Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1 (NCT NCT01479868)
NCT ID: NCT01479868
Last Updated: 2014-10-29
Results Overview
The SVR 12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (\<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels \<25 IU/mL undetectable or HCV RNA levels \<25 IU/mL detectable at 12 Weeks after end of treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
109 participants
Primary outcome timeframe
12 weeks after end of treatment (Week 24 or 48)
Results posted on
2014-10-29
Participant Flow
Participant milestones
| Measure |
TMC435 150mg 12Wks PR24/48
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
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|---|---|
|
Overall Study
STARTED
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106
|
|
Overall Study
COMPLETED
|
97
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
TMC435 150mg 12Wks PR24/48
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
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|---|---|
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Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Sponsor's Decision
|
1
|
|
Overall Study
Initiation of new HCV Therapy
|
1
|
Baseline Characteristics
A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1
Baseline characteristics by cohort
| Measure |
TMC435 150mg 12Wks PR24/48
n=106 Participants
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
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|---|---|
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Age, Continuous
|
48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after end of treatment (Week 24 or 48)Population: Intent to treat (ITT) population included all participants who received at least 1 dose of study drug.
The SVR 12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (\<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels \<25 IU/mL undetectable or HCV RNA levels \<25 IU/mL detectable at 12 Weeks after end of treatment.
Outcome measures
| Measure |
TMC435 150mg 12Wks PR24/48
n=106 Participants
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
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|---|---|
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Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12)
|
73.6 percentage of participants
Interval 65.1 to 82.1
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SECONDARY outcome
Timeframe: 24 weeks after end of treatment (Week 24 or 48)Population: The ITT population included all perticipants who had at least 1 dose of study drug.
The SVR 24 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (\<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels \<25 IU/mL undetectable or HCV RNA levels \<25 IU/mL detectable at 24 weeks after end of treatment.
Outcome measures
| Measure |
TMC435 150mg 12Wks PR24/48
n=106 Participants
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
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|---|---|
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Percentage of Participants With Sustained Virologic Response at Week 24 (SVR 24)
|
72.6 percentage of participants
Interval 64.0 to 81.3
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SECONDARY outcome
Timeframe: Week 4, 12, 24, 36, and 48Population: ITT population included all participants who had at least 1 dose of study drug. Here, "N" (number of participants analyzed) is the number of participants analyzed for this outcome measure, "n" is the number of participants analyzed for this outcome measure at specific time points.
Percentage of participants with HCV RNA less than (\<) 25 IU/mL undetectable (undet.) or detectable (det.)/undetectable at specific time points were observed.
Outcome measures
| Measure |
TMC435 150mg 12Wks PR24/48
n=105 Participants
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
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|---|---|
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Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable
Week 4: < 25 IU/mL HCV-RNA undet. (n=105)
|
65.7 percentage of participants
Interval 56.5 to 74.9
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|
Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable
Week 4:< 25 IU/mL HCV-RNA det./undet. (n=105)
|
88.6 percentage of participants
Interval 82.4 to 94.8
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Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable
Week 12:< 25 IU/mL HCV-RNA undet. (n=97)
|
94.8 percentage of participants
Interval 90.4 to 99.3
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Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable
Week 12:< 25 IU/mL HCV-RNA det./undet. (n=97)
|
97.9 percentage of participants
Interval 95.1 to 97.9
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Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable
Week 24:< 25 IU/mL HCV-RNA undet. (n=90)
|
90.0 percentage of participants
Interval 83.7 to 96.3
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|
Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable
Week 24:< 25 IU/mL HCV-RNA det./undet. (n=90)
|
93.3 percentage of participants
Interval 88.1 to 98.6
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|
Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable
Week 48:< 25 IU/mL HCV-RNA undet. (n=20)
|
100 percentage of participants
Interval 100.0 to 100.0
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|
Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable
Week 48:< 25 IU/mL HCV-RNA det./undet. (n=20)
|
100 percentage of participants
Interval 100.0 to 100.0
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SECONDARY outcome
Timeframe: Week 1 to 48Population: The ITT population included all participants who received at least 1 dose of study drug.
Participants were considered as an on-treatment failure if, at actual end of treatment (EOT), there was confirmed detectable HCV RNA levels.
Outcome measures
| Measure |
TMC435 150mg 12Wks PR24/48
n=106 Participants
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
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|---|---|
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Percentage of Participants With On-treatment Failure
|
17 percentage of participants
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SECONDARY outcome
Timeframe: Week 1 to 48Population: The ITT population included all participants who received at least 1 dose of study drug.
Confirmed increase of more than 1 log10 IU per mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of more than 100 IU per mL in participants whose HCV RNA levels had previously been below the limit of quantification (less than 25 IU per mL detectable) or undetectable (less than 25 IU per mL undetectable), while on study therapy.
Outcome measures
| Measure |
TMC435 150mg 12Wks PR24/48
n=105 Participants
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
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|---|---|
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Percentage of Participants With Viral Breakthrough
|
11.4 percentage of participants
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SECONDARY outcome
Timeframe: Week 1 to 72Population: The ITT population included all participants who received at least 1 dose of study drug. Here, "N" (number of participants analyzed) is the number of participants analyzed for this outcome measure.
Participants were considered to have a viral relapse when, at actual end of treatment, HCV RNA levels were less than 25 IU per mL undetectable; and during the follow-up period, HCV RNA levels were more than or equal to 25 IU per mL.
Outcome measures
| Measure |
TMC435 150mg 12Wks PR24/48
n=87 Participants
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
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|---|---|
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Percentage of Participants With Viral Relapse
|
10.3 percentage of participants
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SECONDARY outcome
Timeframe: Baseline up to Week 72Population: The ITT population included all participants who received at least 1 dose of study drug. Here "N" signifies participants evaluable for this measure.
Participants with normalized alanine aminotransferase levels observed whose alanine aminotransferase levels were out of range at Baseline.
Outcome measures
| Measure |
TMC435 150mg 12Wks PR24/48
n=65 Participants
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
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|---|---|
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Percentage of Participants With Normalized Alanine Aminotransferase Levels
|
81.5 percentage of participants
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SECONDARY outcome
Timeframe: Baseline to Week 72.Population: Participants who received potent anti-HIV treatment with a combination of more than 3 anti-antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed.
Participants had confirmed HIV virologic failure if HIV viral load values were greater than or equal to 50 or 200 copies/mL among those who previously had less than 50 copies/mL.
Outcome measures
| Measure |
TMC435 150mg 12Wks PR24/48
n=93 Participants
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
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|---|---|
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Percentage of Human Immunodeficiency Virus (HIV) Participants With Virologic Failure
Greater than or equal to 50 copies/mL
|
5.4 percentage of participants
|
|
Percentage of Human Immunodeficiency Virus (HIV) Participants With Virologic Failure
Greater than or equal to 200 copies/mL
|
2.2 percentage of participants
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SECONDARY outcome
Timeframe: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72Population: Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here "n" signifies participants evaluable for this measure at specified time point.
Outcome measures
| Measure |
TMC435 150mg 12Wks PR24/48
n=93 Participants
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
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|---|---|
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Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load
Change at Week 4 (n=93)
|
-0.0704 copies per milliliter
Standard Deviation 0.25817
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Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load
Change at Week 8 (n=92)
|
-0.0442 copies per milliliter
Standard Deviation 0.40974
|
|
Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load
Change at Week 12 (n=90)
|
-0.0655 copies per milliliter
Standard Deviation 0.30510
|
|
Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load
Change at Week 16 (n=88)
|
-0.0829 copies per milliliter
Standard Deviation 0.23986
|
|
Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load
Change at Week 20 (n=86)
|
-0.0847 copies per milliliter
Standard Deviation 0.25111
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|
Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load
Baseline (n=93)
|
1.3726 copies per milliliter
Standard Deviation 0.25796
|
|
Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load
Change at Week 2 (n=91)
|
-0.0724 copies per milliliter
Standard Deviation 0.23857
|
|
Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load
Change at Week 24 (n=88)
|
-0.0689 copies per milliliter
Standard Deviation 0.24785
|
|
Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load
Change at Week 28 (n=82)
|
-0.0564 copies per milliliter
Standard Deviation 0.26319
|
|
Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load
Change at Week 36 (n=85)
|
0.0004 copies per milliliter
Standard Deviation 0.24395
|
|
Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load
Change at Week 42 (n=35)
|
-0.0623 copies per milliliter
Standard Deviation 0.29365
|
|
Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load
Change at Week 48 (n=79)
|
-0.0041 copies per milliliter
Standard Deviation 0.36177
|
|
Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load
Change at Week 52 (n=36)
|
0.0011 copies per milliliter
Standard Deviation 0.20767
|
|
Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load
Change at Week 60 (n=40)
|
-0.0184 copies per milliliter
Standard Deviation 0.20940
|
|
Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load
Change at Week 72 (n=38)
|
-0.0265 copies per milliliter
Standard Deviation 0.18323
|
|
Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load
Change at End of study (n=93)
|
0.0099 copies per milliliter
Standard Deviation 0.33435
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72Population: Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here, "n" is the number of participants analyzed for this outcome measure at spcific time points.
Outcome measures
| Measure |
TMC435 150mg 12Wks PR24/48
n=93 Participants
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
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|---|---|
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Mean Change From Baseline in CD4+ Cell Count
Change at Week 8 (n=92)
|
-244.2 cell counts per microliter
Standard Deviation 185.04
|
|
Mean Change From Baseline in CD4+ Cell Count
Change at Week 12 (n=91)
|
-271.7 cell counts per microliter
Standard Deviation 194.49
|
|
Mean Change From Baseline in CD4+ Cell Count
Change at Week 16 (n=88)
|
-275.5 cell counts per microliter
Standard Deviation 183.96
|
|
Mean Change From Baseline in CD4+ Cell Count
Change at Week 20 (n=84)
|
-283.5 cell counts per microliter
Standard Deviation 175.27
|
|
Mean Change From Baseline in CD4+ Cell Count
Change at Week 24 (n=89)
|
-288.8 cell counts per microliter
Standard Deviation 202.31
|
|
Mean Change From Baseline in CD4+ Cell Count
Change at Week 28 (n=82)
|
-252.3 cell counts per microliter
Standard Deviation 203.45
|
|
Mean Change From Baseline in CD4+ Cell Count
Baseline (n=93)
|
640.3 cell counts per microliter
Standard Deviation 243.11
|
|
Mean Change From Baseline in CD4+ Cell Count
Change at Week 2 (n=89)
|
-95.0 cell counts per microliter
Standard Deviation 190.34
|
|
Mean Change From Baseline in CD4+ Cell Count
Change at Week 4 (n=91)
|
-171.5 cell counts per microliter
Standard Deviation 170.67
|
|
Mean Change From Baseline in CD4+ Cell Count
Change at Week 36 (n=83)
|
-198.7 cell counts per microliter
Standard Deviation 225.62
|
|
Mean Change From Baseline in CD4+ Cell Count
Change at Week 42 (n=33)
|
-336.8 cell counts per microliter
Standard Deviation 240.64
|
|
Mean Change From Baseline in CD4+ Cell Count
Change at Week 48 (n=77)
|
-166.6 cell counts per microliter
Standard Deviation 248.25
|
|
Mean Change From Baseline in CD4+ Cell Count
Change at Week 52 (n=35)
|
-202.7 cell counts per microliter
Standard Deviation 222.89
|
|
Mean Change From Baseline in CD4+ Cell Count
Change at Week 60 (n=40)
|
-90.6 cell counts per microliter
Standard Deviation 189.74
|
|
Mean Change From Baseline in CD4+ Cell Count
Change at Week 72 (n=38)
|
-62.9 cell counts per microliter
Standard Deviation 175.61
|
|
Mean Change From Baseline in CD4+ Cell Count
Change at End of Study (n=93)
|
-51.1 cell counts per microliter
Standard Deviation 178.20
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72Population: Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here, "n" is the number of participants analyzed for this outcome measure at spcific time points.
Outcome measures
| Measure |
TMC435 150mg 12Wks PR24/48
n=93 Participants
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
|
|---|---|
|
Change From Baseline in CD4+ Cell Count in Percentage
Change at Week 28 (n=82)
|
3.79 percentage of lymphocyte
Standard Deviation 6.759
|
|
Change From Baseline in CD4+ Cell Count in Percentage
Change at Week 36 (n=83)
|
2.75 percentage of lymphocyte
Standard Deviation 6.492
|
|
Change From Baseline in CD4+ Cell Count in Percentage
Change at Week 42 (n=33)
|
6.41 percentage of lymphocyte
Standard Deviation 6.213
|
|
Change From Baseline in CD4+ Cell Count in Percentage
Change at Week 48 (n=77)
|
2.09 percentage of lymphocyte
Standard Deviation 7.356
|
|
Change From Baseline in CD4+ Cell Count in Percentage
Change at Week 52 (n=35)
|
3.26 percentage of lymphocyte
Standard Deviation 6.838
|
|
Change From Baseline in CD4+ Cell Count in Percentage
Change at Week 60 (n=40)
|
0.25 percentage of lymphocyte
Standard Deviation 5.296
|
|
Change From Baseline in CD4+ Cell Count in Percentage
Baseline (n=93)
|
31.65 percentage of lymphocyte
Standard Deviation 8.390
|
|
Change From Baseline in CD4+ Cell Count in Percentage
Change at Week 2 (n=89)
|
0.42 percentage of lymphocyte
Standard Deviation 6.490
|
|
Change From Baseline in CD4+ Cell Count in Percentage
Change at Week 4 (n=91)
|
2.50 percentage of lymphocyte
Standard Deviation 5.943
|
|
Change From Baseline in CD4+ Cell Count in Percentage
Change at Week 8 (n=92)
|
3.85 percentage of lymphocyte
Standard Deviation 5.930
|
|
Change From Baseline in CD4+ Cell Count in Percentage
Change at Week 12 (n=91)
|
3.93 percentage of lymphocyte
Standard Deviation 6.264
|
|
Change From Baseline in CD4+ Cell Count in Percentage
Change at Week 16 (n=88)
|
5.47 percentage of lymphocyte
Standard Deviation 6.301
|
|
Change From Baseline in CD4+ Cell Count in Percentage
Change at Week 20 (n=84)
|
5.27 percentage of lymphocyte
Standard Deviation 6.961
|
|
Change From Baseline in CD4+ Cell Count in Percentage
Change at Week 24 (n=89)
|
5.50 percentage of lymphocyte
Standard Deviation 7.029
|
|
Change From Baseline in CD4+ Cell Count in Percentage
Change at Week 72 (n=38)
|
0.70 percentage of lymphocyte
Standard Deviation 4.406
|
|
Change From Baseline in CD4+ Cell Count in Percentage
Change at End of study (n=93)
|
0.13 percentage of lymphocyte
Standard Deviation 6.169
|
SECONDARY outcome
Timeframe: Week 1 to Week 72Population: Safety population included all participants who received at least 1 dose of study drug.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 126 that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
TMC435 150mg 12Wks PR24/48
n=106 Participants
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
|
|---|---|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
102 participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
6 participants
|
Adverse Events
TMC435 150mg 12Wks PR24/48
Serious events: 11 serious events
Other events: 103 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TMC435 150mg 12Wks PR24/48
n=106 participants at risk
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
2/106 • Week 1 to Week 72
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.94%
1/106 • Week 1 to Week 72
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.94%
1/106 • Week 1 to Week 72
|
|
Gastrointestinal disorders
Colitis
|
0.94%
1/106 • Week 1 to Week 72
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.94%
1/106 • Week 1 to Week 72
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.94%
1/106 • Week 1 to Week 72
|
|
Psychiatric disorders
Mental status changes
|
0.94%
1/106 • Week 1 to Week 72
|
|
Psychiatric disorders
Psychotic disorder
|
0.94%
1/106 • Week 1 to Week 72
|
|
Blood and lymphatic system disorders
Anaemia
|
0.94%
1/106 • Week 1 to Week 72
|
|
Cardiac disorders
Angina pectoris
|
0.94%
1/106 • Week 1 to Week 72
|
|
General disorders
General physical health deterioration
|
0.94%
1/106 • Week 1 to Week 72
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.94%
1/106 • Week 1 to Week 72
|
|
Infections and infestations
Catheter site infection
|
0.94%
1/106 • Week 1 to Week 72
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.94%
1/106 • Week 1 to Week 72
|
|
Investigations
Aspartate aminotransferase increased
|
0.94%
1/106 • Week 1 to Week 72
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.94%
1/106 • Week 1 to Week 72
|
Other adverse events
| Measure |
TMC435 150mg 12Wks PR24/48
n=106 participants at risk
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
|
|---|---|
|
General disorders
Fatigue
|
45.3%
48/106 • Week 1 to Week 72
|
|
General disorders
Influenza like illness
|
23.6%
25/106 • Week 1 to Week 72
|
|
General disorders
Asthenia
|
22.6%
24/106 • Week 1 to Week 72
|
|
General disorders
Pyrexia
|
11.3%
12/106 • Week 1 to Week 72
|
|
General disorders
Chills
|
8.5%
9/106 • Week 1 to Week 72
|
|
General disorders
Injection site reaction
|
7.5%
8/106 • Week 1 to Week 72
|
|
General disorders
Pain
|
6.6%
7/106 • Week 1 to Week 72
|
|
General disorders
Injection site erythema
|
5.7%
6/106 • Week 1 to Week 72
|
|
Psychiatric disorders
Insomnia
|
25.5%
27/106 • Week 1 to Week 72
|
|
Psychiatric disorders
Mood altered
|
18.9%
20/106 • Week 1 to Week 72
|
|
Psychiatric disorders
Depression
|
17.9%
19/106 • Week 1 to Week 72
|
|
Psychiatric disorders
Anxiety
|
12.3%
13/106 • Week 1 to Week 72
|
|
Psychiatric disorders
Sleep disorder
|
5.7%
6/106 • Week 1 to Week 72
|
|
Gastrointestinal disorders
Nausea
|
29.2%
31/106 • Week 1 to Week 72
|
|
Gastrointestinal disorders
Diarrhoea
|
23.6%
25/106 • Week 1 to Week 72
|
|
Gastrointestinal disorders
Vomiting
|
13.2%
14/106 • Week 1 to Week 72
|
|
Gastrointestinal disorders
Constipation
|
11.3%
12/106 • Week 1 to Week 72
|
|
Blood and lymphatic system disorders
Neutropenia
|
31.1%
33/106 • Week 1 to Week 72
|
|
Blood and lymphatic system disorders
Anaemia
|
28.3%
30/106 • Week 1 to Week 72
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.7%
6/106 • Week 1 to Week 72
|
|
Nervous system disorders
Headache
|
33.0%
35/106 • Week 1 to Week 72
|
|
Nervous system disorders
Dizziness
|
12.3%
13/106 • Week 1 to Week 72
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.9%
19/106 • Week 1 to Week 72
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.1%
16/106 • Week 1 to Week 72
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.5%
8/106 • Week 1 to Week 72
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.6%
7/106 • Week 1 to Week 72
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.6%
7/106 • Week 1 to Week 72
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.0%
17/106 • Week 1 to Week 72
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.2%
15/106 • Week 1 to Week 72
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.5%
8/106 • Week 1 to Week 72
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
6/106 • Week 1 to Week 72
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.4%
11/106 • Week 1 to Week 72
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.4%
10/106 • Week 1 to Week 72
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.5%
9/106 • Week 1 to Week 72
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.8%
21/106 • Week 1 to Week 72
|
|
Investigations
Weight decreased
|
12.3%
13/106 • Week 1 to Week 72
|
|
Investigations
Neutrophil count decreased
|
5.7%
6/106 • Week 1 to Week 72
|
|
Infections and infestations
Nasopharyngitis
|
6.6%
7/106 • Week 1 to Week 72
|
|
Infections and infestations
Upper respiratory tract infection
|
6.6%
7/106 • Week 1 to Week 72
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60