title: Long-term efficacy of darunavir/ritonavir monotherapy in patients with HIV-1 viral suppression: week 96 results from the MONOI ANRS 136 study.
abstract: OBJECTIVE
  Long-term results at week 96 are needed to evaluate the capacity of the darunavir/ritonavir monotherapy strategy to maintain a sustained control of the HIV-1 viral load.
  
  
  METHODS
  MONOI is a prospective, open-label, non-inferiority, randomized, 96 week trial comparing darunavir/ritonavir monotherapy versus a darunavir/ritonavir triple-therapy strategy to maintain HIV-1 viral load suppression in HIV-1-infected patients.
  
  
  BACKGROUND
  NCT00412551.
  
  
  RESULTS
  From 225 randomized patients, 219 patients reached the 48 week follow-up and 211 reached the 96 week follow-up (106 patients in the darunavir monotherapy arm and 105 in the darunavir triple-therapy arm). Baseline characteristics were well balanced between the two treatment groups. At week 96, in intent-to-treat analysis, 91/103 patients (88%, 95% CI 81-94) allocated to the darunavir/ritonavir monotherapy arm and 87/104 patients (84%, 95% CI 75-90) allocated to the darunavir triple-therapy arm achieved an HIV-1 viral load <50 copies/mL, with no statistical difference between the two groups. Throughout the 96 week follow-up, 66/112 patients (59%, 95% CI 49-68) and 79/113 patients (70%, 95% CI 61-78) consistently had HIV-1 RNA <50 copies/mL with darunavir/ritonavir monotherapy and darunavir/ritonavir triple therapy, respectively.
  
  
  CONCLUSIONS
  The MONOI study establishes darunavir/ritonavir monotherapy as durable and efficacious for maintaining virological suppression in HIV-1 patients. Darunavir/ritonavir monotherapy should be considered as a (tailored) treatment option for standard triple-therapy patients who have had a substantial period of viral suppression.
authors.affiliation: INSERM UMR-S 943 and University Pierre and Marie Curie (UPMC) Paris VI, Paris, France. marc-antoine.valantin@psl.aphp.fr
authors.forename: M A
authors.initials: MA
authors.lastname: Valantin
authors.forename: S
authors.initials: S
authors.lastname: Lambert-Niclot
authors.forename: P
authors.initials: P
authors.lastname: Flandre
authors.forename: L
authors.initials: L
authors.lastname: Morand-Joubert
authors.forename: A
authors.initials: A
authors.lastname: Cabiè
authors.forename: J L
authors.initials: JL
authors.lastname: Meynard
authors.forename: D
authors.initials: D
authors.lastname: Ponscarme
authors.forename: F
authors.initials: F
authors.lastname: Ajana
authors.forename: L
authors.initials: L
authors.lastname: Slama
authors.forename: A
authors.initials: A
authors.lastname: Curjol
authors.forename: L
authors.initials: L
authors.lastname: Cuzin
authors.forename: L
authors.initials: L
authors.lastname: Schneider
authors.forename: A M
authors.initials: AM
authors.lastname: Taburet
authors.forename: A G
authors.initials: AG
authors.lastname: Marcelin
authors.forename: C
authors.initials: C
authors.lastname: Katlama
mesh_terms: D019380:Anti-HIV Agents / Q000008:administration & dosage*; D000069454:Darunavir; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D011446:Prospective Studies; D019438:Ritonavir / Q000008:administration & dosage*; D013449:Sulfonamides / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D013449:Sulfonamides; D019438:Ritonavir; D000069454:Darunavir