One more single tablet treatment option

2017-12-13

In the Emerald study 1141 patients on antiretroviral therapy who were virologically suppressed (<50 copies/ml) for at least two months were included in a 2:1 randomized study to receive a single tablet regimen or continue the ongoing treatment. The single tablet was a combination of darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide (TAF) 10 mg taken once daily. Patients with previous non-darunavir virological failure were eligible for the study. After 48 weeks 94.9 % in the study group and 93.7 % in the control group had viral load < 50 copies/ml which means that non-inferiority was achieved. Patients switching to the study regimen had significant improvements of all quantitative measurements of proteinuria compared to the control group. In a substudy of 317 patients, bone density increased at the hip, lumbar spine and femoral neck with the study regimen. Fasting total cholesterol, LDL –cholesterol and total cholesterol/HDL ratio increased statistically significantly in the study group compared to the control group.

Dutertre et al. JAcquir Immune Syndr 2017;76:e23-e26

Comment: This is the first available protease inhibitor-based single tablet regimen. Several studies show that single tablet regimens are preferred by patients and may contribute to improved quality of life compared to multiple tablets regimens although it has not been proven that treatment outcomes differ. It is of course good news that we now have an additional single tablet option that has been shown to be effective and well tolerated in a large phase 3 study. The singe tablet has also been tested in a phase three study in naïve patients.