PMID- 27125364
OWN - NLM
STAT- MEDLINE
DCOM- 20170707
LR  - 20201209
IS  - 1528-4336 (Print)
IS  - 1528-4336 (Linking)
VI  - 17
IP  - 3
DP  - 2016 May
TI  - Fosamprenavir/ritonavir in patients with viral hepatitis coinfection: an 
      observational multicohort study.
PG  - 96-108
LID - 10.1080/15284336.2016.1150409 [doi]
AB  - OBJECTIVE: Safety and tolerability evaluation of adapted dose regimens containing 
      fosamprenavir/ritonavir (FPV/r) in HIV-infected subjects with viral hepatitis 
      co-infection. METHODS: A retrospective multicohort analysis was conducted. 
      Subjects from three European cohorts who started FPV/r or lopinavir/ritonavir 
      (LPV/r) as a comparator contributed data to a centralized database. Subjects were 
      divided into five groups by treatment regimen and level of hepatic impairment 
      (aspartate aminotransferase [AST] platelet ratio index [APRI] score < or >/=2). 
      Multivariable Cox regression analyses controlling for demographic factors, 
      baseline CD4 count, FIB-4 score, use of antiretroviral therapy, and laboratory 
      markers (bilirubin and platelet count) were performed to identify factors 
      independently associated with risk of developing adverse events or safety events 
      (eg, drug discontinuation, alanine aminotransferase (ALT) elevation, hepatic 
      decompensation/death). RESULTS: A total of 1096 patients contributed data to the 
      study. Fosamprenavir/ritonavir (except in subjects with APRI >/=2 receiving 
      standard dose) was associated with a higher two-year risk of drug discontinuation 
      compared with LPV/r. Restricting the analysis to discontinuations due to adverse 
      events (AEs), only subjects who received the reduced dose were more likely to 
      discontinue >/=1 drug in the FPV/r regimen. There were no statistical differences 
      in ALT elevation between groups. Incidence of hepatic decompensation events was 
      similar among groups except for subjects who received non standard doses of FPV, 
      though the number of events was small. CONCLUSIONS: Fosamprenavir/ritonavir 
      discontinuation rate due to AEs or ALT elevation was similar across all 
      European-approved FPV/r doses and to that of LPV/r subjects.  Although liver 
      tolerated antiretrovirals, such as integrase inhibitor and entry inhibitor, the 
      use of FPV/r is acceptable in HIV infected patients with viral hepatitis.
FAU - Nasta, Paola
AU  - Nasta P
AD  - a University Division of Infectious and Tropical Diseases , University of Brescia 
      and Spedali Civili General Hospital, Spedali Civili Hospital , Brescia , Italy.
FAU - Salmon, Dominique
AU  - Salmon D
AD  - b Service des Maladies Infectieuses et Tropicales, Hopital Cochin , 
      APHP-Universite Paris Descartes , Paris , France.
FAU - d'Arminio Monforte, Antonella
AU  - d'Arminio Monforte A
AD  - c Infectious Diseases Unit, Department of Health Sciences , ASST Santi Paolo e 
      Carlo University Hospital , Milan , Italy.
FAU - Pimenta, Jeanne M
AU  - Pimenta JM
AD  - d Worldwide Epidemiology , GlaxoSmithKline , Stockley Park , UK.
FAU - Cerini, Carlo
AU  - Cerini C
AD  - a University Division of Infectious and Tropical Diseases , University of Brescia 
      and Spedali Civili General Hospital, Spedali Civili Hospital , Brescia , Italy.
FAU - Giralda, Mariarosaria
AU  - Giralda M
AD  - a University Division of Infectious and Tropical Diseases , University of Brescia 
      and Spedali Civili General Hospital, Spedali Civili Hospital , Brescia , Italy.
FAU - Winnock, Maria
AU  - Winnock M
AD  - e ISPED , Universite Bordeaux , F33000 Bordeaux , France.
AD  - f INSERM, Centre INSERM U897 , Bordeaux , France.
FAU - Cozzi-Lepri, Alessandro
AU  - Cozzi-Lepri A
AD  - g Research Department of Infection and Population Health , University College 
      London , London , UK.
LA  - eng
PT  - Journal Article
DEP - 20160316
PL  - England
TA  - HIV Clin Trials
JT  - HIV clinical trials
JID - 100936377
RN  - 0 (Carbamates)
RN  - 0 (Furans)
RN  - 0 (Organophosphates)
RN  - 0 (Sulfonamides)
RN  - O3J8G9O825 (Ritonavir)
RN  - WOU1621EEG (fosamprenavir)
SB  - IM
MH  - Adult
MH  - *Antiretroviral Therapy, Highly Active/adverse effects/methods
MH  - CD4 Lymphocyte Count
MH  - Carbamates/administration & dosage/adverse effects
MH  - Cause of Death
MH  - *Coinfection
MH  - Female
MH  - Furans
MH  - HIV Infections/diagnosis/*drug therapy/immunology/*virology
MH  - Hepatitis/diagnosis/*drug therapy/mortality/*virology
MH  - Humans
MH  - Liver Function Tests
MH  - Male
MH  - Middle Aged
MH  - Mortality
MH  - Organophosphates/administration & dosage/adverse effects
MH  - Proportional Hazards Models
MH  - Recurrence
MH  - Retrospective Studies
MH  - Risk Factors
MH  - Ritonavir/administration & dosage/adverse effects
MH  - Sulfonamides/administration & dosage/adverse effects
MH  - Treatment Failure
MH  - Treatment Outcome
MH  - Viral Load
OTO - NOTNLM
OT  - Fosamprenavir
OT  - HCV
OT  - HIV
OT  - Hepatic impairment
OT  - Lopinavir
OT  - Viral hepatitis
EDAT- 2016/04/30 06:00
MHDA- 2017/07/08 06:00
CRDT- 2016/04/30 06:00
PHST- 2016/04/30 06:00 [entrez]
PHST- 2016/04/30 06:00 [pubmed]
PHST- 2017/07/08 06:00 [medline]
AID - 10.1080/15284336.2016.1150409 [doi]
PST - ppublish
SO  - HIV Clin Trials. 2016 May;17(3):96-108. doi: 10.1080/15284336.2016.1150409. Epub 
      2016 Mar 16.