Infection, Human Immunodeficiency Virus
Conditions
Keywords
antiretroviral therapy, hepatic impairment, HIV
Brief summary
APV10017 was a pharmacokinetic study that evaluated the pharmacokinetics, safety and tolerability of fosamprenavir/ritonavir (FPV/RTV) at reduced doses over 14 days in HIV-infected subjects with mild to moderate hepatic impairment (HI). Based on these data, two new regimens have recently been approved by the EMEA and FDA in these patient groups; FPV 700mg BID/RTV 100mg QD for those with mild HI (Child-Pugh score 4-6) and FPV 450mg BID/RTV 100mg QD for those with moderate HI (Child Pugh score 7-9). The Committee for Medicinal Products for Human Use (CHMP) has requested longer-term safety data among this hepatically impaired HIV-infected population who have received the recently updated FPV/RTV dosing regimens. An observational cohort study will be conducted using routinely collected data in three European HIV patient cohorts with a high proportion of hepatitis co-infected individuals. Patients who received FPV/RTV will be followed to address the following objectives. Primary: To assess the safety and tolerability of FPV/RTV-based ART in subjects with mild to moderate hepatic impairment. Secondary: A). To compare the safety and tolerability of FPV/RTV-based ART in subjects with mild to moderate hepatic impairment when compared to FPV/RTV-based ART in hepatitis B (HBV) or hepatitis C (HCV) co-infected subjects with normal hepatic function. B). To compare the safety and tolerability of FPV/RTV-based ART to lopinavir/ritonavir LPV/RTV-based ART in subjects with mild to moderate hepatic impairment.
Detailed description
Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.
Interventions
DRUGIntervention A Standard dose
HIV subjects with HBV or HCV co-infection but normal hepatic function, defined by receipt of FPV 700mg BID/RTV 100mg BID and a baseline AST-platelet ratio index (APRI) score of \<2.0.
DRUGIntervention B Reduced Dose
HIV subjects with mild hepatic impairment, defined by receipt of the recommended reduced FPV/RTV dose (700mg BID/100mg QD).
DRUGIntervention C
HIV subjects with moderate hepatic impairment, defined by receipt of FPV 450mg BID/RTV 100mg QD.
DRUGIntervention D
HIV subjects receiving the standard dose of FPV/RTV despite evidence of abnormal hepatic function according to APRI score: HIV subjects with HBV or HCV co-infection, receipt of FPV 700mg BID/RTV 100mg BID and a baseline APRI score of ≥2.0.
DRUGIntervention E
HIV subjects coinfected with HBV or HCV who have initiated standard doses of LPV 400mg/RTV 100mg and enrolled in the same cohorts as the FPV/RTV exposed subjects.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV infected patients with or without hepatic impairment coinfected with HBV or HCV who started FPV/RTV-based therapy on or after January 1, 2008. The FPV/RTV exposed patients will be stratified into four groups for analysis (see interventions A-D for label/description above), according to their degree of baseline hepatic impairment, which will be defined according to FPV/RTV dose received (and APRI score for interventions A and D). The LPV/RTV intervention group must have started this therapy at approved standard doses on or after January 1, 2008.
Exclusion criteria
* Receipt of FPV/RTV or LPV/RTV within the year preceding the baseline visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables | The incidence of these events was assessed over time during Year 1, censoring participants' follow-up at date of last ALT | An elevation in ALT is defined as a single value \>200 IU/I. |
| Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts | Incidence was assessed over time during Year 1 | An elevation in ALT is defined as a single value \>200 IU/I. |
| Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables | Incidence was assessed over time during Year 1 | An elevation in ALT is defined as a single value \>200 IU/I. |
| Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for APRI-score, and Other Variables | Incidence of these events was assessed over time during Year 1, censoring patients' follow-up at date of last ALT | An elevation in ALT is defined as a single value \>200 IU/I. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Incidence was assessed over time during Year 1 | A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime |
| 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 | Incidence was assessed over time during Year 1 | A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime. |
| 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 | Incidence was assessed over time during Year 1 | A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime. |
| Number of Events of Discontinuation of One or More Drugs in the FPV/RTV- or LPV/RTV Regimen Due to Adverse Events Only | Incidence was assessed over time during Year 1 | Defined as the occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attributed to adverse events only |
| Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events | Incidence was assessed over time during Year 1 | 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). |
| Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Assessed over time during Year 1 | Antiretrovirals discontinued for the first time after starting FPV/r or LPV/r |
| Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen | Assessed over time during Year 1 | Major reasons for discontinuing one or more drugs in the FPV/r or LPV/r regimen |
| 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 | The incidence of these events was assessed over time during Year 1 | 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) |
| Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures | Incidence of these events was assessed over time during Year 1 | 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. |
| Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for APRI-score, and Other Variables | Incidence was assessed over time during Year 1 | A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV. |
| Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for FIB-score, and Other Variables | Incidence was assessed over time during Year 1 | A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV. |
| 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 | Incidence was assessed over time during Year 1 | A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV |
| Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to Adverse Events Only | Incidence was assessed over time during Year 1 | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Median ALT and AST Scores at Baseline | Baseline | Participants characteristics at baseline according to treatment group. |
| Median Blood Platelet Count at Baseline | Baseline | Participant characteristics at baseline according to treatment group. |
| Median Bilirubin Level at Baseline | Baseline | Participant characteristics at baseline according to treatment group. |
| Median Model of End-stage Liver Disease (MELD) Score at Baseline | Baseline | 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. |
| Median FIB (a Model of End-stage Liver Disease) Score at Baseline | Baseline | 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). |
| Median Aspartate Aminotransferase (AST)-Platelet Ratio Index (APRI) Score at Baseline | Baseline | 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. |
| Cluster of Differentiation (CD4) Count at Baseline | Baseline | 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. |
| Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline | Baseline | Participant characteristics at baseline are presented according to treatment group. ART is used for the treatment of HIV. |
Participant flow
Recruitment details
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/.
Participants by arm
| Arm | Count |
|---|---|
| FPV 700 mg BID/RTV 100 mg BID Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID | 43 |
| FPV 700 mg BID/RTV 100 mg QD FPV 700 mg BID/RTV 100 mg once a day (QD) | 15 |
| FPV, Other All other dosages of Fosamprenavir | 8 |
| LPV, Standard Dose Lopinavir (LPV), Standard Dose | 101 |
| Total | 167 |
Baseline characteristics
| Characteristic | FPV 700 mg BID/RTV 100 mg BID | FPV 700 mg BID/RTV 100 mg QD | FPV, Other | LPV, Standard Dose | Total |
|---|---|---|---|---|---|
| Age Continuous | 45 years | 45 years | 44 years | 44 years | 44 years |
| Cohort Distribution Cohort - HEPAVIH | 3 participants | 2 participants | 2 participants | 6 participants | 13 participants |
| Cohort Distribution Cohort - ICONA | 4 participants | 0 participants | 2 participants | 23 participants | 29 participants |
| Cohort Distribution Cohort - MASTER | 36 participants | 13 participants | 4 participants | 72 participants | 125 participants |
| Number of participants positive for Hepatitis B and/or C at baseline HBs-Ag positive test | 9 participants | 2 participants | 2 participants | 21 participants | 34 participants |
| Number of participants positive for Hepatitis B and/or C at baseline HCV-Ab positive test | 37 participants | 14 participants | 7 participants | 82 participants | 140 participants |
| Number of participants who were ART naïve at baseline | 12 participants | 5 participants | 2 participants | 50 participants | 69 participants |
| Number of participants with acquired immunodeficiency syndrome (AIDS) at baseline | 9 participants | 0 participants | 3 participants | 24 participants | 36 participants |
| Number of participants with the indicated alanine aminotransferase (ALT) levels at baseline Baseline ALT <= 200 IU/L | 40 participants | 11 participants | 6 participants | 83 participants | 140 participants |
| Number of participants with the indicated alanine aminotransferase (ALT) levels at baseline Baseline ALT > 200 IU/L | 1 participants | 2 participants | 1 participants | 3 participants | 7 participants |
| Number of participants with the indicated alanine aminotransferase (ALT) levels at baseline Baseline ALT Unknown | 2 participants | 2 participants | 1 participants | 15 participants | 20 participants |
| Sex: Female, Male Female | 11 Participants | 3 Participants | 0 Participants | 38 Participants | 52 Participants |
| Sex: Female, Male Male | 32 Participants | 12 Participants | 8 Participants | 63 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables
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
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ART naïve | Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables | 9 events |
| Not ART naïve | Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables | 4 events |
p-value: 0.0295% CI: [1.26, 29.46]Regression, Cox
Primary
Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for APRI-score, and Other Variables
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
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ART naïve | Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for APRI-score, and Other Variables | 6 events |
| Not ART naïve | Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for APRI-score, and Other Variables | 1 events |
| 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 |
p-value: 0.0595% CI: [1.03, 16.5]Regression, Cox
p-value: 0.6895% CI: [0.16, 16.27]Regression, Cox
Primary
Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts
An elevation in ALT is defined as a single value \>200 IU/I.
Time frame: Incidence was assessed over time during Year 1
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ART naïve | Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts | 6 events |
| Not ART naïve | Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts | 1 events |
| 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 |
p-value: 0.0695% CI: [0.94, 10.82]Regression, Cox
p-value: 0.9695% CI: [0.11, 9.83]Regression, Cox
Primary
Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables
An elevation in ALT is defined as a single value \>200 IU/I.
Time frame: Incidence was assessed over time during Year 1
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ART naïve | Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables | 6 events |
| Not ART naïve | Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables | 1 events |
| 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 |
p-value: 0.1795% CI: [0.65, 12.36]Regression, Cox
p-value: 0.8595% CI: [0.12, 13.33]Regression, Cox
Secondary
Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures
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
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ART naïve | 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 |
| ART naïve | 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 |
| ART naïve | 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 |
| ART naïve | Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures | Severe hepatic events, n=0 | 0 incidence rate |
| ART naïve | 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 |
Secondary
Number of Events of Discontinuation of One or More Drugs in the FPV/RTV- or LPV/RTV Regimen Due to Adverse Events Only
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
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ART naïve | 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 |
| Not ART naïve | Number of Events of Discontinuation of One or More Drugs in the FPV/RTV- or LPV/RTV Regimen Due to Adverse Events Only | 5 events |
p-value: 0.0395% CI: [1.19, 22.02]Regression, Cox
Secondary
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for APRI-score, and Other Variables
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
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ART naïve | 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 |
| Not ART naïve | Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for APRI-score, and Other Variables | 1 events |
| 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 | 4 events |
| 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 | 19 events |
p-value: 0.5795% CI: [0.52, 3.31]Regression, Cox
p-value: 0.2295% CI: [0.04, 2.14]Regression, Cox
p-value: 0.4795% CI: [0.35, 9.91]Regression, Cox
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
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
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ART naïve | 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 |
| Not ART naïve | 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 | 1 events |
| 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 | 4 events |
| 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 | 19 events |
p-value: 0.7295% CI: [0.51, 2.66]Regression, Cox
p-value: 0.2195% CI: [0.03, 2.08]Regression, Cox
Comparison: Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.p-value: 0.1595% CI: [0.74, 6.97]Regression, Cox
Secondary
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for FIB-score, and Other Variables
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
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ART naïve | 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 |
| Not ART naïve | Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for FIB-score, and Other Variables | 1 events |
| 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 | 4 events |
| 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 | 19 events |
p-value: 0.4895% CI: [0.55, 3.55]Regression, Cox
p-value: 0.2395% CI: [0.03, 2.18]Regression, Cox
p-value: 0.5695% CI: [0.29, 9.47]Regression, Cox
Secondary
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to Adverse Events Only
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
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ART naïve | Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to Adverse Events Only | 5 events |
| Not ART naïve | Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to Adverse Events Only | 7 events |
p-value: 0.195% CI: [0.79, 18.05]Regression, Cox
Secondary
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events
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
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ART naïve | Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events | Hypersensitivity reaction | 1 events |
| ART naïve | Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events | GI Tract | 5 events |
| ART naïve | Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events | Pancreas | 1 events |
| ART naïve | Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events | Nervous system | 2 events |
| ART naïve | Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events | Kidneys | 1 events |
| ART naïve | 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
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
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
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ART naïve | 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 |
| Not ART naïve | 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 | 8 events |
| 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 | 5 events |
| 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 | 24 events |
p-value: 0.0395% CI: [1.06, 4.15]Regression, Cox
p-value: 0.0595% CI: [1.48, 8.81]Regression, Cox
p-value: 0.195% CI: [0.85, 6.32]Regression, Cox
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)
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
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ART naïve | 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 |
| Not ART naïve | 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) | 8 events |
| 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) | 5 events |
| 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) | 24 events |
p-value: 0.0295% CI: [1.16, 5.54]Regression, Cox
p-value: 0.0595% CI: [1.54, 11.27]Regression, Cox
p-value: 0.0695% CI: [0.97, 13.9]Regression, Cox
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
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
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ART naïve | 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 |
| Not ART naïve | 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 | 8 events |
| 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 | 5 events |
| 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 | 24 events |
p-value: 0.0195% CI: [1.21, 5.9]Regression, Cox
p-value: 0.000495% CI: [1.61, 12.08]Regression, Cox
p-value: 0.1195% CI: [0.78, 12.03]Regression, Cox
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
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
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ART naïve | 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 |
| ART naïve | 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 |
| ART naïve | 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 |
| ART naïve | 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 |
| ART naïve | 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 |
| ART naïve | 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
Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r
Antiretrovirals discontinued for the first time after starting FPV/r or LPV/r
Time frame: Assessed over time during Year 1
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ART naïve | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Lopinavir/r | 0 participants |
| ART naïve | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Fos-amprenavir/r | 3 participants |
| ART naïve | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Combivir | 0 participants |
| ART naïve | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Atripla | 0 participants |
| ART naïve | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Abacavir | 0 participants |
| ART naïve | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Lamivudine | 0 participants |
| ART naïve | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Truvada | 2 participants |
| ART naïve | 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 |
| Not ART naïve | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Truvada | 0 participants |
| Not ART naïve | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Abacavir | 1 participants |
| Not ART naïve | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Lopinavir/r | 0 participants |
| Not ART naïve | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Combivir | 0 participants |
| Not ART naïve | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Ritonavir (full or booster) | 7 participants |
| Not ART naïve | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Fos-amprenavir/r | 0 participants |
| Not ART naïve | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Atripla | 0 participants |
| Not ART naïve | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Lamivudine | 0 participants |
| LPV, Standard Dose | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Combivir | 0 participants |
| LPV, Standard Dose | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Truvada | 1 participants |
| LPV, Standard Dose | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Atripla | 0 participants |
| LPV, Standard Dose | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Lopinavir/r | 0 participants |
| LPV, Standard Dose | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Fos-amprenavir/r | 2 participants |
| 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) | 2 participants |
| LPV, Standard Dose | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Lamivudine | 0 participants |
| LPV, Standard Dose | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Abacavir | 0 participants |
| LPV, Standard Dose | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Atripla | 2 participants |
| 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) | 0 participants |
| LPV, Standard Dose | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Lopinavir/r | 14 participants |
| LPV, Standard Dose | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Fos-amprenavir/r | 1 participants |
| LPV, Standard Dose | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Lamivudine | 1 participants |
| LPV, Standard Dose | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Abacavir | 1 participants |
| LPV, Standard Dose | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Truvada | 3 participants |
| LPV, Standard Dose | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Combivir | 2 participants |
Secondary
Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen
Major reasons for discontinuing one or more drugs in the FPV/r or LPV/r regimen
Time frame: Assessed over time during Year 1
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ART naïve | 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 |
| ART naïve | 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 |
| ART naïve | 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 |
| ART naïve | 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 |
| ART naïve | 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 |
| ART naïve | 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 |
| ART naïve | 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 |
| ART naïve | 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 |
| ART naïve | 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 |
| ART naïve | 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 |
| ART naïve | 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 |
| ART naïve | 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 |
| ART naïve | 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 |
| ART naïve | 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 |
| ART naïve | 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 |
| Not ART naïve | 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 |
| Not ART naïve | 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 |
| Not ART naïve | 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 | 0 participants |
| Not ART naïve | 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 |
| Not ART naïve | 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 |
| Not ART naïve | 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 |
| Not ART naïve | Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen | Non-compliance | 1 participants |
| Not ART naïve | 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) | 0 participants |
| Not ART naïve | 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 | 0 participants |
| Not ART naïve | 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 |
| Not ART naïve | Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen | Unknown cause | 1 participants |
| Not ART naïve | Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen | Other causes | 6 participants |
| Not ART naïve | 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 |
| Not ART naïve | Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen | Toxicity - Pancreas | 0 participants |
| Not ART naïve | 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 |
| 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 | Co-morbidity | 2 participants |
| 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 | 1 participants |
| 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 | Hypersensitivity reaction | 0 participants |
| 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 | Toxicity - GI tract | 0 participants |
| 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 | Toxicity - Pancreas | 0 participants |
| 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 | Toxicity, mainly from nervous system | 0 participants |
| 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 | Toxicity, mainly from kidneys | 0 participants |
| 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 | Side effects -any of the above unspecified | 0 participants |
| 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 | Simplified treatment available | 0 participants |
| 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 | Structured Treatment Interruption (STI) | 0 participants |
| 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 | Participant's wish/decision | 1 participants |
| 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 | Physician's decision | 0 participants |
| 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 | Non-compliance | 0 participants |
| 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 | Other causes | 0 participants |
| 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 | Unknown cause | 1 participants |
| 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 | Side effects -any of the above unspecified | 1 participants |
| 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 | Hypersensitivity reaction | 1 participants |
| 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 | Physician's decision | 2 participants |
| 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 | Toxicity, mainly from kidneys | 1 participants |
| 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 | Toxicity, mainly from nervous system | 0 participants |
| 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 |
| 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 | Non-compliance | 1 participants |
| 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 | Toxicity - Pancreas | 0 participants |
| 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 | Toxicity - GI tract | 2 participants |
| 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 | Unknown cause | 8 participants |
| 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 | Structured Treatment Interruption (STI) | 0 participants |
| 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 | Simplified treatment available | 2 participants |
| 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 | Other causes | 2 participants |
| 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 | Participant's wish/decision | 3 participants |
| 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 | Co-morbidity | 1 participants |
Other Pre-specified
Cluster of Differentiation (CD4) Count at Baseline
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
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ART naïve | Cluster of Differentiation (CD4) Count at Baseline | 355 cells/microliter (μl) |
| Not ART naïve | Cluster of Differentiation (CD4) Count at Baseline | 331 cells/microliter (μl) |
| LPV, Standard Dose | Cluster of Differentiation (CD4) Count at Baseline | 370 cells/microliter (μl) |
| LPV, Standard Dose | Cluster of Differentiation (CD4) Count at Baseline | 252 cells/microliter (μl) |
Other Pre-specified
Median ALT and AST Scores at Baseline
Participants characteristics at baseline according to treatment group.
Time frame: Baseline
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ART naïve | Median ALT and AST Scores at Baseline | AST | 52 IU/L (International Units per Liter) |
| ART naïve | Median ALT and AST Scores at Baseline | ALT | 64 IU/L (International Units per Liter) |
| Not ART naïve | Median ALT and AST Scores at Baseline | ALT | 53 IU/L (International Units per Liter) |
| Not ART naïve | Median ALT and AST Scores at Baseline | AST | 71 IU/L (International Units per Liter) |
| LPV, Standard Dose | Median ALT and AST Scores at Baseline | AST | 66 IU/L (International Units per Liter) |
| LPV, Standard Dose | Median ALT and AST Scores at Baseline | ALT | 64 IU/L (International Units per Liter) |
| LPV, Standard Dose | Median ALT and AST Scores at Baseline | AST | 45 IU/L (International Units per Liter) |
| LPV, Standard Dose | Median ALT and AST Scores at Baseline | ALT | 52.5 IU/L (International Units per Liter) |
Other Pre-specified
Median Aspartate Aminotransferase (AST)-Platelet Ratio Index (APRI) Score at Baseline
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
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ART naïve | Median Aspartate Aminotransferase (AST)-Platelet Ratio Index (APRI) Score at Baseline | 0.4 APRI Score |
| Not ART naïve | Median Aspartate Aminotransferase (AST)-Platelet Ratio Index (APRI) Score at Baseline | 0.53 APRI Score |
| LPV, Standard Dose | Median Aspartate Aminotransferase (AST)-Platelet Ratio Index (APRI) Score at Baseline | 0.69 APRI Score |
| LPV, Standard Dose | Median Aspartate Aminotransferase (AST)-Platelet Ratio Index (APRI) Score at Baseline | 0.35 APRI Score |
Other Pre-specified
Median Bilirubin Level at Baseline
Participant characteristics at baseline according to treatment group.
Time frame: Baseline
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ART naïve | Median Bilirubin Level at Baseline | 0.74 milligrams (mg)/deciliter (dl) |
| Not ART naïve | Median Bilirubin Level at Baseline | 0.62 milligrams (mg)/deciliter (dl) |
| LPV, Standard Dose | Median Bilirubin Level at Baseline | 0.83 milligrams (mg)/deciliter (dl) |
| LPV, Standard Dose | Median Bilirubin Level at Baseline | 0.50 milligrams (mg)/deciliter (dl) |
Other Pre-specified
Median Blood Platelet Count at Baseline
Participant characteristics at baseline according to treatment group.
Time frame: Baseline
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ART naïve | Median Blood Platelet Count at Baseline | 180 10^9/liter |
| Not ART naïve | Median Blood Platelet Count at Baseline | 146 10^9/liter |
| LPV, Standard Dose | Median Blood Platelet Count at Baseline | 145 10^9/liter |
| LPV, Standard Dose | Median Blood Platelet Count at Baseline | 167 10^9/liter |
Other Pre-specified
Median FIB (a Model of End-stage Liver Disease) Score at Baseline
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
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ART naïve | Median FIB (a Model of End-stage Liver Disease) Score at Baseline | 0.49 FIB Score |
| Not ART naïve | Median FIB (a Model of End-stage Liver Disease) Score at Baseline | 0.64 FIB Score |
| LPV, Standard Dose | Median FIB (a Model of End-stage Liver Disease) Score at Baseline | 1.96 FIB Score |
| LPV, Standard Dose | Median FIB (a Model of End-stage Liver Disease) Score at Baseline | 0.74 FIB Score |
Other Pre-specified
Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline
Participant characteristics at baseline are presented according to treatment group. ART is used for the treatment of HIV.
Time frame: Baseline
Population: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ART naïve | Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline | Length of follow-up | 0.36 years |
| ART naïve | Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline | Tiime on ART | 1.7 years |
| Not ART naïve | Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline | Tiime on ART | 1.0 years |
| Not ART naïve | Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline | Length of follow-up | 0.36 years |
| LPV, Standard Dose | Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline | Length of follow-up | 0.95 years |
| LPV, Standard Dose | Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline | Tiime on ART | 3.21 years |
| LPV, Standard Dose | Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline | Length of follow-up | 0.34 years |
| LPV, Standard Dose | Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline | Tiime on ART | 0.08 years |
Other Pre-specified
Median Model of End-stage Liver Disease (MELD) Score at Baseline
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
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ART naïve | Median Model of End-stage Liver Disease (MELD) Score at Baseline | 5.11 MELD score |
| LPV, Standard Dose | Median Model of End-stage Liver Disease (MELD) Score at Baseline | 6.56 MELD score |
| LPV, Standard Dose | Median Model of End-stage Liver Disease (MELD) Score at Baseline | 2.45 MELD score |