Ongoing Phase 3, single-arm, open-label, prospective, multicenter study*
- Primary endpoint: Proportion of patients with VL <50 copies/mL at 48 weeks (FDA Snapshot)
- Secondary endpoint: Proportion of patients with VL <50 copies/mL (FDA Snapshot) using an observed algorithm at Week 24
DIAMOND was not a pivotal registration trial.
Prior to or when initiating SYMTUZA®, patients should undergo testing for HBV and renal function. Appropriate labs, including liver testing, hepatitis serology, and HIV genotypic resistance testing should be conducted and patients monitored during treatment as clinically appropriate.1
*Study was conducted at 16 sites located in Arizona, California, District of Columbia, Florida, Georgia, Illinois, New Jersey, New Mexico, and Texas.2
†Evaluations could be done sooner based on the availability of results.
‡Screening/baseline safety laboratory findings were evaluated with the following stopping criteria (retesting of abnormal screening/baseline safety laboratory values was allowed once): eGFR (MDRD formula) <50 mL/min, AST or ALT ≥2.5 times the ULN, serum lipase ≥1.5 times the ULN, positive pregnancy test for women of childbearing potential, laboratory results that the investigator believes should result in discontinuation of study medication, or active hepatitis C infection that, in the opinion of the investigator, requires immediate treatment or is expected to require treatment during the study with agents not compatible with the components of SYMTUZA®.
§Resistance was evaluated based on predicted genotypic sensitivity (there was no exclusion based on the presence of specific RAMs). Patients who did not show full genotypic sensitivity to the components of SYMTUZA® (assessed using GenoSure Prime®) were stopped; an exception was resistance to lamivudine/emtricitabine associated with the M184I or V mutation alone.
DHHS guidelines recommend a darunavir-based regimen in RAPID INITIATION3
- The primary endpoint will be reported when all patients have reached Week 48
No patients discontinued due to lack of efficacy or protocol-defined virologic failure
- 13% of patients had ≥50 copies/mL and 6% had no VL data (ITT, FDA snapshot)
¶Observed=patients with missing data were excluded from the analysis.
ALT=alanine aminotransferase; ARV=antiretroviral; AST=aspartate aminotransferase; DHHS=Department of Health and Human Services; eGFR=estimated glomerular filtration rate; FTC/TDF=emtricitabine/tenofovir disoproxil fumarate; HBV=hepatitis B virus; ITT=intent-to-treat; MDRD=Modification of Diet in Renal Disease; PrEP=pre-exposure prophylaxis; RAMs=resistance-associated mutations; ULN=upper limit of normal; VL=viral load.
References: 1. Huhn GD, Crofoot G, Ramgopal M, et al. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in a test-and-treat model of care for HIV-1 infection: interim analysis of the DIAMOND study. Poster presented at: the 22nd International AIDS Conference; July 23-27, 2018; Amsterdam, The Netherlands. 2. NIH U.S. National Library of Medicine. A study to evaluate the efficacy and safety of D/C/F/TAF once daily fixed dose combination (FDC) regimen in newly diagnosed, antiretroviral treatment-naïve human immunodeficiency virus type 1 (HIV-1) infected participants receiving care in a test and treat model of care. https://clinicaltrials.gov/ct2/show/NCT03227861. Updated May 30, 2018. Accessed July 18, 2018. 3. Department of Health and Human Services. Guidelines for the use of antiretroviral agents in HIV-1 infected adults and adolescents living with HIV. https://aidsinfo.nih.gov/guidelines/html/l/adult-andadolescent-arv/0. Published May 30, 2018. Accessed May 30, 2018.