  1  0/135 (0.00%)  1/122 (0.82%) 
Prostate cancer  1  1/135 (0.74%)  0/122 (0.00%) 
Nervous system disorders     
Cerebellar haemorrhage  1  1/135 (0.74%)  0/122 (0.00%) 
Parkinsonism  1  0/135 (0.00%)  1/122 (0.82%) 
Radiculopathy  1  0/135 (0.00%)  1/122 (0.82%) 
Syncope  1  0/135 (0.00%)  1/122 (0.82%) 
Psychiatric disorders     
Confusional state  1  1/135 (0.74%)  0/122 (0.00%) 
Depression  1  2/135 (1.48%)  0/122 (0.00%) 
Mental status changes  1  1/135 (0.74%)  0/122 (0.00%) 
Psychotic disorder  1  0/135 (0.00%)  1/122 (0.82%) 
Schizophrenia  1  0/135 (0.00%)  1/122 (0.82%) 
Suicidal ideation  1  1/135 (0.74%)  0/122 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  1/135 (0.74%)  0/122 (0.00%) 
Nephrolithiasis  1  1/135 (0.74%)  1/122 (0.82%) 
Reproductive system and breast disorders     
Priapism  1  1/135 (0.74%)  0/122 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/135 (0.74%)  0/122 (0.00%) 
Cough  1  0/135 (0.00%)  1/122 (0.82%) 
Dyspnoea  1  1/135 (0.74%)  0/122 (0.00%) 
Lung disorder  1  1/135 (0.74%)  0/122 (0.00%) 
Vascular disorders     
Hypotension  1  1/135 (0.74%)  0/122 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HCV Treatment-Naive (Group A) HCV Treatment-Experienced (Group B)
Affected / at Risk (%) Affected / at Risk (%)
Total   135/135 (100.00%)   120/122 (98.36%) 
Gastrointestinal disorders     
Abdominal pain  1  8/135 (5.93%)  7/122 (5.74%) 
Diarrhoea  1  9/135 (6.67%)  13/122 (10.66%) 
Nausea  1  28/135 (20.74%)  28/122 (22.95%) 
Vomiting  1  18/135 (13.33%)  13/122 (10.66%) 
General disorders     
Asthenia  1  3/135 (2.22%)  7/122 (5.74%) 
Chills  1  17/135 (12.59%)  16/122 (13.11%) 
Fatigue  1  44/135 (32.59%)  34/122 (27.87%) 
Malaise  1  7/135 (5.19%)  7/122 (5.74%) 
Pain  1  4/135 (2.96%)  8/122 (6.56%) 
Pyrexia  1  13/135 (9.63%)  12/122 (9.84%) 
Investigations     
Alanine aminotransferase increased  1  72/135 (53.33%)  66/122 (54.10%) 
Aspartate aminotransferase increased  1  95/135 (70.37%)  89/122 (72.95%) 
Blood albumin decreased  1  8/135 (5.93%)  6/122 (4.92%) 
Blood alkaline phosphatase increased  1  10/135 (7.41%)  18/122 (14.75%) 
Blood bicarbonate decreased  1  13/135 (9.63%)  10/122 (8.20%) 
Blood bilirubin increased  1  32/135 (23.70%)  37/122 (30.33%) 
Blood creatinine increased  1  27/135 (20.00%)  21/122 (17.21%) 
Blood glucose decreased  1  11/135 (8.15%)  4/122 (3.28%) 
Blood glucose increased  1  26/135 (19.26%)  29/122 (23.77%) 
Blood phosphorus decreased  1  10/135 (7.41%)  9/122 (7.38%) 
Blood potassium decreased  1  9/135 (6.67%)  9/122 (7.38%) 
Blood sodium decreased  1  11/135 (8.15%)  14/122 (11.48%) 
Blood uric acid increased  1  11/135 (8.15%)  21/122 (17.21%) 
Haemoglobin decreased  1  74/135 (54.81%)  68/122 (55.74%) 
Lipase abnormal  1  12/135 (8.89%)  20/122 (16.39%) 
Lipase increased  1  6/135 (4.44%)  12/122 (9.84%) 
Neutrophil count decreased  1  115/135 (85.19%)  95/122 (77.87%) 
Platelet count decreased  1  68/135 (50.37%)  73/122 (59.84%) 
Weight decreased  1  20/135 (14.81%)  26/122 (21.31%) 
White blood cell count decreased  1  35/135 (25.93%)  34/122 (27.87%) 
Metabolism and nutrition disorders     
Decreased appetite  1  16/135 (11.85%)  14/122 (11.48%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  6/135 (4.44%)  10/122 (8.20%) 
Myalgia  1  11/135 (8.15%)  14/122 (11.48%) 
Pain in extremity  1  4/135 (2.96%)  13/122 (10.66%) 
Nervous system disorders     
Dizziness  1  7/135 (5.19%)  9/122 (7.38%) 
Headache  1  13/135 (9.63%)  16/122 (13.11%) 
Psychiatric disorders     
Anxiety  1  10/135 (7.41%)  5/122 (4.10%) 
Depression  1  10/135 (7.41%)  7/122 (5.74%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  5/135 (3.70%)  13/122 (10.66%) 
Dyspnoea  1  9/135 (6.67%)  10/122 (8.20%) 
Skin and subcutaneous tissue disorders     
Erythema  1  3/135 (2.22%)  9/122 (7.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: ACTG ClinicalTrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Publications of Results:
Sherman KE, Kang M, Sterling R, Umbleja T, Marks K, Alston-Smith B, Greaves W, Butt A. BIRTH: A Phase 3 Trial of Boceprevir/Pegylated Interferon/Ribavirin in HCV/HIV. IDWeek. San Diego, CA. October, 2015. [Abstract 903]
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01482767     History of Changes
Other Study ID Numbers: A5294 (BIRTH)
11774 ( Registry Identifier: DAIDS ES )
ACTG 5294
BIRTH
First Submitted: November 28, 2011
First Posted: December 1, 2011
Results First Submitted: April 5, 2016
Results First Posted: May 10, 2016
Last Update Posted: June 3, 2016