of patients were satisfied with SYMTUZA®1§¶
DIAMOND: Phase 3, open-label, single-arm, multicenter, prospective study of treatment-naïve adults (N=109) who rapidly started on SYMTUZA® before laboratory and resistance tests were available. Patients were newly diagnosed within 14 days of beginning treatment and were ARV-naïve, except for potential prior use of FTC/TDF for PrEP. Screening/baseline safety laboratory findings were evaluated on Day 3 (+1 week),*† and resistance was evaluated at Week 4 (±7 days)‡ based on predicted genotypic sensitivity.
Key endpoints were: 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 question, for each subscale, and at weeks 4, 24, and 48.1,2
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§
of patients were satisfied with how SYMTUZA® fit into their lifestyle2#
The questions in the HIVTSQs, which address issues of general satisfaction (clinical subscale) as well as lifestyle (ease subscale), are3:
General Satisfaction (Clinical Subscale) Questions
- How satisfied are you with your current treatment?
- How well controlled do you feel your HIV has been recently?
- How satisfied are you with any side effects of your present treatment?
- Would you recommend your present treatment to someone else with HIV?
- How satisfied would you be to continue with your present form of treatment?
Lifestyle (Ease Subscale) Questions
- How satisfied are you with the demands made by your current treatment?
- How convenient have you been finding your treatment to be recently?
- How satisfied are you with the extent to which the treatment fits in with your lifestyle?
- How flexible have you been finding your treatment to be recently?
- How satisfied are you with your understanding of your HIV?
*Evaluations could be done sooner based on availability of results.2
†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, required immediate treatment or was expected to require treatment during the study with agents not compatible with the components of SYMTUZA®.2
‡Resistance was evaluated 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/V mutation alone.1
§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.1 Patients taking SYMTUZA® who scored a 5 or 6 on individual satisfaction items from the 10-item HIVTSQs ranged from 87.5% to 99% at Week 48.1,2
¶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 6.2
#When responding to the individual question: “How satisfied are you with the extent to which the treatment fits in with your lifestyle?”; “Satisfied”=those subjects who responded with a score of 5 or 6.2
ALT=alanine aminotransferase; ARV=antiretroviral; AST=aspartate aminotransferase; eGFR=estimated glomerular filtration rate; FTC=emtricitabine; HIVTSQs=HIV Treatment Satisfaction Questionnaire status version; ITT=intent-to-treat; MDRD=Modification of Diet in Renal Disease; PrEP=pre-exposure prophylaxis; RAM=resistance-associated mutation; TDF=tenofovir disoproxil fumarate; ULN=upper limit of normal.
References: 1. Huhn GD, Crofoot G, Ramgopal M, et al. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in a rapid-initiation model of care for human immunodeficiency virus type 1 infection: primary analysis of the DIAMOND study. Clin Infect Dis. 2020;71(12):3110-3117. 2. Supplementary to: Huhn GD, Crofoot G, Ramgopal M, et al. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in a rapid-initiation model of care for human immunodeficiency virus type 1 infection: primary analysis of the DIAMOND study. Clin Infect Dis. 2020;71(12):3110-3117. 3. Woodcock A, Bradley C. Validation of the revised 10-item HIV Treatment Satisfaction Questionnaire status version and new change version. Value Health. 2006;9(5):320-333.