BONE AND RENAL BIOMARKERS

Change From Baseline in Bone Biomarkers vs a TDF-Containing Regimen

Bone Turnover Markers in
GEMINI 1 & 2 Pooled Analysis1,2

Adjusted mean change from baseline (µg/L) through Week 48
(prespecified secondary endpoint)*

Serum Bone-Specific

Alkaline Phosphatase

1.22

Dovato

(n=716)

vs
P<0.001

4.07

DTG + TDF/FTC

(n=717)

SERUM OSTEOCALCIN

 

0.60

Dovato

(n=716)

vs
P<0.001

6.17

DTG + TDF/FTC

(n=717)

SERUM PROCOLLAGEN 1

N-TERMINAL PROPEPTIDE

0.40

Dovato

(n=716)

vs
P<0.001

13.10

DTG + TDF/FTC

(n=717)

SERUM TYPE 1

COLLAGEN C-TELOPEPTIDE

0.14

Dovato

(n=716)

vs
P<0.001

0.33

DTG + TDF/FTC

(n=717)

*Adjusted for treatment, baseline plasma HIV-1 RNA, baseline CD4+ T-cell count, age, sex, race, BMI, smoking status, current Vitamin D use, and baseline biomarker value.

The clinical significance is unknown.

DTG=dolutegravir; FTC=emtricitabine; TDF=tenofovir disoproxil fumarate.

Change From Baseline in Renal Biomarkers vs a TDF-Containing Regimen

Renal Biomarkers in
GEMINI 1 & 2 Pooled Analysis1,2

Urine biomarkers: Ratio of Week 48 to baseline
(prespecified secondary endpoint)2*

PROTEIN/CREATININE

(g/mol)

0.87

Dovato

(n=716)

vs
P<0.001

1.03

DTG + TDF/FTC

(n=717)

RETINOL-BINDING PROTEIN/CREATININE

(µg/mmol)

0.93

Dovato

(n=716)

vs
P<0.001

1.11

DTG + TDF/FTC

(n=717)

BETA-2 MICROGLOBULIN/CREATININE

(mg/mmol)

0.92

Dovato

(n=716)

vs
P<0.001

1.31

DTG + TDF/FTC

(n=717)

Change from baseline to Week 48 in serum creatinine1*

  • The adjusted mean change in serum creatinine from baseline to Week 48 in patients randomized to DOVATO (n=716) and DTG+TDF/FTC (n=717) was 0.116 mg/dL vs 0.154 mg/dL, P<0.001.
  • Dolutegravir has been shown to increase serum creatinine due to inhibition of tubular secretion of creatinine without affecting renal glomerular function. Increases in serum creatinine occurred within the first 4 weeks of treatment in both arms and remained stable through 48 weeks.

The clinical significance is unknown.

*Adjusted for treatment, baseline plasma HIV-1 RNA, baseline CD4+ T-cell count, age, sex, race, presence of diabetes, presence of hypertension, and baseline biomarker value.

BMI=body mass index.

References:

1. Cahn P, Sierra Madero J, Arribas J, et al; and GEMINI Study Team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019;393(10167):143-155.

2.  Data on file. ViiV Healthcare group of companies. Research Triangle Park, NC.

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