Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Fosamprenavir in Pts With Hepatic Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01054586
First received: January 21, 2010
Last updated: May 2, 2013
Last verified: April 2013
Results First Received: January 14, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Infection, Human Immunodeficiency Virus
Interventions: Drug: Intervention A Standard dose
Drug: Intervention B Reduced Dose
Drug: Intervention C
Drug: Intervention D
Drug: Intervention E

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
As this was an observational, retrospective study, no participants were recruited for participation in this study. For more information about this study, see the protocol in ClinicalTrials.gov and/or search for this study (111949) on http://www.gsk-clinicalstudyregister.com/.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD FPV 700 mg BID/RTV 100 mg once a day (QD)
FPV, Other All other dosages of FPV (excluding FPV 700 mg BID/RTV 100 mg BID and FPV 700 mg BID/RTV 100 mg QD)
LPV, Standard Dose Lopinavir (LPV), Standard Dose

Participant Flow:   Overall Study
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     FPV, Other     LPV, Standard Dose  
STARTED     43     15     8     101  
COMPLETED     43     15     8     101  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD FPV 700 mg BID/RTV 100 mg once a day (QD)
FPV, Other All other dosages of Fosamprenavir
LPV, Standard Dose Lopinavir (LPV), Standard Dose
Total Total of all reporting groups

Baseline Measures
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     FPV, Other     LPV, Standard Dose     Total  
Number of Participants  
[units: participants]
  43     15     8     101     167  
Age  
[units: years]
Median ( Full Range )
  45  
  ( 36 to 62 )  
  45  
  ( 29 to 51 )  
  44  
  ( 36 to 53 )  
  44  
  ( 25 to 74 )  
  44  
  ( 25 to 74 )  
Gender  
[units: participants]
         
Female     11     3     0     38     52  
Male     32     12     8     63     115  
Cohort Distribution [1]
[units: participants]
         
Cohort - MASTER     36     13     4     72     125  
Cohort - HEPAVIH     3     2     2     6     13  
Cohort - ICONA     4     0     2     23     29  
Number of participants positive for Hepatitis B and/or C at baseline [2]
[units: participants]
         
HCV-Ab positive test     37     14     7     82     140  
HBs-Ag positive test     9     2     2     21     34  
Number of participants who were ART naïve at baseline [3]
[units: participants]
  12     5     2     50     69  
Number of participants with acquired immunodeficiency syndrome (AIDS) at baseline [4]
[units: participants]
  9     0     3     24     36  
Number of participants with the indicated alanine aminotransferase (ALT) levels at baseline [5]
[units: participants]
         
Baseline ALT <= 200 IU/L     40     11     6     83     140  
Baseline ALT > 200 IU/L     1     2     1     3     7  
Baseline ALT Unknown     2     2     1     15     20  
[1] Source population from three human immunodeficiency virus (HIV)-infected patient cohorts: ICONA (Italian Cohort of Antiretroviral Naïve Patients), treatment naïve participants at initial presentation in Italy; HEPAVIH, HIV-hepatitis coinfected in France; MASTER (Management Standardizzato di Terapia Antiretrovirale), HIV-infected participants who are either treatment experienced or naïve patients in Italy
[2] Participant characteristics at baseline according to treatment group. Participants were tested for Hepatitis C antibody (HCV-Ab) and Hepatitis B surface antigen (HBs-Ag).
[3] Participant characteristics at baseline according to treatment group. The number of participants who had not received antiretroviral therapy (ART) was recorded.
[4] Participant characteristics at baseline according to treatment group. The number of participants with AIDS was recorded.
[5] Participant characteristics at baseline according to treatment group. The number of participants with the indicated ALT levels was recorded. IU/L = International Units per Liter.



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables   [ Time Frame: The incidence of these events was assessed over time during Year 1, censoring participants' follow-up at date of last ALT ]

Measure Type Primary
Measure Title Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables
Measure Description An elevation in ALT is defined as a single value >200 IU/I.
Time Frame The incidence of these events was assessed over time during Year 1, censoring participants' follow-up at date of last ALT  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
ART naïve Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
Not ART naïve Patients who have previously been exposed to ART therapy

Measured Values
    ART naïve     Not ART naïve  
Number of Participants Analyzed  
[units: participants]
  69     98  
Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables  
[units: events]
  9     4  


Statistical Analysis 1 for Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables
Groups [1] All groups
Method [2] Regression, Cox
P Value [3] 0.02
Hazard Ratio (HR) [4] 6.10
95% Confidence Interval ( 1.26 to 29.46 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p > 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for "ART naïve." "Not ART naïve" is the reference group.



2.  Primary:   Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for APRI-score, and Other Variables   [ Time Frame: Incidence of these events was assessed over time during Year 1, censoring patients' follow-up at date of last ALT ]

Measure Type Primary
Measure Title Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for APRI-score, and Other Variables
Measure Description An elevation in ALT is defined as a single value >200 IU/I.
Time Frame Incidence of these events was assessed over time during Year 1, censoring patients' follow-up at date of last ALT  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD FPV 700 mg BID/RTV 100 mg once a day (QD)
LPV, Standard Dose Lopinavir (LPV), Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  43     15     101  
Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for APRI-score, and Other Variables  
[units: events]
  6     1     6  


Statistical Analysis 1 for Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for APRI-score, and Other Variables
Groups [1] FPV 700 mg BID/RTV 100 mg BID vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.05
Hazard Ratio (HR) [4] 4.12
95% Confidence Interval ( 1.03 to 16.50 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p > 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for "FPV 700 mg BID/RTV 100 mg BID." "LPV" is the reference group.

Statistical Analysis 2 for Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for APRI-score, and Other Variables
Groups [1] FPV 700 mg BID/RTV 100 mg QD vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.68
Hazard Ratio (HR) [4] 1.62
95% Confidence Interval ( 0.16 to 16.27 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p > 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for "FPV 700 mg BID/RTV 100 mg QD." "LPV" is the reference group.



3.  Primary:   Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables   [ Time Frame: Incidence was assessed over time during Year 1 ]

Measure Type Primary
Measure Title Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables
Measure Description An elevation in ALT is defined as a single value >200 IU/I.
Time Frame Incidence was assessed over time during Year 1  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD FPV 700 mg BID/RTV 100 mg once a day (QD)
LPV, Standard Dose Lopinavir (LPV), Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  43     15     101  
Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables  
[units: events]
  6     1     6  


Statistical Analysis 1 for Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables
Groups [1] FPV 700 mg BID/RTV 100 mg BID vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.17
Hazard Ratio (HR) [4] 2.83
95% Confidence Interval ( 0.65 to 12.36 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing an imbalance between the treatment groups (when possible) were included. The following were also included, but p > 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for "FPV 700 mg BID/RTV 100 mg BID." "LPV" is the reference group.

Statistical Analysis 2 for Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables
Groups [1] FPV 700 mg BID/RTV 100 mg QD vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.85
Hazard Ratio (HR) [4] 1.26
95% Confidence Interval ( 0.12 to 13.33 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing an imbalance between the treatment groups (when possible) were included. The following were also included, but p > 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for "FPV 700 mg BID/RTV 100 mg QD." "LPV" is the reference group.



4.  Primary:   Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts   [ Time Frame: Incidence was assessed over time during Year 1 ]

Measure Type Primary
Measure Title Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts
Measure Description An elevation in ALT is defined as a single value >200 IU/I.
Time Frame Incidence was assessed over time during Year 1  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD FPV 700 mg BID/RTV 100 mg once a day (QD)
LPV, Standard Dose Lopinavir (LPV), Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  43     15     101  
Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts  
[units: events]
  6     1     6  


Statistical Analysis 1 for Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts
Groups [1] FPV 700 mg BID/RTV 100 mg BID vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.06
Hazard Ratio (HR) [4] 3.2
95% Confidence Interval ( 0.94 to 10.82 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p > 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for "FPV 700 mg BID/RTV 100 mg BID." "LPV" is the reference group.

Statistical Analysis 2 for Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts
Groups [1] FPV 700 mg BID/RTV 100 mg QD vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.96
Hazard Ratio (HR) [4] 1.06
95% Confidence Interval ( 0.11 to 9.83 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p > 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for "FPV 700 mg BID/RTV 100 mg QD." "LPV" is the reference group.



5.  Secondary:   Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for APRI-score, and Other Variables   [ Time Frame: Incidence was assessed over time during Year 1 ]

Measure Type Secondary
Measure Title Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for APRI-score, and Other Variables
Measure Description A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV.
Time Frame Incidence was assessed over time during Year 1  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD FPV 700 mg BID/RTV 100 mg once a day (QD)
FPV, Other All other dosages of Fosamprenavir
LPV, Standard Dose Lopinavir (LPV), Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     FPV, Other     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  43     15     8     101  
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for APRI-score, and Other Variables  
[units: events]
  9     1     4     19  


Statistical Analysis 1 for Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for APRI-score, and Other Variables
Groups [1] FPV 700 mg BID/RTV 100 mg BID vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.57
Hazard Ratio (HR) [4] 1.31
95% Confidence Interval ( 0.52 to 3.31 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p>0.05.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for "FPV 700 mg BID/RTV 100 mg BID." "LPV" is the reference group.

Statistical Analysis 2 for Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for APRI-score, and Other Variables
Groups [1] FPV 700 mg BID/RTV 100 mg QD vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.22
Hazard Ratio (HR) [4] 0.28
95% Confidence Interval ( 0.04 to 2.14 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p>0.05.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for "FPV 700 mg BID/RTV 100 mg QD." "LPV" is the reference group.

Statistical Analysis 3 for Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for APRI-score, and Other Variables
Groups [1] FPV, Other vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.47
Hazard Ratio (HR) [4] 1.86
95% Confidence Interval ( 0.35 to 9.91 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p>0.05.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for "FPV, Other." "LPV" is the reference group.



6.  Secondary:   Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for FIB-score, and Other Variables   [ Time Frame: Incidence was assessed over time during Year 1 ]

Measure Type Secondary
Measure Title Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for FIB-score, and Other Variables
Measure Description A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV.
Time Frame Incidence was assessed over time during Year 1  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD FPV 700 mg BID/RTV 100 mg once a day (QD)
FPV, Other All other dosages of Fosamprenavir
LPV, Standard Dose Lopinavir (LPV), Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     FPV, Other     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  43     15     8     101  
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for FIB-score, and Other Variables  
[units: events]
  9     1     4     19  


Statistical Analysis 1 for Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for FIB-score, and Other Variables
Groups [1] FPV 700 mg BID/RTV 100 mg BID vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.48
Hazard Ratio (HR) [4] 1.40
95% Confidence Interval ( 0.55 to 3.55 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p > 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for "FPV 700 mg BID/RTV 100 mg BID." "LPV" is the reference group.

Statistical Analysis 2 for Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for FIB-score, and Other Variables
Groups [1] FPV 700 mg BID/RTV 100 mg QD vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.23
Hazard Ratio (HR) [4] 0.26
95% Confidence Interval ( 0.03 to 2.18 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p > 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for "FPV 700 mg BID/RTV 100 mg QD." "LPV" is the reference group.

Statistical Analysis 3 for Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for FIB-score, and Other Variables
Groups [1] FPV, Other vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.56
Hazard Ratio (HR) [4] 1.67
95% Confidence Interval ( 0.29 to 9.47 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p > 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for "FPV, Other." "LPV" is the reference group.



7.  Secondary:   Number of Events of First Discontinuation of FPV/RTV- or LPV/RTV Alone by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts   [ Time Frame: Incidence was assessed over time during Year 1 ]

Measure Type Secondary
Measure Title Number of Events of First Discontinuation of FPV/RTV- or LPV/RTV Alone by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts
Measure Description A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV
Time Frame Incidence was assessed over time during Year 1  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
FPV, Other All other dosages of Fosamprenavir
LPV, Standard Dose Lopinavir, Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     FPV, Other     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  43     15     8     101  
Number of Events of First Discontinuation of FPV/RTV- or LPV/RTV Alone by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts  
[units: events]
  9     1     4     19  


Statistical Analysis 1 for Number of Events of First Discontinuation of FPV/RTV- or LPV/RTV Alone by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts
Groups [1] FPV 700 mg BID/RTV 100 mg BID vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.72
Hazard Ratio (HR) [4] 1.16
95% Confidence Interval ( 0.51 to 2.66 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for " FPV 700 mg BID/RTV 100 mg BID". "LPV" is the reference group.

Statistical Analysis 2 for Number of Events of First Discontinuation of FPV/RTV- or LPV/RTV Alone by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts
Groups [1] FPV 700 mg BID/RTV 100 mg QD vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.21
Hazard Ratio (HR) [4] 0.27
95% Confidence Interval ( 0.03 to 2.08 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for " FPV 700 mg BID/RTV 100 mg QD". "LPV" is the reference group.

Statistical Analysis 3 for Number of Events of First Discontinuation of FPV/RTV- or LPV/RTV Alone by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts
Groups [1] FPV, Other vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.15
Hazard Ratio (HR) [4] 2.26
95% Confidence Interval ( 0.74 to 6.97 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for " FPV, other". "LPV" is the reference group.



8.  Secondary:   Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to Adverse Events Only   [ Time Frame: Incidence was assessed over time during Year 1 ]

Measure Type Secondary
Measure Title Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to Adverse Events Only
Measure Description A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attritubed to adverse events only
Time Frame Incidence was assessed over time during Year 1  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
LPV, Standard Dose Lopinavir, Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  43     101  
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to Adverse Events Only  
[units: events]
  5     7  


Statistical Analysis 1 for Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to Adverse Events Only
Groups [1] All groups
Method [2] Regression, Cox
P Value [3] 0.10
Hazard Ratio (HR) [4] 3.77
95% Confidence Interval ( 0.79 to 18.05 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for " FPV 700 mg BID/RTV 100 mg BID". "LPV" is the reference group.



9.  Secondary:   Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for APRI-score and Other Variables (See Comments)   [ Time Frame: Incidence was assessed over time during Year 1 ]

Measure Type Secondary
Measure Title Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for APRI-score and Other Variables (See Comments)
Measure Description A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime
Time Frame Incidence was assessed over time during Year 1  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
FPV, Other All other dosages of Fosamprenavir
LPV, Standard Dose Lopinavir, Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     FPV, Other     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  43     15     8     101  
Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for APRI-score and Other Variables (See Comments)  
[units: events]
  16     8     5     24  


Statistical Analysis 1 for Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for APRI-score and Other Variables (See Comments)
Groups [1] FPV 700 mg BID/RTV 100 mg BID vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.02
Hazard Ratio (HR) [4] 2.53
95% Confidence Interval ( 1.16 to 5.54 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing an imbalance between the treatment groups were included, but p > .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for " FPV 700 mg BID/RTV 100 mg BID". "LPV" is the reference group.

Statistical Analysis 2 for Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for APRI-score and Other Variables (See Comments)
Groups [1] FPV 700 mg BID/RTV 100 mg QD vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.05
Hazard Ratio (HR) [4] 4.17
95% Confidence Interval ( 1.54 to 11.27 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing an imbalance between the treatment groups were included, but p > .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for " FPV 700 mg BID/RTV 100 mg QD". "LPV" is the reference group.

Statistical Analysis 3 for Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for APRI-score and Other Variables (See Comments)
Groups [1] FPV, Other vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.06
Hazard Ratio (HR) [4] 3.67
95% Confidence Interval ( 0.97 to 13.90 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing an imbalance between the treatment groups were included, but p > .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for " FPV, other". "LPV" is the reference group.



10.  Secondary:   Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for FIB-score and Other Variables   [ Time Frame: Incidence was assessed over time during Year 1 ]

Measure Type Secondary
Measure Title Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for FIB-score and Other Variables
Measure Description A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime.
Time Frame Incidence was assessed over time during Year 1  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
FPV, Other All other dosages of Fosamprenavir
LPV, Standard Dose Lopinavir, Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     FPV, Other     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  43     15     8     101  
Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for FIB-score and Other Variables  
[units: events]
  16     8     5     24  


Statistical Analysis 1 for Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for FIB-score and Other Variables
Groups [1] FPV 700 mg BID/RTV 100 mg BID vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.01
Hazard Ratio (HR) [4] 2.68
95% Confidence Interval ( 1.21 to 5.9 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for " FPV 700 mg BID/RTV 100 mg BID". "LPV" is the reference group.

Statistical Analysis 2 for Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for FIB-score and Other Variables
Groups [1] FPV 700 mg BID/RTV 100 mg QD vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.0004
Hazard Ratio (HR) [4] 4.42
95% Confidence Interval ( 1.61 to 12.08 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for " FPV 700 mg BID/RTV 100 mg QD". "LPV" is the reference group.

Statistical Analysis 3 for Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for FIB-score and Other Variables
Groups [1] FPV, Other vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.11
Hazard Ratio (HR) [4] 3.07
95% Confidence Interval ( 0.78 to 12.03 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for " FPV, other". "LPV" is the reference group.



11.  Secondary:   Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling Current Values of CD4 and Platelet Counts   [ Time Frame: Incidence was assessed over time during Year 1 ]

Measure Type Secondary
Measure Title Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling Current Values of CD4 and Platelet Counts
Measure Description A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime.
Time Frame Incidence was assessed over time during Year 1  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
FPV, Other All other dosages of Fosamprenavir
LPV, Standard Dose Lopinavir, Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     FPV, Other     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  43     15     8     101  
Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling Current Values of CD4 and Platelet Counts  
[units: events]
  16     8     5     24  


Statistical Analysis 1 for Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling Current Values of CD4 and Platelet Counts
Groups [1] FPV 700 mg BID/RTV 100 mg BID vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.03
Hazard Ratio (HR) [4] 2.09
95% Confidence Interval ( 1.06 to 4.15 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for " FPV 700 mg BID/RTV 100 mg BID". "LPV" is the reference group.

Statistical Analysis 2 for Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling Current Values of CD4 and Platelet Counts
Groups [1] FPV 700 mg BID/RTV 100 mg QD vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.05
Hazard Ratio (HR) [4] 3.61
95% Confidence Interval ( 1.48 to 8.81 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for " FPV 700 mg BID/RTV 100 mg QD". "LPV" is the reference group.

Statistical Analysis 3 for Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling Current Values of CD4 and Platelet Counts
Groups [1] FPV, Other vs. LPV, Standard Dose
Method [2] Regression, Cox
P Value [3] 0.10
Hazard Ratio (HR) [4] 2.31
95% Confidence Interval ( 0.85 to 6.32 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for " FPV, other". "LPV" is the reference group.



12.  Secondary:   Number of Events of Discontinuation of One or More Drugs in the FPV/RTV- or LPV/RTV Regimen Due to Adverse Events Only   [ Time Frame: Incidence was assessed over time during Year 1 ]

Measure Type Secondary
Measure Title Number of Events of Discontinuation of One or More Drugs in the FPV/RTV- or LPV/RTV Regimen Due to Adverse Events Only
Measure Description Defined as the occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attributed to adverse events only
Time Frame Incidence was assessed over time during Year 1  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
LPV, Standard Dose Lopinavir, Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  43     101  
Number of Events of Discontinuation of One or More Drugs in the FPV/RTV- or LPV/RTV Regimen Due to Adverse Events Only  
[units: events]
  3     5  


Statistical Analysis 1 for Number of Events of Discontinuation of One or More Drugs in the FPV/RTV- or LPV/RTV Regimen Due to Adverse Events Only
Groups [1] All groups
Method [2] Regression, Cox
P Value [3] 0.03
Hazard Ratio (HR) [4] 5.12
95% Confidence Interval ( 1.19 to 22.02 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Confidence Interval and Hazard Ratio for " FPV 700 mg BID/RTV 100 mg BID". "LPV" is the reference group.



13.  Secondary:   Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events   [ Time Frame: Incidence was assessed over time during Year 1 ]

Measure Type Secondary
Measure Title Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events
Measure Description Defined as the first occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attributed to adverse events only. Adverse events can only be attributed to the body system stated (no further specificity is available).
Time Frame Incidence was assessed over time during Year 1  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
All Participants All Participants, across all arms

Measured Values
    All Participants  
Number of Participants Analyzed  
[units: participants]
  167  
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events  
[units: events]
 
Hypersensitivity reaction     1  
GI Tract     5  
Pancreas     1  
Nervous system     2  
Kidneys     1  
Other side effects (not specified as above)     3  

No statistical analysis provided for Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events



14.  Secondary:   Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r   [ Time Frame: Assessed over time during Year 1 ]

Measure Type Secondary
Measure Title Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r
Measure Description Antiretrovirals discontinued for the first time after starting FPV/r or LPV/r
Time Frame Assessed over time during Year 1  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
FPV, Other All other dosages of Fosamprenavir
LPV, Standard Dose Lopinavir, Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     FPV, Other     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  43     15     8     101  
Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r  
[units: participants]
       
Ritonavir (full or booster)     11     7     2     0  
Lopinavir/r     0     0     0     14  
Fos-amprenavir/r     3     0     2     1  
Lamivudine     0     0     0     1  
Abacavir     0     1     0     1  
Combivir     0     0     0     2  
Truvada     2     0     1     3  
Atripla     0     0     0     2  

No statistical analysis provided for Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r



15.  Secondary:   Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen   [ Time Frame: Assessed over time during Year 1 ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen
Measure Description Major reasons for discontinuing one or more drugs in the FPV/r or LPV/r regimen
Time Frame Assessed over time during Year 1  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
FPV, Other All other dosages of Fosamprenavir
LPV, Standard Dose Lopinavir, Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     FPV, Other     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  16     8     5     24  
Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen  
[units: participants]
       
Virological failure     0     0     1     0  
Hypersensitivity reaction     0     0     0     1  
Toxicity – GI tract     1     0     0     2  
Toxicity – Pancreas     1     0     0     0  
Toxicity, mainly from nervous system     1     0     0     0  
Toxicity, mainly from kidneys     0     0     0     1  
Side effects –any of the above unspecified     0     0     0     1  
Co-morbidity     0     0     2     1  
Simplified treatment available     0     0     0     2  
Structured Treatment Interruption (STI)     1     0     0     0  
Participant’s wish/decision     0     0     1     3  
Physician’s decision     0     0     0     2  
Non-compliance     0     1     0     1  
Other causes     9     6     0     2  
Unknown cause     3     1     1     8  

No statistical analysis provided for Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen



16.  Secondary:   Number of Participants for Which the Reason for Discontinuation of One or More Drugs in the FPV/RTV or LPV/RTV Regimen Was Due to Adverse Events Only   [ Time Frame: The incidence of these events was assessed over time during Year 1 ]

Measure Type Secondary
Measure Title Number of Participants for Which the Reason for Discontinuation of One or More Drugs in the FPV/RTV or LPV/RTV Regimen Was Due to Adverse Events Only
Measure Description Number of participants for which the reason for discontinuation of one or more drugs in the FPV/RTV or LPV/RTV regimen was due to adverse events only. Adverse events can only be attributed to the body system stated (no further specificity is available)
Time Frame The incidence of these events was assessed over time during Year 1  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
All Participants All Participants, across all arms

Measured Values
    All Participants  
Number of Participants Analyzed  
[units: participants]
  167  
Number of Participants for Which the Reason for Discontinuation of One or More Drugs in the FPV/RTV or LPV/RTV Regimen Was Due to Adverse Events Only  
[units: participants]
 
Hypersensitivity reaction     2  
GI Tract     6  
Pancreas     1  
Nervous system     2  
Kidneys     1  
Other side effects (not specified as above)     3  

No statistical analysis provided for Number of Participants for Which the Reason for Discontinuation of One or More Drugs in the FPV/RTV or LPV/RTV Regimen Was Due to Adverse Events Only



17.  Secondary:   Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures   [ Time Frame: Incidence of these events was assessed over time during Year 1 ]

Measure Type Secondary
Measure Title Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures
Measure Description Incidence rates per 100 person-years of follow-up of study primary outcome. The numbers analyzed in the category titles represent the number of patients with each event. Incidence rate is the number of new cases per population in a given time period, where the denominator is the sum of the person-time of the at-risk population.
Time Frame Incidence of these events was assessed over time during Year 1  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
All Participants All Participants, across all arms

Measured Values
    All Participants  
Number of Participants Analyzed  
[units: participants]
  167  
Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures  
[units: incidence rate]
 
ALT elevations/flares after baseline, n=13     18  
1st stop of FPV/RTV or LPV/RTV alone, n=33     55  
1st stop >=1 drug in FPV/RTV or LPV/RTV reg., n=53     102  
Severe hepatic events, n=0     0  
Death or hospitalization due to AIDS, n=1     1  

No statistical analysis provided for Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures



18.  Other Pre-specified:   Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline   [ Time Frame: Baseline ]

Measure Type Other Pre-specified
Measure Title Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline
Measure Description Participant characteristics at baseline are presented according to treatment group. ART is used for the treatment of HIV.
Time Frame Baseline  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD FPV 700 mg BID/RTV 100 mg once a day (QD)
FPV, Other All other dosages of Fosamprenavir
LPV, Standard Dose Lopinavir (LPV), Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     FPV, Other     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  43     15     8     101  
Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline  
[units: years]
Median ( Full Range )
       
Length of follow-up     0.36  
  ( 0.07 to 1.07 )  
  0.36  
  ( 0.04 to 1.02 )  
  0.95  
  ( 0.6 to 1.50 )  
  0.34  
  ( 0.12 to 1.46 )  
Tiime on ART     1.7  
  ( 0 to 12 )  
  1.0  
  ( 0 to 11 )  
  3.21  
  ( 0 to 10 )  
  0.08  
  ( 0 to 12.8 )  

No statistical analysis provided for Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline



19.  Other Pre-specified:   Cluster of Differentiation (CD4) Count at Baseline   [ Time Frame: Baseline ]

Measure Type Other Pre-specified
Measure Title Cluster of Differentiation (CD4) Count at Baseline
Measure Description Participant characteristics at baseline according to treatment group. CD4 count is a measurement of how many functional CD4 T-cells are circulating in the blood. The lower the absolute CD4 count, the weaker the immune system.
Time Frame Baseline  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID No text entered.
FPV 700 mg BID/RTV 100 mg QD Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
FPV, Other All other dosages of Fosamprenavir
LPV, Standard Dose Lopinavir, Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     FPV, Other     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  43     15     8     101  
Cluster of Differentiation (CD4) Count at Baseline  
[units: cells/microliter (μl)]
Median ( Full Range )
  355  
  ( 66 to 1585 )  
  331  
  ( 113 to 912 )  
  370  
  ( 197 to 427 )  
  252  
  ( 7 to 1113 )  

No statistical analysis provided for Cluster of Differentiation (CD4) Count at Baseline



20.  Other Pre-specified:   Median Aspartate Aminotransferase (AST)-Platelet Ratio Index (APRI) Score at Baseline   [ Time Frame: Baseline ]

Measure Type Other Pre-specified
Measure Title Median Aspartate Aminotransferase (AST)-Platelet Ratio Index (APRI) Score at Baseline
Measure Description The APRI score (AST to platelet ratio index) is an index comprised of biochemical values and is used to determine the degree of hepatic fibrosis. It is calculated as follows: APRI score = ([AST level/Upper Limit Normal]/Platelet counts) x 100. AST = Aspartate aminotransferase. In general, APRI scores range from 0 to >2.0, where scores <0.5 indicate no significant fibrosis, scores >1.5 indicate significant fibrosis, and scores >2.0 have been shown to be best correlated with the presence of cirrhosis.
Time Frame Baseline  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
FPV, Other All other dosages of Fosamprenavir
LPV, Standard Dose Lopinavir, Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     FPV, Other     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  43     15     8     101  
Median Aspartate Aminotransferase (AST)-Platelet Ratio Index (APRI) Score at Baseline  
[units: APRI Score]
Median ( Full Range )
  0.4  
  ( 0.06 to 1.73 )  
  0.53  
  ( 0.12 to 3.33 )  
  0.69  
  ( 0.14 to 8.06 )  
  0.35  
  ( 0.06 to 5.04 )  

No statistical analysis provided for Median Aspartate Aminotransferase (AST)-Platelet Ratio Index (APRI) Score at Baseline



21.  Other Pre-specified:   Median FIB (a Model of End-stage Liver Disease) Score at Baseline   [ Time Frame: Baseline ]

Measure Type Other Pre-specified
Measure Title Median FIB (a Model of End-stage Liver Disease) Score at Baseline
Measure Description The FIB-4 score is an index that combines biochemical values (platelets, ALT, AST) and age to determine the degree of hepatic fibrosis. FIB-4 = (Age x AST)/(Platelet counts x ALT1/2). The FIB-4 score ranges between values of 0 to 13. A score of <1.45 indicates no/moderate fibrosis (F0-F1-F2-F3 in the ISHAK classification of fibrosis), whereas a score >3.25 is indicative of extensive fibrosis or cirrhosis (F4-F5-F6). The ISHAK classification of fibrosis is a commonly used scoring system that stages fibrosis from 0-6 (1-2, portal fibrotic expansion; 3-4, bridging fibrosis; 5-6, cirrhosis).
Time Frame Baseline  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
FPV, Other All other dosages of Fosamprenavir
LPV, Standard Dose Lopinavir, Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     FPV, Other     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  43     15     8     101  
Median FIB (a Model of End-stage Liver Disease) Score at Baseline  
[units: FIB Score]
Median ( Full Range )
  0.49  
  ( 0.17 to 3.00 )  
  0.64  
  ( 0.18 to 5.87 )  
  1.96  
  ( 0.25 to 13.47 )  
  0.74  
  ( 0.19 to 4.38 )  

No statistical analysis provided for Median FIB (a Model of End-stage Liver Disease) Score at Baseline



22.  Other Pre-specified:   Median Model of End-stage Liver Disease (MELD) Score at Baseline   [ Time Frame: Baseline ]

Measure Type Other Pre-specified
Measure Title Median Model of End-stage Liver Disease (MELD) Score at Baseline
Measure Description MELD is a scoring system for assessing the severity of chronic liver disease and is used to predict participant survival. It is calculated using biochemical values as follows: MELD = (0.957 x Log[Creatinine]) + (0.378 x Log[Bilirubin]) + (1.120 x Log[INR]) + 0.6431. INR = International Normalized Ratio for prothrombin time. MELD scores range between 0 and 40, with 40 being the most severe, i.e., 100% mortality. In interpreting the MELD score in hospitalized participants, the 3-month mortality is: score >=40, 100% mortality; 30–39, 83% mortality; 20–29, 76% mortality; 10–19, 27% mortality.
Time Frame Baseline  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe. MELD scores are not available for the “FPV 700 mg BID/RTV 100 mg QD” group due to missing data.

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
FPV, Other All other dosages of Fosamprenavir
LPV, Standard Dose Lopinavir, Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     FPV, Other     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  43     0     8     101  
Median Model of End-stage Liver Disease (MELD) Score at Baseline  
[units: MELD score]
Median ( Full Range )
  5.11  
  ( -4 to 11.85 )  
   
   
  6.56  
  ( 5.06 to 8.08 )  
  2.45  
  ( -6 to 22.65 )  

No statistical analysis provided for Median Model of End-stage Liver Disease (MELD) Score at Baseline



23.  Other Pre-specified:   Median ALT and AST Scores at Baseline   [ Time Frame: Baseline ]

Measure Type Other Pre-specified
Measure Title Median ALT and AST Scores at Baseline
Measure Description Participants characteristics at baseline according to treatment group.
Time Frame Baseline  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
FPV, Other All other dosages of Fosamprenavir
LPV, Standard Dose Lopinavir, Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     FPV, Other     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  43     15     8     101  
Median ALT and AST Scores at Baseline  
[units: IU/L (International Units per Liter)]
Median ( Full Range )
       
ALT     64  
  ( 10 to 282 )  
  53  
  ( 28 to 297 )  
  64  
  ( 37 to 568 )  
  52.5  
  ( 7 to 416 )  
AST     52  
  ( 16 to 163 )  
  71  
  ( 24 to 291 )  
  66  
  ( 27 to 157 )  
  45  
  ( 16 to 358 )  

No statistical analysis provided for Median ALT and AST Scores at Baseline



24.  Other Pre-specified:   Median Blood Platelet Count at Baseline   [ Time Frame: Baseline ]

Measure Type Other Pre-specified
Measure Title Median Blood Platelet Count at Baseline
Measure Description Participant characteristics at baseline according to treatment group.
Time Frame Baseline  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
FPV, Other All other dosages of Fosamprenavir
LPV, Standard Dose Lopinavir, Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     FPV, Other     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  43     15     8     101  
Median Blood Platelet Count at Baseline  
[units: 10^9/liter]
Median ( Full Range )
  180  
  ( 45 to 327 )  
  146  
  ( 24 to 246 )  
  145  
  ( 44 to 222 )  
  167  
  ( 39 to 396 )  

No statistical analysis provided for Median Blood Platelet Count at Baseline



25.  Other Pre-specified:   Median Bilirubin Level at Baseline   [ Time Frame: Baseline ]

Measure Type Other Pre-specified
Measure Title Median Bilirubin Level at Baseline
Measure Description Participant characteristics at baseline according to treatment group.
Time Frame Baseline  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups
  Description
FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
FPV, Other All other dosages of Fosamprenavir
LPV, Standard Dose Lopinavir, Standard Dose

Measured Values
    FPV 700 mg BID/RTV 100 mg BID     FPV 700 mg BID/RTV 100 mg QD     FPV, Other     LPV, Standard Dose  
Number of Participants Analyzed  
[units: participants]
  43     15     8     101  
Median Bilirubin Level at Baseline  
[units: milligrams (mg)/deciliter (dl)]
Median ( Full Range )
  0.74  
  ( 0.22 to 9.39 )  
  0.62  
  ( 0.42 to 4.3 )  
  0.83  
  ( 0.48 to 29.2 )  
  0.50  
  ( 0.16 to 10 )  

No statistical analysis provided for Median Bilirubin Level at Baseline




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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