title: Simplification to atazanavir/ritonavir monotherapy for HIV-1 treated individuals on virological suppression: 48-week efficacy and safety results.
abstract: OBJECTIVE
  The objective of this study was to assess the 48-week virological efficacy of atazanavir/ritonavir (ATV/r) monotherapy vs. ATV/r along with two nucleoside reverse transcriptase (NRTIs) in HIV-1 treated individuals with HIV-RNA less than 50 copies/ml.
  
  
  METHODS
  A multicentre, randomized, open-label, noninferiority trial. HIV-1 treated individuals on ATV/r 300/100 mg along with two NRTIs were randomized to receive ATV/r monotherapy or to maintain their antiretroviral regimen. The primary endpoint was the confirmed viral rebound (CVR: two consecutive HIV-RNA >50 copies/ml) or treatment discontinuation for any reason. Individuals who experienced CVR on ATV/r monotherapy reintroduced NRTIs and discontinued the study if HIV-RNA was more than 50 copies/ml after 12 weeks since reintensification.
  
  
  RESULTS
  One hundred and three patients enrolled. By week 48, 11 patients in ATV/r arm and two in ATV/r along with two NRTIs experienced CVR; four (8%) patients in ATV/r and eight (15%) in ATV/r along with two NRTIs discontinued. At the 48-week primary efficacy analysis (re-intensification = failure), treatment success was 73% in ATV/r arm and 85% in ATV/r along with two NRTIs [difference -12.1%, 95% confidence interval (95% CI) -27.8 to 2.1]. According to the analysis considering re-intensification is equal to success, treatment success was 92% in ATV/r arm and 85% in the ATV/r along with two NRTIs arm (difference 7.5%, 95% CI -4.7 to 19.8). At CVR, no mutation was observed in ATV/r arm and reintensification with NRTIs was effective in all individuals. Overall, Grade 3-4 (P = 0.003) and grade 3-4 drug-related (P = 0.027) adverse events were less frequent in ATV/r arm. A significant increase in total and low-density lipoprotein (LDL)-cholesterol was observed as well as a significant improvement in high-density lipoprotein (HDL)-cholesterol, fasting glucose, liver fibrosis and alkaline phosphatase was observed in ATV/r monotherapy in comparison with ATV/r along with two NRTIs.
  
  
  CONCLUSIONS
  ATV/r monotherapy treatment simplification showed lower virological efficacy in comparison with maintaining triple therapy; NRTIs reintroduction was effective in all the individuals.
authors: aDepartment of Infectious Diseases, San Raffaele Scientific Institute bUniversità Vita-Salute San Raffaele cClinic of Infectious and Tropical Diseases, Department of Health Sciences, S Paolo Hospital, University of Milan, Milan dDivision of Infectious Diseases, Azienda Ospedaliera San Giovanni Addolorata eClinical Department, National Institute for Infectious Diseases IRCCS Lazzaro Spallanzani, Rome fInfectious Diseases Unit, IRCCS AOU San Martino-IST, Genova gDivision of Infectious and Tropical Diseases, DIBIC 'Luigi Sacco', University of Milan, Milan, Italy.
authors: Antonella
authors: A
authors: Castagna
authors: Vincenzo
authors: V
authors: Spagnuolo
authors: Laura
authors: L
authors: Galli
authors: Concetta
authors: C
authors: Vinci
authors: Silvia
authors: S
authors: Nozza
authors: Elisabetta
authors: E
authors: Carini
authors: Antonella
authors: A
authors: D'Arminio Monforte
authors: Francesco
authors: F
authors: Montella
authors: Andrea
authors: A
authors: Antinori
authors: Antonio
authors: A
authors: Di Biagio
authors: Stefano
authors: S
authors: Rusconi
authors: Adriano
authors: A
authors: Lazzarin
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects / Q000379:methods; D000069446:Atazanavir Sulfate; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000009:adverse effects / Q000627:therapeutic use*; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use*; D019438:Ritonavir / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D009842:Oligopeptides; D011725:Pyridines; D000069446:Atazanavir Sulfate; D019438:Ritonavir