HI FPV Study: Using Observational Cohorts to Monitor Safety of Fosamprenavir in Patients With Mild/Moderate Hepatic Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 主要终点
- Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infected patients with or without hepatic impairment coinfected with HBV or HCV who started FPV/RTV-based therapy on or after January 1,
- •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.
排除标准
- •Receipt of FPV/RTV or LPV/RTV within the year preceding the baseline visit.
研究组 & 干预措施
HIV pts w/ HBV or HCV, w/ or w/o mild to moderate HI
Patients with HIV coinfected with HBV or HCV with or without mild to moderate HI who are enrolled in one of the participating HIV patient cohorts. These patients will be exposed to FPV/RTV or LPV/RTV.
干预措施: Intervention A Standard dose (Drug)
HIV pts w/ HBV or HCV, w/ or w/o mild to moderate HI
Patients with HIV coinfected with HBV or HCV with or without mild to moderate HI who are enrolled in one of the participating HIV patient cohorts. These patients will be exposed to FPV/RTV or LPV/RTV.
干预措施: Intervention B Reduced Dose (Drug)
HIV pts w/ HBV or HCV, w/ or w/o mild to moderate HI
Patients with HIV coinfected with HBV or HCV with or without mild to moderate HI who are enrolled in one of the participating HIV patient cohorts. These patients will be exposed to FPV/RTV or LPV/RTV.
干预措施: Intervention C (Drug)
HIV pts w/ HBV or HCV, w/ or w/o mild to moderate HI
Patients with HIV coinfected with HBV or HCV with or without mild to moderate HI who are enrolled in one of the participating HIV patient cohorts. These patients will be exposed to FPV/RTV or LPV/RTV.
干预措施: Intervention D (Drug)
HIV pts w/ HBV or HCV, w/ or w/o mild to moderate HI
Patients with HIV coinfected with HBV or HCV with or without mild to moderate HI who are enrolled in one of the participating HIV patient cohorts. These patients will be exposed to FPV/RTV or LPV/RTV.
干预措施: Intervention E (Drug)
结局指标
主要结局
Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables
时间窗: 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 APRI-score, and Other Variables
时间窗: 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.
Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables
时间窗: 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 Current Values of CD4 and Platelet Counts
时间窗: Incidence was assessed over time during Year 1
An elevation in ALT is defined as a single value \>200 IU/I.
次要结局
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)