title: Switch to Dolutegravir plus Rilpivirine Dual Therapy in cART-Experienced Subjects: An Observational Cohort.
abstract: BACKGROUND
  Little information is available on the efficacy and safety of the dual combination of ripivirine plus dolutegravir. This work aims at beginning to fill this gap.
  
  
  METHODS
  All HIV-1 infected subjects treated with ripivirine plus dolutegravir between October 2014 and September 2015 in eight Italian centres were included in an observational cohort. Data were collected at baseline and at weeks 4, 12, 24 and 48.
  
  
  RESULTS
  One hundred and thirty-two subjects were followed for a median of 24 months, mean 33 months. One subject discontinued the study drug at week 24 for headache, one for drug interaction and one died after week 24 of illicit drug abuse. The mean age was 51.8, females 31.7% and non-caucasians 10%. Fifty-seven (43.2%) had at least one failure in their treatment history. Reasons for switching were simplification (53.0%), toxicity (34.8%), drug interactions (n = 7), persistent low-level viremia (n = 4), non-adherence (n = 3) and viral failure (n = 2). Sixty patients (45.5%) had reverse transcriptase (RT) mutations and 69 (44,7%) had protease (PR) mutations. Sixteen had baseline viral replication, 27 had < 50 HIV-1 RNA copies/mL and in 89 (67.4%) no virus was detected (NVD, 0 copies/mL). At w4, 114 (86.4%) had NVD, 15 had 1 to 49 HIV-1 RNA copies/mL and 3 had 50 to 57 copies/mL. At week 24 one subject had viral rebound without mutations due to missed drug refill, 19 had 1 to 49 copies/mL, and 112 had NVD. All 132 subjects were tested at weeks 4 and 24. Of the 50 subjects who had a 48-week follow-up, one had a treatment interruption, four had 1 to 49 copies/mL and 45 had NVD. Among the entire population, one subject had low-level, one intermediate and 4 high-level resistance to rilpivirine: none failed by week 48. Mean serum creatinine increased by +0.1 mg/dL. During the follow-up one patient reported headache and insomnia.
  
  
  CONCLUSIONS
  Ripivirine plus dolutegravir proved safe and effective in this cohort of non-naïve HIV-1 infected subjects.
authors.affiliation: 1st Division of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milano, Italy.
authors.forename: Amedeo F
authors.initials: AF
authors.lastname: Capetti
authors.affiliation: Division of Infectious Diseases, "Careggi", Hospital, Firenze, Italy.
authors.forename: Gaetana
authors.initials: G
authors.lastname: Sterrantino
authors.affiliation: 1st Division of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milano, Italy.
authors.forename: Maria Vittoria
authors.initials: MV
authors.lastname: Cossu
authors.affiliation: Division of Infectious Diseases, "Amedeo di Savoia" Hospital, Torino, Italy.
authors.forename: GianCarlo
authors.initials: G
authors.lastname: Orofino
authors.affiliation: 2nd Division of Infectious Diseases, "Policlinico San Matteo" Hospital, Pavia, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Barbarini
authors.affiliation: Infectious Diseases Clinic, Azienda Ospedaliero-Universitaria di Perugia, Perugia, Italy.
authors.forename: Giuseppe V
authors.initials: GV
authors.lastname: De Socio
authors.affiliation: 2nd Division of Infectious Diseases, "Policlinico Universitario Agostino Gemelli" Hospital, Roma, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Di Giambenedetto
authors.affiliation: Infectious Diseases Clinic, "San Martino" Hospital, Genova, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Di Biagio
authors.affiliation: Infectious Diseases Unit, University of Catania, ARNAS (Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione) Garibaldi, Catania, Italy.
authors.forename: Benedetto M
authors.initials: BM
authors.lastname: Celesia
authors.affiliation: 1st Division of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milano, Italy.
authors.forename: Barbara
authors.initials: B
authors.lastname: Argenteri
authors.affiliation: 1st Division of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milano, Italy.|Whitwaterstrand University, Johannesburg, South Africa.
authors.forename: Giuliano
authors.initials: G
authors.lastname: Rizzardini
mesh_terms: D000328:Adult; D000368:Aged; D023241:Antiretroviral Therapy, Highly Active; D015331:Cohort Studies; D003404:Creatinine / Q000097:blood; D004334:Drug Administration Schedule; D004347:Drug Interactions; D024882:Drug Resistance, Viral; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D019428:HIV Integrase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification; D006261:Headache / Q000209:etiology; D006575:Heterocyclic Compounds, 3-Ring / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010078:Oxazines; D010879:Piperazines; D011728:Pyridones; D012367:RNA, Viral / Q000097:blood; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000068696:Rilpivirine / Q000009:adverse effects / Q000627:therapeutic use*; D007319:Sleep Initiation and Maintenance Disorders / Q000209:etiology; D000099226:Dolutegravir
chemical_list: D003404:Creatinine; D019428:HIV Integrase Inhibitors; D006575:Heterocyclic Compounds, 3-Ring; D010078:Oxazines; D010879:Piperazines; D011728:Pyridones; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D000068696:Rilpivirine; D000099226:Dolutegravir