SYMTUZA® Is the First STR Proven in a Phase 3 Clinical Trial of Patients Rapidly Starting on Treatment

Study Design/Efficacy

DIAMOND STUDY

Phase 3, open-label, single-arm, prospective, multicenter* study1

In this rapid-initiation trial, treatment began before resistance test results were available.1

Key endpoints1:

  • Proportion of patients with VL<50 copies/mL at 48 weeks (ITT, FDA Snapshot)
  • Proportion of patients with VL<50 copies/mL or <200 copies/mL at 48 weeks (Observed Analysis)
  • Descriptive statistics for absolute values in HIVTSQs scores were calculated for each subscale and overall at 48 weeks

 

DIAMOND was not a pivotal registrational 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. Patients not meeting pre-defined safety or resistance stopping rules continued treatment.

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 required immediate treatment or is expected to require treatment during the study with agents not compatible with SYMTUZA®. Stopping rule findings: Investigators reviewed screening/baseline laboratory findings as results became available. 5 patients met safety stopping rule criteria; all had confirmed evidence of AST or ALT elevations 2.5 times the ULN at the screening/baseline visit. 3 of these patients discontinued according to the protocol and the other 2 patients remained in the study based on clinical assessment by the investigator and agreement of the sponsor.

§ 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 M184V mutation alone.

Study Demographics1

Patient Characteristics1

Study Included

21% of patients with CD4+ cell count <200 cells/mm3

25% of patients with viral loads 100,000 copies/mL

SYMTUZA®: High Satisfaction Scores Together With Low Discontinuation Rates

In a validated questionnaire (HIVTSQs) of patients rapidly initiating SYMTUZA®, the mean satisfaction score was 58 out of 60 for overall treatment satisfaction at Week 481*

 

97% OF PATIENTS (n=96)

WERE SATISFIED WITH SYMTUZA®1*†

<1% of patients (n=109)
discontinued SYMTUZA®

due to adverse events over 48 weeks1

  • Only one patient discontinued due to adverse events
    • This patient had allergic dermatitis (Grade 3), pyrexia (Grade 2), and lip swelling (Grade 2)
    • All adverse events resolved after discontinuation of study treatment
NO

discontinuations due to Weight gain, diarrhea, CNS, BONE, or RENAL adverse events1,2

* According to patient-reported outcomes assessed via the HIVTSQs. The HIVTSQs is a validated 10-item questionnaire that measures satisfaction with medication for people infected with HIV. The questionnaire uses a 6-point ordinal scale, with 6 as high favorability and 0 as low favorability.5

When responding to the individual question: "How satisfied are you with your current treatment?”; “Satisfied”=those subjects who responded with a score of a 5 or 6. Patients who scored a 5 or 6 on other individual satisfaction items from the 10-item HIVTSQs ranged from 87.5% to 99% at Week 48.1,2

SYMTUZA®: A Tolerability Profile That Patients Need, and That You Can Rely On

At 48 weeks, the most common adverse reactions (≥2%) in patients rapidly starting SYMTUZA® (N=109) were:

ADVERSE REACTIONS (>2%) GRADE >2 ALL GRADES (1-4)
DIARRHEA (%) 2 12
NAUSEA (%) 2 12
RASH* (%)     4 5
VOMITING (%) 0 4
FATIGUE (%) 0 3

* Pooled preferred terms of dermatitis, allergic dermatitis, rash, macular rash, maculopapular rash, papular rash, and pruritic rash.

Most adverse reactions during treatment with SYMTUZA® were mild to moderate in severity (Grade 1 or Grade 2)

  • Few Grade 3 and 4 clinical laboratory abnormalities occurred in ≥2% of patients, including increases in AST (5%), ALT (3%), and bilirubin (3%)

This is not a complete list of all adverse reactions reported with the use of SYMTUZA®. See Important Safety Information section below for the most common adverse reactions in the treatment-naïve pivotal trial. Please refer to the full Prescribing Information for a complete list of adverse reactions.

SYMTUZA®: Real-World Ready From the Beginning

In a rapid-initiation trial when treatment began before resistance tests were available1

Percent of patients who achieved
undetectable (<50 copies/mL) VLs at Week 481

*Observed=patients with missing data were excluded from the analysis.1

 

No patients had PDVF, and there were no study discontinuations due to lack of efficacy1

 

DIAMOND is 1 of 2 treatment-naïve trials for SYMTUZA®.
AMBER is the registrational trial, studying treatment-naïve patients.4

ALT=alanine aminotransferase; ARV=antiretroviral; AST=aspartate aminotransferase; CD4+=cluster of differentiation; 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; PDVF=protocol-defined virologic failure; 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 in a rapid initiation model of care for HIV-1 infection: primary analysis of the DIAMOND study. Clin Infect Dis.  [published online ahead of print December 27, 2019]. doi:10.1093/cid/ciz1213. 2. Data on File 3. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed January 18, 2019. 4. Orkin C, Eron JJ, Rockstroh J, et al; AMBER Study Group. Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir/alafenamide in treatment-naïve HIV-1 patients [published online December 10, 2019]. AIDS. doi:10.1097/QAD.0000000000002463.