Full Week 48 findings were presented today at the 10th International AIDS Society Conference on HIV Science (IAS 2019) in Mexico City.
Kimberly Smith, MD, Head of Global Research & Medical Strategy at ViiV Healthcare, said: “With HIV now considered a chronic condition and people living with HIV needing antiretroviral treatments for life, taking fewer medicines over a lifetime has become an important consideration for the community. The TANGO study was designed to answer the question, can a 2-drug regimen of dolutegravir/lamivudine maintain viral suppression as well as a TAF-containing regimen? We’re delighted that the Week 48 results of the study confirm that it can. These data present evidence that a dolutegravir/lamivudine 2-drug regimen is as effective as a TAF-containing, 3-drug regimen for people living with HIV.”
The TANGO study was conducted to assess whether adults living with HIV-1 who had maintained viral suppression for at least six months on a TAF-containing regimen of at least three drugs, were able to maintain similar rates of viral suppression after switching to the 2DR of dolutegravir/lamivudine in a fixed-dose combination, compared to continuing the TAF-containing regimen. The study met its primary endpoint for non-inferiority based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre (c/mL) at Week 48, based on the FDA snapshot algorithm. Results showed that switching to dolutegravir/lamivudine was non-inferior to continuing a TAF-containing regimen at Week 48 (snapshot virologic failure: <1% vs. <1%; adjusted difference: -0.3% [95% CI: -1.2, 0.7]).
The proportion of participants with plasma HIV-1 RNA <50 c/mL was high and similar in both arms and demonstrated non-inferiority (93.2% [344/369] of participants in the dolutegravir/lamivudine arm compared with 93.0% [346/372] in the TAF-containing regimen arm).
In the study, no participants on dolutegravir/lamivudine and one participant (<1%) on the TAF-containing regimen met confirmed virologic failure criteria, with no resistance mutations observed at failure. The safety results for the 2DR of dolutegravir/lamivudine were consistent with the product labelling for the medicines.
The percentage of participants who withdrew due to AEs was 4% (13/369) in the dolutegravir/lamivudine arm, versus <1% (2/371) in the TAF-containing regimen arm. The most common AEs were nasopharyngitis (12% [43] versus 11% [41] respectively), upper respiratory tract infections (8% [31] versus 9% [32] respectively), and diarrhoea (8% [30] versus 7% [26] respectively).
Source: Company Press Release