Long-Term Data Show Dolutegravir/Lamivudine Non-Inferiority in Efficacy Versus TAF-Based Regimens in HIV

Additionally, the ITT-E population showed both treatment arms showing a high proportion of participants with plasma HIV-1 RNA c/mL with dolutegravir/lamivudine demonstrating non-inferior virologic suppression to the TAF-based regimen.

Three-year results from the TANGO study presented at the IDWeek 2021 showed that the 2-drug regimen of dolutegravir/lamivudine (Dovato, GlaxoSmithKline) demonstrated non-inferior efficacy and a high barrier to resistance compared to continuation of tenofovir alafenamide fumarate (TAF)-based regimens of at least 3 drugs in virologically suppressed adults living with HIV-1 who had not experienced prior virologic failure, according to a press release.

“These data provide us with further long-term evidence that switching virologically suppressed people living with HIV from TAF-based 3-drug regimens to dolutegravir/lamivudine will not only maintain virologic suppression, but offers a treatment option consisting of fewer medicines,” said lead author and TANGO study investigator Olayemi Osiyemi, MD, founder, CEO and president of Triple O Medical Services and Triple O Research Institute, in a press release. “As we now consider HIV a long-term condition requiring life-long medication, these results give physicians the data they need to have more confidence in switching their virologically suppressed patients who are taking 3 or more medicines. Additionally, these data show no confirmed virologic failures, which is important over a long-term study.”

The results demonstrated the non-inferiority of dolutegravir/lamivudine compared to the continuation of TAF-based regimens in the intention to treat-exposed (ITT-E) population based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per milliliter (c/mL) at week 144. Additionally, the ITT-E population showed both treatment arms showing a high proportion of participants with plasma HIV-1 RNA c/mL with dolutegravir/lamivudine demonstrating non-inferior virologic suppression to the TAF-based regimen.

The overall adverse events were similar between study arms, with the most common being insomnia, increased weight, constipation, depression, flatulence, and nausea. Changes in fasting lipids that generally favored dolutegravir/lamivudine were seen in weeks 48 and 96, and decreases in total cholesterol, high-density lipoprotein, low-density lipoprotein, and triglycerides were observed.

“The latest results from the TANGO study further reinforce Dovato’s role in the HIV treatment landscape, allowing people living with HIV to maintain virologic suppression over the long-term with fewer medicines,” said Kimberly Smith, MD, MPH, head of Research and Development at ViiV Healthcare in a press release.

REFERENCE

ViiV Healthcare presents three-year switch data for Dovato (dolutegravir/lamivudine) confirming long-term, non-inferior efficacy with no virologic failure versus continuation of TAF-based regimens of at least three drugs. GSK. September 29, 2021. Accessed September 29, 2021. https://www.gsk.com/en-gb/media/press-releases/viiv-presents-three-year-switch-data-for-dovato-confirming-long-term-non-inferior-efficacy-with-no-virologic-failure-versus-continuation-of-taf-based-regimens-of-at-least-three-drugs/