title: Dolutegravir/abacavir/lamivudine versus current ART in virally suppressed patients (STRIIVING): a 48-week, randomized, non-inferiority, open-label, Phase IIIb study.
abstract: Simplified dosing regimens are important for patients who face challenges in adhering to HIV-1 therapy. We investigated the safety and virological efficacy of switching to once-daily abacavir/dolutegravir/lamivudine (ABC/DTG/3TC).
  
  
  
  The STRIIVING study was a randomized, open-label, Phase IIIb study in adults with HIV-1 RNA <50 copies/ml on antiretroviral therapy (ART) at enrolment (ClinicalTrials.gov identifier, NCT02105987). Subjects were randomly assigned to switch to ABC/DTG/3TC once daily for 48 weeks (early-switch group) or continue current ART for 24 weeks and then switch to ABC/DTG/3TC (late-switch group). The primary end point was the proportion of subjects with HIV-1 RNA <50 copies/ml at week 24.
  
  
  
  Of 553 subjects enrolled, 275 were randomly assigned to switch immediately to ABC/DTG/3TC and 278 continued on current ART. At week 24, 85% and 88% of subjects who switched to ABC/DTG/3TC or remained on current ART, respectively, were virologically suppressed, indicating that ABC/DTG/3TC was non-inferior (difference in proportion, -3.4%; 95% CI -9.1, 2.4). At week 48, 83% and 92% were virologically suppressed in the early- and late-switch groups, respectively. Adverse events were reported more frequently with ABC/DTG/3TC (66%) than with current ART (47%) by week 24, and in the late-switch group, 60% of subjects reported adverse events post-switch. Pharmacokinetic data supported immediate switch. HIV Treatment Satisfaction Questionnaire scores improved in participants switching to ABC/DTG/3TC versus current ART.
  
  
  
  Data demonstrating non-inferiority of switching to ABC/DTG/3TC versus continuing current ART support ABC/DTG/3TC as an option when considering switch regimens in HIV-1-infected adults with stable viral suppression.
authors.affiliation: Clinique medicale l'Actuel, Montreal, QC, Canada.
authors.forename: Benoît
authors.initials: B
authors.lastname: Trottier
authors.affiliation: UCLA Clinical AIDS Research and Education Center, University of California, Los Angeles, CA, USA.
authors.forename: Jordan E
authors.initials: JE
authors.lastname: Lake
authors.affiliation: CascAIDS Research, Toronto, ON, Canada.
authors.forename: Ken
authors.initials: K
authors.lastname: Logue
authors.affiliation: Central Texas Clinical Research, Austin, TX, USA.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Brinson
authors.affiliation: Hope Clinical Research, San Juan, Puerto Rico.
authors.forename: Lizette
authors.initials: L
authors.lastname: Santiago
authors.affiliation: ViiV Healthcare, Research Triangle Park, NC, USA.
authors.forename: Clare
authors.initials: C
authors.lastname: Brennan
authors.affiliation: ViiV Healthcare, Research Triangle Park, NC, USA.
authors.forename: Justin A
authors.initials: JA
authors.lastname: Koteff
authors.affiliation: ViiV Healthcare, Collegeville, PA, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Wynne
authors.affiliation: GlaxoSmithKline, Stockley Park, UK.
authors.forename: Judy
authors.initials: J
authors.lastname: Hopking
authors.affiliation: GlaxoSmithKline, Stockley Park, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Granier
authors.affiliation: ViiV Healthcare, Brentford, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Aboud
mesh_terms: D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D002170:Canada; D015224:Dideoxynucleosides / Q000627:therapeutic use*; D057915:Drug Substitution; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000187:drug effects* / Q000472:pathogenicity / Q000502:physiology; D006575:Heterocyclic Compounds, 3-Ring / Q000627:therapeutic use*; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010078:Oxazines; D010879:Piperazines; D011728:Pyridones; D012367:RNA, Viral / Q000037:antagonists & inhibitors / Q000235:genetics* / Q000378:metabolism; D016896:Treatment Outcome; D014481:United States; D019562:Viral Load / Q000187:drug effects; D000099227:Abacavir; D000099226:Dolutegravir
chemical_list: D019380:Anti-HIV Agents; D015224:Dideoxynucleosides; D006575:Heterocyclic Compounds, 3-Ring; D019259:Lamivudine; D010078:Oxazines; D010879:Piperazines; D011728:Pyridones; D012367:RNA, Viral; D000099227:Abacavir; D000099226:Dolutegravir