title: Viral blips were infrequent in treatment-naive adults treated with rilpivirine/emtricitabine/tenofovir DF or efavirenz/emtricitabine/tenofovir DF through 96 weeks.
abstract: BACKGROUND
  The clinical impact of transient episodes of HIV viraemia (viral blips) on virological failure and resistance development is not fully understood. Here we investigated the blip frequency and virological outcomes of HIV-1-infected subjects experiencing viral blips among treatment-naive subjects initiating therapy on rilpivirine (RPV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) or efavirenz (EFV)/FTC/TDF through 96 weeks of treatment.
  
  
  METHODS
  Subjects treated with at least one dose of study drug and with at least one post-baseline HIV-1 RNA value were included in this analysis. All on-drug HIV-1 RNA data points and FDA snapshot outcome data through week 96 were utilized. A viral blip was defined as after achieving confirmed suppression (two consecutive HIV-1 RNA values <50 copies/ml), any HIV-1 RNA value ≥50 copies/ml preceded and followed by HIV-1 RNA <50 copies/ml.
  
  
  RESULTS
  Of the 717 subjects with confirmed suppression, 67 (9.3%) experienced ≥1 blip through week 96 with similar blip frequencies occurring in both treatment arms (10.7% RPV/FTC/TDF versus 8.0% EFV/FTC/TDF; P=0.25). A significantly higher proportion of subjects with baseline HIV-1 RNA >100,000 copies/ml experienced blips compared to subjects with baseline HIV-1 RNA ≤100,000 copies/ml and this was observed in both arms. Of 72 total blip events, 61 (85%) were low-level (50-199 copies/ml). Overall, among subjects with blips, 79% were virological successes at week 96, similar to those subjects without blips (83%; P=0.50). More subjects with blips ≥200 copies/ml experienced virological failure compared to subjects with blips <200 copies/ml (36.4% versus 7.1%; P=0.02).
  
  
  CONCLUSIONS
  Viral blips were infrequent and similar among subjects treated with RPV/FTC/TDF or EFV/FTC/TDF. Most blips were low-level and most subjects with blips remained virologically suppressed through week 96 without experiencing virological failure.
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: Danielle P
authors.initials: DP
authors.lastname: Porter
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: Rima
authors.initials: R
authors.lastname: Kulkarni
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: Will
authors.initials: W
authors.lastname: Garner
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Miller
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: Kirsten L
authors.initials: KL
authors.lastname: White
mesh_terms: D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents; D023241:Antiretroviral Therapy, Highly Active; D048588:Benzoxazines; D003521:Cyclopropanes; D024882:Drug Resistance, Viral; D000068679:Emtricitabine; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology*; D015497:HIV-1; D006801:Humans; D008297:Male; D012367:RNA, Viral; D000068696:Rilpivirine; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load; D014766:Viremia
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D012367:RNA, Viral; D000068696:Rilpivirine; D000068679:Emtricitabine; C098320:efavirenz