DTG/3TC Equally Effective as BIC/FTC/TAF in Virally Suppressed Adults

The 2-drug regimen of dolutegravir/lamivudine (DTG/3TC) was compared head-to-head against the 3-drug regimen of bictegravir/emtricitabine/tenofovir (BIC/FTC/TAF) in a randomized clinical trial, whose results were presented in a late-breaking abstract at the 25th International AIDS Conference in Munich, Germany.¹

DTG/3TC, also known as Dovato, and BIC/FTC/TAF, also known as Biktarvy, are both treatments used for patients with HIV. The efficacy of each of these treatments was tested against each other in the PASO-DOBLE randomized clinical trial. The clinical trial aimed to assess adults who were virally suppressed on established treatment regimens and would benefit from treatment optimizations. These patients were randomly assigned to either DTG/3TC or BIC/FTC/TAF to test their efficacy in this population.

DTG/3TC was equally effective in maintaining viral suppression as BIC/FTC/TAF | Image credit: RAJCREATIONZS - stock.adobe.com

The findings after 48 weeks were presented at the annual meeting, with treatment efficacy and safety the primary objectives highlighted as well as weight gain in the patients who received the treatment. The study found that adult patients who were virally suppressed switching to DTG/3TC had non-inferior efficacy in maintaining that viral suppression.²

There were 553 people who participated in this study, of which 277 used DTG/3TC and 276 used BIC/FTC/TAF. All participants were those whose treatment could be optimized. DTG/3TC had non-inferior efficacy when compared with BIC/FTC/TAF after 48 weeks in participants (risk difference, 1.4%; 95% CI, –0.5 to 3.4) who had viral RNA of 50 or less copies/mL.

Participants who switched to BIC/FTC/TAF had a significantly higher rate of weight gain, with an adjusted mean change of 1.81 kg (95% CI, 1.28-2.34) compared with participants on DTG/3TC who had an adjusted mean change of 0.89 kg (95% CI, 0.37-1.41). The proportion of participants who had a weight gain of greater than 5% after 48 weeks was 29.9% in participants on BIC/FTC/TAF compared with 20% in patients on DTG/3TC (adjusted OR, 1.81; 95% CI, 1.19-2.76)

"The exciting findings we’ll be presenting at AIDS 2024 continue to underscore our position as industry leaders in the development of long-acting and 2-drug regimens and our pioneering approaches to both HIV treatment and prevention,” Harmony P. Garges, MD, chief medical officer at ViiV Healthcare, said in a press release.¹ “People living with HIV continue to tell us they want more treatment options to allow for more personal choice to address needs beyond viral suppression. The breadth of the data we’re announcing, including the head-to-head study between [DTG/3TC] and [BIC/FTC/TAF], helps individuals better understand those options.”

ViiV Healthcare, a global specialist HIV company that is majority owned by GSK with Pfizer and Shionogi as shareholders, will also be presenting other notable abstracts at the annual meeting.

“The HIV treatment regimens that are commonly prescribed today are all highly effective, which makes it critical that we study the impact of these therapies beyond just viral suppression,” Esteban Martinez, MD, PhD, chief executive investigator of the PASO DOBLE study, said in a press release.²

References

1. ViiV Healthcare to announce data from largest head-to-head randomised clinical trial for 2-drug regimen Dovato against 3-drug regimen Biktarvy at AIDS 2024. News release. ViiV Healthcare. July 15, 2024. Accessed July 24, 2024. https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/july/viiv-healthcare-to-announce-data-from-largest-head-to-head-randomised/
2. ViiV Healthcare announces positive data demonstrating 2-drug regimen Dovato is as effective as 3-drug regimen Biktarvy for maintenance therapy of HIV-1. News release. Viiv Healthcare. July 23, 2024. Accessed July 24, 2024. https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/july/viiv-healthcare-announces-positive-data-demonstrating/