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A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)

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ClinicalTrials.gov Identifier: NCT01467479
Recruitment Status : Terminated (It was decided by Sponsor on 13 January 2014 to terminate study early at primary efficacy endpoint as part of a decision to modify drug development plan.)
First Posted : November 8, 2011
Results First Posted : March 17, 2015
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Telaprevir
Drug: Ribavirin
Biological: Pegylated Interferon Alfa-2a
Drug: Highly Active Antiretroviral Therapy (HAART)
Enrollment 185
Recruitment Details Study included Treatment-Naïve (no prior hepatitis C virus [HCV] therapy); Prior Relapser (prior HCV treatment with pegylated interferon alfa/ribavirin [Peg-IFN/RBV] and experienced viral relapse); and Prior Null/Partial Responder (prior HCV treatment with Peg-IFN/RBV and had null/partial response) participants.
Pre-assignment Details Efficacy analyses were reported as per highly active antiretroviral therapy (HAART) treatment (reporting arms) and also separately as per prior response (in categories) (Treatment-Naive, Prior Relapser, Prior Null Responder, Prior Partial Responder as well as for Total Participants), unless otherwise specified.
Arm/Group Title T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
Hide Arm/Group Description Participants who were receiving atazanavir/ritonavir (ATV/r) based HAART at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion. Participants who were receiving efavirenz (EFV) based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion. Participants who were receiving raltegravir (RAL) based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Period Title: Overall Study
Started 55 69 61
Treated 54 69 59
Completed 46 52 45
Not Completed 9 17 16
Reason Not Completed
No Study Medication             1             0             2
Adverse Event             1             2             0
Death             0             0             1
Lost to Follow-up             2             5             3
Withdrawal of Consent             3             7             7
Study Terminated by Sponsor             1             3             3
Other             1             0             0
Arm/Group Title T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based) Total
Hide Arm/Group Description Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion. Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion. Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion. Total of all reporting groups
Overall Number of Baseline Participants 54 69 59 182
Hide Baseline Analysis Population Description
The Full Analysis Set (FAS), included all randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 69 participants 59 participants 182 participants
50.4  (8.81) 49.6  (8.84) 48.4  (9.58) 49.5  (9.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 69 participants 59 participants 182 participants
Female
6
  11.1%
9
  13.0%
15
  25.4%
30
  16.5%
Male
48
  88.9%
60
  87.0%
44
  74.6%
152
  83.5%
1.Primary Outcome
Title Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
Hide Description SVR 12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last planned dose of study drug. The plasma hepatitis C virus ribonucleic acid (HCV RNA) level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).
Time Frame 12 weeks after last planned dose of study drug (up to Week 60)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.
Arm/Group Title T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
Hide Arm/Group Description:
Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Overall Number of Participants Analyzed 54 69 59
Measure Type: Number
Unit of Measure: percentage of participants
Treatment Naïve (n= 24, 39, 31) 66.7 59.0 61.3
Prior Relapser (n=8, 11, 4) 75.0 54.5 100
Prior Null Responder (n= 15, 11, 15) 40 36.4 40
Prior Partial Responder (n= 7, 8, 9) 14.3 87.5 55.6
Total (n= 54, 69, 59) 53.7 58.0 57.6
2.Secondary Outcome
Title Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24)
Hide Description SVR 24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 24 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).
Time Frame 24 weeks after last planned dose of study drug (up to Week 72)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety set. Here number of participants analyzed = participants evaluable for this measure and n = participants evaluable for specified categories, for each arm, respectively.
Arm/Group Title T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
Hide Arm/Group Description:
Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Overall Number of Participants Analyzed 53 66 56
Measure Type: Number
Unit of Measure: percentage of participants
Treatment Naïve (n= 23, 38, 29) 65.2 57.9 51.7
Prior Relapser (n=8, 11, 4) 75.0 54.5 100
Prior Null Responder (n= 15, 9, 14) 33.3 22.2 35.7
Prior Partial Responder (n= 7, 8, 9) 14.3 75.0 55.6
Total (n= 53, 66, 56) 50.9 54.5 51.8
3.Secondary Outcome
Title Percentage of Participants With Rapid Viral Response (RVR)
Hide Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. RVR was defined as undetectable HCV RNA (<lower limit of quantification) 4 weeks after the start of study treatment.
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety set. Here, n = participants evaluable for specified category for each arm, respectively.
Arm/Group Title T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
Hide Arm/Group Description:
Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Overall Number of Participants Analyzed 54 69 59
Measure Type: Number
Unit of Measure: percentage of participants
Treatment Naïve (n= 24, 39, 31) 50.0 53.8 74.2
Prior Relapser (n=8, 11, 4) 62.5 72.7 100
Prior Null Responder (n= 15, 11, 15) 26.7 54.5 53.3
Prior Partial Responder (n= 7, 8, 9) 42.9 50.0 44.4
Total (n= 54, 69, 59) 44.4 56.5 66.1
4.Secondary Outcome
Title Percentage of Participants With Extended Rapid Viral Response (eRVR)
Hide Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.
Time Frame Week 4 and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety set. Here, n = participants evaluable for specified category for each arm, respectively.
Arm/Group Title T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
Hide Arm/Group Description:
Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Overall Number of Participants Analyzed 54 69 59
Measure Type: Number
Unit of Measure: percentage of participants
Treatment Naïve (n= 24, 39, 31) 50.0 53.8 61.3
Prior Relapser (n=8, 11, 4) 62.5 72.7 100
Prior Null Responder (n= 15, 11, 15) 26.7 54.5 53.3
Prior Partial Responder (n= 7, 8, 9) 14.3 50.0 44.4
Total (n= 54, 69, 59) 40.7 56.5 59.3
5.Secondary Outcome
Title Percentage of Participants With Undetectable HCV RNA at End of Treatment (EOT)
Hide Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Percentage of participants with undetectable HCV RNA (<lower limit of quantification) at EOT (up to Week 48) are reported. Data for this outcome was not planned to be reported by prior response.
Time Frame EOT (up to Week 48)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who received at least 1 dose of study drug.
Arm/Group Title T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
Hide Arm/Group Description:
Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Overall Number of Participants Analyzed 54 69 59
Measure Type: Number
Unit of Measure: percentage of participants
55.6 63.8 61.0
6.Secondary Outcome
Title Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.
Time Frame Up to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety set.
Arm/Group Title T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
Hide Arm/Group Description:
Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Overall Number of Participants Analyzed 54 69 59
Measure Type: Number
Unit of Measure: percentage of participants
AEs 100 95.7 94.9
SAEs 13.0 11.6 15.3
7.Secondary Outcome
Title Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg)
Hide Description Cmax, Cmin, and Cavg were reported for atazanavir (ATV), efavirenz (EFV), raltegravir (RAL), and telaprevir.
Time Frame Day -14 to Day -1 and Week 1 for ATV, EFV, and RAL; Week 1 for telaprevir
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set.Here, n = participants evaluable for specified category for each arm, respectively.
Arm/Group Title T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
Hide Arm/Group Description:
Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Overall Number of Participants Analyzed 54 69 59
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
ATV: Day -14 to Day -1, Cmax(n=46, 0, 0) 2870  (1580) NA [1]   (NA) NA [1]   (NA)
ATV: Day -14 to Day -1, Cmin(n=46, 0, 0) 991  (635) NA [1]   (NA) NA [1]   (NA)
ATV: Day -14 to Day -1, Cavg(n=41, 0, 0) 1100  (647) NA [1]   (NA) NA [1]   (NA)
ATV: Week 1, Cmax (n=42, 0, 0) 2820  (1570) NA [1]   (NA) NA [1]   (NA)
ATV: Week 1, Cmin (n=42, 0, 0) 1280  (636) NA [1]   (NA) NA [1]   (NA)
ATV: Week 1, Cavg (n=30, 0, 0) 1320  (685) NA [1]   (NA) NA [1]   (NA)
EFV: Day -14 to Day -1, Cmax(n=0, 60, 0) NA [1]   (NA) 3800  (2600) NA [1]   (NA)
EFV: Day -14 to Day -1, Cmin(n=0, 60, 0) NA [1]   (NA) 2560  (1900) NA [1]   (NA)
EFV: Day -14 to Day -1, Cavg(n=0, 51, 0) NA [1]   (NA) 2150  (1680) NA [1]   (NA)
EFV: Week 1, Cmax (n=0, 51, 0) NA [1]   (NA) 3340  (2450) NA [1]   (NA)
EFV: Week 1, Cmin (n=0, 51, 0) NA [1]   (NA) 2290  (1880) NA [1]   (NA)
EFV: Week 1, Cavg (n=0, 47, 0) NA [1]   (NA) 1920  (1400) NA [1]   (NA)
RAL: Day -14 to Day -1, Cmax(n=0, 0, 52) NA [1]   (NA) NA [1]   (NA) 1900  (1880)
RAL: Day -14 to Day -1, Cmin(n=0, 0, 52) NA [1]   (NA) NA [1]   (NA) 196  (198)
RAL: Day -14 to Day -1, Cavg(n=0, 0, 35) NA [1]   (NA) NA [1]   (NA) 483  (429)
RAL: Week 1, Cmax (n=0, 0, 49) NA [1]   (NA) NA [1]   (NA) 2320  (1970)
RAL: Week 1, Cmin (n=0, 0, 49) NA [1]   (NA) NA [1]   (NA) 281  (435)
RAL: Week 1, Cavg (n=0, 0, 34) NA [1]   (NA) NA [1]   (NA) 643  (539)
Telaprevir: Week 1, Cmax(n=49, 59, 54) 3160  (1180) 3780  (1670) 3470  (868)
Telaprevir: Week 1, Cmin(n=49, 59, 54) 1650  (863) 1750  (961) 1840  (741)
Telaprevir: Week 1, Cavg(n=30, 32, 26) 2320  (907) 2430  (1290) 2520  (643)
[1]
Data not reported as no participant was evaluable for this parameter from this reporting group
8.Secondary Outcome
Title Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
Hide Description Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by HAART treatment.
Time Frame Baseline, follow-up (Week 96)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Here number of participants analyzed = participants who were evaluable for this measure and n = participants evaluable for specified categories.
Arm/Group Title T/PR + HAART Regimen
Hide Arm/Group Description:
Participants who were receiving either ATV/r based HAART or EFV based HAART or RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily or 1125 mg three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their respective HAART, as per standard practice and investigator discretion.
Overall Number of Participants Analyzed 180
Measure Type: Number
Unit of Measure: participants
Baseline (n = 180) 2
Follow-up (n = 26) 11
Time Frame Baseline up to Week 52
Adverse Event Reporting Description Adverse events were planned to be reported as per HAART treatment.
 
Arm/Group Title T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
Hide Arm/Group Description Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion. Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion. Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
All-Cause Mortality
T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/54 (12.96%)      8/69 (11.59%)      9/59 (15.25%)    
Blood and lymphatic system disorders       
Anaemia  1  0/54 (0.00%)  3/69 (4.35%)  4/59 (6.78%) 
Neutropenia  1  1/54 (1.85%)  1/69 (1.45%)  1/59 (1.69%) 
Leukocytosis  1  1/54 (1.85%)  0/69 (0.00%)  0/59 (0.00%) 
Ear and labyrinth disorders       
Vertigo  1  0/54 (0.00%)  0/69 (0.00%)  1/59 (1.69%) 
Endocrine disorders       
Basedow's disease  1  0/54 (0.00%)  0/69 (0.00%)  1/59 (1.69%) 
Eye disorders       
Retinopathy  1  0/54 (0.00%)  1/69 (1.45%)  0/59 (0.00%) 
Gastrointestinal disorders       
Diarrhoea  1  0/54 (0.00%)  0/69 (0.00%)  1/59 (1.69%) 
Mallory-Weiss syndrome  1  0/54 (0.00%)  1/69 (1.45%)  0/59 (0.00%) 
Rectal haemorrhage  1  0/54 (0.00%)  0/69 (0.00%)  1/59 (1.69%) 
Vomiting  1  1/54 (1.85%)  0/69 (0.00%)  0/59 (0.00%) 
General disorders       
Non-cardiac chest pain  1  1/54 (1.85%)  0/69 (0.00%)  0/59 (0.00%) 
Pyrexia  1  0/54 (0.00%)  0/69 (0.00%)  1/59 (1.69%) 
Infections and infestations       
Escherichia urinary tract infection  1  1/54 (1.85%)  0/69 (0.00%)  0/59 (0.00%) 
Pneumonia  1  0/54 (0.00%)  1/69 (1.45%)  0/59 (0.00%) 
Psoas abscess  1  1/54 (1.85%)  0/69 (0.00%)  0/59 (0.00%) 
Injury, poisoning and procedural complications       
Clavicle fracture  1  0/54 (0.00%)  1/69 (1.45%)  0/59 (0.00%) 
Investigations       
Hepatic enzyme increased  1  0/54 (0.00%)  1/69 (1.45%)  0/59 (0.00%) 
Metabolism and nutrition disorders       
Hypokalaemia  1  1/54 (1.85%)  0/69 (0.00%)  0/59 (0.00%) 
Musculoskeletal and connective tissue disorders       
Flank pain  1  1/54 (1.85%)  0/69 (0.00%)  0/59 (0.00%) 
Rhabdomyolysis  1  1/54 (1.85%)  0/69 (0.00%)  0/59 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma  1  1/54 (1.85%)  0/69 (0.00%)  0/59 (0.00%) 
Nervous system disorders       
Syncope  1  0/54 (0.00%)  1/69 (1.45%)  1/59 (1.69%) 
Psychiatric disorders       
Anxiety  1  1/54 (1.85%)  0/69 (0.00%)  0/59 (0.00%) 
Renal and urinary disorders       
Renal cyst  1  1/54 (1.85%)  0/69 (0.00%)  0/59 (0.00%) 
Renal failure acute  1  0/54 (0.00%)  0/69 (0.00%)  1/59 (1.69%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea exertional  1  1/54 (1.85%)  0/69 (0.00%)  0/59 (0.00%) 
Pneumonitis  1  1/54 (1.85%)  0/69 (0.00%)  0/59 (0.00%) 
Pulmonary embolism  1  0/54 (0.00%)  0/69 (0.00%)  1/59 (1.69%) 
Skin and subcutaneous tissue disorders       
Rash  1  0/54 (0.00%)  0/69 (0.00%)  1/59 (1.69%) 
Skin lesion  1  0/54 (0.00%)  0/69 (0.00%)  1/59 (1.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   54/54 (100.00%)      66/69 (95.65%)      56/59 (94.92%)    
Blood and lymphatic system disorders       
Anaemia  1  15/54 (27.78%)  17 21/69 (30.43%)  23 16/59 (27.12%)  20
Neutropenia  1  10/54 (18.52%)  13 15/69 (21.74%)  23 4/59 (6.78%)  6
Thrombocytopenia  1  1/54 (1.85%)  1 5/69 (7.25%)  6 0/59 (0.00%)  0
Lymphadenopathy  1  1/54 (1.85%)  1 2/69 (2.90%)  2 0/59 (0.00%)  0
Pancytopenia  1  3/54 (5.56%)  3 0/69 (0.00%)  0 0/59 (0.00%)  0
Haemolytic anaemia  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Lymph node pain  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Lymphoid tissue hyperplasia  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Lymphopenia  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Cardiac disorders       
Palpitations  1  0/54 (0.00%)  0 0/69 (0.00%)  0 3/59 (5.08%)  4
Tachycardia  1  0/54 (0.00%)  0 2/69 (2.90%)  2 0/59 (0.00%)  0
Atrioventricular block first degree  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Bundle branch block left  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Mitral valve incompetence  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Myocardial ischaemia  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Sinus tachycardia  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Tricuspid valve incompetence  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Ventricular extrasystoles  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Congenital, familial and genetic disorders       
Colour blindness  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Ear and labyrinth disorders       
Cerumen impaction  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Ear pruritus  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Hyperacusis  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Endocrine disorders       
Hypothyroidism  1  2/54 (3.70%)  2 0/69 (0.00%)  0 1/59 (1.69%)  1
Hypogonadism  1  2/54 (3.70%)  2 0/69 (0.00%)  0 0/59 (0.00%)  0
Eye disorders       
Photophobia  1  2/54 (3.70%)  2 1/69 (1.45%)  1 1/59 (1.69%)  1
Vision blurred  1  2/54 (3.70%)  2 1/69 (1.45%)  1 1/59 (1.69%)  1
Dry eye  1  1/54 (1.85%)  1 0/69 (0.00%)  0 1/59 (1.69%)  1
Ocular hyperaemia  1  0/54 (0.00%)  0 2/69 (2.90%)  2 0/59 (0.00%)  0
Visual impairment  1  0/54 (0.00%)  0 1/69 (1.45%)  1 1/59 (1.69%)  1
Abnormal sensation in eye  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Blepharitis  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Conjunctivitis allergic  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Eye discharge  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Eye inflammation  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Eye pruritus  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Hypermetropia  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Lacrimation increased  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Ocular icterus  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Gastrointestinal disorders       
Nausea  1  23/54 (42.59%)  27 22/69 (31.88%)  26 19/59 (32.20%)  23
Diarrhoea  1  13/54 (24.07%)  14 21/69 (30.43%)  22 6/59 (10.17%)  6
Vomiting  1  10/54 (18.52%)  10 11/69 (15.94%)  14 11/59 (18.64%)  15
Anorectal discomfort  1  6/54 (11.11%)  6 11/69 (15.94%)  11 9/59 (15.25%)  10
Anal pruritus  1  4/54 (7.41%)  4 10/69 (14.49%)  10 6/59 (10.17%)  6
Haemorrhoids  1  2/54 (3.70%)  2 11/69 (15.94%)  11 2/59 (3.39%)  3
Dry mouth  1  4/54 (7.41%)  4 1/69 (1.45%)  1 5/59 (8.47%)  5
Constipation  1  2/54 (3.70%)  2 5/69 (7.25%)  5 1/59 (1.69%)  1
Abdominal pain  1  2/54 (3.70%)  2 4/69 (5.80%)  4 1/59 (1.69%)  1
Cheilitis  1  1/54 (1.85%)  1 2/69 (2.90%)  2 3/59 (5.08%)  3
Gastrooesophageal reflux disease  1  2/54 (3.70%)  2 2/69 (2.90%)  2 2/59 (3.39%)  2
Aphthous stomatitis  1  2/54 (3.70%)  2 2/69 (2.90%)  2 1/59 (1.69%)  1
Dyspepsia  1  0/54 (0.00%)  0 2/69 (2.90%)  2 3/59 (5.08%)  3
Abdominal pain upper  1  0/54 (0.00%)  0 4/69 (5.80%)  4 0/59 (0.00%)  0
Proctalgia  1  0/54 (0.00%)  0 3/69 (4.35%)  3 1/59 (1.69%)  1
Rectal haemorrhage  1  1/54 (1.85%)  1 3/69 (4.35%)  3 0/59 (0.00%)  0
Flatulence  1  2/54 (3.70%)  2 1/69 (1.45%)  1 0/59 (0.00%)  0
Oral pain  1  0/54 (0.00%)  0 3/69 (4.35%)  4 0/59 (0.00%)  0
Abdominal discomfort  1  1/54 (1.85%)  1 0/69 (0.00%)  0 1/59 (1.69%)  1
Anal ulcer  1  0/54 (0.00%)  0 1/69 (1.45%)  1 1/59 (1.69%)  1
Gastritis  1  1/54 (1.85%)  2 0/69 (0.00%)  0 1/59 (1.69%)  1
Gingival pain  1  0/54 (0.00%)  0 2/69 (2.90%)  3 0/59 (0.00%)  0
Glossodynia  1  0/54 (0.00%)  0 2/69 (2.90%)  2 0/59 (0.00%)  0
Haematochezia  1  0/54 (0.00%)  0 1/69 (1.45%)  1 1/59 (1.69%)  1
Loose tooth  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Toothache  1  1/54 (1.85%)  1 1/69 (1.45%)  1 0/59 (0.00%)  0
Abdominal distension  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Abnormal faeces  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Anal fissure  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Anorectal disorder  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Chapped lips  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Dental caries  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Dysphagia  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Eructation  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Faeces discoloured  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Faeces hard  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Frequent bowel movements  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Gastrointestinal tract irritation  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Gingival bleeding  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Lip dry  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Mouth ulceration  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Odynophagia  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Oesophageal pain  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Oral discomfort  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Oral mucosal erythema  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Palatal disorder  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Rectal fissure  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Retching  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Sensitivity of teeth  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Stomatitis  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Tongue disorder  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Tongue eruption  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
General disorders       
Fatigue  1  26/54 (48.15%)  32 36/69 (52.17%)  43 30/59 (50.85%)  34
Influenza like illness  1  5/54 (9.26%)  5 8/69 (11.59%)  9 8/59 (13.56%)  8
Pyrexia  1  9/54 (16.67%)  10 5/69 (7.25%)  5 7/59 (11.86%)  7
Chills  1  8/54 (14.81%)  8 6/69 (8.70%)  6 4/59 (6.78%)  5
Asthenia  1  6/54 (11.11%)  6 2/69 (2.90%)  2 9/59 (15.25%)  9
Injection site reaction  1  1/54 (1.85%)  1 9/69 (13.04%)  9 4/59 (6.78%)  4
Irritability  1  2/54 (3.70%)  2 5/69 (7.25%)  6 7/59 (11.86%)  8
Pain  1  6/54 (11.11%)  6 2/69 (2.90%)  2 6/59 (10.17%)  6
Injection site erythema  1  0/54 (0.00%)  0 3/69 (4.35%)  5 2/59 (3.39%)  2
Malaise  1  0/54 (0.00%)  0 2/69 (2.90%)  3 2/59 (3.39%)  2
Injection site bruising  1  0/54 (0.00%)  0 2/69 (2.90%)  2 1/59 (1.69%)  1
Injection site rash  1  0/54 (0.00%)  0 1/69 (1.45%)  1 2/59 (3.39%)  2
Crying  1  0/54 (0.00%)  0 1/69 (1.45%)  1 1/59 (1.69%)  1
Feeling hot  1  0/54 (0.00%)  0 2/69 (2.90%)  2 0/59 (0.00%)  0
Thirst  1  1/54 (1.85%)  1 0/69 (0.00%)  0 1/59 (1.69%)  1
Chest discomfort  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Chest pain  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Cyst  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Feeling abnormal  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Gait disturbance  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Injection site pruritus  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Local swelling  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Localised oedema  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Oedema peripheral  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Sluggishness  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Temperature intolerance  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Xerosis  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Hepatobiliary disorders       
Jaundice  1  3/54 (5.56%)  3 0/69 (0.00%)  0 1/59 (1.69%)  1
Cholelithiasis  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Immune system disorders       
Seasonal allergy  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Infections and infestations       
Upper respiratory tract infection  1  1/54 (1.85%)  1 1/69 (1.45%)  1 5/59 (8.47%)  7
Folliculitis  1  1/54 (1.85%)  1 1/69 (1.45%)  1 2/59 (3.39%)  2
Influenza  1  3/54 (5.56%)  3 1/69 (1.45%)  1 0/59 (0.00%)  0
Sinusitis  1  1/54 (1.85%)  2 2/69 (2.90%)  2 1/59 (1.69%)  1
Bronchitis  1  1/54 (1.85%)  1 1/69 (1.45%)  1 1/59 (1.69%)  1
Oral candidiasis  1  2/54 (3.70%)  2 0/69 (0.00%)  0 1/59 (1.69%)  1
Pharyngitis  1  0/54 (0.00%)  0 2/69 (2.90%)  2 1/59 (1.69%)  2
Tooth infection  1  0/54 (0.00%)  0 1/69 (1.45%)  1 2/59 (3.39%)  2
Urinary tract infection  1  1/54 (1.85%)  1 1/69 (1.45%)  1 1/59 (1.69%)  2
Cellulitis  1  1/54 (1.85%)  1 0/69 (0.00%)  0 1/59 (1.69%)  1
Hordeolum  1  0/54 (0.00%)  0 1/69 (1.45%)  1 1/59 (1.69%)  1
Nasopharyngitis  1  0/54 (0.00%)  0 0/69 (0.00%)  0 2/59 (3.39%)  2
Onychomycosis  1  1/54 (1.85%)  1 1/69 (1.45%)  1 0/59 (0.00%)  0
Otitis media  1  2/54 (3.70%)  2 0/69 (0.00%)  0 0/59 (0.00%)  0
Pneumonia  1  1/54 (1.85%)  1 1/69 (1.45%)  1 0/59 (0.00%)  0
Abscess jaw  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Abscess limb  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Abscess soft tissue  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Body tinea  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Campylobacter gastroenteritis  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Candida infection  1  0/54 (0.00%)  0 1/69 (1.45%)  2 0/59 (0.00%)  0
Cardiac valve vegetation  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Eye infection  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Furuncle  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Gastroenteritis viral  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Gingivitis  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Injection site pustule  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Mycoplasma infection  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Oral herpes  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Otitis externa  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Respiratory syncytial virus infection  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Rhinitis  1  1/54 (1.85%)  2 0/69 (0.00%)  0 0/59 (0.00%)  0
Sepsis  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Staphylococcal skin infection  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Tinea cruris  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Tooth abscess  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Urethritis chlamydial  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Urethritis gonococcal  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Vulvovaginal candidiasis  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Injury, poisoning and procedural complications       
Arthropod bite  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  2
Contusion  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Excoriation  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Fall  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Joint dislocation  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Joint injury  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Laceration  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Ligament sprain  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Transfusion reaction  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Investigations       
Weight decreased  1  3/54 (5.56%)  3 6/69 (8.70%)  6 1/59 (1.69%)  1
Neutrophil count decreased  1  1/54 (1.85%)  1 1/69 (1.45%)  1 3/59 (5.08%)  3
Blood uric acid increased  1  1/54 (1.85%)  1 1/69 (1.45%)  1 2/59 (3.39%)  3
CD4 lymphocytes decreased  1  0/54 (0.00%)  0 1/69 (1.45%)  1 2/59 (3.39%)  2
Gamma-glutamyltransferase increased  1  0/54 (0.00%)  0 2/69 (2.90%)  2 1/59 (1.69%)  1
Blood bilirubin increased  1  1/54 (1.85%)  2 0/69 (0.00%)  0 1/59 (1.69%)  2
Activated partial thromboplastin time prolonged  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Alanine aminotransferase increased  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Aspartate aminotransferase increased  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Blood creatine increased  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Blood creatine phosphokinase increased  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Blood glucose increased  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  2
Blood lactate dehydrogenase increased  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Blood triglycerides increased  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Creatinine renal clearance decreased  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Electrocardiogram QT prolonged  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Electrocardiogram abnormal  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Eosinophil count increased  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Glomerular filtration rate decreased  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Haematocrit decreased  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Haemoglobin decreased  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
International normalised ratio increased  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Lipase increased  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Liver function test abnormal  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Neutrophil count increased  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Prothrombin time prolonged  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Reticulocyte count decreased  1  0/54 (0.00%)  0 1/69 (1.45%)  2 0/59 (0.00%)  0
Weight increased  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Metabolism and nutrition disorders       
Decreased appetite  1  8/54 (14.81%)  9 11/69 (15.94%)  12 8/59 (13.56%)  8
Hypokalaemia  1  1/54 (1.85%)  1 6/69 (8.70%)  6 4/59 (6.78%)  4
Dehydration  1  0/54 (0.00%)  0 1/69 (1.45%)  4 2/59 (3.39%)  2
Diabetes mellitus  1  0/54 (0.00%)  0 2/69 (2.90%)  2 0/59 (0.00%)  0
Hypophosphataemia  1  1/54 (1.85%)  1 1/69 (1.45%)  1 0/59 (0.00%)  0
Abnormal loss of weight  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Acidosis  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Gout  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Hyperamylasaemia  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Hyperlipasaemia  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Hypertriglyceridaemia  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Hyperuricaemia  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Hypoalbuminaemia  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Hyponatraemia  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Myalgia  1  8/54 (14.81%)  8 9/69 (13.04%)  9 9/59 (15.25%)  9
Arthralgia  1  5/54 (9.26%)  5 5/69 (7.25%)  6 3/59 (5.08%)  3
Back pain  1  5/54 (9.26%)  6 3/69 (4.35%)  3 1/59 (1.69%)  1
Pain in extremity  1  1/54 (1.85%)  1 2/69 (2.90%)  3 3/59 (5.08%)  3
Bone pain  1  2/54 (3.70%)  2 1/69 (1.45%)  2 1/59 (1.69%)  1
Muscle spasms  1  1/54 (1.85%)  1 1/69 (1.45%)  1 1/59 (1.69%)  1
Neck pain  1  2/54 (3.70%)  2 1/69 (1.45%)  2 0/59 (0.00%)  0
Flank pain  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Joint stiffness  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Joint swelling  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Muscle haemorrhage  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Musculoskeletal pain  1  0/54 (0.00%)  0 1/69 (1.45%)  2 0/59 (0.00%)  0
Musculoskeletal stiffness  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Osteopenia  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Osteoporosis  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Pain in jaw  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Rhabdomyolysis  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Spinal osteoarthritis  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Nervous system disorders       
Headache  1  15/54 (27.78%)  17 17/69 (24.64%)  18 20/59 (33.90%)  23
Dizziness  1  6/54 (11.11%)  7 6/69 (8.70%)  6 6/59 (10.17%)  7
Dysgeusia  1  2/54 (3.70%)  2 10/69 (14.49%)  10 5/59 (8.47%)  5
Disturbance in attention  1  0/54 (0.00%)  0 4/69 (5.80%)  4 4/59 (6.78%)  4
Paraesthesia  1  1/54 (1.85%)  1 0/69 (0.00%)  0 5/59 (8.47%)  5
Hypoaesthesia  1  0/54 (0.00%)  0 0/69 (0.00%)  0 4/59 (6.78%)  5
Dizziness postural  1  2/54 (3.70%)  2 0/69 (0.00%)  0 1/59 (1.69%)  1
Syncope  1  0/54 (0.00%)  0 2/69 (2.90%)  5 1/59 (1.69%)  1
Hypersomnia  1  1/54 (1.85%)  1 0/69 (0.00%)  0 1/59 (1.69%)  1
Memory impairment  1  0/54 (0.00%)  0 1/69 (1.45%)  1 1/59 (1.69%)  1
Migraine  1  1/54 (1.85%)  1 1/69 (1.45%)  1 0/59 (0.00%)  0
Neuropathy peripheral  1  0/54 (0.00%)  0 1/69 (1.45%)  1 1/59 (1.69%)  1
Somnolence  1  0/54 (0.00%)  0 1/69 (1.45%)  1 1/59 (1.69%)  1
Tremor  1  2/54 (3.70%)  2 0/69 (0.00%)  0 0/59 (0.00%)  0
Ageusia  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Allodynia  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Amnesia  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Burning sensation  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Head discomfort  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Hyperaesthesia  1  0/54 (0.00%)  0 1/69 (1.45%)  2 0/59 (0.00%)  0
Lethargy  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Parosmia  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Peripheral sensory neuropathy  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Presyncope  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Sciatica  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Sensory disturbance  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Psychiatric disorders       
Insomnia  1  9/54 (16.67%)  9 14/69 (20.29%)  15 14/59 (23.73%)  16
Depression  1  5/54 (9.26%)  6 7/69 (10.14%)  8 4/59 (6.78%)  4
Mood swings  1  2/54 (3.70%)  2 5/69 (7.25%)  5 3/59 (5.08%)  3
Anxiety  1  3/54 (5.56%)  3 3/69 (4.35%)  3 2/59 (3.39%)  2
Sleep disorder  1  1/54 (1.85%)  1 2/69 (2.90%)  2 1/59 (1.69%)  1
Abnormal dreams  1  0/54 (0.00%)  0 0/69 (0.00%)  0 2/59 (3.39%)  3
Affect lability  1  1/54 (1.85%)  1 0/69 (0.00%)  0 1/59 (1.69%)  1
Anger  1  1/54 (1.85%)  1 0/69 (0.00%)  0 1/59 (1.69%)  1
Restlessness  1  1/54 (1.85%)  1 1/69 (1.45%)  1 0/59 (0.00%)  0
Anxiety disorder  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Bipolar disorder  1  1/54 (1.85%)  1 0/69 (0.00%)  0 1/59 (1.69%)  1
Bruxism  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Depressed mood  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Hallucination  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Libido decreased  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Mood altered  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Panic disorder  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Stress  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Suicidal ideation  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Renal and urinary disorders       
Dysuria  1  1/54 (1.85%)  1 0/69 (0.00%)  0 1/59 (1.69%)  1
Pyuria  1  0/54 (0.00%)  0 2/69 (2.90%)  2 0/59 (0.00%)  0
Enuresis  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Haematuria  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Nephropathy  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Nocturia  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Pollakiuria  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Polyuria  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Renal failure acute  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Urinary incontinence  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Reproductive system and breast disorders       
Erectile dysfunction  1  1/54 (1.85%)  1 1/69 (1.45%)  1 0/59 (0.00%)  0
Benign prostatic hyperplasia  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Genital hypoaesthesia  1  0/54 (0.00%)  0 1/69 (1.45%)  2 0/59 (0.00%)  0
Haematospermia  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Menstruation irregular  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Sexual dysfunction  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Testicular pain  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  4/54 (7.41%)  4 5/69 (7.25%)  5 5/59 (8.47%)  5
Cough  1  4/54 (7.41%)  4 6/69 (8.70%)  6 0/59 (0.00%)  0
Dyspnoea exertional  1  0/54 (0.00%)  0 4/69 (5.80%)  4 2/59 (3.39%)  2
Epistaxis  1  0/54 (0.00%)  0 2/69 (2.90%)  2 2/59 (3.39%)  2
Oropharyngeal pain  1  2/54 (3.70%)  2 2/69 (2.90%)  2 0/59 (0.00%)  0
Wheezing  1  0/54 (0.00%)  0 3/69 (4.35%)  3 1/59 (1.69%)  1
Respiratory tract congestion  1  1/54 (1.85%)  1 2/69 (2.90%)  2 0/59 (0.00%)  0
Rhinorrhoea  1  2/54 (3.70%)  2 1/69 (1.45%)  1 0/59 (0.00%)  0
Nasal congestion  1  0/54 (0.00%)  0 1/69 (1.45%)  1 1/59 (1.69%)  1
Sneezing  1  0/54 (0.00%)  0 1/69 (1.45%)  1 1/59 (1.69%)  1
Dry throat  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Hiccups  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Increased viscosity of nasal secretion  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Oropharyngeal plaque  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Pharyngeal oedema  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Productive cough  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Sinus congestion  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Throat irritation  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Throat tightness  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Upper-airway cough syndrome  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Skin and subcutaneous tissue disorders       
Pruritus  1  22/54 (40.74%)  25 21/69 (30.43%)  22 18/59 (30.51%)  20
Rash  1  16/54 (29.63%)  23 20/69 (28.99%)  25 11/59 (18.64%)  15
Alopecia  1  1/54 (1.85%)  1 4/69 (5.80%)  4 2/59 (3.39%)  2
Dry skin  1  2/54 (3.70%)  2 3/69 (4.35%)  3 2/59 (3.39%)  2
Pruritus generalised  1  2/54 (3.70%)  2 1/69 (1.45%)  1 4/59 (6.78%)  4
Rash pruritic  1  2/54 (3.70%)  2 3/69 (4.35%)  4 2/59 (3.39%)  2
Eczema  1  2/54 (3.70%)  2 2/69 (2.90%)  2 1/59 (1.69%)  2
Rash papular  1  2/54 (3.70%)  2 2/69 (2.90%)  2 1/59 (1.69%)  1
Night sweats  1  3/54 (5.56%)  3 1/69 (1.45%)  1 0/59 (0.00%)  0
Rash erythematous  1  1/54 (1.85%)  1 1/69 (1.45%)  1 2/59 (3.39%)  2
Rash maculo-papular  1  2/54 (3.70%)  2 1/69 (1.45%)  1 1/59 (1.69%)  1
Erythema  1  1/54 (1.85%)  1 2/69 (2.90%)  2 0/59 (0.00%)  0
Acne  1  0/54 (0.00%)  0 0/69 (0.00%)  0 2/59 (3.39%)  3
Dermatitis  1  1/54 (1.85%)  1 0/69 (0.00%)  0 1/59 (1.69%)  1
Hyperhidrosis  1  0/54 (0.00%)  0 0/69 (0.00%)  0 2/59 (3.39%)  2
Macule  1  1/54 (1.85%)  1 0/69 (0.00%)  0 1/59 (1.69%)  1
Photosensitivity reaction  1  2/54 (3.70%)  2 0/69 (0.00%)  0 0/59 (0.00%)  0
Rash morbilliform  1  0/54 (0.00%)  0 0/69 (0.00%)  0 2/59 (3.39%)  2
Skin fissures  1  0/54 (0.00%)  0 0/69 (0.00%)  0 2/59 (3.39%)  2
Angioedema  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Cold sweat  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Dermatitis acneiform  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Dermatitis contact  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Dermatosis  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Erythema multiforme  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Nail disorder  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Neurodermatitis  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Pigmentation disorder  1  0/54 (0.00%)  0 1/69 (1.45%)  2 0/59 (0.00%)  0
Psoriasis  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Rash generalised  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Seborrhoea  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Seborrhoeic dermatitis  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Skin disorder  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Skin exfoliation  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Skin hypopigmentation  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Skin lesion  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Skin mass  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Vascular disorders       
Hot flush  1  0/54 (0.00%)  0 1/69 (1.45%)  1 1/59 (1.69%)  1
Flushing  1  1/54 (1.85%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Peripheral coldness  1  0/54 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Thrombosis  1  0/54 (0.00%)  0 0/69 (0.00%)  0 1/59 (1.69%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.1)
It was decided by Sponsor on 13 January 2014 to terminate the study early at the primary efficacy endpoint (SVR12) as part of a decision to modify the drug development plan. Eligible participants completed virologic follow-up after termination.
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.
PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.
Results Point of Contact
Name/Title: Medical Monitor
Organization: Vertex Pharmaceuticals Incorporated
Phone: 617-341-6777
Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01467479     History of Changes
Other Study ID Numbers: VX11-950-115
First Submitted: November 3, 2011
First Posted: November 8, 2011
Results First Submitted: March 3, 2015
Results First Posted: March 17, 2015
Last Update Posted: March 17, 2015