For treatment-naïve adults with HIV-1. See Full Indication.

BONE AND RENAL BIOMARKERS THROUGH 96 WEEKS FOR DOVATO

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


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

Adjusted mean change from baseline (µg/L) through Week 96
(prespecified secondary endpoint)*

Serum Bone-Specific

Alkaline Phosphatase

0.29

Dovato

(n=716)

vs
P<0.001

2.36

DTG + TDF/FTC

(n=717)

SERUM OSTEOCALCIN

 

0.27

Dovato

(n=716)

vs
P<0.001

4.21

DTG + TDF/FTC

(n=717)

SERUM PROCOLLAGEN 1

N-TERMINAL PROPEPTIDE

11.0

Dovato

(n=716)

vs
P<0.001

23.7

DTG + TDF/FTC

(n=717)

SERUM TYPE 1

COLLAGEN C-TELOPEPTIDE

0.10

Dovato

(n=716)

vs
P<0.001

0.24

DTG + TDF/FTC

(n=717)

The clinical significance is unknown.

*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.3

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

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

Renal Biomarkers in
GEMINI 1 & 2 Pooled Analysis1,2

Urine biomarkers: Change from baseline through Week 96, %
(prespecified secondary endpoint)*

PROTEIN/CREATININE

(g/mol)

-12.2

Dovato

(n=716)

vs
P<0.001

3.2

DTG + TDF/FTC

(n=717)

RETINOL-BINDING PROTEIN/CREATININE

(µg/mmol)

16.2

Dovato

(n=716)

vs
P<0.001

50.8

DTG + TDF/FTC

(n=717)

BETA-2 MICROGLOBULIN/CREATININE

(mg/mmol)

-18.7

Dovato

(n=716)

vs
P<0.001

35.0

DTG + TDF/FTC

(n=717)

Change from baseline to Week 96 in serum creatinine1,2*

  • The adjusted mean change in serum creatinine from baseline to Week 96 in patients randomized to DOVATO (n=716) and DTG+TDF/FTC (n=717) was 0.138 mg/dL vs 0.176 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.3

BMI=body mass index.

References:

  1. Cahn P, Madero JS, Arribas JR, et al. Durable Efficacy of Dolutegravir (DTG) Plus Lamivudine (3TC) in Antiretroviral Treatment–Naive Adults With HIV-1 Infection: 96-Week Results From the GEMINI Studies. Presented at the 10th International AIDS Society (IAS) Conference on HIV Science; July 21-24, 2019; Mexico City, Mexico. Slides WEAB0404LB.
  2. Data on file. ViiV Healthcare group of companies. Research Triangle Park, NC.
  3. Cahn P, Madero JS, 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.

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