Switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir DF from non-nucleoside reverse transcriptase inhibitor plus coformulated emtricitabine and tenofovir DF regimens: Week 96 results of STRATEGY-NNRTI

HIV Clin Trials. 2017 Jul;18(4):141-148. doi: 10.1080/15284336.2017.1338844. Epub 2017 Jul 9.

Abstract

Background: HIV-1-infected, virologically suppressed adults wanting to simplify or change their non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens may benefit from switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (E/C/F/TDF).

Objective: We examined differences in the proportion of participants with HIV-1 RNA < 50 copies/mL (Snapshot analysis), change in CD4 cell count, safety, and patient-reported outcomes in participants switching to E/C/F/TDF from an NNRTI + FTC/TDF (TVD) regimen.

Methods: STRATEGY-NNRTI was a 96-week, phase 3b, randomized, open-label, study examining the efficacy, safety, and tolerability of switching to E/C/F/TDF in virologically suppressed individuals (HIV-1 RNA < 50 copies/mL) on an NNRTI + TVD regimen. Participants were randomized to switch or remain on their NNRTI-based regimen (no-switch).

Results: At Week 96, 87% (251/290) of switch and 80% (115/143) of no-switch participants maintained HIV-1 RNA < 50 copies/mL (difference 6.1%; 95% CI -1.3 to 14.2%; p = 0.12) according to the FDA-defined snapshot algorithm. Both groups had similar proportions of subjects with virologic failure (2.8% switch, 1.4% no-switch). Discontinuations resulting from adverse events were infrequent (3% [9/291] switch, 2% [3/143] no-switch). Three switch participants (1%) discontinued due to renal adverse events (2 of the 3 before Week 48). Switch participants reported significant improvements in neuropsychiatric symptoms by as early as Week 4, and which were maintained through Week 96.

Conclusions: E/C/F/TDF is safe and effective and reduces NNRTI-associated neuropsychiatric symptoms for virologically suppressed HIV-positive adults switching from an NNRTI plus FTC/TDF-based regimen.

Trial registration: ClinicalTrials.gov NCT01495702.

Keywords: HIV; INSTI; NNRTI; Non-inferiority; Patient-reported outcomes; Randomized trial; Single-tablet regimen; Switch.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antiretroviral Therapy, Highly Active* / adverse effects
  • Antiretroviral Therapy, Highly Active* / methods
  • Cobicistat / administration & dosage
  • Drug Combinations
  • Drug Substitution*
  • Emtricitabine / administration & dosage
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / virology*
  • HIV-1* / drug effects
  • HIV-1* / genetics
  • Humans
  • Male
  • Patient Reported Outcome Measures
  • Quinolones / administration & dosage
  • Tablets
  • Tenofovir / administration & dosage
  • Time Factors
  • Treatment Outcome

Substances

  • Drug Combinations
  • JTK 303
  • Quinolones
  • Tablets
  • Tenofovir
  • Emtricitabine
  • Cobicistat

Associated data

  • ClinicalTrials.gov/NCT01495702