Infection, Human Immunodeficiency Virus Clinical Trial
Official title:
HI FPV Study: Using Observational Cohorts to Monitor Safety of Fosamprenavir in Patients With Mild/Moderate Hepatic Impairment
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.
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. ;
Observational Model: Cohort, Time Perspective: Prospective
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