TOPLINE:
In routine care clinics across the US, the fixed-dose, three-drug combination regimen bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) and the two-drug regimen dolutegravir/lamivudine (DTG/3TC) effectively maintained virologic suppression in people with HIV infection, although discontinuations were more common with the DTG/3TC regimen.
METHODOLOGY:
- Researchers conducted an observational study in the US comparing the virologic efficacy and discontinuation rates of the three-drug B/F/TAF regimen and the two-drug DTG/3TC regimen in people with HIV infection who were virologically suppressed (viral load < 200 copies per mL).
- The study included 3713 people who switched to B/F/TAF (median follow-up duration, 16 months) and 2327 who switched to DTG/3TC (median follow-up duration, 15 months) between August 2020 and June 2022.
- Participants were followed up until regimen discontinuation, defined as any modification in the regimen components or an antiretroviral therapy gap of over 45 days, loss to follow-up (12 months after last contact), death, or study end.
- Confirmed virologic failure was defined as two consecutive viral loads of ≥ 200 copies per mL or discontinuation after a viral load of ≥ 200 copies per mL.
TAKEAWAY:
- Incidence rates of virologic failure were 1.7 and 2.1 per 100 person-years among participants who received B/F/TAF and DTG/3TC, respectively. Participants on B/F/TAF were 16% less likely to experience virologic failure compared with those on DTG/3TC (adjusted hazard ratio [aHR], 0.84; 95% CI, 0.59-1.18).
- Incidence rates of discontinuation were 12.4 and 14.8 per 100 person-years for participants treated with B/F/TAF and DTG/3TC, respectively. Treatment with B/F/TAF was associated with a 17% lower likelihood of discontinuation than treatment with DTG/3TC (aHR, 0.83; 95% CI, 0.73-0.94).
- Treatment-related discontinuations accounted for 6% vs 9% of B/F/TAF vs DTG/3TC discontinuations, with the higher proportion of virologic non-suppression largely attributable to the DTG/3TC group.
IN PRACTICE:
“In conclusion, this large study of real-world data in the US confirms that while the likelihood of discontinuation was statistically higher with DTG/3TC than B/F/TAF, both regimens are well tolerated and effective treatment options for virologically suppressed individuals in routine clinical care,” the authors of the study wrote.
SOURCE:
The study was led by Gerald Pierone, Jr, Whole Family Health Center in Vero Beach, Florida. It was published online on August 30, 2025, in HIV Medicine.
LIMITATIONS:
The researchers were unable to evaluate resistance profiles of the participants after virologic failure because resistance data were not available in the electronic health records (EHRs). Reasons for discontinuation were often not documented in the EHRs. Excluding people without any information on follow-up viral loads may have introduced selection bias by removing people who experienced early discontinuation.
DISCLOSURES:
This study was supported by Gilead Sciences. Two authors reported being employees of and holding stocks in Gilead Sciences. Some authors reported receiving financial support in the form of research funding, personal fees, and/or consulting fees from and/or holding positions on the advisory boards of various companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
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