PMID- 25397550
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  - Atazanavir/ritonavir monotherapy as maintenance strategy in HIV-1 treated 
      subjects with viral suppression: 96-week analysis results of the MODAT study.
PG  - 19806
LID - 10.7448/IAS.17.4.19806 [doi]
LID - 19806 [doi]
AB  - INTRODUCTION: The 48-week interim analysis of the MODAT study showed that 
      confirmed virologic failure (CVF) was more frequent in patients simplifying to 
      ATV/r monotherapy compared to maintaining ATV/r-based triple therapy. The DSMB 
      recommended stopping study enrollment but continuing follow-up of enrolled 
      patients. We present the 96-week efficacy analysis. MATERIAL AND METHODS: 
      Multicentre, randomized, open-label, non-inferiority trial (non-inferiority 
      margin -10%). Treatment failure (TF) was defined as CVF (two consecutive HIV-RNA 
      >50 cp/mL) or discontinuation for any cause. In the monotherapy arm, patients 
      with CVF re-introduced their previous NRTIs and remained in the study if HIV-RNA 
      <50 copies/mL within 12 weeks of re-intensification. RESULTS: 101 patients 
      evaluated (Figure 1): 85% males, 21% HCV-positive, median (IQR) age of 42 (36-48) 
      years, baseline CD4+ 576 (447-743) cells/microL. In the 96-week analysis (ITT; 
      TF=failure), efficacy was 64% (32/50) in the monotherapy arm and 63% (32/51) in 
      the triple-therapy arm (difference +1.3%, 95% CI -17.5-20.1). Fourteen patients 
      in monotherapy and two in triple-therapy arm had CVF; median HIV-RNA was 136 
      (72-376) copies/mL. In monotherapy arm, no PI or NRTI associated resistance 
      mutations were observed at CVF. All patients who re-intensified re-suppressed. In 
      monotherapy arm, TF was more frequent in HCV-co-infected patients (64% vs 28%; 
      p=0.041). In the secondary analysis (ITT; re-intensification=success), 82% 
      (41/50) in monotherapy arm and 63% (32/51) in triple-therapy arm were on study at 
      week 96 (difference +19.3%, 95% CI 2.2-36.3). SAEs occurred in four (8%) patients 
      in the monotherapy arm (one left basal pneumonia, one acute coronary stenosis, 
      one traumatic lesion, one nephrolithiasis) and two (4%) in the triple therapy arm 
      (one sepsis, one renal failure). Drug-related adverse events (AEs) leading to 
      discontinuation were three (6%) in the monotherapy arm (two AEs occurred in 
      patients after successful re-intensification) and 12 (23.5%) in the 
      triple-therapy (p=0.023). CONCLUSIONS: Despite the small sample size, the primary 
      96-week analysis showed that simplification to ATV/r monotherapy showed inferior 
      efficacy to maintaining ATV/r triple-therapy but appeared to be superior when 
      re-intensification was considered success.
FAU - Spagnuolo, Vincenzo
AU  - Spagnuolo V
AD  - Department of Infectious Diseases, IRCCS San Raffaele Hospital, Milan, Italy.
FAU - Galli, Laura
AU  - Galli L
AD  - Department of Infectious Diseases, IRCCS San Raffaele Hospital, Milan, Italy.
FAU - Bigoloni, Alba
AU  - Bigoloni A
AD  - Department of Infectious Diseases, IRCCS San Raffaele Hospital, Milan, Italy.
FAU - Nozza, Silvia
AU  - Nozza S
AD  - Department of Infectious Diseases, IRCCS San Raffaele Hospital, Milan, Italy.
FAU - Monforte, Antonella d'Arminio
AU  - Monforte Ad
AD  - Clinic of Infectious and Tropical Diseases, S Paolo Hospital, University of 
      Milan, Milan, Italy.
FAU - Antinori, Andrea
AU  - Antinori A
AD  - Clinical Department, National Institute for Infectious Diseases IRCCS Lazzaro 
      Spallanzani, Rome, Italy.
FAU - Di Biagio, Antonio
AU  - Di Biagio A
AD  - Division of Infectious Diseases, Azienda Ospedaliera San Martino, Genoa, Italy.
FAU - Rusconi, Stefano
AU  - Rusconi S
AD  - Division of Infectious Diseases, Ospedale Luigi Sacco, University of Milan, 
      Milan, Italy.
FAU - Guaraldi, Giovanni
AU  - Guaraldi G
AD  - Department of Medical and Surgical Sciences, University of Modena and Reggio 
      Emilia, Modena, Italy.
FAU - Di Giambenedetto, Simona
AU  - Di Giambenedetto S
AD  - Institute of Clinical Infectious Diseases, Catholic University of the Sacred 
      Heart, Rome, Italy.
FAU - Lazzarin, Adriano
AU  - Lazzarin A
AD  - Department of Infectious Diseases, IRCCS San Raffaele Hospital, Milan, Italy.
FAU - Castagna, Antonella
AU  - Castagna A
AD  - Department of Infectious Diseases, IRCCS San Raffaele Hospital, Milan, Italy.
LA  - eng
PT  - Journal Article
DEP - 20141102
PL  - Switzerland
TA  - J Int AIDS Soc
JT  - Journal of the International AIDS Society
JID - 101478566
PMC - PMC4225259
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 - 19806 [pii]
AID - 10.7448/IAS.17.4.19806 [doi]
PST - epublish
SO  - J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19806. doi: 10.7448/IAS.17.4.19806. 
      eCollection 2014.