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Efficacy | SYMTUZA® (darunavir/cobicistat/emtricitabine/tenofovir alafenamide)

The AMBER Study

This study looked at 725 patients who were starting HIV treatment for the first time to see if they could reach undetectable (<50 copies/mL) after 48 weeks. Of these, 362 patients started SYMTUZA® at the beginning of the study, while the remaining 363 started on PREZCOBIX® (darunavir/cobicistat) plus Truvada® (emtricitabine/tenofovir disoproxil fumarate). The final measure of the study was to see the number of patients who achieved an undetectable viral load (<50 copies/mL) after 48 weeks.

Please read full Prescribing Information for PREZCOBIX®

Effectiveness

91% of patients who were treated with SYMTUZA® reached undetectable (viral load <50 copies/mL) after 48 weeks. *

* There were patients who stopped the study for other reasons. 4% of patients did not reach undetectable. Out of the patients in the study who were in the control group, 88% reached undetectable versus 3% who didn’t.

Tolerability

After 48 weeks, 2% of patients stopped taking SYMTUZA® due to side effects compared to 4% of patients who were in the control group.

The most common side effects occurring in at least 2% of patients taking SYMTUZA® were diarrhea, nausea, rash, vomiting and fatigue. These are not the only side effects of SYMTUZA®.

The DIAMOND Study

SYMTUZA® was studied in 109 newly diagnosed patients who started treatment within 14 days prior to the availability of lab results. The study measured the number of patients who were undetectable* after 48 weeks of treatment on SYMTUZA®.

The DIAMOND study was completed after FDA approval of SYMTUZA®. The safety and effectiveness of SYMTUZA® in patients who had never been treated for HIV was determined in the AMBER study.

*Undetectable is defined as <50 copies/mL.

Effectiveness

In the DIAMOND Study, 84% of patients (92 out of 109) reached undetectable at 48 weeks after rapidly starting treatment with SYMTUZA®.*

It also showed that 100% of patients on SYMTUZA® were able to decrease their viral load to a low level (<200 copies/mL) after 48 weeks.

effectiveness

100%

(96/96)

at Week 48

98%

(94/98)

at Week 24

83%

(85/102)

at Week 12

*Undetectable is defined as <50 copies/mL.

Indicates observed analysis (this excludes patients who may have discontinued early or had missing data.)

Tolerability

Fewer than 1% stopped taking SYMTUZA® due to side effects, and no patients stopped due to side effects involving weight gain, diarrhea, or nerve, bone and kidney function.

The most common side effects occurring in at least 2% of patients taking SYMTUZA® were diarrhea, nausea, rash, vomiting and fatigue. These are not the only side effects of SYMTUZA®.

Before starting SYMTUZA®, you should get tested for hepatitis B virus and kidney function.

Satisfaction

97% of people in a clinical trial were satisfied when rapidly starting treatment with SYMTUZA®.

When asked “How satisfied are you with your present treatment?” in a standardized questionnaire, 97% (93 out of 96) reported that they were satisfied. Out of 109 patients, 96 of them completed a 10-question standardized questionnaire (HIVTSQs) based on a scale of 0-6 (0 = low favorability and 6 = high favorability). Satisfied was defined as reporting a score of 5 or 6. Between 87.8% and 99% of patients responded to individual questions with a score of 5 of 6. Mean total score for the questionnaire was 58 out of 60 at 48 weeks.

The EMERALD Study

The EMERALD study looked at 1,141 patients already being treated for HIV and who were undetectable (<50 copies/mL) for at least 6 months.

At the start of the trial, 763 patients switched to SYMTUZA® while the remaining 378 continued their previously prescribed treatment. The final measure of the study was to see the number of patients who remained undetectable (viral load <50 copies/mL after 48 weeks after switching to SYMTUZA®.

Effectiveness

95% of patients who were treated with SYMTUZA® reached undetectable (viral load <50 copies/mL) after 48 weeks.*

*There were patients who stopped the study for other reasons. 1% of patients didn’t stay undetectable (viral load ≥50 copies/mL), and among patients in the study who didn’t switch to SYMTUZA®, 94% stayed undetectable versus 1% who did not.

Tolerability

1% of patients stopped taking SYMTUZA® due to side effects compared to 1% of patients who stopped due to side effects while on their current treatment.

The most common drug-related side effects occuring in at least 2% of patients on SYMTUZA® were diarrhea and bone weakness. These are not the only side effects of SYMTUZA®.

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Is SYMTUZA® right for you?

Not only is SYMTUZA® one pill that is taken once daily, but it has a high resistance barrier.

Learn more