ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced 96-week data from the TANGO study at the HIV Glasgow 2020 congress showing that the 2-drug regimen (2DR) Dovato (dolutegravir/lamivudine) continued to demonstrate non-inferior efficacy compared to continuation of a tenofovir alafenamide fumarate (TAF)-based regimen of at least three drugs in virologically suppressed adults with HIV-1 who have not previously experienced virologic failure.1 Data from the study revealed that no participants on Dovato (0/369, 0%) and three participants (3/372, <1%) on the TAF-based regimen met protocol-defined virologic failure, and no participants developed resistance mutations upon failure.1
Professor Stéphane De Wit, M.D., Head, Infectious Diseases, Saint Pierre University Hospital, Brussels, and investigator for the TANGO study, said: “For physicians who have been waiting for long-term data on dolutegravir/lamivudine in virologically suppressed adults with HIV, the TANGO 96-week results show that it maintains the efficacy and resistance profile seen in earlier presentations of the study findings. It is also significant to see that in such a large pivotal study, no one experienced virologic failure in the two years that it has been running. These data help to build our understanding of dolutegravir/lamivudine as a complete regimen and expand its strong evidence base, providing clinicians with more confidence to switch from TAF-based 3-drug regimens to dolutegravir/lamivudine.”
Week 96 findings from the TANGO study showed that switching to Dovato was non-inferior to continuing a TAF-based regimen in the Intention to Treat-Exposed (ITT-E) analysis (defined as all participants randomised to the study), based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre (c/mL) at Week 96 (Snapshot virologic failure: <1% vs 1%; adjusted difference: -0.8% [95% CI: -2.0%, 0.4%]).1 In the Per-Protocol analysis (defined as participants who completed the study to 96 weeks), Dovato was shown to be superior to the TAF-based regimen arm (0% vs 1%; adjusted difference: -1.1% [95% CI: -2.3%, -0.0%]).1
The proportion of participants with plasma HIV-1 RNA <50 c/mL was high in both arms and demonstrated non-inferiority in 86% ([317/369] of participants in the Dovato arm vs 79% [294/372] in the TAF-based regimen arm; adjusted difference: 6.8% [95% CI: 1.4%, 12.3%]).1
Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: “Today’s findings from the TANGO study provide more evidence that people living with HIV can keep their virus under control with a dolutegravir-based 2-drug regimen, reflecting the consistent results that we’re seeing in real-world cohorts. Following on from the GEMINI 1 & 2 results presented earlier this week for treatment-naïve adults, these results continue to support the inclusion of Dovato as a recommended therapy in international HIV treatment guidelines.”
Overall adverse event (AE) rates were similar between the two study arms, with more drug-related grade 2-5 AEs in the Dovato arm (6% [21/369]) vs the TAF-based regimen arm (2% [7/371]). Rates of adverse events were similar between treatment arms at both Week 48 and Week 96.1 Fasting lipids were similar to findings seen at Week 48 and generally in favour of Dovato: total cholesterol (TC), low-density lipoprotein (LDL) and triglycerides showed significant differences favouring the Dovato arm, while high-density lipoprotein (HDL) cholesterol changes significantly favoured TAF-based regimens, with no difference in TC/HDL ratios between arms.1 The Week 96 findings also showed indications of better renal function outcomes in the Dovato arm; decreases in glomerular filtration rate (GFR) by cystatin-C* were observed in both arms, with a significantly smaller decrease in the Dovato arm.1 The clinical significance of these changes in biomarkers is unknown.