Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced that data from the phase III TANGO study showed that the 2-drug regimen (2DR) of Dovato (dolutegravir/lamivudine) has similar efficacy to a tenofovir alafenamide fumarate (TAF)-containing regimen of at least three drugs in virally supressed and stable adults with HIV-1.
Image: ViiV Healthcare announces positive week 48 results from TANGO study of dolutegravir/lamivudine. Photo: courtesy of PublicDomainPictures from Pixabay.
Subscribe to our email newsletter
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
