PMID- 29860402
OWN - NLM
STAT- MEDLINE
DCOM- 20191022
LR  - 20191022
IS  - 1460-2091 (Electronic)
IS  - 0305-7453 (Linking)
VI  - 73
IP  - 8
DP  - 2018 Aug 1
TI  - Low-dose ritonavir-boosted darunavir in virologically suppressed HIV-1-infected 
      adults: an open-label trial (ANRS 165 Darulight).
PG  - 2129-2136
LID - 10.1093/jac/dky181 [doi]
AB  - OBJECTIVES: To assess whether low-dose ritonavir-boosted darunavir (darunavir/r) 
      in combination with two NRTIs could maintain virological suppression in patients 
      on a standard regimen of darunavir/r + two NRTIs. DESIGN: A multicentre, Phase 
      II, non-comparative, single-arm, open-label study. SETTING: Tertiary care 
      hospitals in France. SUBJECTS: One hundred HIV-1-infected adults with no 
      darunavir or NRTI resistance-associated mutations (RAMs) and a plasma HIV RNA 
      level </=50 copies/mL for >/=12 months on once-daily darunavir/r (800/100 mg) + two 
      NRTIs for >/=6 months were switched to darunavir/r 400/100 mg with the same NRTIs. 
      PRIMARY OUTCOME MEASURE: Proportion of patients with treatment success: plasma 
      HIV RNA level </=50  copies/mL up to 48 weeks without any change in the study 
      regimen, in a modified ITT (mITT) analysis. RESULTS: At baseline, most patients 
      were male (78%), with a median age of 43 years, median duration of HIV RNA 
      </=50 copies/mL of 35 months and median CD4 T cell count of 633 cells/mm3. 
      Seventy-six percent received tenofovir/emtricitabine and 24% abacavir/lamivudine. 
      Five patients were excluded from the mITT analysis. The rate of treatment success 
      through to week 48 was 91.6% (87/95; 95% CI 84.1%-96.3%). No RAM was detected in 
      three amplifiable genotypes. A total of 212 adverse events (AEs) occurred in 64 
      patients (64%); 9 AEs were serious, none leading to treatment discontinuation. 
      CONCLUSIONS: In HIV-infected patients well suppressed with darunavir/r 
      (800/100 mg) and two NRTIs, a reduction of the darunavir dose to 400 mg/day 
      maintained virological efficacy and was safe over 48 weeks.
FAU - Molina, Jean-Michel
AU  - Molina JM
AD  - Department of Infectious Diseases, Saint-Louis Hospital, AP-HP, Paris, France.
AD  - University of Paris Diderot, Sorbonne Paris University, Paris, France.
FAU - Gallien, Sebastien
AU  - Gallien S
AD  - Department of Immunology and Infectious Diseases, Henri-Mondor Hospital, Creteil, 
      France.
FAU - Chaix, Marie-Laure
AU  - Chaix ML
AD  - University of Paris Diderot, Sorbonne Paris University, Paris, France.
AD  - Laboratory of Virology, Saint-Louis Hospital, AP-HP, Paris, France.
FAU - El Abbassi, El Mountacer
AU  - El Abbassi EM
AD  - Department of Biostatistics, Saint-Louis Hospital, AP-HP, Paris, France.
FAU - Madelaine, Isabelle
AU  - Madelaine I
AD  - Pharmacy, Saint-Louis Hospital, AP-HP, Paris, France.
FAU - Katlama, Christine
AU  - Katlama C
AD  - Department of Infectious Diseases, Pitie Salpetriere Hospital, Paris, France.
FAU - Valin, Nadia
AU  - Valin N
AD  - Department of Infectious Diseases, Saint-Antoine Hospital, Paris, France.
FAU - Delobel, Pierre
AU  - Delobel P
AD  - Department of Infectious Diseases, Toulouse University Hospital, Toulouse, 
      France.
FAU - Desseaux, Kristell
AU  - Desseaux K
AD  - University of Paris Diderot, Sorbonne Paris University, Paris, France.
FAU - Peytavin, Gilles
AU  - Peytavin G
AD  - Department of Pharmacology, Bichat Hospital, Paris, France.
FAU - Saillard, Juliette
AU  - Saillard J
AD  - ANRS, Paris, France.
FAU - Raffi, Francois
AU  - Raffi F
AD  - Infectious Disease Department and INSERM CIC 1413, University Hospital of Nantes, 
      Nantes, France.
FAU - Chevret, Sylvie
AU  - Chevret S
AD  - University of Paris Diderot, Sorbonne Paris University, Paris, France.
AD  - Department of Biostatistics, Saint-Louis Hospital, AP-HP, Paris, France.
CN  - ANRS 165 Darulight Study Group
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - J Antimicrob Chemother
JT  - The Journal of antimicrobial chemotherapy
JID - 7513617
RN  - 0 (HIV Protease Inhibitors)
RN  - 0 (RNA, Viral)
RN  - 0 (Reverse Transcriptase Inhibitors)
RN  - O3J8G9O825 (Ritonavir)
RN  - YO603Y8113 (Darunavir)
SB  - IM
MH  - Adult
MH  - Darunavir/*administration & dosage
MH  - Drug Therapy, Combination
MH  - Female
MH  - HIV Infections/*drug therapy
MH  - HIV Protease Inhibitors/*administration & dosage
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - RNA, Viral/blood
MH  - Reverse Transcriptase Inhibitors/therapeutic use
MH  - Ritonavir/*administration & dosage
MH  - Treatment Outcome
MH  - Viral Load
FIR - Ponscarme, D
IR  - Ponscarme D
FIR - Lascoux, C
IR  - Lascoux C
FIR - Girard, P M
IR  - Girard PM
FIR - Rami, A
IR  - Rami A
FIR - Yazdanpanah, Y
IR  - Yazdanpanah Y
FIR - Simon, A
IR  - Simon A
FIR - Tubiana, R
IR  - Tubiana R
FIR - Duvivier, C
IR  - Duvivier C
FIR - Jeantils, V
IR  - Jeantils V
FIR - Loreillard, D
IR  - Loreillard D
FIR - Poizot-Martin, I
IR  - Poizot-Martin I
FIR - Bernard, L
IR  - Bernard L
FIR - Gras, G
IR  - Gras G
FIR - Allavena, C
IR  - Allavena C
FIR - Bernaud, C
IR  - Bernaud C
FIR - Bouchez, S
IR  - Bouchez S
FIR - Hall, N
IR  - Hall N
FIR - Reliquet, V
IR  - Reliquet V
FIR - Raffi, F
IR  - Raffi F
FIR - De Truchis, P
IR  - De Truchis P
FIR - Charreau, I
IR  - Charreau I
FIR - Bocquet, L
IR  - Bocquet L
FIR - Lemoing, V
IR  - Lemoing V
FIR - Point, G
IR  - Point G
FIR - Molina, J M
IR  - Molina JM
FIR - Chevret, S
IR  - Chevret S
FIR - El Abbassi, E M
IR  - El Abbassi EM
FIR - Gallien, S
IR  - Gallien S
FIR - Tattevin, P
IR  - Tattevin P
FIR - Gras, G
IR  - Gras G
FIR - Chaix, M L
IR  - Chaix ML
FIR - Peytavin, G
IR  - Peytavin G
FIR - Saillard, J
IR  - Saillard J
FIR - Couffin-Cadiergues, S
IR  - Couffin-Cadiergues S
FIR - Madelaine, I
IR  - Madelaine I
FIR - Diallo, A
IR  - Diallo A
FIR - Gibowski, S
IR  - Gibowski S
EDAT- 2018/06/04 06:00
MHDA- 2019/10/23 06:00
CRDT- 2018/06/04 06:00
PHST- 2018/03/01 00:00 [received]
PHST- 2018/04/17 00:00 [accepted]
PHST- 2018/06/04 06:00 [pubmed]
PHST- 2019/10/23 06:00 [medline]
PHST- 2018/06/04 06:00 [entrez]
AID - 5026319 [pii]
AID - 10.1093/jac/dky181 [doi]
PST - ppublish
SO  - J Antimicrob Chemother. 2018 Aug 1;73(8):2129-2136. doi: 10.1093/jac/dky181.