Switch studies in virologically suppressed patients

Switch to BIC/FTC/TAF
GS-US-380-1844 Study : Switch to BIC/FTC/TAF
Original article : Molina JM. CROI 2018, Abs. 22
Last update : 11/05/2018

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • Switching to BIC/FTC/TAF was non-inferior to remaining on DTG/ABC/3TC, at W48
  • No treatment emergent resistance
  • Discontinuation for adverse event was rare: 2% on BIC/FTC/TAF and 1% on DTG/ABC/3TC at W48
  • Study drug-related adverse events occurred with significantly higher frequency in DTG/ABC/3TC arm
  • Increased grade 3-4 amylase was seen in 2% of BIC/FTC/TAF and no patient on DTG/ABC/3TC
  • The lipid, bone and renal parameters of switching to BIC/FTC/TAF were comparable to remaining on DTG/ABC/3TC through 48 weeks

Design

Endpoints

  • Primary: proportion of patients with HIV RNA ≥ 50 c/mL at W48 (ITT, snapshot) ; non-inferiority if upper margin of a two-sided 95.002% CI for the difference = 4%

Baseline characteristics

Virologic outcome at W48

  • No emergence of resistance in either group

Adverse events between D0 and W48, %


* Headache (N = 2), vomiting (N = 1), cerebrovascular accident (N = 1), abnormal dreams (N = 1),
suicidal ideation (N = 1) ; ** headache (N = 1), pruritus (N = 1)

Grade 3 or 4 laboratory abnormalities, N (%)


* All elevations transient and not associated with pancreatitis : lipase normal in 4/7
** Acute HCV infection (N = 3), acute HAV infection (N = 1), alcohol (N = 1), NASH (N = 1)
*** No case of rhabdomyolysis

Median percent change in quantitative proteinuria at W48


UACR: urine albumin:creatinine ratio
RBP: retinol-binding protein
β-2- m: beta-2 microglobulin

  • Median change in eGFR CG at W48:
    - 4.3 mL/min BIC/FTC/TAF vs + 0.2 mL/min DTG/ABC/3TC (p < 0.001)

Median change in fasting lipids (mg/dL) at week 48

Mean % change in bone mineral density

 

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