Trial Outcomes & Findings for Fosamprenavir in Pts With Hepatic Impairment (NCT NCT01054586)
NCT ID: NCT01054586
Last Updated: 2013-05-07
Results Overview
An elevation in ALT is defined as a single value \>200 IU/I.
COMPLETED
167 participants
The incidence of these events was assessed over time during Year 1, censoring participants' follow-up at date of last ALT
2013-05-07
Participant Flow
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/.
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
43
|
15
|
8
|
101
|
|
Overall Study
COMPLETED
|
43
|
15
|
8
|
101
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fosamprenavir in Pts With Hepatic Impairment
Baseline characteristics by cohort
| Measure |
FPV 700 mg BID/RTV 100 mg BID
n=43 Participants
Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
|
FPV 700 mg BID/RTV 100 mg QD
n=15 Participants
FPV 700 mg BID/RTV 100 mg once a day (QD)
|
FPV, Other
n=8 Participants
All other dosages of Fosamprenavir
|
LPV, Standard Dose
n=101 Participants
Lopinavir (LPV), Standard Dose
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
45 years
n=5 Participants
|
45 years
n=7 Participants
|
44 years
n=5 Participants
|
44 years
n=4 Participants
|
44 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
115 Participants
n=21 Participants
|
|
Cohort Distribution
Cohort - MASTER
|
36 participants
n=5 Participants
|
13 participants
n=7 Participants
|
4 participants
n=5 Participants
|
72 participants
n=4 Participants
|
125 participants
n=21 Participants
|
|
Cohort Distribution
Cohort - HEPAVIH
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
13 participants
n=21 Participants
|
|
Cohort Distribution
Cohort - ICONA
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
23 participants
n=4 Participants
|
29 participants
n=21 Participants
|
|
Number of participants positive for Hepatitis B and/or C at baseline
HCV-Ab positive test
|
37 participants
n=5 Participants
|
14 participants
n=7 Participants
|
7 participants
n=5 Participants
|
82 participants
n=4 Participants
|
140 participants
n=21 Participants
|
|
Number of participants positive for Hepatitis B and/or C at baseline
HBs-Ag positive test
|
9 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
21 participants
n=4 Participants
|
34 participants
n=21 Participants
|
|
Number of participants who were ART naïve at baseline
|
12 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
50 participants
n=4 Participants
|
69 participants
n=21 Participants
|
|
Number of participants with acquired immunodeficiency syndrome (AIDS) at baseline
|
9 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
24 participants
n=4 Participants
|
36 participants
n=21 Participants
|
|
Number of participants with the indicated alanine aminotransferase (ALT) levels at baseline
Baseline ALT <= 200 IU/L
|
40 participants
n=5 Participants
|
11 participants
n=7 Participants
|
6 participants
n=5 Participants
|
83 participants
n=4 Participants
|
140 participants
n=21 Participants
|
|
Number of participants with the indicated alanine aminotransferase (ALT) levels at baseline
Baseline ALT > 200 IU/L
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Number of participants with the indicated alanine aminotransferase (ALT) levels at baseline
Baseline ALT Unknown
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
15 participants
n=4 Participants
|
20 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: The incidence of these events was assessed over time during Year 1, censoring participants' follow-up at date of last ALTPopulation: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
An elevation in ALT is defined as a single value \>200 IU/I.
Outcome measures
| Measure |
ART naïve
n=69 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=98 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables
|
9 events
|
4 events
|
—
|
—
|
PRIMARY outcome
Timeframe: Incidence of these events was assessed over time during Year 1, censoring patients' follow-up at date of last ALTPopulation: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
An elevation in ALT is defined as a single value \>200 IU/I.
Outcome measures
| Measure |
ART naïve
n=43 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=15 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
n=101 Participants
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for APRI-score, and Other Variables
|
6 events
|
1 events
|
6 events
|
—
|
PRIMARY outcome
Timeframe: Incidence was assessed over time during Year 1Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
An elevation in ALT is defined as a single value \>200 IU/I.
Outcome measures
| Measure |
ART naïve
n=43 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=15 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
n=101 Participants
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables
|
6 events
|
1 events
|
6 events
|
—
|
PRIMARY outcome
Timeframe: Incidence was assessed over time during Year 1Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
An elevation in ALT is defined as a single value \>200 IU/I.
Outcome measures
| Measure |
ART naïve
n=43 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=15 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
n=101 Participants
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts
|
6 events
|
1 events
|
6 events
|
—
|
SECONDARY outcome
Timeframe: Incidence was assessed over time during Year 1Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV.
Outcome measures
| Measure |
ART naïve
n=43 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=15 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
n=8 Participants
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
n=101 Participants
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for APRI-score, and Other Variables
|
9 events
|
1 events
|
4 events
|
19 events
|
SECONDARY outcome
Timeframe: Incidence was assessed over time during Year 1Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV.
Outcome measures
| Measure |
ART naïve
n=43 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=15 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
n=8 Participants
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
n=101 Participants
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for FIB-score, and Other Variables
|
9 events
|
1 events
|
4 events
|
19 events
|
SECONDARY outcome
Timeframe: Incidence was assessed over time during Year 1Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV
Outcome measures
| Measure |
ART naïve
n=43 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=15 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
n=8 Participants
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
n=101 Participants
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
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
|
9 events
|
1 events
|
4 events
|
19 events
|
SECONDARY outcome
Timeframe: Incidence was assessed over time during Year 1Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
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
Outcome measures
| Measure |
ART naïve
n=43 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=101 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to Adverse Events Only
|
5 events
|
7 events
|
—
|
—
|
SECONDARY outcome
Timeframe: Incidence was assessed over time during Year 1Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime
Outcome measures
| Measure |
ART naïve
n=43 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=15 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
n=8 Participants
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
n=101 Participants
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
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)
|
16 events
|
8 events
|
5 events
|
24 events
|
SECONDARY outcome
Timeframe: Incidence was assessed over time during Year 1Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime.
Outcome measures
| Measure |
ART naïve
n=43 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=15 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
n=8 Participants
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
n=101 Participants
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
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
|
16 events
|
8 events
|
5 events
|
24 events
|
SECONDARY outcome
Timeframe: Incidence was assessed over time during Year 1Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime.
Outcome measures
| Measure |
ART naïve
n=43 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=15 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
n=8 Participants
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
n=101 Participants
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
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
|
16 events
|
8 events
|
5 events
|
24 events
|
SECONDARY outcome
Timeframe: Incidence was assessed over time during Year 1Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
Defined as the occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attributed to adverse events only
Outcome measures
| Measure |
ART naïve
n=43 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=101 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
Number of Events of Discontinuation of One or More Drugs in the FPV/RTV- or LPV/RTV Regimen Due to Adverse Events Only
|
3 events
|
5 events
|
—
|
—
|
SECONDARY outcome
Timeframe: Incidence was assessed over time during Year 1Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
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).
Outcome measures
| Measure |
ART naïve
n=167 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events
Hypersensitivity reaction
|
1 events
|
—
|
—
|
—
|
|
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events
GI Tract
|
5 events
|
—
|
—
|
—
|
|
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events
Pancreas
|
1 events
|
—
|
—
|
—
|
|
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events
Nervous system
|
2 events
|
—
|
—
|
—
|
|
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events
Kidneys
|
1 events
|
—
|
—
|
—
|
|
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events
Other side effects (not specified as above)
|
3 events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed over time during Year 1Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
Antiretrovirals discontinued for the first time after starting FPV/r or LPV/r
Outcome measures
| Measure |
ART naïve
n=43 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=15 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
n=8 Participants
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
n=101 Participants
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r
Ritonavir (full or booster)
|
11 participants
|
7 participants
|
2 participants
|
0 participants
|
|
Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r
Lopinavir/r
|
0 participants
|
0 participants
|
0 participants
|
14 participants
|
|
Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r
Fos-amprenavir/r
|
3 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r
Lamivudine
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r
Abacavir
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r
Combivir
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r
Truvada
|
2 participants
|
0 participants
|
1 participants
|
3 participants
|
|
Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r
Atripla
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Assessed over time during Year 1Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
Major reasons for discontinuing one or more drugs in the FPV/r or LPV/r regimen
Outcome measures
| Measure |
ART naïve
n=16 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=8 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
n=5 Participants
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
n=24 Participants
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen
Virological failure
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen
Hypersensitivity reaction
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen
Toxicity - GI tract
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen
Toxicity - Pancreas
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen
Toxicity, mainly from nervous system
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen
Toxicity, mainly from kidneys
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen
Side effects -any of the above unspecified
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen
Co-morbidity
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen
Simplified treatment available
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen
Structured Treatment Interruption (STI)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen
Participant's wish/decision
|
0 participants
|
0 participants
|
1 participants
|
3 participants
|
|
Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen
Physician's decision
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen
Non-compliance
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen
Other causes
|
9 participants
|
6 participants
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen
Unknown cause
|
3 participants
|
1 participants
|
1 participants
|
8 participants
|
SECONDARY outcome
Timeframe: The incidence of these events was assessed over time during Year 1Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
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)
Outcome measures
| Measure |
ART naïve
n=167 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
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
Hypersensitivity reaction
|
2 participants
|
—
|
—
|
—
|
|
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
GI Tract
|
6 participants
|
—
|
—
|
—
|
|
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
Pancreas
|
1 participants
|
—
|
—
|
—
|
|
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
Nervous system
|
2 participants
|
—
|
—
|
—
|
|
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
Kidneys
|
1 participants
|
—
|
—
|
—
|
|
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
Other side effects (not specified as above)
|
3 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Incidence of these events was assessed over time during Year 1Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
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.
Outcome measures
| Measure |
ART naïve
n=167 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures
ALT elevations/flares after baseline, n=13
|
18 incidence rate
|
—
|
—
|
—
|
|
Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures
1st stop >=1 drug in FPV/RTV or LPV/RTV reg., n=53
|
102 incidence rate
|
—
|
—
|
—
|
|
Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures
Severe hepatic events, n=0
|
0 incidence rate
|
—
|
—
|
—
|
|
Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures
Death or hospitalization due to AIDS, n=1
|
1 incidence rate
|
—
|
—
|
—
|
|
Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures
1st stop of FPV/RTV or LPV/RTV alone, n=33
|
55 incidence rate
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
Participant characteristics at baseline are presented according to treatment group. ART is used for the treatment of HIV.
Outcome measures
| Measure |
ART naïve
n=43 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=15 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
n=8 Participants
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
n=101 Participants
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline
Length of follow-up
|
0.36 years
Interval 0.07 to 1.07
|
0.36 years
Interval 0.04 to 1.02
|
0.95 years
Interval 0.6 to 1.5
|
0.34 years
Interval 0.12 to 1.46
|
|
Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline
Tiime on ART
|
1.7 years
Interval 0.0 to 12.0
|
1.0 years
Interval 0.0 to 11.0
|
3.21 years
Interval 0.0 to 10.0
|
0.08 years
Interval 0.0 to 12.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
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.
Outcome measures
| Measure |
ART naïve
n=43 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=15 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
n=8 Participants
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
n=101 Participants
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
Cluster of Differentiation (CD4) Count at Baseline
|
355 cells/microliter (μl)
Interval 66.0 to 1585.0
|
331 cells/microliter (μl)
Interval 113.0 to 912.0
|
370 cells/microliter (μl)
Interval 197.0 to 427.0
|
252 cells/microliter (μl)
Interval 7.0 to 1113.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
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.
Outcome measures
| Measure |
ART naïve
n=43 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=15 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
n=8 Participants
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
n=101 Participants
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
Median Aspartate Aminotransferase (AST)-Platelet Ratio Index (APRI) Score at Baseline
|
0.4 APRI Score
Interval 0.06 to 1.73
|
0.53 APRI Score
Interval 0.12 to 3.33
|
0.69 APRI Score
Interval 0.14 to 8.06
|
0.35 APRI Score
Interval 0.06 to 5.04
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
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).
Outcome measures
| Measure |
ART naïve
n=43 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=15 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
n=8 Participants
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
n=101 Participants
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
Median FIB (a Model of End-stage Liver Disease) Score at Baseline
|
0.49 FIB Score
Interval 0.17 to 3.0
|
0.64 FIB Score
Interval 0.18 to 5.87
|
1.96 FIB Score
Interval 0.25 to 13.47
|
0.74 FIB Score
Interval 0.19 to 4.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
ART naïve
n=43 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
n=8 Participants
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
n=101 Participants
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
Median Model of End-stage Liver Disease (MELD) Score at Baseline
|
5.11 MELD score
Interval -4.0 to 11.85
|
—
|
6.56 MELD score
Interval 5.06 to 8.08
|
2.45 MELD score
Interval -6.0 to 22.65
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
Participants characteristics at baseline according to treatment group.
Outcome measures
| Measure |
ART naïve
n=43 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=15 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
n=8 Participants
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
n=101 Participants
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
Median ALT and AST Scores at Baseline
ALT
|
64 IU/L (International Units per Liter)
Interval 10.0 to 282.0
|
53 IU/L (International Units per Liter)
Interval 28.0 to 297.0
|
64 IU/L (International Units per Liter)
Interval 37.0 to 568.0
|
52.5 IU/L (International Units per Liter)
Interval 7.0 to 416.0
|
|
Median ALT and AST Scores at Baseline
AST
|
52 IU/L (International Units per Liter)
Interval 16.0 to 163.0
|
71 IU/L (International Units per Liter)
Interval 24.0 to 291.0
|
66 IU/L (International Units per Liter)
Interval 27.0 to 157.0
|
45 IU/L (International Units per Liter)
Interval 16.0 to 358.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
Participant characteristics at baseline according to treatment group.
Outcome measures
| Measure |
ART naïve
n=43 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=15 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
n=8 Participants
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
n=101 Participants
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
Median Blood Platelet Count at Baseline
|
180 10^9/liter
Interval 45.0 to 327.0
|
146 10^9/liter
Interval 24.0 to 246.0
|
145 10^9/liter
Interval 44.0 to 222.0
|
167 10^9/liter
Interval 39.0 to 396.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
Participant characteristics at baseline according to treatment group.
Outcome measures
| Measure |
ART naïve
n=43 Participants
Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
|
Not ART naïve
n=15 Participants
Patients who have previously been exposed to ART therapy
|
LPV, Standard Dose
n=8 Participants
Lopinavir (LPV), Standard Dose
|
LPV, Standard Dose
n=101 Participants
Lopinavir (LPV), Standard Dose
|
|---|---|---|---|---|
|
Median Bilirubin Level at Baseline
|
0.74 milligrams (mg)/deciliter (dl)
Interval 0.22 to 9.39
|
0.62 milligrams (mg)/deciliter (dl)
Interval 0.42 to 4.3
|
0.83 milligrams (mg)/deciliter (dl)
Interval 0.48 to 29.2
|
0.50 milligrams (mg)/deciliter (dl)
Interval 0.16 to 10.0
|
Adverse Events
FPV 700 mg BID/RTV 100 mg BID
FPV 700 mg BID/RTV 100 mg QD
FPV, Other
LPV, Standard Dose
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER