PMID- 25397540
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160121
LR  - 20181023
IS  - 1758-2652 (Electronic)
IS  - 1758-2652 (Linking)
VI  - 17
IP  - 4 Suppl 3
DP  - 2014
TI  - Efficacy and safety of rilpivirine-based regimens in treatment-experienced HIV-1 
      infected patients: a prospective cohort study.
PG  - 19796
LID - 10.7448/IAS.17.4.19796 [doi]
LID - 19796 [doi]
AB  - INTRODUCTION: Rilpivirine (RPV) is a new once-daily, non-nucleoside, reverse 
      transcriptase inhibitor (NNRTI). In treatment-naive patients, RPV has shown 
      non-inferior antiviral activity to efavirenz but data in treatment-experienced 
      patients are more limited. We assessed the efficacy and safety of RPV in 
      treatment-experienced patients switching to a RPV-based regimen. METHODS: Between 
      September 2012 and June 2013, all antiretroviral therapy (ART) experienced HIV-1 
      infected patients with a plasma HIV-RNA level <50 cp/mL, and switching to a 
      RPV-based regimen, were enrolled in this prospective monocentric cohort study. 
      Clinical and laboratory data were collected every 3 months to assess safety and 
      efficacy. The primary endpoint was the proportion of patients with virologic 
      success (HIV-RNA load <50 cp/mL) at 12 months using the FDA snapshot algorithm. 
      RESULTS: A total of 281 patients (76% male, median age: 47 years, 56% MSM) were 
      enrolled in this study. Median lymphocyte CD4 count at baseline was 640/mm(3). 
      Patients have received ART for a median of 7 years and viral replication was 
      fully suppressed for a median of 3 years. Before the switch, 39% patients were 
      treated with NNRTI, 52% with protease inhibitor and 7% with integrase 
      inhibitor-based regimens. Reasons for switch were simplification (176 cases), 
      adverse events (AEs) (93 cases) and others (12 cases). At month 12 (database 
      frozen on June 2014) in the snapshot analysis, 56% of patients met virologic 
      success, 5% experienced virologic failure (n=14) and 39% had no data in the 
      window period. In the LOCF analysis (using data from the previous available visit 
      before month 12), 89% patients were suppressed, 5% had virologic failure and 6% 
      had no data. Genotypic resistance analysis was performed in 7/14 patients at the 
      time of virologic failure (3 of whom had previous NRTI/NNRTI 
      resistance-associated mutations (RAMs)), and new NNRTI and NRTI RAMs emerged in 4 
      patients. RPV-based regimen was generally well tolerated and only 6% of patients 
      discontinued treatment for AEs. Grade 2-4 treatment-related AEs occurred in 39 
      patients: 6 had rashes, 13 neuropsychiatric symptoms, 10 GI symptoms, 10 
      biological abnormalities. At month 12, significant changes from baseline were 
      seen for total and LDL cholesterol (-0.5 and -0.28 mmol/L, respectively, p<0.05 
      for both), and plasma creatinine (+5.8 micromol/L, p<10-4). CONCLUSIONS: In patients 
      fully suppressed on ART, switching to a RPV-based regimen in clinical practice 
      was well tolerated and associated with few virologic failures.
FAU - Gazaignes, Sandrine
AU  - Gazaignes S
AD  - Infectious Disease Unit, Saint-Louis Hospital, Paris, France.
FAU - Resche-Rigon, Matthieu
AU  - Resche-Rigon M
AD  - Biostatistics Department, Saint-Louis Hospital, Paris, France.
FAU - Yang, Chloe
AU  - Yang C
AD  - Medical Department, University of Toronto, Toronto, Canada.
FAU - Gatey, Caroline
AU  - Gatey C
AD  - Infectious Disease Unit, Saint-Louis Hospital, Paris, France.
FAU - Munier, Anne-Lise
AU  - Munier AL
AD  - Infectious Disease Unit, Saint-Louis Hospital, Paris, France.
FAU - Desseaux, Kristell
AU  - Desseaux K
AD  - Biostatistics Department, Saint-Louis Hospital, Paris, France.
FAU - Rozenbaum, Willy
AU  - Rozenbaum W
AD  - Infectious Disease Unit, Saint-Louis Hospital, Paris, France.
FAU - Molina, Jean-Michel
AU  - Molina JM
AD  - Infectious Disease Unit, Saint-Louis Hospital, Paris, France.
LA  - eng
PT  - Journal Article
DEP - 20141102
PL  - Switzerland
TA  - J Int AIDS Soc
JT  - Journal of the International AIDS Society
JID - 101478566
PMC - PMC4225255
EDAT- 2014/11/15 06:00
MHDA- 2014/11/15 06:01
PMCR- 2014/11/02
CRDT- 2014/11/15 06:00
PHST- 2014/11/15 06:00 [entrez]
PHST- 2014/11/15 06:00 [pubmed]
PHST- 2014/11/15 06:01 [medline]
PHST- 2014/11/02 00:00 [pmc-release]
AID - 19796 [pii]
AID - 10.7448/IAS.17.4.19796 [doi]
PST - epublish
SO  - J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19796. doi: 10.7448/IAS.17.4.19796. 
      eCollection 2014.