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)*
*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*
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
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