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)*
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)*
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:
- 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.
- Data on file. ViiV Healthcare group of companies. Research Triangle Park, NC.
- 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.